chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Rash, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N019983, expiry date: 03-MAR-2019, intramuscularly for pneumonia prevention. On the same day, at unspecified time after vaccination, the patient experienced swelling all around right arm. The patient treated the area with hot and cold packs to attempt to reduce swelling. The patient saw an unspecified physician on 09-NOV-2017, but it was uncertain if he received any treatment from him. Lab diagnostics were not performed. Pharmacist request urgent lot check. The outcome of arm swelling was unknown. The causality assessment was not reported.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. No information on the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N019983, expiry date: 03-MAR-2019, intramuscularly for pneumonia prevention. On the same day, at unspecified time after vaccination, the patient experienced swelling all around right arm. The patient treated the area with hot and cold packs to attempt to reduce swelling. The patient saw an unspecified physician on 09-NOV-2017, but it was uncertain if he received any treatment from him. Lab diagnostics were not performed. Pharmacist request urgent lot check. The outcome of arm swelling was unknown. The causality assessment was not reported.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: Swelling, erythema, difficulty moving arm.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Vision blurred
Clinical narrative: This spontaneous report was received from a pharmacist concerning an 83 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 16-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M041394  with expiration date of 23-MAY-2018, for prophylaxis (dose and route of administration were not reported). On 16-OCT-2017, at unspecified time after receiving PNEUMOVAX 23, the patient experienced severe dizziness and blurred vision. The patient did not receive any treatment and had no laboratory diagnostics or studies performed. At the time of reporting the patient did not recovered from blurred vision and severe dizziness. The patient did not receive any treatment. The causal relationship between severe dizziness and blurred vision with therapy with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose and route of administration were not reported; lot number N014946, expiration date 01-FEB-2019). On the same date, the patient received a second dose of the vaccine (dose and route of administration were not reported; lot number N014946, expiration date 01-FEB-2019). No adverse effects were reported. No product quality complaint was filed.
Age: 0.0
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant reporting on a 5 day old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 11-OCT-2017, the patient received an unspecified dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) for prophylaxis (anatomical location, route of administration, lot number and expiration date were not reported) and on 16-OCT-2017, the patient received an unspecified dose of RECOMBIVAX HB) lot # N002920, expiration date 30-SEP-2018 for prophylaxis (anatomical location and route of administration were not reported). The dose administered on 16-OCT-2017, was given as the family was sure that the newborn did not previously receive a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient on approximately in her 60's. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. It was reported that, on an unknown date about 10 years later, the patient experienced a case of shingles (herpes zoster). It was unknown if a treatment was given for the event as well as if laboratory diagnostics/studies were performed. The outcome of herpes zoster was unknown. The causality between ZOSTAVAX and the event was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 23-OCT-2017, the patient was vaccinated inadvertently with an expired dose of PROQUAD lot # M019232 and expiration date 17-OCT-2017 (dose, frequency and route of administration) for prophylaxis, which was reconstituted with a properly stored dose of sterile diluent(manufacturer unknown). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: Information has been received from a non-pregnant 71 year old female nurse that was also the patient, concerning on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-NOV-2017, a prepared dose of M-M-R II lot # M044350 (expiration date were not reported) and sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) splashed onto her face and eye while she was drawing it up. The reporting patient stated that she "flushed her eye with water and irrigated eye with ophthalmic solution for the eye wash". The patient reported that no vaccine splashed onto the unspecified patient scheduled to receive the vaccine. No adverse effect were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient did not have any preexisting physician-diagnosed allergies, birth defects or other medical conditions..The patient's concomitant medications included atorvastatin. The patient's pertinent medical history and drug reactions or allergies were not provided. On 15-SEP-2017, the patient was administered 1 dose of expired ZOSTAVAX, 19400 plaque-forming units (PFU) vial, lot # M042503 with expiration date on 17-AUG-2017, first dose, subcutaneously (exact dose and anatomical location were not reported). The expiration date was not checked by the pharmacist before administration of ZOSTAVAX and the expiration date in a computer was not updated (was wrong). It was reported that the medication error occurred also at the point of administration and preparation for administration. The lot number of the sterile diluent used for reconstitution was M024765 with expiration date on 20-FEB-2019. The patient was not given any other vaccines within 4 weeks prior the date of vaccination with ZOSTAVAX. No adverse effects or reactions occurred, the patient had no bad experience. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA008191:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 18 months old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA which had the lot # N005274, expiration date 03-APR-2018 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician who referred to 13 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JUN-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 06-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 06-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 27-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 14-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 30-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 12-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 49.0
Sex: M
Vaccine: FLUC4, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-NOV-2017 the patient was vaccinated with an expired dose of M-M-R II which had a lot # L041455 with expiration date on 22-OCT-2017, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent which was not expired. At the reporting time no adverse events were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004033: US-009507513-1711USA004034: US-009507513-1710USA009985.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 12 month old female patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 11-OCT-2017, the patient was vaccinated at private doctor's office/hospital with an improperly stored dose of VARIVAX dose 1, lot number M033907 and expiration date on 20-JUL-2018, administered subcutaneously in the left arm for prophylaxis, reconstituted using the sterile diluent (MERCK), which did not experience temperature excursion. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 50 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA005694: US-009507513-1710USA008673.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 12 month old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions or concomitant medications. On 11-OCT-2017, the patient was vaccinated at private doctor's office/hospital with an improperly stored dose of VARIVAX dose 1, lot number N000682 and expiration date on 06-JAN-2019, administered subcutaneously in the right arm for prophylaxis, reconstituted using the sterile diluent (MERCK), which did not experience temperature excursion. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 50 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA008673: US-009507513-1711USA005693.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Mechanical ventilation, Renal disorder, Viral infection
Clinical narrative: Initial unsolicited report received from a consumer on 01-Nov-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose and dose in series route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, after the vaccination, patient had been extremely sick and had been hospitalized (date not reported) and placed on a respiratory. It was also reported that after many doctors stated they did not know what was wrong with her a physical said she had a virus that he been embedded in a flu vaccine that attacked her kidney that caused the problems. Lab test and corrective treatment was not reported. Outcome of the events were not recovered. Documents held by sender: none. Sender's Comments: In this case the patient had been extremely sick due to flu virus which attacked her kidney and caused problems after vaccination with INFLUENZA vaccine MFR UNK). Time to onset is unknown. This is a poorly document case. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain elbow and wrist + muscle pain but not at the site of the injection.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: My baby woke up crying and she had a fever of 101.2 axillary. When I picked her up she started seizing for 20 seconds. Called Doctor answering service when event occurred and was advised by Dr. to monitor and give TYLENOL. The next day my baby was cranky and feverish. Also noted a dime size red bump on Right upper thigh where one of the vaccines was given. I am not sure if manufacturer, as I'm only going by the yellow immunization card that I was given.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Seizure
Clinical narrative: My baby woke up crying and she had a fever of 101.2 axillary. When I picked her up she started seizing for 20 seconds. Called Doctor answering service when event occurred and was advised by Dr. to monitor and give TYLENOL. The next day my baby was cranky and feverish. Also noted a dime size red bump on Right upper thigh where one of the vaccines was given. I am not sure if manufacturer, as I'm only going by the yellow immunization card that I was given.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood pressure increased, Blood test, Feeling cold
Clinical narrative: Approximately 8 hours after receiving the injection (11pm) I became chilly and unable to bet warm despite warm drinks and heating blanket. Then severe shaking chills started and would not stop. BP hit 188/111 and doctor recommended calling ambulance. Taken to ER with infusion of warm saline and blankets. Normal BP 130/75 At end of visit: Temp: 97.7 p.106 Resp: 16  Ox Sat: 95% BP 112/56 Discharged approximately 4 or 5am.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit normal, Haemoglobin normal, Neutrophil percentage increased, Platelet count normal, Red blood cell count decreased
Clinical narrative: Approximately 8 hours after receiving the injection (11pm) I became chilly and unable to bet warm despite warm drinks and heating blanket. Then severe shaking chills started and would not stop. BP hit 188/111 and doctor recommended calling ambulance. Taken to ER with infusion of warm saline and blankets. Normal BP 130/75 At end of visit: Temp: 97.7 p.106 Resp: 16  Ox Sat: 95% BP 112/56 Discharged approximately 4 or 5am.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Urine analysis normal, White blood cell count normal
Clinical narrative: Approximately 8 hours after receiving the injection (11pm) I became chilly and unable to bet warm despite warm drinks and heating blanket. Then severe shaking chills started and would not stop. BP hit 188/111 and doctor recommended calling ambulance. Taken to ER with infusion of warm saline and blankets. Normal BP 130/75 At end of visit: Temp: 97.7 p.106 Resp: 16  Ox Sat: 95% BP 112/56 Discharged approximately 4 or 5am.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Parent called for home care advice on 11/14/17. Reported that the injection site was red warm and swollen. Cool compress and ibuprofen recommended. Mom called for an appointment on 11/15/17. Child was evaluated by a NP. Left arm was warm and red. Area in question was 4cmX4.5cm. Benadryl TID was prescribed.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, induration at injection site.
Sex: U
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives started in appearing in twos just on the side of my body where the shot was given. Every day for about a week two more would pop up and itch for a couple days. Now today, two weeks after the vaccine,  they are starting on the other side of my body.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Headache, Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: I got a Tdap vaccine. I'm currently pregnant. Estimated date of delivery is January 27th, 2018. Symptoms are/were headache, tenderness of the arm and injection location, bruising of injection location, swelling, and a knot under the injection location.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Tenderness
Clinical narrative: I got a Tdap vaccine. I'm currently pregnant. Estimated date of delivery is January 27th, 2018. Symptoms are/were headache, tenderness of the arm and injection location, bruising of injection location, swelling, and a knot under the injection location.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nodule
Clinical narrative: PATIENT SATES MUSCLE ACHES AND PAIN KNOT UNDER MUSCLE FOR MORE THAN 1 MONTH, kNOT IS UNDER MUSCLE NOT NEAR INJECION SITE.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Persistent pain 4+ weeks post vaccination. No signs of infection. Only hurts when lifting arm to about shoulder height & higher. Does not bother at rest, only when raised.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with rheumatoid arthritis (it was also reported that she had no relevant medical history or relevant concomitant medications). On 15-OCT-2017, the patient was intramuscularly vaccinated with 0.5 ml dose of PNEUMOVAX 23 for prevention of pneumonia, lot # M005286, that expired on 08-OCT-2017. Concomitant therapies included methotrexate (manufacturer unknown). As of 15-OCT-2017, it was unknown if she would receive PNEUMOVAX 23 again.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Administration site swelling, Asthenia, Hypoaesthesia, Injection site erythema, Lethargy
Clinical narrative: This spontaneous report was received from a healthcare professional, via MassBiologics, who was referring to a 42 year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with M-M-R II lot # M029229, albumin status: rHA, site of administration: hip (strength, dose, frequency, expiration date and route of administration were not reported) for prophylaxis. Other suspect therapies included tuberculin purified protein derivative, poliovirus vaccine inactivated, TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. Concomitant therapies included SYNTHROID. On 06-MAY-2017, the patient experienced redness, that got increasingly bigger and swelling around the site of administration (right deltoid). It was also reported that the patient had shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness. It was also reported, the patient felt both sore and lethargic on 06-MAY-2017. On 03-JUN-2017 (reported as 1 month post-administration), the patient visited the doctor's office. No treatment was reported. On 28-AUG-2017, the outcome of the adverse events was reported as unknown. The relatedness between M-M-R II and the adverse events was not reported.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a healthcare professional, via MassBiologics, who was referring to a 42 year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with M-M-R II lot # M029229, albumin status: rHA, site of administration: hip (strength, dose, frequency, expiration date and route of administration were not reported) for prophylaxis. Other suspect therapies included tuberculin purified protein derivative, poliovirus vaccine inactivated, TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. Concomitant therapies included SYNTHROID. On 06-MAY-2017, the patient experienced redness, that got increasingly bigger and swelling around the site of administration (right deltoid). It was also reported that the patient had shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness. It was also reported, the patient felt both sore and lethargic on 06-MAY-2017. On 03-JUN-2017 (reported as 1 month post-administration), the patient visited the doctor's office. No treatment was reported. On 28-AUG-2017, the outcome of the adverse events was reported as unknown. The relatedness between M-M-R II and the adverse events was not reported.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Administration site swelling, Hypoaesthesia, Injection site erythema, Lethargy, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a healthcare professional, via MassBiologics, who was referring to a 42 year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with M-M-R II lot # M029229, albumin status: rHA, site of administration: hip (strength, dose, frequency, expiration date and route of administration were not reported) for prophylaxis. Other suspect therapies included tuberculin purified protein derivative, poliovirus vaccine inactivated, TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. Concomitant therapies included SYNTHROID. On 06-MAY-2017, the patient experienced redness, that got increasingly bigger and swelling around the site of administration (right deltoid). It was also reported that the patient had shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness. It was also reported, the patient felt both sore and lethargic on 06-MAY-2017. On 03-JUN-2017 (reported as 1 month post-administration), the patient visited the doctor's office. No treatment was reported. On 28-AUG-2017, the outcome of the adverse events was reported as unknown. The relatedness between M-M-R II and the adverse events was not reported.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a healthcare professional, via MassBiologics, who was referring to a 42 year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with M-M-R II lot # M029229, albumin status: rHA, site of administration: hip (strength, dose, frequency, expiration date and route of administration were not reported) for prophylaxis. Other suspect therapies included tuberculin purified protein derivative, poliovirus vaccine inactivated, TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. Concomitant therapies included SYNTHROID. On 06-MAY-2017, the patient experienced redness, that got increasingly bigger and swelling around the site of administration (right deltoid). It was also reported that the patient had shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness. It was also reported, the patient felt both sore and lethargic on 06-MAY-2017. On 03-JUN-2017 (reported as 1 month post-administration), the patient visited the doctor's office. No treatment was reported. On 28-AUG-2017, the outcome of the adverse events was reported as unknown. The relatedness between M-M-R II and the adverse events was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient's concurrent conditions included breast cancer, depression, blood pressure abnormal and cholesterol abnormal. Concomitant therapies included letrozole (reported also as suspect therapy), losartan potassium (+) hydrochlorothiazide (manufacturer unknown) (reported also as suspect therapy), simvastatin (manufacturer unknown) and VENLAFAXINE ER. The patient did not have any preexisting physician-diagnosed allergies, birth defects or other medical conditions. On 07-SEP-2017, the patient was administered 1 dose of expired ZOSTAVAX, 19400 plaque-forming units (PFU) vial, lot # M042503 with expiration date on 17-AUG-2017, first dose, subcutaneously (exact dose and anatomical location were not reported). The expiration date was not checked by the pharmacist before administration of ZOSTAVAX and the expiration date in a computer was not updated (was wrong). It was reported that the medication error occurred also at the point of administration and preparation for administration. The lot number of the sterile diluent (manufacturer unknown) used for reconstitution was M024765 with expiration date on 20-FEB-2019. No adverse effects occurred, the patient had no bad experience. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA002266.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-OCT-2017, the patient was vaccinated with an adult dose of VAQTA, 50 U/1 ml (route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a 1 year old female patient. The patient's medical history and concurrent condition were not provided. On an unknown date, the patient was inadvertently administered a dose of ZOSTAVAX lot # N016185 and expiration date 31-JUL-2018, subcutaneously (dose and frequency were not provided) for prophylaxis which was reconstituted with a sterile diluent (manufacturer unknown) lot number reported as N014365 and expiration date 11-OCT-2019; instead of an intended dose of VARIVAX. The reporter stated that there was no confusion between the ZOSTAVAX and VARIVAX and stated that the staff member who administered did not pay attention to which vaccine she was administering. No adverse effect reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Limb mass, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient had no pertinent medical history. The patient's concurrent conditions included allergy to Angiotensin converting enzyme inhibitors and allergy to sulfa drugs. The patient's concomitant medications included hydrochlorothiazide, metropolol, albuterol sulfate(PROAIR), canagliflozin(INVOKANA), prednisolone eye drops, bromfenac sodium(PROLENSA) eye drops, and gatifloxacin(ZYMAXID) eye drops. On 07-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N020688 with expiration date 09-MAR-2019, for prophylaxis (dose was not reported). It was stated that 4 hours later, the patient started having redness, swelling and a lump on the unspecified arm used for the administration of the vaccine. Furthermore, the patient was in a lot of pain and was unable to sleep. An unspecified treatment was given for the adverse events. At the time of reporting the outcome of erythema, peripheral swelling, limb mass, pain and insomnia was reported as not recovered. A product quality complaint was not involved. The causality assessment between erythema, peripheral swelling, limb mass, pain, and insomnia with PNEUMOVAX 23 was not provided.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Large red circular area covering most of left upper thigh, skin soft. No tenderness noted. Vaccine adverse reaction. Continue Benadryl every 6 hours as needed for itching/swelling. Observe area for tenderness or fever.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Death
Clinical narrative: Patient passed away on 4/25/2017. Did not talk to parents of child. Request for medical records came from Forensic Center on 4/25/2017 at 2:45 pm and that is when we found out the baby had died.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient's mother contacted the writer and reported that patient had nausea and vomiting that started the night after he received his flu shot.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt. woke up covered with hives the morning following administration of flu vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWOLLEN AT THE SITE OF INJECTION.
Age: 2.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Gait disturbance, Lethargy, Puncture site swelling
Clinical narrative: Child lethargic, leg swollen at puncture site, limping on right leg for 2 days.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Arm soreness at site of injection. Over a month later the arm is still sore. Can't lift objects above head or across body.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: I have gotten the flu shot for years and usually have arm pain for a day or two after and then it subsides. This time the pain started in the afternoon of the shot and got so bad I couldn't lift my arm. The pain did not go away within a few days and has proceeded to get worse 6 weeks later. My arm is weak, the pain is causing trouble sleeping for the past few weeks. I can't lift my arm without pain and activities have been limited (including getting dressed and driving). The pain is in my upper arm that I got the shot in and started the afternoon of the shot. Pain is sometimes in muscle and others closer to the shoulder. I tried Aleve, Advil, Tylenol, etc but none helped. Went to my Primary care who recommended starting with physical therapy. If it's not better I am scheduled for an MRI on 12/12. PMC said that the injection could have been too high in either the joint or bursa, but not 100%.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: I have gotten the flu shot for years and usually have arm pain for a day or two after and then it subsides. This time the pain started in the afternoon of the shot and got so bad I couldn't lift my arm. The pain did not go away within a few days and has proceeded to get worse 6 weeks later. My arm is weak, the pain is causing trouble sleeping for the past few weeks. I can't lift my arm without pain and activities have been limited (including getting dressed and driving). The pain is in my upper arm that I got the shot in and started the afternoon of the shot. Pain is sometimes in muscle and others closer to the shoulder. I tried Aleve, Advil, Tylenol, etc but none helped. Went to my Primary care who recommended starting with physical therapy. If it's not better I am scheduled for an MRI on 12/12. PMC said that the injection could have been too high in either the joint or bursa, but not 100%.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Pain, redness, swelling to injection site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Seen at Doctor's office on 10/26/17. Has had daily fevers since 10/19/17 as high as 102. Denies any other symptoms other than chills and fatigue.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Pain, Wrong technique in product usage process
Clinical narrative: The nurse had difficulty injecting the vaccine in my left arm and injected half of the vaccine. She changed needles and injected the other half of the vaccine in my right arm. Within two hours both shoulders started to hurt. The pain is mainly in the shoulder joints but can radiate down my upper arms and under both arms. The pain increases with certain shoulder movements but also occurs with no arm/shoulder movement. The pain is still present but has decreased from the first day after receiving the vaccine. I have received the flu vaccine for about 25 years without problems and received the high dose flue vaccine for the first time last year without problems.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Blood lactic acid, Chest X-ray normal, Chills, Injection site pain, Pain
Clinical narrative: Pt had been to her PCP on 11/13 for a routine visit and got PREVNAR 13 vaccine IM on her left deltoid. After a few hours she developed sudden onset fever/chills and body ache some pain at the injection site- She took TYLENOL around 4 pm but the fever would not subside so she presented to the ED. She had a temp of 103, WBC of 17 and lactate of 2.4. Had normal Chest x-ray and urinalysis. She was started on vancomycin/ZOSYN and LEVAQUIN. Infectious disease physician consulted - she thought it was a cytokine response. Antibiotics were stopped after 48 hours. Patient became afebrile, white count normalized, symptoms resolved after 48 hours.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Pt had been to her PCP on 11/13 for a routine visit and got PREVNAR 13 vaccine IM on her left deltoid. After a few hours she developed sudden onset fever/chills and body ache some pain at the injection site- She took TYLENOL around 4 pm but the fever would not subside so she presented to the ED. She had a temp of 103, WBC of 17 and lactate of 2.4. Had normal Chest x-ray and urinalysis. She was started on vancomycin/ZOSYN and LEVAQUIN. Infectious disease physician consulted - she thought it was a cytokine response. Antibiotics were stopped after 48 hours. Patient became afebrile, white count normalized, symptoms resolved after 48 hours.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 101.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Pain
Clinical narrative: Patient stated that there was pain after the injection. She states the pain did not subside and she went to a doctor. Patient states the injection caused her bursitis in the arm.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Stiff, painful neck in evenings. Very mild headache. Symptoms go away for the rest of the day then reoccur in the evening. Pain and stiffness is not unbearable. Have not visited a Doctor of taken any pain medication for symptoms.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient complained of right arm pain that was stabbing and keeping her up all night. She stated that the pain had been going on for a week. We told her to inform her doctor of the issue.
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Limb mass
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2017, the patient was vaccinated with a first dose of GARDASIL 9 (route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2017 (reported as after receiving the vaccination), the patient experienced a lump on an unspecified arm. The lump looked like "a mosquito bite" and the patient also was having "aching flu like symptoms". No treatment was given for the events and no laboratory diagnostics were performed. The patient did not seek medical attention. The outcome of the events was not recovered. The causality between the events and GARDASIL 9 was not reported.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 23-OCT-2017 the patient was vaccinated with an expired dose of M-M-R II one vial, once subcutaneously (strength was not reported), for prophylaxis (lot number: L041456, expiration date: 22-OCT-2017) reconstituted with sterile diluent (lot number: M009799 and expiration date on 11-SEP-2018). There were not prior temperature excursions for M-M-R II or sterile diluent. None any other vaccinations were administered within the previous 4 weeks. Additionally, it was also reported that the pharmacist was informed about the potency of the vaccine which was still good. There were no injury or adverse effects reported from the patient.