chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Nodule, Peripheral swelling, Rash macular
Clinical narrative: Pt came on Friday morning and presented a swollen half dollar sized nodule on the back of her arm. Beyond the nodule red blotchy patches surrounded 3/4 of the back of the arm. Pt referred to PT 1st where she received prednisone 20mg to take 3 TS QD x 7 days.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Erythema, Injection site nodule
Clinical narrative: Pt came on Friday morning and presented a swollen half dollar sized nodule on the back of her arm. Beyond the nodule red blotchy patches surrounded 3/4 of the back of the arm. Pt referred to PT 1st where she received prednisone 20mg to take 3 TS QD x 7 days.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: No adverse event, Pregnancy
Clinical narrative: This is a follow-up to a previously submitted VAERS report 694206-1. No Adverse Event -Patient inadvertently received smallpox vaccine before she knew she was pregnant. Pregnancy Outcome: on Nov 2017, patient delivered infant girl at 40 weeks gestation. APGARS: 8/9, Weight 3474 grams, SVD, At 6-day follow up, infant weight -3176 grams. Infant doing well.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This is a follow-up to a previously submitted VAERS report 694206-1. No Adverse Event -Patient inadvertently received smallpox vaccine before she knew she was pregnant. Pregnancy Outcome: on Nov 2017, patient delivered infant girl at 40 weeks gestation. APGARS: 8/9, Weight 3474 grams, SVD, At 6-day follow up, infant weight -3176 grams. Infant doing well.
Age: 33.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Drug administered at inappropriate site, Injection site joint pain, Injection site swelling, Limb injury, Pain
Clinical narrative: Patient reported pain in right shoulder 2-3 hours after vaccination, and pain affecting range of motion. Referred to physical therapy. As of 11/27/2017, patient reported pain improved and range of motion better.
Age: 33.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported pain in right shoulder 2-3 hours after vaccination, and pain affecting range of motion. Referred to physical therapy. As of 11/27/2017, patient reported pain improved and range of motion better.
Age: 50.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Tension
Clinical narrative: Major shoulder and joint pain within hours and symptoms worsen and would spread to other shoulder and arm. Weakness. Throbbing pain, extremely worse at night.
Age: 50.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Asthenia, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Major shoulder and joint pain within hours and symptoms worsen and would spread to other shoulder and arm. Weakness. Throbbing pain, extremely worse at night.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Ageusia, Arthralgia, Dyspepsia, Peripheral swelling, Pollakiuria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling of her entire arm, slight fever, pain in her arm and peeling of the skin on an unspecified date one or two days after the vaccination. Outcome of the events was unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling of her entire arm, slight fever, pain in her arm and peeling of the skin on an unspecified date one or two days after the vaccination. Outcome of the events was unknown.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling of her entire arm, slight fever, pain in her arm and peeling of the skin on an unspecified date one or two days after the vaccination. Outcome of the events was unknown.
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a male patient who received KINRIX (batch number 74G79, expiry date unknown). On 8th November 2017, the patient received KINRIX (intramuscular). On 9th November 2017, 1 days after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional information provided as follows: The age at vaccination not reported. The patient had no previous allergies, birth defects or other medical conditions. The patient previously received 3 doses (vaccine name not provided). The patient had no illness during the time of vaccination. The patient had no pre-existing diagnosed allergies, birth defects, medical conditions. This case was previously reported to manufacturer. At 11:00 hours, the patient received KINRIX. Next day at postmeridian, the patient experienced local reaction on injection site. In November 2017, the event was resolved.
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a male patient who received KINRIX (batch number 74G79, expiry date unknown). On 8th November 2017, the patient received KINRIX (intramuscular). On 9th November 2017, 1 days after receiving KINRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional information provided as follows: The age at vaccination not reported. The patient had no previous allergies, birth defects or other medical conditions. The patient previously received 3 doses (vaccine name not provided). The patient had no illness during the time of vaccination. The patient had no pre-existing diagnosed allergies, birth defects, medical conditions. This case was previously reported to manufacturer. At 11:00 hours, the patient received KINRIX. Next day at postmeridian, the patient experienced local reaction on injection site. In November 2017, the event was resolved.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 74 year-old female patient with drug hypersensitivity to amoxicillin. It was reported none concomitant medications and none medical history. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 in the right deltoid, intramuscularly (strength, dose, frequency and dose number were not reported), lot number N019983, expiration date 03-MAR-2019,  for pneumonia prevention. On 07-NOV-2017 at an unspecified time, after receiving the vaccine, the patient began experiencing pain in area of injection and shortness of breath (dyspnoea). Lab diagnostics or studies were not performed. The pharmacist requested an urgent lot check on the PNEUMOVAX23. The outcome of dyspnoea and vaccination site pain was unknown. The causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 74 year-old female patient with drug hypersensitivity to amoxicillin. It was reported none concomitant medications and none medical history. On 07-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 in the right deltoid, intramuscularly (strength, dose, frequency and dose number were not reported), lot number N019983, expiration date 03-MAR-2019,  for pneumonia prevention. On 07-NOV-2017 at an unspecified time, after receiving the vaccine, the patient began experiencing pain in area of injection and shortness of breath (dyspnoea). Lab diagnostics or studies were not performed. The pharmacist requested an urgent lot check on the PNEUMOVAX23. The outcome of dyspnoea and vaccination site pain was unknown. The causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Asthenia, Chills, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 80-year-old male patient who received BOOSTRIX (batch number 5H2H2, expiry date 14th December 2019). Concomitant products included FLUAD, COREG, CRESTO, enalapril, PLAVIX and PROTONIX. On 27th October 2017, the patient received BOOSTRIX. In October 2017, less than a week after receiving BOOSTRIX, the patient experienced fever. In November 2017, the patient experienced leg pain and weakness of limbs. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the leg pain and weakness of limbs were not recovered/not resolved. The reporter considered the fever to be related to BOOSTRIX. It was unknown if the reporter considered the leg pain and weakness of limbs to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm and FLUAD in right arm as concomitant medication. The patient's body temperature was recorded as 100 degree C. Two weeks following the vaccinations, the symptoms progressed into weakness in all limbs and pain in the legs.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 80-year-old male patient who received BOOSTRIX (batch number 5H2H2, expiry date 14th December 2019). Concomitant products included FLUAD, COREG, CRESTO, enalapril, PLAVIX and PROTONIX. On 27th October 2017, the patient received BOOSTRIX. In October 2017, less than a week after receiving BOOSTRIX, the patient experienced fever. In November 2017, the patient experienced leg pain and weakness of limbs. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the leg pain and weakness of limbs were not recovered/not resolved. The reporter considered the fever to be related to BOOSTRIX. It was unknown if the reporter considered the leg pain and weakness of limbs to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm and FLUAD in right arm as concomitant medication. The patient's body temperature was recorded as 100 degree C. Two weeks following the vaccinations, the symptoms progressed into weakness in all limbs and pain in the legs.
Age: 80.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3, TDAP
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 80-year-old male patient who received BOOSTRIX (batch number 5H2H2, expiry date 14th December 2019). Concomitant products included FLUAD, COREG, CRESTO, enalapril, PLAVIX and PROTONIX. On 27th October 2017, the patient received BOOSTRIX. In October 2017, less than a week after receiving BOOSTRIX, the patient experienced fever. In November 2017, the patient experienced leg pain and weakness of limbs. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the leg pain and weakness of limbs were not recovered/not resolved. The reporter considered the fever to be related to BOOSTRIX. It was unknown if the reporter considered the leg pain and weakness of limbs to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in left arm and FLUAD in right arm as concomitant medication. The patient's body temperature was recorded as 100 degree C. Two weeks following the vaccinations, the symptoms progressed into weakness in all limbs and pain in the legs.
Age: 19.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Patient had syncope while sitting in chair in waiting room with his parents (few mts. after). Heard Mom scream, ran to pt. and had my intern call 911. Tried to wake pt. up. He regained consciousness in a few mts. Gave some water to drink. He was sweaty in forehead. He told he did not eat anything in AM so may be that's why he got dizzy. Got him a cereal bar to eat. He drank more water but threw up. EMT arrived, checked vitals. Told him not to drink anymore water yet. He was ok after that. Pt. signed the release form to not to go to ER. EMT left. Had patient wait for another 20-25 mts. to make sure he was ok. Called after an hr. at home to check on him. Dad told he is doing fine and resting. Pt. did tell EMT, that he felt dizzy about a month ago in the gym while working out.
Age: 34.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse referring to a 34 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-SEP-2017, the patient was vaccinated with PROQUAD rHA lot number M033215 and expiration date of 09-JAN-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported), reconstituted with water sterile diluent (lot number and expiration date were not reported). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1711USA006282.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 70 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 one shot (route, dose number, anatomical location, and expiration date were unknown) with lot # N014946 and expiration date 01-FEB-2019 for prophylaxis. The nurse reported that on the same date, the patient experienced pain, swelling, and redness around injection site after administration of PNEUMOVAX 23. At the time of the report, the outcome of Injection site swelling, injection site pain and injection site erythema was unknown. The nurse did not mention the causality assessment between the events of Injection site swelling, injection site pain, injection site erythema and PNEUMOVAX 23.
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from an unknown age male physician via a company representative referring to himself. There was no pertinent medical history or concomitant therapy. The patient was allergic to penicillin and sulfa. On an unknown date in 1990, the patient was vaccinated with one dose of M-M-R II (dose, route, lot number and expiration date were not provided) for prophylaxis. Other suspect drug included sterile diluent (MERCK STERILE DILUENT) (strength, dose, route, lot number, expiration date and indication were not provided). The reason why the patient received the M-M-R II was because all of the residents were required to receive a dose of M-M-R II regardless of whether or not the residents had M-M-R II in the past. The physician was not sure but he thought he may have received one or two previous doses of M-M-R II in the past (prior to 1990) when he was a child. On an unknown date, after receiving the dose of M-M-R II in 1990, the patient began to experience arthralgia and myalgia. His symptoms lasted for 4 to 6 weeks and then he recovered (pervious reported "myalgia that lasted for 6 weeks''). No lab diagnostics studies were performed. There was no treatment given for the event and not seek medical attention. The causality between the events and M-M-R II and sterile diluent (MERCK STERILE DILUENT) was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # N025568, expiration date 08-DEC-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK) (lot# N021583, expiration date 18-NOV-2019). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (8 degrees Fahrenheit) for 30 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. Concomitant therapies included sterile diluent (manufacturer unknown). On 08-NOV-2017, the pharmacist inadvertently administered ZOSTAVAX to the patient intramuscularly rather than subcutaneously, lot # M042850, expiry date 18-JAN-2018, (dose and site administration were not reported). No adverse effects reported.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 19 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 09-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Gait disturbance, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 70 year old female patient. The patient's concurrent conditions, medical history and drug reactions / allergies were not provided. On 14-NOV-2017, by recommendation of a nurse practitioner, the patient was vaccinated with PNEUMOVAX 23, intramuscular in the right arm for prophylaxis (lot # N025384, expiry date:19-APR-2019). Concomitant therapies included aspirin (manufacturer unknown), atorvastatin, losartan potassium (manufacturer unknown), metformin, metoprolol, insulin degludec (TRESIBA) and vitamin D. On 14-NOV-2017 at night, the patient started with injection site reaction of redness and swelling from right upper arm into clavicle area (injection site swelling, injection site erythema and peripheral swelling) as reported by the Medical Assistant. On 15-NOV-2017, the patient's husband notified the physician office that besides of the right arm injection site swelling down to hand and up to shoulder, and the red site injection; the patient also had pain in the injection site (injection site pain), had numbness (hypoaesthesia) and tingling in the entire right arm (paraesthesia), difficulty at breathing (dyspnea) and at walking (gait disturbance). The patient sought medical attention by emergency room visit on 15-NOV-2017. The patient received an unspecified intravenous medication as treatment. It was unknown if laboratory diagnostics studies were performed. Finally, the medical assistant called back and reported that the patient had not experienced swelling of the fingers, shortness of breath or chest pains. The outcome of injection site swelling, peripheral swelling, injection site erythema, injection site pain, gait disturbance, dyspnoea, hypoaesthesia and paraesthesia was reported as not recovered. The causality assessment between PNEUMOVAX 23 and the aforementioned events was unknown. The reporter considered, injection site swelling, peripheral swelling, injection site erythema, injection site pain, gait disturbance, dyspnoea, hypoaesthesia and paraesthesia were medically significant events.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 70 year old female patient. The patient's concurrent conditions, medical history and drug reactions / allergies were not provided. On 14-NOV-2017, by recommendation of a nurse practitioner, the patient was vaccinated with PNEUMOVAX 23, intramuscular in the right arm for prophylaxis (lot # N025384, expiry date:19-APR-2019). Concomitant therapies included aspirin (manufacturer unknown), atorvastatin, losartan potassium (manufacturer unknown), metformin, metoprolol, insulin degludec (TRESIBA) and vitamin D. On 14-NOV-2017 at night, the patient started with injection site reaction of redness and swelling from right upper arm into clavicle area (injection site swelling, injection site erythema and peripheral swelling) as reported by the Medical Assistant. On 15-NOV-2017, the patient's husband notified the physician office that besides of the right arm injection site swelling down to hand and up to shoulder, and the red site injection; the patient also had pain in the injection site (injection site pain), had numbness (hypoaesthesia) and tingling in the entire right arm (paraesthesia), difficulty at breathing (dyspnea) and at walking (gait disturbance). The patient sought medical attention by emergency room visit on 15-NOV-2017. The patient received an unspecified intravenous medication as treatment. It was unknown if laboratory diagnostics studies were performed. Finally, the medical assistant called back and reported that the patient had not experienced swelling of the fingers, shortness of breath or chest pains. The outcome of injection site swelling, peripheral swelling, injection site erythema, injection site pain, gait disturbance, dyspnoea, hypoaesthesia and paraesthesia was reported as not recovered. The causality assessment between PNEUMOVAX 23 and the aforementioned events was unknown. The reporter considered, injection site swelling, peripheral swelling, injection site erythema, injection site pain, gait disturbance, dyspnoea, hypoaesthesia and paraesthesia were medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, intramuscularly, lot # N020945, expiry date 26-OCT-2017 (exact dose was not provided). There was no adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-valid spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 16-NOV-2017, the patient was vaccinated with expired dose of M-M-R II (albumin status of rHA) (dose, route of administration and site of administration were not provided) lot # L041455, expiration date 22-OCT-2017. No adverse effects were reported. The outcome of the event was unknown.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This non-valid spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In approximately 2017 (reported as "an unknown recent date"), the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiration date were not provided) via the patient's injection port. No adverse effects were reported. The outcome of the event was unknown.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Pain, Vaccination site cellulitis
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to a 75 year old female patient. The patient's relevant medical history and drug reactions/allergies were not reported. On 02-OCT-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 in the right arm (strength, route, dosage schedule and lot number were not reported) for prophylaxis. On the same day, the patient also received a dose of an unspecified flu vaccine at different site. On an unspecified day in October 2017, the patient experienced pain and after that, she went to the emergency room due to the inflammation of her right arm in which PNEUMOVAX 23 was administered. The patient was kept overnight for observation at the hospital and was discharged the following day. On 05-OCT-2017, the patient went back to the physician's office and was diagnosed with cellulitis at the vaccination site which was treated with a daily dose of CEFTIN. The outcome of cellulitis at the vaccination site and the relatedness between it and PNEUMOVAX 23 were not reported.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypoaesthesia, Pain, Paraesthesia, Swelling
Clinical narrative: This spontaneous report was received from registered nurse, via a company representative, referring to a 57 year old male patient with diabetes mellitus. The patient had no drug reactions/allergies or concomitant medications. On 17-AUG-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23, via intramuscular or subcutaneous, for prophylaxis (strength, dosage schedule and lot number were not reported). On 17-NOV-2017, the patient received a second dose of PNEUMOVAX 23 by mistake. On 18-NOV-2017, the patient returned to the physician's office complaining of numbness to the injection site, swelling tingling and pain. The patient was informed to use cold compresses, and TYLENOL for pain. No other treatment was given to the patient. No laboratory diagnostic studies were performed. The outcome of numbness to the injection site, swelling, tingling and pain was reported as recovering. The relatedness between PNEUMOVAX 23 and the adverse events was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 21-AUG-2017, the patient was vaccinated with the first dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported, that on 21-NOV-2017, the patient received the second dose of VAQTA, earlier than recommended. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. From 25-OCT-2017 through 07-NOV-2017,  the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The temperature involved was 35 degrees Fahrenheit for 16 hours. There was no previous temperature reported, and a data logger was not involved.; Sender's Comments: US-009507513-1711USA010360: Original Case : 1711USA003934 US-009507513-1711USA003934: Original Case: 1711USA003934.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Extreme pain in arm that had shot and can't use that arm without pain. Have had pain now for six weeks and it is not getting better. Unable to use arm, limited mobility. Pain now moving up and into my back.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient came to the pharmacy on 10/28/2017 with complaints of shoulder pain from the injection. He states the pain has been getting progressively worse since the shot. He contacted his PCP and was prescribed oral steroids and NSAIDS.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Normal arm soreness abated after a few days. Replaced by extreme tenderness within arm muscle. Tenderness slightly better as of 11/27/2017.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore left arm, it is painful to lift my arm over my head.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: I did not eat anything prior to or following vaccination and I experienced urticarial following administration of vaccination.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: 4 HRS AFTER VACCINE ON 11/25/17 WAS NAUSEOUS AND VOMITING. 11/27/17 HAS NOT BEEN ABLE TO HOLD ANY FOODS DOWN ONLY WATER. NO FEVER.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: Patient started with a severe headache in the evening. By the next morning he had a fever of 102 degrees that lasted for 36 hours. His headache was very bad, his joints and muscles were very painful. He started vomiting in the morning and had no appetite and continued to vomit for 24 hours. Ibuprofen helped a little but did not fully relieve symptoms.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient started with a severe headache in the evening. By the next morning he had a fever of 102 degrees that lasted for 36 hours. His headache was very bad, his joints and muscles were very painful. He started vomiting in the morning and had no appetite and continued to vomit for 24 hours. Ibuprofen helped a little but did not fully relieve symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Thrombosis
Clinical narrative: This spontaneous report was received from a consumer referring to her 15 year old female daughter. The patient's concomitant medications and medical history were not reported. In January 2017, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dosage, schedule and route were not reported) for prophylaxis. The patient had not yet received a 2nd dose in the GARDASIL 9 vaccination series. On 2017 the patient was diagnosed with a blood clot (thrombosis). The reporter said that her daughter was under the care of a physician. The outcome of thrombosis was unknown. The causal relationship between GARDASIL 9 and thrombosis was not provided. Upon internal review thrombosis was determined to be a medically significant event.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Herpes zoster
Clinical narrative: Episode of herpes zoster with an Indeterminate causal relationship (per WHO causality tool) following the anthrax immunization.
Age: 40.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Abortion spontaneous, Allodynia, Arthralgia, Back pain, Exposure during pregnancy
Clinical narrative: 8 month history of fever; vertigo; frequent falls without injury; miscarriage; allopdynia; right side paresthesias, right neck pain; migratory joint pain; fatigue; back pain that cannot be related to the immunizations she received on 30 Mar 2017.
Age: 40.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Fall, Fatigue, Laboratory test, Neck pain, Paraesthesia
Clinical narrative: 8 month history of fever; vertigo; frequent falls without injury; miscarriage; allopdynia; right side paresthesias, right neck pain; migratory joint pain; fatigue; back pain that cannot be related to the immunizations she received on 30 Mar 2017.
Age: 40.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Pyrexia, Vertigo
Clinical narrative: 8 month history of fever; vertigo; frequent falls without injury; miscarriage; allopdynia; right side paresthesias, right neck pain; migratory joint pain; fatigue; back pain that cannot be related to the immunizations she received on 30 Mar 2017.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Muscle spasms, Nerve conduction studies normal, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Immediately knew something was wrong - ignore it. Within a week - extreme pain and spasms. Could not lift a coffee mug, pull sheet over me, or dress without pain. CELEBREX - did nothing. Nerve condition test - OK. MRI - Bursa sac. 2 cortisone shots. 2 therapies.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Immediately knew something was wrong - ignore it. Within a week - extreme pain and spasms. Could not lift a coffee mug, pull sheet over me, or dress without pain. CELEBREX - did nothing. Nerve condition test - OK. MRI - Bursa sac. 2 cortisone shots. 2 therapies.
Age: 31.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Fear of injection, Syncope
Clinical narrative: Pt requested to get Hep B and Flu vaccine at same visit. After vaccines were administered within few minutes, she fainted. Pt was helped by RPH, store manager. Her blood pressure was checked, also heart rate, pt refused to go to ER. Pt was contacted afterwards. She said she is fine but she was scared from the needle. Pt denied any allergy or allergic Rxns to drug/vaccine. Clinical district manager was contacted as well.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity, Tendon injury
Clinical narrative: Restricted arm movement - pain - have been taking ibuprofen - after 2 mos. of pain saw my primary care was told vaccine went into a tendon and it would take months to resolve itself.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4" x 3" superficial area of mild erythema to (L) upper arm. Plus warmth; no streaking or extreme tenderness.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt. described sore arm lasting greater than 2 months. Deltoid muscle sore. No trouble with movement.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient came to the pharmacy 11/26/17 at around noon complaining of arm pain. The patient stated it started about an hour after his flu shot a month ago and has been the same since. His left hand looked swolled and the patient said it would tingle sometimes. I referred the patient to his PCP for follow up.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain, Pain
Clinical narrative: Pain in (R) shoulder when sleeping and when it is moved certain ways. 11/13 went to doctor - shoulder inflammed. Pain began the day following the vaccine and continue to this date.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Unable to lift left arm fully to take off shirt, etc; unable to lift left arm, when sleeping-wakes me up; general soreness, cannot raise left arm in circular motion over head; seen by Dr. 3 times
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Monoplegia
Clinical narrative: Prolonged pain the top left arm at shoulder socket. Feeling of paralysis radiating down arm into hands.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Chills, Dry skin, Eye swelling, Fatigue
Clinical narrative: Rash on palms of hands and at injection site, swollen lymph nodes, myalgia, weakness, swollen eyes, itchy throat x 3 days after PCV-13. RXN Rt deltoid S/P PCV-13 given. Rash. The patient presents for Rash. This episode began 8 days ago and has lasted 3 days. The symptom(s) are described as occurs occasionally. The patient describes the affected area(s) as itchy. Associated symptoms include dry skin, edema and pruritus. Pertinent negatives include fatigue and painful rash. Additional information: Pt was in last week and got a flu shot. Afterwards, she developed itchy rash on hands and feet, myalgia, fever, chills and swollen and red eyes. She feels better today, but she still has small rash on Right shoulder. Also C/O "bumps" on her chest on R side of chest near where she had PCV shot.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site rash, Lymphadenopathy, Myalgia, Ocular hyperaemia, Oedema
Clinical narrative: Rash on palms of hands and at injection site, swollen lymph nodes, myalgia, weakness, swollen eyes, itchy throat x 3 days after PCV-13. RXN Rt deltoid S/P PCV-13 given. Rash. The patient presents for Rash. This episode began 8 days ago and has lasted 3 days. The symptom(s) are described as occurs occasionally. The patient describes the affected area(s) as itchy. Associated symptoms include dry skin, edema and pruritus. Pertinent negatives include fatigue and painful rash. Additional information: Pt was in last week and got a flu shot. Afterwards, she developed itchy rash on hands and feet, myalgia, fever, chills and swollen and red eyes. She feels better today, but she still has small rash on Right shoulder. Also C/O "bumps" on her chest on R side of chest near where she had PCV shot.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia, Rash, Rash pruritic, Throat irritation
Clinical narrative: Rash on palms of hands and at injection site, swollen lymph nodes, myalgia, weakness, swollen eyes, itchy throat x 3 days after PCV-13. RXN Rt deltoid S/P PCV-13 given. Rash. The patient presents for Rash. This episode began 8 days ago and has lasted 3 days. The symptom(s) are described as occurs occasionally. The patient describes the affected area(s) as itchy. Associated symptoms include dry skin, edema and pruritus. Pertinent negatives include fatigue and painful rash. Additional information: Pt was in last week and got a flu shot. Afterwards, she developed itchy rash on hands and feet, myalgia, fever, chills and swollen and red eyes. She feels better today, but she still has small rash on Right shoulder. Also C/O "bumps" on her chest on R side of chest near where she had PCV shot.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Had flu shot (L) arm pneumonia (R) arm. Had reaction to pneumonia shot (R) arm red, swollen. Patient took TYLENOL and used ice on arm. Had fever which could be from flu or pneumonia.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal tenderness, Hypoaesthesia, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Roughly 1 week prior to 10/26/2017 doctor visit pt experienced tenderness to abdomen no rash, then patient started experiencing numbness and tingling in groin and feet which prompted visit. After this initial visit, patient was not diagnosed with issue. Symptoms did not resolve, and continue to progress prompting a return doctor visit and eventual hospitalization. After hospitalization patient was referred neurologist 11/10/2017, patient was scheduled for an MRI 11/24/17, patient was hospitalized immediately after MRI, then diagnosed with Transverse Myelitis 11/24/2017. Patient was started on high dose steroid therapy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Roughly 1 week prior to 10/26/2017 doctor visit pt experienced tenderness to abdomen no rash, then patient started experiencing numbness and tingling in groin and feet which prompted visit. After this initial visit, patient was not diagnosed with issue. Symptoms did not resolve, and continue to progress prompting a return doctor visit and eventual hospitalization. After hospitalization patient was referred neurologist 11/10/2017, patient was scheduled for an MRI 11/24/17, patient was hospitalized immediately after MRI, then diagnosed with Transverse Myelitis 11/24/2017. Patient was started on high dose steroid therapy.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling cold, Injection site discomfort, Injection site pain, Pain
Clinical narrative: Patient called office on 11/21/2017 stating she was experiencing " extreme tendon/ligament fatigue" of her right arm. She stated  "It is like when you paint or rake leaves...but it is not a muscle soreness".  She said pain radiated from injection site to right elbow. She stated injection site "did not have a lump or heat".  Patient denied any skin discoloration of her right arm.  She stated discomfort started 2-3 hours post injection, and became worse during the night. She said she took 650 MG of Tylenol X1. Patient  stated " I don't know if the Tylenol helped or kept the pain from getting worse." She said ice helped. She said she was able to perform good ROM this am. She said arm felt better this am but became sore with movement. I asked if she had any other side effects. She stated "I felt like I could not get warm last night, but I didn't take my temperature". I recommended that she call her MD this am. She stated "I'm not going to call my MD over a boo boo". I told her she experienced an unusual response and that it is best for her to contact her MD today. Patient gave me permission to contact her for follow up. 11/23/2107 10:30 am. I contacted patient. She stated she " felt much better now". She stated she was experiencing "better range of pain free motion". She reported she still has some discomfort with reaching and twisting her right arm while putting it into a sleeve. She states she felt tired and achey yesterday. She continues to deny any discoloration or raised areas at injection site. She states she did not notify her MD of right arm pain, stating she felt "silly". I said she had an unexpected reaction and that she should notify her MD today.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The afternoon after the Flu shot my left arm was painful I took acetaminophen. It was swollen for a couple of days and the area still sore. My shoulder still hurts when I lift my arm and certain movements. I have taken ibuprofen, hot and cold pads. I have done some stretching exercise even if it hurts. I feel relief while resting and don't raise my arm.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Limb mass, Pain in extremity, Skin warm
Clinical narrative: The afternoon after the Flu shot my left arm was painful I took acetaminophen. It was swollen for a couple of days and the area still sore. My shoulder still hurts when I lift my arm and certain movements. I have taken ibuprofen, hot and cold pads. I have done some stretching exercise even if it hurts. I feel relief while resting and don't raise my arm.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 10/30/2017 EMP 1ST REPORTED SYMPTOMS OF REDNESS, HOT TO TOUCH, LUMP AND SORENESS TO HER L ARM WHEN SEEN IN HALLWAY BY ARNP. WAS TOLD TO APPLY ICE, TAKE ANTI-INFLAMMATORY AND AVOID OVER USE. SHE THEN CAME TO OFFICE ON 11/20, AFTER NOT BEING HEARD FROM SINCE HER 1ST VISIT, STATING SHE STILL HAD ONLY SORENESS IN HER L ARM. UPON EXAMINATION EMPLOYEE HAS FULL ROM AND DENIES NUMBNESS OR TINGLING IN HER EXTREMITIES AND WAS ADVISED TO USE WARM MOIST COMPRESS, CONTINUE ANTI-INFLAMMATORY AND LIGHT STRETCHING. HOWEVER ARNP WAS OUT OF OFFICE AND EMPLOYEE WAS ADVISED TO RETURN ON 11/27/17 IS SYMPTOMS STILL PRESIST. SHE RETURNED TO THE OFFICE TODAY AND WAS ADVISED TO FILL OUT A VERS REPORT AND CONTACT THE CDC DIRECTLY.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Limb mass, Pain in extremity, Skin warm
Clinical narrative: 10/30/2017 EMP 1ST REPORTED SYMPTOMS OF REDNESS, HOT TO TOUCH, LUMP AND SORENESS TO HER L ARM WHEN SEEN IN HALLWAY BY ARNP. WAS TOLD TO APPLY ICE, TAKE ANTI-INFLAMMATORY AND AVOID OVER USE. SHE THEN CAME TO OFFICE ON 11/20, AFTER NOT BEING HEARD FROM SINCE HER 1ST VISIT, STATING SHE STILL HAD ONLY SORENESS IN HER L ARM. UPON EXAMINATION EMPLOYEE HAS FULL ROM AND DENIES NUMBNESS OR TINGLING IN HER EXTREMITIES AND WAS ADVISED TO USE WARM MOIST COMPRESS, CONTINUE ANTI-INFLAMMATORY AND LIGHT STRETCHING. HOWEVER ARNP WAS OUT OF OFFICE AND EMPLOYEE WAS ADVISED TO RETURN ON 11/27/17 IS SYMPTOMS STILL PRESIST. SHE RETURNED TO THE OFFICE TODAY AND WAS ADVISED TO FILL OUT A VERS REPORT AND CONTACT THE CDC DIRECTLY.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Swelling the size of peach at injection site, later swelled further down the arm to wrist, slowly resolved over several days, had low grade fever for 2d. Now one week later and still trace swelling but feeling well again.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Neuralgia
Clinical narrative: Redness, swelling, nerve pain at site.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Influenza, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large red and swollen left upper arm that migrated down to elbow. Warm to touch and painful. Pt. applied BENADRYL cream and took oral BENADRYL. Swelling has gone down some. Still a little sore. C/O headache, flu symptoms but they are subsiding.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Large red and swollen left upper arm that migrated down to elbow. Warm to touch and painful. Pt. applied BENADRYL cream and took oral BENADRYL. Swelling has gone down some. Still a little sore. C/O headache, flu symptoms but they are subsiding.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Experienced Redness and burning at injection site day after administration.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vaccine given at 11:20 AM. Patient had nausea/vomiting and diarrhea from mid to late afternoon that same day.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pt still has sore arm that worsens at night. Says he has pain from left shoulder up across back of neck.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a healthcare professional referring to an adult patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot# and dosage regimen was not provided) for prophylaxis. No adverse effects were reported.