chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative concerning a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. The patient fainted after she received her GARDASIL vaccination. The outcome of the event was unknown. Causality between event and GARDASIL was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old male patient. The patient was allergic to sulfa drugs and he was not immunosuppressed. On 09-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (injection, lot # K014835, expiration date as 14-DEC-2015, once, strength and dose were unspecified) subcutaneously in the deltoid muscle of the right arm. No relevant concomitant medications were taken. On an unknown date in July 2015, after receiving the ZOSTAVAX, the patient developed swelling, redness, soreness, tenderness and a hot feeling around the injection site and the injection site reaction was about 1 inch in diameter. Further down the same arm he had swelling, redness and tenderness that was bigger than the injection site reaction. The patient was not seen by his physician so no relevant tests were done. As of 12-JUL-2015, the outcomes of the event were not recovered. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Information has been received from a physician via Pfizer referring to a 65 years old patient of unknown gender. Medical history of the patient was not reported. In 2014 ("last year"), the patient was vaccinated with PNEUMOVAX 23 (lot#, route and dose not reported). It was reported the patient had swelling, redness and discomfort upon PNEUMOVAX 23 "last year" (in 2014). The outcome of the events was unknown. The reporter asked if it is recommended the patient should have a PREVNAR 13, or would that be also a problem for adverse reaction. Additional information has been requested. This is a corrected report. The Aware Date for the initial version should have been 03-JUL-2015 instead of 06-JUL-2015; therefore, MARRS # 1507USA003280 will be deleted from our database and replaced with MARRA # 1507USA011492.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to unknown number of patients of unknown ages and genders. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. On unknown dates, the patients experienced injection site rashes, all of which resolved (date unspecified). This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient received the shingles vaccination through a visit to his PCP for a wellness visit on 7/30/2015 around 0900. Local rxn of itching focal redness and firmness noted the following day, increasing redness soreness to injection site continued 8/1/2015 8/2/15 Presented to me for eval. (L) arm tricep area showed 3cm red, indurated area with a 19cm x 12cm wide area of redness. Function well intact. No SOB. No systemic issues.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pruritus
Clinical narrative: Patient received the shingles vaccination through a visit to his PCP for a wellness visit on 7/30/2015 around 0900. Local rxn of itching focal redness and firmness noted the following day, increasing redness soreness to injection site continued 8/1/2015 8/2/15 Presented to me for eval. (L) arm tricep area showed 3cm red, indurated area with a 19cm x 12cm wide area of redness. Function well intact. No SOB. No systemic issues.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient received the first doses of M-M-R II and (Oka/Merck) VARIVAX on 26-MAY-2011. The patient received the second doses of M-M-R II and (Oka/Merck) VARIVAX on 10-DEC-2014. The patient received the first doses of M-M-R II (dose was not reported, lot # K024036, exp. 26-NOV-2016, rHA) and (Oka/Merck) VARIVAX (dose was not reported, lot # L009204, exp. 17-MAR-2017) on 27-JUL-2015 (extra dose administered). No adverse effects were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Furuncle, Injection site streaking, Pain, Rash
Clinical narrative: She's not sure which shot caused sx. She called July 31st to say "rash returned" on arm that had the follow sx in 2012: started 3-4 hours after-a red line appeared from shot to elbow a boil appeared at the end at elbow. (She spoke to NP about this who advised NOT to pop it. Lasted 3 days, painful, no itching). (Note: pt given TWINRIX even tho had Hep A already).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Haemorrhagic stroke, Intensive care, Malaise
Clinical narrative: Acute hemorrhagic stroke requiring intensive care inpatient hospitalization for prolonged period.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain, Weight bearing difficulty
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 28 year-old female patient who had no medical history, current illness and medications at the time of vaccination. On 11-Sep-2014, the patient received AFLURIA injection (batch number T50007) via the intramuscular route in the left arm. On 12-Sep-2014 (ever since she received the injection), the patient had been experiencing severe shoulder pain and reduced range of motion in the left arm. It was a dull, aching pain that felt like a "bruise" right on the deltoid muscle at the injection site. The pain was somewhat alleviated by ibuprofen and ice, but it persisted for several months since she received her last flu shot. The pain was exacerbated by movements that involved lifting her arm above her head or putting weight on her deltoid/shoulder muscle (as in push-up). The shoulder x-ray was negative. MRI (magnetic resonance imaging) had been recommended as the next step for evaluation. The outcome was not recovered. Reporter's comments: The health authority assessed the case as non-serious, adverse event onset date of 12-Sep-2014, and reported the terms of 'X-ray limb normal' and 'injection site discomfort'.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 28 year-old female patient who had no medical history, current illness and medications at the time of vaccination. On 11-Sep-2014, the patient received AFLURIA injection (batch number T50007) via the intramuscular route in the left arm. On 12-Sep-2014 (ever since she received the injection), the patient had been experiencing severe shoulder pain and reduced range of motion in the left arm. It was a dull, aching pain that felt like a "bruise" right on the deltoid muscle at the injection site. The pain was somewhat alleviated by ibuprofen and ice, but it persisted for several months since she received her last flu shot. The pain was exacerbated by movements that involved lifting her arm above her head or putting weight on her deltoid/shoulder muscle (as in push-up). The shoulder x-ray was negative. MRI (magnetic resonance imaging) had been recommended as the next step for evaluation. The outcome was not recovered. Reporter's comments: The health authority assessed the case as non-serious, adverse event onset date of 12-Sep-2014, and reported the terms of 'X-ray limb normal' and 'injection site discomfort'.
Age: 65.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Blister, Erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old male patient. The patient wasn't taking one concomitant medication and had no pertinent medical history, drug reactions or allergies. On 01-JUL-2015, date the patient was subcutaneously vaccinated with no problem with ZOSTAVAX lot # K020801, expiration date: 31-JAN-2016 (dose not reported) for shingles prophylaxis "with no problem". On 02-JUL-2015 (reported as "the next day"), the patient woke up with a red patch and inflammation at the injection site. On 03-JUL-2015, the area had swollen to the size of a fully extended hand and at the injection site there was full blister that was two inches long. The patient was referred to the emergency room (the patient was not hospitalized) where he was sent home with BENADRYL which he took. No laboratory tests were performed. The patient was seen on 06-JUL-2015 (reported as "today"). The area was scabbed and the blister was gone, but the area was still a little inflammed. It was uncertain if this area was infected. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site scab, Injection site vesicles, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old male patient. The patient wasn't taking one concomitant medication and had no pertinent medical history, drug reactions or allergies. On 01-JUL-2015, date the patient was subcutaneously vaccinated with no problem with ZOSTAVAX lot # K020801, expiration date: 31-JAN-2016 (dose not reported) for shingles prophylaxis "with no problem". On 02-JUL-2015 (reported as "the next day"), the patient woke up with a red patch and inflammation at the injection site. On 03-JUL-2015, the area had swollen to the size of a fully extended hand and at the injection site there was full blister that was two inches long. The patient was referred to the emergency room (the patient was not hospitalized) where he was sent home with BENADRYL which he took. No laboratory tests were performed. The patient was seen on 06-JUL-2015 (reported as "today"). The area was scabbed and the blister was gone, but the area was still a little inflammed. It was uncertain if this area was infected. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AND ITCHY AT INJECTION SITE.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Pyogenic granuloma
Clinical narrative: Cellulitis; pyogenic granuloma.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Palpitations
Clinical narrative: Weakness, palpitations, light headedness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching occurred followed by mosquito bite like welt, Resolved that night.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Clinic was contacted that injection site was very inflamed and swollen the evening post the vaccination. As nurse on staff was not on site; patient was taken to the ER - given Benadryl and topical steroid cream to apply to site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling/redness/pain at injection site; pt was seen at urgent care on 8/2/15 and diagnosed with cellulitis; pt was given Keflex and cortisone cream.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Adverse reaction, Brain injury, Cytogenetic analysis normal, Joint swelling, Laboratory test
Clinical narrative: This spontaneous report was received from patient's mother via other company Pfizer (other company #2015251552) and concerns a 9 week old male patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 17-FEB-1998, the patient was vaccinated with RECOMBIVAX HB (dose and route were not reported, lot # reported as 0748TE). On the same day, the patient was vaccinated with DTAP vaccine (lot #449-069, expiration date September 1999, dose and route were not reported), OPV-MERIEUX (lot # 450139, dose and route were not reported) and hib conj vaccine (lot # M265RF, dose and route were not reported). On 23-FEB-1998, the patient experienced seizures, insignificant brain damage and a very serious reaction (unspecified). The patient did not receive any treatment, except for phenobarbital, 8 ml for seizures. It was reported that the patient was not given any other vaccines prior and he had never experienced the same adverse event before. Since an unspecified day in 1998 (reported as from 17 years), the patient was suffering from swollen joints. It was reported also that the patient was not gaining any weight, was getting taller and did not have any muscle (exact date not reported). On an unspecified dates, the patients underwent loft of lab tests (exact dates and results were not reported). On an unknown date (reported as recent), the patient underwent an unspecified genetic test and everything was normal. The outcome of seizures was reported as recovered/resolved (in October 1999). The outcome of brain damage was not recovered/not resolved (reported as still suffering). The outcome a very serious reaction (unspecified), swollen joints, "was getting taller, was not gaining any weight" and "did not have any muscle" was unknown. The relatedness between the events and RECOMBIVAX HB, DTAP vaccine, OPV-MERIEUX and hib conj vaccine not provided. Upon internal review, the event of seizures and a very serious reaction (unspecified) were considered to be medically significant. Lot number 0748TE is an invalid lot number for hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Muscle disorder, Seizure, Weight gain poor
Clinical narrative: This spontaneous report was received from patient's mother via other company Pfizer (other company #2015251552) and concerns a 9 week old male patient. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On 17-FEB-1998, the patient was vaccinated with RECOMBIVAX HB (dose and route were not reported, lot # reported as 0748TE). On the same day, the patient was vaccinated with DTAP vaccine (lot #449-069, expiration date September 1999, dose and route were not reported), OPV-MERIEUX (lot # 450139, dose and route were not reported) and hib conj vaccine (lot # M265RF, dose and route were not reported). On 23-FEB-1998, the patient experienced seizures, insignificant brain damage and a very serious reaction (unspecified). The patient did not receive any treatment, except for phenobarbital, 8 ml for seizures. It was reported that the patient was not given any other vaccines prior and he had never experienced the same adverse event before. Since an unspecified day in 1998 (reported as from 17 years), the patient was suffering from swollen joints. It was reported also that the patient was not gaining any weight, was getting taller and did not have any muscle (exact date not reported). On an unspecified dates, the patients underwent loft of lab tests (exact dates and results were not reported). On an unknown date (reported as recent), the patient underwent an unspecified genetic test and everything was normal. The outcome of seizures was reported as recovered/resolved (in October 1999). The outcome of brain damage was not recovered/not resolved (reported as still suffering). The outcome a very serious reaction (unspecified), swollen joints, "was getting taller, was not gaining any weight" and "did not have any muscle" was unknown. The relatedness between the events and RECOMBIVAX HB, DTAP vaccine, OPV-MERIEUX and hib conj vaccine not provided. Upon internal review, the event of seizures and a very serious reaction (unspecified) were considered to be medically significant. Lot number 0748TE is an invalid lot number for hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Raynaud's phenomenon
Clinical narrative: DEVELOPED RAYNAUDS SYNDROME.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Paralysis
Clinical narrative: Rt. Medial deltoid became paralyzed and patient could not raise arm for 24 hours.  Condition was painful.  Was resolved by soaking in a hot tub and taking pain killers.  Devastating to not be able to use dominant arm.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Constipation, Headache, Muscle spasms, Myalgia, Nausea
Clinical narrative: Client reports that she had the following: Fever (100.1), Headache, Nausea, Constipation & Muscle Aches with Spasms.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Client reports that she had the following: Fever (100.1), Headache, Nausea, Constipation & Muscle Aches with Spasms.
Age: 30.0
Sex: M
Vaccine: ANTH, MMR, TTOX
Symptoms: Burning sensation, Diarrhoea, Epistaxis, Headache, Pyrexia
Clinical narrative: Vomiting- since 12 July; fever- 12 July to 1 Aug; burning in feet- 15 July to present; teeth hurting-15 July to present, headache- on and off since 12 July, nose bleeds- on and off since July 12; diarrhea -since July 12.
Age: 30.0
Sex: M
Vaccine: ANTH, MMR, TTOX
Symptoms: Toothache, Vomiting
Clinical narrative: Vomiting- since 12 July; fever- 12 July to 1 Aug; burning in feet- 15 July to present; teeth hurting-15 July to present, headache- on and off since 12 July, nose bleeds- on and off since July 12; diarrhea -since July 12.
Age: 65.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received shingles vac and contracted shingles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to 103.5.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: All over body Aches, Left arm Quarter-sized redness & swelling, Sore Throat, pain reported in both arms but swelling occured in Lt arm where Tdap was given.  No allergies reported on screening No history of reactions to Dtap as a child.
Age: 34.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Balance disorder, Computerised tomogram, Coordination abnormal, Diplopia, Hypoaesthesia
Clinical narrative: I woke up and I had double vision, loss of balance and muscle control and coordination and was numb and tingly sensation over my body.
Age: 34.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: I woke up and I had double vision, loss of balance and muscle control and coordination and was numb and tingly sensation over my body.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient broke out in rash took Benadryl Sunday morning went to walk in clinic md gave Depo-Medrol and valcyclovir.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: Patient broke out in rash took Benadryl Sunday morning went to walk in clinic md gave Depo-Medrol and valcyclovir.
Age: 5.0
Sex: M
Vaccine: MEN
Symptoms: Death, Meningoencephalitis viral
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 25 July 2015. A male child patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of Meningococcal vaccine (batch number, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, two days later the patient died of viral meningoencephalitis. Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.
Sex: F
Vaccine: MEN
Symptoms: Apparent death
Clinical narrative: Initial unsolicited report received from a consumer on 29 July 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of MINENGETISE (Manufacture: unknown, batch number, route and site of administration were not reported) on unspecified date. On unspecified date, after vaccination, the patient experienced near death experience (patient was dying after immunization from MINENGETISE and saved). Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: MEN
Symptoms: Meningitis
Clinical narrative: Initial unsolicited report received from a consumer (patient's grandmother) on 26-Jul-2015. A patient (age and gender not provided), whose medical history and concomitant medications were not reported had received a dose of Meningococcal vaccine (batch number, expiry date, dose details, route and site of administration were not provided) on an unspecified date. On an unspecified date post-vaccination, the patient developed meningitis symptoms and was hospitalized (date was not specified). Laboratory investigations and corrective treatment were not provided. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: Initial solicited case was received from the investigator in a trial on 23 July 2015. This case involves a 21-year-old male who developed unspecified disease of pericardium during the study participation. The subject had a significant medical history of elevated cholesterol. On 09 June 2015, 20 days after receiving a dose of ACAM2000 (lot number, route and site of administration not reported), a dose of Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and a dose of Typhoid VICPS (manufacturer, lot number, route and site of administration not reported) on 20 May 2015, the subject developed unspecified disease of pericardium. On 31 May 2015, the subject's troponin I result was abnormal, the highest value was 32.48 and electrocardiogram (ECG) was abnormal. Echocardiogram performed on 31 May 2015 was abnormal. The subject's MRI (brain), MRI (spinal cord), MRI (heart) and Lumbar puncture were not performed. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Relationship of the investigation product as per Company: associated. Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site scar
Clinical narrative: Hypopigmented scar in serpentiginous distribution at site of vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Asthenia, Injection site erythema, Injection site reaction, Lethargy, Muscle twitching
Clinical narrative: LETHARGY, FEVER OF 103, NAUSEA, WEAKNESS, TWITCHING OF ARM WHERE INJECTION WAS DONE, RED WELT AT INJECTION SITE.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: LETHARGY, FEVER OF 103, NAUSEA, WEAKNESS, TWITCHING OF ARM WHERE INJECTION WAS DONE, RED WELT AT INJECTION SITE.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Headache, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Initially felt discomfort and itching of arm, developed swelling and warmth from shoulder to elbow of arm where vaccine placed.  Also had some headache and nausea.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Initially felt discomfort and itching of arm, developed swelling and warmth from shoulder to elbow of arm where vaccine placed.  Also had some headache and nausea.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's wife called 8/3/15 - said the injection site is hot, hurts, is swollen, and is bright red in a 3 in diameter. Told patient to take some ibuprofen and to see a physician if it gets any worse/spreads.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Joint swelling, Musculoskeletal stiffness, Peripheral swelling, Red blood cell sedimentation rate increased
Clinical narrative: Stiff neck & L arms with 1st vaccine, and stiff neck, swelling of R index finger, L wrist, & R knee with 2nd injection given 1 month later.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: X-ray normal
Clinical narrative: Stiff neck & L arms with 1st vaccine, and stiff neck, swelling of R index finger, L wrist, & R knee with 2nd injection given 1 month later.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Patient stated he had a fever of over 103 and ended up in the Hospital. He said the Doctors diagnosed him with Pneumonia from the vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Aphonia, Computerised tomogram abnormal, Dysphagia, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: On July 15, 2015, during a wellness checkup, I received the Pneumovax vaccine. 2 days later I started experiencing a sore throat. It got worse each day and I saw a physician on 7-22. He prescribed a 6 day treatment of Azithromycin. On 7-24, I returned to my physician & was refered to the local ER for a CAT scan. At this point, I could not talk or swallow. The CAT diagnosis was Acute Pharyngitis, unspecified pharyngitis type, and Anterior Lymphadenopathy. This was the most painful sore throat I ever experienced. I'm 73 and never smoked. Could not swallow fluids, or eat food for almost 3 days! I am reporting this as a possible complication from the this Vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pharyngitis
Clinical narrative: On July 15, 2015, during a wellness checkup, I received the Pneumovax vaccine. 2 days later I started experiencing a sore throat. It got worse each day and I saw a physician on 7-22. He prescribed a 6 day treatment of Azithromycin. On 7-24, I returned to my physician & was refered to the local ER for a CAT scan. At this point, I could not talk or swallow. The CAT diagnosis was Acute Pharyngitis, unspecified pharyngitis type, and Anterior Lymphadenopathy. This was the most painful sore throat I ever experienced. I'm 73 and never smoked. Could not swallow fluids, or eat food for almost 3 days! I am reporting this as a possible complication from the this Vaccine.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Fatigue, Feeling hot, Heart rate increased, Nausea
Clinical narrative: NAUSEA, ABDOMINAL PAIN, INCREASED PULSE, FATIGUE, FEELING HOT.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Swelling of the injection site getting worse everyday (Taken Benadryl and applied cold compress), fever, muscle pain, bone pain.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cellulitis, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of the injection site getting worse everyday (Taken Benadryl and applied cold compress), fever, muscle pain, bone pain.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Swelling of the injection site getting worse everyday (Taken Benadryl and applied cold compress), fever, muscle pain, bone pain.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid became red, swollen, hard, and painful.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiff neck on left side followed by severe muscle pain on left side for several days.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Pyrexia
Clinical narrative: High fewer 103+.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Differential white blood cell count, Febrile convulsion, Full blood count, Metabolic function test, White blood cell count increased
Clinical narrative: Febrile seizure, elevated WBC.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Approx. 1.25 hours after receiving vaccine patient started to experience slight pain left arm. On 7/31/2015 patients left arm was slightly red, swollen, itchy, and warm to touch.  As of 8/3/2015 3:45 all symptoms are starting to resolve.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash, Tenderness
Clinical narrative: PT CAME TO THE PHARMACY ON 08/03/15 AND SAID THAT SHE HAS PAIN AND TENDERNESS IN THE ARM SHE RECEIVED THE VACCINE AND ALSO A RASH ON BOTH ARMS AND LEGS.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood bicarbonate, Blood calcium, Blood creatine, Blood glucose, Blood urea
Clinical narrative: PATIENT HAD SEIZURE ACTIVITY AFTER VACCINE WAS ADMINITSTERED.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count, Metabolic function test, Platelet count, Seizure, White blood cell count
Clinical narrative: PATIENT HAD SEIZURE ACTIVITY AFTER VACCINE WAS ADMINITSTERED.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Seizure
Clinical narrative: PATIENT HAD SEIZURE ACTIVITY AFTER VACCINE WAS ADMINITSTERED.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Urine analysis, Vomiting
Clinical narrative: Dizziness, vomiting, & nausea.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode that self resolved. Vital signs taken for 30 minutes and patient discharged home in stable condition.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin induration, Skin warm, Swelling
Clinical narrative: Swelling, redness, skin 'hard' or thickened at touch, hot to touch, extremely painful. Started to dissipate after 4 days. Lasted 5+ days. Ice, Epson salt soaks, anti-inflammatory, Benadryl.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: PATIENT SAID SHE FELT A LITTLE TINGLING AND ITCHY AT THE INJECTION SITE. BUT IT WENT AWAY AFTER 15 MINUTES LATER.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 10/10 pain, swelling, numbness down arm, vomiting, fever and weak grip. Seen again at clinic on 8/3/2015.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: 10/10 pain, swelling, numbness down arm, vomiting, fever and weak grip. Seen again at clinic on 8/3/2015.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Fever and headache.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Pyrexia
Clinical narrative: Fever and headache.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Nuclear magnetic resonance imaging, Pain, Tremor
Clinical narrative: 1-2 weeks post shot in right arm had sorness and aching with weakness and tremors. Reported to PCP at that time and made appointment.  Reported to Employee health at place of employment where shot was administered.  Saw MD at employee health and underwent physical therapy, MRI, orthopedic consultation and 2 different neurologist consultations. Had adverse reaction to predisone pack as well. Currently have on going soreness, aching, weakness, and tremors.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Insomnia, Irritability, Pyrexia, Rash
Clinical narrative: Fussiness, trouble sleeping, fever, rash.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event pt verbally requested MMR but wanted varicella.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt presents to ER with Shingle like rash located Left C4 and C5.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: REDNESS AND BLISTERING AROUND INJECTION SITE.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, C-reactive protein increased, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: 6cmx6cm raised red warm to touch extremely painful to touch area at inj site on right arm wouldn't, move arm, fever 104.1 53 hours after  Pneumovax vaccine. Went to ER based on phone nurse advice, admitted for 3 nights and 4 days.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, White blood cell count increased
Clinical narrative: 6cmx6cm raised red warm to touch extremely painful to touch area at inj site on right arm wouldn't, move arm, fever 104.1 53 hours after  Pneumovax vaccine. Went to ER based on phone nurse advice, admitted for 3 nights and 4 days.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Pain in extremity
Clinical narrative: Severe aches in legs and hands for one year.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose and lot # not reported) intramuscularly. The physician's assistant reported that on an unknown date, the patient experienced Guillain-Barre syndrome after she received GARDASIL. The patient sought medical attention, called the physician assistant office. At the time of the report, the patient's outcome was unknown. Upon internal review Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Concussion, Headache, Loss of consciousness, Malaise
Clinical narrative: Pt received shot (HPV #2) on 7/2/15. On 7/3/15 pt passed out, received a concussion, and began with severe HA and malaise. Was seen in ER x 2 (CT was wnl). Came to my office (her PCP) today for f/u with continued HA (headache) and malaise.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hyposmia
Clinical narrative: Client called 7/16/15. States that after administration of flu vaccine had loss of olfactory sense. Went to ENT. After a month has some sense of smell but not complete.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Borrelia test negative, Chest X-ray normal, Full blood count normal, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: Development of left supraclavicular adenopathy, approximately 0.5cm on 7/13/15, increased to approximately 1.5cm by 7/17/15 CXR negative, nonreactive PPD, Lyme and Mono tests negative. Patient recovered on 10 day course of cefdinir.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal, Tuberculin test negative
Clinical narrative: Development of left supraclavicular adenopathy, approximately 0.5cm on 7/13/15, increased to approximately 1.5cm by 7/17/15 CXR negative, nonreactive PPD, Lyme and Mono tests negative. Patient recovered on 10 day course of cefdinir.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Edema and swelling around injection site "hot" feeling.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash developed after receiving PREVNAR 13 vaccination. Patient noticed rash about an hour after receiving PREVNAR at pharmacy. The next morning, the rash was gone.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Odynophagia, Oropharyngeal pain, Pruritus, Pruritus generalised
Clinical narrative: Reports itchy hands day after vaccine (07/24/15). On 07/25/15 reports progression of symptoms: entire body itching for 30-60 min then went away. Aching in joints, painful to swallow/sore throat. Currently taking antihistamine.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Patient complained of fatigue and muscle weakness. Patient was febrile and in bed for three days per mom.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling of the left deltoid. Physician advised pt to treat with ice and BENADRYL.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Culture urine negative, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Fever, sweats, myalgia, headache.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, sweats, myalgia, headache.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eye movement disorder, Pyrexia
Clinical narrative: Patient spiked temp to 104.2 within about 8 hrs of receiving 4m vaccines at a routine well. Before his fever came down he cried incessantly and had a ? seizure-got very quiet and his "eyes vibrated"-lasted a few seconds, then back to normal. Mom had underdosed TYLENOL for wt.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Seizure
Clinical narrative: Pt received vaccine and became dizzy and layed down flat. Pt was breathing w/ (+) pulses and arousable. Pt was given water and crackers and felt better w/in 5-10 min. Mom stated legs were convulsing but not witnessed by staff.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has red, raised and painful area at site of administration of varicella vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness on injection site starting on 8/1/15. Not getting worse at all. Still redness on 8/3/15 A.M.
Age: 23.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dyspnoea, Injection site pruritus, Throat tightness
Clinical narrative: Rec'd MMR and Hep B. 2 hours later developed localized itching at injection site along with SOB and throat tightness. Sent to ER. Given muscle relaxer and advised to seek eval with allergist.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Grandmother called clinic on 7-23-15 at 3 pm to report swelling in right arm and fever in child. Family decided to take child to MD today and was calling to ask what vaccines child received in right arm to inform MD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count, Petechiae
Clinical narrative: Petechiae to face, neck, upper chest/back.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram normal, Feeling hot, Heart rate increased
Clinical narrative: 12 1/2 hours after injection, had very fast pulse (104) and elevated blood pressure (164/94) and felt very hot, unable to sleep. Went to emergency room 11 AM on 7/7. Symptoms finally subsided in about 24 hours, and mild symptoms for a few days.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: 12 1/2 hours after injection, had very fast pulse (104) and elevated blood pressure (164/94) and felt very hot, unable to sleep. Went to emergency room 11 AM on 7/7. Symptoms finally subsided in about 24 hours, and mild symptoms for a few days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Pt came into pharmacy to show rash. Rash was about size of baseball w/ a dime-sized blister in it. Pt complained of burning/itching. Was referred to PCP.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and tenderness at the injection site. Mother instructed to administer Ibuprofen and use warm compresses and to return call if symptoms do not improve or worsen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Dizziness, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Pt. developed symptoms night of injection. Pt felt "hot"-diaphoretic-like he was going to pass out. Rested in bed x 2 days-generally did not feel well, headache, neck pain, stiff neck but full mobility. Chest pain, intermittent.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt. developed symptoms night of injection. Pt felt "hot"-diaphoretic-like he was going to pass out. Rested in bed x 2 days-generally did not feel well, headache, neck pain, stiff neck but full mobility. Chest pain, intermittent.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot, expiration dates, dose, route unspecified). No adverse effect reported. The outcome of events reported was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Slowly developed swelling redness in a 4"x6" area-left arm at injection site.
Age: 0.04
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a health worker referring to a 15 day old infant of unknown gender. On 02-JUN-2015 the patient was inadvertently vaccinated with VAQTA (dose and route were not reported, strength: 25/0.5 (unit not provided), lot # K007827, expiration date: 09-SEP-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients. The patients' pertinent medical history or drug reactions/allergies were not reported. On unspecified dates from 11-FEB-2015 to 25-JUN-2015, the patients were vaccinated with improperly exposed (Oka/Merck) VARIVAX (subcutaneous, lot: K005427; expiration: 15-APR-2016 and lot: L006383; expiration: 25-FEB-2017 and lot: K005182; expiration: 10-APR-2016 and lot: K005427; expiration: 15-APR-2016 and lot: K015971; expiration: 23-SEP-2016). These vaccines were exposed to 17 Fahrenheit degree for an unspecified length of time. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients. The patients' pertinent medical history or drug reactions/allergies were not reported. On unspecified dates from 11-FEB-2015 to 25-JUN-2015, the patients might have received one of the vaccinated with improperly exposed PROQUAD (Merck) (subcutaneous, lot: K018144; expiration: 10-APR-2016 and lot: K010210; expiration: 17-JAN-2016 and lot: K009470; expiration: 03-JAN-2016 and lot: K018142; expiration: 10-APR-2016). These vaccines were exposed to 17 Fahrenheit degree for an unspecified length of time. No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site urticaria, Purulence, Urticaria
Clinical narrative: This spontaneous report was received from a healthcare student and refers to a 67 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 13-JUL-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, lot # L003216, expiration date 30-APR-2016, subcutaneous. ZOSTAVAX was reconstituted on its sterile diluent, lot number reported as L001656, expiration date 20-DEC-2015. There was no concomitant medication. On 13-JUL-2015, immediately after receiving ZOSTAVAX, the patient experienced injection site urticaria described as three welts with pus around the injection site. There were no laboratory diagnostics studies performed. The patient sought medical attention in the pharmacy at the time of the event. The patient received BENADRYL and after four to five days, on approximately 18-JUL-2015, the injection site urticaria resolved. The relatedness of the event to ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of RECOMBIVAX HB (lot number J014855 - expiration date 16-APR-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010883, 1507USA010884). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Pt with severe localized reaction, redness, pain, and swelling 3-4 cm induration LUE fever 99.0 ax at home afebrile at exam. No limitations in ROM/full use of extremity (+) MSP.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Pt with severe localized reaction, redness, pain, and swelling 3-4 cm induration LUE fever 99.0 ax at home afebrile at exam. No limitations in ROM/full use of extremity (+) MSP.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Lt arm is red, swollen, and warm to touch.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Laboratory test, Lymphadenopathy, Muscular weakness, Myalgia
Clinical narrative: Fever, headache, muscle ache and weakness; apparent lymphadenopathy.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: Fever, headache, muscle ache and weakness; apparent lymphadenopathy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K006960, expiration date 19-FEB-2017 or lot # K011562 expiration date 08-APR-2017. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-JUL-2015 the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, route and dose were unknown) and a dose of PROQUAD (Merck) (lot #, expiration date, route and dose were unknown) (overdose). No adverse experience reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash on opposite shoulder from vaccine administration; near right clavicle with 1 mm of vesiculation.