chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Convulsion, Glossodynia, Laboratory test, Nuclear magnetic resonance imaging, Somnolence
Clinical narrative: Pt had seizure on 5/29/14 while asleep husband states she was making noises and shaking violently. He could not wake her up. She bit her tongue noticed it was sore.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue biting, Tremor
Clinical narrative: Pt had seizure on 5/29/14 while asleep husband states she was making noises and shaking violently. He could not wake her up. She bit her tongue noticed it was sore.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: 6-7-14 fever, very poor appetite, no energy, dazed, weak and lethargic, drowsiness.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: 6-7-14 fever, very poor appetite, no energy, dazed, weak and lethargic, drowsiness.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: 6-7-14 fever, very poor appetite, no energy, dazed, weak and lethargic, drowsiness.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: Fever up to 102, fussiness, poor appetite, lethargy.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: Fever up to 102, fussiness, poor appetite, lethargy.
Age: 0.53
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13, RVX, DTAP, DTAPHEPBIP, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever up to 102, fussiness, poor appetite, lethargy.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Client states she has had a low grade, fever since being vaccinated, fever has been as high as 100 degrees F. Client reports rash, redness and swelling to injection site. Client visited dr 6/12/14 for an allergic reaction and was given an injection steroids and TYLENOL at the visit and told to contact the facility where she received her vaccinations.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large red, swollen, area upper arm at injection site.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Face injury, Head injury, Loss of consciousness
Clinical narrative: Pt passed out after immunizations.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hearing impaired, Hyperhidrosis, Pallor, Paraesthesia
Clinical narrative: Stated could not hear- but able to follow commands and answer questions. Pale, diaphoretic, legs tingling- 4:10 was taken to ER. Walked unassisted from w/c to vehicle: Evaluated at ER 1hr and 20 min- No meds intervention drank several bottles of water.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Dark red spots on face the day after receiving ZOSTAVAX; spots do not itch and are not painful; spots persist for months.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 02-JUN-2014, the patient was vaccinated with an expired dose of PROQUAD (merck), 0.5 ml, SC, left upper thigh, (Lot # H021361, expiry date on 29-MAY-2014). No adverse effects reported at this time. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 13 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Paraesthesia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at vaccine site chils, tingling in hand.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.24
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a from pharmacy technician concerning a currently 14 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 10-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 24 year old patient (gender unspecified). On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.5 ml, subcutaneous, anatomical location unspecified (lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (strength, dosage schedule, route, indication, lot number and expiration date not reported). On an unspecified date the patients developed redness after receiving ZOSTAVAX. At the time of the report the outcome of the event was unknown. This is one of two reports from the same reporter (1406USA005511). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient of unknown age and gender. The physician assistant reported that on 06-JUN-2014 the patient was vaccinated simultaneously with VARIVAX (Merck), injection (strength, dosage, anatomical location, lot # and expiration date not reported) and PROQUAD (Merck), injection (strength, dosage, anatomical location, lot # and expiration date not reported). No adverse effect was reported. No concomitant therapies or medical history were reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Dizziness, Fatigue, Full blood count normal
Clinical narrative: Immediately dizzy. Fever by 4PM. Next day very lethargic with fever. Doctor visit 6/7/2014. High fever remained consistent, with mild improvement on occasion. Returned to doctor 6/11/2014 and had x-ray. Placed on antibiotic for possible pneumonia. Fever continued until 6/12/2014. Returned to doctor for cough 6/13/2014, needed breathing treatment and prescription steroids and inhaler.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Metabolic function test normal, Pyrexia, Thyroid function test normal
Clinical narrative: Immediately dizzy. Fever by 4PM. Next day very lethargic with fever. Doctor visit 6/7/2014. High fever remained consistent, with mild improvement on occasion. Returned to doctor 6/11/2014 and had x-ray. Placed on antibiotic for possible pneumonia. Fever continued until 6/12/2014. Returned to doctor for cough 6/13/2014, needed breathing treatment and prescription steroids and inhaler.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Dizziness, Immediate post-injection reaction, Lethargy, Pyrexia, X-ray
Clinical narrative: Immediately dizzy. Fever by 4PM. Next day very lethargic with fever. Doctor visit 6/7/2014. High fever remained consistent, with mild improvement on occasion. Returned to doctor 6/11/2014 and had x-ray. Placed on antibiotic for possible pneumonia. Fever continued until 6/12/2014. Returned to doctor for cough 6/13/2014, needed breathing treatment and prescription steroids and inhaler.
Age: 71.0
Sex: F
Vaccine: TYP
Symptoms: Borrelia test, Full blood count, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash, fever, swollen lymphnodes.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Blood test, Bronchoscopy, Impaired work ability, Pneumonia
Clinical narrative: This spontaneous report was received from a 34 year old nurse referring to a herself. The patient's medical history includes the drugs DEMEROL which resulted in anaphylaxis and AMBIEN which resulted in hallucinations.On an unknown date in 2010 the patient was vaccinated with PNEUMOVAX 23 intramuscular. Concomitant therapies included SINGULAIR, for asthma. Lab diagnostic tests included blood tests, x-rays and bronchoscopy. On an unknown date in January 2014, the patient developed pneumonia (hospitalization and disability). On 27-JAN-2014, the patient was hospitalized. The patient received the treatment with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown) and recovered from pneumonia on 14-FEB-2014. On 14-MAR-2014, the patient developed pneumonia again (disability) which resolved on 21-MAR-2014 with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown). The patient missed 3.5 months of work due to ongoing (unspecified) disability related to pneumonia. On approximately 15-MAY-2014 (3 weeks ago), the pneumococcal antibodies showed a negative titer result. The patient sought medical attention. There was no intervention required to prevent the seriousness criteria. The event was not life-threatening and there was no PQC involved. The outcome of the events, pneumonia and recurrence of pneumonia was reported as recovered/resolved. The causality of the events was unspecified. The case has been linked with the case 1406USA004888 (Same reporter link) Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a 34 year old nurse referring to a herself. The patient's medical history includes the drugs DEMEROL which resulted in anaphylaxis and AMBIEN which resulted in hallucinations.On an unknown date in 2010 the patient was vaccinated with PNEUMOVAX 23 intramuscular. Concomitant therapies included SINGULAIR, for asthma. Lab diagnostic tests included blood tests, x-rays and bronchoscopy. On an unknown date in January 2014, the patient developed pneumonia (hospitalization and disability). On 27-JAN-2014, the patient was hospitalized. The patient received the treatment with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown) and recovered from pneumonia on 14-FEB-2014. On 14-MAR-2014, the patient developed pneumonia again (disability) which resolved on 21-MAR-2014 with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown). The patient missed 3.5 months of work due to ongoing (unspecified) disability related to pneumonia. On approximately 15-MAY-2014 (3 weeks ago), the pneumococcal antibodies showed a negative titer result. The patient sought medical attention. There was no intervention required to prevent the seriousness criteria. The event was not life-threatening and there was no PQC involved. The outcome of the events, pneumonia and recurrence of pneumonia was reported as recovered/resolved. The causality of the events was unspecified. The case has been linked with the case 1406USA004888 (Same reporter link) Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: 3 days after receiving DTAP in left deltoid left arm from elbow to shoulder had large red welts that were hot and painful. BENADRYL 25 mg taken everyday QD until 5/8/14 and welts resolved 5/10/14.
Age: 73.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus
Clinical narrative: Irritation/itching, induration, erythema, heat at site. Mild dull headache.
Age: 73.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Irritation/itching, induration, erythema, heat at site. Mild dull headache.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial swelling about the size of a nickel.  As progressed during the night and next 7 days grew to approximately 6 inch diameter circle, red, hot to touch and very swollen.  Treated with Ibuprofen, Benadryl and cool compresses.
Age: 1.02
Sex: F
Vaccine: MMR, PPV
Symptoms: Cough, Drooling, Injection site reaction, Pain, Rash generalised
Clinical narrative: LARGE SCATTERED BLISTER LIKE RASH TO BOTH LEGS\ARMS FACE MOUTH AND EAR, COUGH DROOLING PAIN.
Age: 1.02
Sex: F
Vaccine: MMR, PPV
Symptoms: Rash vesicular
Clinical narrative: LARGE SCATTERED BLISTER LIKE RASH TO BOTH LEGS\ARMS FACE MOUTH AND EAR, COUGH DROOLING PAIN.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who 11-MAR-2014 was vaccinated with ZOSTAVAX (lot # J013134, expiration date 17JAN2015). On 12-MAR-2014, the patient died (not further specified) a day after receiving the ZOSTAVAX vaccine. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE REACTION RED RAISED SKIN APPROX 3 TO 4 INCHES ROUND.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE REACTION RED RAISED SKIN APPROX 3 TO 4 INCHES ROUND.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Pneumonia, Streptococcal infection, Upper respiratory tract infection
Clinical narrative: This case was reported by a consumer (subject) via Benlysta Gateway  and described the occurrence of pneumonia in a 63-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified) and treated with Belimumab (Benlysta) for lupus. A physician or other health care professional has not verified this report. Concurrent medical conditions included aortic valve prolapse, high blood pressure, lupus, mitral valve prolapse and penicillin allergy. Concurrent medications included Methotrexate, Verapamil, L-thyroxine), Folic acid, HCTZ, Liothyronine, Vitamin D, Lisinopril, Metoclopramide, Aspirin, Pravastatin, B12 and glucosamine with B12. On an unknown date about 2 or 3 years ago, the subject began treatment with Belimumab (unknown route) at unknown dosing monthly. In October 2013 the subject received unspecified dose of Influenza vaccine (unknown route). In January 2014, 3 months after vaccination with Influenza vaccine and "about a week" after the subject received a dose of belimumab, the patient experienced influenza and possible vaccination failure. In February 2014, 4 months after vaccination with Influenza vaccine and "about a week" after the subject received a dose of belimumab, the patient experienced bad cold. At an unknown time after vaccination with Influenza unspecified and "about a week" after the subject received a dose of belimumab, the patient experienced upper respiratory infection. No further details were provided. In March 2014, 5 months after vaccination with Influenza vaccine and "about a week" after the subject received a dose of belimumab, the patient experienced pneumonia. The subject was hospitalised for 10 days. In April 2014, 6 months after vaccination with Influenza and "about a week" after the subject received a dose of belimumab, the patient experienced streptococcus. At the time of reporting the event of influenza was resolved. At the time of reporting the events of pneumonia, bad cold, upper respiratory infection and streptococcus were improved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml, intramuscular. Lot number and expiration date were not reported. On 06-JUN-2014, the patient received improperly stored (Oka/Merck) VARIVAX exposed to 15F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received PNEUMOVAX 23 (Lot # J015522, expiry date: 21-FEB-2015) that was exposed to 47 Fahrenheit for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938, 1405USA009508 and 1405USA011939 (same reporter link). Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a father refers to his one year old son. The patient's medical history included hypothyroidism. No drug allergies reported. On 28-MAY-2014 the patient was supposed to be vaccinated with one dose of PROQUAD (lot#, dose, route and frequency were unknown) and one dose (lot#, dose, route and frequency were unknown) for routine vaccine. The nurse accidentally gave 2 injections of PROQUAD at the same time and never gave the PROQUAD. No adverse event was reported. There was no treatment given for the event. The patient sought medical attention by seeing a doctor. The outcome of the event was reported as "recovering". The father also reported that "My son uses SYNTHROID 44 MG and next the day uses 37.5 MG (every other day/manufacturer unknown)". Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a physician as part of a marketing research program conducted by Health agency refers to a 14 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL dose and route not reported, for HPV vaccine. No concomitant medication reported. On an unknown date in 2011 (also reported as after 1st or 2nd dose, date unknown, estimated at 2-3 years ago), the patient experienced neuropathy in legs. The outcome of neuropathy in legs was reported as recovering. Therapy was discontinued. The reporter considered neuropathy in legs to be related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, Meningococcal Protein Conjugate and COMVAX, GARDASIL, ROTATEQ which were exposed to 30F to 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were Meningococcal Protein Conjugate and COMVAX and GARDASIL which were exposed to 32F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007005, 1406USA007006). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been adminsitered to patients. The first set of vaccines were RECOMBIVAX HB, Meningococcal Protein Conjugate and COMVAX, GARDASIL, ROTATEQ which were exposed to 30F to 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were Meningococcal Protein Conjugate and COMVAX and GARDASIL which were exposed to 30F for 221 hours adn 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007004, 1406USA007005, 1406USA007006). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source. (Same reporter link: 1406USA007003, 1406USA007004, 1406USA007005, 1406USA007006). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic, Scab
Clinical narrative: This spontaneous report was received from a 64 years old male consumer refers to himself. The patient was allergic to lisinopril (manufacturer unknown). In June 2013 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported) injection to prevent shingles. Concomitant therapies included ZOCOR. After receiving ZOSTAVAX, in Summer of 2013 approximately in June 2013 the patient developed 3 red dots on his right thumb and right bicep. They were itched but went away in a few months. Approximately 3 to 4 months ago (approximately in January 2014) he developed a red dot on his neck that was still there. It had formed a scab since he irritated it while shaving. The patient showed his pharmacist all these dots. The pharmacist ruled out shingles. Blood work was performed without result. No treatment was given for the events. The patient did not seek medical attention. At the time of the report the patient was recovering from the red dot on his neck and scab. The relationship between the event and ZOSTAVAX was not reported. This case is linked to case 1406USA003356 by same patient link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000955, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a patient of unknown age. On 09-AUG-2010, patient was vaccinated with first dose of GARDASIL (lot # and expiry date unknown) injection 0.5 ml, intramuscularly. No concomitant medication was reported. The second dose of GARDASIL was given on 09-AUG-2011, and the third dose of GARDASIL given on 07-JUN-2012. No adverse effects reported. There was no product quality complaint. No further information provided. Outcome of the reported events were unknown. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red circle around injection site. several itchy red bumps on both legs not sure if bug bites or related to arm reaction.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular Rash on extremities, more concentrated near the area of injection; 3 days or so after receiving MMR, Varicella and Hep A vaccines.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age. On 04-JUN-2014 the two patients were vaccinated with M-M-R II, lot# unknown, expiration date: 17-MAY-2014, (dose, route and indication not reported). The nurse stated that M-M-R II had no previous temperature excursions. No adverse symptoms were reported. The reporter did not mention if the patients received any prior doses. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5 ml once, subcutaneous, (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1406USA000955, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of PEDVAX, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, PNEUMOVAX and ROTATEQ were improperly stored (event captured in MARRS# 1405USA012894, 1406USA00955, 1406USA000956 and 1406USA000957 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via Company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose not reported). At month 3 the patient was vaccinated with the second dose of GARDASIL (dose not reported) and at month 5 with third dose. The patient's outcome was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified number patients who are under 50 years old. On an unknown date the patients who are under 50 years old were prescribed with ZOSTAVAX, subcutaneous (strength and dose not reported). No other concomitant therapies reported. There were no known adverse effects reported for those patients. The outcome of the events were unknown. The is one of two reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Received TDaP vaccine at Employee Health on 6/9/2014 by Employee Health RN in (L) deltoid. Had chills, temperature of 103 and hot, red (L) arm with hives on arm the next day. Still feels a little sick but better.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Received TDaP vaccine at Employee Health on 6/9/2014 by Employee Health RN in (L) deltoid. Had chills, temperature of 103 and hot, red (L) arm with hives on arm the next day. Still feels a little sick but better.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number of patients of unknown age. The reporter stated that M-M-R II, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007119, 1406USA007120, 1406USA007121, 1406USA007076 (same reporter link). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse via Pfizer refers to a 68 year old female patient. The patient was preparing treatment for cochlear implant. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date not reported), There was no concomitant medication reported. Nurse reported that on an unknown date orders came in for the patient to get PREVNAR 13 first and then for PNEUMOVAX 23 to be given 8 weeks later, but she received PNEUMOVAX 23 first. Nurse requested info regarding giving PREVNAR 13 second or if they could be given together. Additional information received. Patient demographics updated. Vaccine administration information updates. Pre-existing allergies, birth defects and medical conditions were unknown. Illness at the time of vaccination was unknown. On 24-MAR-2014 at 2:30 pm, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J004080, expiry 22-AUG-2014). Number of previous vaccines was nil. It was reported that the doctor ordered PREVNAR 13 to be given followed by PNEUMOVAX 23 8 weeks later. Patient was given the PNEUMOVAX 23 first, reported as vaccine given out of order. Relevant diagnostic tests and laboratory data were none. Additional information was received concerning the 68 year old female patient who on 24-MAR-2014 at 2:30 pm was vaccinated intramuscularly with a dose of PNEUMOVAX 23 into the left arm, instead of PREVNAR 13. There was no illness at time of vaccination. The patient had no prior medical history, relevant drug history, drug allergies or family history and no AE following prior vaccinations. No relevant laboratory tests were performed. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number of patients of unknown age. The reporter stated that VAQTA, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of several reports. The case is linked to 1309USA013801, 1406USA007118, 1406USA007119, 1406USA007120, 1406USA007121, 1406USA007076 (same reporter link). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 year old female patient. Medical history was not reported. On 09-JUN-2014 the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, lot # H016960, expiration date: 02-DEC-2013, anatomical location was not reported). Concomitant medications were not reported. The reporter stated that expired GARDASIL was administered to the patient on 09-JUN-2014. No adverse effects noted. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number patients of unknown age. The reporter stated that GARDASIL, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of the several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007118, 1406USA007120, 1406USA007121, 1406USA007076 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified number of patients of unknown age. The reporter stated that RECOMBIVAX HB, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007118, 1406USA007119, 1406USA007120, 1406USA007121 (same reporter link). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort, Pain in extremity
Clinical narrative: Very red, warm and swollen at injection site 2 days post vaccination. Patient says arm the whole  way to neck is tight and painful. Felt like it was going up her arm she got the shot.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneously. Lot number reported as J004155, expiration date 05-APR-2015. On 06-JUN-2014, the patient received improperly stored VARIVAX (Merck) exposed to 15F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paralysis, Plasmapheresis
Clinical narrative: Guillain-Barre. Received vaccine on 2/7/14. Feet were numb by 2/18/14. Admitted to hospital on 2/21/14. Was paralyzed completely 2/27/14. Received two treatments of IVGA didn't work. Received seven treatments of plasmapheresis.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. Lot number reported as J014129, expiration date 05-OCT-2015. Other suspect therapies included VAQTA 0.5ml, intramuscular. Lot number J009441, expiration date 23-AUG-2015. On 09-JUN-2014, the patient received improperly stored GARDASIL, and improperly stored VAQTA exposed to 15F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Lot number J014129 in an invalid lot number for GARDASIL. It is a Lot number valid for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous. Lot number and expiration date were not reported. Other suspect therapies included VAQTA 0.5ml, intramuscular. Lot number J009441, expiration date 23-AUG-2015. On 06-JUN-2014, the patient received improperly stored VARIVAX (Merck) exposed to 15F for 86 hours, and VAQTA exposed to 31F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, heat, and redness at injection site, 9cm x 7cm swelling.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen. KEFLEX 500 TID x 10 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphagia, Cellulitis, Fatigue, Injection site pain, Irritability
Clinical narrative: Haven't eaten since Friday, severely tired and grouchy. Developed cellulitis, high fever, have to take 2 different antibiotics and PHENERGAN, severe nausea, arm doubled in size and I am still sick and very grouchy 5 pain, days later. Bumps under arm from elbow to shoulder.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Haven't eaten since Friday, severely tired and grouchy. Developed cellulitis, high fever, have to take 2 different antibiotics and PHENERGAN, severe nausea, arm doubled in size and I am still sick and very grouchy 5 pain, days later. Bumps under arm from elbow to shoulder.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling abnormal, Local swelling
Clinical narrative: At 3AM 5/24, patient woke up feeling "bad". She went to work, had temp by 11A and by 4P it was 103 degrees F. She went home and discovered arm swollen. She went to urgent care.
Age: 0.67
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Cold sweat, Crying, Nasopharyngitis, Screaming
Clinical narrative: Screaming for past 3 hours, inconsolable, cold, clammy.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: Painful rash developed on trunk, arm, wrist and leg. Left side only. This was not at injection site. Lasted 2 weeks.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on arm at administration site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Red hot rash where vaccine given - traveled down arm. On 6/7 - pt came in w/ rash - recommended topical hydrocort/BENADRYL cream - said to go to MD if not better by 6/9 -> on 6/9 went and got antibiotic. Pt on methotrexate - not filled at pharmacy where got vaccine so no knowledge of this.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness 3 1/2 " at injection site tender to touch dx cellulitis treated w/ AUGMENTIN.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash vesicular
Clinical narrative: Pain at site with 10cm of hot erythema and central 4cm vesicular cluster.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying
Clinical narrative: Inconsolable crying for 3 days after vaccination.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker: disease intervention specialist and refers to a 21 year old female patient with allergy to latex, NOVOCAINE, WELLBUTRIN (dosages/frequencies/manufacturers unknown). No concomitant medications and no medical history was reported. It was reported that on 20-MAY-2014 in the clinic the patient was given a pregnancy test which had a negative result and she was vaccinated with GARDASIL (one single shot, lot # J003727, expiry date: 07-NOV-2015, intramuscularly). After the patient left the clinic the pregnancy test had a positive result. The patient became pregnant with LMP of 08-APR-2014 and EDD of 13-JAN-2015. Initial exposure to GARDASIL was at 6 week(s). There was no adverse effects reported. Patient did not seek a medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Swelling of (L) hand. Initially had pain in hand the night vx given then swelling that lasted approx 4-5d. Suspect rheum issue. W/U in progress.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Lymph node pain, Lymphadenopathy, Musculoskeletal pain, Pain
Clinical narrative: 6/12/2014- 5:30 AM. Woke up to arm and shoulder soreness. Progressively got worse through out the day. Extreme painful to lift arm. 6/13/2014 - 5:30 AM. Woke up to same symptoms as above as well as swelling under the arm and upper arm to the elbow. Glands under the arm swollen and very painful. 6/13/2014 - 11:15 AM drs office returned call. Said normal reactions. Watch for severe redness which would indicate an infection and take ibuprofen.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: 6/12/2014- 5:30 AM. Woke up to arm and shoulder soreness. Progressively got worse through out the day. Extreme painful to lift arm. 6/13/2014 - 5:30 AM. Woke up to same symptoms as above as well as swelling under the arm and upper arm to the elbow. Glands under the arm swollen and very painful. 6/13/2014 - 11:15 AM drs office returned call. Said normal reactions. Watch for severe redness which would indicate an infection and take ibuprofen.