chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Fever, malaise, nausea, vomiting and lower abdominal pain. Could not tolerate anti nausea / fever reducer medications. Returned to pediatrician on 08/18. Received IV fluids for dehydration on 08/19. Admitted to hospital on 08/20. Received IV fluids and blood tests showing inflammation of the liver. Released 08/22 at 2:00 PM with discharge diagnosis of acute gastroenteritis.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Liver function test abnormal, Pyrexia
Clinical narrative: Fever, malaise, nausea, vomiting and lower abdominal pain. Could not tolerate anti nausea / fever reducer medications. Returned to pediatrician on 08/18. Received IV fluids for dehydration on 08/19. Admitted to hospital on 08/20. Received IV fluids and blood tests showing inflammation of the liver. Released 08/22 at 2:00 PM with discharge diagnosis of acute gastroenteritis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: 3 inch by 6 inch red, raised, inflammed tissue at surrounding injection site.  Patient kept dermatologist appointment, was given 10mg cetirizine and topical clobetasol.  On 8/22 reaction had significantly subsided.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix abnormal, Therapeutic procedure
Clinical narrative: Abnomal Pap screening after first 2 injections. Biopsy done and diagnosed as cervical dysplasia. Had all abnormal cells removed, then had normal pap screening afterwards.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Rash erythematous
Clinical narrative: Reticular red rash starting within 24 hours of receiving vaccines. No other symptoms. No treatments.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Cellulitis
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of cellulitis of the left thigh in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). On 9 July 2012 the subject received a dose of KINRIX (unknown route), 2nd dose of varicella virus vaccine (Non-GSK) (unknown). In 2012, less than one month after vaccination with KINRIX and varicella virus vaccine (Non-GSK), the subject experienced cellulitis of the left thigh. The site of injection was not known at the time of the report. This case was assessed as medically serious by GSK. In 2012, the event was resolved. The physician considered the event was probably related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK). The physician reported another case with KINRIX via a sales representative. See A0990329A for details on the other case. The vaccine was received through vaccines for children. According to the sales representative, the physician had already reported both cases to VAERS.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Upper (L) arm deltoid muscle red & swollen and warm (baseball size -> softball size in redness) slight tenderness to touch. No drainage. Treatment: 50 mg BENADRYL q 6 hours x 24 hours then as needed, cold compresses. If no better will start BACTRIM.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Convulsion, Laboratory test
Clinical narrative: Patient received 3 separate injections on 8/17/12 and on Saturday 8/18/12 mom was driving with patient when patient had a seizure and was brought to emergency room for evaluation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Left upper arm injection site was red, swollen, hard and warm to touch. Area of erythema surrounding another area of erythema with a total measurement of 3 cm x 4 cm. 3 blisters are present. Gave 80 mg injection DEPO-MEDROL. Patient was to use cold compresses & BENADRYL.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Left upper arm injection site was red, swollen, hard and warm to touch. Area of erythema surrounding another area of erythema with a total measurement of 3 cm x 4 cm. 3 blisters are present. Gave 80 mg injection DEPO-MEDROL. Patient was to use cold compresses & BENADRYL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Left upper arm at injection site had large wheel 3 cm x 3 cm. Area is hard, red, swollen and warm to touch. Two blisters are noted. Gave 80 mg injection DEPO-MEDROL. Patient was to use cool compresses & BENADRYL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Left upper arm at injection site had large wheel 3 cm x 3 cm. Area is hard, red, swollen and warm to touch. Two blisters are noted. Gave 80 mg injection DEPO-MEDROL. Patient was to use cool compresses & BENADRYL.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Received vaccination 6/28/12 - went on vacation 7/4/12 experienced severe fatigue. By 7/11/12 numbness/tingling (R) hands & feet. 7/14/12 - trouble walking. 7/26 dx Guillain Barre. Current in PT/OT also receiving IgG.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia
Clinical narrative: Received vaccination 6/28/12 - went on vacation 7/4/12 experienced severe fatigue. By 7/11/12 numbness/tingling (R) hands & feet. 7/14/12 - trouble walking. 7/26 dx Guillain Barre. Current in PT/OT also receiving IgG.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Loss of consciousness
Clinical narrative: This spontaneous report as received from a licensed visiting nurse refers to a currently 14 years old female patient with allergic rhinitis and no drug reactions/allergies. The patient was vaccinated intramuscularly with lot # (669285/0691AA exp date 17-AUG-2013) dose 1, 0.5 ml of GARDASIL on 22-JUL-2011. The patient was vaccinated with dose 2 (lot # 670050/1229AA exp date 12-NOV-2013) and dose 3 (lot # 672193/1524AA exp date 23-AUG-2014) of 0.5 ml GARDASIL intramuscularly on 10-OCT-2011 and 06-MAR-2012 respectively. No other co-suspects were reported. Concomitant therapy might have include NASONEX. The nurse reported that 2-3 weeks after receiving the first dose (approximately on 05-AUG-2011) the patient developed a nickel sized welt on her right arm at the site where she received the injection. It was also reported that 3-4 months after receiving her third dose (in January 2012) the patient again developed a nickel sized welt on her right arm at the site where she received the injection and once again 4 months after receiving her third dose (in July 2012) she developed a nickel sized welt on her right arm at the site where she received the injection. The patient's mother did not notify the office these events until 06-AUG-2012, during an office visit. The patient was seen in the office that day because she "passed out" (medically significant upon internal review) after having breakfast that morning. No treatment information was reported and no lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) delt. area red swollen, warm to touch - Dad brought child in, and mom pick her up next day - Noticed it was red - Child c/o arm hurting - advised to put ice on/off - TYLENOL for pain - if got worst to see PCP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: (L) delt. area red swollen, warm to touch - Dad brought child in, and mom pick her up next day - Noticed it was red - Child c/o arm hurting - advised to put ice on/off - TYLENOL for pain - if got worst to see PCP.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Rash
Clinical narrative: Patient broke out in light rash on chest and abdomen after receiving varicella, MENVEO, and GARDASIL vaccine. Rash resolved a few minutes after onset. 2 tsp of BENADRYL were given as directed by Dr.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Pain & swelling in deltoid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Received KINRIX & MMR IM (L) arm on 8/20/12 --> pain 8/21/12 --> red 8/22/12 --> I put patient on KEFLEX, TYLENOL on 8/22/12.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Night sweats, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient developed fever > 102, night sweats, nausea, body aches, (L) arm pain and swelling that he developed the night of the injection. Sxs persisted > 48 hours.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient developed fever > 102, night sweats, nausea, body aches, (L) arm pain and swelling that he developed the night of the injection. Sxs persisted > 48 hours.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pain, swelling, redness in left arm.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Abdominal pain upper, Chills, Headache, Muscle spasms, Nausea
Clinical narrative: 8/15/12 8:00pm Headache and leg cramps - Given TYLENOL. 6;00am 8/16/2012- fever (100.5), chills, leg and arm cramps, Headache, nausea, stomach ache. Gave her TYLENOL @ 6:00am. 5:00p.m same symptoms. Gave her MOTRIN (400mg) and BENADRYL 10:00 p.m. better, slight HA.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: 8/15/12 8:00pm Headache and leg cramps - Given TYLENOL. 6;00am 8/16/2012- fever (100.5), chills, leg and arm cramps, Headache, nausea, stomach ache. Gave her TYLENOL @ 6:00am. 5:00p.m same symptoms. Gave her MOTRIN (400mg) and BENADRYL 10:00 p.m. better, slight HA.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, itching, swelling, warmth. Hard lump. Went to Dr. & got KEFLEX for 10 days (250mg QID).
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Red bump on RT arm where vaccine was given, rash.
Age: 1.03
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Electroencephalogram, Musculoskeletal stiffness, Staring
Clinical narrative: Staring spells with limb stiffening. Possible seizure activity. Followup/diagnostic testing ordered.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Paraesthesia oral, Vision blurred
Clinical narrative: Face flushed, tongue "feeling thick", eyes feeling foggy -> evaluated by MD. Given 50mg BENADRYL IM -> EMS called. Patient observed and monitored -> IV access placed 20g to right hand -> patient transferred to hospital.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt. called stating arm, red, swollen & hot to touch: Advised pt. to put ice over areas. No more than 10-15 min at a time.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema
Clinical narrative: Area of erythema about 5 cm in diameter, non tender, no drainage.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache
Clinical narrative: Pt received MENACTRA in (R) deltoid IM. Pt stated he got headache the next morning and felt really tired/fatigued. Pt Reported he felt fine the next day while in our office for another procedure. Advised to take MOTRIN/TYLENOL for HA. No local reaction.
Age: 65.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Full blood count, Headache, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Myalgia swollen painful lymph nodes headache.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Cough, Fatigue, Headache, Pain
Clinical narrative: 8/13 - 8/20 - extreme fatigue, all over body aches, cough, h/a's -- Pt. treated by PCP (Pt. was treated for bronchitis shortly after PNEUMOVAX prior to onset of above sx).
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: West Nile virus test negative
Clinical narrative: 8/13 - 8/20 - extreme fatigue, all over body aches, cough, h/a's -- Pt. treated by PCP (Pt. was treated for bronchitis shortly after PNEUMOVAX prior to onset of above sx).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Patient reported severe itching which started approximately 2 weeks ago (from 8/13/12) she said she has had a few skin eruptions which looked like pox.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site haematoma, Nodule
Clinical narrative: (R) thigh with bruising. 1 x 2 cm knots felt in muscle. No exudate. Non tender.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Lip blister
Clinical narrative: Patient presented with (L) arm - injection sight being red & swollen with a hard nodule. Also patient has broken out w/ blisters externally on lips (primarily (L) side which are painful.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pain
Clinical narrative: Patient presented with (L) arm - injection sight being red & swollen with a hard nodule. Also patient has broken out w/ blisters externally on lips (primarily (L) side which are painful.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Pallor, Rash
Clinical narrative: Blanching rash on left side of face approximately 25 min after vac given.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: The patient presented back to the pharmacy 2 days after receiving a flu & pneumonia shot. He complained of redness & swelling near the injection site and chills and fatigue suggested treatment was to ice the area and return to pharmacy if not resolved in 2 days.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection Pt seen at ER tx with KEFLEX.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Diarrhoea, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Several days after administration pt. developed fatigue, hair, vomiting, diarrhea, still going 2 wks after administration.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pregnancy test, Urine analysis, Vomiting
Clinical narrative: Several days after administration pt. developed fatigue, hair, vomiting, diarrhea, still going 2 wks after administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness at injection site "rash per patient", she reported it to us 8/22/12.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abnormal behaviour, Dizziness
Clinical narrative: 30 mins after receiving MENACTRA #1 & HPV #1 mom states pt had behavioral changes, dizziness & "acted drunk" until about 9 pm the same day.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying
Clinical narrative: Cried up to five hours on day vaccines given, somewhat consolable. No treatment given as we were notified 1 month after event.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 73 year old female patient with glaucoma, depression, high cholesterol and pentazocine and TALWIN allergy who on 15-AUG-2012 was vaccinated with dose 1 PNEUMOVAX23, intramuscular in her left arm (lot number reported as 1258AA, expiration date 24-APR-2013) and FLUZONE, in her left arm (route, lot number and expiration date were not provided). Concomitant medications included FLUOXETINE, MELOXICAM, BUSPAR, AZOPT, TRAVATAN, brimonidine tartrate, COMBIGAN, ZOCOR and TRAZODONE HYDROCHLORIDE. The pharmacist stated that on 15-AUG-2012, after the vaccination, latter at night, the patient's left arm became red and hot form the shoulder to the elbow. No treatment information was reported. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 73 year old female patient with glaucoma, depression, high cholesterol and pentazocine and TALWIN allergy who on 15-AUG-2012 was vaccinated with dose 1 PNEUMOVAX23, intramuscular in her left arm (lot number reported as 1258AA, expiration date 24-APR-2013) and FLUZONE, in her left arm (route, lot number and expiration date were not provided). Concomitant medications included FLUOXETINE, MELOXICAM, BUSPAR, AZOPT, TRAVATAN, brimonidine tartrate, COMBIGAN, ZOCOR and TRAZODONE HYDROCHLORIDE. The pharmacist stated that on 15-AUG-2012, after the vaccination, latter at night, the patient's left arm became red and hot form the shoulder to the elbow. No treatment information was reported. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (lot # reported as H006530, exp date 09-MAR-2014) on an unknown date. On an unknown date the patient experienced an unspecified injection site reaction. The patient sought for medical attention via unspecified contact. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a consumer refers to her niece of unknown age on an unknown date was vaccinated with the second dose of GARDASIL (Dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient had an allergic reaction to the second dose of GARDASIL. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient had an allergic reaction was unknown for GARDASIL. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a certified pharmacy technician (CPhT) concerning a patient who on 05-JUN-2012, "yesterday" was vaccinated with a dose of exposed MMR II (Lot#666834/0284Z, Exp Date: 12-FEB-2012). No adverse effects reported. Follow up information has been received from a health care professional concerning a 5 year old male patient who on 05-JUN-2012 at 16:45, was vaccinated with the first dose of MMR II that was outdated (12-FEB-2012), subcutaneously in the left thigh. No further information is available.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: This spontaneous report was received from a other health professional refers to a 15 years old male patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, who on 10-JUL-2012 at 11:30, was vaccinated subcutaneously in her left deltoid with the first dose of VARIVAX (lot number 1274AA) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUL-2012 the patient experienced erythema multiforme with fever 102. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for erythema multiforme and fever 102 was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 54 year old female patient who on approximately 24-MAY-2012 (reported as about 3 weeks ago) was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On approximately 24-MAY-2012 (reported as about 3 weeks ago) the patient had a lot of swelling and redness at the injection site. The patient did not seek medical attention. At the time of report, the patient was recovered. Follow up information was received from the registered pharmacist reporting that the 54 year old female patient with a previous history of shingles and no illness at the time of vaccination, on 22-MAY-2012 at 14:00 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (subcutaneously on her upper back arm, it was the arm that had shingles (lot number 669862/0363AA, Exp. Date: 09-JUN-2012). The pharmacist stated that on 23-MAY-2012, the patient's arm had a lump with a fever and it itched. The experience lasted two weeks and in June 2012, it went away on its own (Also reported as not recovered. The relatedness for a lot of swelling at the injection site, patient had an arm with a lump that itched, patient had an arm with a fever and a lot of redness at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 54 year old female patient who on approximately 24-MAY-2012 (reported as about 3 weeks ago) was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On approximately 24-MAY-2012 (reported as about 3 weeks ago) the patient had a lot of swelling and redness at the injection site. The patient did not seek medical attention. At the time of report, the patient was recovered. Follow up information was received from the registered pharmacist reporting that the 54 year old female patient with a previous history of shingles and no illness at the time of vaccination, on 22-MAY-2012 at 14:00 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (subcutaneously on her upper back arm, it was the arm that had shingles (lot number 669862/0363AA, Exp. Date: 09-JUN-2012). The pharmacist stated that on 23-MAY-2012, the patient's arm had a lump with a fever and it itched. The experience lasted two weeks and in June 2012, it went away on its own (Also reported as not recovered. The relatedness for a lot of swelling at the injection site, patient had an arm with a lump that itched, patient had an arm with a fever and a lot of redness at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a 24 years old female consumer refers to herself who was not pregnant with no pertinent medical history. The patient was vaccinated intramuscularly with first, second and third doses of 0.5 ml GARDASIL (lot number not reported) respectively on 19-SEP-2007, month 2 (approximately in November 2007) and month 6 (approximately in March 2008). Concomitant medications included ORTHO TRI-CYCLEN. The patient fainted within 5 minutes with the fist and second dose of GARDASIL. The patient was told to lie down and had a cold compress applied for treatment. The patient had sought unspecified medical attention. The outcome was unknown. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old female patient. The patient was vaccinated SC. into left arm with a dose of ZOSTAVAX (lot # (670820/0660AA, expired date 04-AUG-2012), 0.65 ml, on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to himself, who was a male patient of unknown age with none pertinent medical history and none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously "about 3 years ago", approximately in 2009. No concomitant medications were reported. It was reported that the patient had since then subsequently developed shingles. The patient had experienced 1 out outbreak of shingles. Treatment was given by using VALTREX. And the shingles was "very limited and responded quickly to VALTREX". The outcome of shingles was reported as recovered on an unspecified date. The patient sought for medical attention via an office visit. This is one of several reports received from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not provided). No other co-suspects were reported. On an unknown date, the patient experienced unspecified adverse event after the patient received GARDASIL. No treatment information was reported. At the time of the report, the patient's outcome was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 58 years old female patient with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot number 0363AE; Expired date 16-MAR-2013) on 21-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2012 the patient experienced injection site reaction involving 2 inches of swollen, bruising and warm area after the vaccination with ZOSTAVAX. Ice treatment was given for adverse event. The patient was not recovered at the time of report. The patient had seen the pharmacist for medical attention. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 12 month old patient who on 31-MAY-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 671913/1945AA). The nurse mentioned that on 14-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 12 month old male patient with a history of rash and lactose intolerance and no illness at the time of vaccination who on who on 31-MAY-2012, was vaccinated SQ in the left leg with the first dose of VARIVAX (Merck) (lot# 671913/1945AA) at 19:00 pm. The nurse reported that the patient went to the clinic on 14-JUN-2012 with a rash described as "several erythematous papules with vesicles developing on arms and legs". The patient was diagnosed with varicella. At the time of the report, the patient's outcome was unknown. The patient did not have any testing done. A lot check has been initiated. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash, Rash pustular, Scab
Clinical narrative: Information has been received from a nurse concerning a 24 month old patient who on 19-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 24-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 2 year old female patient with no pre-existing allergies no birth defects and no medical conditions and no illness at the time of vaccination who on 19-SEP-2011, was vaccinated with the first dose of VARIVAX (Merck) (lot# not provided). The nurse reported that the patient went to the clinic with a healing rash described as "patient had a fever of 103, the following day she broke out into rash (vesicles and pustules), rash began on genitals then arms and legs. The rash were scabs for past 3 days. The patient had a daycare with other children with same rash". The patient was diagnosed with varicella. The patient did not have any testing done. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 24 month old patient who on 19-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 24-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 2 year old female patient with no pre-existing allergies no birth defects and no medical conditions and no illness at the time of vaccination who on 19-SEP-2011, was vaccinated with the first dose of VARIVAX (Merck) (lot# not provided). The nurse reported that the patient went to the clinic with a healing rash described as "patient had a fever of 103, the following day she broke out into rash (vesicles and pustules), rash began on genitals then arms and legs. The rash were scabs for past 3 days. The patient had a daycare with other children with same rash". The patient was diagnosed with varicella. The patient did not have any testing done. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 4 years old female patient. The patient was vaccinated with lot # (666029/1456Y) RECOMBIVAX HB (dose and route not reported) on 16-AUG-2012, that expired 06-AUG-2012. No adverse event effect had been reported or observed. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Papule, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 26 month old patient who on 24-FEB-2011 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 667920/0860Z). the nurse mentioned that on 23-APR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports form the same source. Follow up information has been received from the registered nurse concerning the male patient with no illness at the time of the vaccination. The patient's medical history included bronchiolitis, croup and eczema. The patient was vaccinated subcutaneously in the left leg with lot # (667920/0860Z) dose 1 of VARIVAX (oka/merck) (VARIVAX) on 24-FEB-2011 at 15:30hrs. No other co-suspects and no concomitant medications were reported. On 23-APR-2012 the patient went to the clinic with rash described as "scattered small papules and vesicles; some intact, others with scabs-bilat arms, back "s/ of abdomen and s/ of legs, lots of excoriation. No edema, scaling or petechial". The patient was diagnosed with varicella. No treatment information was reported. No lab diagnostic testing was performed. The patient was seen on 11-JUN-2012 and had no rash, the outcome of the patient's events was reported as recovered. The relatedness for the reported events was not provided for VARIVAX (Oka/Merck). Alot check has been initiated. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Health care worker refers to a patient of unknown age who on 02-AUG-2012 were vaccinated with a dose of MMR II, (lot# 670592/0872AA) (dose and site of administration were not reported). Other suspect therapies given on the same day included a dose of VARIVAX (lot # 670723/1210AA) (dose and site of administration were not provided). No concomitant medications were reported. Health care worker reported that both doses of vaccine were reconstituted with vials of sterile water diluent, lot # (G001720) which had expired in July 2012. No adverse events were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Antibody test negative, Hand-foot-and-mouth disease, Rash pruritic, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 years old male patient with asthma and with no drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of VARIVAX (lot number 1474Z, expired on 29-OCT-2012) on 22-APR-2011. There was no other concomitant medication. On 06-JUL-2012 the patient developed hand and mouth disease. The patient developed itchy rash allover the body except his back and scalp. The patient had no fever. On 23-JUL-2012 the patient had a varicella titer test but the titer was negative. The patient sought for unspecified medical attention. No treatment was given. On 26-JUL-2012 the patient recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to his wife of unknown age with none pertinent medical history and none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously "about 3 years ago", approximately in 2009. No concomitant medications were reported. It was reported that the patient had since then subsequently developed shingles. The patient had experienced 3 outbreaks of shingles. Treatment was given by using VALTREX. And each case of the shingles was "very limited and responded quickly to VALTREX". The outcome of shingles was reported as recovered on an unspecified date. The patient sought for medical attention via an office visit. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, PNC, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
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 an unspecified number of patients of unknown age. The patients were vaccinated with a dose of MMR II (lot #, dose and route not reported) on unspecified dates. The nurse reported that over the last 2 months (since approximately June 2012), patients may have been administered vaccinees that had been improperly stored. No adverse effects were reported. At the time of the report, the nurse was unable to confirm the number or identities of the patients who may have been involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received form a pharmacist concerning a patient of unknown age and gender who on an unknown date might had received 4 times the recommended dose of PNEUMOVAX 23 (dose, route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist refers to her 7 years old daughter with no pertinent medical history and no drug reactions or allergies, who on an unknown date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 27-JUL-2012, her daughter broke out in a rash that looked like chickenpox. Oatmeal bath was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for patient broke out in a rash that looked like chicken pox was unknown for VARIVAX (Merck). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a two patients of unknown age who on 18-JUL-2012, were vaccinated with a dose of VARIVAX (Merck) (lot number 669557/1700Z, Exp. Date: 12-SEP-2012, also reported as 09-DEC-2012) (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter who on an unknown dates was vaccinated with the three doses of GARDASIL (dose, route and lot numbers not reported) but they were administered not in the correct time frame. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 23-JUN-2011. The patient was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported) late on 10-JUL-2012. The patient was not experiencing any known symptoms. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX lot # (669692/0615AA) (dose and route not reported) on 04-AUG-2012. That expired on 02JUL2012. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who sometime in June 2012, was vaccinated subcutaneously with an usually dose of MMR II (dose and lot number not reported) that was reconstituted in an expired diluent. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 years female patient with no pertinent medical history and with no drug reactions or allergies. The patient was vaccinated intramuscularly with the complete series of three doses of GARDASIL (Lot # and dose not reported) on unspecified dates. No other concomitant medications. On 01-AUG-2011 a pap smear found that the patient had become infected by 13 HPV types. including types 16 and 18, at some point after the vaccinations. It was not known if the patient sought for medical attention. No treatment was given. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first, second and third 0.5 ml dose of GARDASIL (Lot # not reported) respectively on 30-SEP-2011, 02-DEC-2011 and 06-JAN-2012. It was not known if the patient sought for medical attention. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a two unspecified patient of unknown age who sometime in May 2012, were vaccinated subcutaneously with a dose of MMR II (dose and lot numbers not reported) that were reconstituted in an expired diluent. No adverse effects were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 months old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Age: 7.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a consumer refers to his niece, a 7 years old female patient with allergic to gluten as an infant (the consumer thought that the patient had since passed). The patient was vaccinated intramuscularly with a "standard 1st dose in the arm" of GARDASIL on 09-AUG-2012. No concomitant medications were reported. On 09-AUG-2012 the patient broke out in red bumps all over her arms and legs. BENADRYL was given for the AE. It was being evaluated as to whether or not the patient would continue with the series of GARDASIL. There was no lab diagnostics studies performed. At the time of reporting, the patient was recovering. The patient did not seek any medical attention as the doctor told her to just take BENADRYL. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, site and lot number not provided). Subsequently, two days after receiving ZOSTAVAX (Merck), the patient experienced rash. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: This spontaneous report was received from a physician refers to a 49 days old male patient. The patient was vaccinated orally with the first dose ROTATEQ (lot # reported as 0033AE) on 27-JUL-2012. Concomitant therapy included PENTACEL. On 28-JUL-2012 the patient experienced bloody mucus in the stool with no fever or other apparent changes. The physician decided not to give the patient dose 2 and 3 ROTATEQ. No treatment was given for the AE. The therapy of oral ROTATEQ was discontinued. The AE was improved after stopping therapy of oral ROTATEQ. The outcome of bloody mucus in the stool was recovered on an unspecified date. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a Bachelor of Science in Nursing refers to a patient who was vaccinated with the first dose of VAQTA on 27-DEC-1995 and the second dose on 22-MAY-1996. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.