chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Hypersensitivity, Rash
Clinical narrative: rash; shingles; rash and redness behind the ear; hypersensitivity reaction; This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) (batch number 272M2, expiry date 7th December 2021) for prophylaxis.   On 6th April 2020, the patient received Shingrix. On 9th April 2020, 3 days after receiving Shingrix, the patient experienced rash, shingles, erythema and hypersensitivity reaction. On an unknown date, the outcome of the rash, shingles, erythema and hypersensitivity reaction were unknown.   It was unknown if the reporter considered the rash, shingles, erythema and hypersensitivity reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix and 3 days later came back with a rash and redness behind the ear which she deemed to be a hypersensitivity reaction. Five days after that he presented with what appeared to be a case of shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The reporter reported that her neighbor received Shingrix. The patient was in her 60s. The patient was fine after the 1st dose, but felt sick for one day after the 2nd dose.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; the patient was 17 years old, he received first dose of GARDASIL 9 on 7/29/2016 and the second dose ofGARDASIL 9 on 8/10/2017.; This spontaneous report was received from an administrator referring to a 17 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 29-JUL-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 10-AUG-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Abscess drainage, Injection site abscess, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Patient developed an abscess on the left thigh where he received his 2nd dose of Pediarix and HIB. It initially started as a hard knot but then became red and fluctuatant about 1 month after the shots. He was seen in the office on 2/21/2 and advised to use warm compresses and started on PO Bactrim. He returned 1 week on 2/28/20 later due to no improvement and the abscess was drained in the PCP office. Abscess recurred and the patient was seen again on 3/13/20. An US of the abscess was done at that time which showed a superficial 2.5 x 2.4 x 0.7 complex irregular collection which is partially fluid-filled and extends to the fascia and along the anterior muscle plane. He was seen by Pediatric Surgery and it was drained again with loculations broken upon 3/20/30.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient developed an abscess on the left thigh where he received his 2nd dose of Pediarix and HIB. It initially started as a hard knot but then became red and fluctuatant about 1 month after the shots. He was seen in the office on 2/21/2 and advised to use warm compresses and started on PO Bactrim. He returned 1 week on 2/28/20 later due to no improvement and the abscess was drained in the PCP office. Abscess recurred and the patient was seen again on 3/13/20. An US of the abscess was done at that time which showed a superficial 2.5 x 2.4 x 0.7 complex irregular collection which is partially fluid-filled and extends to the fascia and along the anterior muscle plane. He was seen by Pediatric Surgery and it was drained again with loculations broken upon 3/20/30.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Flu like symptoms started the next morning after the second shot, approximately 14 hours.  Fever, chills, body aches, nausea, headache and tiredness all presented very prominently about 24 hours after the shot.  I had to miss the next day at work (second day) due to fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms started the next morning after the second shot, approximately 14 hours.  Fever, chills, body aches, nausea, headache and tiredness all presented very prominently about 24 hours after the shot.  I had to miss the next day at work (second day) due to fever.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Irritability
Clinical narrative: increased redness; increased fussiness; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA103148 and 2020SA103147 via same reporter.  This case involves a 14 months old female patient who experienced increased redness and increased fussiness (erythema and irritability), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) ; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  The patient received 0.5 ml first and second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route at the left thigh for prophylactic vaccination on 19-Feb-2020 and 16-Apr-2020. Lot and expiry date powder and liquid vial was reported as UJ164AB,U6622AA and 16-Feb-2021, 16-Feb-2021).  On an unknown date, the patient developed non-serious increased redness and fussiness (erythema and irritability) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data were not reported.  Final diagnosis were erythema and irritability.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Irritability
Clinical narrative: increased redness; increased fussiness; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA103148 and 2020SA103059 via same reporter.  This case involves a 2 months, 1 week and 3 days old female patient who experienced increased redness and fussiness (erythema and irritability), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 13-Apr-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route at the right thigh for prophylactic vaccination. Lot and expiry date powder and liquid vial was reported as UJ164AB,U6622AA and 16-Feb-2021, 16-Feb-2021).  On an unknown date, the patient developed non-serious increased redness and fussiness (erythema and irritability) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data were not reported.  Final diagnosis was erythema and irritability.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Irritability, Pyrexia
Clinical narrative: increased redness; increased fussiness; had a fever of 99.8 F; Initial information received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA103059 and 2020SA103147 via same reporter.  This case involves a 2 months old female patient who experienced increased redness and fussiness (erythema and irritability) and  fever of 99.8 Fahrenheit (pyrexia) , while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR).  On 16-Apr-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ164ABA and expiry date 16-Feb-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 17-Apr-2020, the patient developed a non-serious increased redness and fussiness (erythema and irritability) and  fever of 99.8 Fahrenheit (pyrexia) 1 day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Laboratory test results included: Body temperature - 99.8 Fahrenheit   Final diagnosis were pyrexia, erythema and irritability.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Asthenia, Feeling hot, Head injury, Headache, Hypertension
Clinical narrative: About 3 and 1/2  hours after receiving the 3 vaccines she fainted. She was completely unconscious for about 15 seconds. When she woke up she said her head hurt, she was hot and she felt weak. She did hit her head when she fell. She said right before she suddenly felt very tired and then remembered waking up. Only other symptoms were pain in each arm from injections. An ambulance was called and they said everything looked ok and she felt better. Since then she's had no other symptoms besides slight pain in her arms.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Loss of consciousness, Pain in extremity, Syncope
Clinical narrative: About 3 and 1/2  hours after receiving the 3 vaccines she fainted. She was completely unconscious for about 15 seconds. When she woke up she said her head hurt, she was hot and she felt weak. She did hit her head when she fell. She said right before she suddenly felt very tired and then remembered waking up. Only other symptoms were pain in each arm from injections. An ambulance was called and they said everything looked ok and she felt better. Since then she's had no other symptoms besides slight pain in her arms.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Facial paralysis, Pyrexia
Clinical narrative: More than 24 hours (but less than 36 hours) from receiving his 3 vaccines, child developed low grade fever (Tmax 100.4F) and drooping of left face. Seen in ER at outside facility and diagnosed with Bell's Palsy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Autoimmune haemolytic anaemia, Hyperlipidaemia
Clinical narrative: Adverse event; epigastric pain; pelvic pain; unspecified hyperlipidemia; acute upper respiratory tract infection; pain joint, leg/ knee pain; abdominal pain; Insomnia; Autoimmune hemolytic anemia; Information has been received from medical records, concerning a case in litigation and refers to a 58-year-old female patient (pt). Her past vaccination included Tdap on 23-JUN-2011. On 11-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 mL, lot # 1253AA, expiry date was not reported but upon internal validation was established as 01-NOV-2012 (route of administration and vaccination site were not specified) for prophylaxis. On 13-MAR-2012, the pt had a hospital discharge follow-up (dates and reason for hospitalization were not reported). On 22-MAR-2012, the pt presented for hospital discharge f/u and was diagnosed with autoimmune hemolytic anemia. On 22-MAY-2012, she presented for routine general medical examination, autoimmune hemolytic anemia and unspecified insomnia. on 17-MAR-2014, she was diagnosed with abdominal pain. On 24-MAR-2014, she presented for abdominal pain. On 24-APR-2014, she had routine general medical examination and screening for diabetes mellitus. She was also diagnosed  with insomnia. On 23-JUL-2014, the pt was seen for knee pain (pain in joint). On 15-DEC-2014, she was diagnosed with acute upper respiratory tract infection and insomnia. On 25-FEB-2015, she presented with abdominal pain. On 26-MAY-2015, she was diagnosed with unspecified hyperlipidemia. On 29-AUG-2015 and 10-JUL-2015, she presented with abdominal pain. On 24-OCT-2015, she was diagnosed with abdominal pain and pelvic pain. On 06-SEP-2017, she was diagnosed with epigastric pain. On 21-SEP-2017, she was diagnosed with unspecified abdominal pain. The outcome of the events and the causality assessment were not provided.    Upon internal review, the event of autoimmune hemolytic anemia was determined to be medically significant.   All available medical records will be provided upon request.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pelvic pain, Upper respiratory tract infection
Clinical narrative: Adverse event; epigastric pain; pelvic pain; unspecified hyperlipidemia; acute upper respiratory tract infection; pain joint, leg/ knee pain; abdominal pain; Insomnia; Autoimmune hemolytic anemia; Information has been received from medical records, concerning a case in litigation and refers to a 58-year-old female patient (pt). Her past vaccination included Tdap on 23-JUN-2011. On 11-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 mL, lot # 1253AA, expiry date was not reported but upon internal validation was established as 01-NOV-2012 (route of administration and vaccination site were not specified) for prophylaxis. On 13-MAR-2012, the pt had a hospital discharge follow-up (dates and reason for hospitalization were not reported). On 22-MAR-2012, the pt presented for hospital discharge f/u and was diagnosed with autoimmune hemolytic anemia. On 22-MAY-2012, she presented for routine general medical examination, autoimmune hemolytic anemia and unspecified insomnia. on 17-MAR-2014, she was diagnosed with abdominal pain. On 24-MAR-2014, she presented for abdominal pain. On 24-APR-2014, she had routine general medical examination and screening for diabetes mellitus. She was also diagnosed  with insomnia. On 23-JUL-2014, the pt was seen for knee pain (pain in joint). On 15-DEC-2014, she was diagnosed with acute upper respiratory tract infection and insomnia. On 25-FEB-2015, she presented with abdominal pain. On 26-MAY-2015, she was diagnosed with unspecified hyperlipidemia. On 29-AUG-2015 and 10-JUL-2015, she presented with abdominal pain. On 24-OCT-2015, she was diagnosed with abdominal pain and pelvic pain. On 06-SEP-2017, she was diagnosed with epigastric pain. On 21-SEP-2017, she was diagnosed with unspecified abdominal pain. The outcome of the events and the causality assessment were not provided.    Upon internal review, the event of autoimmune hemolytic anemia was determined to be medically significant.   All available medical records will be provided upon request.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE LAST TWO DOSES OF VIVOTIF ON TIME; This spontaneous case (PVX2019-1562) report was received from a pharmacist on 17-Jun-2019. It describes an adult female consumer who "missed to take last two doses of Vivotif on time". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 10-Jun-2019 and 12-Jun-2019, respectively, but missed to take her last two doses.  Action taken with Vivotif was not applicable   The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take last two doses of Vivotif on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last two doses of Vivotif on time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: DID NOT COMPLETE VIVOTIF COURSE ONE WEEK BEFORE TRAVEL; TOOK THREE UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1808) was received from a caregiver on 15-Jul-2019. It describes a 16-year-old adolescent female consumer who "took three unrefrigerated doses" (PT: Product storage error) and "did not complete Vivotif course one week before travel" (PT: Inappropriate schedule of product administration). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid prophylaxis.  Case report: The consumer took three unrefrigerated doses of Vivotif on 07-Jul-2019, 09-Jul-2019, and 11-Jul-2019, respectively. Then, she bought new pack of Vivotif and took first dose from it on 13-Jul-2019. She had a planned trip on 20-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" and "did not complete Vivotif course one week before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses" and "did not complete Vivotif course one week before travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case report (PVX2019-1960) was received from a nurse on 29-Jul-2019. It described a 79-year-old elderly female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took second and the third dose of Vivotif in a row. The doses were taken on 26-Jul-2019, 28-Jul-2019, and 29-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1973) was received from a pharmacist on 30-Jul-2019. It described a 49-year-old adult female consumer who "took unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The Vivotif was dispensed on 26-Apr-2019 and was left out at room temperature. The consumer completed the full course with unrefrigerated doses of Vivotif taking doses on 22-Jul-2019, 24-Jul-2019, 26-Jul-2019, and 28-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE FOOD 10 MINUTES AFTER TAKING VIVOTIF; DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1964) was received from a nurse on 30-Jul-2019. It described a female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration) and also "ate food 10 minutes after taking Vivotif" (PT: Product administration error). The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take Vivotif according to schedule and ate food 10 minutes after taking the fourth dose of Vivotif. The doses were taken on 22-Jul-2019, 24-Jul-2019, 27-Jul-2019 and 30-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" and also "ate food 10 minutes after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" and also "ate food 10 minutes after taking Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: FORGOT TO TAKE REMAINING DOSES AFTER SECOND DOSE; This spontaneous case report (PVX2019-2440) was received from a pharmacist on 25-Sep-2019. It described a male consumer who "forgot to take remaining doses after second dose" (PT: Product dose omission), during oral Vivotif schedule, for typhoid fever prophylaxis.  Case report: The consumer took only two doses of Vivotif on day 1 and day 3. Then, he forgot to take remaining other two doses.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take remaining doses after second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take remaining doses after second dose" was considered as not applicable.
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2466) was received from a consumer on 30-Sep-2019. It described a female consumer who "took unrefrigerated dose of Vivotif" (PT: Product storage error), while therapy on Vivotif (lot no: 3003281) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 28-Sep-2019, which was left out of the refrigerator for almost 24 hour. On 30-Sep-2019, she took the second dose.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated dose of Vivotif" was considered as not applicable.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Eye movement disorder, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Vaccine was administered to pt and immediately following pt became pale and diaphoretic, and eyes rolled back and pt began to collapse. Pt was assisted into a laying position on exam table and ice pack was applied to back of neck. Pt aroused within a few seconds and layed for another 5 minutes. She was assisted to sitting position and was given apple juice and she was able to drink it. PA-C did enter exam room and check on pt after syncopal episode. Pt remained for 30 minutes of observation after episode. Color returned after juice was given and pt had no further c/o. Vital signs taken and were stable.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Flare of chronic inflammatory arthritis in chest and extremities.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Ataxia, Coordination abnormal, Dyspnoea, Dysstasia
Clinical narrative: Heart Palpitations, difficulty breathing, foot drop, ataxia, uncoordinated movement, blurred vision, muscles aches, cramping, flank pain in left and right flank, kidney pain in lift and right kidney area, severe tremors in left hand/arm severe tremor in right hand/arm, severe tremor in right leg. Inability to walk or stand in excess of 16 hours a day for 11 consecutive days. Experience complete muscle freezing (Frozen Man Syndrome) for 11 days. Sequel, increase in nephropathy symptoms in  arms and legs. Pain and severe muscle cramping  in back legs and neck. Painful lymph nodes in legs arm pits and neck. Patient experienced inability to walk or stand in excess of 16 hours a day.  Patient was week and uncoordinated and unable to judge distances and experienced bumping into walls and tripping on floor rugs.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Flank pain, Gait disturbance, Hypersensitivity, Lymph node pain, Muscle disorder
Clinical narrative: Heart Palpitations, difficulty breathing, foot drop, ataxia, uncoordinated movement, blurred vision, muscles aches, cramping, flank pain in left and right flank, kidney pain in lift and right kidney area, severe tremors in left hand/arm severe tremor in right hand/arm, severe tremor in right leg. Inability to walk or stand in excess of 16 hours a day for 11 consecutive days. Experience complete muscle freezing (Frozen Man Syndrome) for 11 days. Sequel, increase in nephropathy symptoms in  arms and legs. Pain and severe muscle cramping  in back legs and neck. Painful lymph nodes in legs arm pits and neck. Patient experienced inability to walk or stand in excess of 16 hours a day.  Patient was week and uncoordinated and unable to judge distances and experienced bumping into walls and tripping on floor rugs.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Muscle spasms, Myalgia, Nephropathy, Palpitations, Peroneal nerve palsy
Clinical narrative: Heart Palpitations, difficulty breathing, foot drop, ataxia, uncoordinated movement, blurred vision, muscles aches, cramping, flank pain in left and right flank, kidney pain in lift and right kidney area, severe tremors in left hand/arm severe tremor in right hand/arm, severe tremor in right leg. Inability to walk or stand in excess of 16 hours a day for 11 consecutive days. Experience complete muscle freezing (Frozen Man Syndrome) for 11 days. Sequel, increase in nephropathy symptoms in  arms and legs. Pain and severe muscle cramping  in back legs and neck. Painful lymph nodes in legs arm pits and neck. Patient experienced inability to walk or stand in excess of 16 hours a day.  Patient was week and uncoordinated and unable to judge distances and experienced bumping into walls and tripping on floor rugs.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Renal pain, Tremor, Vision blurred
Clinical narrative: Heart Palpitations, difficulty breathing, foot drop, ataxia, uncoordinated movement, blurred vision, muscles aches, cramping, flank pain in left and right flank, kidney pain in lift and right kidney area, severe tremors in left hand/arm severe tremor in right hand/arm, severe tremor in right leg. Inability to walk or stand in excess of 16 hours a day for 11 consecutive days. Experience complete muscle freezing (Frozen Man Syndrome) for 11 days. Sequel, increase in nephropathy symptoms in  arms and legs. Pain and severe muscle cramping  in back legs and neck. Painful lymph nodes in legs arm pits and neck. Patient experienced inability to walk or stand in excess of 16 hours a day.  Patient was week and uncoordinated and unable to judge distances and experienced bumping into walls and tripping on floor rugs.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP
Symptoms: Allergy test, Milk allergy, Muscle twitching, Rash erythematous, Tremor
Clinical narrative: The same night baby started  having body tremors and twitching. Within 48 hours was unable to tolerate formula and would projectile vomit every bottle. Baby developed an allergy to all formulas. Baby had a pink/red sandpaper like rash on cheeks that developed.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP
Symptoms: Vomiting projectile
Clinical narrative: The same night baby started  having body tremors and twitching. Within 48 hours was unable to tolerate formula and would projectile vomit every bottle. Baby developed an allergy to all formulas. Baby had a pink/red sandpaper like rash on cheeks that developed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak 7 weeks after injection in the setting of NO stressors.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient's son came to pharmacy to pick up antiviral medication a few weeks after their 2nd dose of Shingrix. Son stated that mother had mild/moderate shingle like rash across mid section of body sometime after receiving the 2nd vaccine. Reporter informed patient's son that while no therapy is perfect, that this is not a typical outcome, and that this information would be reported to manufacturer through due processes.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Continue pain at injection site; unable to lift arm over head without pain. Pain started within one day of injection.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash & shingles VALACYCLOVIR 1 GM BID
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Chest X-ray, Culture urine, Febrile convulsion, Laboratory test normal, Otitis media
Clinical narrative: Febrile seizure 4-11-2020 ER visit 103 fever Labs - normal Treated in ER for otitis media rt ear
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Respiratory viral panel, Urine analysis
Clinical narrative: Febrile seizure 4-11-2020 ER visit 103 fever Labs - normal Treated in ER for otitis media rt ear
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Dyskinesia, Muscle twitching
Clinical narrative: About 24' after vaccines given, pt had 2 separate episodes of jerking of arms & head twitch to side with mouth open. The jerking happened q5 sec and lasted 15 min. No LOC. Temp 100.6, Tylenol given after 1st episode. Gave 3 days of Tylenol yesterday. Pt up more at night. By 4/15/20 morning pt was back to normal. No episodes. 99' temp.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age and his spouse. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 11-JUL-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)) pt suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). He also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. Pt's wife holds a derivative claimed for her loss of consortium as a result of pt's injuries. Pt's sustained severe and permanent personal injuries. Pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Herpes zoster has been considered a disabling event by the reporter.
Sex: F
Vaccine: TYP
Symptoms: Dysphagia, Dyspnoea, Swelling face
Clinical narrative: SWELLING FACE; TROUBLE IN BREATHING; TROUBLE IN SWALLOWING; This spontaneous case (794331-1) was extracted through VAERS database on 26-Apr-2019. It describes a 24-year-old female consumer had swelling face, trouble in breathing, and trouble in swallowing, after the administration of oral Vivotif (lot no: 3003238) for travelling.  Case report: The consumer took the first dose of Vivotif on 27-Dec-2018 at 11 am. Later, at 3 pm, her face started to swell and she had trouble in breathing and swallowing. She took Benadryl (diphenhydramine) for it and the events got resolved, but came back at 11 pm. Again, she took Benadryl and events were resolved.   She also reported that she has had injection for travelling. On 01-Feb-2019, she received injections for typhoid and did not have any reaction.   The consumer had no medical history.  The consumer had no laboratory test.  Action taken with Vivotif was unknown.  The consumer had recovered from the events of swelling face, trouble in breathing, and trouble in swallowing.  Company's Comment: In this case, it was reported that the consumer had swelling on her face, trouble in breathing, and trouble in swallowing, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had swelling on her face, trouble in breathing, and trouble in swallowing, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: RASH; This spontaneous case (795308-1) was extracted through VAERS database on 26-Apr-2019. It describes a 67-year-old female consumer who had rash, after the administration of oral Vivotif (lot no: 3003238) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 19-Dec-2018 and developed rash to right side of face. Then, she took the second dose on 21-Dec-2018 and rash spread to the left side of face to neck. Apart from this she had no itching or any other symptoms.  The consumer was allergic to Biaxin, it causes wheezing to her.  The consumer had no laboratory test.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the event of rash.  Company's Comment: In this case, it was reported that the consumer had rash, four to five days after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash, four to five days after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: FLU4, TYP
Symptoms: Fatigue, Incoherent, Nail discolouration, Nausea, Somnambulism
Clinical narrative: NAIL DISCOLORATION; SLEEPWALKING; INCOHERENT; EXHAUSTION; This spontaneous case (798409-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by a consumer via health authority. It describes an 8-year-old female consumer who experienced nail discoloration, exhaustion, sleepwalking, and incoherent, while being on oral Vivotif (lot no: 3003220) and intramuscular Fluzone quadrivalent (influenza virus vaccine) (lot no: UJO28AB) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 24-Jan-2019 and within one hour, she experienced nausea and exhaustion which continued throughout the day. Also, he was sleepwalking and incoherent. Then, next morning he felt better.  Action taken with Vivotif and Fluzone quadrivalent was unknown.   The consumer had recovered from the events of nail discoloration, exhaustion, sleepwalking, and incoherent.  Company's Comment: In this case, an 8-year-old female consumer who experienced nail discoloration, exhaustion, sleepwalking, and incoherent, following administration of Vivotif and Fluzone quadrivalent (influenza virus vaccine). There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.; Sender's Comments: Company's Comment: In this case, an 8-year-old female consumer who experienced nail discoloration, exhaustion, sleepwalking, and incoherent, following administration of vivotif and Fluzone quadrivalent (influenza virus vaccine). There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.
Sex: F
Vaccine: TYP
Symptoms: Blister, Blood culture, Diarrhoea, Pruritus, Rash
Clinical narrative: BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; RASH ON TORSO, BILATERAL ARMS AND HANDS; DIARRHEA; This spontaneous case report (827455-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. It described a 59-year-old female consumer who had blister itching and draining/ secretion discharge (PT: Blister, Pruritus, and Secretion discharge), rash on torso, bilateral arms and hands (PT: Rash) and diarrhea (PT: Diarrhoea), while being on oral Vivotif for an unknown indication.  Case report: The consumer took second dose of Vivotif on 29-Jul-2019. On 31-Jul-2019, she had rash, blister itching and draining, secretion discharge, and she had rash on torso, bilateral arms and hands and diarrhea.  Medical history included HTN (hypertension), hypothyroid, celiac disease, dermatitis, anaemia, polyarthralgia, restless leg, and rosacea.  Allergy included tuna allergy, gluten allergy, morphine allergy, and erythromycin allergy.  Lab test included aerobic swab culture taken from rash and blood culture ordered on 07-Aug-2019.  Concomitant medications included Olux (clobetasol; foam), clobetasol ointment, Voltaren gel (diclofenac), vitamin D (cholecalciferol), Prozac (fluoxetine), Nizoral shampoo (ketoconazole), Accuretic (quinapril), Requip (ropinirole), Armour thyroid (levothyroxine).  Action taken with Vivotif with respect to the reported events was unknown.  The consumer had not recovered from the reported events.  Company Comment: A consumer took the second dose of Vivotif and then had a blister with secretion discharge, pruritus, rash and diarrhea. The events were not recovered at the time of the report. Considering the case information and potential of Vivotif to cause rash, pruritus, diarrhea, the causality of all the reported events is assessed as possible with Vivotif (confounded by consumer's medical history of dermatitis and celiac disease). The events, blister and secretion discharge are unlabeled as per CCDS. ; Sender's Comments: A consumer took the second dose of Vivotif and then had a blister with secretion discharge, pruritus, rash and diarrhea. The events were not recovered at the time of the report. Considering the case information and potential of Vivotif to cause rash, pruritus, diarrhea, the causality of all the reported events is assessed as possible with Vivotif (confounded by consumer's medical history of dermatitis and celiac disease). The events, blister and secretion discharge are unlabelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Secretion discharge, Skin culture
Clinical narrative: BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; BLISTER ITCHING AND DRAINING/ SECRETION DISCHARGE; RASH ON TORSO, BILATERAL ARMS AND HANDS; DIARRHEA; This spontaneous case report (827455-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. It described a 59-year-old female consumer who had blister itching and draining/ secretion discharge (PT: Blister, Pruritus, and Secretion discharge), rash on torso, bilateral arms and hands (PT: Rash) and diarrhea (PT: Diarrhoea), while being on oral Vivotif for an unknown indication.  Case report: The consumer took second dose of Vivotif on 29-Jul-2019. On 31-Jul-2019, she had rash, blister itching and draining, secretion discharge, and she had rash on torso, bilateral arms and hands and diarrhea.  Medical history included HTN (hypertension), hypothyroid, celiac disease, dermatitis, anaemia, polyarthralgia, restless leg, and rosacea.  Allergy included tuna allergy, gluten allergy, morphine allergy, and erythromycin allergy.  Lab test included aerobic swab culture taken from rash and blood culture ordered on 07-Aug-2019.  Concomitant medications included Olux (clobetasol; foam), clobetasol ointment, Voltaren gel (diclofenac), vitamin D (cholecalciferol), Prozac (fluoxetine), Nizoral shampoo (ketoconazole), Accuretic (quinapril), Requip (ropinirole), Armour thyroid (levothyroxine).  Action taken with Vivotif with respect to the reported events was unknown.  The consumer had not recovered from the reported events.  Company Comment: A consumer took the second dose of Vivotif and then had a blister with secretion discharge, pruritus, rash and diarrhea. The events were not recovered at the time of the report. Considering the case information and potential of Vivotif to cause rash, pruritus, diarrhea, the causality of all the reported events is assessed as possible with Vivotif (confounded by consumer's medical history of dermatitis and celiac disease). The events, blister and secretion discharge are unlabeled as per CCDS. ; Sender's Comments: A consumer took the second dose of Vivotif and then had a blister with secretion discharge, pruritus, rash and diarrhea. The events were not recovered at the time of the report. Considering the case information and potential of Vivotif to cause rash, pruritus, diarrhea, the causality of all the reported events is assessed as possible with Vivotif (confounded by consumer's medical history of dermatitis and celiac disease). The events, blister and secretion discharge are unlabelled as per CCDS.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthritis, Back pain, Patellofemoral pain syndrome, Rheumatoid factor, Tendonitis
Clinical narrative: After Shot I got Arthritis of Bilat Knees. Bilat Patellofemoral Syndrome. Tendinitis of bilat quadriceps Tendon. Dorsalgia
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb
Clinical narrative: After Shot I got Arthritis of Bilat Knees. Bilat Patellofemoral Syndrome. Tendinitis of bilat quadriceps Tendon. Dorsalgia
Sex: M
Vaccine: HPV9
Symptoms: Drug effective for unapproved indication
Clinical narrative: This treatment resulted in complete clinical remission and histologic cure without residual pain and with return of full function of the hand; Given our experience using combined systemic and intratumoral administration of the 9-valent HPV vaccine for SCCs, we offered the same to this patient;  This literature marketed report was received from the authors as stated above concerning a 87 year old male patient. The patient medical history included renal transplant. Other concurrent conditions were not reported. Concomitant medications included mycophenolic acid, tacrolimus and methylprednisolone.  On unspecified dates, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) 2 intramuscular (IM) vaccine injections at 0 and 6 weeks. Two weeks after the second IM dose, the vaccine (0.5 mL) was diluted in 2mL of sterile normal saline and 0.5 mL of 2% lidocaine and was injected intratumorally. Two months after the first intratumoral injection, a second intratumoral dose was administered. Cumulatively, the patient received 2 IM and 2 intratumoral doses. Nine months after the first IM injection of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown). The authors stated that this treatment resulted in complete clinical remission and histologic cure without residual pain and with return of full function of the hand (drug effective for unapproved indication). The observed benefit may be owing to a combination of antiviral, antitumor, and immunologic effects.  The authors considered drug effective fr unapproved indication to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; on 13-MAR-2020 an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies was provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection as prophylaxis (strength, dose, anatomical location, and vaccination scheme frequency were not reported; lot number S022755 verified to be a valid lot number; expiration date was reported as 07-FEB-2021, but upon internal validation established as 22-JUL-2021). The vaccine was stored at a temperature of -13.4 celsius degrees (C°) for a timeframe of 1 hour and 30 minutes (product storage error), without previous temperature excursion. A digital data logger was involved. No additional information or adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported.; A patient received a dose of a vaccine that had been improperly stored; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On 20-APR-2020 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, subcutaneous for prophylaxis (lot number S032353, expiration date 14-OCT-2021). Additionally sterile diluent (MERCK STERILE DILUENT) was reported.  The administered dose of the vaccine experienced a temperature excursion between -9 degrees Celsius to 8 degrees Celsius for 3 hours/59 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  No adverse event was informed by the reporter.