chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her 1st dose of the Shingrix series in the Left deltoid on 9/21/19, she said the next day her arm swelled up and became red and warm to touch. This then went away after about 24-36 hours but has come back on morning of 9/28/19. She came in to pharmacy to ask about reaction, her arm was red and warm to touch. I instructed her to take some NSAIDS (Ibuprofen) and an antihistamine and referred her to contact PCP to be examined for possible cellulitis infection.
Blisters on right side of forehead and scalp, saw healthcare professional on 7/31/2023 and we are treating it like shingles with Valacyclovir HCL 1 gra tablets 3x daily for 7 days and Desonide 0.05% cream.  I am reporting this because it is claimed that: "Can the Shingrix vaccine cause shingles? No. Shingrix contains only a small part of the varicella zoster virus that causes shingles. Shingrix does not contain any live varicella zoster virus."
No adverse effects reported; Patient received unspecified dose of Pedvaxhib that was improperly stored; This spontaneous report was received from a Registered Nurse and was referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 10-MAY-2018, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # N003536, expired date in November 2019, was storage out of the recommended range at 8.72 Celsius Degrees during 1h 35 minutes (total time including previous temperature excursions).  On 02-JUL-2018, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # N003536, expired date in November 2019, (strength, dose, frequency, route, and anatomical location were not reported), for prophylaxis. The digital datalogger was involved. No adverse effects were reported.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received vaccine PENTACEL (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; PREVNAR for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On an unknown date, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U1953AAA via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. Pentacel given to a patient and afterwards the practice received an email that shipment was delayed. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The kid started vomiting intensely during the night at 1:30 am. Then followed fever. Both symptoms lasted until 7:30 pm. Both symptoms brought tiredness and body aches.
Few hours after the first dose, had a mild headache, tired and little achy; first dose, the patient experienced aches, headache and fatigue.; first dose, the patient experienced aches, headache and fatigue. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001C21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, FLUTICASONE, GABAPENTIN, TETRACYCLINE, FINASTERIDE, PSEUDOEPHEDRINE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.). At the time of the report, PAIN (Few hours after the first dose, had a mild headache, tired and little achy), HEADACHE (first dose, the patient experienced aches, headache and fatigue.) and FATIGUE (first dose, the patient experienced aches, headache and fatigue.) outcome was unknown.            No treatment information were provided.   This case was linked to MOD-2021-280015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received and it contains no new information.
Headache & Myalgia Narrative:  Per nursing report: "complaint of severe headache and body ache [2/3/22]. Employee state that she received the Booster (M) vaccine on 2/2/22. "
I early February I had pressure behind my eyes, muffled ears. It felt like I was having some sinus drainage issues, yet it didn't feel like a sinus infection. I started experiencing extreme dizzy sensation in my head, it felt as if when I moved my head it would take a moment for brain to move. I went to a local pharmacy and discovered I had vertigo caused by allergies. I was advised by the pharmacist to try ZYRTEC to clear my allergies. Within the hour of taking the ZYRTEC my symptoms were cleared, it did take five days for the vertigo to be completely gone.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date in March 2014 (also reported as about one to two weeks ago) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) subcutaneous. On an unknown date in March 2014 (also reported as four days after receiving ZOSTAVAX) the patient experienced patchy rash all over her body. The patient sought medical attention and was treated with BENADRYL and MEDROL DOSEPAK. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included Tetanus vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent and Tetanus vaccine. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent and Tetanus vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent and Tetanus vaccine. Additional details were reported as follows: The age at vaccination was not reported. But, it could be 61 or 62 years old. In 2017, the patient received Influenza vaccine Quadrivalent and Tetanus shot on an unknown arm. The patient stated that, she was hardly sore after a tetanus shot and flu shot received in the present year. This case has been linked to case US2018GSK055626, reported for the same patient.
Arm pain for over 3 weeks at the injection site by my right arm, it?s so sore it?s hard to lift hand up or to hold things, also breast pain in the right side that I never had before. This has lasted 3 weeks. Within 48 hours after the shot I had tingling and numbing and soreness. Distressed about my arm pain 3 weeks later it feels like someone punched my arm.
Swelling and pain in lymph node in armpit on same arm as injection site. Pain causing a lot of discomfort- was worried it might be cancer. Pain started 5 days after injection.
This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 17-years-old male patient received TRUMENBA, at single dose and MENACTRA, both on 24Sep2018 for immunisation. Medical history was none. There were no concomitant medications. The patient experienced cellulitis in left arm, headache, fatigue, sweats and chills on 25Sep2018 with outcome of unknown. No fever and vitals were normal. Information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect meningococcal group b rlp2086 contributed to the development of the reported events cellulitis in left arm, headache, fatigue, sweats and chills .
Mother reports child having several seizures, grand mal in appearance.  First one 1/31/06. Pt. did have high fever at time of seizure.
Patient received pneumo vacc. in right shoulder, approximately 4 hours later patient developed rash, pain, red, warm, swollen area measuring 14/14cm. Ice applied BENADRYL IV administered, team to evaluate patient.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 28-JUN-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested
Patient didn't receive full dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of MEDICATION ERROR (Patient didn't receive full dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced MEDICATION ERROR (Patient didn't receive full dose of the vaccine). At the time of the report, MEDICATION ERROR (Patient didn't receive full dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.   No treatment medication were provided.
After receiving 2 mo imm. baby cried while taking bottles for the 1st day.  Then OK next day then cried while bottling for next 2-3 weejs,
Pt is 16 yrs old and given  Pfizer on 6/16/21 for the first dose and Moderna for the second dose on 7/14/21
Fever; Chills; Was miserable/knocked me on my butt; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (For tolerance of 1st dose of shingles vaccine, refer case US2022AMR193075).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and feeling abnormal. On an unknown date, the outcome of the fever, chills and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever, chills and feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR193075   Additional Information: GSK Receipt Date: 23-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The second shot of shingles vaccine knocked him/her on butt with fever and chills for two and half days.  The patient stated that, it was miserable and still better than shingles. Additional Supportive Information: The follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR193075:Same reporter
every joint in my body was super painful; light fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever). At the time of the report, ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-377003, MOD-2021-377031 (Patient Link).
pruritus and rash at injection site on day 4 after administration, spreading and persistent after 2 days
A report was received from a health care professional on 5 November 2003 concerning a 37 year-old female vaccine who experienced a red, swollen area with hot spots on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a red, swollen area with hot spots from shoulder to elbow.  the area was 10 x 10mm.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
Information has been received from a health professional concerning a 9 year old female pt who on 20-JUN-1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 23-APR-2004, the pt developed breakthrough chickenpox with 50 to 500 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603,  WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
pt recv vax 1JUL97 & 14JUL97 was feverish & devel 20 pox on back, chest & one on face accompanied w/body aches;
Extreme chills & shaking - lasted for an hour Killer headache - lasted all night Aches in hips & knees I felt like I had to throw up, but didn't. Ears were itchy inside.
Itching; Swollen left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm) and PRURITUS (Itching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen left arm). On 12-Apr-2021, the patient experienced PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swollen left arm) and PRURITUS (Itching) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided
headache, sinus congestion, runny nose; started on 04/27, still present as of 05/03.
On 1-27-21 my mother received her first dose of the Moderna COVID-19 vaccine (031L2A). The next day she felt something in the back of her left knee. The following day (2 days) after the injection she saw her primary care physician for the discomfort in the back of her knee. She was treated for what was believed to be a soft tissue injury. She received her second dose of the Moderna COVID-19 (14M20A) vaccine on Friday 2-26-21. The next day the back of her knee started to bother her again. She saw her doctor on Monday3-1-21 and had an x-ray. On Tuesday the doctor's office called and said her x-ray  was clear. Friday morning, 3-5-21 my father heard a loud noise (thud) and  found my mother unresponsive on the bathroom floor at approximately 8:30am. He called 911. She was transported to the hospital via ambulance. The emergency room physicians worked on her for over an hour and were unable to get her back. Her time of death was 10:12am. The primary cause of death listed on her death certificate is pulmonary embolism.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided.
Saturday 9/8/18 had the shingles booster shot. At 8am Sunday 9/9/18, felt miserable, and sore throughout the body. Felt bad most of the day, until 9 pm. Noticed swelling in the lip and a cold sore.  On Monday 9/10/18, noticed cold sore on lip and called primary care provider, their earliest available was Tuesday 9/11/18 at 8:15am, and the doctor prescribed Valtrex. Used the Valtrex to treat and the sore is still there on 9/12/18.
Right deltoid area with extensive erythema, warmth from shoulder to just above elbow. Tender to palpitation. Pain with ROM (range of motion) of shoulder.
Increase - flare - of inverse and plaque psoriasis that would not clear with the usual steroid creams that had cleared the psoriasis in the past
Pt given 2nd dose of pfizer vaccination given by LVN  RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney  0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same.  0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating "I think I just have to go home and take a nap" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home.  0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN.   In ED pt  given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv
Information has been received from a registered nurse concerning a 66 year old female who on 05-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 657558/0461U).  On 07-JUN-2007 within twenty four hours of vaccination, the patient experienced injection site reaction.  The reaction was described as a slightly raised red area with a three inch diameter around the injection site.  The patient sought unspecified medical attention.  The outcome was not reported.  There was no product quality complaint.  Additional information has been requested.
Low-grade fever (100.4 F); Body aches; Headache; Injection site pain; bruising injection armpit; lymph node pain and swelling; This is a spontaneous report from a non-contactable consumer (patient herself). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 16Feb2021 10:00 (age at vaccination: 22 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via unknown route, in the left arm on 26Jan2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. On 16Feb2021 15:00, the patient experienced low-grade fever (100.4 f), body aches, headache, injection site pain, bruising injection armpit and lymph node pain and swelling. The patient was not diagnosed with covid prior vaccination nor was tested for covid since vaccination. The outcome of the events was recovered on an unknown date in 2021.   No follow up attempts are possible. No further information is expected.