chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subject was enrolled in study 208355 / 117 and received her 1st dose of the study vaccine on 09/08/97. Twenty-on days post study medication, the subject was diagnosed with pneumococcal meningitis. She was hospitalized and treated with Ceftriaxone and Penicillin. Fourteen days after onset, the pneumococcal meningitis resolved and the subject was discharged. The investigator reported the pneumococcal meningitis was severe, serious, life-threatening and unrelated to study medication.
Unbearable pain in her right thumb; This is a spontaneous report from a contactable pharmacist. The pharmacist reported same events for two patients. This is second report for his wife's client. A female patient of an unspecified age received her second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter's wife was at work (she was a hair stylist) and was talking with one of her clients.  Her client (the patient) who was a nurse said recently she had also taken the vaccine (2nd shot) and said the weirdest thing had happened. She told that she can't hold anything in her right hand and she had been experiencing unbearable pain in her right thumb when she used it for anything.  The reporter still spoke with the lady who had pain too and she said the same thing and they knew it came after the second shot of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045702 same reporter/product/event, different patient
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 57-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 04-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
pt recv vax 1DEC95 & 25APR97 pt devel breakthrough chickenpox w/over 100 lesions;
I experienced itchy hives almost welt like pink spots all over my body 5 days post vaccine. I saw PCP who advised me to take Benadryl and or Claritin and use hydrocortisone cream. Continued for 3 days and reaction was still severe.  Called pcp and he prescribed MethylPrednisolone  dosepak for 6 days and to continue with hydrocortisone cream application m.
Anaphylaxis - taken to ER. Given epinephrine shot and Benadryl shot.
started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; chills and fatigue; chills and fatigue; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 37-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN6207), via intramuscular route of administration in left arm on 20Apr2021 at 12:15 (at the age of vaccination 37-years-old) as single dose for COVID-19 immunisation on workplace clinic. The patient's medical history included spleen ruptured when he was 18. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN5318), via Intramuscular route of administration in left arm on 03Mar2021 at 12:15 as historical vaccination single dose for COVID-19 immunisation. On 21April21 at 03:00, the patient started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place", had chills and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. No treatment received for adverse event. The outcome of the adverse event was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant therapy provided. On 06-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II (route and dose not reported, lot # K005110, expiration date 04-APR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had shots 1 and 2 at pharmacy. With BOTH shot 1 and shot 2, he had severe chills, fever 102, aches, exhaustion. Fever brought down by acetaminophen. Aches treated with ibuprofen. Total duration of feeling crummy: 36-40 hours.
itching; red blotches on my arm; hot at the injection site; became uncomfortable; uncomfortable sleeping on that side; The injection site was itchy; The injection site was red; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable) and INSOMNIA (uncomfortable sleeping on that side) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable), INSOMNIA (uncomfortable sleeping on that side), VACCINATION SITE PRURITUS (The injection site was itchy), VACCINATION SITE ERYTHEMA (The injection site was red) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable), INSOMNIA (uncomfortable sleeping on that side), VACCINATION SITE PRURITUS (The injection site was itchy), VACCINATION SITE ERYTHEMA (The injection site was red) and VACCINATION SITE PAIN (injection site soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details include antihistamine for itching, red blotches on my arm and became uncomfortable and rubbed it with some steroid cream for red blotches had come together and made a big red spot.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information received on 12-May-2021 as contact information updated.
Warm/tingle feeling up neck and into ears at time of vaccination (immediate onset) Swollen lymph nodes in the neck and armpit on left side of body - onset 2 days post vaccination.  Lasted about 1 week Congestion and ringing in ears - onset immediate.  Lasted about 3 weeks
pt recv vax 8APR99 & started having inflamed site & swelling on 10APR99;upper arm became painful & swollen;saw PMD on 12APR99 given hydroxyzine HCL 25mg q 6hr sx are improving;
Patient states she has had severe arm pain and loss of mobility for a week after receiving FLUZONE HD and PREVNAR 13. She called on 10/21/16 stating she still had arm pain. She has not seen a doctor as of 10/21/16, I encouraged her to do so.
weakness in L arm, spine and head. By the end of the week she could no longer crawl or go up stairs.
Patient received a Flu vaccination in the R arm -states the immunization was given very high near the "shoulder bone" - immediately she began to experience excruciating pain - didn't report to nurse because she thought it would go away in a few days - She is unable to lift her arm over her head -she went and saw her Dr. because she has a history of MS - the Dr repoted that it was not an exacerbation of the MS but it may be nerve damage and would take 6-8 wks to heal - She called today because it has been over 30 days and there has been no improvement - Her Drs are sending her to the emergency room today because the pain is so excruciating her blood pressure is running 200s/100s and is uncontrollable - She states the Dr. has "maxed" her out on BP medication - She currently takes Vicodin 1 every 6-8 hrs. but it is prescribed for every 4 hrs -She states she doesn't want to become addicted - Patient was encourage to follow through with the Emergency Room instructions per her Dr. and to take the Vicodin as prescribed.
Syncopal episode, vital signs stable.  Interventions implemented, recovered, and released.
This spontaneous report was received from a nurse regardinga patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M040267 and expiry date: 14-MAY-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 35 Fahrenheit to a time frame of 15 hours. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 13-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
6 hours after receiving vaccine, I started to get the chills, then body aches, then very intense shaking to go along with the chills and body aches. I felt terrible and the shivering was uncontrollable. I took one 200 mg of ibuprofen at 9 or 10pm, and another one at 11pm. That seemed to help and I fell asleep. When I awoke in the morning, I had a pounding headache. The headache was debilitating and lasted all day. The headache subsided around 6 pm 10/11/21 after taking a 200 mg ibuprofen. All of the above is unlike anything I have ever experienced, even with a fever or flu. It was misery, and I am a good sport, I didn't expect to have any side effects. These events came on vicious and strong.
Lt arm pain, body aches, cold chills, elevated temp, slight nausea, slight headache  Also, not completely sure of lot #. There was a water drop in the middle of the lot # that blurred the number. I believe the above number is correct.
About nine hours after my vaccination, and, immediately following very mild outdoor exercise, I began to experience muscle aches which then quickly progressed to chills and a fever of about 99.8 F.  The fever and chills lasted about 24 hours. The muscle aches lasted longer. Symptoms resolved almost completely within 48 hours. I treated the symptoms with Tylenol.
Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21.  POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21.  Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia.
one hour after receiving the second moderna vaccine the patient developed the sensation of facial swelling, scratchy throat.  She presented to the ED one hour after that and was found to have some erythema to the chest, no facial swelling remaining, resolution of scratchy throat and clear lungs. normal VS.  She was provided with prednisone, benadryl, pepcid. She reported complete resolution of symptoms after another hour and was discharged with three day script for prednisone, pepcid, and claritin as well as prn epipen.
This case was reported by a consumer via call center representative and described the occurrence of injection site tingling in a adult female patient who received ENGERIX B Pediatric (batch number 9232L, expiry date unknown). Co-suspect products included ENGERIX B Pediatric (batch number 9232L, expiry date unknown). On an unknown date, the patient received the 1st dose of ENGERIX B Pediatric and the 1st dose of ENGERIX B Pediatric. On an unknown date, less than a day after receiving ENGERIX B Pediatric and ENGERIX B Pediatric, the patient experienced injection site tingling, inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site tingling was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. The reporter considered the injection site tingling to be possibly related to ENGERIX B Pediatric and ENGERIX B Pediatric. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The caller stated that she received her 1st dose in the hospital as a hospital worker. She stated the nurse used two vials for the vaccine but she did not have the lot or know if it was two paediatric doses used. She planned to contact them back. She stated she only received the one vaccine that day. She stated that day she experienced tingling of pins and needles in her right arm, which was the arm she received the vaccine in and continued to experience that 2 weeks afterwards. She refused to provide contact information or demographics. Serial number was provided for her to call back with additional details from facility. Consumer called back and provided name, which had been correct on initial form. She provided the lot number of the product used and it was two paediatric doses that she was given, which led to an inappropriate age at vaccine administration for both the pediatric doses of ENGERIX B. It was unknown if the patient received both the pediatric doses of ENGERIX B on same arm or different arm.
Period was 4 days shorter in may, 6 days late in June, lasted 7 days and then continued to spot days after, July 12 days late, and period finally came. It  is light, no cramps hardly.. took several ho; Period was 4 days shorter in may, 6 days late in June, lasted 7 days and then continued to spot days after, July 12 days late, and period finally came. It  is light, no cramps hardly.. took several ho; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration, administered in Arm Left on 14May2021 15:00 (age at vaccination: 36-years-old), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (age at vaccination: 36-years-old), as dose 1, single for covid-19 immunisation. It was reported that the patient's period was 4 days shorter in May2021, 6 days late in Jun2021, lasted 7 days and then continued to spot days after. In Jul2021, it was 12 days late, and period finally came. It was light, no cramps hardly. These events required physician office Visit  The patient took several hormone and pregnancy tests, and everything came back fine. The patient reported that her period was just missing which made her think that she was V pregnant (sic) and was not. The doctor suggested that it was an immune reaction to the vaccine. The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Somnolent - symptoms. Treatment - IV solutions, observation -> emergency room. Adverse event - hypotonic hyporesponsive episode.
LIL BRAIN FOG; ARM SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 03-JUN-2021, the subject experienced lil brain fog. On 03-JUN-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lil brain fog and arm soreness was not reported. This report was non-serious.
Patient called and said that her Right arm pit was tender and had a slight bump.  NO redness noted. Received Pneumonia 23  (rt arm) on 10/2.   She also mentioned that her neck glands were sore the day prior.  She will follow up with provider if redness, more swelling or other items occur.  She didn't know if related to injection or not.
pt recv vax & exp MS;pharmacist reported three pt;they were assigned WAES96051400 through 96051402;
This spontaneous report as received from a health department nurse refers to a patient who was administered received a dose of VARIVAX (Merck) (lot # 671162/1207AA, exp date: 26-JUL-2013) (which was stored at an average temperature of 8F-14F for six months) on 02-JUL-2013. No adverse effects reported. Nurse practitioner stated the facility made the decision on their own to revaccinate their patients and declined having this SR sent to GVS for evaluation. This is one of several reports received from the same source (linked case # 1312USA007988 and 1312USA012254). Additional information has been requested.
did get vaccinated, four months later I had the shingles, in my face,\ Suspected Vaccination failure; I had the shingles, in my face,; very painful; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine and four months later experienced the shingles on face, very painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Within a few hours of receiving my first shot, my left fingertip went numb. It is almost 5 months later and it has been number 24/7.
Had significant redness and what looked like bruising appear a while after the shot. We did not notice any reaction at the injection site until 7/4/22 (8 days post vaccine) but it is possible it was there a few days earlier and we didn't notice. He says there is no tenderness or pain or itchiness at the injection site. We gave some children's loratadine (1 ml of 5mg/ml concentration) and the next morning (7/5) it was smaller
Significant redness, swelling and warmth of lower thigh from hip to knee. Prednisone, Benadryl, Motrin, Augmentin.
Feeling  hot spots on the legs after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling  hot spots on the legs after booster) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Feeling  hot spots on the legs after booster). At the time of the report, FEELING HOT (Feeling  hot spots on the legs after booster) outcome was unknown.            No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2021-007799, MOD-2021-002376 (Patient Link).
Severe headache, nausea and vomiting, fever, joint pain, stiffness, fatigue
Fever (highest temp=101) started on 03/09/18. Generalized rash, small red bumps, not itchy, started last night, 03/11/18. Bilateral wrist pain.