chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the vaccine at 3pm,  went home and arm started hurting but not bad. Started getting very restless while trying sleep, developed a bad headache and muscle aches and pains during night around 4-5am. Kept getting worse, by 8:30 am had chills, lethargy and generalized weakness. Felt as bad as when I had COVID 60 days prior.  Husband and I both had COVID then and he also got very sick after shot with same symptoms but low grade temperature of 100.5. Our symptoms lasted into next day and evening. Finally feeling some better by midnight. I had good day on 3rd day and then that night very restless and couldn?t sleep. Wiped out all day. Brain very foggy, achy and just not feeling well.  Fifth day just seem to tire easily and wanting to nap which I don?t usually do.
Mom to clinic 11/1/02 reports child on antibiotics 2 days several facial rash-close to eyes to MD at advised no more MMR mom reports rash onset Sunday worsening through Wednesday 10/28/02 to clinic 10/31/02-note on chart to MD's note no more MMR.
body ache; joint pain; This is a spontaneous report received from a contactable consumer or other non-health care professional. This consumer (patient's wife) reported for husband (patient).  A 62-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/ Lot number: not reported) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient had no side effects until after 12 days on an unspecified date patient experienced with body ache and joint pain. Outcome of the events was unknown.  No follow-up attempts are needed; Information related to batch/Lot number could not be requested. No further information is expected.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). This consumer reported similar events for 2 patients. The reporter is the patient. A male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (unknown manufacturer), for immunisation. The patient developed pain/body ache, and headache, with  outcome of unknown. Additional information: Upon follow-up, patient got the 2nd shot yesterday had a body ache and headache. He asked was it ok to take Tylenol and received response as correct. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021304328 same reporter/drug/AE, different patients.
Patient  fainted shortly after receiving the vaccine, was unconscious for a few seconds and became alert right after that. 911 was called and arrived within 5 minutes; in the meantime patient was provided an ice pack. Patient was contacted at 7pm to check how they were feeling, and they reported that they were feeling well.
Information has been received from office staff concerning a 7 year old male who on 7/30/97 was vaccinated SC on the left side with a dose of varicella virus vaccine live (lot # 622749/0544E). On 2/21/04, the patient developed a rash on the body for 48 hours. Unspecified medical attention was sought. It was unknown if the patient had recovered. The reporter also mentioned the patient's sibling (WAES0404USA00506) was was also vaccinated with varicella virus vaccine live and experienced a similar reaction. Additional information has been requested.
REdness and swelling at site of injection. Generalized Erythematous Urticarial Rash.
Fever, rash, body aches, not eating. 4/3/14 fever 102.2; 4/4/14 fever 101.4; 4/6/14 full body rash thru 4/8/14. 6-7 days no eating, no sleeping.
lower than normal blood pressure left arm 82-52 right arm 76-50 heart rate 60 (normal)
a patient that was intended to receive an HPV vaccine received Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 45-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594) for prophylaxis.   On 22-SEP-2023, the patient received Boostrix. On 22-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: a patient that was intended to receive an HPV vaccine received Boostrix instead).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The nurse reported the patient who was intended to receive the HPV vaccine received Boostrix vaccine which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Patient got 0.2ml dose from THE PURPLE VIAL MEANT FOR 12+ YEARS. Dispensed NDC. It was dispensed in error instead of the pediatric formulation. The dose is right but the vial is different.  I notified the patient's mother . She is aware and she is monitoring. No adverse effects , so far .
Employee woke up with triggered trigeminal nerualgia (previously diagnosis), and double vision, causing vertigo and nausea.  Her vision was better if she closed one eye.  She was vomited throughout the day on 4/24/21, 4/25/21 - with the nausea, double vision and vertigo getting better on 4/26/21 and completely resolved on 4/27/21.  On 4/27/21 employee reports aching, sore arm and fatigue.  States she feels like she did when she had COVID 19 which she reports having in January 2021.  Messaged her provider to see if she should get dose 2 of the COVID 19 vaccine.
Needle injury; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle injury in a patient who received HBV (Engerix B) (batch number x9ft7, expiry date 31-MAR-2024) for prophylaxis.   On 13-MAR-2023, the patient received Engerix B. On 13-MAR-2023, immediately after receiving Engerix B, the patient experienced needle injury (Verbatim: Needle injury). The outcome of the needle injury was unknown.   It was unknown if the reporter considered the needle injury to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the needle injury to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:12-APR-2023 The healthcare professional informed that the back stop came off Engerix-B pre-filled syringe during injection and resulted in instability of the product and a needle stick injury.  The reporter consented to follow up.
Heahaches, body aches, chills, and dizziness. Dizziness has lasted for a week and still ongoing.
After getting second shingrix vaccine I experienced severe muscle and joint pain, then a small cyst on my testicles grew rapidly causing severe pain. I went to my urologist, Dr who started treatment with antibiotics. The cyst seems to keep growing and is very painful.
FluLaval administered to a 2 months-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 957A7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The medical assistant reported that there was documentation in medical record that a 2 month old patient was administered FluLaval QIV vaccine. Clinic was unsure if the patient actually received the dose, or if it was documented as given in error.   The patient had been seen in clinic since that date and has had no ill effects noted.  The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of Flulaval QIV vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
pt had bells palsy in the past and then got  after her first covid shot and second shot. on 4/6 and 5/17 shot dates
C/o heavy arm day after receiving vaccine 8/2/11. 8/3/11 today c/o left arm "big", "sore", "tight", "feel like it has a fever". States will see doctor if not better by tomorrow 8/4/11.
Sudden onset of fever, chills and bodyaches on 11/10/08 less than two weeks after flu vaccination followed by neurogenic bladder which required two emergency room visits on 11/11/08 and 11/12/08 resulting in intermittent self-catherization for one week; developed peripheral neuropathy in lower extremities on 11/13/08 requiring neurologist care; developed Bell's Palsy on 11/21/08 requiring neurologist care and hospitalization from 11/22-11/30/08 with steroid treatment for Guillain-Barre Syndrome. Follow-up visit with neurologist every two weeks and recovering from nerve damage at home until January 2, 2009.  2/10/09 D/C summary received for DOS 11/22-30/2008 with D/C DX:  Autoimmune Non-demyelinating Axonopathy (variant Guillain Barre Syndrome).  Pulmonary Embolism. Pt initially presented to PCP with c/o acute urinary retention and leg weakness which began ~11/11/08. Tx with self cath. Some improvement by 11/19/08, however developed complete R facial paralysis and admitted 11/22/08.  Pt tx with Solumedrol and IVIG with improvement in sx noted. Pt developed acute dyspnea c/w PE. Started on anti-coagulation meds. At d/c facial paresis resolved. Mild easy fatigability and paresthesias in the legs.  Normal DTRs.
pt recvd vax 12FEB93 & devel a fever of 101 which persisted for 48 hrs; also devel ear pain & knee & hip pain as well as pain in lt ankle which caused pt to limp; pt exp h/a; lab eval revealed inc ANA w/nucleolar pattern as well as inc ESR;
I am experiencing redness, itching and swelling .  Started in hands and moves to face, legs and torso.  It happens about three times a day.
This spontaneous report was received from a pharmacist referring to an unspecified number of unspecified patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX, 19400 plaque forming units (PFU),(dose, route of administration were not reported), lot # N011366, expiration date 12-MAR-2018, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F (19 °F) during a time frame of 1 hour 15 minutes. Digital data logger was not involved. No previous temperature excursion was reported.
arm got sore; she was also tired and sleepy; she was also tired and sleepy; She felt discomfort the minute she got the shot; little more tender at the injection site; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Jan2021 12:45 (Lot number: E63247) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "started breaking out in shingles" (unspecified if ongoing), notes: Caller adds that last October, she started breaking out into shingles. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm got sore"; FATIGUE (non-serious), SOMNOLENCE (non-serious), outcome "recovered" and all described as "she was also tired and sleepy"; DISCOMFORT (non-serious), outcome "recovered", described as "She felt discomfort the minute she got the shot"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "little more tender at the injection site". Additional Information: The patient has not received any other products. On the first vaccine, her arm got sore, but she did not have problems so she thought that she would take the second. Her arm was sore right away from the first shot. It lasted a couple of days. She felt discomfort the minute she got the shot until a few days, 2 or 3 days later. She was also tired and sleepy, so it was not what she would have called an intense reaction to the shot. She did not think anything of it. It went away. There was a period of 20 minutes where she sat and waited after getting the vaccination and she said she was okay because she just got the shot and maybe it would hurt a little bit, but her arm did get progressively a little more tender at the injection site. Then it went up to her shoulder. This only lasted for a few days after the first vaccine. The shot was given lower not in shoulder muscle but a little below it. The second shot was given higher in her muscle than the first one. She figured this was why it did not hurt as much.  It was like on the back where it changed from muscle to flatter area, more like below the curve of your shoulder muscle toward the back side.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355267 Same patient, different dose and event.
pt was given hep B vax #3 & devel a blister about 2" linear on inj line;
stiff shoulder & arm @ inj site; seen by PMD @ end of MAY; takes APAP w/little relief; still hurts p/3months;
Admit from assisted living for vomiting, diarrhea, disorientation likely d/t COVID-19 infection per notes. ID advised no tx with steroids or abx necessary, had already previously been diagnosed and monitored. Required no O2. CXR negative. Hx of Type II DM, HTN, ESRD, treated for hematuria (chronic indwelling catheter). DC'd to SNF.
This case was reported by a physician and described the occurrence of myositis at the injection site in a 22 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient was previously healthy, with no history of adverse events following previous vaccinations and no known allergies.  There was no history of collagen vascular disease or muscle diseases.  On 09/08/2004, the patient received the first dose of Twinrix in the right deltoid muscle (lot HAB278A4).  Approximately one day after the first dose of Twinrix, on 09/09/2004, the patient experienced myositis that was localized to the right deltoid muscle.  The patient was seen by a physician one month after vaccination, on 10/08/2004.  The physician described the myositis as an injection site reaction.  The patient did not report any systemic symptoms, including fever.  The event was not disabling or incapacitating.  The event resolved on an unspecified date before 11/03/2004.  The immunization series with Twinrix was discontinued.  The physician considered the myositis to be related to vaccination with Twinrix.
This patient received Varivax 10/21/97; he has recently been around a cousin with clinical varicella, a sibling (also previously vaccinated) developed varicella 2 weeks ago and today this patient has clinical symptoms of varicella.
Pateints mother called into our office (primary care) and reports the patient was given 5 vaccines at a local health dept the morning of 9/28/2021. Mother reports later that evening patient c/o chest pain and he was taken to a local ER. Mother reports her son had an abnormal EKG and also had a chest x-ray. The patient was dx with chest wall inflammation and sent home. Mother called our office on 9/30/2021 to schedule an ER f/u visit. She was concerned about her son still feeling abnormal and now has backpain. Advised his mother to take him back to the ER for reevaluation .
Narrative:  Patient became hypertensive, flushed, felt "weird", tachypnic, tachycardic within minutes of vaccine administration. Received EpiPen dose and sent to emergency room. Per patient (no outside records)no further intervention was done and was not admitted.
One hour following vaccine administration, employee complained of headache 4-5 hours later nausea. Both resolved Tuesday (1 day later). Arm became sore on night of vaccine administration. Following morning redness at site and under arm noted. Some chest pain. Saw PCP 8/26/10, advised rest, ice and ibuprofen.
Vaccine given at 11:30am, uticaria noted 8 minutes after, during 30 minute observation. Benadryl 25 mg given at 12:05. At 12:34 Patient stated improvement to itching. Patient instructed to follow up with primary care provider and to go to the emergency room if symptoms worsen.
Broke out in hives one day following 2nd injection of Moderna. Hives started on neck and chest and continue to move upwards towards my right and left side of neck, and down the right side of my arm (side the injection was given).
moderna covid-19 vaccine eua  ..fever of 100 deg when waking up..normal for me is 97.9..
Temp 101.3, widespread vesicles.  Diagnosis: Varicella Treatment: Acyclovir
Vaccine was administered (Pediatric Monovalent Moderna) as requested but lot number expired the week prior on 2/17/23.  Box was not labeled with expiration date so the administering nurse while I was out was not aware to no longer use that specific lot number.  No adverse reports or side effects were noted.  Attempts were made to notify family.  Pt is coming in at the end of the month for second dose.
Chills lasting <1-hour, Fever 103.8 lasting about 6-hours, soreness at injection site last >24-hour.  Took OTC Tylenol and 325mg aspirin.  Fever broke after approximately 6-hours and temperature was normal 8-hours after onset of chills/fever.
Cellulitis Left upper arm, mild fever. Rx cephalexin 500mg 4xd x 5 days.
Frozen shoulder; This spontaneous case was reported by a physician and describes the occurrence of PERIARTHRITIS (Frozen shoulder) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder) (seriousness criterion medically significant). At the time of the report, PERIARTHRITIS (Frozen shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and contributing comorbidities include sarcoidosis, afib, nonischemic congestive cardiomyopathy w/ ICD, DM2, HTN, HLN, Dementia/ senile. Patient required hospice care on 2/19/21 and had lost significant weight up to that point and had a chest tube in place.
left me with some type of hardness on my skin; Muscle ache; Tiredness; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: EW0179), via intramuscular route of administration, administered in Arm Right on 10May2021 as 1st dose, single dose for covid-19 immunisation. Patient received second dose via intramuscular route of administration, administered in arm right on 03Jun2021 (Lot number: EW0180) as single dose for covid-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine because patient was really skeptical about vaccine. The patient confirmed that he had taken both the shots. The patient's medical history and concomitant medications were not reported. The patient confirmed that he experienced side effects only after the first shot. The patient really quite got the alternative measures though but was really concerned about the vaccine that he received recently. On 11May2021 the patient experienced some type of hardness on skin, muscle ache, tiredness, arm pain. Patient was saying he was afraid for his life now. He wanted to know what was going on. Patient had been okay after the second dose, but wanted to know what could he do? He was quite careful for his life now. When probed if he was still experiencing the problem he stated, he was okay now. He thought the second time it was like some arm pain. He thought he had doubt after seeing all this stuff all over the news and talk this hard stuff and potentially putting the life in danger. He did not receive any treatment for the events, he just rested. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Client complained of numbing feeling to throat and tongue. Able to drink fluids without difficulty. No stridor noted 02 Sats 100%. Made aware to follow-up with MD if symptoms persist and call 911 if symptoms worsen.
The injection was received on 5/13/11 and the patient started experiencing swelling, warmth, itch, tenderness, and a pink ring around the injection site by 5/15/11. She applied BENADRYL cream on 5/16/11 with some relief.
Information has been received from a consumer concerning a 62 year old female who on 03-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). In the evening of 04-MAR-2009 the patient ate shrimp and broke out into hives. Also the injection site was itchy and swollen. No other information was provided. Additional information has been requested.
Hedache, Myalgia, Redness at site, fever, swollen glands last two days. Narrative:
Near syncope-reported feeling like about to pass out. Brought via wheelchair to med screening for evaluation by medics. Hyotensive. 66/30. Pt. laid  down and monitored by EMT/paramedic for at least 10 mins. Oral hydration brought BP up 120/75. Patient observed another 10 minutes. Then released with husband . Patient and husband traveled from South America, over night for Vaccine. Recorded by RNs
Minutes after the vaccine was administered Dr. re-entered the exam room to speak to the parents. He exited the room and asked us to mark a raised bump that had formed on the patients right thigh. It measure 3/4in wide and 1in long. Patient stayed in the office for 30 minutes longer and upon leaving the office the bump was gone but the leg was still red.