chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient awoke following am with cellulitis of vaccinated arm. She was treated in ER on same day and still recovering.
Facial edema started on 5/22/2019 - continues intermittently to date ER visits Referral to dermatologist Abdominal pain started in Aug-Sept 2019 - continues to date Visit to OBGYN abdominal ultrasound CT scan at Hospital  Referral to GI doctor - colonoscopy performed Allergy doctor and allergy testing Multiple visits to ER OBGYN visit Primary care visit Back to GI  Since receiving this vaccine, my daughter has experienced numerous episodes of facial swelling and abdominal pain and the conditions continue to worsen.  Currently, we are in our longest episode.  It started on 11/10/20 and is still occurring (4 weeks) - symptoms include abdominal pain, fever, facial swelling, and fatigue.  We have been to 7 doctors who have run numerous tests and have not found anything to contribute symptoms to.
slight fever, chills, aches, headache, tired, fever blister (got fever blister with first shot too)
10/28/2010 MODERATE Other. Mother notified clinic that child's entire thigh was red and very swollen. Patient taken to see Dr. Dr states it was an allergic reaction.
Shingles; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 16:00 (Lot number: FJ1611) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: Hoshimotos Thyroiditis. Concomitant medications included: NALTREXONE HCL and unspecified vitamins and supplements. Past drug history included: Naproxen, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8732, Anatomical Location: Left arm, Route of Administration: Unspecified, Time of Administration: 09:15), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, Anatomical Location: Left arm, Route of Administration: Unspecified, Time of Administration: 09:15), administration date: 26Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: HERPES ZOSTER (non-serious) with onset 05Jan2022 at 13:00, outcome "recovering", described as "Shingles". The event "Shingles" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster. Additional Information: Patient began experiencing pain from a shingles outbreak that has lasted until & through (still experiencing) today's report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of herpes zoster and included treatment with 2 x steroids packs and 1 antiviral and gabapentin.
Fever, Body ache with tremendous pain in legs. Experiencing  early symptoms of periods with mild blood while urinating
Arm became extremely red from shoulder to elbow, sizeable hard knot formed at injection site, site was hot to the touch, began running fever which last couple of days, entire arm was throbbing and very painful for 1 week. Severe headache and difficulty thinking; thoughts seemed muddled. Started Epsom salt warm compresses to injection site which began reducing knot slightly and after one week, knot still remains at injection site. Could not stand for anyone or anything to touch right arm during entire week.
Pt developed significant angioedema and swelling about 6x6" at site of DTaP admin. Benadryl 12.5 mg 4 x per day for a few days.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 25-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
1/12/07 - Received Rotavirus vaccine. Surgery for intussusception 4/2007.  5/18/07 Received medical records from hospital which reveal patient experienced 1 day history of vomiting, retching, fever, bloody stools.  Abdomen was soft but tender in RUQ.  Admitted 4/8-4/9/07.  Unable to reduce completely & taken to OR for laproscopy reduction of intussusception & appendectomy.  Findings at surgery were 10cm of small bowel invaginated into cecumProgressed well post operatively & d/c to home next day to f/u in clinic.  FINAL DX: Intestinal intussusception, surgically reduced./ss 5/25/07 Received medical records from PCP but vax records not included.  T/C to PCPs copy service to request vax records/lot #s.  States will mail to me.  7/3/07 T/C to PCP to check status of request.  States unable to print info to include lot #.  States info on VAERS report is correct.
Narrative:  Patient received the vaccine on 12/28 and had Tmax of 100.2 F (oral) on 12/30 AM (although on EMR vitals is recorded as 99.4 F). He also c/o soreness on injection site, and provider noted ~ 8 cm erythema on injection site. Patient denies other systemic symptoms. Fever and localized myalgia treated with PRN APAP.  Symptoms:  Fever, ErythemaMultiform & Localized myalgia on injection site; localized erythema ~ 8 cm injection site Treatment:  ACETAMINOPHEN 650 MG Other Q6H PRN
Patient's leg where shot was administered was bloody and the wound area continued to redden and swell to more than 5.5 x 5.5 inches [warm to touch].  Multiple trips and calls to the doctor includes now antibiotics, antihistamine and monitoring.
Expired vaccine used-beyond use date of 15 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant  medication was not reported. Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes. On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31-Jan-2022, Moderna confirmed that revaccination was not required.  Treatment medication was not reported.
The patient received dose one of Moderna vaccine and on her return in 3 weeks was given Pfizer; there were no adverse affects
- HR spiked within first few minutes of shot; fluctuated up to 180 that day.  Both hands were immediately weak and aching.  Went to ER to monitor for reaction.    - Continuing elevated HR episodes for first week; strong left arm pain?couldn?t move or touch for first few days  - Panic attack-like responses approx. once per day for first week.  Rush of heat through hands, throat, face, rapid HR, dizziness  - Increasing joint and muscle pain; also describe as a deep ?bone pain.?   Started in feet, wrists/hands and progressed to both legs, hips, back, neck.  Acceleration of symptoms starting on or about 3/14.  - Saw PCP multiple times for pain; went to ER on 3/16 for severe pain, weakness.  Have been confined to bed or in bath with Epsom salts due to pain.  Starting steroid treatment and nerve pain treatment today 3/17.  - Also experiencing extreme dry mouth and clamminess.  For first week after shot, had tingling/irritated feeling in my tongue any time I ate or drank ? no changes in diet.
she should have gotten a full dose as her 3rd dose because she is immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Reporter states that a patient got her 1st two doses of the Moderna Covid-19 Vaccine, then a booster dose 6 months later.  Then saw her doctor who told her she should have gotten a full dose as her 3rd dose because she is immunocompromised.   Caller states that they do not have any additional information at this time.
Mother brings child to clinic concerned about red, firm knot in left deltoid. 4cm x 3 cm reddened, warm, firm area over deltoid muscle. Mother states child had fever 103.5 last night and today, child fussy, decrease appetite, child alert, playing in clinic room. T96 degrees tympanic no distress noted
High Heart Rate; High BP; Dizziness; Confusion; Diarrhea; Shortness of breath; Lost 15 pounds; Loud in the ears; Headache; Fatigue; vomiting; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-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 28-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Antacids, Mortrin and Tylenol.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
pt recvd vax 2PM 9JUL92 & @4PM pt cried (high pitch) until 7PM seen @ hosp 8PM;
A big red rash to arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A big red rash to arm at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    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 RASH (A big red rash to arm at injection site). At the time of the report, RASH (A big red rash to arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their wife who received Moderna vaccine and post receiving the vaccine the patient developed a big red rash to arm at injection site which resolved 5 days after the first vaccine. The patient did not seek any medical attention.  Concomitant medication included blood pressure medication.   This case was linked to MOD-2021-067353, MOD-2021-106494, MOD-2021-244811 (Patient Link).
Temp 103F decreased to 101 with Ibuprofen. Fussy 1 1/2 hour.
COVID-19 vaccine given high on the arm, outside of true deltoid site. Patient noted immediate significant pain at the injection site. Ibuprofen helped. Patient contacted her employee health staff and her PCP related to concerns for risk for possible should joint damage and questions about efficacy if the vaccine was placed outside of the deltoid. Pt was able to supply pictures for her PCP to review. At this time, there is no further information on if the patient had any ongoing pain. However, the patient did not re-contact her PCP which is reassuring.
After the 3rd dose I had tremendous chills and I was shaking. The next morning, some GI issues like diarrhea. 8/28/22 I felt a scratch throat and I woke up in the middle of the night and running a very low fever, it was 99.8 and I had the feeling of feeling very hot. At 4AM 8/29/22 I had a home test which was positive. I saw the doctor to get PAXLOVID. I did not have any worsening symptoms. From that Monday & Tuesday, I was very tired and I had a bad headache. Wednesday I developed the worst sore throat I ever had. Friday evening I felt better and Saturday I felt like nothing ever happened. I had no congestion.
Rash on back and stomach, abdomen areas. Fever 102.4F rectal.
Bloody nose; This case was reported by a consumer and described the occurrence of epistaxis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was unknown.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient asked if a bloody nose be associated with the Shingrix shingles vaccine. The reporter wanted to know if the shingles vaccine (2 doses) need to be repeated or is it a onetime vaccine. This case was identified as duplicate of case US2021AMR017945. All details from the case US2021AMR017945 were already added in this case. The case US2021AMR017945 will be deleted from Argus and the case US2021AMR018024 will stand as case of record for this patient.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown. It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician told sales representative that another physician received the dose of the SHINGRIX vaccine recently. The patient experienced horrendous side effects. The patient said that it almost looked like she had shingles on her arm. The patient got redness at the injection site and blisters at the injection site. The patient reported for assistance. At the time of reporting, the reporter felt like he was giving too much information and did not to continue providing further details. Physician did not want to report this to GlaxoSmithKline. The reporter did not want follow up on this report. Sales representative would attempt to collect further details during next visit.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 12-NOV-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sudden pain, immobility in left arm, hand and fingers; onset around 6:30 p.m. Pain radiates from arm to neck. Two x 500mg Acetaminophen taken. Nausea without emesis and headache; onset around 7 p.m.  4 ounces hot water decoction of fresh ginger slices consumed. Chills (no fever); onset around 8:40 p.m.
Hives in trunk and legs, swelling of left leg.  Benadryl for itching hives
Pain on the injection site, body aches, fever, chills, no appetite to eat, pressure in my ear
RIGHT ARM HURTS CONSTANTLY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced right arm hurts constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm hurts constantly. This report was non-serious.
Pt recv vax on 11/3/98; on same day pt exp raised erythematous rash all over body; 11/4/98 itchy hives on chest, arms, stomach; tx=Benadryl & Prednisone
36% sudden hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 (at the age of 61-year-old) as 1st dose, single for COVID-19 immunisation.  Medical history included allergy to sulfa antibiotics. Patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication. The patient experienced 36% sudden hearing loss in left ear on 18Apr2021. The event resulted in physician office visit and she was currently using a hearing aid. Outcome of event was not recovered.   Follow up needed, further information has been requested.
Mom states pt breathing hard, foaming at mouth following morning p/vax; Taken to ER;
He also doesn´t feel stable on his feet; he stumbles; he feels like he has been hit; moderate pain in the arm; it did bleed a little; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it did bleed a little, moderate pain in the arm, he feels like he has been hit, he also doesn´t feel stable on his feet and he stumbles.   The patient's medical history was not provided by the reporter. Concomitant medications reported included blood pressure medication, rosuvastatin and fenofibrate drugs used for unknown indication.   On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient experienced it did bleed a little. On 31 Jan 2021, the patient experienced moderate pain in the arm. On 01 Feb 2021, the patient experienced he feels like he has been hit. On an unspecified date, the patient experienced he also doesn´t feel stable on his feet and he stumbles.  Lab details were not provided.  Treatment for the events included aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, it did bleed a little was considered as resolved.  The outcome of events moderate pain in the arm, he feels like he has been hit, he also doesn´t feel stable on his feet and he stumbles, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site pain, feeling abnormal and injection site hemorrhage) a causal relationship cannot be excluded. However, very limited information regarding these events- balance difficulty, and gait disturbance has been provided at this time.  Further information has been requested.