chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4424759-003714030.  by a consumer of a 32 years old female with events of and non-serious Maternal exposure during pregnancy, restless leg syndrome after first covid-19 vaccine, gestational diabetes, Could not sleep after first covid-19 vaccine, and more tired with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. In 2022, the patient experienced gestational diabetes. On unknown date(s) in 2022, the patient experienced more tired, could not sleep after first covid-19 vaccine, restless leg syndrome after first covid-19 vaccine, maternal exposure during pregnancy. On unknown date, restless leg syndrome after first covid-19 vaccine recovered/resolved. On unknown date, could not sleep after first covid-19 vaccine recovered/resolved. Pfizer Biontech Covid-19 Vaccine was also considered suspect. The fetus was exposed to maternal use of Humira in utero. The patient was 35 weeks pregnant as of 21Nov2022. Maternal use of Humira was ongoing. This case was a follow-up to case 22K-163-4424759-00.  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 01Mar2016 as unk (40mg/0.4ml), citrate free (Lot number: 1160679) subcutaneous for Crohn's disease. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "non-serious maternal exposure during pregnancy/35 weeks pregnant", "gestational diabetes" and "more tired" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information available, the causal association between the events maternal exposure during pregnancy, gestational diabetes, fatigue, restless leg syndrome, insomnia and suspect drug  BNT162b2 (BNT162B2) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recvd vax & exp a limp episode, became pale, clammy cool skin surface & some difficulty rousing approx 40 mins p/inject; adivsied mom to return w/child or go to family MD;
Six hours after vaccination, patient developed palpitations and dizziness. Presented to ER and EKG completed, which came back normal. Four days post vaccination, patient developed sudden onset dizziness/lightheadedness, imbalance with walking, and brain fog. Symptoms were intermittent and continue to be present to date (5/28/2021).  Patient was treated with meclizine without relief.
Hives all over the body; Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (mild).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient denied having any food allergies.  No concomitant medications were reported.
Vaccine was Wednesday, on Friday I started feeling tenderness in left armpit. Throughout the day it became more uncomfortable and started swelling. Lymph nodes were not swollen. The next day it was still quite swollen, less tender. Started subsiding Sunday. Monday almost back to normal. No other symptoms.
Tongue swelling (sensation) 45 in after vaccine injection with subjective throat tightness
Doctor Visit 12/23/1999, Antibiotic Given Fever High Pitched Screaming Nasal Congestion Sneezing Spitting Up Breast Milk Eardrum Red
3NOV93 1 hr p/shot lt arm started swelling, knot appeared & reddened area on posterior upper lt arm; mom states immun site was very warm; mom states immun site was very warm; elbow swollen;
Patient was given a flu shot in the right arm, then the Menactra vaccine in his left. After receiving the Menactra vaccine, he slumped over and was lowered to the ground. His eyes rolled in to the back of his head, but when his name was called, he immediately responded and woke up.
I experienced headache, nausea and chills all night long and into the day following my second dose of Shingrex. I have never had a reaction to any inoculation before.
Eye pain- felt like eye strain or exhaustion in eyes; Dry eyes; Left arm pain; General exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 11:45 (Lot number: EW0158) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Sulfa Drugs" (unspecified if ongoing). Concomitant medication(s) included: SLYND; ALLEGRA; IBUPROFEN. Vaccination history included: Bnt162b2 (Lot number- EW0150,, Administration date- 31Mar2021, 10:15 am,, Dose number- 1, Left arm), administration date: 31Mar2021, when the patient was 44 years old, for covid-19 immunisation. The following information was reported: EYE PAIN (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Eye pain- felt like eye strain or exhaustion in eyes"; DRY EYE (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Dry eyes"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Left arm pain"; FATIGUE (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "General exhaustion". Therapeutic measures were not taken as a result of eye pain, dry eye, pain in extremity, fatigue.  Additional Information: No Covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected.
fever; Suspected Invalid administration of dose; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 30-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-Significant Follow up
Pt presents to the office with bump on her left leg x 4 days, It is tender to the touch with deep palpation. No fever or other symptoms at this time. No increased redness or rash noted.
Redness and pain at injection site noticed a couple days after done, BENADRYL, with cold compresses, could also take naproxen to help with the inflammation and pain.
Pain in the left arm where the shot was administered started tingling up and down my arm about an hour or so then about 4 hours later my arm was hurting throbbing in the upper part very painful then came pain to my chest on that  same side across from my arm very intense couldn?t sleep without taking Tylenol in the morning still was painful had to take more Tylenol I can?t even go 4 hours without taking pain reliever it?s like every 3 hours or I?m crying in pain still hurts doesn?t seem to lessen even though I take the pain medication the pain is still there not hurting so bad I want to cry but it?s 3 hours later and it gets worse very intense pain. How much longer? Do I have to go to through this.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 12 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 12 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
On 9/16/09 took Influenza shot.  On 9/16/09 sick with flu.  On 10/16/09 feeling of numbness in feet.  On 10/19/09 feeling of numbness weakness in feet and legs.  Legs and feet felt cold continuously.  On 11/2/09 while at work numb/weakness feeling moved up into thighs, stomach, back & hands.  Severe pain in lower back.  Tight feeling around abdomen.  Went to E.R.
On Friday, November 16, 2007 our 25 year old daughter received a Gardasil vaccine from our family medical practice. At 3:00 a.m. on Saturday, November 17, 2007 she awoke came to our bedroom saying she wasn't feeling well. She fainted in the doorway, and became rigid. When she came to, my husband and I carried her to her bed where she lost consciousness, became rigid again and lost continence. We called 911. The EMT's arrived, checked her vital signs and recommended that we contact our physician the next day. We took her to the doctor's office and they told us to take her to the emergency room for further tests which we did that day. The physicians suggested that due to the incontinence and rigidity/lost of consciousness she had suffered a seizure.
COVID 19 Treatment; COVID 19 Treatment; Vaccine Brand Other=Moderna/Vaccine Administration Date=22Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GJ6665), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 011C20A), in right arm, on 17Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] resp inhalation, start date: 01Nov2021; ASMANEX resp inhalation, start date: 01Nov2021; SINGULAIR, start date: 01Feb2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Nov2021. Past drug history included: Codeine, reaction(s): "Known allregies: codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "unknown", described as "Vaccine Brand Other=Moderna/Vaccine Administration Date=22Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient received anti-viral treatment with Paxlovid from 11Feb2023 to 16Feb2023.
I received the Pfizer vaccination in April and I recently have been diagnosed with Bell's Palsy; This is a spontaneous report. A 63-year-old male patient received BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration in left arm in the early afternoon on 23Apr2021 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization in a hospital. Medical history included bell's palsy. Family medical history relevant to events was reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no concomitant medications/other products reported. Historical vaccination included BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. The patient received the vaccination in Apr2021 and recently had been diagnosed with bell's palsy on 11Sep2021. The patient understood that this might be a possible side effect. The patient requested to provide any information regarding the event. It was reported that there was no investigation assessment and no relevant tests performed. These events didn't led to emergency room and physician's office visit. The outcome of the event was not recovered at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
10 days after first dose (4/13/21) my menstrual cycle began and at the same time multiple lymph nodes swelled up all over my body. Right and left armpits had multiple (6+ each side) protruding lymph nodes, one node on the right side was very large. Lymph nodes in chest, jaw and groin were also swollen.  The lymph node swelling lasted the entire menstrual cycle (about 6 days) and then went back to normal. I drank 100 oz of water on day the node swelling reduced which I account for the reduced swelling but note it also recovered at the end of menstrual cycle.
Information has been received from a health professional concerning an 11 yr old female with no pertinent medical history and no drug reactions/allergies who on 25Jan99 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 21Sep05 the pt developed a mild case of chickenpox. There were no lab diagnostic studies performed. The outcome was reported as not recovered. There was no further information available. There was no product quality complaint involved. Follow up information indicated that the pt presented to the office on 23Sep05 with complaints of a rash over her body. She was diagnosed with a mild case of varicella. Lesions were noted around her trunk, right ear lobe and scalp. The outcome was reported as recovered. No additional information is expected.
Patient states she has pain, limited range of motion an difficulty sleeping since receiving the vaccine. Patient going to doctor today wanting reimbursement for appointment and tests.
Day 1 = Headache (within one hour of vaccine), sore arm  Overnight = Nausea, stomach cramps, vomiting and headache, sore arm Day 2  = Fever 100.8 (took Advil and Tylenol every 4-6 hours), chills, body aches, slightly nauseous, sore arm Day 3 = Fever 100.8 (took Advil and Tylenol every 4-6 hours), body aches, horrible taste in my mouth and coating on my tongue, very pink skin from my waist to my neck, sore arm Day 4 = itchy skin on my back, sore arm
This spontaneous report as received from a pharmacist (patient's mother), via a company representative, refers to a 5 year old male patient. The patient's medical history included skin issues. On an unknown date (at the age of 12-18 months) the patient was vaccinated with first dose of VARIVAX. Dosing information, route of administration and lot number were not provided. In approximately 2008 (reported as 5 years ago) the patient developed a mild case of either shingles or chickenpox. Medical attention was sought (unspecified manner). Patient was treated with ZOVIRAX. The rash was unilateral. the patient had fully recovered (date not provided). Causality assessment was not provided.
Feeling tired 10/31, broke out with lesions 11/1. Lesions to head/chest/back. To stay home from school until all lesions are scabbed/dry.  Father had shingles about two weeks before child became ill.
Pruritus, pain, erythema, and induration that has spread to entire back of upper arm (above the elbow)
Pain/itching at injection site; discoloration at injection site; headache; body aches.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient reported numbness immediatley following injection in shoulder neck and ear.  he then report numbness moving across his face and throat and tongue.  Patient then reported feeling very hot.  Gave him 25 mg of benadryl and called 911 .  Emt's reported hypertension (172/110) and sent him to hospital for treatment
No additional adverse effects reported; A physician states that on 04/20/2020 a patient was administered an improperly stored dose of VARIV AX.; This spontaneous report has been received from a physician, referring to a patient of unknown gender and age, Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided.  On 20-APR-2020, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot number S010465 (had not been valid upon internal validation) and expiration date 20-MAY-2021 (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at 14 Fahrenheit (F) for a timeframe of 339 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.
Painfull, hyper-sensitive, very weak legs and knees To the point of legs "giving out" and collapsing during movement.  Still dealing with symptoms on a daily basis, still can not bend my legs...knees too painful.  Could this possibly be due to the Covid vaccine?
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Health facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Woke with pink nonraised itchy rash on front of neck 3 consecutive mornings after receiving vaccinations. Tx with Benadryl q 6hours. No rash on day 4. No addtional s/s of reaction. No previous hx or similar event.
body ache and sore arm; headache; fever; sore throat; runny nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (body ache and sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
Redness & swelling appeared on 7/9/11 to upper (L) thigh, was painful to touch, no pain now. (1.5 cm induration & 8x4 cm erythema now). F/u w/PCP if fever or increased redness or tenderness.