chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got COVID; got COVID; sore throat; sneezing; third (booster) dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 22Feb2021 (at 22-years-old); the second dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 17Mar2021 (at 22-years-old); and a third (booster) dose of intramuscular BNT162B2 (solution for injection; Lot FF8839 expiry information not provided) as a single dose in the left arm on 13Oct2021 (at 23-years-old). The patient had no medical history nor any known allergies. The patient denied being diagnosed with COVID-19 prior to receiving the vaccines. The patient denied receiving any other vaccine within four weeks of these vaccines or any other medications within two weeks; the patient was not pregnant at the time of vaccine. The patient reported that on 31Dec2021 she got COVID with mild symptoms of sore throat and sneezing. A SARs-COV2 nasal swab was positive on 31Dec2021. There was no treatment received for the events. The outcome of the events was recovered on unspecified dates.
Complained of pain all afternoon after. Randomly expressed discomfort over next two days. On the third day, a red bump, surrounded by redness appeared on the spot where the MMRV shot was given.
Redness and swelling R arm 5 cm diameter (delt). Emesis x2 day of inj. Mom reports decrease in size since onset.
Pediatric vaccine was mixed on 11/24/2021 at 9 am and was not salvaged by closing pharmacist end of day. Pharmacy was closed on thanksgiving. On 11/26/2021 at 2 pm, the pharmacist drew out 1 dose from the expired diluted vaccine kept in the fridge since 9 am 11/24/2021 and gave it to the patient. After incident happened, at around 2:45 pm, Pfizer was contacted and the case was reported with all of patient's demographic info and vaccine info (with patient's father's consent). Patient's parent was contacted same day. On 11/29/2021 at around 8:20 am, patient's parent was contacted, and we were informed that patient experienced sore arm and no fever or other side effects reported.  Safety report was done with Pfizer on 11/29/2021. Regarding stability of vaccine, we're still waiting from Pfizer to get the info.
C/o rash on back, chest/trunk. Had immunization 9/13/11 - FLUZONE. Allergic rxn - flu vaccine. 1) No flu vaccine in future. 2) ALLEGRA susp 1/2 tsp PO BID x 7.
Pt presented @ office w/large local rxn, lt thigh had large reddened area measuring 3 3/4" x 5" very warm to touch & tender to touch; tx heat, message, DPH & APAP to be cautious w/next booster of tetanus, should get no further pertussis;
day of vax >24 hrs of unconsolable crying & inc sleepiness was limp when awake by mom's report 10JAN94;
Information has been received from a nurse referring to a 14 years old male patient. The patients' concurrent conditions and concomitant medication were not reported. No pre-existing physician-diagnosed allergies, birth defects and medical conditions. On 24-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose unknown, lot # M040412 with expiration date 30-JUN-2019) intramuscularly in the right deltoid. The refrigerator temperature was at 35 degrees Fahrenheit on 18-JAN-2018 (also reported as "the vaccine was exposed to a temperature between 32 to 35 degrees Fahrenheit for 8 hours"). No adverse reaction reported for the patient. The patient tolerated well. A digital data logger was involved. No previous temperature excursion was reported. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA008643.
77 year old female with PMH of HLD, RA, CAD, C-Diff, CVA with residual right-sided hemiparesis and expressive aphasia who presents emergency room for evaluation for Lethargy and hypotension. Spouse reports pt has been Lethargic and not been her usual self. Pt is unable to give history due to the fact that she has hx of stroke with Aphasia. Obtained hx from spouse, and pt's chart.   In ED pt is found to be hypotensive with a UTI. Patient was found to have a BP in the 60s today by EMS, and c/o feeling weak and lethargic. Patient was given fluids by EMS and brought to the ED. Pt was started on with Ceftriaxone for her UTI. Holding Pt's blood pressure medications in lieu of hypotension on admission.
Blood Clots in my left leg. I?m taking blood thinners. Eliquis 5mg.  Still healing.
no adverse affects; improperly stored MMR II was administered; Information has been received from a pharmacy technician referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-AUG-2019, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # R027063, expiration date: 20-SEP-2020, strength, dose, frequency and route were unknown) that was improperly stored (incorrect product storage). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was exposed to temperature at 70 Fahrenheit degrees for 4 days. The data logger was involved. No previous excursions were reported. No adverse effects were reported.
Immediately after getting vaccinated I had regular symptoms like headache fever and nausea.  however today you notice whiteheads or white spots  on the skin in the area around the neck and itching in the area
Sore throat; Fever; Headache; Feeling unwell; Achiness; Fatigue; Swollen lymph nodes; Chills; Sore arm; Congestion; This is a spontaneous report received from contactable female consumer (patient herself). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 03Mar2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A day after vaccination, patient experienced sore throat, fever, headache, feeling unwell, achiness, fatigue, swollen lymph nodes, chills and sore arm. Patient currently had sore throat and congestion and was getting better now. The second dose of patient scheduled on 31Mar2021, and wanted to postpone the second dose as her husband will have a heart surgery pacemaker on the following day - She does not want to feel sick since she will take care of her husband post-surgery. The outcome of events Sore throat and Congestion were recovering and for other events outcome was unknown.  Information on lot/batch number has been requested
Several weeks after receiving my second dose of the Moderna vaccine, I began feeling pressure in the upper left side of my breast, as if a seatbelt was pushing on my chest. This sensation was present even when I had no clothing on.  It persisted for months.  I went to see my OB/GYN NP to see if I might have something going on in my breast. She conducted a breast exam and found nothing.  She gave me orders for a mammogram if it did not subside in a few more weeks, stating that sometimes the Covid vaccine affects lymph glands and causes inflammatory responses that can last a while.  I had a routine mammogram and breast ultrasound scheduled for September 22nd.  The sensation started decreasing, so I just waited until that September appointment.  The mammogram and ultrasound came back negative, but I continue to have the sensation from time to time.  It is not daily, but several days per week.
Immediate lower back pain, generalize body aches and weakness, fatigue for 4 days now.
PT is a 14 y.o. right handed female referred for evaluation of tremor. Tremor primarily involves the right hand and right pinky.  Onset of symptoms was sudden, not related to any specific activity but was noted to be 2 days after 2nd dose of pfizer covid vaccine. Never had tremor before. Denies pain, numbness, tingling, hyperesthesia. Symptoms are currently of mild to moderate severity. Tremor exacerbated by running. . Tremor is alleviated by resting extremity but it does not go away. Denies fatigue, denies anxiety or whole body jitteriness. She denies voice change, sleep disturbance, drooling during sleep (wet pillows), rigidity, postural changes, difficulty in initiating movement, difficulty with walking, difficult with posture, difficulty with swallowing and balance problems
No adverse event; HCP reported VARIVAX was administered after a temperature excursion to a patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions and concomitant therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U015847 with expiration date of 19-MAY-2023, which had been verified to be a valid lot # for varicella virus vaccine live (Oka/Merck) (VARIVAX), administered once for prophylaxis (strength, dose, and route of administration were not provided) that experienced a temperature excursion of 8.42 Fahrenheit grades (F) for a time frame of 1 hour, 2 minutes. No previous temperature excursion reported, if a data logger was involved was not reported (product storage error). No further information provided and no additional adverse event (AE) (no adverse event) reported.
Blood vessel bursts in whites of eye; Feeling of pressure on eye; General ill feeling; eye discomfort; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in right arm, on 24Mar2021 (at the age of 59 years old) at 13:15, as a single dose, for COVID-19 immunisation. Medical history included Colon re-section surgery in 2020 due to diverticulitis. The patient did not have allergies to mediations, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162b2. On 24Mar2021 (at 4:00pm), the patient experienced blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events, blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling, was recovering.   Follow-up attempts are completed. No further information is expected.
Ringing in left ear starting evening of second vaccine during sleep initially, but progressing to all day. Scheduled appointment with M.D. on April 12th; diagnosed as Tinnitus and prescribed MethylPREDISolone Tablets 4 mg (21 tablets); could not sleep April 13th and suggested OTC Rx for Benadryl, one tablet before bed; second appointment April 28th, prescribed second Rx for Predisone; third appointment May 6th and recommended consultation with internist for depression/ anxiety Rx and follow-up for other treatment options with ENT upon return to another area on May 8th. Appointment with Dr. on May 12th; prescribed Prednisone 10mg (19 tablets) and Brain MRI scheduled for May 24th with follow-up visits to Dr on June 2nd. Video visit with internist on May 12th for anxiety, prescribed ESCITALOPRAM/ Lexapro, 10 mg, started May 13th. Also taking 6 Advil per day, 200 mg and continue to take one Benadryl at bedtime for sleep.
Red, swollen 8x8cm erythema left upper arm, hot to touch, no fever.
Patient received vaccine and passed out approximately 5 minutes afterwards.  Patient regained consciousness and sat up but lost consciousness again for about 30 seconds.  The patient regained consciousness.  911 was called.  911 told us to place the patient on his side and wait for paramedics.  Paramedics arrived and took control of situation.  The paramedics took the patient out on a stretcher.
My husband tested positive; I became symptomatic. That Monday, I was tired with fatigue. I contacted my doctor on the 21st of November. She prescribed PAXLOVID. I was just having fatigue and I developed some lightheadedness and posture instability. It continued for three to five days and then cleared up. I feel fine now. I have gotten a cold since then and have now a residual cough.
Low grade fever. "Chicken pox spots" 3 in x 2 in. Redness to injection site. Soft induration and redness blanches.
sore arm; left boob was very tender; feeling lousy; kind of sick; really bad headache; wasn't given properly/not clear of how much I got; put the needle in, took it out, put it back in; bleeding; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (put the needle in, took it out, put it back in), UNDERDOSE (wasn't given properly/not clear of how much I got), VACCINATION SITE HAEMORRHAGE (bleeding), PAIN IN EXTREMITY (sore arm) and BREAST TENDERNESS (left boob was very tender) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported. .    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (put the needle in, took it out, put it back in), UNDERDOSE (wasn't given properly/not clear of how much I got) and VACCINATION SITE HAEMORRHAGE (bleeding). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), BREAST TENDERNESS (left boob was very tender), FEELING ABNORMAL (feeling lousy), ILLNESS (kind of sick) and HEADACHE (really bad headache). On 30-Jan-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (put the needle in, took it out, put it back in) and UNDERDOSE (wasn't given properly/not clear of how much I got) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding), PAIN IN EXTREMITY (sore arm), BREAST TENDERNESS (left boob was very tender), FEELING ABNORMAL (feeling lousy), ILLNESS (kind of sick) and HEADACHE (really bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter. patient mentioned ice cold running down her arm until her fingers, unclear of how much serum she got in her body.    This case was linked to MOD-2021-039117, MOD-2021-231750, MOD-2021-231750 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR : Details of Doses, AE outcome; Sender's Comments: This report refers to a case of Wrong injection technique  and underdose for mRNA-1273  with  associated AEs, based on available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  .
SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD  TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.
pt. c/o tingling of her nose after the pfizer vaccine.  pt. symptom was resolved and pt. went home.
Post vax, the pt developed chickenpox. The pt sought unspecified medical treatment. Follow up data states the patient recovered 03/10/2000. No further information is available.
Bell's Palsy left face; This is a spontaneous report from a contactable physician. A 50-year-Old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single, and via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included hyperlipidaemia, dust mites allergy, shrimp allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced Bell's palsy left face on 08Sep2021. The event resulted in emergency room/physician's office visit. The patient received treatment with prednisone and valacyclovir. The outcome of event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of Bell's palsy left face  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.
Apnea requiring respiratory support infection screen (CBC, Bld cx) with empiric antibiotics x 48 hrs.
Vaccine site was red and irritated initially, which resolved. Fevers and chills next 2 nights, diarrhea since 1/24/17, slightly sore throat, trouble moving arm.
While sitting in vaccination chair, patient immediately started c/o of dizziness, and hearing sounding muffled, diaphoretic and hot. Alert and oriented with BP 110/88 P52 and O2 99% on room air. Cold water given with gatorade insert. Cold compress also placed on patient. After 5 minutes, patient stated she "felt better." Alert and oriented x3. Left with mother. No acute distress noted.
NO ADVERSE REACTION REPORTED - NO TREATMENT NEEDED BECAUSE NO SYMPTONS OR SIDE EFFECT
Diagnosed with Bells Palsy. Developed symptoms on 27 DEC 06.  Immunization was on 06 DEC 06.  Initial symptoms included loss of taste.  Numbness began 29 DEC 06. 1/26/07 Received medical records from hospital which reveal patient seen in ER on 12/31/06 with left facial weakness with forehead involvement & left eye tearing.  Seventh cranial nerve palsy on left c/w Bells phenomenon. Tx w/steroids, eye ointment & d/c to home to f/u with PCP.  FINAL DX: Left facial Bells Palsy.
Vaccine was given at 1 pm on 12/30/18. At around 5 pm I called to check to see how she was doing because she had had issues with a previous vaccine given (flu and pneumo together). At 5 pm she said she had no issues. On 12/31/18 at 9 am she called me to let me know that she had gotten a very bad headache at around 8 pm the previous night and spiked a fever of 100.9 degrees F that was not going down. She also had started to have the injection site become enlarged and painful to the touch- swelled 1-2 inches past injection site with red center. She had been taking TYLENOL and she asked me to call her nephrologist to see about ibuprofen. The nephrologist ok'd her to take ibuprofen max of 800 mg per day for up to five days due to potential complications of stents in her kidneys.
Approx 24 hours after Varivax given patient had onset of redness and swelling at site of Varivax. We saw patient back in office 2 days after Varivax given a 8 x 9cm erythema with 5 x 6cm area of induration / more sig. erythema and advised to take Advil 900mg TID. Dx: Local reaction to Varivax.
Patient became light headed after receiving vaccine and passed out briefly.  She was complaining of being dizzy and nauseous.   After several minutes of laying in the floor and not feeling better, EMS was called.  While waiting for the EMS she complained of trouble breathing.  EMS took her to the hospital.
Croup, cough, congestion. Tx: ORAPRED/oral steroid.
9/11/06, received DTAP-IPV-IPV-HBV, PCV7, Hib. 9/13/06, to ER for fever and Bulging fontanel. Temperature 100.8F.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment for COVID-19 Test; (25Sep2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received antiviral Pfizer drug for the treatment of COVID-19 from 15Sep2022 to 20Sep2022. Patient received vaccine and No other medication received in 2weeks. Patient had no known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.