chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "she had a bad back ache./back is sore"; DISEASE RECURRENCE (non-serious) with onset Nov2021, outcome "not recovered", described as "I am having a back ache that is something that reoccurring". Additional information: it was reported that, she received the booster dose yesterday and she had a bad back ache. Actually, she had a question. She was asking if she can take Tylenol (Suspect captured for query) and she already gave the number of our Pfizer medical information department as well". She got her booster shot yesterday, she was having a back ache that was something that reoccurring. It doesn't have anything to do with the vaccine or COVID or anything like that. It was something that reoccurs that she had. All she wanna know if she could take some Tylenol to help her back ache if it won't mess up with vaccine or anything. Her back was sore and she just want to take some aspirin (suspect captured for query) if she can. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness, swelling and rash. Soreness and swelling lasted 2 weeks and rash is still active a month later.
Feels anxious, sweating, shortness of breath, dizziness, unable to concentrate, and nausea.
The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.
Intense shivering, fever, muscle aches, fatigue for 3 hours. Took Advil , bundled up in warm clothing, and slept 2 hours.  Woke up feeling normal temperature, however, like I had the flu.  Slept 3 more hours.  Woke up and feel fine except very fatigued.
Headache; swollen throat; cough; chest congestion; diarrhea; chills; tiredness; nausea; body ache; This is a spontaneous report from a contactable consumer. This 48-Year-old male consumer reported.  A 48-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6199, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 02:30 PM (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications were not reported. On 08Mar2021 02:00 am, after the vaccination, the patient experienced Headache, swollen throat, cough, chest congestion, diarrhoea, chills, tiredness, nausea, body ache. The reporter assessed all events as non-serious. No other vaccines taken in four weeks; no other medications taken in two weeks. Patient was not diagnosed with covid prior vaccination. And not tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
This spontaneous report as received from a pharmacist via a company representative refers to a 67 year old female patient. On 10-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date not reported) (one time injection, subcutaneously). On 12-JUL-2013, the patient developed a rash at the injection site after receiving ZOSTAVAX. At the time of reporting, the outcome was unknown. It's unknown if the patient sought medical attention. Additional information has been requested.
Myalgias, worse at the end of the day, better at the beginning of the day, lasting over 2 weeks. Peak symptoms were on days 4-6 of illness.
CHILD AWOKE WITH SWELLING OF EYES AND MOUTH AND LEFT ARM. SHE ALSO WAS COVERED WITH HIVES ON HER ARMS, LEGS, TRUNK, BUTTOCKS AND FACE. SHE WAS SEEN IN THE ER AT HOSPITAL AND TREATED WITH PREDNISONE AND BENEDRYL. SHE WAS ALSO VOMITING AND HAD A LOW GRADE FEVER.I SPOKE WITH MOTHER THE NEXT DAY AND THE CHILD HAD RECOVERED ALMOST COMPLETELY - THE HIVES WERE GONE AND THE SWELLING WAS IMPROVING GREATLY.
Fatigue, headache, nausea, body aches within one hour of injection.  Went to bed at 8 pm.  Woke up at 9 pm with swelling, tenderness and pain under right arm radiating down arm to hand along with severe pounding and rapid heart rate.  Symptoms lasted two hours while awake and then I fell asleep until 7 am next morning.  Felt fatigued, nausea, body aches and weak for 5 days.
INCORRECT PRODUCT STORAGE; PATIENT RECEIVED JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 04-JAN-2022, the patient experienced patient received janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237039. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220650111, 20220649045, 20220649488, 20220649417, 20220649421, 20220649626, 20220649803, 20220649884, 20220649915, 20220650185 and 20220650933.
Pt was sick at her stomach, had a red, swollen, painful arm where vaccine was administered.
Patient with history of 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note "67 YO female with PMH distant Hx DVT RLE (not on OAC), COPD, MDD, DM2, GERD, HLD, HTN who presents 12/7/22 with altered mentation secondary to tripping a week prior to presentation. She lost consciousness for about an hour. She reports right-sided weakness. She did not report any numbness or slurred speech. She was found to be covid positive. Neurological examination revealed BL LE weakness. MRI of the brain revealed acute to subacute bilateral ACA infarcts. TEE showed a small PFO and EF of 60-65%. CTA of the head and neck showed proximal occlusion of this azygos anterior cerebral artery variant. High-grade stenosis of the right vertebral artery ostium. Repeat CT head 12/10 showed evolving ischemic infarction, likely subacute, in the anterior cerebral artery distribution bilaterally. No evidence of hemorrhagic transformation. Anti-thrombin 3 was 99, factor VIII was 293. She was monitored in the hospital with serial neurochecks and treated with DAPT. She was evaluated by neurology who recommended DAPT for 90 days and after that to Dc ASA and continue Plavix, to continue Atorvastatin 40mg daily, and to pursue a 30 day event monitor to evaluate for arrythmias, as well as a heme outpatient workup. She improved clinically and was assessed to be appropriate for discharge to rehab on 12/15/2022   Neurological Exam on Day of discharge- AAOx3, Sensation intact in all dermatomes.  No asterixis present, cranial nerves intact. Finger to nose testing intact. Heel to shin slight deficit on left fully intact on right.slight motor deficit on left upper extremity."
Covid 19 after first dose of Pfizer Covid 19 Vaccine; Covid 19 after first dose of Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart patient (heart disorder), has high blood pressure, has had 13 surgeries on her legs for blood clots; and she had no problems with her vaccines, quadruple bypass surgery, Diabetic. There were no concomitant medications. Patient caught Covid 19 herself when was taking her husband to the hospital.She had already had one of her Pfizer Covid 19 Vaccines.Now, States she has taken both doses and her booster dose with no problems. She got COVID, but the doctor caught it and gave her some special medicine and she is fine. The outcome of the events was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Experiencing slight pain in the injection site on both arms, but more often in the right arm. Headaches come and go. Pain in arms are not consistent and switch arms. Feels like I got the shot a week ago, but it's been 3 months.
Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old patient of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-SEP-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Pt was treated by a physician for the following injury resulting from zoster vaccine live (ZOSTAVAX) use: Bell's Pallsy. Pt claimed damages as a result of: injury to themselves, loss of consortium, loss of services, economic losses.  Upon internal review, the event of facial paralysis was considered to be medically significant.
Used desensitization process due to prev. flu shot reactions.  Covid vaccination given in small doses alternating arms.  Sore throat started 2 hrs after vaccination; then body aches, sweating, some nauseu...hit hard 6 hrs after vaccination. 2nd day feverish but no fever, brain fog, fatigue, some vertigo; overall flu-like symptoms but no fever lasted 2.5 days.  Fatigued and feverish on any exhertion.  Pre-dawn 7th day woke up due to loud emergency alarm about 5am; thought apartment on fire or tornado.  Realized sound was in my head; left ear blocked by ringing about 75%; less in right ear but was in both.  First 2 hours were the worst; got better gradually over next 8-9 hrs.  Became an intermittent thing ..
6 days ago she came in for her Hep A and Flu shot. After that she had blurred vision and a headache.  L eye.  Went to dance right after that and at dance blurry vision then headache.  HA pushing, forehead, behind eyes. Lasted several hours.  Took ibuprofen and went to bed.  Still had HA in am.  Some days small HA, sometimes worse.  Ibuprofen prn since then.  (tylenol last night) Taking it 2-3 times a day since then.  Since then the blurred vision is gone but the headache has been there everyday since.
Pt reports not feeling well on Tuesday after shot, on Wednesday pt experienced swelling and rash on arm, Sunday the reaction went away, small swelling and rash on lower arm below bicep today, pt took aspirin, pt took ibuprofen, pt did have fever tuesday, will go next wednesay to Dr to Dr.
Patient reports that a headache started the evening of the vaccine.  She has experienced daily headaches since then.  They usually occur in the afternoon around 4:00 PM and interfere with her daily life.   She often has to stop what she is doing for the day.  Patient has an appointment with a neurologist to discuss her ongoing migraines and if the vaccine is related to them.
Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who in September 1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007 the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
During the 15 minutes observation following vaccine administration , patient experienced severe nausea, acid reflux, tongue numbness and headache.
The pt experienced pain in right arm going down to fingers about 10 - 15 minutes post vax. The pt also experienced swelling in fingers, tingling and numbness in right fingers and wrist. Throat felt funny while eating some lunch at 12:00. Saw MD when symptoms did not subside. He gave pain medication and advised no further Hep B vaccines.
Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022; Received expired first booster dose  beyond manufacturer date of expiry; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose  beyond manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 08 JUL 2022 after expiration date on 05 JUL 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient received first booster dose of Moderna COVID-19 vaccine about 2 PM. The manufacturer expiration Date reported as 05 JUL 2022. Number of doses/vials reported was 1 dose / 1 Vial.   The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 08 JUL 2022 9 AM.  No treatment drugs were reported.
We were tested for Covid on 5/3 because we had to fly. My husband and I were negative at that time and I had no symptoms. We came home on 5/4. 5/5, I woke up feeling totally drained, but I attributed it to jet lag. But later that afternoon, I began feeling chilled so I took my temperature and it was 101.5. So I took a Covid test at home on 5/5 and that was negative. On 5/6, I was feeling better and went shopping and out to dinner. But on 5/07, I woke up with a wet cough so I tested myself for Covid again and it came back positive. I called the on call doctor at my doctor?s office who prescribed Paxlovid which I started right away. The day after I began taking the medicine, I was feeling about 80% better and at this point I am feeling completely better.
This spontaneous report was received from a pharmacist via a company representative and refers to herself, a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, 1 vial, (route of administration, anatomical location, lot number and expiration date were not provided). The vaccine was administered by an unspecified pharmacist. There were not concomitant medications reported. On an unknown date, the patient got a rash and swelling, and it was hot to the touch, she also felt a knot at the injection site. The patient did not see medical attention and she treated the adverse events with ice only. There was no product quality issue involved. The outcome of injection site nodule, injection site warmth, injection site swelling and injection site rash was reported as recovered on an unspecified date, reported as "2 weeks after received the ZOSTAVAX vaccine". The reporter did not assess the relatedness of injection site nodule, injection site warmth, injection site swelling and injection site rash with ZOSTAVAX vaccine. This is one of two cases from the same reporter. Additional information is not expected since the reporter contact details were not provided.
Information has been received from a consumer concerning her 19 year old daughter who on an unspecified date in January 2007, was vaccinated with her first dose of GGARDASIL vaccine (yeast) (Lot #, site, and route not reported). There was no concomitant medication. On an unspecified date in May 2007, the patient was vaccinated with her third dose of GARDASIL vaccine (yeast) (Lot #, site, and route not reported). No information was provided regarding the second vaccination with GARDASIL vaccine (yeast). On an unspecified date in June 2007, the patient experienced a red rash in her hip area going up to her breast area. The patient has been having this rash on and off since June 2007. The patient has sought unspecified medical by visiting "a couple of doctors and dermatologists and no one can determine the cause." As of the time of this report, the red rash was persisted. No additional information is available. Additional information has been requested.
Around 24 hours post COVID vaccination into her left delt,  she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)
This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 16-SEP-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M009768 with expiration date at 23-FEB-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
low grade fever; headache; didn't feel wel, felt foggy; a little ear pain deep inside; sinus hurt; swollen lips; lip twitch; tingling in fingers/tingling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside) and SINUS PAIN (sinus hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Endometriosis.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On 11-Mar-2021, the patient experienced PARAESTHESIA (tingling in fingers/tingling in feet). On an unknown date, the patient experienced PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips) and MUSCLE TWITCHING (lip twitch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) at a dose of UNK dosage form. At the time of the report, PYREXIA (low grade fever), HEADACHE (headache), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips), MUSCLE TWITCHING (lip twitch) and PARAESTHESIA (tingling in fingers/tingling in feet) outcome was unknown and MALAISE (didn't feel wel, felt foggy) was resolving.
Pt received the flu vaccine on 10/7/16 and began to feel ill that night. She complained of fatigue, severe diarrhea, fever and body aches along with a bruise and lump at the site of injection. The symptoms lasted for about 7 days.
Mild Chest pains when even a little active. Severe tiredness / fatigue. Need to rest.
Vertigo, Dizziness, Ear Full Ness, Hearing Los, Tinnitus - Menieres Deseas
This case was reported by a consumer (the subject) and described the occurrence of got sick in a 57-year-old female subject who was vaccinated with influenza vaccine (unknown manufacturer). A physician or other health care professional has not verified this report. Concurrent medications included ADVAIR diskus and VENTOLIN HFA. On an unspecified date in October 2013 the subject received a dose of influenza vaccine (unknown, left arm). In November 2013, 1 month after vaccination with influenza vaccine, the subject experienced 'got sick' and was 'coughing'. The subject was noted to have consulted her physician, details not provided. At the time of reporting the outcome of the got sick and was coughing were improved. The subject also reported that "every year get sick around Christmas after getting flu vaccine (unknown)"; no other details were provided. The outcome of the subject getting sick was unspecified.
3 weeks after the second dose of Moderna, a baby was conceived with gonadal dysgenesis (missing one X chromosome). The fetus had no heartbeat at gestational age 18 weeks and 4 days.
Patient's arm became red, hot, and swollen all the way to her elbow. Her arm is painful and she has terrible malaise.
Severe pain in tail bone area within 2 days following vaccinations.  MRI 4 months later showed a Tarlov Cyst.  All symptoms associated with a symptomatic Tarlov cyst were experienced and continue for more than one year.
Case number PHEH2014US011475 is an initial spontaneous report received Medical assistant via company (reference number: NA14-002351) on 05 Jun 2014. This report refers to female adolescent patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13017, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml on 02 Jan 2014. It was reported that she developed cellulitis starting either same day evening or next day morning. The outcome of cellulitis was not reported. The event was assessed as non serious by the reporter and causality of the event was not reported.
Mother reports hives next day, hands and head. Itchy all over-given BENADRYL antihistamine and helped symptoms.