chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age (Age: 65; Unit: Unknown as reported) received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced arm soreness on an unspecified date. The patient stated she had nothing, absolutely nothing and it worried her. She asked if she needed to have antibodies checked to see if there was something with the dose that wasn't right. She stated she needs to had lab work done anyway. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on an unspecified date. The outcome of the event was reported as unknown.  Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
This morning I noticed a pink rash in the shape of a triangle below the vaccine site.  It is slightly warm to touch, does not itch or hurt but is in the shape of a perfect triangle approximately 2 inches large
No additional AE's. No PQC; Nurse stated that this lot of VARlV AX had been administered to one patient after undergoing the temperature excursion.; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies was not provided.  On 02-MAR-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number S024363 and expiration date on 06-AUG-2021, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). The nurse stated that this lot of the vaccine was administered to the patient after undergoing the temperature excursion (product storage error).  The vaccine was stored at a temperature of -50 Celsius (C) to -15 C; for a timeframe of 0 hours, 15 minutes, 0 seconds; with a previous temperature excursion of 4.3 C for 3 hours, 37 minutes, 0 seconds. The call was due to a Digital Data Logger. No additional adverse events were reported.
has Bell's Palsy; started having a weird taste in her mouth; felt sharp pains in her jawline; eyes started twitching and her eyelids would not close; eyes started twitching and her eyelids would not close; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: FA8448 expiry date was unknown) via an unspecified route of administration arm left on 28Aug2021 15:00 (at the age of 51-years-old) as a single dose for covid-19 immunisation. Medical history and no concomitant medications. Prior Vaccinations (within 4 weeks): Reporter stated she has never had a vaccine. Reporter declined to provide HCP contact information and states she can look at her medicine but then stated she does not know the HCP's name or other information. Stated her patient card has the lot number handwritten on it and has another person on the line and call recording notification provided on the line again; Reporter stated she has her glasses on and can't see the lot number written and it looks like FA8448 and the card does not have the NDC, or expiry date written on it. Provide the time of onset of AE(s): Reporter stated she was not sure when the Bell's Palsy began but she started having a weird taste in her mouth about a week ago and after that felt sharp pains in her jawline and her eyes started twitching and her eyelids would not close and that happened within the past week on Saturday, stated her eyelids started not being able to close three days ago. Stated the weird taste in her mouth was ongoing and she went to her dentist for something to do with infection in her mouth and took Amoxicillin for that and the Amoxicillin did not work, and she still has the weird taste in her mouth; stated her eyes stopped closing and the twitching began and she went to her doctor and he told her this on 09Sep2021. Stated the weird taste in her mouth was ongoing and the same as when it began; stated the Amoxicillin was in an orange pharmacy bottle and the dose is 875mg but because it was an orange pharmacy bottle, it has no lot, expiry date or NDC. Stated for her eye twitching, the eyes were twitching a couple of days ago and maybe last Friday and Monday and Tuesday they were twitching and then Wednesday her eyes would not close. Stated she has not had the 2nd dose of the Pfizer Vaccine and it was supposed to be next Saturday. Reporter asked if she could get a copy of this report and was provided with report reference number. Outcome of the events Taste disorder and pain in jaw was not recovered, all othe events was unknown.  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Employee stated 4-5hrs after receiving vaccine she begin to feel dizzy, lightheaded. Symptoms progressed to fever, nausea and vomiting on Thursday & Friday, vomited x 3, fever subsided Friday night, vomited x 1 on Saturday. States she is to be seen by her PCP on Tuesday (10/31/17). Feels better today, no other symptoms noted.
Fever of 102 started 1 day after immunization. WBC 38.1 + neutrophils 88. Now with mild headache 2 weeks after immunizations.
Pt contacted health clinic on Apr 22 at approximately 0900 stating he was experiencing numbness and tingling in his right arm/hand, no other symptoms/side effects stated.  Pt indicated that symptoms started yesterday morning, Apr 21 and got worse this morning when he woke up which prompted him to contact the clinic.  Pt was instructed to f/u at urgent care/er to rule out other medical conditions.
Stiff neck, fever 104, sleeplessness, 14 days antibiotic (Claforan) in hospital say, ICU 2 days.
pt recvd vax;2 wks later,n,d,stomach aches,several colds;serum iron low per blood test;lost 10lbs;dx crohns disease june 1994;at that time was having d 15 to 20 times per day;anemia;on prednisone;was on ascole,flagel,cipro,levsin;takes herb
I initially thought dizzy spells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 at 09:00 as dose 1, single (Lot number: IN6206) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Possible IgG present for gluten" (unspecified if ongoing), notes: Have been gluten free 25 years at time of vaccination (suggest autoimmune reactions); "Possibly relevant hypothyroid diagnosed at age 16" (unspecified if ongoing), notes: Onset date: No symptoms at time of vaccination. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "I initially thought dizzy spells". Therapeutic measures were taken as a result of dizziness.  Additional information: Family medical history relevant to adverse events (AES): None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029003 Same patient, same product (dose 2), different event.;US-PFIZER INC-202300035945 Same patient, same product (LOE), different event.;
Day 9- start of itching,, warmth and redness on injection site. Day 12 - intense itching, and induration worsening., relieved with Allegra 180mg.  Day 13 - Size of induration 10x6cm , Allegra helpful. Day 16 - Essentially resolved.
A week after the vaccine I was still feeling achy and inflamed joints. I saw a nurse and I got prednisone a week later. I started experiencing pain in my upper right abdomen and shoulder. The prednisone helped a lot. I stopped the prednisone and had to go to the ER on 12/11 due to an inflamed gallbladder and had to have it removed. About a month later I was fully recovered.
I had an earache, but I didn't have any other symptoms. The nurse said she had an earache when she had COVID-19. They doctor tested me for COVID-19. The result was positive. She prescribed Paxlovid. I took it twice a day for five days. I was exhausted and unusually hungry. Those were the only symptoms I experienced. It lasted for about four weeks. I still have lingering exhaustion.
Pt had covid19 in 11/2020, now with immediate onset of sepsis of unclear source after 1 dose Pfizer vaccine as well as rapid atrial fibrillation and heart failure
This spontaneous report as received from a healthcare worker refers to a 60 year old female patient with allergy to SULFA, allergy to CIPRO, allergy to CRESTOR and dexamethasone (manufacturer unknown) allergy. The patient's medical history included hyperlipidaemia, arthritis and fibromyalgia. On 12-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # K000996, 0.5 ml, intramuscular for prevention of shingles. Concomitant therapies included NEURONTIN, ASPIRIN and NIASTAN. On 12-AUG-2014, the patient experienced massive diarrhea, almost fainted, injection site was warm to touch with red streaks on arm and swollen after receiving KEFLEX and was discharged home. There was no hospitalization. Venous Doppler scan was performed which was normal. Unspecified lab studies were also performed. The outcome of events was unknown. Product quality complaint was not involved. Causality of events with ZOSTAVAX was unknown. Additional information has been requested.
Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Client received TD on 2/6/07 on LD claimed 2 days later the hand was stiff and hurting (LH) 2/8/07. On 2/13/07 she claimed her arm had a raised lump and open with drained. She also mentioned went MD has a prescription of antibiotic and came to the clinic.
patient  received 1st dose of covid 19 vaccine , she call for help while waiting  for her observation time states she feels faint  she was in and out of consciousness ice pack applied  back of her neck and forehead. patient states she had hx of passing out when she had blood draw or receiving injection ,she feels much better after  observing additional 20minutes
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002496: US-009507513-1712USA002494: US-009507513-1712USA002495:
22APR99 pt presented redness on inj site;couple of day later observed local rash on inj site denies other signs or sx;28APR99 macular papular dry;
This spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerns a 59-year-old, adult female patient. On 12-Oct-2018, the patient was administered expired suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse effects were reported by the patient after vaccination. The reporter assessed the case as non-serious. Follow up received from the pharmacist on 31-Oct-2018: Updated patient's date of birth and age (59 years) in the patient's tab. Added batch number (195245) in the product's tab. The narrative was amended accordingly.
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014755, lot# M031802, lot# M035456, lot#M038744 (expiration dates not reported) and lot# M034799 with expiration date of 01-FEB-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004394: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004409: US-009507513-1708USA004395:
Received 2 TRUMENBA at 12:02 PM. Had light breakfast at 10:40 AM - only ate 1/2 apple. Drove self home - ate lunch at restaurant afterwards. Felt dizzy at 3:45 PM. No syncope. Saw spots in front of eyes, nauseated. Took 1 ADVIL for sore arm and rested in bed. Feeling better 30 mins. later. 8/8/18 - called patient - no further complaints.
child recv vax & 12MAY97 mom devel 30-40 lesions;
Erythema and swelling of L upper arm approx 12cm x 10cm. Very warm to touch x2 days. Cephalexin RX given cellulitis.
Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that, the patient received total 4 doses, and this was 2nd booster dose.  On 07-Feb-2022, the vials were initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow-up received contains no new information.
70cmx60cm red area (knot) on upper arm, warm to touch, developed about 48 hours after administration of vaccine. Treatment ice and Ibuprofen. Reported to Occupational Health Nurse.
About 12 hrs after my second shot, I had fever, chills, and body aches. That lasted 24 hours.   Minor brain fog followed the next day.  THen I was fine. A day before I hit my 2-week mark, I got really dizzy and started experiencing some mild confusion/forgetfulness, and had an inability to focus on anything.  It was so bad that I went to the doctor and he couldn't find anything wrong.  Then I found a forum online of people complaining about dizziness 2 weeks after their moderna shot and thought it best that I report it.
(Approx.times)10:35am vaccinated;11:35 reported itching,welts on arms,auxilla,waist, abodmen/pelvic area;11:40Benadryl 50mg orally taken;12;05 some relief of itching;12:30 itching less,welts less red;4:11 felt better, itching confined to feet, welts lighter,repeated Benadryl 50mg.at 4:15pm and 8:00pm with 25mg at bedtime. On 10/24/03 at 10:30 reported no itching, welts almost gone. Client at no time experienced respiratory or other difficulties.
achy; wicked cold in the night; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2021, the patient received the 2nd dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced pain and feeling cold. On an unknown date, the outcome of the pain and feeling cold were unknown.   It was unknown if the reporter considered the pain and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingrix and was wicked cold in the night and achy. The follow-up would not possible as no contact details were available.
Information has been received from a health professional concerning an 80- year old male patient who sometime in late April or early May 2008 was vaccinated with a dose of ZOSTAVAX vaccine at another site. On 21-NOV-2008, the patient developed the shingles. The patient sought unspecified medical attention. At time of reporting, it is unknown if the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/23/2008. Follow-up information has been received from a  completed questionaire on 10-FEB-2009, from a nurse practitioner. It was reported that the 80 year old male patient with rheumatoid arthritis, gastroesophageal reflex disease, coronary artery disease, chronic obstructive pulmonary disease, osteopenia, protate cancer, vitamin B12 deficiency and chronic renal insufficiency and a history of chickenpox in childhood, in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine at a local pharmacy. Concomitant therapy included methotrexate,REMICADE, PRILOSEC, metoprolol, ACTONEL, TYLENOL, and cyanocobalamin. On 31-NOV-2008 the patient developed 3 small clusters of vesicles in the right side of back and lateral chest. Systemic symptoms included mild skin eruptions and neuralgia. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a maximum body temperature measurement of 98.6. There was no a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain reaction. There was no  a photo taken. As of 08-JAN-2009 the patient recovered. Additional information is not expected.
Patient received vaccine in public vaccine clinic, was recovered for 15 minutes and drove self home.  Upon walking into her apartment, began feeling extremely tired, dizzy and weak, then developed GI symptoms.  Was seen by her pcp on 02/19.  It was noted that she was newly bradycardic, 40 bpm.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with M-M-R II. Concomitant medications were not reported. It was reported that the M-M-R II vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of M-M-R II are administered consistently throughout the period of January 2014 to May 2014. No adverse effects was unknown. This case was linked to 1405USA000152, 1406USA000393, 1406USA000394 and 1406USA000395 (same reporter link). Additional information has been requested.
Patient reports rash on left arm that started a few days ago. Became worse today. Increasing in size, itchy. Patient is treating with OTC interventions currently.
Patient received the regular quadrivalent vaccine (under 65 year old dose) and patient is 67 years old
6 days after the shot the lymphnodes in my armpit became swollen and very painful.  after two days it has reduced but still has not gotten completely better.
At 1142, patient reported minimal chest discomfort to nurse Patient reported the chest discomfort started at approximately 1130 and stated "it comes and goes". Patient reported he took deep breathes and walked after it started. Patient reported history of anxiety attacks and similar episodes in March 2021. At 1150, Nurse assessed patient vitals: blood pressure 148/92 mmHg, pulse 78 beats/minute, and SpO2 98%. Patient offered 911. Patient refused 911. Patient reported he was nervous before getting the vaccine and stated "I know it's all mental". At 1205, nurse assessed patient vitals: blood pressure 140/98 mmHg, pulse 82 beats/minute, and SpO2 98%. At 1212, nurse assessed patient vitals: blood pressure 142/90 mmHg, pulse 76 beats/minute, and SpO2 99%. Patient reported he wanted to leave. Nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on V-safe, and to follow up with primary care provider. At approximately 1220, patient left facility with unlabored respirations and steady gait.
stroke like symptoms; joint pains; can not walk or perform my routine, hard to work; heart palpitations; can not walk or perform my routine, hard to work; This is a spontaneous report from a contactable consumer (patient). The 36-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke like symptoms, joint pain, can not walk or perform my routine, hard to work, heart palpitations on an unspecified date. Reported as: The patient had no significant medical conditions. The patient got the first dose of COVID vaccine three weeks ago and been to multiple doctors and emergency room in three weeks. "I had stroke like symptoms but all CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans returned normal, all my blood work, blood sugar levels, blood pressure, thyroid levels are normal. I have joint pains so severe that I can not walk or perform my routine, hard to work( I work desk job). On top of it, I have heart palpitations for the last two days and no one knows why". The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
This spontaneous case reported by a consumer, describes the occurrence of fatigued in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigued. At the time of the report, fatigued outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Reporter did not allow further contact.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient came on 09/21/22 to the pharmacy counter to share that she was having sporadic rash and itchiness appearing and disspearing around her body ever since she got the Flu shot. She confirmed she has not experienced swelling on her lips or throat or other symptoms. She as counseled to take a non-drowsy antihistimine for the daytime and bendaryl at noght before sleeping. If the rash/itchiness continues she was adbised to see her doctor for medical review. Her profile was updated.
After 20 minutes, pt complained of dry, swelling in roof of mouth, dry throat making it difficult to swallow. BP 134/100, P-68, T-98.4F. No SOB or other difficulties breathing. Observed for a total of 45-60 minutes. No edema of roof of mouth or uvula or throat observed.