chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Date: 11Sep2022 / Moderna, Date: 13Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 036B21A), in left arm, on 07May2021 as dose 2, single (Lot number: 014C21A), in left arm, on 10Dec2021 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight/obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Pfizer, Date: 11Sep2022 / Moderna, Date: 13Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 03Apr2023 to 07Apr2023.
Fever above 100 for approximately 24 hours, not relieved by medication. Severe migraine, dizziness, joint pain, injection site soreness that radiates into neck.
Felt very sleepy; felt very tired; Sore arm; Very low energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy), SOMNOLENCE (Felt very sleepy) and FATIGUE (felt very tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy) and FATIGUE (felt very tired). On an unknown date, the patient experienced SOMNOLENCE (Felt very sleepy). At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy), SOMNOLENCE (Felt very sleepy) and FATIGUE (felt very tired) outcome was unknown. Not Provided          It was reported that the patient might be taking diabetes medication (unspecified).  No information regarding treatment was provided. This case is for caller's son's dad and is crosslinked with MOD21-020942 and MOD21-020907.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-MAY-2021 updated contact information, professional physical mail.
Patient reported COVID arm (red, itchy, swollen arm) with symptoms appearing 8 days following vaccination
Information has been received from a physician concerning a 12 month old male who, in February 2008, was vaccinated with MMR II. Concomitant therapy included VARIVAX (MSD), hepatitis A vaccine (inactive) (manufacturer unknown) and PREVNAR. Eleven days post vaccination, in approximately February 2008, the patient experienced measles described as a "systemic measles like rash." The patient was seen by the physician. Subsequently, the patient recovered from measles with systemic measles like rash. This is one of two reports from the same source. Additional information has been requested.
significant pain in hips and joints. Feels like the nerves in my legs are pinched  Headache dizziness cold sweats
Menstruation symptoms during the first day of the first period after my first shot was severe. Headache, dehydration, extreme nausea, digestive upset, slight lightheaded ness, hot/cold sweats, more painful cramping than ever before in my life. None of this has never happened to me during a period before.
Member was suppose to receive first dose of Pfizer and member was given in error Pfizer bivalent. Dr. was notified. Per Dr. adverse member is to come back in 2 weeks and receive one dose of Pfizer mono. Member was advised to stay at clinic  for 30 minutes and be monitored for any adverse reactions. Member stayed the 30 minutes. Member verbalized feeling well. Member left clinic after 30 minutes.
PATIENT CALLED AND SAID SHE IS HAVING SEVERE ARM PAIN AND REDNESS.
I received the anthrax vaccination in Apr/May 2002. Every month I experience severe burning, aching and tenderness in my deltoids of both arms after receiving vaccinations. The pain is mostly in my Lt arm as that arm received 2 injections; the Rt arm received only 1. Every month like clockwork during my cycle, I would experience these pains and could feel nodules at the injection sites. In the last 2-3 months, these pains have been occurring weekly. The burning pain is very similar to the pain I experienced when I received the injections. The pain is so uncomfortable that I could not even lift heavy objects or lay on that side. In the last month, my left arm has had joint pain to the point that I could not even move my arm up and down or side to side. A simple task, such as ironing was very painful. This pain seems to be getting worse and becoming more persistent.
At first I was feeling tired. Then I was feeling congestion, running nose, cough, short of breath. I went to the hospital after 2 weeks of feeling bad and was diagnosis with pulmonary aneurism. I was put on a blood thinner the treat.
Fainting day after vaccine; Sweating; High blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 01Jan1987 (ongoing); "Diabetes", start date: 01Jan2017 (ongoing); "Bipolar Disorder", start date: 01Jan2019 (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: EL32646), administration date: 14Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: FL9264), administration date: 05Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: FE3592), administration date: 27Aug2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 23Jun2022, outcome "recovered", described as "Fainting day after vaccine"; BLOOD GLUCOSE INCREASED (non-serious) with onset 23Jun2022, outcome "recovered", described as "High blood sugar"; HYPERHIDROSIS (non-serious) with onset 23Jun2022, outcome "recovered", described as "Sweating". The events "fainting day after vaccine", "sweating" and "high blood sugar" required emergency room visit. Patient went to ER, kept for observation. The patient underwent the following laboratory tests and procedures: Blood glucose increased: (unspecified date) High; SARS-CoV-2 test: (Jun2021) Positive. Therapeutic measures were not taken as a result of syncope, hyperhidrosis, blood glucose increased.
Extreme blurred vision, Decreased vision left eye due to grade 4 optic nerve inflammation.
This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Upper Arm Right on 25 May 2021 (Batch/Lot Number: EW0187) as single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medication(s) included cetirizine hydrochloride (CETIRIZINE) at 10 mg once daily taken for allergy, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for allergy, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Upper Arm Right on 27Apr2021 for COVID-19 immunisation. It was reported that the patient got Pfizer Vaccine (first and second shot), on Tuesday and the patient had under her arm like a pretty big knot. The patient stated the event started Today (27May2021). The patient just had a question about her COVID-19 Pfizer vaccine, about the side effects, is it normal to have a lump under your armpit (Further clarified as side effect after getting the vaccine). It was just persisting. The patient did not take any treatment for the event. Outcome of the event was not recovered.
Information has been received from a registered nurse concerning a female "between 70 to 80 years of age", who on 11-OCT-2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23.  Concomitant therapy influenza virus vaccine (unspecified).  Subsequently, the patient developed redness at the injection site.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  This report is one of three from the same source.  Additional information has been requested.
Swelling, redness, large lump to right thigh treated with ice, massage, elevation, Keflex, ibuprofen prn, Benadryl every 6 hours and Prednisolone X 5 days.
More than expected swelling, redness, heat in (R) upper arm from shoulder -> elbow. (+) pain. Pt reports that day after vaccine "had large knot" in (R) axilla. Resolved when examined 9/10/11. Pt c/o numbness at site.
Headache and nausea at 0730 on 1/20. Had to leave work.
This spontaneous report as received from a healthcare worker refers to three patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 21-JUL-2015, the patients were vaccinated with an improperly stored doses of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
The morning I got sick I woke up with a severe migraine and sinus infection. I ran a low grade fever all day and developed a rash on my legs. The rash spread to the rest of my body. I have seem doctors and dermatologist trying to fix the problem for the past 2 years.
Fever body aches arm pain at hour 11  On days 4 to 7 pinpoint red blood type blisters on all finger tips  Easy bruising yellow and blue all over body
Headaches, muscle aches, racing pulse, nausea, chills, temp of 101.7
approximately 6 days after receiving the 1st shot, I woke up that morning and the the lymph nodes in my left arm pit were swollen.  Also occurring 6 days later I had a rash near the injection site and the area around the injection site was hard.
I had a skin reaction (welts) over my shoulders, stomach, and back. I took OTC anti-itch cream. The reaction only lasted two days
About 9 days after getting my second covid vaccine i developed pain and blisters in my mouth and gums, which then spread to a very painful breakout on my chin.  Two days after this started i woke up with  a swollen bottom lip and the pain had gotten severe so I went to the emergency room around 6 am and was diagnosed with herpes zoster or shingles as they called it.  I was given a prescription for Valtrex and a prescription for a topical ointment.  It has been a full week since then and the pain I am in is probably the worst pain ive ever experienced and am still dealing with
She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches round under the skin; Rash; Pain in arm; This spontaneous case was reported by a 70-years-old female consumer who received first dose of mRNA-1273 and experienced event rash.    The consumer's medical history was not provided.   Relevant concomitant medication was reported as acetylsalicylic acid (aspirin) for an unknown indication.  On 14-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the consumer experienced the event rash.   Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.   The outcome of event was unknown.   The follow-up was received on 27-Jan-2021 and it included that the consumer had experienced events she bled down her arm like she never bled before, pain in arm, red warm 3inches round under the skin, warm to touch and tender to touch.  On an unknown date, the consumer experienced the event she bled down her arm like she never bled before.  On 14-JAN-2021, the consumer experienced the event pain in arm.  On 23-Jan-2021, the consumer experienced the events red warm 3inches round under the skin, warm to touch and tender to touch.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.   The outcome of events was unknown.  The follow up information was received on 27 Jan 2021. The outcome of rash (unknown), erythema and pain (recovered) of extremity was updated.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of hemorrhage, and nonserious unexpected pain in extremity, feeling hot, tenderness, and expected erythema, rash.  Event onset on Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
the vaccines administered after the refrigerator lost power and lost temperature control; the vaccines administered after the refrigerator lost power and lost temperature control; A spontaneous report was received from a health care professional concerning a 53-year-old, black or African American, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of vaccines were administered after the refrigerator lost power and temperature control.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the refrigerator lost temperature control, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, the vaccines administered after the refrigerator lost power and lost temperature control, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a 53-year-old patient who experienced non-serious event of vaccines were administered after the refrigerator lost power and temperature control (out of specification product use, product storage error) for mRNA-1273 (Lot # 027L20A, Expiration date-unknown). There were no reported AEs associated with the events of vaccines were administered after the refrigerator lost power and temperature control.
Hard lump and red streak at site of injection per patient phone report 8/26/14.
2 seizures between the 7th and 8th day; red swelling day 2-5; diarrhea day 5-7; irritibility.
I have had diarrhea since I received the vaccine 6 times a day. I checked in with my doctor and he ordered bloodwork and collected a stool sample, both results came back normal. I am now being referred to an enterology doctor. I drinking electrolyte mix daily.
This spontaneous report as received from a nurse refers to three unspecified patients of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in July 2014, the doses of (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (lot # and expiry date unspecified), that underwent a temperature excursion were administered to those patients. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Symptoms included runny nose and cough. Took course of Paxlovid and symptoms cleared. Symptoms returned 9 days after initial occurrence with a positive home test, abated 6 days later.
2.5 cm x 2.5 cm indurated, red area (L) thigh site of 7/22/08 VARIVAX.
Information has been received from a health worker (medical assistant) concerning a patient of unknown age and gender. On 03-APR-2015 the patient was vaccinated with a dose of expired (Merck) VARIVAX (0.5 ml, once, lot # J003228, expiration date: 15-MAR-2015, subcutaneous). No adverse effects were reported. Additional information has been requested.
Client reports having his flu and PPV 23 vaccine at 12:30 p.m. on 12/12/06, at 5:00 p.m. he noticed swelling in his right arm. When he got up in the morning it was swollen from shoulder to elbow, hot with fever and painful. He took Benadryl to help. Today (12-13-06) it remain swollen, hot to touch and painful. Encouraged him to see his doctor today.
Nurse administered vaccination 1 min. later or less, client had face in steering wheel, passed out and urinating on herself.  Client stated she thinks this happened because of the anxiety of getting vaccine.  Client given ammonia inhaler and stabilized awaiting EMS arrival.
pt recvd vax 22JUN95 & 30JUN95 pt exp fatigue;tested for mono & anemia (results unk); 3wks later pt was still fatigued;no further details were provided;
fever 12-24 hrs post vax no temp taken by parent; high pitched cry which started morning of 10AUG93; not crying more than usual just high pitched & unusual sounding when did cry & seemmed as though breathing was difficult-stuffy nose;
8 MINUTES AFTER COVID 19 VACCINE THE PATIENT COMPLAINED OF "THROAT  TIGHTNESS." NO C/O SHORTNESS OF  BREATH 170/95 P. 80 P.O 99%  EMS EVALUATED THE PATIENT  2/19/21 2PM. THE PATIENT WAS ABLE TO  TOLERATE WATER. REST, COOL AIRD AND  THE PATIENT IMPROVED. THE PATIENT WAS  DISCHARGED IN CARE OF HIS WIFE.  HX ANXIETY HYPERTENSION LOSARTAN 25MG  NORVASC 10MG
Pain in arm and neck Arm swelling Itching and rash down left side Day 2  Rash arm bigger and hot red spot bigger Lots of advil and Benadryl Itching and sore pain in all muscle  Chills and fever heart racing pulse in 90s on resting bo 127/72 Day 3  Arm swollen and still red bigger than yesterday Itching all over  Headache ears ringing  Achy all over  Still have rash Day 4  Swollen arm a little better still red Itching in arms hands and face is worse Rash better taking Benadryl around the clock hands are swollen Day 5  Still taking Benadryl arm still swollen red and itching all over rash is better
My son woke up on 11/26/17 with swelling and pain in legs and lower back. Would not walk. There were also small petechiae on legs. Later in afternoon took him to ER where the ER doctor diagnosed him with HSP (Henoch-Schonlein purpura). Over next week swelling become widespread and very bad rash on legs. His pediatrician did routine urinalysis to monitor blood and protein in urine. Over next several weeks he developed nephrotic-range proteinuria and was sent to pediatric nephrologist at Hospital. The nephrologist monitored his labs closely and by early January kidney function was declining rapidly so nephrologist ordered kidney biopsy and started long-term immunosuppressant medical treatment. My son is now on 4 different medications to hopefully cure his HSP. Medicines (IMURAN, enalapril, prednisolone, ranitidine). We are hopeful he can be off the medicines in 2 years but nephrologist indicated it could be a lifelong battle since treating HSP has mixed results.
No adverse event.    vaccine was opened on 7/6/22, placed back in the refrigerator on 7/6, removed from refrigerator on 7/7 and administered approximately 24 hours and 30 minutes after opening on 7/6
pain, swelling, redness at site after 2 days. this went away. came back 7 days post-injection with edema, induration, pruritis. no pain. size about 2.5in in diameter.
Has been on and off sick; She is very sick; Threw up all through the night; Sweating; Chills; Her symptoms seems to be little bit nerve-racking; Nausea; This is a spontaneous report from a contactable consumer (husband) or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date (Wednesday) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included foot operation (She had surgery in her leg, major surgery in November), pain, bone disorder (lot of vitamins like Calcium and Magnesium and things like that to keep her bone strong). Concomitant medications included calcium (CALCIUM) and magnesium (MAGNESIUM). The patient experienced has been on and off sick; she is very sick, threw up all through the night, sweating, chills, her symptoms seems to be little bit nerve-racking and nausea on an unspecified date. The patient underwent lab tests and procedures which included blood test: unknown results on an unknown date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I started experiencing muscle soreness in the back of my legs that I thought were due to hiking, but the soreness never went away and never recovered. Then it traveled from the back of my legs to the side of my legs and my calves. They originally diagnosed it as T band issues and gave me some stretches. I took ibuprofen 400-600 mg as needed. I continued walking and staying active & the soreness got worse. I could no longer do my daily tasks and my hamstrings were really tight. They gave me different stretches. And then eventually I ended up getting sent to PT per my request. That seems to be helping. I still take ibuprofen as needed. And I was also recently prescribed anti-inflammatory and there was a blood test that inconclusive and xrays showed that there was some deterioration in my back, possible birth defect in my hip, but it didn?t relate directly to what was happening. My therapist seems to think its all musculoskeletal related.