chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt c/o tightness in her throat, "feels like it is closing," skin is blotchy.  EMS called, epi pen given.  Patient escorted to ambulance for further evaluation.
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after receiving vaccination patient reported tongue and throat itching but able to swallow. Administered diphenhydramine 25 mg. Vital signs: pulse 100 beats per minute, blood pressure 136/78 mmHg, respirtory rate 21 breaths per minute, and pulse oximetry 95% on room air.  Patient observed, symptoms improved, and patient discharged to home stable.
pt recvd vax & had a sz arms & legs were jerky & pt was not breathing;
4 hr p/vax began w/inconsolable screaming then fever, vomiting, diarrhea;lasted 2 days w/fever 102.5;treated w/APAP only;
Case symptom onset 7/23/2021 which included fever, subjective fever, chills, rigors, muscle aches, loss of taste and smell, fatigue, cough, shortness of breath and loss of appetite. As of 7/30/2021 case was still symptomatic. Antibody Infusion Treatment was also scheduled for 7/30/2021.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Systemic: Pt developed infection at injection site-Mild, Error: Infection / Cellulitis (diagnosed by MD)-
decent size lump; redness; Vaccine given in the middle of their arm; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of vaccine administered at inappropriate site and experienced descent size lump and redness which seemed to grow.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient received vaccine in the middle of her arm. The patient stated that she experienced descent size lump and redness which seemed to grow, which is now stopped but is still there.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vaccine administered at inappropriate site, was considered resolved and descent size lump and redness which seemed to grow, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced  a product administration error of  product administration at inappropriate site and  non-serious expected events of injection site induration, and  injection site erythema . There were no AEs associated with product administration at inappropriate site. The events of injection site induration, injection site erythema  occurred 1 day (same day) after first dose of mRNA-1273 . Based on the current available information and temporal association between the use of the product and onset of the events  a causal relationship cannot be excluded.
Pt was vaccinated on 06/08/00 and on 01/07/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's have chicken pox that were vaccinated.
Extension of second dose, more than 28 days later; A spontaneous report was received from consumer (patient's daughter) for a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extension of second dose, more than 28 days later.  The patient's medical history was not provided. No concomitant product use was reported.  On 12-Jan- 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient was scheduled to receive the second dose of two planned doses of vaccine on 13-FEB-2021, but the site was closed. The patient was rescheduled to receive the second dose on 01-MAR-2021. The reporter was aware that the rescheduled dosing date is past 28 days marker. The reporter was concerned with the risk of extending out the second dose.  Action taken with 2nd dose of mRNA-1273 was unknown.  The outcome of the event, extension of second dose, more than 28 days later was recovered/resolved.  The reporter did not provide the assessment for the event extension of second dose, more than 28 days later.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Patient was found deceased on arrival in his living quarters after not showing up for work. This was approximately 14 days after his second pfizer vaccination. We have no reports of previous signs or symptoms in the days preceding his death. Patient had not visited the clinic since receiving his second shot in the series
On 4/6/22, I received my first dose of the Covid vaccine. From Saturday 4/09/22-Saturday 4/16/22, I was on vacation. I ate almost every meal out. Throughout the day on 4/17/22, I did not have an appetite. I ate a small meal at 2pm (salad, sweet potatoes, brussel sprouts/pecans/some bacon bits/apples and bread). By 4pm I was having diarrhea and gas. At about 9pm, I vomited and continued having diarrhea. I went to bed shortly after and slept through the night. The next morning I vomited again, but it was just bile as my stomach was empty. I ate a piece of toast and a banana. No more diarrhea or vomiting for the rest of the day.  Yesterday, 4/21/22, I went out to eat. I got a warm bowl with rice, tomatoes, avocado. Last night, 4/21/22, I woke in the night with extreme bloating. My belly looked like it had a balloon in it. I went to the bathroom and had very watery diarrhea. I vomited a lot at one time. I had excessive gas. I was in the bathroom for about an hour. I stayed home from school the next day and did not vomit again. I had some diarrhea earlier around 5pm but nowhere near as bad as before. I still feel a little gassy but other than that, symptoms have resolved for now.
I had general joint pain starting the day after the vaccine. After two days it all went away except my knees. I have never had any issues with my joints or knees before this.; By the end of the day it hurts a lot to walk up stairs.; This is a spontaneous report from a contactable other health care professional. A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in left arm on 08Feb2021 at 10:00 AM as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity, iodine allergy, autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). No COVID prior vaccination. COVID tested post vaccination was no. On 09Feb2021 at 09:00 AM, the patient experienced general joint pain starting the day after the vaccine. After two days it all went away except my knees. I have never had any issues with my joints or knees before this. It started suddenly after the vaccine. Two weeks after the vaccine my knees are still sore. By the end of the day it hurts a lot to walk up stairs. Throughout the day they feel mildly sore and will sometimes click as I bend them. Treatment was not received for the events. The outcome of events were not recovered.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a physician via a company representative referring to a currently 79 year old female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were unknown by the reporter). On an unknown date, the patient developed shingles. Furthermore, the patient sought medical attention and contacted the doctor. At the time of the report, the outcome of herpes zoster was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with ZOSTAVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA004491.
rash, tiny red bumps on arms, legs, trunk, diaper area. Developed 10 days after receiving VARIVAX. Lasted approx 5 days.
Pt. had IPV & Tdap & MENOMUNE on 5/9/11 & began oral Typhoid in prep for trip 5/25. Took oral Typhoid last dose at 10PM 5/16/11. Woke up at 4 am 5/17 with swollen, sore (L) elbow, red & hot to touch with sm scab on skin. Had been gardening earlier in week. Probably not related to vaccines or Typhoid oral. Referred to MD to assess for cellulitis.
24 hours after vaccine oesophageal discomfort. Hunger spasms, improved by eating. Stomach sensitivity.
Chills, fever, malaise, headache, weakness, ongoing but improved (also profuse sweating)-aseptic meningitis and focal encephalitis. The discharge summary received on 3/23/04 states pulmonary nodule, pulmonary edema, bronchiectasis, swollen lymph nodes, anorexia, weight loss, atelectasis, nausea andn sedation. 60-day follow up on 04/21/04: "Pt has recovered from adverse events.  Pt developed focal encephalitis and aseptic meningitis temporally associated with influenza vaccination.  His headaches were disabling but have resolved.  Coincedental versus cause and effect...other cases?" Medical records state myalgia, arthralgia, dizziness. msv
Blisters between fingers, palm hand; Mild rash up to the arm; Nerve pain; one finger is pretty much crippled; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister, rash, nerve pain and activities of daily living impaired. On an unknown date, the outcome of the blister, rash, nerve pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the blister, rash, nerve pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient did not end up with blisters until after the booster shot.  The patient only had couple of blisters between the fingers a few small ones and palm of the hand and then a rash, mild rash that went up the arm.  But, his/ her all started in the nerves and with nerve pain.  The patient now had one finger that was pretty much crippled.  That's on his/ her right hand. The patient was right-handed and had no idea if he / she would ever get the use of that finger back again.  The patient advised people to get the shot if they coukd, because if they did not know what nerve pain was trust him/ her they don't want to find out. Additional Supportive Information: The follow-up would not possible as no contact details were available.
About 1 hour after vaccinations, lt. arm became weak & developed all body weakness. 4 days after vaccinations her body weakness much improved.
Fainting on 2022-02-16, Adverse effect of other vaccines and biological substances, initial encounter on 2022-02-16.
pt recvd vax & 3-4 days later exp contact dermatitis-like sx & itchy target-like,erythematous papules & plaques on feet,hand,& scattered on trunk;later found to have gianotti-crosti w/multiple erythemas which were papular & follicular
Per caller they have two patients who recieved the Pfizer Covid 19 Vaccine undiluted from two different vials.; Per caller they have two patients who recieved the Pfizer Covid 19 Vaccine undiluted from two different vials.; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported similar events for 2 patients. This report is for 1st of 2 patients. This pharmacist reported for a patient that:  A patient of unspecified age and gender received BNT162B2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date two patients received the pfizer COVID-19 vaccine undiluted from the two different vials. The event reported was medically significant. The clinical outcome of the event was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between event Overdose and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101142025 same reporter/product/event, different patient
I contracted COVID-19 on 06/19/2022 with symptoms of severe cough, and heavy congestion. I was prescribed Paxlovid on 06/21/2022. I was ill for 3 to 4 days before my symptoms began to resolve. I am still experiencing a persistent cough. I sought care for my lingering cough and was told to hydrate a lot and it should resolve on its own.
Patient received Spikevax vaccine at 830 AM on 10/16, and reported to ED at 3:30 PM complaining of SOB. Also Hypoxemia and felt feverish. She was admitted on 10/16/23 to the hospital. Her physician contacted the pharmacy at 3:00 PM on 10/17 to inform us of the admission--He states she is currently stable and expected discharge is tomorrow, 10/18.
Injection site pain, swelling down arm to elbow and around shoulder -- started within 20 minutes of injection and lasted 4 days 9 hour post injection = Fatigue 24 hours post injection = Diarrhea  Nausea Dizziness Headache
Severe lower back pain, right side. Severe leg pain, right leg. "shooting pain" above right knee. Severe skin sensitivity right leg between knee and groin front and inner thigh. Adverse events have lasted months. Appointment with MD Dr. on 7/15/2019.   Received Famciclovir [500 MG Oral Tablet - Take 1 Tablet Every 8 Hours For 7 Days.] 2nd visit 7/25/2019, received Gabapentin, taken 2,100 mg daily until 12/1/2019. Daily Advil, Tylenol and/or Aleve continue to this day.
Patient received vaccine during working hours on 2/10/2021.  Coworkers reported patient was acting abnormally this morning upon arriving to work.  After medical assessment and testing, patient was diagnosed with a ischemic stroke and transferred to higher level of care.
Red, smooth patch around injection site noticed 10 days after vaccine , ~2?x2? square. This might be unrelated but two days before this I had a sore left elbow  that I thought could be tendonitis, although I had no known precipitating activity that I could think responsible for it. After the rash  resolved my elbow became really red - prior to that it had just been painful - it?s still a bit red but the rash has resolved
FELT NAUSEATED, WOOZY., FAINTED BUT VERBAL FOR SOMETIME THEN RECURRED AGAIN, EMT RESPONDED TO THE ORIGNAL INCIDENT. OVERALL COMPLAINT:- FAINTING
I started to feel symptoms about 24 hours after I took the booster. My first three shots were Pfizer, not Moderna.   Then, my symptoms continued. So, on Tuesday, June 28, I took an at-home COVID test and it was negative. I repeated that on Wed. June 29 with a PCR test. Also, negative. I then took two more COVID tests on June 30 because I had frriends arriving that night. Both tests were negative.  I had learned that I had been exposed on the evening of Saturday, June 26.  My symptoms continued.   Then, on Saturday, July 2, I tested positive with both an at-home test and a PCR test.  I now think that perhaps I had the normal reaction on the Sunday and Monday after i took the  Moderna booster and then started to perhaps get symptoms from actually getting COVID.  So it seems that perhaps the timing of the booster and me actually getting COVID caused a bunch of confusion about what was going on.  But I was told to fill out this form anyway.
No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 16-MAR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), one dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The medical assistant reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent a temperature excursion above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for a time frame of 15 minutes, as recorded by the data logger. There was a previous temperature excursion above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for 21 minutes, also recorded by the data logger.   No adverse effects were reported.
pt recv vax 7JUN95 & 17AUG95 pt lab results revealed the presence of meningitis;
rash started on face neck & abd;had it on face neck, abd & legs on 10APR99;no resp distress;no wheezing;crabby, fussy, dec appetite;
COVID-19 diagnosed; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 diagnosed) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesteremia, Paroxysmal atrial fibrillation and Allergy. Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), FAMOTIDINE and ATORVASTATIN from an unknown date to 18-May-2022 for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (COVID-19 diagnosed). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 diagnosed) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive with COVID-19 symptoms.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Pfizer oral formulation for treatment of COVID-19 on 14-May-2022 and end on 18-May-2022.  Device date was reported as 27-May-2022.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown interval (vaccination date not provided) after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid (on 14-May-2022, the same day of the onset of COVID-19) for COVID-19 for 5 days and had Positive antigen test and COVID-19 symptoms 8 days after treatment with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown interval (vaccination date not provided) after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid (on 14-May-2022, the same day of the onset of COVID-19) for COVID-19 for 5 days and had Positive antigen test and COVID-19 symptoms 8 days after treatment with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient came back to pharmacy and reported widespread itching and raised "lumps" presenting on back of neck and back.  Patient was given and instructed to use antihistamines and monitor over next several hours and days, if any signs of shortness of breath or difficulty breathing or low blood pressure, contact emergency health services immediately.
Patient stated she felt lightheaded. Vitals stable, monitored for 30 minutes. Patient sent home with spouse. Patient advised to go to the ER if symptoms persist or worsen
Pain, redness, swelling, itching, calor at injection site of Moderna COVID-19 vaccine booster dose.  (First two doses were Pfizer) Affected area is about 2 to 2.5 inches around the injection site. Pain was worst at one day after vaccination and all symptoms are still ongoing at day 5 post-vaccination
2300-  11Jan 2021-Body Chills, he was feeling cold, sweating, and he threw-up-his words/with a headache 0800-12 Jan today-Headache & threw-up again-his words Advised to drink electrolyte fluids-when he feels like he can, Tylenol and/or motrin-when he feels he can-worse-go to ER Keep his leadership updated/aware of his condition
Runny Nose, Congestion, Coughing, Fever, Ear Infection, tiredness, wheezing - symptoms still on going. Amoxicillin & Clavulanate for Ear Infection Albuterol via Nebulizer for Wheezing12/7/2009 ED record for 11/25/2009, patient with c/o's runny nose, fever, cough, wheezing,  ear pain and decreased appetite, tx: Albuterol inhaler, tylenol/motrin DC DX: Bilateral OM and wheezing
patient was given both TDAP and HEP A. When she got home she developed nausea and vomiting. She called our office this morning, but did not go to ER or Urgent care. We are treating accordingly.
Delayed menstrual period. Cycle typically very regular but period now delayed by over 8 days and counting. Pregnancy test negative.  Also, COVID arm during both shots (itching, swelling, redness).
Information has been received from a physician concerning a 21 year old female with a history of a high risk life style (behaviour disorder), who was vaccinated with the series of GARDASIL on unreported dates.  Subsequently, after the completion of the GARDASIL series, on an unspecified date, the patient had an abnormal Pap test.  It was reported that the patient sought unspecified medical attention, but no treatment or outcome information has been provided.  Additional information has been requested.