chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/11: received Moderna vaccine from the Pharmacy at 5:30 PM. Right upper arm.  03/12 & 13: very sore in the right upper arm and shoulder 03/14-15: shot spot soreness faded, but pain in right side of body worsened. Start to feel pain in right wrist. 03/16-18: Pain flareup, pain level 5-8 constant without any rest. 30+ hr. Cannot use wrist at all. Visited Urgent care and received a trigger point injection. Visited PCP and received Toradol. 03/19-03/23: Pain level 4-6, could use wrist now. Pain from lower back and heel which don?t have pain before. Pain worse at night. 03/24: Feel really tired and fatigued, and can hardly keep my eyes open. Never have fatigue in the past. 03/25-26: Still feel tired and fatigued and struggle to keep eyes open.
Per ER note from hospital on 8-20-21, patient had uncontrollable shaking, nausea, and headache following injection.
vaccine administered 7 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 7 days after first puncture) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 7 days after first puncture). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 7 days after first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-332855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up  Attached: No new information.
Initial misuse report received from a healthcare professional on 18 March 2014. The cas was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The patient had received unstable FLUZONE and IPOL. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
booster; I recently tested positive for COVID after receiving my Pfizer booster in Oct2021; I recently tested positive for COVID after receiving my Pfizer booster in Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I recently tested positive for COVID after receiving my Pfizer booster in Oct2021"; IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster".  After 3 days, most of the symptoms went away. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2016154515), license partner for ENBREL. Initial Receipt Date = 02Nov2016. This non-serious spontaneous report (USASP2016154515) was reported to Amgen on 02Nov2016 by a consumer and involves a female patient who felt ill, gives her Enbrel vaccines in her thighs/sometimes they hurt, and got a virus while receiving Enbrel.  No historical medical condition was reported. The patient's current medical condition included Rheumatoid Arthritis. No relevant concomitant medications were provided. Co-suspect medication included Prevnar. The patient began Enbrel on an unknown date. The patient stated that she had been on Enbrel a couple of times. On an unknown date in 2015 last year, the patient had the first installment of the pneumonia vaccine, Prevnar 13, and she felt ill afterwards for about a week. The patient was on Enbrel for about five months when she got the first round of the pneumonia vaccine. On an unknown date in 2015 while on holiday, the patient got a virus that would not go away. Subsequently, the patient discontinued Enbrel for two months. After an unspecified time frame, the patient resumed Enbrel therapy. On an unknown date, the patient stated that her husband gave her Enbrel vaccines in her thighs and sometimes they hurt and sometimes they did not. The patient stated that it was more the stinging of the medication being delivered that hurt. The patient was inquiring if it would be better to give the injection on an area of her thigh that has more fat on it. This time the patient was Enbrel straight through nine months. The patient stated that now she need her second installment of the pneumonia vaccine, the Pneumovax 23. The patient inquired whether she need to stop Enbrel when she receive the vaccine. The patient discussed with her physician about this already and he told her that it was not a live vaccine, but stopping the Enbrel would be optional for her. On an unknown date in 2016 this year, the patient got the flu shot and had no problems. No treatment information was provided. The outcome of the events malaise, injection site pain, and viral infection were reported as unknown. Action taken with Enbrel was reported as unknown for the events malaise and injection site pain. Action taken with Enbrel was temporarily withheld for the event viral infection. The causal relationship between the events malaise, injection site pain, viral infection and the product Enbrel was not provided by the consumer.
Severe arm/shoulder pain. The pain began with initial needle stick. The pain is still the same if not worse after 21 days
pt became nauseated w/vomiting w/in 10 minutes of vax; c/o swollen face, & neck beginning 25MAR93; sx subsided 27MAR94;
Itching is now spreading in small blisters down my arm from the shoulder; The location where I received the vaccine was itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 27A2A2 and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency; CORTISONE for Itching, at an unspecified dose and frequency and CETIRIZINE 19-Jun-2021 at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching) had resolved.            No relevant concomitant medications were provided.  Patient had itching and he covered it with a band aid. Two months from the day of reporting, the itching started to spread down from his shoulder in tiny blisters. The patient tried cortisone and other creams, however they did not work. According to the patient, calamine lotion was the only treatment which stopped the itching. Patient used cetirizine and it removed the allergic reaction in 6 days after taking it on June 19th. The blisters merged into 3 plaques the size of a penny; the small ones disappeared. Patient experienced sleepiness and weakness for several days after taking just one pill of cetirizine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional Information received: Updated Event occurred country was changed On 03-Jul-2021: Additional Information received: Updated treatment medication, event outcome and narrative.
It seems my menstrual period has been altered. I have experienced a lot of pain on the left breast since the vaccine. I had a doctor appointment for my menstrual period. I was informed lots of people have experienced this after the vaccine. Hopefully it will go away after 6 months.
Patient transported to Hospital via ambulance from his home on 3/6/2022 and died at the hospital same day from myocardial infarction. Had not felt well since 1/11/22 when he was seen in clinic at Health Facility by Dr.  for UTI, dyspnea, fatigue. Treated for UTI and pneumonia. EKG was done at the time as well as  a chest X ray .  His wife believes that his death was due to side affects from the Covid-19 vaccine.
Information has been received from a nurse referring to a 13 year old female patient. The patient had no pertinent medical history and no drug allergies. On 03-NOV-2014, the patient was vaccinated with her first dose of GARDASIL intramuscularly (dose and lot # were not reported). The second dose was given on an unknown date. On 05-MAY-2015, the patient received the third dose (lot # reported as 1007531, expiration date unspecified). There was no concomitant therapy. On 15-MAY-2015, the patient experienced arthralgia and aching in her knees and ankles. The patient's father called a physician for medial attention. Unspecified dose of ibuprofen as needed was given to the patient as treatment. No lab test was done. At the time of this report, the patient had not recovered from the event. The causality between the event and the vaccine was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of RECOMBIVAX HB (lot # R006746 exp date 09-NOV-2020) (dose not reported) intramuscularly.  There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010173: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214.
This spontaneous report as received from a consumer refers to a 66 years old male patient with no drug reactions or allergies. The patients medical history was not specified by the reporter. The patient was vaccinated (dosing route unknown) with ZOSTAVAX (lot number and expiry date were not provided) on 2006. No other co-suspects were reported. Concomitant medications included: aspirin and TYNALON. On 06-NOV-2012 the patient nose stated to get soar, later on he did start getting in upper lip, right hand side of the face, and on the roof of the mouth. Did develop a case of the shingles. No treatment information was reported. The outcome of nose started to get soar, did develop a case of shingles, he did start getting tingling on the roof of the mouth, he did start getting tingling right had side of the face and start getting tingling in upper lip is unknown. The relatedness for nose started to get soar, did develop a case of the shingles, he did start getting tingling on the roof of the mouth, he did start getting right hand side of the face and start getting tingling in upper lip is unknown for ZOSTAVAX. The patient did not receive any treatment for the event. No additional information is not expected.
Patient was ordered MMR and Varivax on 04/02/2022. Medical assistant immunized patient with MMRV (PROQUAD) and Varicella (Varivax), this patient receiving two varicella immunizations on 04/02/2022. Patient is not known to have any adverse reactions til this day.
Pt.'s mother states after receiving the 2nd dose of Phizer 07/08/2021, starting experiencing shortness of breath the following day 07/09/2021. Urgent Care visit 07/10/2021 gave steroid shot, follow-up with Cardiologist. Worsened 07/11/2021 ER visit, Colchicine prescribed 2 weeks with follow-up with Cardiologist. Still experiencing shortness of breath.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016164803) on 28-MAR-2016. This case involves a female patient (age not reported), who was vaccinated with a dose of Flu Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, at the time of vaccination, the patient was hurt and could feel the needle go in. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
This spontaneous report as received from a nurse practitioner refers to a 12 month old male patient. The patient's medical history includes a pneumonia which he had recovered from. On 01-DEC-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L023592 expiration date 26-JUN-2017 (frequency and route of administration were not specified), and he was also vaccinated with a dose of MMRV (Merck) (manufacturer unknown) lot number reported as L016393, expiration date 08-NOV-2015. The reporter stated that the patient was administered VARIVAX (Merck) normally and then accidentally given MMR and V (Merck), also reported as "MMR/Varicella Combo" which then makes a double dose of VARIVAX (Merck). Concomitant medications were not reported. The outcome of accidental overdose was unknown. Additional information is not expected, as the reporter did not give consent to be contacted.
Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.; Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.; Dose Number: 1 (Bivalent); This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:45 as dose 1, single (Lot number: Gj3275) at the age of 39 years, in left arm for covid-19 immunization. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "known allergies: flu vaccine". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Oct2022 at 10:45, outcome "unknown", described as "Dose Number: 1 (Bivalent)"; RASH PUSTULAR (medically significant), PRURITUS (medically significant) all with onset 06Nov2022 at 16:00, outcome "recovering" and all described as "Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.". The event "developed raised itchy raised red pustule lesions 3-4 new lesions per day. went to doctor to be seen because the lesions hurt deeply into the tissue." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash pustular, pruritus.  Clinical course: Additional information: If other vaccine in four weeks: No. Other medication in two weeks: No. Facility type vaccine was Workplace clinic. No other vaccine in four weeks and other medication in two weeks. covid tested post vaccination: Unknown. Treatment provided was Acyclovir. Developed raised itchy raised red pustule lesions 3-4 new lesions per day. Went to doctor to be seen because the lesions hurt deeply into the tissue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events.-WRONG PRODUCT ADMINISTERED ,RASH PUSTULAR ,PRURITUS 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.
Rash on left shoulder (same side as vaccine). Red, itchy bumps lasted several weeks.
Patient presented to ED day after her second COVID vaccine (unknown Mfr), patient had dizziness and body aches causing her to fall striking her head and loosing consciousness.
Information has been received from a registered nurse concerning a 13 year old female with no known allergies and hypercholesterolemia who on 6/19/1995 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live. There was no concomitant medication or illness at the time of vaccination. The reporter indicated that a week ago, on approximately 5/13/2005, the patients titer was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that on 5/14/2005 at 9:51am, the patient had two titers drawn and was found to be non immune. The patient had no adverse events following prior vaccination. See laboratory sections for all other laboratory results. No further information is expected. The registered nurse also reported that the patients sister had a negative titer after vaccination with varicella virus vaccine live (WAES0505USA03115).
I mistakenly gave the patient a 4th dose of the Pfizer vaccine.  Per our EHR,  she was vaccinated on 6/27/2021 and 3/7/3022 per the Immunization registry.  I read the 2022 vaccine as 2021 by mistake and told her and her Mom that she needed a booster.  After giving the booster, my staff alerted me that she had received her last dose one month prior and was not due for a booster.  I let Mom and the patient know immediately. I spoke to Mom about 2 hours later. Her daughter was fine but she gave me dates from their vaccine card which were different.  The first dose was on 6/26/2021 and not 6/27/2021 and she received a second dose on 7/17/2021 that was not in the registry.  So, this was a fourth covid vaccine.
Initially, loss of appetite, fatigue and muscle aches. Then uncontrollable shaking, fever spike, high blood pressure, high heart rate and a sensation my skin was on fire. Finally a lingering migraine. In ER; given Benadryl, fentanyl, solumedrol and Zofran IV. Doctor didn't know what else to do. Symptoms eventually stopped once vitals became more stabilized.
Expired Havrix administered; 26 YO received pediatric dose; 26 YO received pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.  On 10-APR-2023 16:00, the patient received Havrix pediatric. On 10-APR-2023 16:00, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered), adult use of a child product (Verbatim: 26 YO received pediatric dose) and underdose (Verbatim: 26 YO received pediatric dose). The outcome of the expired vaccine used, adult use of a child product and underdose were unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 10-APR-2023 The Healthcare Professional was unsure what dose number in the series this was, and no reactions were reported.  The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up via email. An adult patient received a pediatric dose that had also expired, which had led to expired vaccine used, adult use of a child product and underdose.
Migraine; Low blood pressure; Profound tachycardia; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Stent placement in 2021.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia). At the time of the report, MIGRAINE (Migraine), HYPOTENSION (Low blood pressure) and TACHYCARDIA (Profound tachycardia) outcome was unknown. Not applicable    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Irregular.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided.
She reports waking up with a very sore left deltoid on 3/30/10. The redness grew that day and is still really bad on 3/31/10. Her arm is warm, red and very painful. She feels her hand strength is more weak.