chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body covered in rash/every time they try to stop the Prednisone the rash comes back; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for a female patient (reporter's mother-in-law). An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on an unspecified date as second dose, single dose for covid-19 immunisation. prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown; formulation: solution for injection; expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as first dose, single dose for covid-19 immunisation. Patient reported that after getting the second Covid shot, her body was covered in a rash. They had been able to control it mildly with Prednisone, but every time they try to stop the Prednisone the rash came back. Looking for advice on treatment. They took her to the doctor, and he was the one to prescribe the Prednisone and then given loratadine for the rash, it was a pill and there was an ointment prescription also. consumer tried Calamine and some Neosporin where she had scratched it to like a blister. They will be done with the second dose of the Prednisone soon. She was to take 3 of the 5mg once a day the first time. Consumer wanted to know what they should did since had been done with the second dosed of prednisone. consumer Declined to provide further report details and would like to know what to do, what was next step. Recommended for patient to see further medical advice from medical provider since Pfizer was unable to provide medical advice. consumer stated that he will just be had to get her to see a specialist or allergist and thought that Pfizer could refer her or recommend one. Maybe there have been other people who had this rash. No further details provided. Action taken for prednisone was unknown. The outcome of event was unknown.  Information regarding the Lot/Batch number has been requested.
Pain in right shoulder.  Hurts to lift arm over head.  Hurts to lift arm out to the side.  Tried to throw a ball for my dog and couldn't throw very far at all.  Painful shoulder joint.  Injection site of influenza immunization is very high up on my right arm just below my shoulder joint.
possible adverse reaction of blood clot following J&J CoVid vaccine. J&J Vaccine received: 4/5/21 Fracture of 5th proximal phalanx: 4/16/21 Pt wearing constrictive device at location of DVT after 4/16/21 Pt taking OCP daily for years
had blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (had blood clots) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (had blood clots) outcome was unknown.            No concomitant medications were reported. It was reported that patient had the blood clots after Moderna covid shot and clarified it was either the 2nd Moderna covid shot or the third Moderna covid shot, not sure but it was the Moderna covid vaccine. Patient received all moderna shots. So patient was hesitant to get the new latest version of covid19 vaccine.  No treatment medications were reported.  Company Comment This spontaneous case concerns an unknown age and gender patient with no medical history reported who experienced the unexpected medically significant seriousness criteria AESIs of thrombosis unknown days after 3rd. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. At the time of the report, the outcome of the event was unknown. The medical history is a contributor for the events. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Information has been received from a physician concerning his 11 (also reported as 10) year old granddaughter with no pertinent medical history or drug reactions/allergies who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown).  There was no concomitant medication.  The patient had 3 seizures.  In June 2007, the patient experienced a seizure 10 days after her first dose of Gardasil.  The first seizure lasted about 90 minutes (also reported as the patient experienced the onset of "a fugue-like" state lasting several hours).  The patient was examined in the emergency room and released.  On an unspecified date in June 2007 the patient had an electroencephalography (EEG) and a magnetic resonance imaging (MRI) and the results were normal.  The patient was not admitted to the hospital.  The patient recovered from the first seizure.  On an unspecified date the patient experienced a brief lack of conscious activity and "appeared to be vacant or far away".  The patient was not experiencing any muscle jerking or twitching during an episode.  In August 2007, the patient experienced a second seizure a few days after her second dose.  The patient recovered from the second seizure.  On 30-JAN-2008 the patient experienced a third seizure in school.  By the time the father arrived at her school the patient was more responsive but still was unable to remember her father's name.  The patient recovered a few minutes later.  The patient is asymptomatic other than the seizures.  The patient had not received her third dose of Gardasil.  No further information was available.  Follow-up information was received from the grandfather who reported that his granddaughter is "transiently confused following these episodes, had no warnings they are starting, and remembers nothing about them".  Upon internal review seizure is considered to be an other medical event.  Additional information has been requested.
Moderna vaccine was administered  from a vial that was punctured 4 days prior to administration. Vial was always stored in the refrigerator and was never involved in any temperature excursions. But dose was administer from a vial that was opened 12/09/2021 and dose was administered 12/13/21.
Day one after 2nd covid shot sore muscle at injection site and overall body ache, I had chills, extreme tiredness, headaches, lasting a few days
Cellulitis infection to left arm with noted erythema and pain, low grade fevers.
This spontaneous report as received from a medical assistant refers to a 14 years old male patient with no illness at time of vaccination and no known drug allergies. The patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL, IM, right deltoid on 28-DEC-2011 at 10:14 AM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received above vaccine during time of refrigerator failure. Temps found to be <32 degrees. The patient was re-vaccinated due to vaccine compromise. No adverse reaction reported. There was no lab studies performed. This is one of several reports from the same source. Additional information is not expected.
Information has been received from a physician concerning a 16 year old female who on 09-AUG-2007 was vaccinated with her first dose of Gardasil (lot# 656049/0187U). On 11-OCT-2007 the patient was vaccinated with her second dose of Gardasil (lot# 657621/0387U). On 12-OCT-2007 the patient experienced pelvic pain which did not subside and an unspecified vaginal discharge. On 18-OCT-2007 the patient was seen by the physician and the physician noted an absence of dysuria and fever. The patient was referred to a gynecologist. Additional information has been requested.
Dizziness ~4 hours post vaccine (3/29/21) Fatigue and chills following day (3/30/21)
Patient recieved shot on 8-17-20. Went to the hospital on 8-18-20 for kidney stones. While there the Doctors noticed Patient had some cellulitis around the area of the shot and gave Keflex to treat it. Was Discharged on 8-21-20 with a 10 day supply of antibiotics.
Patient was suppose to receive Tdap but was given Td (Tenivac) instead.  Patient is to return and receive the correct vaccine.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
40 y/o female who developed  anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening."  Received epi from medical team but initially refused ER visit.  Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing  being additonal symptoms.  She was agreeable to transport after the second episode.
shaking and it seems to be getting worse; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking and it seems to be getting worse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking and it seems to be getting worse). At the time of the report, TREMOR (shaking and it seems to be getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were  reported  No treatment medication were provided
Received the Recombinant Zoster Vaccine injection shortly after 9:30 am at the Clinic on March 1st.  By about 1:00 am on Saturday, March 2nd, started feeling feverish, nauseated, cold shivers in spite of extra blankets and severe pain at site of injection. Muscle aches were so bad that had great difficulty arising from bed to use the bathroom. Symptoms continued the rest of Saturday with temperatures measured by a temple thermometer ranging from 99.8 to 100.4. Nausea and temperature finally subsided by Sunday late afternoon, but still experienced unusual fatigue. My wife also received the same type of vaccine within a few minutes of mine, had many of the same symptoms, but hers had mostly subsided by mid-Saturday morning.
Systemic: Headache-Severe, Additional Details: patient said day after receiving vaccine she has migraine attacks. she has been on botox and migraine medication. she wants distric leader to follow up for the next step.
itching all over that area/itching around her waistline/It looks all red and pimply; the swelling continued around the site; injection site had big blisters on it and it was quite painful was quite painful.; Hives; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.), PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply), URTICARIA (Hives) and INJECTION SITE SWELLING (the swelling continued around the site) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058081) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine on 30-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 03-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced URTICARIA (Hives). On 04-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.). On 05-Nov-2023, the patient experienced INJECTION SITE SWELLING (the swelling continued around the site). On an unknown date, the patient experienced PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply). At the time of the report, INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.), PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply), URTICARIA (Hives) and INJECTION SITE SWELLING (the swelling continued around the site) had not resolved.            No concomitant medication was reported.  Patient went to emergency room who thought she had shingles. Patient was given an antibiotic, antiviral, and steroid, started taking before reporting.   This case was linked to MOD-2023-748616 (Patient Link).
During vaccine administration, the vaccine leaked out of the syringe at the site where the needle connects to the hub.  The vaccinator reported the entire dose leaked out of the syringe and she believed none of the medication was administered to the patient. Another dose was drawn up & administered without incident
I started having a lot of shoulder pain. I called my orthopedic doctor who sent me to physical therapy. There everything had gotten worse, and I could not continue. I knew something was wrong with my entire body in May. I had to stop physical therapy because I was in so much pain. After it gotten so bad I called my PCP who recommended I see a rheumatologist. I was prescribed medication cortisone. It does inhibit my ability to do this. I hurt in my neck and shoulders. At this point I do think this is permanent. It has been going on for almost a year a now.
Leg pains; Legs feels weak; Fatigue; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pains), MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pains) and MUSCULAR WEAKNESS (Legs feels weak). At the time of the report, PAIN IN EXTREMITY (Leg pains) had not resolved and MUSCULAR WEAKNESS (Legs feels weak), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received updated patient information, Moderna Vaccine details, concomitant medication details, patient had no problems with first vaccination and event outcome.
I tested for COVID-19 upon feeling lethargic after returning home from a trip. I took a COVID-19 home antigen test. It was positive. My doctor ordered PAXLOVID. Upon first dose, I experienced a severe metallic taste. After starting the medication, the symptoms of coughing, nasal drainage, lethargy, body aches, headaches, and fever were minimal compared to other members of household. I took my day 5 at home test and still tested positive. After day 5 test, symptoms returned. I had a backache, nasal drainage, and lethargy. I didn't have a fever. I continued to isolate and rest. On day 10, I tested negative.
This case was reported by a physician via sales rep and described the occurrence of rash in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to BEXSERO. Additional details were reported as follows: The health care professional was contacted by the patient regarding the rash that had appeared. The patient stated that, rash was showing for about 2 days. The patient didn't know if it was related to the suspect vaccine or not. The health care professional didn't want to be contacted. The representative had only this information regarding the event or product.
This spontaneous report as received from a nurse refers to a 12 month old female patient. On 22-APR-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). It was reported that the patient received improperly store VARIVAX exposed to maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning female patients who on unknown dates were vaccinated with a dose of GARDASIL (doses, routes and lot numbers not reported). Subsequently, on an unknown date, those patients experienced ovarian cysts. At the time of the report the patients' outcomes were unknown. It was unspecified if the patient's sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful. This is an amended report. The therapy start date and concomitant therapy were detected as they were incorrectly entered.
felt like I was coming down with Covid again effects lasted 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 13:15 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D3; ASPIRIN LOW; PROBIOTICS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EL3247, Date/Time: 08:15, Anatomical Site: Left arm, Route of administration: Intramuscular), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "body aches", "fatigue", "low grade fever", "I felt like I was coming down with COVID again". The following information was reported: SUSPECTED COVID-19 (non-serious) with onset 2021, outcome "unknown", described as "felt like I was coming down with Covid again effects lasted 3-4 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant drugs included Multivitamins. Vaccination facility type was Hospital. Prior vaccinations was None. For both injections, patent felt like she was coming down with COVID again. Effects lasted 3-4 days. Patient did not take any medications for symptoms. Spoke with someone who got the same manufacturer shots at the same location who did not have COVID. they had no effects from the injections. Weird. Patient Would like to know if she was still eligible to donate convalescent plasma.  No follow-up attempts are possible. No further information is expected.
Miscommunication about getting Pneumonia vaccine. Received it 2 yrs prior in 2008.
Severe full body aches; weakness; alternating chills and sweating; alternating chills and sweating; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; CLARITIN [CLARITHROMYCIN]; NECON 7/7/7. Vaccination history included: Bnt162b2 (Dose number: 1, Administration time: 10:15 AM, Vaccine location: Left arm, Headache lasted for 1 week.), administration date: 27Mar2021, when the patient was 50 years old, for COVID-19 immunisation, reaction(s): "Headache", "Neck pain". The following information was reported: PAIN (non-serious), outcome "recovered", described as "Severe full body aches"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; CHILLS (non-serious), HYPERHIDROSIS (non-serious), outcome "recovered" and all described as "alternating chills and sweating". Therapeutic measures were not taken as a result of pain, asthenia, chills, hyperhidrosis.  Additional information: Patient did not take any other vaccines in prior of COVID-19 vaccination. No known Allergies. Patient did not test COVID-19 post vaccination. The events Severe full body aches, weakness, and alternating chills and sweating after 2nd dose that lasted for several days. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452130 Same patient and drug; Different dose and events
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030L20A) for COVID-19 immunization. No medical history reported. On Jan 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 25, 2021, patient experienced vaccination site pain (sore arm at the injection site). At the time of the report, vaccination site pain (sore arm at the injection site) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-328755 (patient link).