chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product THIOMERSAL (THIMEROSAL) for an unknown indication.    Previously administered products included for Product used for unknown indication: Otezla. Past adverse reactions to the above products included No adverse event with Otezla. Concurrent medical conditions included Psoriatic arthritis. Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for an unknown indication.   In July 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started THIOMERSAL (THIMEROSAL) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash). At the time of the report, PRURITUS (itching/after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose on JUN2023 when she experienced itching all over her trunk, arms and back/, it was just itching without rash) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient stated she had already received 6 Moderna COVID-19 Vaccines so far, but she mentioned she did not had the dates, only remembered her last dose of the Bivalent vaccine she got was in JUL2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743895 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743895:Mono valent case
Swelling, redness, and warmth in arm several hours after receiving PNEUMOVAX.  BENADRYL was given to the patient.
Raised bumps; Warm; Oval Pattern at injection site; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Raised bumps), INJECTION SITE WARMTH (Warm), INJECTION SITE REACTION (Oval Pattern at injection site) and VACCINATION SITE RASH (vaccination site rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Raised bumps), INJECTION SITE WARMTH (Warm), INJECTION SITE REACTION (Oval Pattern at injection site) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, SKIN REACTION (Raised bumps), INJECTION SITE WARMTH (Warm), INJECTION SITE REACTION (Oval Pattern at injection site) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information received through TCR. Added patient email
Severe Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C219) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (Severe Chills). At the time of the report, CHILLS (Severe Chills) outcome was unknown.            No relevant concomitant medications were provided, Treatment medication were not reported The event started the next day morning after the vaccination. The patient asked if the event was normal and if a sore arm was normal. No treatment information was provided.
Child presented to the hospital the day after shot with large hives all over his body, severe itching - treat with prednisone and Benadryl.
Itching and rash on left shoulder at injection site started approximately 5 days after shot Left hip and thigh pain started night of shot, lasted 24 hours
FATIGUE/SLIGHTLY TIRED; FEVER; CHILLS; HEADACHE; LEG CRAMPS; TWITCHY MUSCLES; BACK ACHES; ACHES; THIRSTY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and prolapsed mitral valve. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication, atenolol for high blood pressure, hydrochlorothiazide for high blood pressure, and acetylsalicylic acid. On APR-2021, Laboratory data included: Blood pressure (NR: not provided), and Fever (NR: not provided) 92.7 F. On 10-APR-2021, the subject experienced leg cramps. On 10-APR-2021, the subject experienced twitchy muscles. On 10-APR-2021, the subject experienced back aches. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced thirsty. On 10-APR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 103 F. On 10-APR-2021 17:00, the subject experienced chills. On 10-APR-2021 20:00, the subject experienced fever. On 10-APR-2021 23:00, the subject experienced fatigue/slightly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps, twitchy muscles, back aches, aches, thirsty, chills, fever, and headache on 11-APR-2021, and was recovering from fatigue/slightly tired. This report was non-serious.
vomiting; headache; Concerned about her son's heart rate and asking if they need to bring him to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), on 20May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 21May2022, outcome "unknown"; VOMITING (non-serious) with onset 21May2022, outcome "unknown"; HEART RATE ABNORMAL (non-serious) with onset May2022, outcome "unknown", described as "Concerned about her son's heart rate and asking if they need to bring him to the hospital". Therapeutic measures were taken as a result of vomiting, headache.  Additional information: A Caller reported that her son received the Pfizer covid-19 vaccine on Friday 20May2022 and her son started vomiting and had a headache on 21May and gave her son Tylenol. The caller was also concerned about her son's heart rate and asking if they need to bring him to the hospital.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Slight fever at first on Saturday. Fever and chills on Sunday.  Fever/chills/aches and pains continuing on till 10/21. Taking Ibuprofen.
Large red, raised area hard to touch and warm to touch at injection site. Approximately 3 inches wide and 2 inches long. Itching around site as well.
Pt has a raised rash over her entire body. She also is nauseous and vomited. Pt has had the flu shot several years in a row with no problems. She couldn't think of any other contributing factor.
Information has been received from a Registered Nurse referring to a 33 year old patient of unknown gender. Information regarding concurrent conditions and medical history was not provided. On 02-JUN-2015 the patient was inadvertently administered a dose of PROQUAD (Merck), subcutaneous (dose, dose #, lot # and application site were not reported) (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Felt dizzy.  I felt this same way on the first moderna shot, however  the first moderna shot I had more sever dizziness compared to today?s booster shot. After revisiting my moderna booster today,  I felt: dizzy, like the room was tipping, and like my eyes where heavy.  Almost like i was drunk.
BODY ACHES; ITCHINESS; BUMP ON FACE UNDER LOWER LINE OF THE EYE/BUMP ON THE RIGHT SIDE OF THE CHEEK/RASH; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to left arm, on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included paracetamol. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced itchiness. On APR-2021, the subject experienced bump on face under lower line of the eye/bump on the right side of the cheek/rash. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, body aches, itchiness and bump on face under lower line of the eye/bump on the right side of the cheek/rash was not reported. This report was non-serious.
Patient received the correct vaccine and was clinically appropriate (correct interval between dose 4 and 5).  However, the vaccines, while they were in-date, were 16 days out of their beyond-use date (BUD) from their 10-week period of storage in the refrigerator after removal from the ultra-cold freezer.   We contacted Pfizer, and the manufacturer provided us with stability and clinical efficacy data.  The data suggested, after we consulted our corporate clinical pharmacist coordinator, that we need to re-vaccinate at no particular interval.  No harm was implicated.  We contacted the patient, and he had not had any adverse effects and was amenable to re-vaccination when he got the chance.
I did not eat dinner; woke up with hives; I had itching in my hand/ Itching all over/itching was worsened; This is a spontaneous report from a contactable consumer (Patient).   A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 03Apr2021 between 13:10 to 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunisation. The patient's medical history was reported as none. Family medical history relevant to adverse events was none. There were no concomitant medications. The patient did not receive any products. There was no history of previous immunization with the Pfizer vaccine that was considered as suspect. Additional Vaccines administered on Same Date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no adverse events following prior vaccinations, The patient reported that she was experiencing a side effect. On 05Apr2021, the patient did not eat dinner and had itching in hand in the night at 20:00, but that was mostly all. The patient got the vaccine Saturday evening (03Apr2021) and got hives 06 Apr2021 morning. On 06 Apr2021, patient woke up in the morning and went into bathroom and looked in the mirror and she had hives all up and down her arms around 9:00am and had itching all over. The patient had hives on her arms, back, thighs, lower stomach, and around her panty line area. Hives was reported as worsened on an unspecified date in 2021 and she can see them on her side now and she did not see them there before. The patient knows that hives are a side effect but she did not think it would be this late. The patient did not know if she needs to go to the doctor for care or if she should take Benadryl or what she should do. The patient wanted to know if this was a side effect from the vaccine and she should get second dose of Pfizer-BioNTech COVID-19 Vaccine or not. The patient did not receive any treatment for the events. Adverse events did not require a visit to emergency Room or physician Office. This report was not related to a study or program. Investigation assessment was not done. The patient did not recover from events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Anaphylaxis, dizziness, flush, itching, nausea, headache, heart racing, difficulty breathing. Gave me EpiPen. Was in ER for 4 hours after. Took antihistamine every 6 hours for 3 days.
experienced rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (experienced rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced RASH (experienced rash). At the time of the report, RASH (experienced rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
by mistake, the patient got a third dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was given in Feb 2023) and Shingrix (the second dose was given in May 2023).   On 04-OCT-2023, the patient received the 3rd dose of Shingrix. On 04-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: by mistake, the patient got a third dose).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The nurse called to report the administration of a third dose to a 50 year old female patient. The healthcare professional mentioned that by mistake, the patient got a third dose, which led to extra dose administered. The reporter asked for safety information regarding this situation. The healthcare professional did not provide information about the third dose administered (lot number, exp date). The reporter consented to follow up.
Fainted, Fever, Chills within 14 hours after shot.  Daily heart flutters/palpitations since first does but less frequent as time progressed from first does on 3/5/2021.  Received second Moderna dose on 4/2/2021 and heart flutters/palpitations ramped up again but have continued to subside as the days/weeks progress.
Given vaccine at work site, Nsg unit reports 2AM - tachycardic rate 130, BP increase systolic 150 drank water, sat 1 hr sx resolved. Next day. Fever 101-103 through Monday 10/21 body aches/fatigue 10/22/19 sx resolved.
On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an hour and didn't happen again until the next evening, around 5pm. That episode lasted for hours, and I finally went to bed at 9pm due to being so tired. The palpitations stopped sometime in the night. The next afternoon, I decided to lay down for a bit as I was still feeling quite a lot of fatigue and SOME body aches since the day after the injection. When I laid down, palpitations started again within just a few minutes. I got up, and they stopped in a few minutes. Since that last episode, I have only had the occasional "flip-flop" in my heart. I've never had palpitations prior to this, (beta blocker is for a too fast heart rate with no palpitations)so thought it might be a reaction.  I'm scheduled for the 2nd dose on 3/27 and want to make sure it is safe for me to get that. Contacted my Doctor's office this morning, but haven't heard back as yet.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L038534, expiration date 19-AUG-2017; dose was not reported). No adverse effects were reported. ROTATEQ was not supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue, body aches, headache, sore throat, sinus pressure, vomiting, shortness of breath
Within 4 weeks of the Tdap vaccine, developed numbness and tingling of both soles of feet. Over the next 4 week N/T gradually moved up to waist. Then it subsided. Total time of N/T was about 8 weeks.
Within 5 minutes of given vaccines, child fainted.  She was laid down on the exam table and within 5 minutes of that she vomited a small amount.  Her BP was 94/60.  She sat up after that and was given crackers and juice.  Kept her in exam room for about 30 minutes.  She recovered without incidence.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported same adverse event for different patients. This is second of the three reports. A patient (age, ethnicity and gender unknown) received PREVENAR 13 single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced stinging during injecting of PREVENAR 13. Therapeutic measures taken in response to the event were unknown. Clinical outcome of event was unknown at time of this report. Follow-up (26Nov2013): Follow-up attempts completed. No further information expected.
2 of the doctors did not convert with antibody test which was performed about 10-18 days after the 2nd Pfizer vaccine dose; This is a spontaneous report from contactable physician. This physician reported similar events for 2 patients. This report is second of two reports.   A patient of unspecified age and gender received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: note reported), both via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated/ received the product at a hospital. The patient medical history and concomitant medications were not reported. The physician reported that several doctors have received both vaccines and 2 of the doctors "did not convert with antibody test." HCP stated the test was performed "about 10-18 days after the 2nd Pfizer vaccine dose." The patient underwent lab tests and procedures which included COVID-19 antibody test: did not convert with antibody test on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130815 same drug/reporter/event, different patients
The hospital thought I had a stroke; My entire right side of my face went numb including my throat, tongue and behind my right eye into my head,; causing the vision in my eye to become distorted and double vision.; causing the vision in my eye to become distorted and double vision.; This is a spontaneous report from a contactable consumer reporting for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 17:00 (at the age of 53-year-old) (Lot Number: FC3182) as DOSE2, SINGLE for covid-19 immunization. The patient was nonpregnant. Medical history included high blood pressure. The patient was allergy to Penicillin, nuts, seafood and egg yolks. Historical vaccine included BNT162B2(first dose, lot number:FC8448) administered in Arm Left on 13Aug2021 14:30. The patient's concomitant medications included lisinopril (LISINOPRIL) 10 mg. Clinical course: her entire right side of her face went numb, including throat, tongue and behind right eye into the head on 10Sep2021 18:30, and that cause the vision in her eye to become distorted and double vision on 10Sep2021 18:30. Then she visited an Emergency room/department or urgent care and the hospital thought she had a stroke on 10Sep2021 18:30. Adverse event resulted in hospitalization for 1 day. Outcome of all the events was recovering and therapeutic drug was administrated. The patient underwent lab tests included computerized tomogram (CT) scan and magnetic resonance imaging (MRI) on an unspecified date with unknown result and Nasal Swab (SARS-CoV-2 test) showed negative on 13Sep2021.
Shortly after midnight, started  in bed with chills for about 2 hours then felt warm then cold and back and forth.  Woke up around 7:30am with a fever.  At 8:45am, walked upstairs to use the bathroom.  While in the bathroom, felt dizzy and passed out.  My wife and son heard a thud sound.  My wife opened the door and I tumbled out still unconscious. I regained consciousness moments later. I was examined by paramedics who arrived at my home.
Started breaking out in serve hives on arms and legs, this has been ongoing and become a weekly occurrence.  I have been to my PCP, an allergist, my psychiatrist and physician. I have taken allergy meds regularly and stopped taking the Amour Thyroid to see if those remedies would help.
This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported.  On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705: