chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Rash, UrticariaPruritus pain and inflammation at injection site Narrative: The same day she received the vaccine, the patient reported pain  and inflammation at the injection site (redness, swelling, itching). She also reported a headache and having pain in her back and legs. That night, she took acetaminophen 500mg once, and repeated the dose following day.  Other Relevant History:
This is a spontaneous report from a contactable consumer, (patient). A 60-year-old (non-pregnant) female patient received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FH8028), at the age of 60, via an unspecified route of administration, in the left arm, on Oct 31, 2021, at 10:15, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8734), at the age of 60, via an unspecified route of administration, in the left arm, on Mar 31, 2021, at 11:45; and received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0172), at the age of 60, via an unspecified route of administration, in the left arm, on Apr 21, 2021, at 11:30; both single dose, for COVID-19 immunisation. On Nov 3, 2021 (72 hours after the vaccine), patient experienced rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures taken as a result of rash at injection site included treatment with ice (iced site) and an unspecified topical steroid cream. Since the vaccination, patient has not tested for COVID-19. The outcome of rash at injection site: not resolved (at the time of this report).
Patient was administered IPOL and PEDIARIX at the same time resulting in an additional dose of IPV with no reported adverse event; Initial information received on 26-Jan-2023 regarding an unsolicited valid  non-serious case received from a physician via call center.  This case involves a 6 years old female patient was administered ipol and pediarix at the same time resulting in an additional dose of ipv with no reported adverse event while receiving vaccines Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) and Ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Jan-2023, the patient received of suspect Ipv (vero) Suspension for injection (formulation) at a dose of 0.5 ml(millilitre) last dose once (strength and expiry date-not reported) (lot V1B891M) via intramuscular route in the left deltoid for immunisation.  On 26-Jan-2023, the patient received suspect Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero) not produced by Sanofi Pasteur (strength, formulation, dose lot number and expiry date not reported) via intramuscular route in the left deltoid for immunisation.  On 26-Jan-2023 the patient developed a non-serious event patient was administered ipol and pediarix at the same time resulting in an additional dose of ipv with no reported adverse event (extra dose administered) (latency-same day) following the administration of Ipv (vero) and following the administration of Diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
She has also felt lethargic; right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs; she couldn't even touch her arm, and it is red; had a dull headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 038C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache) outcome was unknown.            Treatment also included Drinking as much as she can. No concomitant medications reported Patient believes that the reactions could be covid arm.   This case was linked to MOD-2021-436255, MOD-2021-436403 (Patient Link).
leukocytoclastic vasculitis (LCV)/petechial/purpuric lesions on lower legs and feet/crops of lesions/rash; This is a spontaneous report from a contactable health care professional. An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular administered in Arm Left on 09Apr2021 (Lot Number: ER2613) as dose 1, single for covid-19 immunisation in Pharmacy or Drug Store. The patient medical history was not reported. No known drug allergies. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began with petechial/purpuric lesions on lower legs and feet on 19Apr2021. Patient has had continued crops of lesions appear since that time. Has worsened over time. Was diagnosed with leukocytoclastic vasculitis (LCV). A biopsy was collected on 12May2021. The patient was put on an oral prednisone taper, showed improvement on high doses but once tapered down, rash returned worse with no resolution. Visited 3 times and 2 visits to her pediatrician has not resolved. Continued worsening over time. Events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination: Nasal Swab, SARS-CoV-2, NAA on 11May2021 with Negative result. The outcome of event was not recovered. Event was reported as non-serious and not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event leukocytoclastic vasculitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
08/4/04 received lot, dose, no event, manufacturer, different lot number than 2nd dose. 9/13/04 2nd dose, small amount soreness, several days after noted lump, not sore, area now getting smaller, small lump after injection, area getting smaller.
Symptoms started on Saturday morning (1/16/2021)  following the shot having been administered the previous day (1/15/2021) at 1:00 p.m. in the afternoon.  Initially, I had a slight, constant  headache and "medium" fatigue.  I dismissed it as not important because it was relatively minor. and I am generally fatigued at the end of a work week.  The headache lasted all day but was fairly low level. I did not sleep well that night but was able to function during the next day (1/17/2021)  without a problem.  I don't remember if the headache was present that day.  However, on Sunday evening (1/17/2021) (around 6:00 p.m. or so) chills started to go up and down my body and my hands were very cold.  I had no fever.  I added more garments to keep warm and ignored or was distracted by my activities of the evening. Monday (1/18/2021) during the day the chills continued to go up and down my body  intermittently-- not really staying in one place -- but my hands remained very cold.  It should be stated that I prefer colder temperatures; i keep my house between 60-62 degrees in winter and I am able to stay comfortable with a shirt and sweater in that environment.  So, on Monday, the fact that I had chills was remarkable to me. The chills were intermittent. Tuesday (1/19/2021) I worked from home all day and had an electric heater going focused very closely on my body all day.  I was cold but don't remember having chills.  Tuesday evening the chills returned, along with a significant headache that circled my head (not focused in one spot), my body ached, my eyeballs ached; I had intestinal cramping .and I simply could not get warm due to the constant "full-body" chills. I went to bed with a heated mattress pad on,  flannel sheets, a comforter an d a thick wool  blanket. I could not get warm.  I was not able to sleep at all the entire night due mostly to the (major) physical discomfort and (minor) worry as to what was going on. I DID NOT have a fever. Around 8:30 on Wednesday morning, I was able to fall asleep as the chills had diminished and I was worn out. The body and eyeball aches were still present as was the intestinal cramping. Later that afternoon the symptoms started to diminish and I was able to sleep Wednesday night. I did not eat anything on Wednesday as I was not interested in food due to the discomfort of  the intestinal cramping. I was able to smell food and had not lost my sense of taste.  Thursday morning (1/21/2021,  I finally felt like I could eat and had  some food which tasted delicious to me.  I was able to get warm, had slight headache, cramping was mostly gone, ..I still had (reduced levels) body aches and eyeball aches.  I had no chills.  I was able to consume and tolerate reduced amounts of food.  Friday (1/22/2021) I was tired but able to function and felt as if I was returning to feeling like myself.  Today, Saturday(1/23/2021, I am feeling about 95% myself and relieved to have this behind me.  I am very concerned about how I might react to the second dose of the vaccine.  I am going to consult the local hospital and my PCP there to inquire about the advisability of getting the second dose.
Patient fainted after sitting down in observation.  Disoriented and scared once alert.  Complained of nausea and headache.  EMS called.  Patient alert and agreed to go to hospital.    Vitals @ 12:11p: 110/80 BP, 84 Pulse, 98% O2.
On 06/04 I woke up and I had a lot of water leakage and I let it go throughout the day a little longer. I called the OBGYN and I went in and had it checked around 4:00PM. There were several tests that were run. I was leaking amniotic fluid. I had to go into labor that day. The pregnancy was considered pre-term because I wasn't due until 07/15. On 06/05, my baby was born at 5lb, 5oz. After I was told I had to go into labor, I was induced. I received a cervix softener and than I was given Pitocin. I was induced at 10PM on 06/04 and I delivered  at 12PM on 06/05. I was in labor for 14 hours. Right now my baby is in the NICU and she will hopefully be coming home 06/13. If she does come home on 06/13, she will have been in the NICU for 8 days. I was given penicillin and betamethasone, which is supposed to help with the development of the babies lungs. All of her tests have come  back normal. The only issue was with her bilirubin levels.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm 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 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient had no known allergies, no other medications in two weeks. Patient was treated with Paxlovid form 15Jun2022 to 21Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccine given 8/19/2019. Rash, tenderness, warmth occurred 8/26/2019 on right upper arm deltoid-injection site. No fever or joint pain. Patient took Benadryl 8/26 and rash improved by next day of appointment 8/27/2019. Prescribed Benadryl and prednisone. Referred to PCP.
A pharmacist reported that a male patient received an injection of influenza virus vaccine (manufacturer unknown) "ten years ago." Approximately 24 hours post vaccination, the patient developed swollen lips, a rash and hives. He was seen by  a physician. No furter information was available at the date of this report.
Approximately 24 hours after 2nd dose had muscle aches all over body. Chills. Slept all day. Next morning all aches were completely gone. Had no side effects from 1st dose.
Pt noted rash in trunk and upper back starting 6 hours post-vaccination, described as redness, skin peeling, and hives  - has gotten worse over next few days and decided to report the situation April 18, 2021. Pt denied dizziness, syncope, respiratory distress. Pt sees dermatologist on a routine  basis and is due for her skin injection (dupilumab ) for eczema.
Date of death: 9/29/2022  COVID positive: 9/20/2022  Admitted to local Medical Center on 9/20/2022 for respiratory failure.  Discharge diagnosis: hypoxic respiratory failure, COVID-19 viral pneumonia  Vaccination: Moderna x2  County: "Private".
A report has been received from a Health Professional concerning a 29 year old, female subject who has been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 06-OCT-2014. It was reported that on 06-OCT-2014 FLUMIST QUADRIVALENT was administered to pregnant patient. The outcome of event of pregnant patient received FLUMIST QUADRIVALENT is unknown. The outcome of pregnancy was unknown. The report was considered to be non-serious.
had an episode where patient wet his pants; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 8 years old male patient who had an episode where he wet his pants (urinary incontinence), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Sep-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6654A via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious had an episode where patient wet his pants (urinary incontinence) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was had an episode where patient wet his pants.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown.  Documents held by sender: none.
Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis (Beginning in the end of 2022,) since 2022.    On 15-Jan-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain). At the time of the report, ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain) 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.   No concomitant information was reported. It was reported that beginning in the end of 2022, (Current hand Arthritis got worst, and needed to visit Dr. since prior to 2022 right hand exhibited no symptoms. Since Feb 2023, both hands are gradually getting worse and feeling more pain.  No treatment information was provided. Company Comment: This is a spontaneous case concerning an elderly patient of an unknown gender, with a history of Arthritis, who experienced the non-serious unexpected, AESI event of arthritis, which occurred on the following month after a dose of mRNA-1273 vaccine, received as the fifth dose of COVID-19 vaccination schedule. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-734049 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734049:Monovalent
Chest pain an hour later; Little bit of soreness immediately; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain an hour later) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Narcolepsy and Endometriosis. Concomitant products included AMITRIPTYLINE, BUSPIRONE, GABAPENTIN (NEURONTIN) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain an hour later) (seriousness criterion medically significant) and PAIN (Little bit of soreness immediately). On 13-Apr-2021, CHEST PAIN (Chest pain an hour later) and PAIN (Little bit of soreness immediately) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include birth control pills. Treatment medication included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-128681 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I received the flu shot in my left upper arm and since that day I have had significant pain when moving my arm certain ways. I cannot lift my arm more than approximately 45 degrees, reach forward or across my body to buckle my seatbelt or take my shirt off without severe pain in my arm.
Swelling, redness and a hard bump at the injection site (Right thigh IM). NP recommended OTC Benadryl for patient's symptoms.
Severe muscle aches started within 1 1/2 hrs of receiving vaccine by the 3rd day walking was difficult & pain was constant in lg muscles of legs, arms & upper back. Unusually fatigued experience for days 4 & 5 post vaccination.
This is an administration error. Parents lied about patient's age to obtain the vaccine for their son . Patient has 15 years at the time of vaccine administration (04/09/2021). No adverse events reported so far. The administration error was reported to the Electronic Immunization System . Parents were instruted to wait until the patient gets 16 yrs to obtain the second dose, as per recommendation of the Health Department. They were aldo instructed about the importance of telling the truth in every official document requesting vaccine administration or any other health service.
Symptom onset: 330 am 10/14 with Hot Flashes  only; more symptoms began around 630-7pm  on 10/14 with muscle aches, fatigue, headache, stomachache, sore throat, dry cough.  Still with symptoms on day 5 of HA, stomachache, dry cough, and tiredness.  Had an unusual breakout of acne around chin area and side of nose. (not related to mask wearing).
Within hours post vax, the pt developed an injection site reaction characterized by swelling, warmth, and a softball sized area of redness. Three days later, she developed flu-like symptoms. She was seen by the physician who indicated that she experienced an allergic reaction. She recovered within 7 days.
Fever of 101+, severe muscle spasms, rash, headache, fatigue
Patient - right lower extremity swollen, painful with motion (evening of vaccination). Following day (7/21/12) - increased swelling, decreased movement and mother noticed she was favoring other leg (left) when standing- 7/22 - fevers also noticed. Came to hospital on 7/24.