chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Diarrhea; mild headache; chills; fever; joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), HEADACHE (mild headache), CHILLS (chills), PYREXIA (fever), ARTHRALGIA (joint pain) and NAUSEA (Nausea) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-124459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Updated dose 2 information.
I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 3/24/2022 CARDIOGENIC SHOCK I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/20/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 3/20/2022 CARDIOGENIC SHOCK I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 3/24/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/20/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.0 CARDIOGENIC SHOCK 3/20/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 3/24/2022 CKD STAGE 5 (GFR <15) I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 3/20/2022 CKD STAGE 5 (GFR <15) R57.0 CARDIOGENIC SHOCK 3/20/2022 CKD STAGE 5 (GFR <15)
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot #R006218, expiration date 28-AUG-2019 for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute PROQUAD was properly stored. No adverse effects were reported. The vaccine was exposed to temperature excursion between minus 14 degree Celsius (C) and minus 10 degree C (average minus 12 degree C) for a time frame of 25.5 hours without previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter (# 1901USA010583). Sender's Comments: US-009507513-1901USA010583.
1 wk p/vax exp dry, red throat & inc thirst; 6 wks later had an earache; seen by MD & prescribed Amoxicillin for 10 days;
Narrative:  Booster dose was given at non-agency medical center - limited access to pfizer vaccine information therefore no lot, expiration, site of administration, etc. reported here.
Information has been received from a consumer concerning his approximately 16 month old daughter who had a slight cold at the time of vaccination but no fever. On 06/14/04, it was reported that approximately three months ago, at about noon time, the patient was vaccinated with a dose of measles virus vaccine live (Moraten) (lot # unknown). The father reported that by 3 a.m. the child developed bronchial spasms and was taken to the emergency room. By the time they arrived at the emergency room, 1 1/2 hours later, the child was better and no treatment was necessary. The child was not hospitalized. It was unknown if laboratory diagnostic studies were performed. No further information is available.
Right anterior thigh with large erythematous, warm, tender. Area just noticed to injection site. No induration.
Vaccination given higher than ideal location.  Immediate pain with needle insertion.  Immediate pain when medication injected.
Patient reports red rash, about 2 inches in diameter, became warm to the touch and was slightly itchy. She reports being able to put anti-itch cream on the site for relief.
Heart palpitations, fluctuations, accelerated heart beat, dizzy spells with disorientation, delirium and sweating, vision problems
Patient reports high fever to 101, left arm hurt and swelled and had a "giant hive size of hand print" and muscle cramps and biceps turned hard, wrist swelled to where fit bit had to be removed. Then prodrome of shingles started 6/10 and she broke out in the vesicular shingles rash 6/11. right superior anterior chest.
Erythema noted to left upper arm at injection site with tenderness to palpation. Treated with BENADRYL 25mg PO.
I didn't have any immediate reactions after receiving the vaccine because everything was fine. I didn't start to have any effect from the vaccine until September 2021 when I developed dizziness from vertigo that usually last a couple of hours, but now it has been going on for well over a week. I have had low energy since but I am also anemic so it was a hard recovery due to always being tired. My dizziness and energy levels is getting better.
Rash B/L legs - Bumpy rash with fever vaccines given 7/27/09 reaction 7/28/09.
02/20/2021 at 6:30am  when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back.  9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom.   During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased.  Treated with heat.
Fainted; nauseous; Felt faint; very pale; Incoherent; Confused; Clearing throat multiple times; This case was reported by a nurse via call center representative and described the occurrence of fainting in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H535B, expiry date 25th September 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 3X2KX, expiry date 30th June 2021) for prophylaxis.   Previously administered products included Dtap vaccine (received on an unknown date) and Flu vaccine (received on an unknown date).   On 12th October 2020, the patient received Boostrix (intramuscular) and FluLaval Tetra 2020-2021 season. On 12th October 2020, less than a day after receiving Boostrix and FluLaval Tetra 2020-2021 season and an unknown time after starting Albuterol, the patient experienced fainting (serious criteria GSK medically significant), nausea, felt faint, pallor, incoherent, confusion and throat clearing. The patient was treated with salbutamol sulphate (Albuterol), dexamethasone and oxygen. On 12th October 2020, the outcome of the fainting and felt faint were recovered/resolved. On an unknown date, the outcome of the nausea, pallor, incoherent, confusion and throat clearing were unknown.   It was unknown if the reporter considered the fainting, nausea, felt faint, pallor, incoherent, confusion and throat clearing to be related to Boostrix and FluLaval Tetra 2020-2021 season.  Additional information was provided as follows: The patient after receiving both vaccines felt nauseous ,faint, and very pale. She fainted and came to 1 to 2 minutes later. After coming, she was incoherent, confused and clearing her throat multiple times. Albuterol dexamethasone and oxygen administered. The reporter consented to follow up.
3 hours later had severe itching over whole body, hair started to fall out after 10 days. Called PCP he suggested Benadryl. 04/04/21 hair went completely bald.
Seriousness criteria other medically significant (OMIC). Initial report received on 8/1/06 from the pts parent. A male pt had received an injection of DTP USP, lot number 2A41126, on an unspecified date. The age of the pt was reported as 13 although the pts age at the time of the event was not specified. Per the reporter, the pt had suffered encephalopathy as a result of receiving the injection. On set date of the event was not reported. Recovery status was not reported. Additional medically relevant information was not provided.
Note: this was a POSITIVE effect worthy of study! I was resigned to being a long hauler after 8 werks of 100 degree fever and fatigue, but on 3rd day after first Pfizer vaccine, I woke up totally symptoms free. Did the vaccine give me something my body couldn?t produce, or just push my immune system to kick out a new round of fresh antibodies?    This could be extra good news for longhaulers.  Should be studied.....
Pt got immunization 11/13/13, but didn't notice reaction until 11/15/13 when she got flu shot in other arm. She has a red rash larger than a half-dollar with a hardness the size of a quarter in the middle. The hardness is tender to touch. Left arm is achy between elbow and shoulder. Rash and lump are the same size on 11/18/13, but arm is not so tender.
bad headaches/ headaches come and go and are often debilitating; The day the shot stopped hurting, her whole body started to feel different/ strange.; shot hurt when it went in; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (The day the shot stopped hurting, her whole body started to feel different/ strange.), VACCINATION SITE PAIN (shot hurt when it went in) and HEADACHE (bad headaches/ headaches come and go and are often debilitating) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 2C1181162) for COVID-19 vaccination.     The patient's past medical history included Epilepsy. Concomitant products included WARFARIN SODIUM (COUMADIN) for Epilepsy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (The day the shot stopped hurting, her whole body started to feel different/ strange.) and VACCINATION SITE PAIN (shot hurt when it went in). On 24-Mar-2021, the patient experienced HEADACHE (bad headaches/ headaches come and go and are often debilitating). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (The day the shot stopped hurting, her whole body started to feel different/ strange.), VACCINATION SITE PAIN (shot hurt when it went in) and HEADACHE (bad headaches/ headaches come and go and are often debilitating) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Med Info Agent: Patient stated that she received her 1st dose of the Moderna COVID 19 vaccine on 16FEB2021 and her 2nd dose on 20MAR2021 at Health Department. A week after getting the 2nd dose, she started having headache. She has Epilepsy and takes Coumadin. Her doctor thinks the headache might be due to her Epilepsy, but she does not agree because she has always had Epilepsy. She takes Half a Tylenol every 8 hours to relieve the symptom. The symptom is still ongoing.   1st dose Lot #:: 2C1181162 (Patient unsure, it could be ZC1181162) Exp Date: Left Date Received: 16FEB2021 Arm of injection: Left  2nd Dose Lot #: 011L20A Exp Date: Unknown Date Received: 20MAR2021 Arm of injection: Right Consent for safety to follow-up: Yes   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: non significant followup
This spontaneous report as received from a medical assistant refers to patients of unspecified age and gender. The medical assistant reported that, on unknown date, VAQTA (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported.   Follow-up information has been received from the medical assistant who provided the patients details. It was reported that an approximately 1 year-old patient of unknown gender, on an unspecified date in 2014 was vaccinated with a dose of VAQTA lot number J005010, expiration date 23-OCT-2015 (dose, frequency, route, anatomical location not reported) that from 09-JUN-2014 was exposed to temperatures between 29 degrees F and 30 degrees F. This is one of several reports from the same source. Additional information is not expected.
red, pustular skin rash treated with Cephalaxin 500mg BID x 7d and Valtrex 1GM BID x 5d
I was really really tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored programs. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization. The patient's medical history included chronic illness, auto-immune disease, surgical procedure from 12Apr2021, and chronic pain. The patient previously received the first dose of BNT162B2 (Batch/Lot number was not reported) on 12Mar2021 for COVID-19 immunization. The patient's concomitant medications included morphine taken for chronic pain, anti-depressant (unspecified), and acid reflux medication (unspecified); start and stop dates were not reported. The patient reported that she received both of the vaccines and she underwent a surgical procedure on 12Apr2021 due to chronic illness that might interfere with the effectiveness of the vaccine as per her daughter. She said that she didn't know about it and said if she knew, she would reschedule the surgical procedure. She received the 1st dose on 12Mar2021 and received the 2nd dose on 09Apr2021 (more than 21 days). She also took medication like morphine for chronic pain, anti-depressant, acid reflux medication and she also received sedative drugs through spine during the surgery. The patient said that she has auto-immune disease and she wanted to get a second opinion from Pfizer's professionals. The patient took the second shot on 09Apr2021 and had a procedure two days later. The patient also stated the she was really really tired, but didn't have any fever on Apr2021. The outcome of the event tired was unknown.   Information about lot/batch number has been requested.
Patient received first dose of Moderna vaccine in August 2021. Two weeks subsequent to that, he was diagnosed with Covid-19 and was given the Regeneron monoclonal antibody infusion within 48 hours of diagnosis. He received his second Moderna injection 90 days after the Regeneron on 11/28/2021. The following morning, he went to work and initially felt fine. He had a rapid onset of fever up to 103 and was confused. He was sent home from work and drove around for an hour and a half (which he doesn't recall) until he was pulled over by law enforcement under suspicion of DUI. His wife brought him to the local ED for evaluation where he improved after IVF and treatment of his fever. No source of infection was uncovered. He was kept under observation overnight and released the following day back at baseline.
4x4cm erythema around injection site 6x6cm induration 2x2cm bruise. Pruritus extending 1/2 way to elbow with patches of pink rash.
fatigue, body aches, chills, severe camping in calves, eye and nose drainage, sinusitis Narrative: 79 yo male with PMH CKD stage 2, s/p CABG, chronic back pain, hypothyrodism, DM, HTN was seen on hypothyrodism, DM, HTN was seen on 3/19/2021 due to adverse reactions for J&J vaccine, which patient received on 3/13/2021. Pt reported having eye and nose drainage, SOB with walking (pt has ongoing SOB, on MDI inhaler, ,muscle cramps, pain, headaches, he had mattering from his eyes that his eyes stuck together upon awakening. Pt was evaluated and dx'd with acute sinusitis and was given gentamicin eye drops, amoxicillin and prednisone.
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL.  The patient developed rash on her back a few days after receiving GARDASIL.  The patient sought medical attention at the office.  The outcome of the event was unknown.  No further information is available.
Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy" (unspecified if ongoing), notes: had a Hysterectomy when she was 27-28 years old; "really weak", start date: Sep2022 (unspecified if ongoing); "cough", start date: Sep2022 (unspecified if ongoing); "RSV", start date: Sep2022 (unspecified if ongoing). Concomitant medication(s) included: PREMARIN taken for hormone replacement therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: Body height: 5' 1.5", notes: States she used to be 5' 1.5" but as a normal part of again she lost height; lost height, notes: States she used to be 5' 1.5" but as a normal part of again she lost height; SARS-CoV-2 test: Positive, notes: Tested Positive for Covid 19 after 3 Pfizer Covid Vaccines. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: RSV was in Sep2022. The doctor said he was not going to send her out to get a test for RSV, he was just going to treat her for it, so she didn't really have a test but had the symptoms and the treatment was the same. She states it hasn't bothered her since. Reporter states she was just really weak and had a cough. Covid was in Oct2022. States it didn't last very long either. She reports she was really tired again. States she even had a total of 3 Pfizer Covid Vaccines.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The causal association of reported event lack of efficacy and Covid 19 illness is assessed as probably related to suspected Vaccine BNT162B2 based on temporal exposure and disease occurrence as reported. Case will be reassess once new information such as date of vaccination will be reported
Reported Symptoms: Confusion; Encephalopathy; Tachycardia; Narrative: Patient received three doses of Pfizer and one dose of Moderna COVID 19 vaccine. The patient presented to the ED on 6 November 2022 with confusion and tachycardia. The patient was admitted with COVID 19. The patient was treated with diltiazem. The patient was discharged on 16 November 2022 in stable condition. Reported per EUA. Other Relevant Hx: Other: covid encephalopathy
Temporary paralysis in right hand (happened two different times); Daily diarrhea with a very odd foul smell; Daily diarrhea with a very odd foul smell; Sharp severe pains in left and right groin; Sharp severe pains in right armpit; Severe sore throat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Sep2021 18:00 (at the age of 35-year-old) (Lot Number: FC5184) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 11Sep2021, the patient had daily diarrhea with a very odd foul smell, temporary paralysis in right hand (happened two different times), sharp severe pains in left and right groin, sharp severe pains in right armpit and severe sore throat lasting for days. The events resulted in doctor/HCP/clinic office visit. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were assessed as non-serious by the reporter.  Follow-up attempts are completed. No further information is expected.
I was began to feel unwell the week of the 02/14/2022, upper respiratory issue and since I have a history of sinus infection, I thought it was that; however, I had a workplace exposure COVID and was tested 02/24/2022 positive for COVID received the directives from my workplace. I also contacted my physician. It felt like a mild sinus infection.
Information has been received from a registered nurse concerning a 12 month old patient who on 17-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  She did not know if it was product confusion but felt it was human error only.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a registered nurse concerning a 12 month old patient who on 17-AUG-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD). The nurse learned of the event second hand from a co worker, and did not know the physician's name, the lot number or have any patient information. The nurse reported that the event was "just human error" that the patient received ZOSTAVAX (Oka/Merck), since the packaging was not similar. The patient did not experience any adverse event following the vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Extreme swelling and pain of left arm with a feeling of heaviness and inability to move arm. The following day, her entire body felt heavy and hard to move. No fever. No rash. By the 3rd day after the vaccine she started to improve and after a few more days was better. Pt reported reaction on 8/12/16.
Fluctuating total body urticaria.  Treated with antihistamine/steroids.
Shoulder and arm where shot administered was VERY sore and muscle ache increased over time.  Within 72 hours, unable to raise left arm without significant pain.  Approximately 3 weeks later, visited family doctor who prescribed short term steroid treatment.  This alleviated much of pain.  Doctor stated she noticed swelling in arm.  Reaction was NOT from improper administration of shot.  It has now been approximately 3 months and there is still pain and problems with raising arm, but it has noticeably lessened.  My wife received the same vaccine at the same time and had a similar reaction.