chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 12 hours from the moment of vaccination: intense cranial pressure, severe headache and nausea for 5 days at which point I experienced sensations in my heart and then at ten days after vaccination I experienced tingling and prickling sensation in my lower left arm and my lower left leg.  My right calf muscle started to feel weak and heavy.   I am now at 21 days after vaccination and am suffering headaches and nausea.
Patient had the normal injection of first dose in the series of Pfizer COVID-19 vaccine. The patient waited in the facility for the standard 15 minutes when fainted (syncope). I rushed over within 10 seconds to turn the patient onto her back. I checked for a pulse and breathing. There was a faint pulse and breathing initially, which seemed to stabilize after about 2-3 minutes. She became conscious again after about 2 minutes of unconsciousness. Patient was diaphoretic with shallow and rapid breathing. EMT was called and arrived about 20 minutes later. Blood pressure read by the EMT: 105/56 about 30-40 minutes after the injection (20-25 minutes after the syncope). Patient was not given anything for treatment besides purified water. Patient was told to follow-up with primary care doctor for the second dose if required.
She was experiencing chest pain and pressure; She was experiencing chest pain and pressure; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the dose 1 of BNT162B2 for Covid-19 Immunization on an unknown date and no events reported. On an unspecified date, patient was experiencing chest pain and pressure, so her pediatrician recommended a trip to the emergency room (ER). The patient advocate mentioned that Pfizer may want to further study these cases and/or enroll these patients in a clinical study (possibly with some compensation). The outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
PATIENT PASSED AWAY BEFORE THEY COULD RECEIVE THE SECOND DOSE OF THE SHOT.  WE ARE NOT SURE IF IT WAS VACCINE RELATED OR NOT.
DIARRHEA; SICK TO STOMACH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and sick to stomach. This report was non-serious. This case, from the same reporter is linked to 20210436338.
This spontaneous report was received from a registered nurse regarding a 12 year old female patient. Pertinent medical history was reported as none. On 10-SEP-2013 the patient was vaccinated with GARDASIL, injection, lot # J007354; expiry: 20-FEB-2016, 0.5 ml, intramuscular in the left arm. Concomitant medications were none. On an unknown date the patient experienced slight bleeding at the injection site and discomfort. There was no treatment given for the event. Patient sought medical attention and called the office. There was no product quality complaint (PQC) involved. It was also reported that the patient's parent recently notified the office by phone after being informed of the GARDASIL recall. The nurse also adds 19 doses of recalled GARDASIL were administered to other unspecified patients on unspecified dates. No adverse effects reported. The outcome of discomfort and slight bleeding at the injection site was reported as resolved on an unknown date. Causality assessment was not provided. Additional information has been requested.
upset stomach; Having LBM; feels very tired; This spontaneous case was reported by an other caregiver and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DIARRHOEA (Having LBM) and FATIGUE (feels very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The reporter stated that no treatment was received by the patient.
Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-months-old (reported as 1 day shy of 5 months) female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UT6315SA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh on 24-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient was not given any other vaccines during this visit. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse event occurred or not following the vaccination. 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 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. Documents held by the sender: none. Follow-up information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. The report contains no new information.
itchy red, swollen area around injection site, appearing 7 days after injection ("COVID Arm")
patient reported pain radiating into the neck and down to the elbow starting  the day after vaccination. Patient still experiencing some pain after 8 days and is scheduled to see her provider.
Tachycardia up to 157bpm went to ED received EKG, labs and 2 liters of fluid
Rubella vaccine given 10/11/02. Rash appeared 10/18/02 on legs and knees 10/25/02  10/27/02 stiff and swelling, soreness, numbness in both hands
Arm was EXTREMELY sore for 3 days. However, arm was warm and tender for 3 weeks.
Patient with 3 COVID vaccines who admitted with positive COVID PCR and dypsnea.  Provider d/c note:  "Brief Summary of Hospital Stay: Presented with acute fluid overload after missing dialysis and was found to have acute Covid 19 with suspected sepsis due to bacterial pneumonia. He required low flow oxygen initally but was able to return to room air. He was treated with Augmentin and doxycyline empirically until 11/3. Patient had profound weakness and was not able to return home. Needed subacute rehab in additon to his ongoing renal replacement therapy 3x weekly. Waiting for placement was the main issue for the past 13 days of admit."
Pruritis and erythema starting 2days after Td vaccination, at vaccination site. No tenderness, mild edema. Rx - Benadryl.
This spontaneous report was received from a currently 52 year old male patient. The patient's concurrent conditions and medical history were not reported. On 27-SEP-2013, the patient was vaccinated with M-M-R II (lot # J002934 with expiry date on 14-MAR-2015, 0.5 ml, subcutaneous) for prophylaxis (strength and anatomical location were not reported). Concomitant medications were not reported. On an unknown date, the patient developed a lot of pain in his right arm. The patient sought medical attention as he was seen in an unspecified emergency room on an unspecified date due to the pain in his right arm was getting "progressively worse". The patient stated that he was prescribed unspecified pain medication and unspecified muscle relaxers on an unspecified date for the right arm pain. Moreover, he experienced a loss of range in motion in the right arm and was diagnosed with Shoulder Injury Related to Vaccine Administration (SIRVA) on an unspecified date by an unspecified physician. At the time of reporting, the outcome of pain in extremity and injected limb mobility decreased was reported as not recovered/not resolved. The relatedness between the events and the vaccination was not reported. No product quality complaint was involved. Additional information has been requested. This is an amended report. HCP of primary reported has been updated to NO. Sender's Comments: MERCK 1606USA000878: Mfr number.
Patient had Moderna Vaccine Dose #1. He started to feel light headed. He fell from chair to floor. He was unconscious when first found approx 950 am. Nurse administered Chest compressions. Patient regained consciousness. EMS was called 9:52 am by clinical staff. At same time vitals were stable 129/62, oxygen sat at 95%, pulse 77. No supplemental oxygen or medications were administered.  Vitals at 10:02am  130/74 pulse 78 oxygen sat 95%. Vitals at 10:07 were 113/76 oxygen sat 98% pulse 79. EMS was on scene at 10:08am. Patient stated he has a history of vasovagal syncope. He denies any current medications, medical history, or allergies. He refused EMS services to be transported to hospital stating he was "fine" and he "usually has these reactions". He denied any diffculty breathing, shortness or breath, chest pain, palpitations, or any symptoms pertaining to an anaphylaxis reaction.
Information has been received from a physician concerning a 61 year old male patient who in May 2007 (exact date unknown) was vaccinated with a dose of ZOSTAVAX. On 27-MAY-2008, the patient presented to the office with a rash. The physician stated that the rash was shingles and the patient is also experiencing postherpetic neuralgia (PHN). At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
CDC reports: 5 mo infant developed fever to 104.4, was lethargic & hypotonic following immun; Report states: NCVIA reportable event. Pt to received DT only in the future.
Didn't get the full dose; saw a bubble in the needle; A spontaneous report was received from a consumer concerning a 75 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wrong technique in device usage process and didn't get the full dose.  The patient's medical history was not provided.  Concomitant medications were not provided.  On an unknown date the patient received their first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient states that when she was getting her first dose she saw a bubble in the needle and wasn't sure if she received a full dose.  Treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, experienced wrong technique in device usage process and didn't get full dose were considered resolved.; Reporter's Comments: This case concerns a 75 year old female patient who received her first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced wrong technique in device usage process and didn't get the full dose. There were no reported adverse events after the vaccine was administered in this case of wrong technique in device usage process and incomplete dose administered. .
Over 8 liquid stools (clear to yellow in color) on 11/13/2007.  Fussy on 11/12/2007 and 11/13/2007.  Fever up to 40 C on 11/12 and 37 C on 11/13.
Within 8-10 minutes he started to feel dizzy then passed out; lost consciousness; had seizures (no prior seizure history); eventually came two and was driven home; after had continuous sneezing and nasal drainage for two days and felt awful for four months with cold like symptoms
Pt reported fever x 1 day (not measured) warm, hot (L) Deltoid with pain directly following injection x 4-5 days. Ecchymosis @ injection site size 10 x 4cm. Tx with KEFLEX, ice/NSAID prn.
CHEST PAIN RATING 10/10 AND HEADACHE WITH 'FOGGY HEAD'.
You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 19-MAY-2014 the patient was vaccinated with improperly stored VARIVAX lot # H018451, dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Rash on entire body no respiratory distress. Pulse ox 99% at room air  distress. Patient was prescribe Hydroxyzine 10mg/5ml.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and unknown gender. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical office for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Patient was COVID positive on 11/17/2021.  Because of this repeat COVID testing not obtain.  She does not have respiratory symptoms, fever, or other symptoms suspicious for COVID-19.  Patient was a transfer from a HCF. Vaccine Lot number not document in current EMR
Headache on left side of head within an hour of shot Full headache 3 hours after injection  Nausea 7 hours after injection Aches & chills 12 hours after injection Headache and nausea through 48 hours after injection
Flu-like symptoms developed and got progressively worse in the first 12 hours after the vaccine and remained for approximately 36 hours.  The flu-like symptoms included muscle aches, nausea, stomach pain including more significant pain in the upper left stomach area, headache and fatigue with difficulty sleeping.  I needed to take time off from work due to these side effects and had difficulty performing daily activities.  Also experienced pain at injection site that got worse in the first 12 hours and lasted also approximately 36 hours.  Minor nausea, stomach pain and injection site pain have continued after 36 hours with ability to return to daily living activities.
Woke up following morning at about 8am with tinnitus in both ears. Waited a long time to see if it would subside; it did not. Went to Dr. to consult with him. He recommended I go see an ENT. I went to Center, on September 9, 2021, and was tested for possible hearing loss and tinnitus. The testing was "positive" for both.  My tinnitus worsened after my Moderna booster shot and I will make another separate report for this separate event. The same testing center re-evaluated me on March 29, 2022, and said my tinnitus had indeed worsened a bit.
Ended up in ER and was admitted with heart inflammation, irregular heartbeat, dizziness, chest pain, racing heart. No treatment administered. Symptoms lasted for more than a month.
Throbbing pain from shoulder to elbow.  Tingling from elbow to fingers.  Pain often wakes me in the middle of the night.  Must lay on my back with arm straight on my side.
07/19/12 - vaccine administered by public health department. 07/20/2012 - Hospital reports client history indicates visit to Acute Care Express with symptoms of: rash (arms and legs), shortness of breath, and fever of 103. Also states prescriptions: antibiotics and steroids given by acute care physician, started 07/23/2012. 07/24/2012 - To ED with c/o - continued and worsening shortness of breath per nurse. Report received by public health representative.
Two weeks after first shot, severe left shoulder, neck and head pain. went to chiropractor for six weeks. Eased up, Still have severe flare ups, of severe pain. mild pain in between. Been going on, for eighteen months now.
Red blotchy irregular shaped welts all over entire body: arms, hands, legs, feet, ears, cheeks. Lethargic. Administered Benadryl as instructed by pediatrician. No results were found. Administered oral steroids in afternoon and, now 5 hrs later still no change in symptoms.
Left Arm. Extreme pain by evening of 10/22.Fever,  Bright red, hot skin , upper arm..moving down to elbow/arm crease with extreme swelling 10/23 worsening 10/24 (upper arm circumference 1 inch+ larger than right arm!). Went to Urgent Care at 4:30 10/24/19. Diagnosed as Cellulitus(682.9,L03.90) left arm. Marked my arm instructing to go straight to ER at hospital if redness moves below markings as IV antibiotic/admission to hospital will be necessary. Caused by bacteria entering injection site during shot administration. Given antibiotic by injection by Urgent Care and prescription for Augmentin 875-125 mg tablet taken twice a day for 10 days. Slow improvement each day. Much better as of 11/2/19.
Large, feverish knot that continued to enlarge to approx 4 in. in diameter. The knot tended to be above the skin, more than under.
This is a spontaneous report from a contactable consumer reported for herself. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 10Jan2017 at single dose for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced nausea and threw up, chills, feels achy and did not feel well on 13Jan2017 with outcome of unknown.
has been experiencing diarrhea since yesterday and until today/I have lots and lot of diarrhea; Headache; I feel little bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "has been experiencing diarrhea since yesterday and until today/I have lots and lot of diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel little bad". Therapeutic measures were taken as a result of diarrhoea, headache, feeling abnormal.  Additional information: Patient has been experiencing diarrhea since yesterday and until today, he wanted to be assisted with his current situation. He got his first dose last Friday (02Apr2021) and his next dose will be on 23Apr2021. This is normal or something to do. it was Pfizer covid vaccine. he was calling because he feel little bad yesterday and today about you know that the headache and a lot of diarrhea he called you for information is this normal or not."When probed for did you took any treatment for the events consumer stated "no the paper they gave me in the hospital they tell me if you feel something vomit or diarrhea or fever take a Tylenol. I took a Tylenol."When probed for do you take any other medications consumer stated "I take for a longer time cholesterol pills but right now I took a Tylenol (Treatment) for diarrhea and headache."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash on his chest, back, and neck,; rash itches like crazy; it is spreading down to his waist and right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, GABAPENTIN, GLIPIZIDE and INSULIN for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm). At the time of the report, RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.