chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient herself). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the right arm on 21Dec2020 at 07:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included asthma. The patient had no known allergies; no allergies to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 at 06:00, the patient experienced nausea, diarrhea, and upset stomach, which were assessed as non-serious. The patient did not receive treatment for the adverse events. The patient was recovering from the events "nausea, diarrhea, and upset stomach."
Blotches on arms and legs; Itchy; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: En6208) via an unspecified route of administration in left arm on 16Mar2021 at 11:15 (at the age of 84-year-old), as a single dose for COVID-19 immunisation. It was reported that the patient was allergic to past drug codeine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included simvastatin (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN) for unknown indication. On 16Mar2021, at 13:15, the patient had various size blotches on his arm and legs (skin blotches) which extremely bothersome and itchy. Therapeutic measures were taken for the events skin botches and itchy included treatment with a cream (unspecified cream). The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events skin blotches and itchy was resolving at the time of this report. No follow up attempts are needed. No further information is expected.
Pt developed eye swelling of left eye the morning after she had the vaccine.  The swelling went down on its own by time of doctor's visit.  IT did not hurt or itch.  Eye was not injected.  No other symptoms.
Moderna COVID-19 Vaccine EUA Booster( Had same presentation after 2nd vaccine injection given April 8). Hematuria:   Vaccine Injection given 11/15 and beginning 11/16 and 11/17, urine got progressively darker with recognized hematuria apparent 11/18.
Pt developed hives throughout the body approx 5 days after receiving first dose of pfizer covid vaccine. Pt additionally received FLU vaccine 3 days after.
Flu-like symptoms; first dose > 35 days ago; Unstable blood pressure; Itching, which lasted up to 9-10 days; Pain at the site of injection was longer than typical for other people; Headache/headaches wouldn't go away; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days), VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) and HEADACHE (Headache/headaches wouldn't go away). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) had resolved and HYPERTENSION (Unstable blood pressure) and HEADACHE (Headache/headaches wouldn't go away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160-170 (High) blood pressure was high..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
This case was reported by a healthcare professional and described the occurrence of fever in a female subject aged between 40 and 49 years old who was vaccinated with influenza vaccine TRIVALENT (FLULAVAL, GlaxoSmithKline), pneumococcal vaccine, unspecified (Pneumovax, Merck) and tetanus and diphtheria toxoids adsorbed (Tetanus diphteria vaccine, Sanofi Pasteur) for prophylaxis. On an unspecified date in September 2008, the subject received an unspecified dose of FLULAVAL (.5 unknown, unknown), an unspecified dose of Pneumovax (unknown), and an unspecified dose of Tetanus diphteria vaccine (unknown). At an unspecified time after vaccination with Flulaval, Pneumovax and Tetanus diphteria vaccine, the subject experienced fevers of over 102 degrees Fahrenheit during the next five days. The subject treated her symptoms at home, but was seen in the physician's office for a follow-up. At the time of reporting, the event was improved. Follow-up information received on 07 October 2009 indicated that the subject was 34 years old at the time of event. Onset of fever was 13 September 2008 and on an unspecified date, the event resolved. The subject never received Tetanus diphteria vaccine, it was recorded in error, and Flulaval and Pneumovax were given in the same unknown arm.
Bell's Palsy.  Facial paralysis on one side. Onset 7/13/2021 Outcome uncertain. Treatment just started.
Generalized varicella-like rash, greater than 50 lesions on face, neck, trunk, arms, buttocks, and legs
Severe leg pain, particularly in knees for 24 hours after vaccine administration.  IBUPROFEN administered by parent, no further treatment.
Giving expired vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date FEB-2023) for prophylaxis.   On 03-JUN-2023, the patient received Menveo. On 03-JUN-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Giving expired vaccination). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter reported that he or she had an incident as giving expired Menveo vaccine. The patient received a Menveo which was already expired, which led to expired vaccine used.
Pt developed HA, dizziness, and nausea about 10 minutes after vaccine. Denies chest pain, palpitations, SOB, but does endorse "indigestion"." Hx HTN, took all BP meds this AM. BP in clinic 203/84 and 186/81. Pt taken to ER.
collapsed on floor; This case was reported by a nurse via market research programs and described the occurrence of fainting in a male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Previously administered products included took old shingles vaccine (received old shingles vaccine on an unknown date).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, less than a day after receiving Hz/su + AS01B, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   The reporter considered the fainting to be possibly related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported. After received Shingrix the patient collapsed on floor that night and the reporter had to call ambulance to assess.  The patient did not received 2nd dose, no money back, but the reporter did more than VAERS. The reporter had not given permission for follow up.
Associate developed a rash and tachycardia. Received two doses of po benadryl. Symptoms resolved.
A little Sore Arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little Sore Arm after first shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little Sore Arm after first shot). On 27-Feb-2021, PAIN IN EXTREMITY (A little Sore Arm after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-386713, MOD-2021-386715 (Patient Link).
This spontaneous report as received from a physician refers to a currently 20 years female patient with prednisone allergy and no pertinent medical history. The patient was vaccinated with dose 1 GARDASIL (Lot # not reported) "a few years ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported that within 24 hours after GARDASIL dose was given, the patient experienced muscle aches. vomiting and nausea. The patient did not seek medical attention. No treatment was received for the adverse events. There were no lab diagnosis or studies performed. The patient recovered within 2 days of adverse events onset. No further information is available.
Pharmacist went to administer vaccine and the needle  would not penetrate through the patient's skin. The dose was wasted and patient was re-dosed with a new syringed and vaccine was properly administered. Original syringe and contents went into the sharps container.
sick; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The patient was calling to make recommendations on Pfizer booster shots. She mentioned that she already had her 2 doses of vaccines and she recently had her Pfizer booster shot. She said as well that before getting the booster shot she was sick and she had a cough now when she had her booster shot she had her Pneumonia together she claims that she got well. She wants to see if Pfizer can have a correlation between the Booster shots and Pneumonia shots/vaccine. Unable to gather 1st and 2nd dose dates  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, fever, 100 degrees, body aches, intractable nausea, inability to eat, chills, sweats.
sick; Initial information was received on 13-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic) who had sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
patient reported generalized itching in her arms and legs as well as lightheadedness. She was given dephenhydramine 12.5mg/5l oral solution. Pt provided with water. Sx resolved. Pt was monitored for 30 minutes from symptom onset and 55 minutes from time of vaccine administration.
This spontaneous report was received from a nurse via employee refers to a 11 year old male patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-JUN-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (lot#, expiry date and dosage details were not provided). Other suspect therapies included TDAP and meningococcal vaccine (MCV), which were administered along with GARDASIL 9 on the same day. On the same day of vaccination, the patient experienced "fainting" after the use of GARDASIL 9. The patient did not receive any treatment. No product quality complaint (PQC) was involved. The patient recovered from the event. The reporter did not provide any causality assessment. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA010727.
Pt reports that after getting the FLUAD vaccine she began having muscle spasms and twitching from her shoulder down to her elbow particularly when lifting or extending her arm. Pt states that the current pain was a 9 out of 10 (08/21/2017). On 8/21/2017, pt went to urgent Care and received a prescription for MEDROL DOSE PACK.
miserably sick; Initial information received on 22-Nov-2020 and 30-Nov-2020 (Live Follow-up) regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who had miserably sick (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient had miserably sick (Illness) 3 years in a row. Since then not had the flu shot and only time since then the patient may had the flu once in 2003. Not been ill since then.  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
rash on side of mouth; Slight cough; Laryngitis; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL MUCOSAL ERUPTION (rash on side of mouth), COUGH (Slight cough) and LARYNGITIS (Laryngitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Banana), Allergy (Plant) and Drug allergy.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (Slight cough) and LARYNGITIS (Laryngitis). On an unknown date, the patient experienced ORAL MUCOSAL ERUPTION (rash on side of mouth). At the time of the report, ORAL MUCOSAL ERUPTION (rash on side of mouth) had resolved and COUGH (Slight cough) and LARYNGITIS (Laryngitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported .  No treatment medication reported.
Mod to severe headache fatigue chills nausea. One of the worst illness I've ever felt. Lasted only 1 day but same intensity. Very concerning. I did have same side effects after first but mild compared to this. Could not function. I feel good now but I do not want to go through that again.
same affliction - neuropathy; This is a spontaneous report received from a contactable Consumer from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction - neuropathy". The consumer reported the patient had the "same affliction" in different part of the body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
fatigue; elevated temperature; diarrhea; soreness in left arm; rash to left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm), FATIGUE (fatigue) and PYREXIA (elevated temperature) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature). On 17-Apr-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. On 17-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation.  Medical history included severe peanut allergy.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy.  She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021.  She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient seem to have syncope right after receiving Tdap boostrix vaccine.  She was gently placed on the floor. She came to a couple of second s later and said she feels but has a headache.  EMS was called immediately and medic attended to her.  She said she felt okay and medic said her readings were normal. She was then place in an ambulance to wait for her mother.
Patient received expired vaccine. Pfizer recommend revaccination. Patient was contacted to schedule an appointment. She rescheduled for 3/10/2022. Stated she had no adverse reaction to the booster dose she received.
The night of the vaccine administrations the patient stated she experienced an "itchy rash" on her arm that extended to her face, neck, and down her legs and back.
About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip.  Took Zyrtec and symptoms went away.
Red swollen arm at injection site where DTaP was given LD/IM- noticed next day given cold compress.
Headache, Arthralgia, Fever, FATIGUE. CHILLS PAIN TO INJ SITE Narrative:
administered Rotarix intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number M4ar7, expiry date 6th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd February 2022, the patient received Rotarix lyophilized formulation (intramuscular). On 23rd February 2002, the patient started Rotarix Oral Applicator Device. On 23rd February 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after starting Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter consented to follow up with email follow-up.