chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; This is a spontaneous report from a contactable Pharmacist via medical information team. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives after the 1st dose of vaccine. The reporter asked should the patient receive the second dose. The reporter stated that he heard about the patient from another pharmacist and was asking question for information purposes. The outcome of the event was unknown.   Information about Lot/batch number has been requested.
Heavy menstrual cycle lasting 7 days.   Normal menstrual cycle is light lasting 3 days.
Leg muscle cramps or spasms; experiencing a thingness in her left leg; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (experiencing a thingness in her left leg) and MUSCLE SPASMS (Leg muscle cramps or spasms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced MUSCLE TIGHTNESS (experiencing a thingness in her left leg). On 21-Aug-2021, the patient experienced MUSCLE SPASMS (Leg muscle cramps or spasms). On 21-Aug-2021, MUSCLE TIGHTNESS (experiencing a thingness in her left leg) had resolved. At the time of the report, MUSCLE SPASMS (Leg muscle cramps or spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
"3 x5 inch area of coalesced redness (right) anterior thigh that is warm to touch. No exudates. No hematoma formation." per ARNP, 05/13/10 11:33 am. 5/12/10 Mom phoned health center, reported "red knots" on right leg where vaccines given.
This case involves adult and unknown gender patient who had worst case of flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient, medical treatment(s), 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 not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient had non-serious event worst case of flu ever (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "no shot since, no flu since". It is unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event had worst case of flu. There will be no information available on the batch number for this case.
2 days after vaccination fever 99.4 degrees F. Generalized macular rash. No anaphylaxis noted. Went to ER and was given oral TYLENOL and BENADRYL.
Patient was seen in ER 6/18 9 days after vaccination for chest pain described as pressure. Labs including troponin were negative. EKG had some diffuse T wave inversions. Patient was seen in clinic 2 weeks post vaccination with persistent chest pain but EKG is normalizing. Referred for ECHO and cardiology evaluation.
This spontaneous report was received from a back office lead and refers to a 17-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 10-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1ml, right deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm pain began within 2 hours. Within 4 hours neck and back pain began. Within 24 hours, all over body aches began (mostly noted in back, chest, thighs and toes). These were not relieved by acetaminophen.  The symptoms (minus the arm pain) were resolved within 24 hours of onset. The arm pain dissipated within 4 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension-1" (unspecified if ongoing), notes: Hypertension-1. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: No. Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from an office manager refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unspecified dates beginning "sometime in June 2017", the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042169, expiry date 22-JUN-2017; lot # M044397, expiry date 20-JUN-2018; lot # M042822, expiry date 19-JUN-2018, orally (dose was not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 17 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA004649:
Fast heart rate; fever; This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a adult male patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 6th March 2020, less than a day after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever and fast heart rate. The reporter consented to follow up.
He got his vaccine, and was doing fine.  Went to bed and when he got up this morning stated that he had a headache at around 8:00 AM.  His wife said that she spoke with him around 10:00 AM and that he was throwing up and having sharp pains in his back.  He has a temperature of 102.   His wife is not at home with him, but has a call in to his doctor.
Patient developed fever (101F), acute chest pain and was brought to care at the local ED.  He was found to have symptoms and labs consistent with myocarditis.  CXR/AXR WNL.  His peak troponin was 2.01 (occurring approximately 3d after the vaccine).  He had a normal echocardiogram and EKG.  Additional labs included a WBC count of 9, normal BNP, mildly elevated CRP at 2.5, and positive COVID-19 RNA.  Symptoms improved with ibuprofen provided orally.  Hospitalized overnight at a HCF for ongoing monitoring.  Discharged ~24h later with down-trending troponin of 0.68.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Pt was pale-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received Boostrix Vaccine. He was instructed to sit for 15 minutes after the vaccination. After sitting for a few minutes, pt got up and started to walk towards his friend. He felt dizzy and fell, he stated he didnt get hurt. Pt got up, was walked to a chair and sat down. He looked pale and stated he cannot see. EMS was called, by the time EMS arrived pt felt and looked better. Pt was taken out by EMS.
Patient received his first dose Moderna on 7/28/21. Pt made appt with clinic for booster dose  Patient was given Moderna booster dose 0.25 mL. Reviewed CAIRS and pt should have gotten the full dose 0.5 mL. Called pt back x 5 and LVM for pt to come back get full dose. Pt did not answer.
Patient first became dizzy, then did not have dizziness after 2 minutes. Patient then became dizzy again, felt like bubbles in throat, abdominal pain, got hot, started sweating, and started heaving.
Labored breathing, and sensitivity and pressure  at heart chest area.  Very noticeable even just sitting quietly, and persisted for 4 months improving slowly month by month.  Not quite 100% recovered after 7 months.
received dosing of GARDASIL 9 outside of the recommended dosing schedule/at 0, 1 and 3 months; no adverse effects; This spontaneous report was received from a pharmacist concerning a patient of unknown age, gender and race.  The patient's medical history, concomitant medications, concurrent conditions, drug reactions/allergies or historical drugs were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (first dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, one month after the first dose, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (second dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, 3 months after the first dose, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form (third dose), intramuscular (anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
The next day woke up with rash at site of injection; one week later developed tremor- right arm; pill rolling motion; stops with intention
A 15 year old female pt with on past medical history, had received an IM, arm injection of Menactra, lot number U1822AA, on 6/26/06. On the same day, post vaccination, the pt developed a fever of 103.7 degrees F, body aches and headache. The following day, the pt was examined by a physician, and her temperature was 99.2 deg F. The pt was prescribed Tylenol to reduce body aches and headaches. At the time of this report, the pt had not recovered.
Healthy 3 1/2 month female infant received immunization PEDIARIX, ACTHIB, PREVNAR and ROTATEQ and dev. low grade fever with mottling of extremities and problems breathing 12 hrs later.
Extreme lethargy; Exacerbated symptoms of peripheral neuropathy; Difficulty sleeping; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer representative. An 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 28Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. On Sunday (28Mar2021), the patient had exacerbated symptoms of peripheral neuropathy throughout the evening with difficulty sleeping. Day 1 post-vaccination (Monday, 29Mar2021), the patient experienced extreme lethargy. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
08/31/21 The patient presents following Fall, jut prior to arrival. Pt reports to have been walking down stairs when he experienced a trip and fall down stairs. Pt struck his head and landed on the left side of his body. Pt was unable to stand up, and subsequently crawled to his door, and began screaming for help. Pt's niece came out and found pt lying on the floor with significant amount of blood. Pt c/o pain to his RLE and left hip. PT PRESENTS WITH SOB X24HOURS. PT STATES THAT HE WAS COVID + IN JULY. PT HAS A HX OF AORTIC VLVE REPLACEMENT.Patient was tested for COVID-19 and test came back positive.  Chest x-ray showed bilateral infiltrates and multifocal pneumonia.
signs and symptoms of COVID -19 started on or about 11/10/21, tested as COVID+ on 11/24/21. Sign and symptoms included increase weakness and fall, hypoglycemia, hypoxia with SpO2 at 80% on 15 L non-rebreather, diarrhea and loss of taste. Hospitalized 5 days 11/25/21-11/29/21, discharged to home
Presented to Clinic 3 days post vaccination with red swollen and painful injection site on left SQ arm, states pain is a 1-2 out of 10 when resting and a 3-4 out of 10 with movement, 3-4 out of 10 when touched. Sent to Hospital.
expired vaccine given to a patient, with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old male patient who used expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot U6900AA, Expiry date: 18-Nov-2022) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient used expired Diphtheria-2/Tetanus/5 Ac Pertussis vaccine, with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Nurse called to inquire if there is an extension of expiration date for vaccines. She also wanted to know if an expired vaccine given to a patient is valid and if not when this should repeated. Nurse does not want to provide email address at the time of call. Please see transfer screen for details. Product used : Used."  Action taken with Diphtheria, Tetanus and Acellular Pertussis Vaccine 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.
The day of the injection I had a very sore arm, just like my first dose. Then around quarter after midnight, I got up to use the bathroom. I recall extremely vivid dreams, and a little bit of disorientation. On my way back to bed I thought I?d take another ibuprofen to help me sleep because my arm was so sore. I remember feeling very dizzy, I did take my pill, and then I woke up on the floor. I was extremely disoriented and there was a shrill ringing in my left ear. As I came to, I recall really finding relief in the cold tile, and being concerned that I may have hit my head. I did a mental scan of my body and nothing felt painful, though stiff and sore, as I had the flu. I got back in bed and looked at the time, about 20 minutes had elapsed. The rest of the night I tossed turned, and felt quite feverish. I attempted to find radial and carotid pulses, which were extremely weak. That night, I  never did get a temperature, because I was quite disoriented. This morning I?ve been quite stiff and low energy. I feel discomfort in my kidneys, and have taken care to stay hydrated. I have reduced appetite, and some achiness in my body. My temperature right now is 100 even. It?s almost 3 o?clock, so about 28 hours has elapsed. I did not seek further medical care, as I live alone and transportation i would be a hurdle. I also not super concerned, mostly I just want you all to document that I painted, as I have not found that to be listed as a common side effect for the Moderna vaccine. I did call up a friend who is a paramedic, and feel reassured by her two cents.
Severe calf pain, exhaustion, joint pain, headaches, nausea, loss of appetite, vision changes ,general feeling. Of being flulike    Since august 18. Still continuing
Employee receveid DTap shot (Adacel). 57YO female  who is a nurse with history of  DM type II presents with left arm edema, erythema and pain.  She states that on Thursday she had her DPT shot and had no pain, or fevers.  On Friday she noted that while at work 7-8/10 pain with increased warmth and swelling and she used ice. Over Saturday and Sunday she began to have" flu like symptoms", including fever, chills and sore throat with HA.  She has had decreased appetite and has had some nausea.  She took vitamin C for sore throat and two Tylenol with some relief.  She note increased axillary pain especially with movement and decided to come to hospital for cellulitis.   She denies vomiting, SOB, CP, diarrhea, constipation, or current sore throat, chills, fever or HA.  MR received revealing an a 1 night ER admit for a c/o left arm pain, erythema, and edema which began 1 day s/p DTaP vax.  This progressed to "flu-like symptoms" (fever, chills, sore throat) 24 hours after initial symptoms.   PE: WNL except 8 cm. erythematous, edematous, raised lesion, warm to touch. DX: Cellulitis s/p vaccination. Tx'd with IV and po clindamycin.
Vaccines given at 12:40, patient did not exhibit s/s of reaction. Patient walked over to lab in clinic for blood draw and LVN assisting with blood draw saw rash on left arm. I was called to lab to assess patient, red rash noted to bilateral arms and across chest, patient c/o itching at site. Denied  s/s of SOB, itching at throat, n/v, LOC. NP from clinic onsite and called to lab, informed of situation and examined patient, ordered Kenalong 40mg IM once to be administered to patient. Medication administered at Left Deltoid without complications @1300.   1310: Patient's rash light pink in color, c/o itching at site. Denies that s/s are worsening. Patient given information on if s/s worsen to go to ER for care, if throat become itchy, SOB, swelling occurs, LOC call 911. Patient stated understanding, lives at home with mom, advised patient to inform mom if s/s progress.    Information about patient's status given to NP, advised patient to be d/c. D/C at 1:15.
Patient fully vaccinated and was diagnosed and hospitalized with COVID 19 8/14/21. Patient was treated and discharged.
Presented to Emergency for ongoing Chest pain. Found triple coronary bypass grafting was needed with a 90% blocked left main artery
Mild nerve pain in back teeth on left side (top and bottom). No visible signs of cavities.
Patient reports she had COVID infection in November 2020. Reports uneventful without infusions or medications. Reports "recovered easily", but had burning tongue as a s/s. Reports resolved "quite a while after recovery". Reports after receiving first dose of COVID vaccine, s/s of burning tongue returned and was still experiencing s/s, though lessened, at time of 2nd COVID vaccination on 3/17/2021.
I had noticed some chills and had a fever. I checked my temperature and since I was running a fever, I didn't go to work and I did take a COVID test which came back negative. I had some sharp stomach pain but it didn't come with anything. So normal bowel movements, no pains. The fever almost seemed as if it would go away and come back. It was like I didn't have a fever and I wouldn't take anymore medication because I was taking fever reducers. When I would let that extend on, my fever would come back. So I went back on the same course. I did a telehealth visit with my doctor due to the symptoms and she told me to monitor them and if they got better or worse then definitely call back. There was nothing really that they could tell me and I've never had a fever with stomach pain and no other symptoms. No illness symptoms.
muscle fatigue; Included fever of 101.3 F; chills; nausea; vomiting; intense headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had reaction from the 2nd dose of COVID-19 vaccine which included fever of 101.3 F, chills, muscle fatigue, nausea, vomiting and intense headache on an unspecified date which lasted for approximately 48 hours. The outcome of these events was recovered as it lasted for approximately 48 hrs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patients husband reported to us that patient had slight injection site pain, swelling and redness. Reported nausea  and achy muscles that caused patient to call out of work.
constipation; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Within a week after the patient experienced Constipation and patient wanted to know if this is a normal side effect and if this has been reported with the vaccine. Spoken from attached VR-Consumer Inquiry Management. A review of the Prescribing Information did not find information regarding constipation as a reported side effect. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Patient referred HCP for further guidance. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.