chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle cramps in back; Feeling a little foggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling a little foggy) and MUSCLE SPASMS (Muscle cramps in back) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Kidney disorder.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling a little foggy). On 19-Jan-2021, the patient experienced MUSCLE SPASMS (Muscle cramps in back). On 20-Jan-2021, FEELING ABNORMAL (Feeling a little foggy) had resolved. At the time of the report, MUSCLE SPASMS (Muscle cramps in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment for the events included Tylenol   This case was linked to MOD21-019546, MOD21-041828 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI; Sender's Comments:  MOD21-019546:crosslinked MOD21-041828:
Vaccination site red, swollen, painful  down deltoid toward elbow. Day of vaccination- no problem reported. Day after vaccination symptoms as described. Day#2 after vaccination, things improving, pain less, swelling decreasing.
Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff at Immunizations clinic to verify date of last dose. No adverse events reported.
Swollen painful right armpit lymph node nearest injection site (in upper right arm). Joint skin and muscle pain throughout body. Fatigue and drowsiness. Treated with ibuprofen and rest. Symptoms remain extant at this reporting.
Achy feeling, pain in joints, runny nose (severe), watery eyes, sneezing, sleepy, slight dizzy spells, cough, sore throat, fatigue. Symptoms are ongoing.
sore arms for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms for couple of days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tracheostomy (tracheotomy on their neck). Concurrent medical conditions included Lung disorder NOS, Blood pressure high and Blood glucose abnormal. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms for couple of days). At the time of the report, PAIN IN EXTREMITY (sore arms for couple of days) had resolved.            Concomitant product include medication for sugar,medication for high blood pressure and 4 different inhalers for lung problems. No treatment information was provided.   This case was linked to MOD-2021-405059, MOD-2021-405079 (Patient Link).
More freq. HTN, meds no longer worked even when dose increased by 2 times. Suspected infarction in ER, chest pain, freq. HA, ongoing neurological pain head - lumbar shifts. F/U with cardiologist on 9/1/16.
Approx 2 weeks after 2nd shot, I developed severe body aches and felt like I had the flu and a week or so after that I had vertigo, tinnitus and extreme exhaustion. That lasted for  2-3 days and then dizziness to present, but lessening
Arm red and swollen above vaccine with hive on chest, three more hives on back same side. Right arm.
11/12/2022 I was walking and started having difficulty breathing. After walking more, I had trouble breathing. I was at a medical aid station at a football stadium and they recommended I go to the emergency room. After I got to the emergency room, they put tubes down my throat. They hooked an IV up to me, but I do not know what it was. My lungs were filled up with fluid. I had bloodwork which showed Enzymes for a heart attack. The took the fluid out of my lungs. I had a heart Cath done and determined it was not from a heart attack that my enzymes were high. Then I was told it was a respiratory issue. After multiple respiratory tests, they have all come back okay. They believe it had something to do with the fluid in the lungs. I was released home without knowing exactly what it was.
confused; suspected UTI; This is a spontaneous report from a non contactable consumer. This consumer (daughter) reported for a 77-year-old female patient that  A 77 years old female patient (not pregnant) received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Mar2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medications were not reported. On 09Mar2021 at 09:00 patient was taken to ER as was confused and not herself. The patient was being held overnight. The patient was hospitalized and UTI. was suspected.  At the time of the reporting the patient was unknown.  No follow-up attempts are possible; Information on the batch/lot number could not be obtained. No further information is expected.
Pt experienced the following after receiving the Vitamin K and Hep B shots: 1. Neurologic inconsolable screaming 2. Total body contortions/arching of back and neck 3. Jaundice shortly after birth that lasted over two weeks and required blue light therapy  4. Stopped breathing within 72 hours of receiving vaccines (sent home prior to 72 hour watch period for preemies... received stimulation from Grandma and came to. Called pediatrician after hours and was told it was just a "spell" that happens to babies from time to time. Did not advise to seek further care and claimed it did not happen as a result of the vaccine) 5. Constant ear infections (needed tubes at 2.5 years) 6. Minimal verbalization until age 2, even though his receptive skills displayed full understanding. Used his own signs to communicate needs (Hippocampus is verbal communications center) 7. Qualified for Early On interventions for Speech. Receptive skills were above average, but language skills below.  8. Physical Outbursts 9. Poor nutritionally gut function causing whiteish loose stool. Lacked enzymes needed for proper gut function since enzymes wiped out by vaccines and antibiotics from constant ear infections. 10. Head banging 11. Rocking 12. Eating plastic and other nonfood materials because lacking stomach lining due to loss of enzymes
First was Left arm pain (within 10 minutes of administration), then about 12 hours later started with shakes/chills (teeth chattering), cold sweats, fever (up to 100.1F), headache, muscle aches, mild joint pain,vomiting x 2  (shot given at 6:30 am and started feeling better at 7:00a.m then next day).  Have had fatigue for several days after the shot a well as mild arm pain at injection site.
Redness to Site on injection noted Saturday(8/3/19) evening with warmth to touch and pain with pressure.  Patient noticed redness had increased on Monday (8/5/19)morning  upon waking up and  an additional area of redness and warmth just below the first area was noted. Denies any other symptoms at this time.  Came in to clinic for evaluation
tachycardia; hands and nail bed turned blue; blood sugar and blood pressure dropped; blood sugar and blood pressure dropped; weakness; dizziness; very pale; hands were icy cold; labyrinthitis; This is a spontaneous report from a contactable nurse (reporting herself). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Aug2021 (at the age of 37-years-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, supraventricular tachycardia (does carry an EpiPen and said heart is not functioning great) and allergy. The patient's concomitant medications were not reported. On 20Aug2021, the patient received her first dose of the vaccine, about 10 minutes after administration, patient experienced tachycardia, forty-five minutes to one hour after administration her hands and nail bed turned blue, blood sugar and blood pressure dropped, she experienced weakness, dizziness, hands were icy cold, labyrinthitis and was reportedly very pale. It was reported that not even 45 minutes to maybe an hour after receiving the first dose Pfizer BioNTech Vaccine, the caller hands and nailbeds turned blue, hands were icy cold, blood sugar dropped, blood pressure dropped, everything dropped. The caller was transported to the emergency room from the caller department she works in, the caller coworkers called the paramedics. In the emergency department where she was told she had labyrinthitis and severe dizziness and was prescribed steroids. The patient was out of work for two weeks. On 20Aug2021, the patient underwent lab tests and procedures which included blood glucose was dropped, blood pressure measurement was dropped. The patient outcome of the events was unknown at the time of this report.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Temp 103 degrees - 6/5/13 pm Seizure on 6/6/13 at approx 10:45 am, lasting 5 mins per mother.
I tested positive for Covid-19. Some of my symptoms included a head cold, headache, tiredness, and generally felt weak.
12 hrs after shot felt tired. Followed by 8 hrs of fever and chills. Fever as high as 101.8. Body aches. After fever broke intense joint knee pain for 1 hr.
Suicide; A spontaneous report was received from a consumer concerning a patient, of unknown age/gender, who received Moderna's COVID-19 vaccine and experienced suicide.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date the patient experienced suicide.  Treatment information was not provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The patient died on unknown date. The cause of death was reported as suicide. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Suicide
FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402505(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 11 years old female patient who was administered Influenza quadrivalent recombinant vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2022, the patient had received a dose of 0.5 mL total of suspect Influenza quadrivalent recombinant vaccine standard (lot number UJ887AA, expiry date- 9-Jun-2023) ) (with an unknown formulation) via intramuscular route in the left deltoid for Immunization.  On 16-Sep-2022, (latency same day), the patient had developed a non-serious event flublok being administered to pediatric patients with no reported adverse event (product administered to patient of inappropriate age) following the administration of  Influenza quadrivalent recombinant vaccine  No lab data was reported  Action taken with Influenza quadrivalent recombinant vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patients with no reported adverse 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.
Pt. states that after receiving the 2nd dose of Phizer 08/03/2021, started to experience body aches and developing a rash throughout the chest. Rash is noticeably hot to the touch with welps forming. Primary notified but has yet to reach out to Pt. Still continuing to experience the fatigue with body aches.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N020502, expiry date: 08-FEB-2019) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 11:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 11:45, the patient experienced face swelling 30 minutes after receiving vaccine, it lasted for 2 hours and it looked like fluid retention and also the patient experienced a mild fever which lasted for a couple of minutes. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events mild fever, face swelling and fluid retention was resolved on 30Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
three hours later spiked a fever of 103.2.; I had chills; strong chills with teeth; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN8730 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm left on 31Mar2021 11:00 (at the age of 57 years) single dose for covid-19 immunisation. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206 and expiration date was not reported) first dose via an unspecified route of administration, administered in arm left on 09Mar2021 15:30 single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity for Penicillin & erythromycin from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen and Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 01Apr2021 12:00 the patient experienced chills, took Tylenol and three hours later spiked a fever of 103.2. It didn't last long and didn't had the normal strong chills with teeth chattering. The clinical outcome of the events were recovering.  Information on the lot/batch number cannot be requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got COVID". Patient was supposed to get her booster dose in Dec2021 but she got COVID. Reporter was asking what was the dosing schedule for the booster dose and caller mentioned that the CDC recommends people to get the booster dose after atleast 5 months if they receive the Pfizer primary series.  The lot number for bnt162b2 was not provided and will be requested during follow up.
With fever, Skin rash which initially was told to be nothing to worry about and then as contact dermatitis and later declared as eczema(chronic). Hydrocortisone 2.5% prescribed. And it keeps coming back after every few days.
Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of Recombivax HB in the past (dates unspecified), and now is showing "negative titers".  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report.  Additional information will be provided if available.  This is one of several reports received from the same source.  Additional information has been requested.
Admitted with complete heart block;  vaccine lot number, etc unknown   Just received 2nd dose 3/10/21
PATIENT EXPERIENCED VASOVAGAL SYNCOPE, A FEW MINUTES AFTER RECEIVING THE VACCINE. PATIENT REGAINED CONSIOUSNESS IN MATTER OF SECONDS. PATIENT SAT ON FLOOR AND THEN MOVED TO CHAIR. PATIENT REPORTS HE FELT BETTER SEVERAL MINUTES AFTER THE REACTION. PATIENT REMAINED WITHIN PHARMACY AREA FOR DURATION OF ~30 MINUTES. NO OTHER ADVERSE EVENTS OCCURRED .
Nausea, headache, malaise for one day following injection. Sore arm and bruising for several days following injection.
Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put on antiviral medication.  Nerve pain in my neck/headaches on my right side (same side as shingles).
but he have never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020). Additional patient notes included The patient was not immunocompromised.  On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but he have never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt Date: 11-JUL-2023 The reporter was a pharmacist technician. The reporter reported that patient had never received second dose of Shingrix.  The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix ,which led to incomplete course of vaccination.
Pt. became slightly lightheaded immediately after receiving GARDASIL #3.  She layed down but continued talking & said she felt fine.  She walked out to the waiting room to sit for 15 min as per office policy/protocol.  She fainted while sitting & was eased to floor.  She was roused to consciousness immediately with 0.3 ml ammonia inhalant BP 126/80 pulse 72. Remained in office X 10-15 min. Stated she felt fine & left with her mother.
inj site (rt upper arm) still bruised p/5 days; still warm & very sore;
Information has been received from a certified medical assistant concerning a 12 yr old female, with no known allergies, who on 29Nov01 was vaccinated with a dose of varicella virus vaccine (route and Lot # unk). On 12Apr05 the pt experienced full blown case of chickenpox. Outcome not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Approximately 5 hours after second dose of Moderna vaccine began to feel tired with nausea and a headache.  Approximately 8 to 9 hours after receiving vaccine also experienced chills, muscle aches, soreness at injection site, body aches, and a fever of ~101.7 degrees F.  The Fever continued for approximately 24 hours, as well as all other symptoms.  Approximately 40 hour after receiving vaccine developed a metallic taste in mouth when eating or drinking food. Nausea, headache, lethargic feeling continued ~40 hours after vaccine as well.
Received vaccine on the 24th of February and then  4th of March had red itchy patch to left upper arm - remains present on 3/10/2021
Vaccine administered after the beyond use date . The BUD date was 01/17/2022
Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The Reporter stated that a 0.5mL dose from a red cap and a label with a light border was administered as patient 2nd booster dose (4th dose) instead of 0.25mL.The patient was not immunocompromised. Treatment information was not provided.