chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave a "whole vial, 6 doses to one patient."; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Reporter informed that the Clinic across the street gave a whole vial, 6 doses to one patient. HCP was unsure if the Vaccine was diluted or undiluted because They weren't answering their phone, so he can't find out right now. HCP was also unable to provide any patient information at this time. Reporter was at a hospital and he was got a safety issue at one his clinics across the street (as reported). They gave a whole vial to a patient, he clarified as six doses. He didn't know if they should send them to the ER or just monitor them at the clinic for an hour. He was concerning for any guidance on that. The patient experienced overdose on an unspecified date with outcome unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on plausible dose, event relationship post vaccination, and the causal role of BNT162B2 vaccine cannot be excluded for the reported even. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
sore arm; achy, headache, dizzy and would not eat; dizzy; felt weak-ish; upset stomach; headache ,felt weak-ish, upset stomach and a temperature of 103.8; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and ARTHRALGIA (sore arm) in a 78-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.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE, LUBIPROSTONE (AMITIZA), POTASSIUM, DOCUSATE SODIUM (STOOL SOFTENER) and CALCIUM for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8). On 11-Feb-2021, the patient experienced PAIN (achy, headache, dizzy and would not eat) and DIZZINESS (dizzy). On 12-Feb-2021, the patient experienced ARTHRALGIA (sore arm). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8) outcome was unknown and ARTHRALGIA (sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood pressure measurement: 152/92 mmHg (High) 152/92. On 10-Feb-2021, Body temperature: 103.8 (High) temperature of 103.8. On 10-Feb-2021, Heart rate (60-100): 103 (High) 103. On 10-Feb-2021, Oxygen saturation: 89-90 (abnormal) 89-90. On 11-Feb-2021, Body temperature: 98.6 (Borderline) 98.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications reported were blood pressure, thyroid and antidepressant and bipolar medications (unspecified).  It was reported that, the patient was treated symptoms with cold towels on his extremities, gave fluids and acetaminophen. Caregiver stated patient was feeling better on 12-Feb-2021, but still has a sore arm.   This case was linked to MOD-2021-089359 (Patient Link).
fever, unsteadyness, uncontrolled muscle tremors. sent to ER for evaluation on 1/29/21.
Patient visited the clinic on 08/17/2021 for other reason, told the nurse that he got COVID-19 vaccine Janssen on 08/10/2021 at COVID clinic later afternoon. Patient he had sever side effects, fever as high 102F, body ache,  muscle ache, all joints pain, super fatigue, no appetite, not able to get out bed. He stated he was a health man, never had this before.  The symptoms started the second morning, he lied down on bed for 2 days, the second 2 day his symptoms did not improve, he forced him to get out of bed, forced him to eat something. Even after one week on 08/17/2021 he visited the clinic for some other service, he stated he still did not totally recovery.  Patient stated he did not see a doctor for his side effects, only took acetaminophen for his fever and body ache.
Chills 8 hours after shot; Arm soreness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lopreeza (MANUFACTURER UNKNOWN) 0.5 mg and melatonin (MANUFACTURER UNKNOWN) 1mg on an unknown date for unknown indication. On 19Mar2021 at 00:00, the patient experienced chills 8 hours after shot and arm soreness. The patient did not receive treatment for the reported events. The clinical outcome of the events chills and arm soreness were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection
COVID drug reaction with shingles.; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for self that the patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid drug reaction with shingles on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient c/o "flushing" at 1725. Patient offered water.  1730 patient complained "I am not going to lie, I am not feeling well." Reported that "the water didn't want to go down" and c/o "throat shutting down." Reports feeling nauseous and started to itch both lower arms.  1737 0.5ml epinephrine administered IM to right deltoid, 911 called.  BP 132/82, pulse 92, O2 96% on RA.  EMS arrived at 1745 and transported to ER at 1758.  Called client morning of 1/15 and reported Benadryl given IV while transported to ER, discharged to home at 2130 on 1/14.
swollen lymph nodes under her left arm; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 13Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swollen lymph nodes under her left arm. The clinical outcome of swollen lymph nodes under her left arm was unknown.     No follow-up attempts are possible; information about lot number cannot be obtained.
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/3/21 (013A21A) Moderna Dose 2 3/29/21 (017B21A) COVID Positive 9/24/2021 Hospitalized  9/20/21-10/5/21  10/13/21: History is obtained from patient as well as a personal review of records. The patient is 71-year-old gentleman with known history of cholangiocarcinoma, malignant pleural effusion, recently diagnosed PE, recent COVID19, chronic leukocytosis and other medical problems. His oncologist is Dr. (Privacy). He was hospitalized from 9/20/2021 to 10/5/2021 at the Medical Center. He was discharged to a Nursing and Rehab Center. He was diagnosed with PE on 9/20/2021.  He tested positive for  SARS-CoV-2 on 9/24/2021.  Was treated with remdesivir, dexamethasone and Actemra.  He underwent thoracentesis on 9/28/2021  and pleural fluid showed malignant cells. Please see records from last hospitalization for more details.   He was sent from nursing home to emergency department for white cell count of 32.7.  I reviewed patient's previous records.  His white cell count on 10/4/2021 was 29.91.  Emergency department he was found to have increased oxygen requirement from baseline 2 L to 4 L. Chest x-ray showed moderate bilateral pleural effusions and possible bilateral lung infiltrates.  After coming to floor patient complained of lower back pain and abdominal pain.  Rated the pain as 8 on a scale of 1-10.  No aggravating or relieving factors. Denied fever or chills.  Lab work showed white cell count of 44.08.  Patient was discharged home on Eliquis and dexamethasone.  10/20/21: Patient discharged to hospice.  10/22/21: Patient deceased.
Cramps; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue). At the time of the report, MUSCLE SPASMS (Cramps) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt says her menstrual cycle has been off from her daughters since getting the vaccine when they have been perfectly synced up to this point
Patient was giving High Dose flu shot but only 54 years old.  Was feeling "fine, just tender arm, took some tylenol".
Felt immediate Pain at the injection site his left arm when the vaccine was administered; Injection site swelling; Injection site redness; Headache; Shivering; Dry heaves; Achy all over; Could not sleep on left side due to the arm pain; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (injection site pain, after receiving 1st dose on 27th August 2019, see case US2019158372).   On 28th October 2019 11:00, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm. On 28th October 2019, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, headache, shivering, dry heaves, general body pain, insomnia and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt pain at the injection site on his left arm when the vaccine was administered. The pain progressed and swelling and redness presented at the site. The patient also had a headache, shivering, dry heaves and achy all over body. The patient barely slept and had to take a hot shower to stop the shivering. The patient could not sleep on left side due to the arm pain. The patient received 1st dose and had adverse events, for tolerance refer case US2019158372.
REDNESS TO AREA OF SHOT OF MMR .5U ON 21 JAN 03 AT THE 7th DAY, SWELLING AND PUSS POCKET FORMED 9th DAY, TEMPERATURE OF 101.1 ON THE 7th DAY, LOSS OF APPETITE ON 7th DAY. WENT TO IMMUNIZATION CLINIC AT 200H (SAME NURSE THAT GAVE SHOT TOLD ME TO GO TO PRIMARY CARE PHYSICIAN).  NO AVAILABLE OPENINGS SO I WENT TO THE EMERGENCY ROOM AT 200H.  ONCE AT THE EMERGENCY ROOM THEY TOOK A CULTURE OF PUSS AND DETERMINED THAT THE SHOT AREA WAS INFECTED WITH CELLULITISE.  THEY ADMINISTERED AN IV WITH ANTIBIOTICS AND PRESCRIBED VICADIN AS NEEDED FOR PAIN AND DICLOXACILLIN 2000 MG A DAY.
Patient received HEP A vaccine on 6/11/08 - developed hives 24 hours later.
PROJECTILE VOMTING, LOSS OF MEMORY, UNABLE TO STAY AWAKE
congestion; legs were very painful; some fever; got infected with covid-19/ breakthrough case; a little bit of malaise; slight fatigue/ extreme fatigue/ they were very tired; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RABEPRAZOLE SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL ALLERGY 24HR), MAGNESIUM, AZELASTINE, COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (a little bit of malaise) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired). In August 2021, the patient experienced DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case). On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and PYREXIA (some fever). At the time of the report, DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful), FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) and PYREXIA (some fever) had resolved.        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.   Patient treatment included Over-the-counter stuff.  Patient said that she is in her 70s.
Swelling, stiffness, rash, itching and pain in hands and feet.  Follow-up itching  all over body.
first dose at 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Maculopapular rash started on 1/4/18. On 1/5 had temp 102 that lasted only for a few hours, no fever since. On 1/6 rash had spread to all over body and parents took to urgent care. Urgent Care did bloodwork and gave Dexamethasone sodium phosphate - 6mg. Platelets were low and ANC was low. Seen in office on 1/8 - still had rash and also had petechia. No other bleeding noted. Labs recheched on 1/12/18 and were improved. Currently mom states rash almost gone.
Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting approximately 8 hours before tapering down to moderate pain level approx 30 hours following injection.
This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
Pt received her first dose of the Moderna COVID19 vaccine. While sitting in observation pt reported a new onset of headache. BP was 121/100, 126/86, 146/106, 118/70. Pt was noted be very nervous stating her husband is an ?anti vaxer? and they had a big argument about her getting vaccinated. Pt was very fixated on her BP and requested it be checked numerous times. Pt was evaluated by EMS. Pt signed a refusal for transport to the ED and was told to contact her PCP.
Full body rash - itchy, red, painful - spreading over 24 hour period to cover 90% of body. Swollen, red ears, warm to touch
heavy headaches/headaches; heavy headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "heavy headaches/headaches"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "heavy headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked to offer any advice in case these headaches were related since there's no other reason the patient could identify. Also, reported that the duration for heavy headaches was 3 days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Narrative:  COVID infection with hospitalization following COVID vaccine series 07/11/20 COVID positive 12/22/20 COVID negative 01/29/21 COVID vaccine dose #1 02/19/2021 COVID vaccine dose #2 04/19/2021 COVID negative 09/05/21 COVID negative 10/17/21 COVID vaccine dose #3 11/23/21 COVID negative 01/31/22 COVID positive, hospitalized s/p left knee replacement & found to be COVID positive 02/01/22 discharged from hospital, no COVID symptoms
Diagnosed with ERYTHEMA MULTIFORME  Day 4 - started having generalized itching. Day 5 - rash developed on lower legs, generalized body itching Day 6- hives developed on legs above knees, generalized itching, rash Day 7 - hives, target lesions started on torso, thighs, lower legs, back Day 8 - 10 - continued with generalized hives, target lesions, itching, skin discoloration remained with resolution of hives.  Steroid and two antihistamines given
Pt came in today, 3/4/18, for a CMR. I started talking about vaccines and he said he didn't want any more vaccines because his shoulder was still hurting after we gave him 2 vaccines in October. Pt says it started hurting the day after and still hurts today. It is his left shoulder. He says moving his arm makes it worse but nothing seems to make it better.
Pain in injected arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062B20A) for an unknown indication.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101947 (Patient Link).
This spontaneous report was received from an approximately 77 year old male patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified). Concomitant medication included hydrocortisone. On an unknown date, after receiving ZOSTAVAX, the patient experienced itchyness and rashes on both legs and arms. On his right side of the waist, he developed white bumps. The patient did not seek any medical attention. No treatment was provided. No laboratory diagnostic tests were performed. The outcomes of all the events were unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
I got hypertension several hours after the dose, i felt very uneasy and my heart was beating  really hard.