chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program "IBCC (Inbound Call Center for HCPs)". A contactable Health Care Professional on behalf of physician reported similar events for three patients. This is the first of three reports. A patient of an unspecified age, gender, race and ethnicity received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was S62923; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018128826 Same reporter/drug/event, different patients; US-PFIZER INC-2018129036 Same reporter/drug/event, different patients.
Patient presented to pharmacy on 11/8/18 reporting that since his flu shot on 10/30/18, his arm has been sore and there is a slight lump in the area of where he got his shot. He presented with classic signs of bursitis, most likely due to the shot being given too high on his right arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE(medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Testing positive since on now 15 day from original; (02Dec2022) Negative, notes: On 6th day, 2 antigen tests both negative; (02Dec2022) Negative, notes: On 6th day, 2 antigen tests both negative; (06Dec2022) Positive, notes: tested positive on the 10th day after initial test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Immediate vertigo like symptoms following vaccine, woke up mid way through the night with massive tinnitus. When I got up that morning I had vertigo. I gave it 48 hours before contacting my healthcare provider. At the 5 hour mark everything resolved except for the tinnitus. ENT referral. My arm was very sore in the joint and this persisted for about 2 to 3 months, it was deep pain and very concerning.
Pt cried during vaccines, then pussed out right after.  Pt was kept in office for 20 min.  Nursing well and went home.  Around 6pm had a seizure lasting 15-20 sec.
6/11/2021 1:30 started feeling dizzy when I bent over from there it was just dizziness all the time like my equilibrium was off.  4:00 arm starts to hurt  4:28 dizziness getting worse and felling very tired  6:30 dizziness gone fell tired no energy bla  9:00 pm dizziness is coming and going  6/12/2021  6:33 am. Dizzy on and off during the night when I would turn over  1:07 called Dr to check on symptoms was advised is not a listed side effect and if it gets worse to got in to see Dr but to stay hydrated  1:25 off phone but worse now fell nauseous laying down to sleep  3:00 up from nap nasha gone but still dizzy. Trying to chug water.  5:30 felling better no dizzy just sluggish still chugging water  11:00pm arm doesn't hurt as much and dizzyness gone, chug water  6/13/2021   Got up in the night to use restroom and got dizzy and had to lay back down.  7:50am  woke up felling out of sorts not like my self slightly dizzy I can fell it's still there. Starting with sport drink  10:14. Laying down not feeling right in brain  12:20. Took a B12 removed all of my acupuncture points except for two on my legs and added two to the bottom of my feet still feeling dizzy tired and out of it  6:10pm doing a bit better no dizzyness but still fell like my head is cloudy and I'm tired
dose administered from a vial that was in refrigeration and then was refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen) had resolved.            No concomitant and treatment medications are provided by the reporter.
redness at injection site; swelling at injection site; flu-like symptoms; nausea; fever; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The GlaxoSmithKline Field representative called in to report this adverse event narrated to her by a scheduling agent at the doctor's office.  At around the end of 2018, the patient received the 2nd dose of the Shingrix in her right arm. The patient's age at event onset was not reported but it could be 55 years or 56 years. The patient had swelling at the injection site (right arm) which resolved within 24 hours, redness at the injection site (right arm) which resolved within 24 hrs, flu like symptoms with fever of 101 degree F which resolved in 24 hours and nausea which also resolved within 24 hours.  No hospitalizations was reported.  Additional information was not provided as this was second hand information. The reporter consented to follow up.      Lab Comments: On an unknown date, body temperature was checked
This spontaneous report as received from a registered nurse via a representative refers to a male patient of unknown age. At unspecified time, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose, route not reported) at unspecified unidentified private physician's in the recent past. On an unknown date, the patient received the second dose of GARDASIL (lot #, expiration date, dose, route not reported) at unspecified time. After receiving the second dose of GARDASIL, the patient "started to have seizures". The cause for seizures was being evaluated and that the patient was due to have third dose of GARDASIL in January 2014. It was unknown how the patient was doing presently. The outcome of the event was unknown. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Systemic: Fever-Severe, Additional Details: I was contacted by Urgent Care to inform me that the pt presnted with 102 degree F fever on 11/02/2021. The patient returned to the same urgent care on 11/08/2021 complaining of continued high fever and referred them to the Emergency Room. I have not been able to contact the patient or family and I have left a message on their voicemail requesting them to call me. The Pfizer Covid-19 vaccine was administered into the Left Deltoid.
General, mild, flu-like symptoms; Headache; Brain fog; Muscle aches; Skin sensitivity; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 10:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously 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 27Mar2021 at 10:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. 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. On 18Apr2021 at 06:00, the patient experienced general, mild, flu-like symptoms the day following the injection. The patient also experienced headache, brain fog, muscle aches, skin sensitivity and mild fever. Appetite and digestion seemed to be normal. On day two, symptoms seemed to be declined quickly, saved for a bit of brain fog. Largely as he might have expected, just reporting it to assist with data collection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events general, mild, flu-like symptoms, headache, brain fog, muscle aches, skin sensitivity and mild fever were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Localized arm pain, Intestinal cramping, tired, joint pain the day after the vaccine shot.  Advil and nap provide quick relief. Painful, swollen, warm, rash located two inches away from injection sight on left arm developed two days after vaccine shot.  Exercised as usual plus additional arm movement to relieve arm pain.
approx 17 days p/ vax pt presented w/mild case of chickenpox that appeared to be a variant of chickenpox. pt afebrile
NO ADVERSE EVENT, JUST ERROR; GAVE PATIENT THIRD DOSE OF ZOSTER VACCINE, GAVE 1ST DOSE IN NOVEMBER, AND ANOTHER ENTITY GAVE 2ND DOSE INBETWEEN WITH OUT INFORMING US.
swollen arm; some pain; This is a spontaneous report from a contactable consumer (Patient's wife reported for husband).   A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration on 30Jan2021, as a first dose single dose for COVID-19 immunisation. Medical history included over the holidays, in which patient was hospitalized for COVID virus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that reporter and the patient both received their first dose of the COVID vaccine on 30Jan2021. On an unknown date, patient's wife stated that her husband (75 year old, male), did not have a reaction like her and only had a swollen arm and some pain. Patient's wife states that they are in both excellent physical shape, walking and biking daily and she was not on any medication. Caller asked due to her previous reaction from the vaccine, is it absolutely necessary to take the second vaccine or does she have enough immunity from already having the Covid virus and the first vaccine. Caller asked, What about the 6 people in the clinical trial that had Covid, did they get the second dose. Caller stated that she is trying to get an authoritative answer, which is why she directly called Pfizer. Caller asked if there was someone else that could answer her question or if I could pass the question along, so she could receive a recommendation on if she absolutely needs to take the second dose. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  .
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 11-NOV-2016, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a Physician Assistant. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Only liquid component given; Only liquid component given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA733A, expiry date 31st October 2023) for prophylaxis.   On 6th December 2022, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The nurse to report an adverse event for Menveo.  The reporter reports just the MenCYW-135 liquid conjugate was given to the patient on 6th December 2022, in the right deltoid.  It was not mixed with the MenA lyophilized conjugate component.  The reporter gives permission to be contacted by GSK. Additional Supportive Information: the patient was administered with Menveo, where he only received liquid conjugate without mixing with lyophilized conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine
on and off low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (on and off low grade fever) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (on and off low grade fever). At the time of the report, PYREXIA (on and off low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient has been experiencing fever for a month now.  No concomitant medications were reported. Treatment information was not provided.
Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt vaccinated with Engerix-B felt out of body, forgetfulness, insomnia, felt like she had alzheimers, confusion.
Felt clamy and had headache soon after vaccination.  Felt achy all over.  Headache has continued until 8/16.  Double vision started 6/16 and lasted approx. 1/2 hr.  Diaphoretic 8/16/21 while at and sweated through shirt.  8/17/21 coughed up bright red blood in the AM one time. He describes it as more bright red in the AM and has not happened since. He is short of breath.
Information has been received from a case in litigation (WAES#0610USA13557) from a physician via medical records concerning a male who on unspecified date was vaccinated with PNEUMOVAX (lot number, route and site not reported). Subsequently the patient experienced allergy. It was unknown if the patient sought medical attention. The outcome was unknown. No further information is available.
Developed a fever, rash beginning on the right thigh at injection site, complained of pain. Rash moved up into the trunk and face. As of 06/29/17 rash is beginning to recede in the opposite manner as it appeared. Patient seen in the clinic on 06/29/17.
Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg Ibuprofen 3 times a day for 5 days and doing much better.
pt recvd flu vax & approx 7 days later, devel sinusitis w/swelling around the sinus cavities & over the bridge of the nose; pt also had a local reaction w/ a 4cm band of erythema encircling the arm;
Patient was given a concentrated dose without diluent. When followed up with, patient only exhibited sore arm, no other symptoms. Patient was informed they may have been given a concentrated dose and to follow up with doctor if they did exhibit any external concerning symptoms. Patient was counseled on possible reactions to Pfizer.
Onset 3-4 after vaccine administration: developed fever and chills (after shower). Pt began having trouble breathing (slight heavier breathing than normal) for about 1 hour, pt possibly anxious. Fine next morning.
Shortly after getting the vaccine, my hcg beta labs (pregnancy) started to not increase like they should. I had an ultrasound on 06/11/21 showing a 6w5d fetus with a heartbeat of 129 bpm. I had another ultrasound on 06/29/21 that showed the fetus was no longer alive and  had stopped growing at 7w6d. I was diagnosed with a missed miscarriage and had a d&c to remove the tissue on 07/01/21.
This spontaneous report was received from a pharmacist via a company representative refers to a 59 year old female patient. The patient had no pertinent medical history. On 26-OCT-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date, the patient developed red circle at the injection site, the rash appeared around the injection site and it was warmth to touch. She went to the pharmacy for medical assistance and the events were treated with hydrocortisone cream. The outcome of the events was unknown. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
BONE PAIN IN RIGHT SOLE OF FEET AND BOTH ARMS, FINGERS AS WELL AS WRISTS ON BOTH HANDS; INTERMITTENT FEVER; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. On 02-JUN-2021, the subject experienced intermittent fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent fever on 05-JUN-2021, and had not recovered from bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. This report was non-serious.
at 9:00 am I had the 3rd gardasil shot and about 10 minutes later I was feeling sick, nausea,diarriah, stomache pains, insomnia, heart palpatations,feeling like my skin is on fire.sweaty, cold and hot flashes.
Tinnitus, loud ringing in my ear is non stop and causing insomnia, headaches, and loss of concentration.
Initial and follow up information has been received as part of a pregnancy registry, from a physician, concerning a 19 year old caucasian female patient with migraine headaches and cervical dysplasia, and no known drug allergies, who on 23-Aug-2006 was vaccinated with the first dose of Gardasil (Lot #653650/0702F), and on Oct-2006 was vaccinated with the second dose of Gardasil (Lot #653735/0688F).  The physician reported that since she received her second dose, she has become pregnant; confirmed by a pregnancy test which was positive.  The date of the LMP was 01-FEB-2007, estimated date of conception on 15-FEB-2007, with an estimated date of delivery on 08-NOV-2007.  She has not received the third dose.  Pregnancy is normal to date (no adverse event).  Prenatal vitamins (manufacturer unspecified), 1 tablet daily, were initiated on 21-MAR-2007.  Follow up information from the physician indicated that on 18-May-2007, the patient had an "uncomplicated urinary tract infection;" treatment included nitrofurantoin (MACROBID).  Routine prenatal labs were within normal limits, and on 26-AUG-2007, the patient's hemoglobin was 11.9 (units not specified).  There were no complications during pregnancy.  On 24-AUG-2007, ferrous sulfate (SLOW FE) was initiated.  On 30-OCT-2007, at 38.5 weeks of gestation, the patient vaginally delivered a normal caucasian male infant, with a birth weight of 3825 grams and an Apgar score of 8/9.  There were no complications or abnormalities.  Additional information is not expected.