chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called the pharmacy to report that she had passed out in her kitchen on the morning of 9/1/21.  She was feeling disoriented, dizzy before passing out, but nothing else was out of the ordinary.  She did not feel like she was going to pass out when her vaccine was given.  Did report a bit of a headache soon after her vaccination  After her vaccine on 8/30/21 she also reported the following side effects: - fever - body aches - nausea - chills - dizziness - headache
1 of 2 pts who exp an inject site react which consisted of a red & swollen area; poss cellulitis; @ the time of this report, ATB had not been prescribed; pt recovered;
Pt's younger sister fainted after her vaccines today. Pt had blurry vision and muffled hearing. She states that she felt light headed. She laid down on the floor and elevated her legs. She did not faint. RN put a cool cloth on her head. RN observed pt for 15 minutes. RN called mom later this afternoon to CK in and mom states that both girls are doing fine.
Patient was fully vaccinated 3/10/21 and was admitted for COVID19 9/28/21. Patient remains admitted hypoxic, on oxygen
Child is 15, accidentally gave Moderna half dose for booster vaccine verses Pfizer booster dose. Child tolerated well, have informed Parent of dosing of Moderns vs Pfizer.
Could not move; Joint aches; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ARTHRALGIA (Joint aches), CHILLS (Freezing) and MOBILITY DECREASED (Could not move) outcome was unknown.            This case was linked to MOD-2021-031859 (Patient Link).
On 4/25/16 0945 patient reported a "tennis ball size bulls eye" on (L) upper outer arm after taking a shower. She reports site hard and hot with questionable early blister at injection site. Arm is sore with pain rated 2-3 (on 0-10 scale) and vague itching. Pain was rated 4-5 the previous 2 days. Patient unable to check temperature.
Fever of 104.1 lasting for 24 hours, Brady aches, chills, swelling the size of a baseball and redness at injection site
tinnitus in left ear; This is a spontaneous report received from a non-contactable consumer.  A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). Concomitant medication included: EXCEDRIN [CAFFEINE;PARACETAMOL]. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 10Mar2021, outcome "recovered" (17Mar2021), described as "tinnitus in left ear". The event "tinnitus in left ear" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Additional medications received within two weeks of vaccination included lupus medications. She did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food and other products. The patient was not diagnosed with COVID-19 prior to vaccination, and she had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE and HEADACHE in a 54-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE and HEADACHE. At the time of the report, MALAISE  and HEADACHE outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment was provided.   This case was linked to MOD-2021-370195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 09-Nov-2021 the follow up received on 09-NOV-2021 contains No new information.
Patient became febrile on 11/17/21 and developed bright erythematous rash that was worse at creases. She was treated with PO amoxicillin due to presumed scarlet fever. She continued to be febrile and rash became maculopapular throughout body. She was seen in ED on 11/21 and had labs that showed slightly elevated liver enzymes and UA showed pyuria without any UTI symptoms. She was tested for mononucleosis and negative. She was given Rocephin IM in ED and switched to cephalexin as physician concerned rash was from mononucleosis. She then continued to fever and developed conjunctivitis. Patient was admitted to Pediatric Floor on 11/23 to rule out MIS-C but on day of admission CBC and inflammatory markers were nearly normal with downtrending LFTs. She was started on doxycycline to treat murine typhus as it is endemic in the region and Rocephin empirically while awaiting cultures. She has been afebrile since admission on 11/23 and had a normal ECHO by cardiology.
Two days after receiving the shot I woke up with nasal congestion and was coughing.  The next few days I started having chest congestion, mucus, runny nose, sore throat, wheezing and body aches. The symptoms continue to this day although not as severe as the first week. I've been using cough drops and mucus relief to help with coughing and congestion.
I received a flu shot, FLUZONE HD 20129-20 #0.5, NDC# 49281-0405-65, Mfg: SANOFI PASTEUR, on October 3, 2019, about 3:30 pm, I awoke at 4 am (on October 4th with chills, and a fever of 99.9', which is persisting. The pharmacy dispensing it.
Information has been received from Licensed Practical Nurse concerning a 25 year old female patient with asthma and a medical history of sexual transmitted disease who on 26-JUN-2013 was vaccinated with a first dose of GARDASIL (dose, route and lot # not provided) an on 30-SEP-2013 at 14 weeks of pregnancy was vaccinated with a second dose of GARDASIL (dose, route and lot # not provided). Concomitant therapies included influenza virus vaccine (unspecified) (manufacturer by Sanofi) and prenatal vitamins (unspecified)). The patient became pregnant with LMP of 24-JUN-2013 and EDD of 31-MAR-2014. There was no treatment given for the event. No adverse effect was reported.  Additional information has been requested.
About a week after I have developed chronic non stop itching. It?s extreme to the point I scratch until I have bruises and sores. I started taking Zyrtec to help (thinking it was allergies and/or stress) daily. It goes away after taking Zyrtec but pops back up in the afternoon daily so I take two. The need for multiple doses is because I had gastric bypass in 2009, so medications run through me quickly. I take great care of my skin and no changes to products. I have reported it to multiple doctors and was thought to be stress. I?m currently in a halfway house and explained to nursing that ever since this second vaccine I have to take it. I thought my immune system was in protest (I have RA and had Covid twice.) The nurse didn?t think I was crazy and told me I?m not the first person who said this of the Moderna shot and said it could be an allergic reaction. Makes soo much sense to me.
24 hours after receiving vaccine reported vaginal bleeding like she was getting a period. patient on Nexplanon and usually does not get a period.  Received first vaccine on 4/26/21 and second one on 5/24/21
Pt called our office 2/20/14. Stated "there was a 2 inch area of redness to start with. 2/14/14 started with a rash at the site that spread to shoulder to elbow with swelling and itching. States saw his dermatologist who put him on a Z pack and ? ointment. Pt seen in our office 02/20/2014. He prescibed Zyrtec, con't topical steroid and call if worse.
Chest pain; Unsteady gait; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 83 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 13Apr2022, outcome "unknown"; GAIT DISTURBANCE (hospitalization) with onset 13Apr2022, outcome "unknown", described as "Unsteady gait". The events "chest pain" and "unsteady gait" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: (Apr2022) Unknown. Therapeutic measures were taken as a result of chest pain, gait disturbance.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events chest pain, gait disturbance and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees, and Investigators, as appropriate
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patients ended up getting the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 10 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.
This spontaneous report was received from a Registered Nurse referring to an 18 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 27-MAR-2018, the patient was vaccinated with PROQUAD, subcutaneous route (dose, frequency, anatomical location, lot # and expiration date were unknown) after receiving VARIVAX (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, reconstituted with sterile diluent (MERCK) (lot # and expiration date were unknown). No adverse effects were reported.
Pt states wife did not respond p/receiving 3 doses of Engerix-B;
Itchy at injection site, injection site red, warm and swollen, felt ill ran fever of 100 for a couple of hours. Tired. Taking Benadryl and Advil.  4/9/21 - felt better still a little tired, injection site still swollen, warm and red
Information has been received from a registered nurse concerning a 19 year old female with asthma who on an unspecified date was vaccinated with a first dose of GARDASIL. "5 days after vaccination", the patient experienced faintness, shortness of breath and chest tightening in the morning. She went to the Emergency room and was given an unspecified inhaler but it did not relieve her symptoms. She had some labs done, which came back negative. The emergency physician believed that this could be a late response from GARDASIL. The patient was sent home and recovered next day. Additional information has been requested.
This spontaneous report was received from healthcare student in pharmacy referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 14-JAN-2016, the patient was vaccinated with expired doses of M-M-R II lot # J010601 and expiration date on 30-AUG-2015, (route, frequency, dose and strength were not reported). No concomitant medications were not reported. No adverse event was reported and no product quality complaint was involved. Additional information has been requested.
Extreme Chills, Very Cold, Terriable Headache, Low Grade Fever, Very Weak, Upset Stomach. Felt like I had a bad case of the flu. I had to stay home from work 1/7/21 and 1/8/21 Most of the effects are gone but I still do not feel good but alot better than before. Its 2 Days after the shot.
No additional AE information provided; Customer states that a partial dose of expired PROQUAD vaccine (LOT U009259 exp. 9/19/2022) was accidentally administered to a patient today, 9/21/2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 21-SEP-2022 (also reported as "today"), the patient was accidentally administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA) (PROQUAD) partial dose of 0.5 milliliter (ml) (lot # U009259, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live[rHA] [PROQUAD], expiration date reported and upon internal validation established as 19-SEP-2022) (anatomical location and route of administration were not reported) with sterile diluent for prophylaxis (Expired product administered).  The vaccine was properly stored with no temperature excursions. No additional adverse event was reported.
First two days very tender at site.  4-5 days later site very itchy. 8-9 days later got itchy again, when scratching realized there was fairly hard swelling approx. 2" x 1" area; reddish in color
The questionnaire asked if I had been to a doctor since my last shot and I went for an earache which I am sure is not related to the vaccine. I was diagnosed with a flare up of my TMJ dysfunction.
This initial spontaneous report was received from a physician referring to a 12 weeks old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 12-SEP-2015, at 14:41 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. This is one of two reports received from the same reporter.
Information has been received from a physician concerning a 70 year old female who on 12-MAR-2008 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 659759/1873U). On 09-MAR-2009 the patient developed shingles. At the time of this report, the outcome was unknown. Unspecified medical attention was sought. Additional information has been requested.
pt fully vaccinated and tested positive for covid 8/27/2021. hospitalized 8/30/2021 - received tocilizumb and remdesivir, dexamethasone, Oxygen
h/a,weakness,nausea,fever,t100.0;tx APAP,IV-NaCl,heparin lock;
if he can "relapse" back into the coronavirus (rebound); if he can "relapse" back into the coronavirus (rebound); 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 22-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "if he can "relapse" back into the coronavirus (rebound)". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter wanted to know that other adverse effects can he expect with the Paxlovid treatment, he and his son were taking Paxlovid and had experienced some adverse effects such as diarrhea for two days (from the first dose). They already had 3 doses of the Pfizer COVID-19 vaccine. During the call he mentioned that Pfizer should make a medication more effective and with less adverse effect. He also asked if there are deaths reported with Paxlovid, if he can "relapse" back into the coronavirus (rebound) after finishing the treatment, and if there are adverse effects reported from stopping the treatment abruptly. During the call also mentioned that the treatment does not give "the effect you want". Reporter considers that the recommended dose is very high.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate mild shoulder pain that began to significantly worsen 3 hours post vaccination.  The pain/inflammation is continuing to worsen and have lost most function of my shoulder now overnight.  The injection was placed too high and anterior likely into the shoulder joint.
Has red welt about the size of a quarter at injection site. Has a mild red rash on other parts of body.
Not feeling well; Aches and pains all over; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medications within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021, the patient reported that he did not feel well and had aches and pains all over. 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. The clinical outcome of the events not feeling well and aches and pains all over was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Malaise; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (Malaise) and PYREXIA (Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Fever). At the time of the report, MALAISE (Malaise) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication was provided.   This case was linked to MOD21-090768 (E2B Linked Report).; Sender's Comments:  MOD21-090768:invalid document
Information has been received from a RN on 10-SEP-2001 concerning a 33 year old female with infertility and no allergies who "approximately 7-10 days ago" was vaccinated with a dose of Meruvax II. On 10-SEP-2001 the pt had swollen glands and a low grade fever. the pt sought unspecified medical attention. Additional information has been requested.
KNOCKED OUT THE NEXT DAY; WAS NOT IN A LOT OF PAIN; SOME CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced knocked out the next day, was not in a lot of pain, some chills, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the knocked out the next day, fatigue, some chills and was not in a lot of pain was not reported. This report was non-serious.