chrisvoncsefalvay/vaers-outcomes huggingface dataset:
just didn't feel well; felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home; stomach pains; discomfort in the middle of his stomach that led to him vomiting; discomfort in the middle of his stomach that led to him vomiting/throwing up all night; pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up; exhausted; could not eat; very sore; Horrible reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: MALAISE (non-serious), outcome "unknown", described as "just didn't feel well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting"; VOMITING (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting/throwing up all night"; PAIN (non-serious), outcome "unknown", described as "pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up"; FATIGUE (non-serious), outcome "unknown", described as "exhausted"; DECREASED APPETITE (non-serious), outcome "unknown", described as "could not eat"; PAIN (non-serious), outcome "unknown", described as "very sore"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "Horrible reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (13Apr2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 29-year-old male patient that:  Additional Context: This consumer called on behalf of the patient who is reporter's partner. The patient is at work. The patient was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine on 31Mar2021. He had a horrible reaction afterwards. Reporter called to see if it was smart for him to get his second dose of Pfizer-BioNTech COVID-19 Vaccine related to his having the horrible reaction after the first dose.
Information was received from a pharmacist who on 13Sep2012 while administering an injection of the ZOSTAVAX (vial 19400) (lot # 0562AE, expiration date 20Mar2013) to a patient, had gotten a few drops of the vaccine in her eyes. She immediately flushed her eyes with water. The pharmacist reported that she had a little bit of irritation but no other symptoms. No additional information was provided. No additional information is expected.
Pt. c/o nausea, dizziness, feeling hot, clammy, couldn't hear for a little bit
PAIN IN SHOULDER; ARM/DELTOID PAIN; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced arm/deltoid pain. On an unspecified date, the subject experienced pain in shoulder. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm/deltoid pain, and pain in shoulder. This report was non-serious.
pt recv vax 19NOV98 11AM & stated got hot, began sweating & felt like passing out;states vomited a very small amount;had no sneezing, SOB, hives or swelling VS remained stable when checked every 5min for 30min;nausea/faintness was relieved
slept all the time; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all the time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (slept all the time). At the time of the report, SOMNOLENCE (slept all the time) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-304900 (Patient Link).
Patient died of a heart attack on 1/31/21, 2.5 weeks after vaccination
In addition to a very sore arm, experienced chills, body aches, headache, blurred vision, lethargy.
On 05/06/21 at 5am woken up by heart racing, palpitations, extreme need to urinate. Most symptoms subside the next day except feeling dehydrated, mild shortness of breath during my twice a week exercise class. I do recall feeling my heart beat more when laying down.  On 06/15/21 is my 1st hospitalization for PVCs. Severe palpitations start when leaning back. Taking magnesium to help control the PVCs and I started sleeping sitting up. Worst during sleep in early morning. Better during the day but still present. Went to MD and had EKG. MD recommended I go to hospital. Hospital put in an IV line but did not give me fluids. Still had PVCs, but felt better when released from Hospital. PVCs diagnosed, but no underlying heart issues.  Followed up with PCP. He found my Vitamin D was low so I started taking Vitamin D. Hospital prescribed beta blockers, which I tried. They made PVCs worse at night, and I developed chest pain.   On 07/09/21 is my 2nd hospitalization at Medical Center for chest pain and PVCs. They gave me an IV which helped my chest pain. Still had PVCs but chest pain subsided. Released from hospital. Again no underlying heart issues. Was finally able to see a cardiologist, who prescribed heart monitoring.   Saw an allergy specialist, at Hospital because I suspected something I was eating was making the PVCs worst. Went on an anti-inflammatory heart healthy diet with olive oil which helped. Decided to replace the fish oil I was taking with flaxseed oil. Stopping the fish oil helped. When I tried to stop the flaxseed oil, PVCs got worse.  Although I still need to sleep sitting up; the PVCs started to improve with the diet change, avoiding stress, time and rest. Can still get chest pain under stress. The pain was especially worst on my left side and into my left arm. Stopped wearing my smart watch monitor which is on my left arm. This has helped.
Fatigue, diaphoresis, tightness of jaw, myalgia of elbows and wrists.  No rash. No treatment.
First 48 hours unremarkable. After this period, episodes of fever, shivers, muscle ache, joint pain, night sweats.
a 10 year old male was administered Flublok Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who was administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1962, expiry date: 30-Jun-2020 via intramuscular route in the right arm on 09-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose and also received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient reported having blue hands after receiving both doses of the covid vaccine. The outcome of the event was unknown. Information about batch/lot number has been requested.
Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; This is a spontaneous report from a contactable other health care professional (patient). A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration administered in Left arm on 26Mar2021 14:30 (age at vaccination: 49-year-old) as single dose, for covid-19 immunization. (vaccination facility: Hospital). Medical history included Allergies to medications, food, or other products: Wellbutrin alveoli penicillin from an unknown date and unknown if ongoing. No concomitant medications were not reported. patient was diagnosed with COVID-19, Prior to vaccination. Did not received any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 on unspecified date for covid-19 immunization. On 26Mar2021 (12:00 AM, as reported), the patient experienced Fever of 103 chills nausea headache body aches started at 3 am. Still having them and on 7:50 pm next day. This was awful. Patient was not received any treatment for the events. Patient was not tested for COVID-19, Since the vaccination. The outcome for the evens was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from an other health professional concerning an 11 year old male patient who on 02-SEP-2010, in the morning, was vaccinated with three booster shots, one of which was a dose of VARIVAX (Merck) (lot# not reported). The patient had not eaten so his mother took him to a local restaurant shortly after. The child passed out in the restaurant. He was given a cold compress and he soon came to and was breathing and coherent. He was then given orange juice. He was taken away by ambulance. The patient was hospitalized. At the time of this report, the patient had recovered. Additional information has been requested.
pain at the site of injection after first dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the site of injection after first dose). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection after first dose) outcome was unknown.        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.   Reporter did not allow further contact
Pain went down to her elbow for 2 months or more; Excruciating pain on right arm after second dose for 2 months or more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00GB21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure management, COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more). At the time of the report, PAIN (Pain went down to her elbow for 2 months or more) and VACCINATION SITE PAIN (Excruciating pain on right arm after second dose for 2 months or more) outcome was unknown.            No treatment information was provided.  The patient after their second dose had excruciating pain on the right of their arm (site of injection) and the pain went down to their elbow for 2 months or more.   This case was linked to MOD-2021-403382 (Patient Link).
Information has been received from a pharmacist informed by the nurses in the hospital concerning an approximately 2 day old male infant with no pertinent medical history and no drug reactions/allergies who in "July 2011, over the weekend", on approximately 02-JUL-2011, was vaccinated intramuscularly with the first dose of RECOMBIVAX HB (Thimerosal Free) (Lot # 668308/0491AA, exp date 30-APR-2013). There was no concomitant medication. It was reported that the patient received his first dose of RECOMBIVAX HB in his "thigh" before leaving the hospital after his birth. Minutes after the vaccination was given, the patient's leg turned completely red, and a few minutes later only the back of the child's leg was red and then only a small circle at the injection site was red and within 20 minutes all the redness disappeared completely. No lab diagnostics studies performed. It was not specified whether the patient sought medical attention. The patient recovered on approximately 02-JUL-2011. Additional information has been requested.
This case was reported by a nurse and described the occurrence of fainting in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the fainting and chest pain were unknown. It was unknown if the reporter considered the fainting and chest pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable. Two weeks after the reporter had stress test, in a meeting, the reporting nurse and nurses were discussing SHINGRIX vaccine when a coworker reported to the group of nurses that she saw many patients come to the emergency room (she worked in emergency department), with symptoms of heart attack and fainting days after getting the SHINGRIX vaccine. The reporting nurse was asking, had GlaxoSmithKline (GSK) had any reports of chest pain or fainting symptoms after receiving SHINGRIX vaccine. This case was linked with case US2018GSK219276, reported by the same reporter (master case).
My daughter aged 14, went to the doctor on Tuesday for allergies. While there the doctor gave her the 2nd shot to the 3 shot series of GARDASIL. The following day she broke out all over her body in a terrible rash. She complained of her feet hurting and the joints in her hands. I had given her BENADRYL to help. The next day once again she woke up even worse than the first, the hives had spread.
flu-like symptoms Thursday am - Friday pm redness, swelling, erythema at injection site Saturday - Sunday Urgent Care prescribed hydroxyzine 12.5mg
Addendum 12-October-2015: Upon second medical review the product code was changed to 390 (INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE). Initial unsolicited case received from literature on 17-Sep-2015 and additional information received on 20-Sep-2015. Abstract: The CDC's Advisory Committee on Immunization Practices voted for universal flu vaccination to expand protection against the flu. In addition to this administration expansion, six new influenza vaccines have been introduced into the market possibly introducing new allergenic potentials. We report two cases of delayed anaphylaxis to the flu vaccine. This case involves a 42-year-old female patient who was vaccinated with 0.1 mL intradermal dose of FLUZONE Intradermal Vaccine (batch number, dose and site of administration were not reported) on unspecified date. It was reported that patient had tolerated her first influenza vaccination 2 years prior without incident. The patient reports a rash with amoxicillin but denies allergies to egg or latex. The patient otherwise denies any past medical history and currently does not report taking any medications. On unspecified date, 3 hours post-vaccination patient experienced anaphylaxis, dry cough, chest pain, dyspnea, palpitations and bilateral periorbital angioedema. Lab tests included intradermal testing which showed a 6-7 mm wheal and 12 mm of erythema for the same at 1:100 concentrations. Prick testing was negative to egg yolk/white. Latex prick testing was negative. Patient did not receive any corrective treatments. It was reported that symptoms were resolved within 24 hours without treatment. Upon medical review, the case was considered as serious due to important medical event: Anaphylaxis. Documents held by Sender: none. Follow-up information received from a literature on 01 October 2015. The patient had received Amoxicillin (batch number, dose, expiry date were not reported) on an unknown date. On an unknown date, after receiving amoxicillin the patient had developed rash. The outcome of the event rash with amoxicillin was not reported. Sender's Comments: Follow up received on 01-October-2015 does not change the previous medical assessment. Anaphylaxis is listed with INFLUENZA SPLIT TRITON INTRADERMAL THIOMERSAL FREE VACCINE. This case meets Level 2 definition for anaphylaxis of the Brighton Collaboration. Complementary information regarding any drug or food intake during the period between vaccination and the event as well as allergic testings to identify the culprit antigen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Upper GI bleeding; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8729) via an unspecified route of administration into left arm on 09Apr2021 12:30 (at the age of 50-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ep7534) into left arm on 19Mar2021 12:30 PM (at the age of 50-year-old) for COVID-19 immunisation. The patient experienced upper GI (gastrointestinal) bleeding on 11Apr2021 07:00. The patient was  brought to the physician's office and treated with acid blockers and had a scheduled follow-up with the GI doctor. Outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Swelling in both legs and tightness in both legs. Has md appointment today 4/19
This is a spontaneous report from a contactable consumer or other non healthcare professional from a Pfizer sponsored Program  Support. A 94-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 07Oct2021 as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling at injection site, redness at injection, experiencing the arm where he received the injection is inflamed and swollen for the past 5 days. The arm swelled and it was very red and has been lasting about 3 or 4 days now and it was still there. Clinical outcome of the event was updated as unknown. The lot number for vaccine was not provided and will be requested during follow-up.
PATIENT DEVELOPED SYMPTOMS STARTING THE MORNING AFTER VACCINATION. SYMPTOMS INCLUDE FEVER, NAUSEA, DIZZINESS, SWOLLEN LYMPH NODES UNDER ARM OF INJECTION SITE
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, several hours after receiving SHINGRIX, the patient experienced shivering, coldness, headache, fever, pain in arm and bedridden. On an unknown date, the outcome of the shivering, coldness, headache, fever, pain in arm and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, coldness, headache, fever, pain in arm and bedridden to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccination in the early afternoon and developed the effects as noted later that evening and into the night. The patient felt better the next day, but had relapsed chills and fever and also developed a headache that lasted a day and a half. The symptoms were lasted about 3 days in all.
Mild soreness to right arm from date of vaccination that has not stopped as of April 30. Muscle spasms to right arm that cause strong pain during spasms. Severe headaches to right side. Sharp stabbing intense headaches that come and go quickly.