chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 hours later began feeling a general "ick" like when coming down with something, then moderate headache and body aches, especially my back. This lasted less than 2 days.  Other things, mostly starting 5 or 6 days later and some cropping up as late as 4/11.    Random itchy red rashes on each shoulder and back of upper arm that would go away within an hour or 2.   Itching and possibly bumps on buttocks and thighs.  Intensely itching palms for a little while on 2 or 3 different days.  Sudden appearance of a 4 x 4 inch patch of 15-20 bumps of various sizes in the crook of my left elbow (injection arm) with bright red skin. These looked similar to mosquito bites or blisters but didn't itch. It completely disappeared without a trace within an hour.    Tingling tongue followed by tongue swelling on 4/6/21.  I had eaten my bran flakes with some rice pudding a little bit before this, both of which I'd eaten every day for the past week or so and had had several times in the past. On the advice of my doctor's nurse, my husband drove me to an urgent care center. By the time we got there, probably 1.5 hours after this started, the swelling was some better. The nurse practitioner that I saw prescribed an antihistamine and 3 days of one 20 mg prednisone pill a day. I've never had a tingling or swelling tongue before in my life. I took only a half of one prednisone on 4/6, no Allegra.  On 4/7 the random itchy red rashes mostly on arms/shoulders happened once or twice and disappeared fairly quickly, but my upper lip swelled. I could feel it happening as I sat in my recliner in the morning. I hadn't had anything to eat yet. The doctor advised I take my Allegra and prednisone I received at urgent care on 4/6, so I did. The lip swelling gradually went down over a few days, but it still feels irritated on the inside of the lip as of 4/11.   Diarrhea beginning around 1:30 a.m. 4/8. Lasted about 3 days. I only very very rarely have diarrhea.  Mild sore throat starting Friday 4/10. Better by Saturday. Sore throats are so rare for me that I can't remember the last one, possibly several years ago.
Infanrix was given to a patient 11 years old instead of Boostrix; Infanrix was given to a patient 11 years old instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7C9NS, expiry date 12-JAN-2024) for prophylaxis.   On 08-JUN-2023, the patient received Infanrix. On 08-JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was given to a patient 11 years old instead of Boostrix) and wrong vaccine administered (Verbatim: Infanrix was given to a patient 11 years old instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Jun-2023 The office manger asked that it was a valid dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Boostrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sweaty, clammy skin, pain (L) upper chest, flushed face, P 94, B/P 128/89. Patient went to ER & was told there "probable reaction to flu vaccine".
I went to city when COVID-19 numbers were rising. I was home for about 8 or 9 days and developed symptoms on June 11th. I tested myself on that day and was negative, then tested myself on June 13th and was positive. I had congestion, runny nose, cough, occasional intense headache on the back of my head which was peculiar, and occasional total exhausted. I believe I spoke with my doctor on June 14th, I think. Over all it wasn't too serious, my doctor did not prescribe anything. I took some Mucinex and occasional Tylenol but that was it. It lasted until June 28th and finally negative, before that previous tests were still positive. Tested again on June 30th and was fine.
Unable to read words in a book or verbalize those words  for several minutes.  Accompanied & followed by a headache.
Undiluted vaccine administered to the patient. As of now, she has not experienced any adverse reactions.
2 hours post vax became anxious, flushed, rash on chest, pulse elevated, B/P increased 133/93, diaphoresis. (BENADRYL) diphenhydramine 25mg PO, prednisone 20mg PO.
Nausea and fatigue caused her to not be able to proceed with a pulmonary function test on 15-Apr-2022 after 45 minutes of testing, she felt like she had been poisoned; Fatigue; Nausea; She was unable to do her regular chores around the house; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Nausea and fatigue caused her to not be able to proceed with a pulmonary function test on 15-Apr-2022 after 45 minutes of testing, she felt like she had been poisoned), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was unable to do her regular chores around the house), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A and 034F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Jhonson vaccine. Past adverse reactions to the above products included No adverse event with Johnson and Jhonson vaccine. Family history included Family history of cancer (husband is a cancer patient). Concurrent medical conditions included Asthma (regularly uses a nebulizing inhaler).   On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). On 15-Apr-2022, the patient experienced FEELING ABNORMAL (Nausea and fatigue caused her to not be able to proceed with a pulmonary function test on 15-Apr-2022 after 45 minutes of testing, she felt like she had been poisoned). In April 2022, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was unable to do her regular chores around the house). On 17-Apr-2022, NAUSEA (Nausea) had resolved. At the time of the report, FEELING ABNORMAL (Nausea and fatigue caused her to not be able to proceed with a pulmonary function test on 15-Apr-2022 after 45 minutes of testing, she felt like she had been poisoned) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was unable to do her regular chores around the house) outcome was unknown and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, Pulmonary function test: result not known Result not known.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included regular use of nebulizing inhaler. On 14-Apr-2022 evening patient had nausea and fatigue. Patient's nausea lasted for 72 hours and the fatigue has continued until today. Patient hired a housekeeper as the patient was unable to do the regular chores around the house. The Patient have been married for almost 40 years. Patient had not taken any medications or treatments for the symptoms   This case was linked to MOD-2022-547038 (Patient Link).
"About 2 hours after administration she had nausea and vomited x1. She reported having dizziness during the evening and is 100% improved this morning."
real sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "real sick".  Additional information: She states on 01Oct she got number 3 of the COVID-19 Vaccine and number 3 made her real sick but nothing like this. She states she felt like sleeping and didn't want to eat and really made her sick. She states she understand Corona from Pfizer has had bad effect. Caller states this was just something unusual and she wanted to call and tell Pfizer. Caller declines the report. Caller states she is not going to sue Pfizer or anything. She states her son got Moderna and he is vomiting when he got the Moderna. Caller declines to complete a report on her son. Caller states she doesn't want to do anything bad and she doesn't want to report her name or anything. She states how many more would have died without this. She states she had her 3rd dose of the Pfizer COVID-19 vaccine on 01Oct and wants to mention that she is almost 88 years old. She states her son is only 50 years old but was truly sick. Caller states the information was probably in the report as she did report this after her 3rd dose of the COVID-19 Vaccine in Oct. She states only one day and then this was 2 days. She states maybe with number 5 of the COVID-19 vaccine she hopes she will not have this effect. Caller states she knows this Call handler didn't make the vaccine. She states some people have died because of this and is bad. She states money needed to be payed for this. Caller states she just wanted Pfizer to know. She was told if something unusual occurred then to report the event. She states she is a natural born (withheld). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a breakthrough case of Covid, so fatigue, aches, chills and flu like symptoms for at least 24 hours.
Expired vaccine beyond manufacturer expiry date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter thinks that it was the second dose for all recipients but was not sure.  No relevant concomitant medications were reported. No treatment information was provided.
Patient did not receive vaccine in clinic, was given vaccine at pharmacy location. Came to clinic 2 days after injection, symptoms began 12-24 hour after vaccination. Red rash under injection site, warm to touch covering lower half of upper arm. Patient reports skin itchiness all over and itchy throat. Patient states 48 hours after injection that itchiness has improved significantly but rash has doubled in size
Warmth and redness near administration site and wrapping redness around to underside of left arm. Diag: Cellulitis and abscess.
Resident with physical decline prior to vaccination. Noted with fever, t. 100.6 after 24 hours,  and t. 99.2 in 48 hours post vaccine with  increasing physical decline with confusion. Sent to hospital for evaluation.
Felt aches all over (armpits, back, muscles joints all over neck). Feet & fingers cold & tingling, headache, temp, flushed face, blotchy skin (lasted x2 days).
pt c/o fever, pain in bones all over body, h/a, hurt to move lt arm;
Pt had a syncopal event w/ associated flushing/sweating.  Pt was cold and clammy.  LOC x10 seconds.  Pt oriented to self, date, situation. Vitals: 16:59 102/57, 61, 16, 99% -- > 17:04 113/51, 65, 16, 99% -- > 17:09 106/65, 75, 16, 98% -- > 17:35 108/57, 67, 18, 98% Ammonia Inhalant used x3 Pt given juice.  Recommended pt f/u w/ PCP.
Odd sensation in arm and chest area.  Nauseous & sensitivity sensation.  Didn't think much of this at the time, however this sensation has continued and carried over with the second dose.  Currently still have that sensation occasionally.  I did mention it to PCP at the time, and he felt it was safe to continue with second dose.
Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) 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.   No concomitant medication information were provided.  No treatment information was provided.  The vaccine was placed in the refrigerator on 20-May-2021. The vaccine expiration date was 19-Jun-2021. No Other Adverse Events were reported.
Second Pfizer dose 4/10; headaches, fatigue, malaise, light fever on 4/11, resolved by 4/12; bad headaches began 4/19, continued off and on for 10 days; on 4/24 severe fatigue episodes began with muscle weakness, dizziness and brain fog; tested negative for COVID-19 4/27; contacted PCP on 5/3 and tested positive for EBV 5/4
Moderna COVID-19 Vaccine EUA  Very blurred vision in right eye. Could barely see. (If I had gone a far distance to get my shot, I would not have been able to drive home.) Lasted about 15 to 20 minutes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:30 as dose 4 (booster), single (Lot number: GH9694), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Diabetes" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: JANUMET, start date: Feb2008; HYDROCHLOROTHIAZIDE, start date: Feb2008; LEVOTHYROXINE, start date: Jan2004; ATORVASTATIN, start date: Jan2010; LOSARTAN, start date: Jan2015; AMLODIPINE, start date: Jan2015; VITAMIN D [VITAMIN D NOS], start date: Jan2005; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI, start date: Jan2000; MAGNESIUM, start date: Jan2022; BAYER LOW DOSE, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive; (06Mar2023) Positive; (12Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: No known allergies. The patient tested positive for COVID on 21Feb2023 and exhibited symptoms until the 26th. On 06Mar2023, I developed symptoms, i.e. runny nose, fever, etc. and again tested positive for COVID. Patient was still testing positive 7 days later (12Mar). Patient received Paxlovid from 21Feb2023 to 26Feb2023 as anti viral COVID 19 treatment.
Paralyzed can't feel/move my legs; feel tired; Paralyzed can't feel/move my legs; This is a spontaneous report received from a contactable consumer (patient). An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took 1st dose of BNT162B2 for COVID-19 immunization. Patients wife and patient had the second dose, in the middle of the night paralyzed can't feel/move his legs. 03:00 am felt better. 10 days since the shot, feel tired. Mentioned it to the doctor. Rapid COVID Test. Covid have the second dose. Then patient had the five day thing. Feeling very tired. Doctor stated could endure 6 months. Patient and his wife are gonna take another rapid test. Patient saying have your stock. The outcome of the events was unknow.  Information on lot number/batch number has been requested.
A report was received on 1/2/02 concerning a 76 year old male patient who experienced COPD exacerbation 6 days after receiving Fluvirin vaccine on 11/10/98. The causality assessment was stated as possible. (OMIC)
Had the vaccine, Shingles came back/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient 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 Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine. The patient experienced Shingles. The reporter stated that it did not work for everyone. Follow-up would not possible as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting
painful bl!stering rash on her right leg/was diagnosed with Herpes Zoster; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance and for the prevention of shingles. On an unspecified date, pt experienced a painful, blistering rash on her right leg. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster and post herpetic neuralgia. Thereafter, pt had continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, pt had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine pt's symptoms and diagnoses had resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution arid/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of the events of herpes zoster and post herpetic neuralgia was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events of herpes zoster and post herpetic neuralgia to be disabling.
Pt called 12/10/2001 in the morning stated after few hours of flu shot pt was very sick over the weekend like hoarseness voice, fever, moderately wheezing on her lungs, coughing and body weakness for three days. Pt stated never felt like thi before with previous flu shot. Pt stated felt very sick until today 12/20/2001.
pt followed several yrs for brain injury from necrotizing frontal lobe encephalitis-doing well no sz x 9 mos recvd vax -grand mal szs x 2, 3' & 2' that evening;
Fever 101, red bumps around arm near injection site and on back, itchy, swelling, numbness and tingling.
This case was reported by a nurse and described the occurrence of allergic hives in a 4-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. There were no concurrent medications. On 23 February 2006 at 3:24 p.m., the subject received a dose Pediarix in the left thigh (lot AC21B05AA). The nurse reported that this was the "1st dose of Pediarix, but this was the 5th dose in the diphtheria and tetanus toxoids and acellular pertussis vaccination series", Pediarix is only recommended for the first three doses in the diphtheria and tetanus toxoids and acellular pertussis vaccination series. On 24 February 2006, "in the morning", approximately 1 day after vaccination with Pediarix, the subject was seen at a physician's office and was treated with diphenhydramine hydrochloride (Benadryl) and compresses. On 27 February 2006, the redness and swelling at the injection site resolved. The allergic wheal resolved on an unspecified date on or after 27 February 2006 and on or before 11 March 2006. The nurse considered the events to possibly be related to vaccination with Pediarix.