chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in the waiting room after vaccine and began to feel dizzy after 10 minutes. She became unconscious and began to stumble unto the floor but was caught and held by her mother. After 1 minutes, the patient regained consciousness. She was given cold water and rubbing alcohol to forehead to help her. Her mother reported that the patient has a fear of needles and was anxious. The ambulance arrived but was refused by patient. The fire department arrived and monitored patient's blood pressure.
my granddaughter had covid, no symptoms. Then, I started weak, tired on  covid  in 29aug2021  and had the infusion friday. I saw my doctor . Cant smell and no appetite to eat
Right upper arm had some faded redness as of 8/12/03. Mom stated area had been very red, warm, and swollen after the injection but had improved alot. No medications prescribed.
Abcess at L arm injection site; febrile, redness, swelling, warmth, hard; treatment: Augmentin
Swollen, sore, redness over 3 inches in diameter with itching at injection site-remains unchanged to date.    Fever, aches, leg cramps lasted 30 hours.
12/23-12/25 immediate localized injection site reaction.  12/29-1/6 delayed type hypersensitivity, rubor.  1/6 treatment started, methylprednisolone.
Developed hard, painful knot at site of injection. Recommended to ice intermittently, pain improved some. Next day developed extensive bruising without pain on upper arm and knot became less painful and smaller.
vaccine was given to  patient that was supposedly expired with no reported adverse event; Initial information received on 06-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Global Media Information (under the reference 00714462).  This case involved a 11 years old female patient who was given an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was supposedly expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (lot and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination..  On 29-Sep-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot U5654AA and EXP: 04/27/2017) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine use (same day latency).  It was reported that "patient was administered Adacel intramuscularly into the right lower thigh on 29 Sep 2017. The lot number for the Adacel was U5654AA. The expiration date that was recorded was 27 Apr 2017, which, if correct, would mean that the patient had received an expired dose of Adacel. However, the reporter thinks that the expiration date may have been recorded incorrectly, and the Adacel might actually have had a later expiration date. Reporter was calling to check and see what the expiration date is for Adacel given lot".  At time of reporting, the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Started having pain in arm within 5 hrs, had fever of 102 deg F by 12 hrs went up to 103.5 deg F, chills, body ache, HA, nausea lasted for 72 hrs.
On DAY #6:  Swollen left arm with large, red, itchy whelp at site of injection.  Lymph nodes on left side are swollen and sore.  Felt a little excessive low energy.  All cleared up by DAY #10.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-NOV-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a hospital (did not specify whether admitted; therefore, considered Emergency Room visit until follow-up is received) for the onset of varicella pneumonia which is caused by the varicella zoster virus. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, varicella pneumonia was considered to be a medically significant event. Additional information has been requested.
1 hour after vax pain in left arm started along with inching and "dots" broke out around injection site all the way to the elbow, hand feels like its asleep all the time, throat feels swollen
This case was reported by a consumer and described the occurrence of autism in a 8 year old male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. Medical history included gluten free diet. On 5/17/97, the subject received the second dose of Engerix B (lot # ENG2118A2). Approximately eight years after vaccination with Engerix B, on an unspecified date on or after 4/14/05, the subject was diagnosed with autism. The autism was ongoing at the time of initial reporting, 7/13/05. Comment: autism was assessed as medically serious (OMIC).
Developed "COVID Arm" 8 days post injection. Was diagnosed and treated as Cellulitis.
Experienced tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Experienced tenderness) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Drug allergy (Allergic to various medications) and Allergy NOS (Allergic to things outside).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (Experienced tenderness). On 15-Feb-2021, TENDERNESS (Experienced tenderness) had resolved.            Patient was not under any concomitant or regular medication.  It was reported that the patient experienced tenderness on the day of vaccination, and it lasted for about 1 to 2 days approximately. Patient did not had COVID positive test or diagnosis.  No treatment was given.   This case was linked to MOD-2022-492310, MOD-2022-492314 (Patient Link).
Evening of immun, pt ran temp of 103.6F, exp loss of appetite & soreness in the legs where shot was recvd; Parents took pt to ER where they were instructed to double dose of APAP & give cool bath; Mom had Lyme disease during pregnancy;
I have been sick for a week. Got my first vaccine 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago) 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 ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago). At the time of the report, ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medication reported.
Bitter taste in mouth - food, licking lips/fingers, taking chewable medicine. Approx 12 hours after injection
03/29/2021 at 02:00 AM awakened by Apple watch notifying me that my heart rate was dangerously high at 220, then sweating, deep breaths and monitored my condition, checked my heart rate watch until 87 or so and went back to bed. I noticed that a month later 04/24/2021, I started noticing my heart rate more frequently became high, randomly raised. 07/27/2021 I had a bad episode that would not adjust to normal and on the verge of consciousness, called urgent department and could not be seen until 07/30/2021, was seen advised to see a Cardiologist referral.  Saw Cardiologist twice and have periodic follow- ups.  Monitoring and gaging the episodes.
ICC Note-presenting today for Sore Throat (coughing, headache, chest tightness, onset: 2days )
Vaccination failure; COVID-19; Vaccine brand other: Moderna/vaccine brand: Pfizer / BioNTech; 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 56-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Ee8727), on 16Apr2021 as dose 2, single (Lot number: Er8735) and on 06Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02May2022 as dose 4 (booster), single (Lot number: 057m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper cholesterol" (unspecified if ongoing), notes: other medical history: Hyper cholesterol; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: SIMVASTATIN. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin", notes: known allergies: aspirin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02May2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine brand: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (19Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was Adult (18-64 Years). Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 07Dec2022 to 12Dec2022 for Covid-19. Cold- like symptoms and positive lateral flow test on 19Dec2022.
I?m not entirely sure if what?s going on with me is in fact from my vaccine, but feel it is. I did get the rash at the injection site and a sore arm but not severe. It?s what started 2 days later and continues now 8 days later. I woke with red itchy pimple like sores on both upper legs, they have now come on both legs, my neck and cheek along with my arms & torso. Some seem like water blisters and others more welts  Holiday weekend & haven?t heard from my MD I?ve read some who have Covid19 have presented with such sores but would like to know are others having my symptoms?  Should I be worried about 2nd dose
Engerix-B administered after temp excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B 10 mcg) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 13th February 2023, the patient received the 2nd dose of Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The clinic manager stated that the Engerix-B was exposed to 30.9 F for 4 hrs, 30 minutes and was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional supportive information: The vaccine was exposed to 30.9 F for 4 hours, 30 minutes, which led to incorrect storage of vaccine. Note: Engerix B 10 mcg was not coded as Pfs as its is not available. The case had been linked with US2023025429 and US2023025426 reported by same reporter.; Sender's Comments:  US-GSK-US2023025426:Same reporter - Engerix B case US-GSK-US2023025429:Same reporter - Engerix B case
Patient contracted COVID after being fully vaccinated Presented on 9/14/2021 to ER with complaints of SOB, cough, fever for two weeks.
Headache; Nauseous; Fever; Chills; Have some pain at the injection site; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Lot Number: ER8731) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I had a question, I got my first COVID Vaccine yesterday (14Apr2021 ), it is a Pfizer shot and last night I had side effects like I have a fever, I have chills and stuff like that but I feel fine now. I just want to make sure if it safe to go to work, can I make people sick as I had fever last night."When paraphrased the above concern, consumer stated, "Yes, I feel fine right now, it was just last night." When again probed for side effects, the patient stated, "Fever, chills and I had a little bit of headache this morning (15Apr2021) too. I was feeling little nauseous this morning (15Apr2021) as well and I have some pain at the injection site." The outcome of events was recovered in Apr2021.  No follow-up attempts are needed. No further information is expected.
100F fever for around 18 hours or so. Typical fever symptoms such as pain in limbs and nausea. Generally disabling and had to call off school.
pt recv vax w/in 10min raised, red area around site;given DPH in lt arm advised to remain in lobby for 20 more min;c/o tightness in throat;advised to go to ER;
Patient was recently adopted, she has HIV and was here to receive vaccines. Per our infectious disease dept, she was supposed to receive Tdap, flu, PREVNAR and MMR. The nurse gave KINRIX instead. Patient had no known adverse reaction to this vaccine.
pt recvd vax & devel a markedly swollen arm from the shoulder to the elbow which was warm to touch & red;devel flu-like sxs & diarrhea;arm looked like as if had cellulitis & was hosp overnight;tx included ciprofloxacin;resolved w/in 4-5 day
Fever, Chills, Sweating, Sleeplessness, Sick to Stomach, Diarrhea, Body Aches, Sore at the injection site
Febrile seizure, turning red and unresponsive 24 hrs (1 day) after vaccines received. Given rescue breath by grandmother - patient became responsive. Admitted to hospital same day with normal EEG and evaluation; normal labs. D/C home next day.
Upper stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Upper stomach pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Upper stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Upper stomach pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.   This case was linked to MOD-2021-307921 (Patient Link).
10 days later got shingles; Worst pain i ever had; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had worst pain. The patient ever had got the new vaccination and 10 days later got Shingles. Additional supportive information:  Follow-up would not possible as no contact details were available.
no adverse event; patient received PROQUAD instead of MMR II; patient received PROQUAD instead of MMR II; This spontaneous report was received from a medical assistant referring to a 30-year-old female.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 27-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, (lot #U029319 has been verified to be valid, expiration date 19-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age), instead of received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered) this was supposed to be her first dose of the M-M-R II vaccine. It was reported that the patient had a previous positive varicella titer but it was unknown if she had natural immunity or vaccine-induced immunity. No adverse event was reported.
This spontaneous report from a contactable medical assistant on behalf of the medical office. A 86 year-old Caucasian female patient received PREVNAR 13, lot number M51194, expiry date 01May2017) intramuscularly on the right deltoid on 01Mar2016 at 14:54 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced weakness, fatigue and arm pain on 01Mar2016. No swelling, heat or redness to the arm occurred. The patient did not recover from the events. The doctor did not express if the events were related to the PREVNAR 13. Follow (01MAY2016): Follow-up attempts completed. No further information expected.
pt had high pitched, hoarse cry & was congested;pt was not eating well & mom took pt to hosp ER 24MAR99;
Achy; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood pressure management. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Achy), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            Other concomitant medications included blood pressure and thyroid medicines. The patient did not take any medication for the symptoms.
head cold; tested positive (rapid) for covid Saturday; tested positive (rapid) for covid Saturday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 at 10:00 as dose 2, single (Lot number: EN6855), in left arm and on 17Aug2021 at 15:00 as dose 3 (booster), single (Lot number: EW0178) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALLOPURINOL, start date: Jul2014; OMEGA 3 [FISH OIL], start date: Jan2021; TYLENOL ARTHRITIS, start date: Jan2021.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 16Apr2022, outcome "not recovered" and all described as "tested positive (rapid) for covid Saturday"; NASOPHARYNGITIS (non-serious) with onset 27Apr2022, outcome "not recovered", described as "head cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive; (16Apr2022) Positive; (24Apr2022) Negative; (25Apr2022) Negative; (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, nasopharyngitis. The patient tested positive (rapid) for covid on Saturday 16Apr2022 and the patient received treatment with anti viral Paxlovid from 16Apr2022 to 20Apr2022 for covid-19. And tested negative (rapid) the following Sunday 24Apr2022 and again on the Monday 25Apr2022. Symptoms having largely disappeared. Then developed head cold after 2 days on 27Apr2022 and now test positive for Covid (rapid & pcr). The patient received treatment with sudafed / Tylenol. No Known allergies.