chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced injection site pain.  On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.
pt recv vax 16APR98 & broke out on face 29APR98 & 30APR98 & all over body measles-like rash all over body;
received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Dec2020 at the first single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received first dose of covid vaccine on 19Dec2020 tested positive on 31Dec2020.  The outcome of events was unknown.  Information about Lot/Batch has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
Left Arm is itchy and red and has a large patch. It is also warm to the touch
Dad states patient had an allergic reaction to the ADACEL (Tdap) redness, swelling & itchy - approx 15-20 cm of redness. Has applied cold compresses & improving. No wheezing or difficulty breathing. Dad wanted reaction noted in chart.
Left arm with 2 cm diameter erythematous lesion on upper arm. Treatment: cool compresses, monitor.
Confusion; Circumstance or information capable of leading to medication error.; administer Rotarix by injection; to administer Rotarix by injection; This non-serious case was reported by a physician via call center representative and described the occurrence of product packaging confusion in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral). On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced product packaging confusion (Verbatim: Confusion), circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error.), inappropriate route of vaccination (Verbatim: administer Rotarix by injection) and wrong technique in product usage process (Verbatim: to administer Rotarix by injection). The outcome of the product packaging confusion, circumstance or information capable of leading to medication error, inappropriate route of vaccination and wrong technique in product usage process 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:24-MAY-2023  Reporter was the healthcare professional(HCP).Reporter stated that her nursing staff mentioned confusion over the presentation of the Rotarix vaccination compared to other GlaxoSmithKline products.  Reporter stated product was a syringe with gray luer-lock cap and they have three other GSK vaccines that come in syringes that look similar.  Reporter was concerned about nursing staff possibly placing a needle on syringe and attempt to administer Rotarix by injection.  Reporter mentioned potential medication errors due to this event. No Product quality complaint filed. Adverse Event filled.  The reporter consented to follow up. The nurses reported confusion in packaging which may led to administration of Rotarix through injection which led to product packaging confusion, circumstance or information capable of leading to medication error, inappropriate route of vaccination  and wrong technique in product usage process.
Where the injection site was (left thigh) it was red/raised and was sore to the touch. On 3-21-12 I noticed some red spots on face and chest. She had a fever in the evening that lasted on and off through 3-22-12. Called the doctors office on 3-22-12 who instructed to continue to give Motrin (every 8 hours) and Tylenol (every 4 hours) for the fever and use an cold wash cloth for the swelling. Today 3-23-12 I have noticed the rash starting to disappear, the fever to be gone and the redness on her leg starting to go away.
I tested positive for Covid after my J&J vaccine.  I had blood in my urine before testing positive to Covid. I had a virtual telemedicine and was told it also probably a bacterial infection in the blood. On 03-14-2021 I was to have knee surgery but had to postponed it due to I having Covid. I tested positive for Covid on 04-01-2021. I was prescribed Doxycycline for ten days. Today I still have blood in my urine ad I have messaged my doctor for a call back.
pt recv vax 28FEB96 & pt exp pain in both knees;pt seen by pvt MD & was treated w/NSAID;
Within a few minutes waiting in the car I was dizzy. Then for three days I had fever muscle aches headache ringing in the ears and fatigue. Currently on day eight and I still have vertigo, ringing in the ears and fatigue.
shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-JAN-2022.The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around April 2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly, after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles. As direct and proximate results of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX), also the patient experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zoster Vaccine Live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX) wrongful conduct, patient 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. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of shingles was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The event shingles was considered to be disabling by the reporter.
Red, blotches on arms, trunk, with itching. 2-3 day time frame, no Tx, spontaneously went away.
This case was reported by a healthcare professional and described the occurrence of axillary arm pain in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given on 2 October 2012. Concurrent medications included TUBERSOL. On 2 October 2012 at 08:30 the subject received unspecified dose of BOOSTRIX (.5 cc, unknown, left arm). On 4 October 2012, 2 days after vaccination with BOOSTRIX, the subject experienced axillary arm pain. The subject is a staff member who was vaccinated on 02 October 2012 and complained of pain in her left axilla area that has moved around to the front. It started two days after the vaccination and has become worse each day especially at night time. The reporting healthcare professional did not think it was related to the vaccination. The reporter was unsure if the subject received a hepatitis B vaccine on the same day, if she was given the hepatitis B vaccine it was a GSK vaccine. At the time of reporting the axilla arm pain was worse. The healthcare professional considered the event was unrelated to vaccination with BOOSTRIX.
Approximately 10 minutes following vaccination, I began feeling very itchy on arms, head, back of neck.  No rash.  Took Benadryl itching became better.  After approx 3 to 5 days, began experiencing axillary lymph pain on side of  vaccine (left arm) and continued to experience intermittent itchiness in various areas throughout body.  On the evening of the 7th day, a raised red spot about the diameter of two quarters side by side appeared.  Axillary pain  continued.  On 8th & 9th days, red spot was warm and increased in size, color  has now become less bright.  I continue to experience axillary pain and intermittent itchiness.   Should I receive 2nd vaccine?
CoughWheeze  ON 4/23/21 DEVELOPED SEVERE BRONCHIAL COUGH, WITH WHEEZING NO HX OF ASTHMA STATE HAD COUGH WITH FIRST DOSE ALSO  Narrative:  ON 4/23/21 DEVELOPED SEVERE BRONCHIAL COUGH, WITH WHEEZING NO HX OF ASTHM STATE HAD COUGH WITH FIRST DOSE ALSO, PLACED ON ALBUTEROL INH AND TESSALON CAPS
Fever and irritable x 3 days onset 2/18/12 also hyperactivity.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Multivitamin medication in 2 weeks vaccine. Treatment of COVID-19 with Paxlovid, started from27Jul2022 to 01Aug2022.  No follow-up attempts are possible. No further information is expected.
EXTREMELY SWOLLEN, RED, AND HOT TO THE TOUCH, FATIGUE, FLU LIKE SYMPTOMS, HEADACHE.
I had mensural bleeding or spotting every day for 6 weeks. Then I went for 3 months I went without a period.
Broke out with fever 5 days ago & a fine rash - scattered on trunk. Still had fever when she came in on Monday 9-27-10.
AKI, abnormal LFTS, lactic acidosis, elevated PT/INR 1 week post covid booster
A pharmacist reported that a 74 year old male consumer started ZOSTAVAX (expiry April 2012), 0.65 ml once, on 09-MAR-2013. The patient's relevant medical history concomitant medications, and past drug history, concomitant medications, and past drug history were unknown. On 09-MAR-2013, he was immunized with an expired dose of ZOSTAVAX, this was administered by a pharmacy student. According to the pharmacist, he was not experiencing any adverse reactions. His relevant laboratory data is unknown. As of 12-MAR-2013, it was unknown if he will continue to received ZOSTAVAX. The outcome of the patient's immunization with an expired dose of ZOSTAVAX was unknown. Additional information has been requested.
Site: Pain at Injection Site-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient called the pharmacy on 05/15/2023 complaining that he cannot lift his arm- said he started to get pain in his shoulder/arm starting the evening of 05/06/2023 and it just continued to get worse to now he struggles to put a shirt on and cannot lift his arm to wash his hair. Also states trouble sleeping at night due to pain at night.
they had multiple vaccine MRNA-injured people in her family; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: INJURY (non-serious), outcome "unknown", described as "they had multiple vaccine MRNA-injured people in her family".  Additional information: The caller said that they got an advertisement in the mail from (Withheld mail) from Pfizer. The caller would like to opt out of the advertisement that she got through mail. The caller refused to provide her email address and phone number. The caller stated that they had multiple vaccine MRNA injured people in her family. I created the manual AE form because the caller stated that they had multiple vaccine MRNA-injured people in her family including her husband.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300182139 same drug /event different  patient;
Swelling of the right index finger/associated fingers on the his right hand also swelled up; Extreme joint tenderness; Injection-site soreness/the pain level was a 7 or 8; The tenderness and swelling of his right index; This case was reported by a consumer via call center representative and described the occurrence of swelling of fingers in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th July 2020, 3 hrs after receiving Shingrix, the patient experienced swelling of fingers, joint tenderness, injection site pain and pain in fingers. On an unknown date, the outcome of the swelling of fingers, joint tenderness, injection site pain and pain in fingers were not recovered/not resolved.   It was unknown if the reporter considered the swelling of fingers, joint tenderness, injection site pain and pain in fingers to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experiencing swelling of the right index finger, extreme joint tenderness, and injection-site soreness after receiving their first dose of the Shingrix vaccine. The patient received the shot at Pharmacy, and around 5pm that same day was when the adverse reactions occurred.  The patient reported that his associated fingers on the his right hand also swelled up but there was no point tenderness that occurred like in his right index finger. He reported that the pain level was a 7 or 8 on a scale of 1 to10. The tenderness and swelling of his right index finger started 3 hours after the injection and the reaction was improved today but still was unresolved. The adverse reactions were not resolved, and had same like that for the past 2 days. The reporter consented to follow up.
First dose of Moderna was on  March 22, 2021 - Left Arm.  Minor body pain lasted 2 days.  Minor gastro reaction two hours after administration.    Second dose of Moderna was on April 19, 2021 - Left Arm.  No immediate reactions.  Waited for 30 minutes at clinic site then released home.  Next day - fever, body aches, nausea, "flu like" sickness which lasted 4/20/21 and 4/21/21.  Back to "normal" on 4/23/21.  Allergic reaction (severe hives) started the morning of 5/1/21.  Used claritin and Benadryl with no improvement.  Hives increased in severity.  Went to urgent care on 5.5.21.  Told to use Benadryl at night and Claritin in the morning.  Also prescribed Prednisone 60 mg for 5 days (take it if symptoms do not improve).  I waited 2 more days and filled (and started taking)  the Prednisone  on 5/8/21.    Severe hives and itchy rash all over my body continued (including on my face, in my ears, and under eyelids).  Scheduled an appointment with PCP provider on 5/11/2021.  Prescribed different histamine prescriptions Famotidine 10 mg and Desloratadine 5mg.  PCP recommended allergy shots and will refer for that if symptoms have not improved.
This employee sent me an email on 12/23/20.   "Subject: Re: Attention Covid Vaccine Volunteers  Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional  symptoms.     I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails.  I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB>   She sent me this email describing the reaction: Here explanation of the reaction:     Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January.   following up:   I received my shot at 8:15 am, within approximately  45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day.   At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches.  I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not.  Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours.   Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night."  I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
normal sore arm, but also swelling in right axilla and into right breast only after booster shot, no symptoms with other 2 vaccines
Following morning woke up with headache and excessive vomiting; Following morning woke up with headache and excessive vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), HEADACHE (non-serious) all with onset 20Oct2022 at 07:15, outcome "unknown" and all described as "Following morning woke up with headache and excessive vomiting". Therapeutic measures were not taken as a result of vomiting, headache.  Additional information: Patient had no known allergies. Patient was not tested COVID post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt evaluated by neurology, sx reported suspected to be due to demyelinating lesion. Right side numbness.
Hives.  First appearance was on her stomach/front torso at 4:00am on 12/5/21.  Cleared up with Benedryl, but reappeared later in the day (12/5/21) on her back.  Have continued to appear and move around her torso on each subsequent day.  The patches of hives appear to be getting smaller each time they reappear and they are managed with Benedryl and hydrocortisone 1% cream.  Had to leave school on 12/6/21 but the rest of the week she?s been able to stay at school.  Had a  consult with her pediatrician  on 12/6/21 and she felt the hives were likely due to the recent vaccine, but there is no way to link the hives to the vaccine for certain.  No other exposures that could have caused the hives are thought to have occurred.
Patient c/o difficulty breathing 20 minutes (10:33 AM)after receiving her first dose of Pfizer vaccine. She reported hx of anaphylactic reactions to Motrin and dermatographia. Vital signs initiated immediately, encouraged deep breathing exercise, water and ice pack were provided. At 10:36 AM, hives were noted on the face where she had mask on before. Client was given Benadryl 25 mg oral as per standing order. Extended observation for an additional 15 minutes. The hives disappeared after 10 minutes. Patient verbalized relief of difficulty breathing, Vital signs were normal, and left the site accompanied by her husband.
Administrative deviation only; no adverse event resulted from this deviation. This patient received a mixed series of COVD-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date of the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due. We understand that although CDC provides considerations for a mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting. Note second vaccination date is listed.
This spontaneous report as received from a nurse refers to a 13 year old patient. On 20-NOV-2015, the patient was inadvertently vaccinated with a dose of adult formulation of VAQTA (lot# L017757 and expiry date: 08-APR-2018). No adverse effects were reported. Additional information has been requested.