chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; dizziness; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the headache and dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported to having headache and dizziness two days after receiving the second dose of Shingrix vaccine three months ago. The symptoms had not resolved.  The patient wanted to know if the symptoms were related to the second dose of Shingrix vaccine. The reporter did not consent to follow-up.
Patient was here with mom for second dose Moderna vaccine. Approximately 90 seconds after administering the vaccine patient began coughing and choking.  His face turned red and cheeks were a little puffy.  Dr was immediately brought into the room and evaluated patient.  Oxygen was 90% so blow-by oxygen was given via Ambu bag since facemask was not available.  No wheezing heard  per Provider. No medication was administered.  After approximately 4 minutes of blow-by oxygen patient was maintaining an oxygen saturation of 98% on room air.  There was no oral swelling per provider so patient was brought to the emergency room by mom escorted by this RN and MC for further evaluation and monitoring.
Eyesight in right eye -- floaters and light flashes when blinking, to date it hasn't subsided.  In June and to date, chronic constipation -intestinal motility unrelated to diet or Bristol chart type of feces.  Neurologically suspected, pending further diagnostic testing.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 30-MAY-2018, the patient was vaccinated with a improperly stored ROTATEQ (which had a lot # of N032567 and an expiration date of 10-MAY-2019, per oral; however, dosage number were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unknown date: 47°F to 77°F for 24 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507512-1807USA013076.
HEMORRHAGIC RASH, PROFOUND FATIGUE, WEAKNESS, DIZZINESS NEAR SYNCOPE, NAUSEA.
experiencing moderate to severe frozen shoulder syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient 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. Vaccination history included: Bnt162b2 (I have only received Pfizer vaccines and have received every shot offered since 2020 by Pfizer), for Covid-19 Immunization. The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "experiencing moderate to severe frozen shoulder syndrome". Clinical course: The reporter stated, "Can you please provide me with the side effect profile of all Covid-19 vaccines and boosters. I have only received Pfizer vaccines and have received every shot offered since 2020 by Pfizer. I am experiencing moderate to severe frozen shoulder syndrome".    The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient reports her arm was sore for 3 weeks after vaccine administration. Patient also pointed to sight of administration. The skin at this site looked discolored, rough, irritated. Patient says site no longer hurts now.
Lump found above left collarbone. Painful, tender to touch.  Have an appt with my PCP 1/13 to be assessed.
Patient felt dizzy at 8:30 am after receiving her first Moderna vaccine. BP 110/62 Pulse 60, Resp. 18. Patient was observed by nurse in waiting area until her symptom resolved. Patient then left the clinic after she began feeling better shortly after.
I started with a cough, and it kept getting progressively worse and I thought I had a sinus infection They tested for COVID-19 at COVID-19 testing clinic at the Hospital - special part of the hospital. Started taking: Prednisone and another pill for a cough (Perl) - Sudafed and Mucinex on November 2nd. I am a week out and I'm better but still not 100%. Still coughing - but I'm getting better.  I had the flu vaccine - I think in August of 2021. I had that at Pharmacy.
It was 20 minutes after vaccination my throat was closing. I went to the ER and they gave me Benadryl. I had headaches on the crown of my head for four days After the headaches subsided, I was really short of breath after five days and was unable to work. I am normally in good shape. I went back to the Emergency Room and they did more tests which was a week after the vaccine.
Headache, Arthralgia, Fever, NauseaVomiting, arm pain, Narrative:
COVID-19; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, after receiving the first vaccine dose, the patient came down with COVID-19.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was not reported.; Reporter's Comments: This case concerns a patient who experienced a non-serious unexpected event of COVID-19, which occurred after first dose of mRNA-1273 administration. Very limited information regarding the event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
19 days after I got the vaccine my baby passed away in my womb. I delivered her the next evening at 3lbs 11 oz . I have MTHFR gene as well. I am not sure the vaccine caused her death but wanted to provide this information. I also have an 8 year old son with one kidney I received the vaccine as well. (Don't believe vaccine caused kidney).
Minor aches and pains; Headache; Small fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (Small fever). On an unknown date, the patient experienced PAIN (Minor aches and pains) and HEADACHE (Headache). At the time of the report, PAIN (Minor aches and pains), HEADACHE (Headache) and PYREXIA (Small fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information mentioned.
Itching after a week of receiving the vaccine; Inflammation after a week of receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching after a week of receiving the vaccine) and INFLAMMATION (Inflammation after a week of receiving the vaccine) 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 PRURITUS (Itching after a week of receiving the vaccine) and INFLAMMATION (Inflammation after a week of receiving the vaccine). At the time of the report, PRURITUS (Itching after a week of receiving the vaccine) and INFLAMMATION (Inflammation after a week of receiving the vaccine) outcome was unknown.            No concomitant and treatment medications were reported.
Zero Antibodies 2 weeks post second vaccination; A spontaneous report was received from a healthcare, concerning several of his patient who received Moderna's COVID-19 vaccine, they did not develop antibodies 14 days post second Moderna COVID-19 Vaccination  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, prior to the onset of events, their patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. After 14 days, prior to the onset of events, their patient received their second of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.  One of his patients had the second Moderna COVID-19 Vaccine on 26JAN2021, Blood was drawn on 5FEB2021 and sent to Lab. The results came back with zero Antibodies. Other patients had similar results with similar time span No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, Zero Antibodies 2 weeks post second vaccination was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the event (nephrolithiasis) has been provided at this time. Further information has been requested.
Wrong  QR code was scanned at administration - inputting an expired lot number. The correct lot, non expired product was administered to pt. No adverse effects noted.
This spontaneous case reported by a physician, describes the occurrence of headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
tightness in my throat; my tongue has been burning; My tongue, it is irritating; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration on 24Feb2021 10:30 (Wednesday) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date (since Wednesday, 40 minutes later), the patient experienced tightness in my throat, her tongue has been burning (it's not swollen, it's not red, it's not peeling), it is irritating. The doctor instructed her to take antihistamines, and they help a little bit. It was still happening on Friday (26Feb2021). The patient has no other problems. Injection site was fine, there was no swelling, have no fever and no flu like symptoms. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
RIGHT THIGH SWELLING AND PAIN 1 DAY AFTER RECEIVING IMMUNIZATIONS.  tHIGH WARM AND TENDER TO TOUCH. PROBLEM IS OF MILD SEVERITY
No further AE.; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 01-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, one time, lot #w029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) which temperature excursion occurred. No further adverse event (AE). Temperature excursion occurred on 02-AUG-2023 and 04-AUG-2023.
First 2 days I had high fever, nausea, vomiting, chills, shaking, migraine, fatigue, and body aches. It is one week after my second injection and I still have severe fatigue, body aches, sore throat, nausea, headache, and swollen lymph nodes.
Patient stated feeling cold on the day after vaccination. Had a temperature of 102 degrees. Patient passed out later in the afternoon on Friday and woke up on the floor. Patient had increased blood pressure at doctor's appointment today (146/?), normally 118/?. Injection site is extremely red and covers most of upper arm, hot to the touch.
Intussusception, projectile yellow vomit, pale, dehydration, lethargic, little response to pain.
lights very bright; Severe head and neck ache.; Severe head and neck ache.; severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); severe body aches (every joint hurt, couldn't move, even yawning hurt, teeth hurt, even finger joints); Nausea; diarrhea; extreme exhaustion; cough; eyes hurt; slurring speech; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 08Mar2021 (age at vaccination was 48 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITINE), ibuprofen (MOTRIN IB), prednisone, aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA 11) and fluticasone all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Mar2021 at 9:00 am, the patient experienced severe head and neck ache, very severe body aches (every joint hurt, could not move, even yawning hurt, teeth hurt, even finger joints), nausea, diarrhea, extreme exhaustion, cough, eyes hurt, slurring speech and lights very bright. 600mg motrin did not help, 1000mg Tylenol for next available dosing time did not work, nothing worked. The outcome of the events was not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
A couple of days after I received the vaccine I noticed painful swollen glands on my neck and lumps on my arm. I was also retaining water badly. Days later I also discovered that the lipoma's I already knew I had, had become larger and painful and had multiplied all over my upper body (mostly on the left side). The pharmacist who I was working with (I am in charge of the vaccine clinics for our organization) was in and he said he wouldn't not vaccinate me until I sought medical attention after feeling the lumps. I visited my doctor before receiving my 2nd dose on 1/17/21 who stated to "just get the 2nd dose at this point" (she advised me against getting vaccinated at the time - but I felt a little pressured due to my job) and stated that she DID NOT RECOMMEND me getting a 3rd/booster in the future. After receiving the 2nd dose, I had more swelling and an increase in the # of lipoma's including some that are still painful. None of these lumps have gone away and I still continue to feel I have swollen glands in my neck.
anaphylactic response; This is a spontaneous report from a contactable consumer (the patient). A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) via an unspecified route of administration on 18Feb2021 08:45 a.m. at the age of 72 years old, at single dose in left arm for COVID-19 immunisation. No other vaccine was received in four weeks. No COVID prior vaccination, no COVID tested post vaccination. Medical history included Parkinson's. Concomitant medication included atorvastatin, carbidopa, flecainide, escitalopram oxalate (LEXAPRO), and metoprolol succinate (TOPROL), all taken for unspecified indication from an unspecified date. The patient previously took codeine and experienced "allergies: Codeine", dextropropoxyphene hydrochloride (DARVON) and experienced "allergies: darvon". The patient experienced anaphylactic response (onset date reported as "13Feb2021", pending clarification) which resulted in emergency room/department or urgent care. No treatment was received for the event. The outcome of the event was recovered on an unspecified date.
My first covid- 19 shot I had on March 27, 2021 with no side effects My second covid-19 shot I had on April 27, 2021. At first I felt find but with in 2 hours I felt fluish but had no fever, I drank plenty of water but felt 'off' the rest of the day. The next day I felt tired and went to work for awhile but came home with in a few hours. I ate chicken noddle soup and took a nap. At 1:00 pm on April 28th I started running a fever of 100 degrees and that lasted till 6:00 am on April 29th.  I took ibuprofen from 4/28 to 4/29. I still feel tired and weak and I have a little 'brain fog'.
Sore arm; A bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Digestion impaired, Depression, Irritable, Hair loss and Memory loss. Concurrent medical conditions included Oil allergy and Reaction to sulfites (Allergic to sulfite or histamine allergy.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication was not reported.  It was reported that patient is taking allergic injections.
very sore arm, full body aches, chills, fatigue  Still happening, but has been  less than 24 hours since vaccination
Information has been received from a physician concerning a "40+" year old female who was vaccinated on an unspecified date with a dose of MMRII (Lot # not reported). Approximately 3 weeks post vaccination the pt developed parotitis. Unspecified medical attention was sought. On an unspecified date the pt "recovered without incident". The reporter indicated that the pt had not been vaccinated at her office, and that there was no way of tracking the pt's previous medical care. Additional information is not expected.
He passed out; His blood sugar was 143; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the right arm on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included hypopituitarism. Concomitant medication included somatropin (NORDITROPIN) taken for hypopituitarism. He passed out (emergency room visit needed) on 17Jan2021, his blood sugar was 143 in Jan2021. Caller stated that her son received his first dose of the Pfizer COVID vaccine on 17Jan2021, stated he passed out. Caller stated they had to drive 3 hours away to get the vaccine and wanted to know that if because he experienced this after the first dose if it would be possible to find somewhere closer to home to get the second vaccine. Caller stated she is in the trial as an adult, that she reached out to her trial coordinator and they told her that they can only administer to persons in the trial. Son feels like maybe there is a drug interaction, caller stated she was not sure about this. Stated after her son passed out, they called an ambulance, states the Medic watched him for about 45 minutes, stated they ran some tests in Jan2021, he did go home that day. His blood sugar was 143 in Jan2021. Heart Rate monitor in Jan2021 she couldn't see so is unsure of the readings. The outcome of the event passed out was recovered on 17Jan2021, of other remain event was unknown.
Three hours after vaccination, patient experienced discomfort (shoulder and arm felt on fire) felt like the shoulder was dislocated. patient almost went to urgent care. Patient could not sleep or find comfortable position. This pain continued at the same intensity for a couple more days, then she called Pharmacy and RPh on duty recommended she take ibuprofen, patient complied but this treatment did not alleviate pain. She went to her PCP that Friday because pain was intolerable, MD found inflammation in upper arm, and said MD said vaccine had been injected into patient's joint, instead of Deltoid muscle. MD recommended patient continue using ibuprofen. Pain in upper arm and shoulder continues to this day 6/19/19, and can only lift arm up halfway, cannot rotate arm yet.
Approximately 4-6 hours after immunization, noted edema, erythema to deltoid (lt). After 24 hours noted superficial erythematous streaking of the skin with lymph node enlargement and tenderness (lt) axillary. Fever 99.6F on 1/24. Symptoms hadn't worsened and was examined with recommendation to cold compress and anti-inflammatory prn. On 1/28/03 TC from pt - symptoms resolved.
Had my second dose of Moderna on Monday 3/8/21 - had routine bloodwork on Thursday 3/11/21 and it threw all my liver function numbers out of sorts.  Retook bloodwork Thursday 4/9/21 and numbers are all back to normal. Wanted to make people aware that they should wait awhile after vaccine for accurate results.
are there any adverse reactions expected due to third dose being given too early, No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age (reported as 6) patient who received 0.5 ml third dose of vaccine IPV (VERO) [IPOL] (lot: N1J45, expiry date: 05-Oct-2019) too early on 22-Aug-2019, via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no concurrent vaccines given  It was an actual medication error due to inappropriate schedule of vaccine administration.  At the time of reporting the patient had no adverse 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 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.  List of documents held by sender: none.