chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid Virus; Tested positive for Covid Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No other vaccine in four weeks. No covid prior vaccination and covid tested post vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "not recovered" and all described as "Tested positive for Covid Virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient presents after a near syncopal episode. Was at work when she felt dizzy, nauseous and flushed. Felt like she was going to pass out. Patient appears pale and uncomfortable, but nontoxic. She is tachycardic but blood pressure stable. Has a faint erythematous rash on her neck. Give IV Benadryl, IV solu-Medrol and IV fluid in Emergency Department. Basic labs were obtained and are unremarkable.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient was experiencing redness and a lot of swelling at the injection site following administration of BEXSERO. The reporter agreed to be contacted for follow up via mail. No other specifics were provided.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose). At the time of the report, VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose) outcome was unknown.            No concomitant medication was reported.  No treatment medicine has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter information and vaccine information is updated.
1 day after 2nd dose noted headaches, eye pain, photosensitivity, chills, low appetite which have persisted to 6 days post-vaccine.
My lymph nodes were extremely swollen in my neck, collar bone area, elbows and shoulders.  I had the shot in my left arm but both arms were very sore and weak.  I could not talk for two days due to the swollen lymph nodes (no sore throat).  Had the usual fever, chills and aches and paid from the second shot but this was over and above those "normal" side effects.  It is 12 days out and I am still "sick" and have been tested twice for covid 19 with both test results negative. Have any side effects this far from the shot date seems very abnormal from all information on the Pfizer shots.
From mailed correspondence received on 03/11/02 regarding a 59 year old received Influenza (Fluzone SV '01-'02) vaccine on 10/18/01 at 4 pm, it was reported by the patient that on 12/24/01 he developed rapid onset flu symptoms consisted of 103.5 degree F fever, chills, sweats. Patient did not see a physician. Strain of Flu was not confirmed by culture. These symptoms are currently unresolved. Patient receive vaccine at local Osco drug store. Additional information received on 03/11/02 from mailed correspondence patient reported that he developed flu symptoms on 12/2/01. He developed fever (103 degrees F orally), chills, sweat, body aches, light cough and no nasal discharge. Symptoms lasted above 4 days easing. Flu not confirmed by culture. Patient recovered. The case is closed.
large inflammation between my shoulder and the base of my neck/ shoulder; very tender; It's soft, and it looks like a mass area; Shoulder pain; pain in the arm where I had the injection; in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area) and ARTHRALGIA (Shoulder pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.). On an unknown date, the patient experienced INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection). At the time of the report, INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection) outcome was unknown.            The patient had pain in the arm where had the injection she expected that. On Saturday morning, in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder. it was significantly swollen. It looks soft like a mass area were  tender. Concomitant and Treatment medications details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: F/U received on 08-NOV-2021: New events added, patient demographics updated.
Screeching cry x 1 1/2 hrs, leg red & swollen;
This is a spontaneous report from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose in Nov2016 (3 weeks before this report) for immunisation. The patient medical history and concomitant medications were not reported. In 2016, after I received Prevnar 13, he caught a cold, although not initially. He was in a closed car with a guy that was sneezing all over me. He got a fever but he was getting stronger now. The outcome was unknown. He queried when can it get the flu vaccine and the Shingles vaccine.
By noon 12/15/04, felt nauseated with a mean HA, took ibuprofen. 0200 12/16/04, vomited; 0500 18/16/2004 felt like my head was going to burst, 1100 12/16/04 unable to get out of bed, chills, diaphoretic, dry heaving- drank Gatorade darkened room, 12/17/04 still had HA 12/18/04 HA resolved.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003724, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
Around noon I started to feel extremely tired and by 2 PM I had severe chills and a headache and felt really weak.  It is very warm today and I feel so cold despite that.
Pt was brought in by mother who asked that she received the Moderna first dose, information was entered in the system and screening questions completed, countermeasure provided,   All went well, Vaccine given to pt. in left arm Lot # 035C21A, once writer was entering the vaccine given and to choose the arm, system failed/ shut down.  I restarted and re-entered all information and thats when the computer stated pt. under 18 could not receive vaccine at this site.   Floor Manager contacted regarding same, report written, mother signed consent and screening on paper.
On day five after getting my first shot, I started having bad lower back pain (flu like).  I applied heat locally to relieve my symptoms. On day 7, I noticed a cluster of blisters on my back adjacent to my spine. The blisters rash spread around my waist on my right side and by day 11 I had a positive diagnosis for shingles.
pt recv vax; infant found lifeless in crib on the am following the day of vax; no premonitory signs or sx reported;autopsy revealed SIDS;
Initial report was received from a healthcare professional on 20 January 2012. A patient (age and gender not reported) had received an Intramuscular (IM) injection of ADACEL; sanofi pasteur lot number C4023AA in left deltoid on 16 January 2011. On an unspecified date, the patient left axilla became swollen and tender; with five to ten pain levels. No further information was available at the time of this report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Lips began to swell and throat felt as though there was something stuck in the back of my throat for over 8hrs. Was able to breath, cough and swallow
The morning after I got the vaccine, I felt very tired. Within two hours of waking up, I felt body aches all over. After another hour or two, I felt a massive headache behind my eyes and around my head. It felt like I was hit with a brick. I also felt nauseous on and off. On March 10th, two days after the shot, I woke up around 6am soaking wet in sweat. My hair, clothes and blankets were drenched in sweat. The bodyaches and nausea were gone by this date. The headache lasted a whole week.
Rash on left/right arm and  to lower ribs. Continues to spread to right wrist. Consulted MD and was prescribed mometasone furoate0.1%. Has helped some but hasn't cleared completely.
Fever and severe chills and body aches. Definitely flu symptoms. Lasted 24 hours, then I gradually started feeling better. By the third day I feel normal, but a little tired.
green bret syndrome and he died from it; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious social media case from a consumer.  This case is linked to case 2021SA003660 (same reporter).  This case involves male patient (of an unknown age) who had green bret syndrome and he died from it (Guillain-Barre Syndrome) after receiving NFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious green bret syndrome and he died from it (Guillain-Barre Syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome was reported as fatal for the event Guillain-Barre syndrome.  It is unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome.  Information on the lot number was requested.; Sender's Comments: This was a poorly documented social media case involves male patient (of an unknown age) who had Guillain-Barre Syndrome and died from it, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: green bret syndrome
Vomiting, fever, chills x36 hours; started post 12 hours from shot. 7 days arm still sore at site.
Per grandmother, pt had a seizure in the back seat of car 2 1/2 hours after flu shot & Hep A shot given. No fever.
Unwell; headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy). At the time of the report, MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy) outcome was unknown.
A physician reported that a 25 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/17/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103.
Patient came in for a check up and immunizations.  She had a fever of 100.7 and had vomited once the day before.  She also had a runny nose for one day.  Approx 8 hours later, baby had a fever to 103.5 and had febrile seizure lasting under 5 minutes.
3/30 untill now I have experienced pain in my arm on 3/31 and 4/1 experienced low grade fever.  4/3 experienced diarrhea (unsure if its related) on 4/4 theres a red rash on my left arm near vaccination site. Hurts to the touch and feels hot
COVID-19 virus test positive on 10-Jun-2022; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 virus test positive on 10-Jun-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety, Depression and Asthma. Concomitant products included LAMOTRIGINE and FLUOXETINE HYDROCHLORIDE (FLUOXITINE UNIMED) for Anxiety and Depression.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced COVID-19 (COVID-19 virus test positive on 10-Jun-2022). At the time of the report, COVID-19 (COVID-19 virus test positive on 10-Jun-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2022-689923 (Patient Link).
Patient came in the pharmacy 1 week after she received her  Pneumonia vaccine stating  she couldn't lift her arm and shoulder pain same night she received her Pneumovax on Nov 4th which progressed every day until Nov 7th pt started with stomach cramps and little nausea. Nov 8th along with stomach pain and nausea pt started bad pain in her rib cage and pain in rib cage progressed until 11/13/19. I spoke to patient  today and she stated rib cage pain is getting better but still pt experience pain here and there every day.
This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
It is Monday 4/5/2021 day after Easter.  Vaccine was not pulled from freezer for today.  Vaccine was pulled at 8:35 to 8:40 am to thaw at room temperature. All 20 customers for morning clinic were called to let know clinic delayed until 9:30 am at time, but since vaccine needs 1 hour to thaw, the first vial was not drawn until 9:45 am.  A husband and wife was called in to get vaccine originally scheduled for 9:15 am to get vaccine. The husband was 1st.  The wife, was second.  She was afraid of shots and did not want to see needle. I only had a 1 and one-half inch needle drawn. So I asked if she was ok with me drawing vaccine in front of her. She was ok. I got the 1 inch needle ready with separate syringe and drew up vaccine . I forgot to draw the vaccine because I went to give shot in left arm and vaccine plunger did not move. I looked at plunger, and it was at bottom. I realized my error. So I informed patient.  I did not put band-aid on at first as well. She did notice a drop of blood. So I placed a band-aid on her arm.  She was ok with me giving the shot in right arm at 10:15am .  She was ok.  Vaccine  is accounted for with no extra plus I'm very confident no vaccine was given in left arm.   I called her to see how she was doing.  She was fine and cheerful.  I also clarified her prescriber name to let them know.  I told he if she has any questions let us know.
Patient was given his 2 mo, vaccines at 3wk 5d old. No adverse event occurred.
Woke up about 3am on 23rd with body aches, chills, headache.  Had to leave work early that day due to inability to work.  Woke between 1-3:00 am on the 24th with large hives over entire body, each hive with burning, itching and pain and all of my joints were very painful.  Continued to have very bad headache also.
3 hrs after injection of Pneumovax patient developed pain, redness and swelling to a large area of the RT deltoid.  Area of swelling is improving but still present after 48 hrs of local treatment with ice packs.
Pruritic rash  of legs and torso which started  about 10-14 days after 2nd vaccine shot. No other symptoms. Has not resolved with oral and topical steroids  and  Benadryl after 2 weeks.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 20-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and Hepatitis A Vaccine, Inactivated (VAQTA) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Stroke with right upper extremity weakness.  Weakness improved, has mild residual weakness at this time.  That still may improve in the coming months.
We had not received our stock of bivalent Pfizer booster for age 5-11 year old's. Explained  to the family that they would need to wait until the bivalent booster came in. Parents were very adamant that they wanted to still receive the monovalent booster and that they did not want to wait for patient to receive his COVID booster until the bivalent came in. They were wanting the vaccine even though it was the monovalent. Staff was never communicated what to do in the situation that the parents were actively requesting the monovalent over the bivalent booster. Patient was not harmed.