chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parent registered the patient at the mass vaccination clinic while outside of the acceptable age requirement for vaccination.  We were alerted afterwards to this error due to age of patient.
Chest pain, Pericarditis, Atrial fibrillation, Coronary Artery Disease, Non-sustained ventricular tachycardia.
Blood spotting around left nipple (seen in two bralets and tank top- she did not feel any discomfort) appear to have started 5 or 6 days after the shot, on the same side of the body as the vaccine was administered.  She has not started her period yet, but has started light breast development and hormonal mood changes in a monthly cycle. Having heard some odd hormonal/inflammation reactions are occurring in women after the vaccines- I thought this might be one that could be seen in the emerging pubescent girls and so should report it.  I have a personal history of excess sex hormones (high baseline DHEA-S leading to high levels of Estrogen, Progesterone, and Testosterone), so as my daughter- she may also have more hormones than average.
chills; myalgia; fatigue; fever; This case was reported by a nurse via sales rep and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, myalgia, fatigue and low grade fever. On an unknown date, the outcome of the chills, myalgia, fatigue and low grade fever were recovered/resolved.   It was unknown if the reporter considered the chills, myalgia, fatigue and low grade fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had chills, myalgia, fatigue, and low grade fever after vaccination.
Sudden idiopathic hearing loss of the right ear; Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side/Tinnitus; Information was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 22-FEB-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss along with pressure and tinnitus. Plaintiff was diagnosed with sudden idiopathic hearing loss of the right ear and sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side. As a direct and proximate result, Plaintiffs symptoms have resulted in physical limitations not present prior to using Merck's product. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, sustained serious, progressive, severe, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of sudden hearing loss and deafness neurosensory was considered as not recovered. The reporter considered sudden hearing loss and deafness neurosensory to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, sudden hearing loss and deafness neurosensory were considered to be medically significant events.
Sore arm at vaccination site, chills, body aches, headache, sore throat.
Wednesday evening after Monday shot had an extreme HSV-1 outbreak.   Prone to these outbreaks but this one was so extreme involving the entire mouth, sores on inside of mouth, tongue, lips and running down the nerves to the chin.   The outbreak is so extreme decided to report it so others that suffer from HSV-1 can be prepared prior to the shot.  I also had a more severe reaction to the 3rd shot than either of the previous two, high fever, chills, headache, and severe muscle pain for 24 hours.  I did not have an HSV-1 outbreak after either of the previous vaccines - all three have been Moderna.
Initially, flu-like symptoms, then vomiting and then HORRIBLE nervous system issues (anxiety and insomnia) that continue today.
Covid arm - Near site of injection, significant swelling, redness, pain, and itching  8 days after injection
This serious spontaneous case, initially received on 26-Dec-2017, from a consumer, concerns an adult (reported as under age 65) female patient of unspecified age. The patient's current illness Included asthma and concomitant medications were not reported. The patient's vaccination history included annual influenza vaccine. On an unspecified date in 2014, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date (same year), after vaccination, the patient became very sick and was diagnosed with Influenza B (confirmed through unspecified lab tests). It was reported that, the patient was less than 65-year old, at that time and did not receive a strong vaccine that year. The outcome of the event was not reported. The reporter assessed this case as non-serious and causality of the events as related to the suspect vaccine. Case  Comment: Although the event influenza and vaccination failure occurred with a plausible temporal relationship, the causality for the event influenza and vaccination failure cannot be assessed with respect to the suspect vaccine as the case lacks the information regarding the strain of influenza with which the patient was diagnosed with influenza, clinical presentation, detailed investigations (swab and blood culture, immunological tests), immune status of the patient prior to vaccination, concurrent medications and relevant medical history. The company assessed the case as serious (medically significant).
rash, itchy all over 15FEB99 @ 6PM;pred-zyrtec;
Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Had a rash under right breast after 1st dose; PCP diagnosed as fungal infection and prescribed a powder.  Told patient to follow up if she had a reaction after 2nd dose.  itching on injection site arm up to neck and lethargy on day 3 after 2nd dose.
Information has been received from a physician concerning a 14 year old female who on 19-MAY-2007 was vaccinated with the 1st dose Gardasil.  There was no concomitant medication nor pertinent medical history.  Subsequently the patient experienced syncopal episode within 5 minutes.  Blood pressure was 110/70 and pulse rate was 72.  Unspecified medical attention was sought and no treatment was required.  Subsequently, the patient recovered from syncopal episode.  Additional information has been requested.
mistakenly gave an expired vaccine/ no AE; Initial information was received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a Physician via Media Information (under reference- 00892151) and transmitted to Sanofi on 09-Dec-2021.  This case involves a 27-year-old female patient who mistakenly gave an expired RABIES VACCINE [IMOVAX RABIES]. with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 08-Dec-2021, the patient received 1 ml (total) dose of suspect RABIES VACCINE [lot T1B813M and expiry date 07-Dec-2021] via intramuscular route in the left arm for prophylactic vaccination.  It was reported "Caller states that she mistakenly gave an expired IMOVAX vaccination to a patient that is a veterinary student on 08DEC2021. Caller states that she thought the date was 07DEC2021 but it was actually 08DEC2021 and the IMOVAX expired on 07DEC2021. Caller asked for information on how to proceed in this situation. Caller states that she would like to get an answer because the patient will be leaving to return to school soon. Caller asked if IMOVAX was an inactivated vaccine and if she could revaccinate the patient immediately".  It was a case of actual medication error due Expired vaccine used (latency was on same day).  At the time of reporting, 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.
I had moderate cold like symptoms, low-grade fever, runny nose, cough. I tested positive on day two of not feeling well. I emailed my doctor who prescribed Paxlovid. Within 48 hours I started feeling like my old self. I am now back in the gym and working out like normal.
6 hrs after shot I noticed that my tongue was sore as if I had eaten a lot of pineapple. (I have not eaten  pineapple in a while so this was not the cause of the pain) It did not cause problems with airway.  - I had a lowgrade fever 12 hrs after getting the shot. It lasted 48 hrs. It was 99.2 - My entire right arm was in pain for 48 hours. It felt like my collar bone was broken.  - A red itchy rash appeared after the fever broke. It is larger than last time, near the injection site and it  swollen and there is numbness. - Ibuprofen helped with fever but not with pain. Antihistamine does not help with rash.  - the rash continues to get bigger.  I already submitted an adverse event for shot #1
Large knot developed at injection site. Larger area surrounding knot. Dr. diagnosed infection at site of injection.
Vomited x1 approximately 30 -45 minutes after being vaccinated. Immediate recovery
believe, very strongly that it was administered SQ instead of IM no doubt in her mind she was administered the second dose subcutaneously instead of intramuscularly; she believes her second dose was dosed incorrectly (SubQ) and she believes it to be invalid; bubble under the skin; This is a spontaneous report from a contactable other healthcare professional (patient) via Medical Information Team.   A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: Jun2021), via subcutaneous route, administered in Arm Left on 01Mar2021 at 16:00 (age at the time of vaccination was 70 years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic lung disease from 2017 and ongoing. There were no concomitant medications reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramusculary, administered in Arm Left on 06Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. prior Vaccinations (within 4 weeks) and Relevant Tests were reported as no. Reportedly, history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations) were not available. On 01Mar2021 at 16:00, the patient experienced believe, very strongly that it was administered sq instead of intramuscularly no doubt in her mind she was administered the second dose subcutaneously instead of intramuscularly and she believes her second dose was dosed incorrectly (subq) and she believes it to be invalid. On 01Mar2021, the patient experienced bubble under the skin. It was reported that, the reporter was a retired medical assistant who received her second dose of Pfizer-Biontech Covid19 vaccine yesterday and believed that the dose was given subcutaneously instead of IM. the patient also reported a bubble under the skin. She asked what should be done next and asked does she need another dose. The patient asked, what was the efficacy data for 1st dose, since she believed her second dose was dosed incorrectly (SubQ) and she believed it to be invalid. She mentioned strong data coming out of Israel as well. There was no doubt in her mind she was administered subcutaneously instead of intramuscularly and she doesn't know what to do about that. The outcome of the event bubble under the skin was unknown.   No follow-up attempts are possible. No further information is expected.
15 mins after injection: Tingling in the back of my head, sudden dry mouth including tongue, some noticeable difficulty swallowing, heart palpitations. Next day woke up with flu like symptoms: dizziness, fatigue, body aches - every joint in my body hurt with the exception of hands and feet, fever - 100.5, headache. As day progressed,  loss of appetite and nausea. The following day fever reduced to 99.8, nausea subsided but all other symptoms remained. I slept as much as possible and did not feel fit to resume activities for 4 days. The headaches lingered for approximately two weeks.
enlarge nodes Rt axilla, cervical and occipital area. (approx 20 min) fever, chills.
About 36 hours after booster shot I woke up in the night with itchy legs.  The itching disapeared by the morning. On the 11th day after the booster shot my head was extremely itchy during the evening hours, the itching was gone by the morning. The 12th day in the early evening (around 3pm) my wrists were itchy, I noticed I had a single hive. By later that evening around 6pm, my legs began to itch again, this time there were multiple hives.  That evening when I was about to fall asleep I suddenly (within a matter of 5 mins or less) developed a soar throat and then the taste of chemicals in my mouth, my throat was starting to burn. I woke up several times throughout the night to burning in my throat and the taste of chemicals in my mouth and throat that I needed to try to cough out.  The next morning was throat was raw and soar but the chemical taste was gone, the hives were still present and would appear and disapear in different places on my body throughout the day and were very itchy.  On the 13th day my ears began to extremely burn and itch and their was pressure in my ears as well. My tongue felt swollen so I decided to call my dr. we tried OTC benadryl, allegra pepcid to no avail. after 21 days i went back to the dr and he prescribed me steroids and prescription strenght antihistamines. I am waiting to see if it helps
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination were not reported. After vaccination, the patient had an outbreak. The patient wanted to know, how long did it take the 1st dose to start working. In 2018, the patient's physician had given prescription of Acyclovir. The call center representative asked to the patient, his date of birth and provider information if safety department would like to follow up with that provider.
After 30 min pt develops swelling & blinking leg then mom put ice on her thigh and getting better.
3 Hours after receiving vaccine menstrual period appeared again (previous period was 9/23-9/28) and experienced arm pain, fatigue, chills and itching all over body. Approximately on 10/4 or 10/5 arm pain increases followed by swelling, black and blue bruising, redness, and itching. Swelling, itching, redness, and pain extended to elbow. On or around 10/10, joint pain throughout. Difficulty gripping, painful to walk. This lasted a few days. Sensitivity in the right arm from shoulder to fingers has not dissipated. Still painful to lean on arm. Still experiencing shoulder, elbow joint, wrist, and hand joint pain in right arm. Pins and needle feeling and bruised feeling. 11/2/21 experiencing sharp shooting pain where the swelling and redness once was lasted a few hours. Sensitivity in the right arm from shoulder to fingers has not dissipated. Still painful to lean on arm. Still experiencing shoulder, elbow joint, wrist, and hand joint pain in right arm. Pins and needle feeling and bruised feeling.
Transient synovitis of R hip 2 days after nasal H1N1. Also mild runny nose. Resulted in inability to ambulate and missed school day.
More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.; think I need to go vomit right now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now) 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 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now). At the time of the report, VACCINATION COMPLICATION (More side effects than they had with the second dose. She states the side effects seem to be lasting longer than after the second dose.) and VOMITING (think I need to go vomit right now) outcome was unknown.            Patient has think that he has been given a full dose instead because he seem to be having a lot more side effects than  he did after the second dose   Reporters states that side effects seem to be lasting longer than after the second dose  No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-363309 (Patient Link).
Had extremely itchy rash for 2 days and then was a bit itchy for 2+ weeks after vaccination.
Fever over 101F; severe headache; muscle pain throughout body; dizziness; swelling under left armpit; making raising left arm difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asperger syndrome" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "known allergies Ceclor"; Tegretol, reaction(s): "known allergies tegretol". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "Fever over 101F"; DIZZINESS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering"; MOBILITY DECREASED (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "making raising left arm difficult"; MYALGIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "muscle pain throughout body"; HEADACHE (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "severe headache"; AXILLARY MASS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "swelling under left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, dizziness, axillary mass, mobility decreased.  Additional information: Fever over 101F, severe headache, muscle pain throughout body, dizziness, swelling under left armpit making raising left arm difficult. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
20NOV92 appeared irritable, fatigued; 21NOV92 sudden, acute swelling of one knee; 22NOV92 pain in knee, pain jaw, difficulty walking or opening mouth, neck pain, fever-seen in ER; 22NOV to 25JAN92 inc joint involvement, fever headaches;
Beginning within 15 minutes, patient began to experience nausea and dizziness as with the first shot (Lot #EM6205 given 03-03-2021) Approximately 6 hours post vaccination patent began to have muscle and skin pain that interfered significantly with mobility. The muscle and skin pain has continued. Patient had  very limited ability to ambulate for  3 wks, Currently improving but not resolved. Began to break out in shingles today.
DOSE ONE RECEIVED 04/19/2021, DOSE 2 RECEIVED 05/07/2021.  PT ASYMPTOMATIC AT TIME OF TESTING.  REPORTS LATER THE SAME DAY AS TESTING  HE HAD SUBJ FEVER, CHILLS AND FATIGUE.  PCR POSITIVE 05/21/2021.
1 month after I had my 4th dose of the Moderna vaccine, I had a stroke and was hospitalized for 2 nights.
Chills , muscle aches  ,sore arm , no appetite , fever100.4  fatigue
15 years old patient received the Flublok / no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 15 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that patient that received the Flublok last year that was 15 years old.  At the time of reporting no adverse reaction was reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Pt received PNEUMOVAX and intradermal flu. Developed HA, weakness, myalgia fever to 101 and localized rash (red, swelling, warm) in (L) U ext. Pt was seen 3 days later and was afebrile, decreased in size of rash (shoulder to mid humerus confluent, macular).
Pt vaccinated with DTP culture proven pertussis infection. Had 2 doses of DTP.