chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Background: Exposed to Granddaughter who began experiencing fever, nausea and vomiting the evening of 3/19. Ten of twelve of the children in her preschool class (and many of their parents also) experienced the same symptoms beginning that evening or the following day. Granddaughters mother (my daughter) and father (son-n-law) also began experiencing the same symptoms on 3/21 and 3/22, respectively. I was also exposed to them on those dates. Their symptoms all resolved within two-three days. My adverse experiences: I was vaccinated at noon on 3/23. Shortly after midnight, 3/24, I began experiencing the same symptoms (see background) as my family members. The symptoms persisted throughout the days of 3/24 and 3/25. On 3/25 I visited my internist, Dr., who prescribed ciprofloxacin and ondansetron. He also ordered a COVID-19 test, for which I was negative. Shortly after midnight, 3/26 I awoke diaphoretic, noting my nausea had resolved. Also at that time, I began experiencing joint pain and a dull ache in my chest. By around 4 am the joint pain had subsided, but the chest pain had increased, to the point that I went to the Hospital ER. Although my ECG was inconclusive, troponin levels drawn were indicative for a possible NSTEMI. A cardiac catheterization was performed showing no coronary artery disease and normal cardiac function. After an echocardiogram was performed and further troponin levels decreased over the day, I was diagnosed with MYOCARDITIS, and told it was likely a result of a suspected virus that was presumed to be the cause of my previous GI illness. I was released from the hospital on 3/27. I have experienced no further symptoms since my hospitalization.
Initial information received from a healthcare professional on 15 July 2013. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of Tetanus Toxoid vaccine (manufacturer unknown, batch number, dose number, route and site of administration were not reported) on an unspecified date (unknown number of years ago). On an unspecified date, the patient presented rash. Complementary investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not reported. Documents held by sender: none.
MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a little bit; headache; was actually worried of getting the shot because I am on 3 different main pill (Unspecified medications) that I take every day and now I have not taken them; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an intramuscular route on 07Jun2021 (at the age of 59-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included COPD, high blood pressure, chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis), moderate to severe asthma, smoker. When confirmed if the patient had any vaccination 4 weeks prior to Pfizer COVID 19 Vaccine, patient stated, "I am supposed to go back as far as I know for second dose, 3 weeks on 28th". The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was a tad swollen. It kinda hurt. It doesn't hurt unless she lay or press on it and arm was aching a little bit. Other than that she took it pretty well. She had a headache but didn't last too long. Patient stated that she has heart pills that she takes twice a day. She stopped taking it yesterday. She stated, I didn't know if it would interfere/ how it would interact with it. She also has blood thinner and acid reflux. Patient wants to knew when she can continue taking her medications. Patient was actually worried of getting the shot because she was on 3 different main pill (Unspecified medications) that she take every day and now she had not taken them. Patient stated that she didn't underwent any lab test but she took a scan like 3 or 4 month since she had anything like that then. The patient took Tylenol as a treatment for events. The outcome of the events was unknown.  Follow-up attempts are needed. Information about lot/batch number requested.
Moderate symptoms of runny nose and sneezing from the day of vaccine (1/16/21)
3/25 - Did not feel well, tired, eyes hurt 3/26 - Felt better during the day.  Took a Benedril when I went to bed (10:00pm) 3/27 - 03:00am - woke up, couldn't swallow, throat on fire, got glass of water was able to take a few drinks.  Looked at throat, tonsils and uvula very swollen almost one in back of throat.  Felt like throat was closing.  Kept drinking water and hot tea to try to keep swallowing.  Was a little better in AM.  3/27 - 09:00AM - went to Urgent Care.  Saw Nurse Practitioner.   She did strep test which was negative and said no bacterial infection.  Did nothing else.   3/27 - I took Benedril every 6 hours  throughout day.  Throat sore and red, but better.  3/28 - Throat better - still a little red and swollen 3/19 - felt fine.
A few minutes after the injection I felt strange sensations in my arms. About half an hour after the injection started feeling a little dizzy and tightness in chest and throat. Later in the evening I had mild flu like symptoms, chills aches. The following morning was a Sunday and was feeling better but later that day throat started hurting. Throat progressively became swelled and irritated and extremely sore. Flu like symptoms returned. Throat was swelled and to the peak of pain on Monday night. Tuesday morning I was seen at a clinic and it was a little bit better. It started getting better after that but also it has now been a week and a half and throat is still a little bit irritated. I also have brown splotches that appeared on my face either the night of the vaccine or the morning that have not went away.
Pt reporting in messaging:  The inoculation itself was painless, and I scarcely thought of it again Monday evening and all day yesterday (Tuesday 16 Nov) till about 24 hours had passed. Very suddenly I began to shiver and shake - more violently than I can recall since 1998 when I was living abroad and had a serious case of the flu that was circulating.  I experienced spasms in my neck and throat so strong that I used my hands to prevent my jaws from involuntarily biting my tongue or perhaps breaking a tooth. I could not control my shaking and felt colder than I have ever felt in my life. I could not walk properly I was shaking so hard. I quickly turned on an electric throw blanket and piled coats and blankets on myself. Within about thirty minutes the symptoms were reduced but far from gone.  When a breath of air touched my skin it felt like ice and the shaking would accelerate, as would the spasms in my neck and jaws. I was so ill that I felt it wiser to stay home and address the symptoms than to call for assistance because I'm in an apartment complex which is a bit remote and have seen ambulances getting lost out here. I was concerned that trying to meet the ambulance driver would result in the uncontrollable spasms, which even impacted my breathing for a time.  In short, I felt it more dangerous to call for an ambulance than to address the symptoms myself. I had a fever but don't know what my temp was as my thermometer is still in storage. My son, who was not here when this started, said I was very hot. The lymph nodes in my groin swelled and were tender.  I finally fell asleep and awoke in a few hours feeling better but far from normal. Throughout the day today I have either been sweating, or shivering as I am doing as I write. I hurt all over and I have only eaten a bit, and rested today.  Recently I have been feeling very hale and healthy, almost recovered from the move, so this was a big surprise, especially considering that I experienced virtually no side effects to the first two doses.  I have not exaggerated - if anything am unable to aptly describe the symptoms. It was a bit scary for a while.  I hope this will be reported to Moderna.
This case was reported initially by a consumer and described the occurrence of diarrhea in a 2 month old female patient who received DTaP , hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). The reporter is the mother of the patient . Follow up information was subsequently provided by the vaccine responsible physician. Medical history , reported by the physician, noted that prior to administration of Pediarix , on an unspecified date, the patient developed diarrhea "on her original formula. "The formula was changed to a lactose free formula. On 29JULY2004, a well child examination revealed that the patient was in "overall good heath." On 3AUGUST2004, the patient received the first dose of Pediarix. On 3AUGUST2004, the patient also received injection of Hib conjugate vaccine and 7 valent pneumococcal conjugate vaccine. The patient's mother reported that, "the night of" 03AUGUST2004, the patient experienced diarrhea and "was sleeping more than usual." The patient's mother described the patient as "having 12 loose stools a day." The patient was seen at a physician's office on 5AUG2004. The physician reported taht the diarrhea was unresolved and that the infant's abdomen was soft and that the child was playful. The patient was prescribed hyoscyamine (Levsin). The physician also reported that the diarrhea previously experienced on the original formula was "now starting to relapse on the lactose free formula." The event was ongoing at the time of follow up.
SkinRash, ErythemaMultiform & UrticariaPruritus Narrative:
Syncope after MCV4 Pt complained not feeling well, MA had pt lie down and past out briefly. Pt recovered quickly and Pt monitored/Evaluated by provider.
Myalgia, Arthralgia, NauseaVomiting, chills Narrative:
Patient presented to clinic to receive her first dose of Moderna Covid 19 Vaccine. Client stated that she had not received any other vaccines in last 14 days.  After vaccinating client, staff opened client's profile in the immunization information system to log the vaccination. Upon looking up the client, staff discovered that client had a record of receiving the Jannsen Single Dose covid vaccine on 04/10/2021 at another pharmacy.   Staff contacted the client by phone, who confirmed that she had received the Jannsen vaccine, but thought it was "recalled for being ineffective" so had scheduled another immunization.  Staff explained the rationale behind the pause in Jannsen immunizations was not related to efficacy, but rather to potential side effects. Staff encouraged client to report her extraneous vaccination to her healthcare provider, and to discuss the side effect risks of the Jannsen vaccine as well. Staff informed client that she would not need to get a 2nd dose of Moderna vaccine at this time. Client expressed understanding of this information and expressed no concerns of ill effects at this time.
This spontaneous report was received from a 71 year old male patient. The patient's medical history included hernia operation in abdomen area. On an unknown date in 2010 (reported as "about 5 or 6 years ago"), the patient received ZOSTAVAX, (route: subcutaneous) in the left arm. The patient's concomitant therapies included PRINIVIL as blood thinner and HYZAAR as water pill. The patient had shingles every year after that. He also mentioned that he had gotten the shingles on his head, arms and chest and this year he got it on his face. He also stated that he sought medical attention the first year he got the shingles and they advised to use AIDANCE Skin Care for shingles and an unspecified antibiotic he did not have the name. The outcome and causality of the events were unknown. Additional information has been requested.
Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 47 years old male patient who received 0.5 ml of first dose of vaccine PENTACEL (batch number: UI952AAA, expiry date: 17-May-2019) instead of vaccine ACT-HIB (batch number, expiry date, dose, dose in series not reported) (route and site of administration were not reported for both the vaccines) on 21-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunization. It was case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. It was not reported if any adverse event was experienced or not. 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.
Information has been received from a physician concerning a 6 year old male who in 1998 was vaccinated with a dose of varicella virus vaccine live. It was reported that "he has developed" chickenpox with more than 100 lesions. The child was not hospitalized and the nurse stated that this case of chickenpox was uneventful. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.  **This Is in follow up to report previously submitted on 5/14/2004 information has been received from a nurse concerning a 6 year old male with no allergies or medical history who, at a well check up on 06/22/1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 62538000060H). Concomitant therapy that day included a first dose SC in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 621993/0026H). it was reported that he has developed chickenpox with more than 100 lesions. The child was not hospitalized and the nurse stated that this case of chickenpox was uneventful. Unspecified medical attention sought. No produce quality complaint was involved. Follow up information from the nurse indicated that on 03/04/2004 at 9:50, mom reported that there were red bumps all over. The child was seen by the physician who described them as vesicular puttules lesions with erythema in differing stages of development on trunk and face. Treatment included Aveeno, Diphenhydramine HCL (Benadryl), calamine lotion and no ASA, isolate. The patients mother called on 3/5/2004 to report that the child had over 100 lesions all over the body. The report indicated that the treatment was the same. No lab or diagnostic test were done. The patient recovered on 3/10/2004 (also reported as 3/14/2004) and returned to school on 3/11/2004. Additional information is not expected.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 1st patient out of 27 adult patients described by the reporter.
Pt recv vax in 8/98; on 9/3/98 pt exp meningitis; illness; migraine headaches
contracted COVID; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) and FEELING ABNORMAL (brain fog) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 033F21A, 009C21A and 006B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Environmental allergy and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-May-2022, the patient experienced COVID-19 (contracted COVID). On an unknown date, the patient experienced FEELING ABNORMAL (brain fog). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID) and FEELING ABNORMAL (brain fog) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: excess of 103.         Even with the Paxlovid patient had symptoms of fatigue and brain fog for 10 days. The symptoms fever in excess of 103, body aches, chills, congestion was subsumed under diagnosis of contracted COVID. Patient had virtual appointment with doctor. The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658071 (Patient Link).
Initial unsolicited report received from  non healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2018343471) on 20-Feb-2019. This case involves adult patient (age and gender not reported) who was paralyzed for 24 hours, while received vaccines FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (last year), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unspecified date, patient presented with serious paralyzed for 24 hours (paralysis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. No Lab data was reported. Final diagnosis was paralyzed for 24 hours. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for paralyzed for 24 hours. Documents held by the sender: none.; Sender's Comments: Patient presented with 24 hours paralysis after vaccination. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
petechiae & purpura noted 8 days p/vax became worse over next 3 days no major bleeding;
2nd dose Moderna vaccine given 14 days after 1st dose. Negative symptoms at time of 2nd dose administration.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant therapies were no reported. On an unknown date, the patients have been administered with improperly (stored 3 unspecified) doses of ZOSTAVAX (dosage scheduled and route of administration were not provided) lot # M036297, expiration date 14-NOV-2017, for prophylaxis. It was reported that the temperature excursion was for 144 hours 15 minutes at 3° degrees C. There was no previous temperature excursion  or data logger issue. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
pt became dizzy & had diarrhea & vomiting, BP was inc 200; pt went to the hospital & they kept for 4 hrs;
A physician reported that a 6 month old infant received Prevnar and Tripedia vaccines on 1/24/01. Within minutes, post vax, the child developed flushing, especially facial flushing, and swelling at the site of the Prevnar injection. The child was treated with diphenhydramine and recovered. Additional information received from the patient's allergist on 03/12/2001 indicated the patient also developed facial swelling.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Familial hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ZOLPIDEM; CLONAZEPAM; ATENOLOL; REPATHA. Vaccination history included: janssen covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 17Mar2021, when the patient was 52-year-old, for COVID-19 immunisation; bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 18Jan2022, when the patient was 53-year-old, for COVID-19 immunisation; bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 27May2022, when the patient was 54-year-old, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: 25Sep2022, when the patient was 54-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: Jul2022, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE ), administration date: Jun2023, when the patient was 55 years old, for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with nirmatrelvir; ritonavir (PAXLOVID) from 02Oct2023 to 06Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330644 Same patient and product, Different dose and events (LOE);