chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My wife reported headache post vaccination; This is a spontaneous report from a contactable consumer (patient's husband) via a medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, consumer called on behalf of his wife. Consumer states "me and my wife received the Pfizer COVID-19 vaccine yesterday. My wife reported headache post vaccination on an unspecified date in 2021. Enquired can consumer use antipyretics or pain reliever after vaccination with the Pfizer-BioNTech COVID-19 vaccine or not. He was been recording his wife's side effects on (smartphone-based tool name). Consumer states "Can consumer take alcohol post vaccination or not. It's been 24 hours since consumer got his vaccine. Consumer have read on the internet that doctor's stating drinking alcohol 24 hours after receiving the vaccine was considered safe." Consumer states "the fact sheet indicates 0.5 % people have reported swollen lymph nodes post vaccination. A few years back, he had swollen lymph node. However, it was treated with medication. He was feeling a lot better now. The symptoms due occur when he catches cold. He wants to know if the sides effects could accelerate with the vaccine. Caller didn't notice any swollen in the lymph nodes post vaccination. The event was considered as non-serious by the consumer. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a consumer regarding a currently 23 year old female patient (also reported as daughter of the patient). Patient's prior vaccinations included DTP, HAVRIX or VAQTA, HIB (unknown type), GARDASIL, influenza, influenza (unknown type), MENACTRA or MENVEO, MMR, Polio OPV, TD, DTAP, AFLURIA and VARIVAX. The patient's concomitant medication and medical history were not reported. On 10-FEB-1994, patient was vaccinated (age at vaccination was 1 day old, infant) with hepatitis b vaccine (recombinant) (Manufacturer unknown) dose 1 (strength, route of administration, lot#, expiry date was not reported) for prophylaxis. On 18-APR1994 and 08-FEB-1995 the patient was vaccinated with dose 2 and dose 3 of hepatitis b vaccine (recombinant) ( Manufacturer unknown) (Inappropriate drug schedule). On 12-JUL-2017, Hepatitis B surface antibody assay been done and found to be Non-Reactive and value was less than 3.10 IU/L, (also reported as Hepatitis B antibodies (protection) were not detected). On an unknown date in September 2017 an additional booster dose of hepatitis b vaccine (recombinant) (Manufacturer unknown) was administered to the patient. It was also reported an additional titre will be drawn. The action taken and outcome of the events was unknown. The relatedness of the events to the therapy with hepatitis b vaccine (recombinant) (Manufacturer unknown) was unknown.
About 2 days after the vaccine, I noticed enlarged lymph nodes in the left arm pit.  I could not raise my arm over my head for 3 days.  At day 4 post vaccine, I also noticed enlarged lymph nodes around my groin area.  I consulted with the doctor via telehealth who advise to keep an eye on it and to report back if not resolved in 1 month.  On 3/11/2021 I had break through menstrual bleed. It was a small amount of blood for 24 hours then it stop.  I had a pap done which was normal and I have not had another episode.  I followed up with my gyno.   I am menopausal and have not had a menstrual cycle since 2014.
CLINICAL IMPRESSION 1. COVID-19  2. Acute respiratory failure with hypoxia  3. AKI (acute kidney injury)
1/31/2023 reported to HCP for bruising, fatigue, contusions. Blood drawn and results on 2/2/23 showed critically low platelets. Unsure if related to vaccinations.
Light-headiness, chest pain on evening of injection, along with high blood pressure (155/88).  High blood pressure lasted through the evening of the injection plus 2 days, with readings decreasing each day.  This morning  (4/11) was my first (almost) normal blood pressure reading.
patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Dose-1) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. Treatment medications were not reported.
PENTACEL was administered to a 6 month old male patient without being reconstituted with no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 month old male patient who was administered 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without being reconstituted, [lot UJ343ABA and expiration date unknown] via intramuscular route in unknown administration site for prophylactic vaccination on 1st dose on 06-Feb-2020, 2nd dose on 08-Mar-2020 and 3rd dose on 19-Oct-2020 (product preparation error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); HIB VACCINE (HIB VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to the Active ingredient not added to diluent (latency same day).It was reported as a patient got only the liquid part of the Pentacel.  At the time of report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
AFTER RECEIVING THE VACCINE AUGUST 27,2022 DONOR HAD NO SYMPTOMS. AUGUST 28, 2022 DONOR FELT SLIGHT SORENESS IN R-DELTOID. ON AUGUST 29,2022 DONOR WOKE UP AROUND 6AM TO GET READY FOR WORK AND NOTICED HIS ARM FELT LOCKED & WAS STIFF, HARD TO MOVE AND SORE. DONOR FELT A KNOT ON HIS ARM AND SAW REDNESS AROUND THE INJECTION SIGHT. BY THE END OF THE DAY DONOR STATED HE FELT LIKE HE HAD A FEVER, HE WAS WARM, WEAK, AND TIRED. AUGUST 30, 2022 THE REDNESS SPREAD TO R-PECTORIAL & UNDER R-ARMPIT. THE REDNESS DIDNT RECEDE TO THE R-DELTOID UNTIL SEPTEMBER 1, 2022. ON SEPTEMBER 2, 2022 THE KNOT GOT A  LITTLE SMALLER. ON SEPTEMBER 4,2022 THE INJECTION SIGHT HAD NO REDNESS OR KNOT PRESENT BUT DID FEEL ITCHY.
Was was pain in calf area and having a hard time breathing and very tired..   went to doctor on 4/20/2021 Doctors Diagnosed with Pulmonary Embolism
I had a fever of 101F, chills, body aches, extreme sore throat. I went to the doctor they tested me for COVID-19, strep, influenza, RSV. All tests came back negative, I was advised to go home get plenty of rest, drink fluids and it should clear itself up. In a couple of days I was feeling much better.
I have a rash at the injection site; Covid arm; This is the third shot; This is the third shot; This is a spontaneous report from a contactable physician (patient). A 38-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration on 09Jan2021 at 13:00 as a dose 1, single in the left arm and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC2181) via an unspecified route of administration on 09Jan2021 at 15:00 as a dose 1, single in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Sep2021, the patient experienced rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm and on unspecified date of 2021 patient received third shot of Covid vaccine. Patient did not received treatment for events. The patient underwent lab tests and procedures which included Covid test Unknown- saliva test was negative on 16Sep2021. The outcome of the events rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm was resolving, and other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
received 1st and 2nd dose of Shingrix / developed Shingles twice; Leukemia; Shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), leukemia (serious criteria GSK medically significant) and shingles. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the vaccination failure, leukemia and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, leukemia and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reporteed but selected as an adult as per vaccine indicaion. The reporter stated that, the patient received 1st and 2nd dose of Shingrix 2 years before the date of reporting, and experienced shingles 2 times,1st in 2019 and 2nd time in 2020. The patient had leukemia and was under immunosupressive treatment. No further details were reported
Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itching over swollen arm; itching over other parts of body; itching over other parts of body, warm to touch; Swelling at the injection site; Warm on the injection site; knot at injection site; Slight arm pain; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 mL, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 12Mar2021 at 09:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included Type II Diabetes; High Blood pressure (usually maintained by medication); low iron anemia, migranes; lichen planus; detached retina; prior to vaccination, patient was diagnosed with COVID-19. Other concomitant medications were received within 2 weeks of vaccination. The patient's known allergies included ciprofloxacin (CIPRO) (Highly allergic), moxifloxacin hydrochloride (VIGAMOX) and moxifloxacin hydrochloride (AVELOX), all experienced allergies. Slight arm pain evening of vaccination date on 12Mar2021 at 21:15. Small knot at injection site and arm pain following two days from 13Mar2021, larger knot at injection site and arm pain third day and arm pain, with warm to area to touch by late evening on 14Mar2021. By morning of fourth day (15Mar2021) area of injection site swelling three to five times more than evening before (14Mar2021), red, slight rash over swollen area, arm pain. By afternoon on 15Mar2021 itching where arm was swollen and continues to swell, and itching over other parts of body, warm to touch. NO fever during any of this time. Elevated blood pressure on 12Mar2021 at 21:15. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 01-APR-2019, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneously, lot # R024015, expiration date 19-FEB-2020 for prophylaxis (dose was not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (14.1F) for 7 hours and 35 minutes, as recorded by a data logger. The administered dose of the vaccine experienced a previous temperature excursion of 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (14.1F) during a time frame of 10 hours and 35 minutes. No adverse effects were reported. The outcome of the event product storage error was not reported.
Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a six months old female patient who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (lot: UT6315RA) via unknown route in the left thigh and 0.25 ml dose of same vaccine with lot: UJ087AB via unknown route in the right thigh, on 26-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PENTACEL for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to extra dose administered (6 month old patient was administered 2 doses of fluzone (one 0.5ml dose and one 0.25ml dose))  It was unknown whether the patient had any 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.
Client received yellow fever on 8-5-2010. She notified this office on 8-17-10. She said several days after the immunization, she had pressure in her chest, difficulty breathing, congestion and aches. Reported low grade fever with chills and took TYLENOL & BENADRYL on 8-15-10. She felt some confusion.
Patient had  the Pfizer Covid vaccine Wednesday, July 21 around 4:45pm. (This was received at a local pharmacy, I did reach out to them and they confirmed the injection and provided additional vaccine information.) The next morning he woke with tinnitus and hearing loss in the right ear. Seen in the ENT clinic on July 26. Audiogram done that day showed moderate to severe sensorineural hearing loss in the right ear. Mild hearing loss in the left. No previous audio for comparison but patient states he has had no previous problems with his hearing, tinnitus or previous otologic surgeries. Also symptoms of tinnitus which he described as a loud, constant humming sound. No history of tinnitus prior to the loss. Of note he takes prn sildenafil but had not taken any in the weeks leading up to the hearing loss. Seen in the clinic on 7-26-2021. Started on a high dose prednisone tapper and MRI with IAC pending. Plan to see him back in the clinic in one month with an audiogram.
No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Feb-2022, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant Follow up received; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Patient said her arm is swollen, hot and redness around her arm w/lots of soreness. Patient said she has a fever as well. Patient was directed to take ibuprofen, BENADRYL, and use cold pack and told see her PCP or go to ER.
POSTMENOPAUSAL 26 MONTHS, BEGAN MENSTRUAL BLEEDING 21 DAYS AFTER J& J COVID VACCINE
We got a phone call on 8/5/10 from mom stating pt had a reaction after vaccines given on 6-11-10, mom states that pt woke up next day with a lump on (L) arm with discharge from it, mom didn't pay attention to this issue, since she thought it was normal, after 2 months she called us to find out if it was a normal reaction or not.
Hives in her face/ all over the body/switch places/Hives appear mostly after taking showers. Breaking out with hives/hives started as 3 welts and then it expanded all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives in her face/ all over the body/switch places/Hives appear mostly after taking showers.) and URTICARIA (Breaking out with hives/hives started as 3 welts and then it expanded all over the body) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 036B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Nov-2021. Concurrent medical conditions included Lactose intolerance and Inflammatory bowel disease (Worse constipation because of the medication that she is taking for the hives.) since 2018. Concomitant products included LINACLOTIDE (LINZESS) for Inflammatory bowel disease.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced URTICARIA (Breaking out with hives/hives started as 3 welts and then it expanded all over the body). On an unknown date, the patient experienced URTICARIA (Hives in her face/ all over the body/switch places/Hives appear mostly after taking showers.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency; HYDROCORTISONE on 27-Jan-2022 for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 27-Jan-2022 for Hives, at an unspecified dose and frequency. On 27-Jan-2022, URTICARIA (Breaking out with hives/hives started as 3 welts and then it expanded all over the body) had resolved. At the time of the report, URTICARIA (Hives in her face/ all over the body/switch places/Hives appear mostly after taking showers.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, COVID-19: positive (Positive) Positive.         Initially, patient consulted to a doctor and they administered Hydrocortisone cream and a dose of Benadryl and it went away after 3 hours. However they were coming back all the time, mostly when she took a shower and they appeared on different parts of her body. She was currently still experiencing hives and it has not been better. The hives were not consistent and switch places, they were then appearing also on her face. She was currently taking Allegra and Zyrtec for her symptoms.   This case was linked to MOD-2022-486107, MOD-2022-486108 (Patient Link).