chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of hives in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hives, injection site erythema, injection site swelling and injection site pain. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives, injection site erythema, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the hives, injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A GlaxoSmithKline Medical Information Scientist in the field called the GlaxoSmithKline Response Center today (on the reporting day) and said that yesterday afternoon around 2 PM central time. The reporting pharmacist attending 2018 annual conference told him that the patient who was older than fifty years of age got hives the morning following her first dose of SHINGRIX. The patient also had redness, swelling, and pain of her arm described as all being symptoms occurring at the site of injection which occurred within 6 hours of after the SHINGRIX was received. The patient's symptoms was treated with BENADRYL. The sales representative did not have contact information for the reporting pharmacist. The reporting pharmacist said that the patient was one her patient but it was unknown where the vaccine was administered at this time. No further details were provided. The reporting pharmacist planned to call back GlaxoSmithKline's response center with reference number with any further details learned.
COMPLICATIONS FROM THIS VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple female patients of unknown race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date,15% of those who got complications from this vaccine, died. Fifteen percent of the 36 women who ended up in the ICU died. Which is 9 of 16 million people who got this vaccine. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220157677-covid-19 vaccine ad26.cov2.s-Complications from this vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COMPLICATIONS
Dear Sir or Madam,    I had my Moderna shot on 3/06/21, which was a Saturday. Yesterday morning, I woke up with my arm having a red spot the size of my palm, swollen, itchy and uncomfortable.  I also woke up with a very burned face. It looks like a bad sunburn, but only on my face. It burns and is hot to touch. I think they are related, since I woke up with both of them. I have not changed any detergents and if was detergents on my sheets, by arms and legs would have something too. I have not had any cosmetic procedures done on my face. Please advise.
Patient received 0.3 ml dose prior to vial being reconstituted. Patient has no symptoms at this time .
sick with normal side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6200) at the age of 69 years as dose 2, single and administered in arm left, administration date 17Feb2021 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Feb2021, outcome "unknown", described as "sick with normal side effects".  Additional Information: Patient received her third dose of the Pfizer COVID-19 Vaccine (lot: 301308A), Anatomical location: upper left arm, on 27Sep2021. She was sick with normal side effects that she had before with the initial vaccine series, but her left arm at the site of the injection looks like a huge red spot. It's hard and hot and black and blue in the middle. She was not feeling well enough to go out to the Emergency room. She had no doctor at this time due to retirement or leaving the practice. She called to find out if her arm symptoms have been reported so she knows if she should go out tomorrow to the Emergency Department and be evaluated. The patient was very concerned about the side effects. The patient was advised to go see somebody and she told as it was difficult to go see somebody right now, she was weighing out rather to go to Urgent care or not. Patient reports slight swelling and itching after receiving the third dose Pfizer Covid Vaccine. Slight swelling, she did not actually look for a couple days, the swelling was there yesterday, 30Sep2021 but the patient forgot to mention when reporting to Pfizer previously. The caller has been itching for a couple of days. The way the caller feels this morning is everything improved. Caller states the itching, was persistent, the itching happening now and was not happening when the caller reported to Pfizer previously. Patient states she received the third dose Pfizer Covid Vaccine because of her age and wouldn't say compromised immune system but she has medical issues and is overweight.  No follow-up attempts are possible. No further information is expected.
Patient received Pfizer COVID Vaccine at approximately 5 weeks pregnant. She reported having a miscarriage
Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Keeping me up at night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female (Non-pregnant) patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FR28744), via an unspecified route of administration, administered in am left on 01May2021 at 12:00 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Known allergies from Aleve, and prior to vaccination, the patient diagnosed with COVID-19. The patient's concomitant medication included losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced started with 1st dose, muscle twitches in lower legs, in the last 2 months, after second dose, increasing; and keeping me up at night. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg with no adverse event; Patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg with no adverse event; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a other health care professional via call center.  This case involved a 3 years old male patient for whom reported that patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg (Incorrect dose administered and Exposure via skin contact), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2020, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-UJ533AB, Expiration date- 30-Jun-2021) via intramuscular route in the right vastus lateralis for prophylactic vaccination.   On 24-Oct-2020, It was reported that patient jolted during injection causing the needle to come out and half of the vaccine went into the patient and the other half went on the leg (Incorrect dose administered and Exposure via skin contact).   No adverse event was reported.  No laboratory test 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 medication error out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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 started getting a bad sore throat and thought that maybe it was an allergy. I went to bed not feeling well on 12/29/2022. I made an appointment with the doctor, and I tested positive for COVID-19. I was prescribed Paxlovid, an antibiotic, and steroid. At that time, I was mostly tired, but my sore throat quickly went away, but I didn't feel too sick. After I took the Paxlovid, though, I had a relapse. I then called another doctor and got an antibiotic and a steroid. It took another two weeks before I fully recovered, and I feel fine now.
This spontaneous report was received from a pharmacist refers to a unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, indication, route of administration were not reported, lot # reported as L048452 with expiration date 01-MAR-2017). No adverse effects reported. Additional information is not expected, the reporter did not wish to be contacted.
p/vax mom reported that child had fever of 102.9 & was irritable, unwilling to eat, had diarrhea w/some vomiting;mom was giving pt APAP & was instructed to see MD;
(L) arm red, swollen with pain started BACTRIM DS tabs 1 tab po BID x 7 days.
I had congestive, fatigue, and mild fever. These symptoms been going on since Dec 17th,  I went to a clinic to get a COVID-19 test, positive results.
Narrative:  Patient with reported stroke symptoms a few hours after initial vaccination (first dose) of COVID-19 vaccine, although patient also elderly with hypertension so has other risk factors for stroke.
Childs mother called at 9:30am this morning reporting that the child had nausea and vomiting during the night. She stated child vomited once during the night and once early this morning. Reports stomach "pain". Mother denied child had a fever. Mother stated she had not treated the child with any medications.
Started with mild itching, then slight rash.  Itching and redness increased over 2 - 3 days and then diminished.  Rash was about 3 - 4 inches in diameter at highest level of symptoms.
Client woke up at 0500 on 10/10/17 with fever, body aches and Left shoulder pain. Client stayed home from school. Grandmother (guardian) gave client ibuprofen. Fever cleared. Client sent home from school on 10/11/2017 with fever and headache.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's concomitant medications, pertinent medical history, drug reactions, allergies, concurrent conditions, past therapies were not reported. On 19-FEB-2018, the patient was vaccinated with expired dose of GARDASIL 9 injection, expiry date: 01-FEB-2018 for prophylaxis whose dose, route and frequency were not reported (lot number was reported as unknown). It was reported that GARDASIL 9 did not have any temperature excursions prior to administration. No adverse effects were reported. It was reported that there was no product quality complaint (PQC) involved.
Received a dose of the Pfizer BioNTech Covid vaccine yesterday, however a month ago she received a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (Received a dose of the Pfizer BioNTech Covid vaccine yesterday, however a month ago she received a dose of the Moderna vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 23-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MEDICATION ERROR (Received a dose of the Pfizer BioNTech Covid vaccine yesterday, however a month ago she received a dose of the Moderna vaccine). On 23-Mar-2021, MEDICATION ERROR (Received a dose of the Pfizer BioNTech Covid vaccine yesterday, however a month ago she received a dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received a dose of the Pfizer BioNTech Covid vaccine on 23-Mar-2021, however a month ago she received a dose of the Moderna vaccine.  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Arm red and warm to touch, and itching started next day. Still itching 5 days later.
2033-Employee c/o an itchy throat, difficulty swallowing, feeling flushed. Rapid Response called to vaccine clinic. 2035-BP 178/112, HR 86, RR 16, Temp 97.7, O2 98% 2038-BP 178/114, HR 82, RR 16, O2 98% 2043-BP 182/119, HR 83, RR 16, O2 98% 2044-Rapid Response took employee to ER for further evaluation/monitoring. When the rapid response team reported back to the charge nurse of the vaccine clinic, he stated the employee did well once he was in the ED and  was discharged approximately 15 minutes after arriving in the ED.
I had a high fever, chills, muscle aches, lack of appetite, headache, and feeling horribly. I also, had a chronic cough after the vaccine.
This spontaneous report was received from a nurse refers to 12-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: Original Case : 1709USA000054.
15 MINUTE LATER I FEEL - MAREADA, SENSACION DE DESMAYO, TEMBLOR, HORMIGUEO EN EL BRAZO DE LA INYECCION (BRAZO IZQ), LENTITUD AL HABLAR, DOLOR DE CABEZA, DEBILIDAD. 1:30 HOUR LATER I FEEL - DOLOR DE CABEZA, DEBIL, DOLOR EN LA NUCA, DOLOR EN EL OMOPLATO IZQ.
Patient taken to ER on 7/30/21 at 1800 for fever of 103, resolved with tylenol.  Patient back in ER on 8/7/21 for rectal bleeding.  Ultrasound showed Intussusception, hospitalized overnight.  Discharged on 8/8/21.
third shot of Moderna, 2 Pfizer shots previously; third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) and INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 25-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously). 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) had resolved and INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
had shingles after the first dose of Shingrix was given on 28Aug2019; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. 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 received as follows: The reporter stated that the patient experienced shingles after the first dose of Shingrix. The reporter stated that she does not know how soon after receiving Shingrix the patient had shingles, but she could obtain this information from the patient upon follow up from safety. The reporter consented to follow up.
RANDOM VAGINAL SPOTTING; SWOLLEN LIP; NAUSEA; VOMITING (THREW UP TWICE); FELT "FUZZY"; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included nausea, and vomiting, and concurrent conditions included acne, and allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included spironolactone for acne, and cetirizine hydrochloride for allergies. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced felt "fuzzy". On 11-APR-2021, the subject experienced vomiting (threw up twice). On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced swollen lip. On 13-APR-2021, the subject experienced random vaginal spotting. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt "fuzzy", vomiting (threw up twice), and nausea on 11-APR-2021, swollen lip on 12-APR-2021, and chills, and fever on 10-APR-2021, and had not recovered from random vaginal spotting. This report was non-serious.
Break through case of COVID   I called my PCP office and was given a Rx for Paxlovid.  As of today I have 1 more dose to take.   I am currently still in the masking when around others stage of the disease.
1 day p/vax  pt admit to hosp; dx=Hib meningitis; tx w/Rocephin
26 yr old Military Student pilot (previously in excellent physical condition without any underlying conditions), reports that he received in June 2021.  He presented to clinic with concerns about fluttering/racing of hear, heart noticed his heart rate has felt elevated in the last 2 months. Patient reports the heart rate feels racing during the morning for approximately 2 hours , and that he feels fairly tired following the event. Patient reports that his physical training has been harder to complete due to the racing heart race, the patient feels as though he is losing his breathe more often and getting tired more quickly. Patient reports no intervention, but he did attempt to change diet and exercise. EKG demonstrated pericarditis sent for labs, ECHO and cardiology consult to rule out myocarditis.
The patient has not received the second dose; severe rash/rash  4 inches by 4 inches in size; joint pain; headache; itchy rash; red rash; hives; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Drug allergy (epinephrine).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (extreme dizziness). On 20-Apr-2021, the patient experienced RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose). At the time of the report, DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were  reported  for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.
recpvered w/polio disability; pt developed fever, rash, then lost use of legs; devel arthritis of both knees; polio dx'd, then found Bruton's agammaglobulinemia; undergoing PT; walks, but rt leg has muscle atrophy;
Syncopal episode about 15 minutes post vaccination.  BP was 76/44.  IV fluids started and patient transported to ER by EMS.
Patient's wife reports tingling/numbness in fingers and toes; paralysis of lower half of body; possibly Gillain-Barre Syndrome; ICU admission
Muscle pain and fatigue  Dizziness  Headache  Fever Nausea  Vomiting  Hives Pain and swelling at injection site