chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2022 at 10:00 as dose 4 (booster), single (Lot number: G75342) at the age of 75 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: MIRTAZAPINE; ZOLOFT; CONCERTA; OMEPRAZOLE. Past drug history included: Known allergies: cypro, reaction(s): "Known allergies: cypro"; Known allergies: epinephrine, reaction(s): "Known allergies: epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The current age of the patient was 76 years. The other medications which patient received in 2weeks were mirtazapine, zoloft, concerta, omeprazole, concerta.
Deep muscle pain of deltoid and triceps with deep palpation or extension of left arm above shoulder height.
About 2 days later around injection site developed a rash from left upper arm lasting 5-7 days.
got half a dose; medication spill outside the body; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4r9r, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental underdose and syringe leak. On an unknown date, the outcome of the accidental underdose and syringe leak were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The child patient only got half a dose of Pediarix vaccine before they accidently hit the syringe and the rest of medication spill outside the body, which led to accidental underdose and syringe leak. Interpretation of "outside the body" was outside the body of the syringe. The reporter consented to follow up.
pt recv vax 17JUL95 & 7APR97 pt exp vaccine failure/chickenpox & dx w/varicella;
This is a spontaneous report from a non-contactable consumer from a non clinical study program. A 24-month-old female patient of an unspecified ethnicity received four doses of PREVNAR; all via unspecified routes of administration on unspecified dates at single doses. The patient's medical history and concomitant medications were not reported. Since an unknown date in Feb2008, the patient was sick and diagnosed with pneumonia for which she went to the emergency room. The events occurred after she had received the four doses of PREVNAR. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events were unknown. The clinical outcome of the event, pneumonia, was unknown. No follow up attempts possible. No further information expected.
very bad allergic reaction starting around 19:30-20:00 on 14Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left Arm on 14Apr2021 17:20 (at age of 53 years old) as single dose for COVID-19 immunization. Medical history included arthritis, asthma when she was a kid. Concomitant medications included meloxicam taken for arthritis from Apr2021 to 15Apr2021; omeprazole (OMEPRAZOL) from Apr2021 to 15Apr2021. For Concomitant Products Meloxicam and Omeprazole: Started unknown date last week, in Apr2021. She has not taken this today due to the very bad allergic reaction event. This consumer is the patient who was administered her first dose of Pfizer-BioNTech Covid-19 Vaccine on 14Apr2021 at 17:20. She reported onset of very bad allergic reaction starting around 19:30-20:00 on 14Apr2021. She was seen in the emergency room where she was kept for observation and treatment where they gave her some medicine and then released her; but was not admitted to the hospital for this event. She had to go to the emergency room, she broke out in hives and the right side of her face was swollen. The right side of her face is still swollen a little bit, especially over the top of her eye is swollen; but when she got to the emergency room her whole face was swollen and she had hives all over her body. In the emergency room they gave her medication and she stayed in the emergency room for like maybe 3 hours. She drove herself to the emergency room, but someone had to drive her home from the emergency room because she could not drive herself home. AE required a visit to Emergency Room. No Physician Office visit. The patient was not hospitalized, seen in emergency room only. Regarding testing/investigations such as blood work, lab work, cultures, scans, x-rays caller reported they did all that last night (14Apr2021), but she has no further information or results to provide for this report. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
5-10 minutes after vaccine & PPD placed had brief generalized convulsion. Seemed "out of it" afterward. Returned to our clinic (was in the car). Transported by ambulance to hospital.
Patient c/o localized rash at injection site, fever of 102.5, headache and nausea at 7pm the evening same day vaccine administered, treated with MOTRIN and BENADRYL - no SOB, cough, CP follow up with MD on 10/06/2009.
Reported by the employer that one employee that received a flu vaccine on an on-site program 10-26-2011.
Arm Soreness; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization.  Medical history included chronic autoimmune hives. No allergies to medications, food, or other products. Concomitant medications included within 2 weeks of vaccination, Azo Cranberry, MVI Vitamins Nos, Menopur, Follistim and Ganirelix. On 08Apr2021 at 18:30, the patient experienced arm soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not received treatment for the adverse event. since the vaccination, patient not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Numbness of face and neck lasting an hour.  Severe debilitating neck pain and headache lasting approximately 10 hours
Pt recv vax on 10/14/98; on 10/16/98 pt exp swollen, red Rt arm at vax site.
Ten hours after receiving the vaccine I experienced terrible chills that caused my teeth to chatter, fever, body pain and nausea like I thought I would vomit. This lasted for a full 24 hours after receiving the vaccine, and took a full 48 hours for all flu-like symptoms to subside.
upset stomach; I literally cried all day. I cried even at work for a whole 24 hours, crying for no reason/When I woke up I was crying; like I was depressed; This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported the side effects she experienced from the first shot. She stated that it wasn't real severe. The first day she was fine, upset stomach. On the second day, she literally cried all day. She cried even at work for a whole 24 hours, cried for no reason, like she was depressed. She didn't think anything about it. She mentioned it during the second shot and they told her to report it. She was fine after that, it was just for that whole day, when she woke up she was crying. Outcome of the events crying and depressed mood was recovered, while for the event abdominal discomfort was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician, via a company representative, concerning a 15 year old female patient with no pertinent medical history, who on 16-AUG-2007 was vaccinated with the first dose of Gardasil (Lot #658490/0802U).  There was no concomitant medication.  On 16-AUG-2007, after the vaccination and while the patient was leaving the office, she fainted.  The physician called the "rescue squad," however, the patient was not taken to the hospital.  She was monitored and then released to home.  The patient recovered on the same day, 16-AUG-2007.  Additional information has been requested.
The doctor suggested Ibuprofen and Tylenol and that helped me feel better. I am fine now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 10Nov2021 (Lot number: FE3592) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose of covid-19 vaccine), for Covid-19 immunization; Bnt162b2 (Second dose of Covid-19 vaccine), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 10Nov2021, outcome "recovered" (2021), described as "The doctor suggested Ibuprofen and Tylenol and that helped me feel better. I am fine now". Therapeutic measures were taken as a result of feeling abnormal. Additional information: It was stated that doctor suggested Ibuprofen and Tylenol and that helped him feel better. he is fine now."  No follow-up attempts are possible. No further information is expected.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 66 years old female patient (height: 70.5 and weight: 205 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the 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 holders 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.
Parotitis onset 4/28/03, urticaria onset 4/29/03.
Patient experienced extremely swollen arm which was heavy and painful at the injection site. Patient was also lethargic for several days and very irritable
pain in her left wrist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in her left wrist) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in her left wrist). At the time of the report, ARTHRALGIA (pain in her left wrist) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored M-M-R-II (lot # N010495, expiry date: 31-MAR-2019) reconstituted with improperly stored sterile diluent (lot # M014034, expiry date: 20-NOV-2018) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA002182: US-009507513-1802USA004686.
The patient reported pain in left arm starting the evening of the injection, July 6. This got worse over the next two days and additional sx included hot skin and erythema in the form of a red stripe on his skin, approx 3-4" wide and 8" long, from the injection site to his elbow. He described the pain as severe soreness and tenderness, not tingling. No rash, no swelling, no trouble breathing. He had no ADE when he received the first dose of SHINGRIX on 4/17/18. He has been treating with ice and EXCEDRIN, and the pain and redness decreased slightly from 7/8 to 7/9. He will continue to treat with ice and monitor closely. I advised him to see a doctor if sx remain or get worse, or if he has any signs of a severe allergic reaction.
Started vomiting at 8:00 several times. Extreme neasua following the rest of the day
Had lab work for yearly physical on 12/30/2020. ALT (alanine aminotransferase) and AST (aspartate aminotransferase) levels increased. No treatment but rechecked hepatic panel on 01/14/2021 with AST and ALT back to normal levels
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # K021950, Expiry date : 10-NOV-2016, NDC# 0006-4681-00, Expiry date :  23-AUG-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) as prophylaxis.   There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved.   On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported.   This is 1 of 6 reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007802:
Patient reported itching on chest, red blotchy spots present. Reported itching in palms and all over.  Patient evaluated by RN. Denied Shortness of breath or respiratory distress.  Medical director was notified and Benadryl 50 mg was given.  Patient tolerated this well. Vital signs were taken.  Heart rate was-80, SPO2 -100 %, Blood Pressure was 118/72. Itching improved and patient was released after being observed.
came down with it immediately after ,and she was diagnosed with Swine flu; She was sick for several weeks; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA313295.  This case involved an adult female patient who was diagnosed with Swine flu (H1N1 influenza) and was sick for several weeks (Illness), while she received(INFLUENZA VACCINE (MONOVALENT).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE MONOVALENT(INFLUENZA VACCINE (MONOVALENT) (Unknown)  produced by unknown manufacturer( lot number not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, immediately after the vaccination the patient was diagnosed with Swine flu (H1N1 influenza) and was sick for several weeks (Illness), (unknown latency) following the administration of INFLUENZA VACCINE MONOVALENT.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Patient received the high dose flu vaccine. Patient had received the regular flu vaccine in the past, but this was his first time receiving the high dose version. There were no known allergies and no other contraindications. Within 10 minutes of vaccine administration, patient began sweating profusely and experienced a dry mouth. Patient was given oral diphenhydramine 50mg and also had two small glasses of water. Within 5-10 minutes of taking the diphenhydramine dose, all symptoms of an allergic reaction had subsided, and BP & pulse were both normal. Patient left the pharmacy (feeling better) about half an hour after receiving vaccine. This vaccine was added as an allergy to the patient's profile at our pharmacy. Patient said he would inform his primary care doctor about the allergic reaction to Fluzone High-Dose.
pt devel severe h/a, nausea, vomiting & general illness 11/2 weeks p/shot. lost 6lbs overall. refusing to complete HEP B series shot
Cannot Pick Anything with her Left Arm; Left Bicep pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TEMAZEPAM, DOXYCYCLINE, THYROID (ARMOUR THYROID), FLECAINIDE, METOPROLOL, APIXABAN (ELIQUIS) and DENOSUMAB (PROLIA) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot Pick Anything with her Left Arm) and INJECTION SITE PAIN (Left Bicep pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No new information received On 04-May-2021: No new information received
This spontaneous report has been received from a currently 34 year old female patient who was also a registered nurse concerning herself. The patient's pertinent medical history included gluten intolerance. The patient's drug reactions or allergies included allergy to latex. The patient's concomitant therapies were reported as whatever vaccines they administered to 1 year olds in 1984. On 30-NOV-1984 or early December 1984, when the patient was one year old, she was vaccinated with M-M-R II, 0.5 ml once for prevention of measles, mumps and rubella (dose number, route of administration, anatomical location, lot number and expiration date were not provided). On the same day, she developed fever and hives and it was reported that she was brought back to the doctor. It was unknown if treatment was given for the events or if lab diagnostics or studies were performed. It was also reported that because of those events, she did not get any further doses of M-M-R II, however, the patient stated that she had had multiple titers done since then and she was immune to measles, mumps and rubella. On an unknown date (reported as after stopping the therapy), the patient had recovered from pyrexia and urticaria. The causal relationship between M-M-R II and the events was unknown.
RASH ON LEGS, BACK, CHEST AND STOMACH; ACHY JOINTS; STIFF JOINTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stiff joints. On APR-2021, the subject experienced achy joints. On 15-APR-2021, the subject experienced rash on legs, back, chest and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on legs, back, chest and stomach, achy joints and stiff joints was not reported. This report was non-serious.
4 or 5 hours after receiving injection I began to feel lightheaded, a little weak, lacked energy. By 6:00 pm, neck muscles especially began to ache, soreness in neck area. (Yes, I thought this was strange.) Slept poorly. I possible was running a very low grade fever. Same symptoms this morning, the day after injection. Soreness in arm as well but to be expected. No additional redness.
1 hr p/ vax on same day pt exp ``subjective fever''  also vomiting. on 7/18 pt also exp mild pharyngeal erythema.  7/26 pt exp a zoster rash w/greater than 20 vesicles.