chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 22Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 08Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: The patient tested himself again on the 11th day and COVID was back. Therapeutic measures were taken as a result of vaccination failure, covid-19. This report about COVID-19 treatment. Patient had no known allergies. Other medical history included asthma. Patient received the vaccine. Patient did not receive other medications in two weeks. Patient received treatment for the event as COVID-19 treatment was paxlovid from 22May2022 to 27May2022. He tested himself again on the eleventh day and COVID-19, he was still feeling sick, it was like the pills extended the timeline of mess being sick with COVID-19.  No follow up attempts are possible. No further information is expected.
Per the patient she started to get hives 2 hours after the vaccine which were mild and resolved with Benadryl. The next day the patient had a severe flareof pain to the site.
Patient received 0.5 ml of Pfizer covid 19 vaccine for their second dose. Patient is not experiencing any side effects at the moment the phone call was made but was instructed to monitor any unusual side effects/symptoms for the next week.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing), notes: Low thyroid; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment with Paxlovid with treatment start date as 15May2022 and treatment stop date as 18May2022, for indication of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11:20 - Felt lightheaded w/ driving. 11:30 - Blacked out w/ driving. EMS - vitals; pt. declined ED visit went to Police Dept. to rest/wait called office 12:12.
Nausea, vomiting, headache.  After pt vomited she felt better.  At that time she was given crackers and apple juice.  As time past she became better. The onset was immediate (within 10 mins) and lasted about 30 mins.
Hot flashes; Injection site pain; fever; nausea; chills; tiredness; This case was reported by a other health professional and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago from the date of reporting ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report.   The patient need second shot of Shingrix. It has been one year. This led to incomplete course of vaccination. The reporter asked where he could get the vaccine.   Follow up information received from other health professional on 11th May 2020: The patient stated she has reported an adverse event to GlaxoSmithKline previously. On 27th April 2020 05:00, the patient received the 2nd dose of Shingrix.  In April 2020, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever, nausea, chills, tiredness and hot flashes.  On an unknown date, the outcome of the injection site pain, fever, nausea, chills and tiredness were recovered and the outcome of the hot flashes was unknown. This case US2020AMR040764 is a duplicate of US2020AMR079364. All future correspondence will be submitted to US2020AMR040764.
Redness and warmth at injection site 10 x 13cm. Pain at injection site (minimal). Cold compress advised (apple to reddened area).
Metal taste in mouth about 12-20 hours after second injection. Lasted approximately 2-3 days. Ran slightly elevated temp (~100F) for a day, but fever responded well to Tylenol and subsided within 48 hours.
5 year old female patient accidentally received a Flublok Quadrivalent vaccine in Right Thigh. No adverse event; 5 year old female patient accidentally received a Flublok Quadrivalent vaccine. No adverse event; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who was accidentally administered a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1924, expiry date:  30-Jun-2020 via intramuscular route in the right thigh on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to vaccine administered at inappropriate site and inappropriate age at vaccine administration.  The patient did not experience any adverse Events at the time of report.  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.
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-418964 (Patient Link).
Puffy eyes. Right more than left; This is a spontaneous report from a contactable other-HCP. This 39-year-old female other-HCP (patient) reported for herself that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscularly at left arm at single dose for COVID-19 immunization on 30Dec2020 02:00 PM. Relevant medical history was none. Relevant concomitant drug was unknown. The patient experienced puffy eyes, right more than left on 30Dec2020. The event was assessed as non-serious. No treatment was received for the event. Outcome of event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 01:30 (Lot number: EN6202) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lyme disease" (unspecified if ongoing), notes: 14 years of Lime disease, treatment successfully completed 3 years ago.; "Food allergy" (unspecified if ongoing), notes: Food sensitivities (many, not anaphylactic). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered" (Mar2021), described as "sore arm for 24 hours". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Patient was tense and nervous to get his COVID-19 vaccine (Pfizer) after seeing another patient feeling light-headed after his respective vaccine. The patient was pacing back and forth deciding if he should get his vaccine or come back another day. He decided to get vaccinated. Immediately after the vaccine was administered the patient, while still sitting down,  passed out and leaned forward falling on the floor. As the intern reached down to help the patient he came to and was able to get back on the chair on his own. At that point the PIC and the intern remained with the patient for observation and provided water. The patient remained under observation for about half an hour and expressed he felt well enough to go home.
Fever (Documented in ER 104 degrees) nausea, vomiting, shaking chills 12 hrs s/p injection. Treated with IV ZOFRAN.
This spontaneous report was received from a medical assistant regarding an unknown patient of unknown age and gender. Medical history, concomitant therapies and concurrent conditions were not reported. On 09-SEP-2017, the patient received an expired first dose of ZOSTAVAX, 19400 PFU, subcutaneously, Lot# M035696 and expiration date 07-SEP-2017, for profilaxis (Route of administration and anatomical location were not provided). No adverse events occurred.
Joint achiness started approximately 5 hours after the shot, then a severe head-ache started at 2am (8-9/10).  This was followed by a fever of 102.7 via temporal scanner that lasted 30+ hours (on Tylenol and Ibuprofen).  Nausea was intermittent, HA and Fever were constant for approximately 30 hours.
This is a serious literature case, initially received on 29-Apr-2019, concerning an adult female patient of an unspecified age (reported as middle-aged healthy woman). The objective of the article was that a variety of environmental risk factors can trigger the onset of rheumatic disorders. Vaccines stand next to antibiotics as a nineteenth-century medical breakthrough impacting the human evolution and survival. Evidently, an age-old process of conferring immunity without active infection, practiced in civilizations, introduced and advocated in modern medicine at the time of renaissance by prominent physicians. Vaccines tend to stimulate both the humoral and cellular immunity depending on the type of antigenic stimulation. As with any other medical-intervention, even vaccines sometimes result in adverse events. Vaccine-related side effects were increasing exponentially with higher availability, awareness, and reporting. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date, after vaccination (reported as close proximity to immunization), the patient developed rheumatoid arthritis. It was reported that the disease remained chronic, required continuous standard treatment. The outcome of the event was not reported. It was reported that the vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart and this might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena (related). This case is original case 201903240 and is one of the 3 cases linked due to same reporter (author). The reporter concluded that although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, they might be able to find the at-risk groups and lower the incidence.; Reporter's Comments: A middle-aged female patient developed rheumatoid arthritis, after administration of INN Flu Vaccine (reported as close proximity to immunization). Considering the plausible temporal relationship between vaccination and reported event and lack of any underlying conditions or alternative more plausible causes, the company conservatively assessed the event as possibly related to suspect vaccine. The company assessed the event 'rheumatoid arthritis' as serious (medically significant).
I developed a self-limited vasculitis (episcleritis and dermititis) about 7 months after this vaccine dose.  I honestly doubt it had anything to do with the vaccine, considering the time interval, but have filled this out at the request of the person from a facility who called me re: my answers to the vaccine followup text message I had received about 2 weeks ago.
About 30 to 45 min after my first shot of the COVID vaccine, I did not feel well.  Thinking I would feel better when I got home,  I left.    I did not say anything to the pharmacist.  Within two hours after the shot, I was confused (reality and what wasn't, had anxiety, rapid heart rate).   I have never had any of these before in my life.   I took two Benadryl and laid down  and  started feeling better about an hour or two later.  The next 4  days  I was extremely nauseous.  A week after the shot I am having the same feeling in my legs as I got a week after I got the TDAP in  2017.  Weak painful legs with a gurgling sensation in my veins due to inflammation.  In 2017, I was tested and my ANA was high.  I have not ever had this problem in my life except after the TDAP in 2017 and the COVID vaccine in 2021.
High fevers on and off since vaccines - Ongoing since vaccines Knee pain in both knees - Ongoing since vaccinnes Throwing up- Started today Cough- Ongoing since vaccines Runny nose- Ongoing since vaccines Stomach pain- Started today More aggressive- angry Feet Hurt- Ongoing
Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, for tolerance refer case US2022067612).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022067612   Additional Information: GSK Receipt Date: 20-APR-2022  Reporter's Comments: The reporter was the patient's husband.  Reporter did not know lot number or expiration date.  Patient not available to give consent for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022067612:Same Reporter
Redness, swelling pain,hardness, fever at site of injection one day after vaccine.
A nurse reported that an adult female received an injection of Flu Shield (2001-2002 formula) and subsequently developed a fever, vomiting, diarrhea and felt sick. No further information was available at the date of this report. This is 1 of 4 pts from this facility who had an adverse experience following receipt of Flu Shield (2001-2002 formula) lot 4018032. See MCN: HQ0185226JAN2002, HQ0408301FEB2002 and HQ0408501FEB2002.
Information has been received from a health professional concerning an 8 year old female with no medical history and no allergies who on 21-OCT-1998 was vaccinated with 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 626409/0666H). Concomitant therapy included a multivitamin. On 29-APR-2007 the patient developed a varicella rash. The patient had about 40 lesions and had a fever of 101 degrees Fahrenheit. At the time of this report. The patient had not recovered. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. The patient's twin sister experienced one questionable lesion following this vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0705USA03172). Additional information has been requested.
Redness and swelling with heat began soon after injection and worsened over the next 12 hours. Limited to upper arm below deltoid injection site.
Stiffness of arm; Soreness of arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included WARFARIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness of arm) and PAIN IN EXTREMITY (Soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
pt recv vax 25MAR98 & 27MAR98 approx 3PM brought pt to office so PHN could observe site;according to mom no problems noted until around 6:30 26MAR98 hive-like area 1 1/2";red/hot to touch;entire thigh area appeared swollen;c/o h/a;
Administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.
Pt complained of back pain and I had her sit down. After returning with water a few minutes later, she c/o tightening in her throat. Benadryl 50mg PO given x 1 at 1724. At 1528, pt stated her throat was getting tighter. Epi 0.3mg given IM in L thigh at 1729 and after it was given, she asked if it was safe during pregnancy. Told her it was. EMS called and in transit. Pt stated her throat was getting tighter and Epi 0.3mg given IM in R thigh at 1738.  EMS arrived and pt taken to the Hospital in stable condition. Pt was shaking, but O2 sats were at 97% and HR 106 after EPI. Pt had no other complaints other than previously stated. Pt had 3 children with her who stayed with employee until husband arrived and took them with him. Texted pt's husband at 2030 and he stated they were home and doing well.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender.  Medical history, concurrent conditions and concomitant medications were unknown by the reporter.  In approximately 2014 (reported as about three years ago), the patient received ZOSTAVAX (route and lot # not provided). The patient "recently" reported to the pharmacist that they had gotten a case of shingles "later" (date not specified). The pharmacist reported that the patient looked like they had decreased symptoms. The pharmacist attributed the event to the vaccine. Additional information has been requested.
Experienced Tachycardia. Heart beat went up without any physical effort multiple times starting approximately 8hours after the shot and ending after 30 hours.  Higher BPM reported: 179 BPM.
Mom reports, since vaccine pt. has shaking episodes. Patient has episodes 1-3 times a day now (post four days) mom reports after vaccine given patient episodes were 8-10 times a day for about 8 weeks.
I had a cough. I felt innervated with very little energy. I had some body aches and a headache. I was also very fatigue. I still have cough and I now wheeze as well. The doctor diagnosed asthma and that's something I never had before.
Pt presented to pharmacy on 11/10/18 stating she was hospitalized after her flu shot (a few Hrs later). She experienced nausea/faintness.
About 9 hours after I received the vaccine, I noticed a small, itchy patch of hives on my lower torso, covering a patch of skin about five inches long by two inches wide. The hives were raised and red, on my right side, diagonally between my belly button and hip. About 24 hours later, they have not spread but have not shrunk.