chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had sever pain in my entire body , fever and chill at the same time, I couldnt sit on my bot for three days. I called the clinic and I told them but they said there is nothing they could provide but pain medications.
medical emergency called for detainee "vomiting and passed out". Medical arrived to A12 at 11am and detainee was alert and oriented x 4 lying on floor, she stated she felt dizzy and nausea and vomited once and ran to the bathroom to vomit, upon return she passed out and the next thing she remembers is the other detainees standing over her. Witnesses say they caught her before she fell and she did not hit her head. She does complain of "tachycardia and right side head pain" and points to parietal lobe. She was transported to local ED by EMS.
I was newly pregnant (5-6 weeks) when I decided to follow my OB-GYN's guidance and opt in to get the flu shot at my (then) current employer. It was Oct 6, 2009 (I found an email dating back to that specific day where I mention the pain I was in to my husband, I should also be able to dig up DM's with a friend I was having the day on Chat). I had been administered the shot, went back to my desk, and pretty immediately started feeling an extreme heaviness in my entire arm that was injected. As more time passed that morning, I started to feel like I had a full-blown flu in my arm -- an achiness and paralyzed feeling. I ended up leaving work that day. In being 5 weeks pregnant, I was terrified that I had made a bad decision in getting that flu shot -- something felt so wrong about what happened.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. On an unknown date, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
69 years old received the FLUBLOK QUADRIVALENT instead of FLUZONE HIGH-DOSE QUADRIVALENT, no AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 69-year-old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  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.  There will be no information on the batch number for this case.
Fever began Tues 11/5. Saw PCP 11/7. MD seen in ER 11/11. Dx flu and bronchitis with diff breathing, chest pain, joint pain. Tx-Biaxin, Benzotaten, Vicoclen.
Patient had migraine headache, diarrhea, difficulty breathing, angina, restless legs at night.
Severe body aches, fevers, chills, nausea, dizziness, weakness, severe headache, vision trails beginning 24 hours after injection and continuing for the next 48 hrs.
eyes rolled back, body became limp, color very pale; nonresponsive for approx 30seconds; BP 60/20 @ 10:50, BP 70/48 @ 10:55, 72/58 @ 11:01, 72/58 @ 11:05; c/o high mid abd pain; no resp distress;los consciousness; limp, non responsive;
A few hours after vaccination, had chills, temp 100 degrees, HA. Given Tylenol X 1  On 7/19/20 AM, still had fever + HA. Had hives on forearms + thighs. Given Benadryl, Tylenol  7/19/20 afternoon, continued sx. Gave Benadryl  07/20/20 No fever, No hives, slight HA.
received doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 049l21a and 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2022 at 10:41 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022 at 12:02 PM, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022 at 12:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received doses from vials affected by a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (received doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received full dose for both doses. Patient received doses from 1st and 6th vials. It was reported that 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range.  It was reported that no adverse event occurred at time of administration or were reported thereafter.  Treatment medication was not provided by the reporter.
pain in the arm & shoulder joint where shot was given. Still feels like I have been punched, area hurts when the shot was given and the shoulder joint feels like it is pulled out of socket. date of shot 6/21/2021 and todays date 7/21/2021.
1/30  Reaction tongue and lips tingling. Right arm w rash and chest tightening.  Today lips 8and tongue tingling. EMS evaluated. BP 128/84 P 86 SaO2 98% No further issues  resolved - home 2:55
Child was lethargic, and fell asleep. Child woke up and began gagging, and trying to vomit. Child began to seize, and was not able to make eye contact, eyes were glassed over and looking off to one direction. Child was not responding to any communication, and was unresponsive to touch, or verbal commands, and began to gag/vomit again.  Child began to lose coloring, and was not able to keep eyes open.
1 hour after administration, patient developed sore throat; 3-4 hours after administration patient developed fever running at 102.4 degrees F and was shivering.
APPROX 2 MINS AFTER RECEIVING VACCINE, PT STARTED C/O TONGUE AND LIPS TINGLING.
made the patient fairly sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: made the patient fairly sick).  The outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingrix.     The company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 29-AUG-2023 The reporter was the husband of the patient.   The Shingrix vaccine made the patient fairly sick.  It was not clear which dose of Shingrix the patient experienced the event The reporter did not provide further information about the patient.  The reporter denied to follow-up. The case is linked with US2023118061, by same reporter.; Sender's Comments:  US-GSK-US2023118061:1st report
DTaP placed on right arm on 5/19/03. Presented 5/21/03 with 5 cm round erythematous, tender around injection site.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication was reported.  No treatment medication was reported.  This case pertains to patient number 8 out of 40.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Fever 101 degrees, chills, shivering, achy and very tired. Temp lasted for 2 days and tiredness for 3days
had an allergic reaction about 5 to 7 days after the vaccine; whole body was itchy and it progressively got worst, came to like her whole body was itchy; felt like skin was on fire; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Lot number: EL9265, Expiration Date: Not Reported) intramuscularly, administered in the right arm on an unspecified date (at the age of 30-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported she has no history of allergic reaction in the past. The patient experienced had an allergic reaction about 5 to 7 days after the vaccine, whole body was itchy and it progressively got worst, came to like her whole body was itchy, and felt like skin was on fire on an unspecified date. Patient reported that after the first dose, she had an allergic reaction about 5 to 7 days after the vaccine, where her whole body was itchy and it progressively got worst. It came to like her whole body was itchy, and felt like her skin was on fire. She just took some allergy medication, two Cetirizine (ZYRTEC) and a diphenhydramine (BENADRYL) and she was fine. She spoke with her doctor and informed the clinic before she had her second dose and they all said, because it was 5 days after, was that they can't really attribute the events to the vaccine. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
My heart was racing about two days before a routing medical appointment. At the doctor's office, my EKG was abnormal. My heart rate was very high. They started me on a low dose beta blocker and was referred to a cardiologist. I was diagnosed with Atrial Tachycardia. It is currently controlled by taking 50mg of metoprolol two times per day.
Approximately 22 hours after receiving Pfizer vaccine #1, he became febrile to 100 degrees fahrenheit, and desaturated down to mid 80% on RA requiring  O2 via NC at 2l. Was taken and admitted with impending respiratory failure.
Frozen shoulder pain is ongoing. Reduced range of movement in left arm along with pain when moving arm in certain ways.
Pt states following flu shot on Friday bottom of rt foot started itching; shortly p/started devel hives on arms, upper legs, hips; following flu shot had some aching & chilling & nausea;
The second of the 2 doses of the Moderna vaccine was administered on the 38th day; vaccine was administered 8 days beyond its expiration date; headache; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day), EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date), HEADACHE (headache) and FATIGUE (Fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 019B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  The patient's past medical history included Hypercholesterolemia on 01-Feb-2021. Concurrent medical conditions included Hyperlipidemia, Acid reflux (esophageal) and Constipation. Concomitant products included CALCIUM CARBONATE from 17-May-2021 to an unknown date for Acid reflux (esophageal), DOCUSATE from 01-Jun-2021 to an unknown date for Constipation, GEMFIBROZIL from 24-Feb-2021 to an unknown date for Hyperlipidemia.   On 08-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021 at 9:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day), EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date), HEADACHE (headache) and FATIGUE (Fatigue). On 10-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The second of the 2 doses of the Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (vaccine was administered 8 days beyond its expiration date) had resolved. At the time of the report, HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received and updated patient demographics, medical history, product information. Added concomitant (Gemfibrozil). Updated start date of all events and added new events (headache and fatigue).
Shingles outbreak on both arms and some on legs; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 23Sep2021 08:30 AM (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included colon cancer, yeast allergy and mycotic allergy. No covid prior vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced shingles outbreak on both arms and some on legs on 01Oct2021 06:30 AM. Not covid tested post vaccination. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The clinical outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt seen at approximately 10am for well check and had normal exam. Shots given-DTaP/IPV/Hib and Hep B and Prevnar #1. About one hour later at home began to cry continuously an din "unusual" way. Pt on Prilosec and Bavison for moderate GE reflux too. Fine by am 3/19/03.
The symptoms  started 11/2/22 and were the worst  on 11/3/22 day and night. Arm was huge, red, had fever and chills, pain. I took acetaminophen for fever and diphenhydramine for possible allergic reaction on 11/3-11/5. Itching developed 11/5 and continues.  Swelling has gone down and redness is fading today.  Slowly getting better. The swelling was 2 1/2? below injection site.  I was unable to lay on right side because of pain.
pale, sz-heart rate 34, unresponsive & limp;ER 02 started-IV administered given epi, DPH & Decaden;responded w/02 & IV med heart rate inc 90;
Information has been received from a registered pharmacist concerning a 70 year old male patient with asthma and type 2 diabetes mellitus and no drug reactions/allergies who on 20-APR-2012 was vaccinated SQ with a dose of ZOSTAVAX (dose and lot # not provided). The pharmacist reported that the patient who was administered ZOSTAVAX at the pharmacy developed itchy, red dots on both arms and hands on 01-MAY-2012. No treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The patient sought medical attention, called the pharmacy. Follow-up information has been received from the registered pharmacist provided a new information about the patient, who was vaccinated SQ in the right arm in deltoid region with a dose of ZOSTAVAX (Merck) (lot# reported as G007869) (dose not provided). The pharmacist reported that patient 1-2 weeks after receiving vaccine, developed itchy on both arms and hands, red dots on both arms and hands (approximately on 01-MAY-2012). Patient had also just started taking "ZPak" for respiratory infection (approximately in 2012). No treatment required for rash. None relevant diagnostics test were performed. The patient recovered "after 2-3weeks" (approximately on 22-MAY-2012). Additional information is not expected.
Chest tightness, pressure, and central chest pain.  Palpitations that started a week after both shots and lasted approximately 5-6 weeks after both injections.  An echo was done in July which was normal.
dry heaves; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (dry heaves) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETCHING (dry heaves) and CHILLS (chills). At the time of the report, RETCHING (dry heaves) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Took HCG test prior to SP vaccination, negative. Found out she had a +HCG March 31, 2003. Otherwise well, no complications with vaccination.
fever of 101; soreness; lower back pain; This is a spontaneous report from a contactable consumer (patient's mother). A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid vaccine on 31Mar2021, and he experienced soreness and lower back pain on an unspecified date in 2021. That morning (02Apr2021), he woke up with a fever of 101. The patient's mother was asking if she can give him Tylenol and they were told that they could not give him Tylenol with the shot. The patient underwent lab tests and procedures which included body temperature: 101 on 02Apr2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
This spontaneous prospective pregnancy report as received from a nurse via company representative refers to a 18 year old female patient. No medical history was reported. In 2014 (exact date was not reported, the company representative believed the doses were administered today (17-MAR-2014) but she could not confirm) the patient was vaccinated with GARDASIL (lot number, expiration date, strength, dose, route were not reported). Other suspect therapies included VARIVAX (lot number, expiration date, strength, dose, route and indication were not reported) administered on unspecified date in 2014 (exact date was not reported, the company representative believed the doses were administered today(17-MAR-2014) but she could not confirm). No concomitant medications were reported. The nurse stated that after receiving the vaccines, the patient called the office and stated that she was four months pregnant, with last menstruation period (LMP) in approximately November 2013. Date of conception and estimated delivery date (EDD) were unknown. No adverse effect was reported at the time of the report. The pregnancy outcome was pending. Additional information has been requested.
sick; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's past vaccinations included INFLUENZA VACCINE taken it last 6 years. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information on the batch number for this case.