chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 minutes I began to have shaking chills. I felt weak and went to bed immediately when arriving home and covered with multiple blankets. I continued to shake constantly for the first hour or so and then remaining cold, periodic shaking for a total of 3 hours. Then I became burning hot, had nausea, headache, general body aches and pains, weakness to the point where I felt like I couldn't stand up. After another 3 hours I got out of bed for a couple of hours and tried to eat some oatmeal, getting some of it down. The serious coughing continues. I did sleep waking up 4 times during the night with coughing spells. Today I am still having periodic shaking chills even with extra clothing and turning the heat in our unit up. Thus far today I have had a piece of toast and a cup of milk.
This patient received a 2nd dose of Moderna and they were only 17 years old at the time the Moderna vaccine was given. Also the patient received their 1st dose of Moderna on 7/8/21, only 20 days in-between doses.
1st dose 21 Oct 2022, 2nd 01 dec 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 53-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 1st December 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received 1st dose Flulaval vaccine on 21st October 2022. The patient stated to the staff that she did not received her Flu vaccine this season, so another dose of Flulaval vaccine was received. The reporter reported that afterwards, it was discovered that the patient already received a dose of this season. The reporter did consent to follow up. Additional supportive information: The patient received extra dose of FluLaval Quadrivalent, which led to extra dose administered.
48 hours after injections I started to feel as if I was getting a cold. By the next day I was coughing painfully and nose was running. Also had sore throat. Covid tests over two days were both negative. Just been back are sore but I think from coughing
Passed out immediately after vaccine taken by ambulance to Hospital came home heart palpitations shortness of breath, heaviness on chest. followed up with the doctor. Followed up in Healthcare emergency room, is now  seeing a Cardiologist. She has had a abnormal Transthoracic Echocardiogram. Moving forward is being scheduled for a Cardiac MRI, hopefully soon.
No adverse reactions reported; patient received one dose of expired VAQTA; This spontaneous report was received from a nurse and refers to an 18-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On 17-JUN-2019, the patient was vaccinated with a one dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), intramuscular, lot # R009953, expiration date 12-JUN-2019 (frequency and anatomical location were not reported) for prophylaxis.  On 17-JUN-2019, the patient received an expired dose of hepatitis a vaccine, inactivated (VAQTA). No adverse reactions were reported. There was no temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008316:
This initial spontaneous report was received from a Registered Nurse and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On 27-JUN-2017, the patient was vaccinated with VARIVAX (lot # M049126; expiration 15-DEC-2018) and diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid (reported as Tdap) (lot # 3457Y; expiration 20-MAY-2019) when she was 15 weeks pregnant. The sterile diluent was unknown by the reporter. The nurse reported that the patient spoke a different language and an interpreter was present for the immunization consent and the patient did not say she was pregnant. No adverse effects were reported. The outcome of the pregnancy was pending. Additional information has been requested.
pt recv vax;next am, pt had ataxia & torticollis;mom felt pt fell down more & staggered more;seen at neurologist;MD felt exam possibly nl;
RUE edema, erythema, welts s/p PNEUMOVAX 23 immunization - 48 hrs previously. Sx not localized to the injection site but encompass the entire right upper arm.
7/22/03 1:30 PM Mother of pt called and stated that about 3 hours after pt received the first of his second post-exposure rabies on Mon. 07/21/2003, he became sleepy and slept for 2 1/2 hours. He normally does not take naps. He also developed a rash on his face and neck-he denies any trouble breathing or swallowing. Mother states no fever and acts normally. She reported it to her pediatrician. The rash has not changed since it first appeared and is otherwise behaving normally. Dr was contacted and advised to either have the mother give him 50 mg Benadryl prior to vaccine or get a titer done with the possibility of having to receive another dose later. The mother decided to give the Benadryl and have him receive his final vaccine on Thurs. 7/24/03. 7/24/03 Mother gave child Benadryl to child prior to 2nd shot. Tolerated well. 7/28/03 Spoke with mother on phone. Child tolerated the shot well. When they arrived home, child slept 1/2 hour-no rash was noted. Mother stated that child had this rash once before when he ate strawberries.
Patient had no symptoms and remains symptom free. At time of injection was h/o of immunoglobuin x 4 doses between 10/26/21 and admission to hospital for ARF on CKD d/t covid on 11/15/21.
Information has been received from a company representative reporting that a physician reported that a female (age not reported) who during the week of 07-APR-2008 was vaccinated with the first dose of GARDASIL (lot not reported) and experienced hives all over her body. By the next morning the hives were gone. No further information is available.
Fainted about 40 minutes after vaccine administered. Had not eaten but became nauseated and could not eat. 300 PM Temp 102. Passed out 2-3 times during day. Went to sleep late afternoon, woke up at 9 PM. Temp resolved; no further fainting. Went to school next morning.
Case number PHEH2013US024868, is an initial spontaneous report received from a pharmacist on 26 NOV 2013.  This report refers to a 71-year-old male patient. His medical history and concomitant  medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309201, expiration date: April 2014) at dose of 0.5 ml intramuscularly on 03 NOV 2013. On the same day after vaccination, he experienced persistent pain at the injection site. He did not seek for medical care from a health care professional at the time of reporting. The outcome of the event was condition unchanged. The seriousness and causality of the events was not reported.
I experienced lack of energy, walking across the house makes me out of breath and when I went to take a shower I fainted and was rushed to the hospital and they said I fainted due to lack of potassium and low iron. I am severely anemic and will be receiving iron infusions from now on.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 19-AUG-2015, the patient was vaccinated subcutaneously in the left upper arm with 0.5 ml doses of MMR II (therapy type was not reported) (lot number K016154 and expiration date 24-SEP-2016). Concomitant therapy was not reported. On 24-AUG-2015 (reported as five days post vaccination), the patient developed rash on her stomach and back. The pharmacist stated that he would recommend cortisone cream as treatment for the event. The outcome of the event was reported as not recovered. The patient sought medical attention, she called pharmacy on 02-SEP-2015 (reported as today). The relatedness between the event and the MMR II was not reported. Additional information is not expected as the reporter did not wish further contact.
Post vaccination, recipient c/o lightheadedness.  He remained awake and alert.  Skin was pale, warm/dry.  Denied any SOB, dyspnea or itching.  Layed recipient on the floor in a supine position with legs elevated.  VS monitored.  Observation (physician) on site.  Assisted to sitting position and then onto wheelchair.  Escorted to observation area and monitored.  Recipient remained awake, alert and conversant.  Ambulatory with steady gait.  Released at 1345 without incident.
Mother reports that 2 hours after administration child's face was swollen and she was taken to ER. She was given prednisone at ER, and recovered. By 8/11/14 the swelling had "pretty much resolved". She had a PPD placed on 8/8/14 as well and returned for PPD read on 8/11/14 and mom said she was much better. She has eczema with dry patches on face and neck.
Fever that went away the next day; This is a spontaneous report from a non-contactable non-healthcare professional or consumer. An adult non pregnant female patient of an unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN, formulation Solution for injection) on an unknown date in Mar 2021 as a dose 2, single for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation (Dose number: DOSE 1, SINGLELot number: UNKNOWNStart date: UNKNOWN). It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in Mar2021, the patient experienced fever that went away the next day. Therapeutic measures taken for fever was unknown. The outcome of the event fever was resolved the next day on an unknown date at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (05Jul2021) Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide#1 and stop Date/Time populated as Mar2021
Neck pain; Neck Stiffness; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUBLOK. On 3rd November 2019, 4 days after receiving Shingrix, the patient experienced neck pain and stiff neck. On an unknown date, the outcome of the neck pain and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the neck pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and FluBlok vaccine on the other arm. The patient experienced neck pain and stiffness and went to the emergency room due to this. The patient went home the same day. The patient was still experiencing neck pain and stiffness.  No further details were provided.
I also got sick after second shot; I was Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: ER8755) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Lot: ER8737), administration date: 09Apr2021, for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I also got sick after second shot"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "I was Nauseous". Therapeutic measures were not taken as a result of illness, nausea.  Additional information: Patient got badly sick this happened all at the above on the day after the covid vaccine it lasted about a week on and some days she felt good , others not so good. She also got sick after the second shot and it was and suddenly this has happened it was nauseous , no material treatment for either one.  No follow-up attempts are possible. No further information is expected.
she had an adverse reaction to the 2nd shot; her arm was sore; her arm was sore and red; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red). At the time of the report, IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient has received 4 doses of the Moderna COVID-19 vaccine so far, including 2 primary doses and 2 booster doses. No treatment medicine were reported.   Reporter did not allow further contact
No appetite 4/3, 4/4 began diarrhea and fevers.
Rcv'd vaccine 3-4-16 Rxn started on 3-5-16 went to urgent care and rcv'd BENADRYL and steroid - arm swollen from shoulder to elbows; picked here on 3-7-16 - S/s improved - Dr advised to continue BENADRYL/MOTRIN PRN.
Got covid vaccine booster and arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen). At the time of the report, VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen) had not resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of got covid vaccine booster and arm got swollen with Adalimumab Solution for Injection was not provided.  No treatment information was provided.
passed out at work; extreme fatigue; body aches for a few hours; This is a spontaneous report from a contactable consumer.  An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the following day, 18Apr2021, the patient experienced extreme fatigue and body aches for a few hours, then she passed out at work. The outcome of the events was unknown.  Information about lot/batch has been requested.
After receiving the Anthrax vaccination, felt light headed and almost past out. Felt light headed for about five minutes.
Injection site red, warm, induration 9x9cm, irregular in size and shape (Per DR). Temp 39.2, arm sore, patient noted fever and chills within 24-48 hours of vaccine. Medical records state cellulitis. msv
ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) 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, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. On 18-DEC-2014 the patient was vaccinated with a single pediatric dose of RECOMBIVAX HB (first dose, 0.5 ml, intramuscular, lot number was not reported). No adverse effects reported. Additional information has been requested.
A legal complaint was received from an attorney alleging that a male child received series of Hib-Titer, Act-Hib, Tri-Immunol, Tripedia, MMR II, and Engerix B vaccines as well as an injection of Varivax vaccine from August 1991 through June 1996. According to the complaint, "as a result of the mercury in the thimerosal-containing vaccination received during these developmental years, the plaintiff now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." This event was considered medically important (OMIC). No further information was available at the date of this report.
The week before I had a terrible migraine. I got sore throat and runny nose and sinus congestion with a cough. I tested at home, and I was COVID-19 positive. I called urgent care they prescribed PAXLOVID, because I have asthma and they thought it would be best. I started feeling better at least 24 hours after starting the PAXLOVID. I was tired for maybe a week or more. It was more tired than normal.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, injection site pain and feeling unwell. On 6th March 2018, the outcome of the headache and injection site pain were recovered/resolved. On an unknown date, the outcome of the feeling unwell was recovering/resolving. The reporter considered the headache and injection site pain to be probably related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe injection site pain and headache, which were resolved by day 3 after vaccination. The patient still felt under the weather almost 1 week after vaccination. The healthcare professional (HCP) who reported the event was not associated with the HCP who vaccinated the patient and therefore was unable to provide lot number or expiry date of the vaccine.
Axillary lymph nodes enlarged; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Axillary lymph nodes enlarged) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a double mastectomy 2.5 years ago and is a cancer survivor.).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (Axillary lymph nodes enlarged) and CHILLS (Chills). At the time of the report, LYMPHADENOPATHY (Axillary lymph nodes enlarged) had resolved and CHILLS (Chills) was resolving.            Concomitant product use was unknown by the reporter.  Treatment information was not provided  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 April 2021  includes reporter contact details was added and Updated event outcome from unknown to recovered resolved
Patient received booster dose at 3 months instead of 5 months after the 2nd shot
Pt had TDaP admin 8/29. Initially develop pain & swelling at site. On 9/4 developed severe itching. No rash, hive or systemic reaction.
She received her first dose of the coronavirus vaccine from Moderna this morning at 930.  15 minutes later at 945 she began experiencing shortness of breath, nausea, and rash on the back of both of her arms.  She was administered 0.3 mg of epinephrine IM into her right deltoid as well as 50 mg of Benadryl and an albuterol breathing treatment.  She was then transported to the emergency department.  On arrival to the emergency department, approximately half an hour after receiving epinephrine states she is feeling significantly improved and her rash has resolved.
Red, swollen, and hot area directly below injection site. (Approximately 4" x 3").