chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max; next menstruation was OVER 3 weeks LATE.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2022 at 09:15 as dose 1, single (Lot number: FK5618) at the age of 11 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [LORATADINE]. Vaccination history included: Flu shot (known allergies Flu Shot), for Immunisation, reaction(s): "allergies: Flu Shot".  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Mar2022, outcome "unknown", described as "Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max"; MENSTRUATION DELAYED (non-serious) with onset 04Mar2022, outcome "unknown", described as "next menstruation was OVER 3 weeks LATE.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed. Additional Information: No other vaccine in four weeks. Other medications in two weeks- Claritin. No COVID prior to the vaccination. Adverse event- Menstruation after receiving first dose lasted 2.5 weeks, typically only lasts 4-5 days max. Then after that period, next menstruation was over 3 weeks late. No follow-up attempts are possible. No further information is expected.
SEVERE ARM SORENESS. MUSCLE & BONE ACHES ALL OVER BODY. EXHAUSTION,
Headache & Myalgia Narrative:  DOSE 1-DAY 1-2; INJ SITE MUSCLE PAIN;FATIGUE; HA DOSE 2 DAY 1-3 INJ SITE MUSCLE SORE;FATIGUE; MYALGIA
Pt. noted fine, non raised rash on abdomen and back on Saturday evening 4/19/14, denies itching, fever, joint pain or other sx., resolved spontaneously 4/21/14.
palpitations, arrhythmia w/ dizziness and shortness of breath, prompted patient to go the the hospital
Case fully vaccinated with Pfizer with second dose administered on 2/18/2021. Tested positive for COVID on 9/24/2021. Admitted to Hospital on 9/24/2021 and expired on 10/16/2021 while still hospitalized.
chills, fatigue, headache, fever up to 102.3, sore throat, lack of appetite  Illness lasted about 27 hours.
Starting on 07/28/2022, I started having a lot of body aches all over and chest pain. My back was throbbing at one point. I had some nausea and threw up once. I also had a fever which lasted for a full week. Thursday, Friday, and Saturday, the fever was over 100 degrees. On Thursday, it got up to 102. Sunday and Monday, it was between 99.5 and 100.5. I saw my PCP on Tuesday and my temperature was still elevated to 99 degrees and they said that they could feel the heat radiating off me. My temperature is normally around 97.7 degrees. My doctor did not prescribe anything or do a COVID-19 test. They advised that I treat with Advil and Tylenol and call back if things worsened. My fever finally broke on Thursday and got back down to 98 degrees.
No adverse event; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 26-MAY-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U024508 with expiration date: 02-FEB-2023, as prophylaxis (dose and route of administration were not reported). The vaccine suffered a temperature excursion at 8.3 F degrees for 15 minutes. There were no previous temperature excursions. No adverse event was reported.
Sore arm, headache, aches, chills, fever of 102.6.
BACK SORE; CAN BARELY GET OUT OF BED; ALL JOINTS SORE; This spontaneous report received from a patient via a social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 1) (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination. No adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2), the patient experienced back sore, all joints sore, and can barely get out of bed. The reporter stated that "I work construction. since my booster my back is sore along with all my joints. And i can barely get out of bed. I have not missed a day in over a year so iam not a whiner. And for those who say believe in science. Its not a vaccine by definition. Vaccines you get once". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back sore, all joints sore and can barely get out of bed was not reported. This report was non-serious.  Version created to amend previously reported information on 09-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Mild fever, bad soreness, dizzy, numb arm, headache, body aches on left side of body
The vaccine contained A/Michigan/45/2015 (H1N1)pdm09-like virus; an A/Singapore/INFIMH-10-0019/2016; AND B/Colorado/60/2017-like virus (B/Victoria/2/87 lineage). Quadrivalent vaccine also includes a B/Phuket/3073/2013-like (B/Yamagata lineage) virus. The symptoms were: itching and tingling and I took ZYRTEC; I went back to the room where the nurse was because I began to have the increase need to swallow. Approximately 10 minute later, I became disorientated, confused, and unable to respond. The nurse gave me EPI and BENADRYL. The ambulance was called and I was given more BENADRYL in the ambulance. At the hospital I was given DECADRON and BENADRYL again. I was observed for 3 hours and released. I am scheduling appointments with my allergist and primary doctor.
Information has been received from a registered nurse, concerning her 88 year old male father in-law, with a history of renal failure (patient had 20% of renal function), who on 21-MAR-2011 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). Nurse reported that about 10 days later, her father in-law developed a body rash that was extremely itchy. On an unknown date, the patient visited an urgent care, where he was treated with a five day course of oral prednisone. Three days later, the rash worsened. The rash was described as full body, all areas affected except palms of hands, soles of feet and face. The legs had pustules on them. Nurse reported that patient could not wear shoes due to the discomfort from the rash. Nurse also reported that patient was experiencing body ache, fatigue, constipation, loss of appetite and breathing difficulty. She stated that on 29-APR-2011 patient visited the Emergency Room for the worsening rash. Blood work was drawn (results inconclusive) and a chest x-ray was taken (no pertinent findings). Patient was given IV fluids and discharged the same day. Nurse reported that the rash continued to worsen. Patient then, on 06-MAY-2011 visited his family physician, who admitted him into the hospital. Patient was treated with IV steroids and more unspecified tests were performed (results not provided). On 07-MAY-2011 Patient was released and at the time of the report was still afflicted with the rash. IV prednisone, CALAMINE and BENADRYL were given as treatment for the events. Nurse stated that patient was scheduled to visit his physician on 16-MAY-2011. At the time of the report the patient's outcome was not recovered. Breathing difficulty, constipation, loss of appetite, fatigue, body ache, body rash that was extremely itchy and the legs had pustules on them were considered to be disabling. Additional information has been requested.
Patient reported that on 09/12 (3weeks after the vaccine) she had a stroke.
PATIENT WAS PROVIDED 0.1 ML INSTEAD OF THE REQUIRED 0.5 ML; PATIENT IS SCHEDULED FOR 9/23 TO RECEIVE FULL DOSE ?Moderna COVID-19 Vaccine EUA?
The 6m-5 years was given to 6yo by mistake. No adverse reaction noted. Mom has been notified by the PCP. They will revaccinate in 8 weeks as recommended.
having Covid 19 after he got both doses of the Covid Vaccine; Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as 1st dose, single and 2nd dose, single (Batch/Lot number was not reported) for Covid-19 immunization. Medical history included heavy smoker and alcoholic (heavy drinker). The patient's concomitant medications were not reported. It was reported that the patient was hospitalized after having Covid 19 after he got both doses of the Covid vaccine. The patient ended up diagnosed with Covid 19 on an unspecified date and was hospitalized in the Intensive Care Unit on an unspecified date. The patient is currently out of the hospital. The outcome of events was unknown.  Information about lot/batch number has been requested.
Mom noticed 2 dots of redness and progressively got worse during the day. Mom noticed this a.m. approx 08:00.
Information has been received from a medical assistant to multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (strength, frequency and route not reported, lot # L033693 and Expiration date 31-MAY-2017. The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red rash on the tops of both of thighs; the pattern resembled a net or web. It did not hurt or itch or burn, and no other symptoms. Occurred after sitting outside for 2 hours for lunch in the sun (but legs were covered by pants, so not a sunburn). The rash faded slightly and then intensified again over the course of the day/night. The next day it was gone and it has not yet returned. Appeared 8 days after my 2nd vaccine shot (Pfizer).
weak; nauseated; body aches; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of weakness in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAR-2023, the patient received Shingrix. On 17-MAR-2023, less than a day after receiving Shingrix, the patient experienced weakness (Verbatim: weak), nausea (Verbatim: nauseated) and general body pain (Verbatim: body aches). On 11-MAY-2023, the outcome of the weakness, nausea and general body pain were resolved (duration 1 month 24 days).   The reporter considered the weakness, nausea and general body pain to be related to Shingrix.     The company considered the weakness, nausea and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-OCT-2023 The reporter called to provide the allergic reaction patient had to vaccine first shot. The patient felt nauseated, was weak and had body aches for 2 to 3 weeks and did not get 2nd dosage
Dx by MD 18NOV91 bilateral brachial plexitis (L>R), probably post vax; 48 hrs post vax c/o nausea, malaise; 96 hrs post vax upper ext weakness (L>R) w/painful fasciculations; difficulty fine motor control, myalgias, arthralgias, back pain;
headaches; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter. No treatment information was provided.
he collapsed twice; has difficulty standing up; he got sweats; got a fever; he was exposed to COVID a week and a half ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID. The reporter is the parent.  A 22-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "transgender" (unspecified if ongoing), notes: He is also transgender and is taking estradiol 2mg and spironolactone 50mg for his transitioning.; "autistic" (unspecified if ongoing), notes: autistic; "COVID", start date: Aug2022 (unspecified if ongoing), notes: he did have COVID in Aug2022 very mild case. Concomitant medication(s) included: ESTRADIOL taken for transgender hormonal therapy; SPIRONOLACTONE taken for transgender hormonal therapy. Vaccination history included: Covid-19 vaccine (Dose 1, manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), manufacture unknown), for COVID-19 immunization. The following information was reported: DYSSTASIA (non-serious) with onset 09Dec2022, outcome "unknown", described as "has difficulty standing up"; SYNCOPE (medically significant) with onset 09Dec2022, outcome "unknown", described as "he collapsed twice"; PYREXIA (non-serious) with onset Dec2022, outcome "unknown", described as "got a fever"; HYPERHIDROSIS (non-serious) with onset Dec2022, outcome "unknown", described as "he got sweats"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Dec2022, outcome "unknown", described as "he was exposed to COVID a week and a half ago".  Additional Information: Reporter said that her son is 22 years old and he's autistic. He got his first vaccine, second vaccine, his first booster and she took him to get his second booster yesterday. He had no problems with the other boosters, but they found out yesterday that he was exposed to COVID a week and a half ago. Her son was 250 pounds and he passed out on the floor. They tried to get into him and got him to his room. He sweats and he has a fever. Reporter wants to know what things she needs to do. Should she bring him to the hospital or give him another COVID shot. He just got into bed, and he is now sleeping. He had no problems with his previous doses, and he did have COVID in Aug2022 very mild case. Reporter stated that her son got exposed at college. Reporter stated that she has got the COVID test out and will test him when she was done with this call. Reporter declined a safety report at this time because of the severity of her son's condition, reporter stated that she would like to immediately call the provider, reporter stated that she was shaking and very anxious because she woke up finding her son the floor and would like to do the report as follow up  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
About 2-3 hr after vaccine administered had about a 1 hr episode of severe shaking, as if he was freezing, but yet he wasn't. He sat in his car for the hour & had the heater on full blast till if subsided. Same incident happened last yr. when had HD Flu. No reaction to post doses of Flu.
Patient reported "radiating pain" from the injection site to the fingers. Also reported a minor "tingling" sensation near fingers from approximately 600pm on 1/8/13 until the morning of 1/10/13. Also reported some redness and swelling at site which resolved by 1/10/13.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 with Paxlovid. The patient did not have any known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
rash broke out all over my neck; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231; expiration date not provided), via an unspecified route of administration in the left arm on 04Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Mild anxiety, Sjogrens, Perimenopausal, and Allergies to tree nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram and estradiol (ESTROGEN). On 10Jan2021 06:00, 6 days after injection, the patient had rash broke out all over her neck which has not fully resolved after treatment with oral prednisone 20 mg for 10 days. The outcome of the event was not recovered. The patient has not been tested for COVID post vaccination.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Injection site in Left Deltoid was very swollen, red, warm to touch.  Client complained of tenderness.
rt arm tender, swollen, warm, dec ROM achy;erythematous 4cm rash;allergic rxn;tx w/Medrol dose pace  & claritin;
Period started 03/20 after just getting off 03/11. Lasted 12 more days with light spotting, heavy clotting and cramping.
Presented to ED 10/8 w/ c/o loss of appetitie associated w/ n&v; tested + Prior to ED encounter, pt had tested +COVID 3 days prior & received monoclonal but was not improving hence pt presented to ED; pt admitted for COVID-19 PNA; 10/8 - tx w/ cefipime, decadron, remdesivir, zinc; pt did not require anything above 2L NC during stay and was weaned to RA on discharge.
Diarrhea; Nausea; Dizziness; Fever; Chills; Aches; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and unknown if patient had been tested for the COVID-19, post vaccination. On 05Mar2021 at 19:00 hours, patient experienced diarrhea, nausea, dizziness, fever, chills and aches. Patient received no treatment for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
A nurse reported that a 75 year old male received an injection of flu shield on 11/28/2001. Immediately after receiving the injection, he developed a "soreness of left arm." He was treated with prednisone. After completion of the prednisone therapy, he complained of "overall muscle aches." Follow-up info received on 02/11/2002 indicated that he was diagnosed with polymyalgia rheumatica. A sedimentation rate was 57. FOLLOW-UP information received on 05/06/02 indicated that the physician believes that there is no relationship between polymyalgia rheumatica and the vaccine administration. The physician believes that the polymyalgia rheumatica has resulted from a progression of symptoms over many months.
4 hours after first dose, patient reported a rash that started at the injection site and spread up the arm and onto back. Pt reported that the rash lasted for 3 days and was itchy.
3RD DOSE PFIZER COVID VACCINE GIVEN 6/16/22 #FP7135; pt had a positive COVID test 10/3/22 at a local health care facility (SNF);  pt admitted to a local hospice facility on 10/14/22; with PVD dx and GIP for pain; pt passed away in the hospice facility
I experienced ?brain fog? or some sort of neurological episode which has been continuing off. I wasn?t able to talk and while looking in my cellphone camera I couldn?t locate my face. I just sat and stared. I experienced an intense headache after and currently experiencing the headache.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 09-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K007982, expiration date 03-JUN-2016, dose, frequency and route were not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.