chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; It was stated that the patient was 4 months pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (COVID-19) and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant). At the time of the report, COVID-19 (COVID-19) outcome was unknown and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had symptoms including sore throat, runny nose, and body aches.  Concomitant and treatment medications were not provided.  Company comment This spontaneous case concerns a female patient of an unknown age with Maternal exposure timing unspecified and no medical history reported, who experienced the unexpected, non-serious event of COVID-19. The patient received the first and second dose of mRNA-1273 vaccine. It was reported that the patient was experiencing symptoms including sore throat, runny nose, and body aches and tested positive for COVID 19. She reported also that she was four months pregnant. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Vaccination failure could not be assessed since the exact vaccination dates are unknown.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with Maternal exposure timing unspecified and no medical history reported, who experienced the unexpected, non-serious event of COVID-19. The patient received the first and second dose of mRNA-1273 vaccine. It was reported that the patient was experiencing symptoms including sore throat, runny nose, and body aches and tested positive for COVID 19. She reported also that she was four months pregnant. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Vaccination failure could not be assessed since the exact vaccination dates are unknown.
Shingles: Splitting headaches Blisters Severe Body aches Fatigue
Case previously recorded as MA2009-3291. Initial case report received from a health care professional via MedCom on 26 OCT 2009. The patient, age and gender unknown, was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) on 23 OCT 2009. The patient, under 4 years, was inadvertently given Novartis H1N1 vaccine. No adverse event was reported. Reference no.: NA09-007031.
Post vax, the patient experienced hives. The patient recovered from their experience. The physician also reported 4 other patients who developed hives after being vaccinated with varicella virus vaccine live. Additional information has been requested.
at 11pm started to lot of soreness, lump in armpit. Periods of feeling very hot, chills and profuse sweating. woke up at 11pm, 1am, 3am, 5am 'woke up every few hours with intervals of profuse sweating'. 12/18/2020 feels like 'never happened' other than some soreness in arm.
Associate notified this nurse that after receiving the influenza vaccine on 09/28/2022, associate woke up with a painful blister on her tongue and on her chin.
Mouth sores:  first one (upper left side of cheek inside mouth) appeared about 3 hours after shot.  Second one (inner & outer upper lip on right side) appeared about 36 hours after shot.  Third & fourth (one in back of throat & one on right side of tongue) appeared 2 days after shot.
This spontaneous report as received from a nurse practitioner refers to a 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUNOVAX 23 (lot # H013399, expiry date was 07-MAR-2014 and route was not reported) 0.5 milliliter (ml) in the ar. The nurse reported that at least 3 patients who were vaccinated with the same lot of PNEUMOVAX 23 developed huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and were prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX 23 before. The outcome of all the reported events was unknown. Additional information has been requested.
injection site became red, swollen, itchy, painful and hard lump under the skin within 24 hours of injection.  Appears that injection was not given in the muscle but below.
Headache, fever (102 oral 101 oral) nausea x1 emesis inj. site/arm hurt. Felt better later afternoon 6-25-15.
subcutaneous injection rather than intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her 1st dose of Shingrix 28-SEP-2019 as a intramuscular injection in her left arm.).   On 30-DEC-2019, the patient received the 2nd dose of Shingrix (subcutaneous, left arm). On 30-DEC-2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: subcutaneous injection rather than intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 27 June 2023 The reporter was a patient who was a nurse, and reported that she received her 2nd dose of Shingrix, 30-DEC-2019 in her left arm as a subcutaneous injection rather than intramuscularly. The reporter consented to follow up. This case was linked with the case US2023089239 reported by same reporter. The patient received shingrix as subcutaneous injection rather than intramuscular which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2023089239:Same reporter
Event occurred after 2nd vaccine. First vaccine was on 5/14/21 and the second one on 6/11/21. Pt tested positive for COVID-19 on  1/20/22.
Post vaccine pt became dissy and felt lightheaded. Pt transferred to med obs via wc. Pt reported feeling better after sitting on stretcher. Vitals obtained and monitored. Pt had no complaints of chest pain. Pt had no complaints of SOB. Pt released at 14:21. Vitals as follows: 1407 LYING BP 161/89 HR 80 RR 18 SpO2 100% 1419 SITTING BP 136/83 HR 73 RR 18 SpO2 98%
I took a positive pregnancy test on 9/17/21. This was my first pregnancy. I received the Janseen Vaccine 9/28 against my better judgement. I was mandated by the mayor. I started bleeding heavily on 10/3.  I reported to the doctor 10/4 the baby was measuring 5 weeks with no heart beat. This was a week behind what I originally thought. I believed I should have been 6 weeks based on my menstrual cycle. I continued bleeding and cramping the whole week. I returned to the doctor 10/12 and the doctor confirmed I had miscarried. The doctor said it?s possible the baby stopped growing at 5 weeks ( which is when I received the vaccine).
Developed hives on 06/25/02. Not itchy, no fever. On no other medications, no known exposure to others. Started on Benadryl. T-98.2, P-104, R-20.
Got shot noon Thursday no adverse effects besides moderately tired until 3pm Friday.  Then fatigue set in, headache, fever of 101, and lymph nodes in left arm very tender and swollen to size of goofball. Night sweats on Friday night and struggling to sleep because of tenderness under arm. Saturday morning adding left lymph node in collarbone area swollen. Both were swollen the size of eggs, warm to the touch and very tender. But no more fever. However still fatigued. The injection site still warm, slightly swollen, and patches of red on left arm. For 5 days my left arm ached, tingling and began to feel numb. Used ibuprofen, Tylenol, cool and warm compresses, and slept a lot. Woke Monday to now adding right collarbone lymph node starting to swell. Called Dr on Monday and went in at 4:30pm. Just continued same home treatment understanding it may take weeks to get back to normal.
04/07/2021 injection site began hurting 2 months after, then radiated 12 inches down my left arm and I have muscle and joint pain in both hands, in my index fingers, it hurts if I tap my finger, like a pressure pain when tapping on things like a keyboard. I have weakness in both legs when sitting, if I lift them and it is also present when I go upstairs, hip pain as well in both hips but more in left hip, I also had 6 weeks of sciatica, which I never had before.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: LEFT ARM SIZE OF SOFTBALL
at the 6 month mark, the liquid portion only was given instead with the powder (act-hib component) with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old and unknown gender patient who was given diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] at the 6 month mark, the liquid portion only was given instead with the powder (act-hib component) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunization (product preparation error) (latency- same day).  Patient got PENTACEL at the 2 month, 4 month and plans to get for the 12 - 15 months mark but at the 6 month mark, the liquid portion only was given instead with the powder (ACT-HIB component). The caller is asking if the patient is completely protected because they've gotten all of PENTACEL at 2 months and all of PENTACEL at 4 months then they missed the powder potion at the 6th month and they are going to get all PENTACEL at 12 to 15 month.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
patient developed raised red, itchy rash on chest - same side where shot was administered; responded well to Benadryl
in correlation with the first shot, she has not had her period since then; she had a very strange light period, it never became a real period, just spotting the whole time; This is a spontaneous report from a contactable consumer (patient). A clone report is created to document the friend experience. This is report one of two. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736, Expiry date: unknown), via an unspecified route of administration, administered in arm right on 04Jun2021 16:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was none. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN, Tablet) for sleep, norethisterone (MANUFACTURER UNKNOWN, Tablet) for birth control, norethisterone (DEBLITANE, Lot number: 20076009, Expiry date: Oct2022) for birth control. It was reported that patient took COVID vaccine to protect her children. Investigation assessment was no. She did not take any other vaccines within 4 weeks prior COVID vaccinations and no AEs following prior COVID vaccinations. On an unspecified date, it was reported that in correlation with the first shot, she has not had her period since then, she had a very strange light period, it never became a real period, just spotting the whole time. Now she has not had another period at all in Jul2021, Aug2021 and Sep2021. She has not had any tests or treatment yet and not visited emergency room or physician office. The seriousness of the event in correlation with the first shot, she has not had her period since then was serious and medically significant and the other was non-serious. The outcome of the event in correlation with the first shot, she has not had her period since then was not recovered and other event was unknown.  No follow-up attempts possible. No further information expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    This case was linked to MOD-2021-012462 (Linked Report).; Sender's Comments:  MOD-2021-012462:same reporter, different patient
26JUL98 11AM pt devel chickenpox-like rash (fine pin-point red rash all over body);28JUL98 devel T106 R @ 430AM;pt taken to hosp;had CXR, blood workup & MD r/o meningitis, pneumonia & the rash didn't devel pustules;dx viral illness;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of RECOMBIVAX HB (lot # M023718, expiration date 09-AUG-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
his throat started swelling; he had hives/a rash about 1-2 hours; he had hives/a rash about 1-2 hours; had an allergic reaction; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 52-year-old male patient who experienced his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed non-serious his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "consumer wants to know the ingredients in FLUZONE QUADRIVALENT. He states that last year he took the vaccine and had an allergic reaction and is trying to find out if he can get the Covid-19 vaccination. He is not even sure what brand of "flu shot he had". He wants to receive a Covid-19 vaccine but since he had a reaction to another vaccine his Doctor wanted him to do "research" on the flu vaccines he might have received. He stated that he had hives/a rash about 1-2 hours after receiving the flu vaccination and he was given BENEDRYL by urgent care. Shortly after he started seeing the hives/rash his throat started swelling. Urgent care gave him another "BENEDRYL like medicine". He thinks this occurred in October or November of 2020. Both conditions resolved shortly after each medicine was administered".  Details of laboratory data were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL).  At time of reporting, the patient was recovered from the events.  There will be no information available on the lot number for this case.
After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.
pt recvd vax & Lt arm became swollen; arm was edematous & erythematous & hot to touch; pt penis also became swollen; took to pmd who told mom it was vax rxn;
Pt went to ER on 08/13/2009 for local reaction of right  arm. Pt was treated with Benadryl 25mg IM, prednisone 40mg po, Zantac 150mg po. Today, pt c/o right arm numbness, burning, itching, and soreness.
pt recv vax & exp severe rash requiring visit to ER or MD. 4 other pt w/similar rxn WAES97050025 through WAES97050028
Fever; Headache; Chills; Achy; Slept all morning; Little nausea; This case was reported by a consumer and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and had no problem).   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, chills, pain, daytime sleepiness and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, pain, daytime sleepiness and nausea were unknown.   It was unknown if the reporter considered the fever, headache, chills, pain, daytime sleepiness and nausea to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, the patient received Shingrix and started experiencing symptoms that night. The patient experienced fever, headache, chills, achy, and a little nausea. On the reporting date, the patient did not went to work. The patient slept all morning for 4 hours and started to feel a little better compared to the morning on the reporting date. The patient had been taking Tylenol every 4 to 6 hours and thought that had helped. The patient had not reported these events to her doctor. The patient asked that how long would the side effects of the shingles shot last.
Patient had local inflammation reaction at site of injection, then few days later a itchy rash appeared on stomach that dr thought was a reaction to the vaccination
patient reports moderate neck pain that radiates down her left arm. this arm is different than the one she got the vaccine in, but stated that it started right after the shot and is still causing problems as of 2/21/20
Aching pain. Bruise about 2 inches down from top of shoulder. From the aching pain, I feel faint and nauseated.
Starting in August in had a persistent cough that would start in the morning, go away by afternoon, then come back in the evenings. It did tend to be a bit productive. After three months of dealing with the cough that did not want to go away, I made an appointment with my family doctor who referred me to a Pulmonologist. I was able to get into the Pulmonologist to discuss my symptoms he did a breathing test. I did very well on this test. He recommended a saline nasal rinse and gave me azelastine/fluticasone nasal spray that made me dizzy and sick. I stopped it after a couple of weeks. By the early part of February, the coughing had finally stopped.
Patient received the vaccine on 31-Mar-2022  which had got expired on 24-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022  which had got expired on 24-Mar-2022) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022  which had got expired on 24-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 31-Mar-2022  which had got expired on 24-Mar-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the second booster dose.  Patient received the vaccine on 31-Mar-2022 which had got expired on 24-Mar-2022.  Concomitant drugs were not reported.  Treatment details were not given.
Chills, headache, fever, muscle aches, sore arm, nausea, fatigue lasting for 3 days
Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; unknown lot number received on 23 January 2012, lot number C4026AA received on 06 March 2012 and lot number C4275AA received on 06 June 2012 (routes and sites of administration not reported). The subject developed cough on 03 October 2012, approximately 4 months after the last dose. Paroxysmal coughing (without a whoop) began on 09 October 2012 and cold-like symptoms developed on 17 October 2012. The subject also experienced posttussive vomiting, sleep disturbance, and apnea (dates not reported). Laboratory testing included positive PCR on 09 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 23 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient reports, blurry vision, headache, facial swelling, parts of the mouth swelling, specifically tongue swelling. No reported problems with breathing or airway restriction. Patient did not seek medical care for adverse event.
Temp went to 105 same night immun given; Parents were giving APAP as directed but did not bring fever down; Taken to Hosp where was treated for fever;
Shortness of breath middle of night. Accompanied by fever, fatigue, headache, dizziness and nausea