chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 218 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 29 October 2013. These 218 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 29 October 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3228AA received on 03 March 2009, dose two lot number C3280AA received on 29 April 2009 and dose three lot number C3362AA received on 14 July 2009 and one dose of DAPTACEL, lot number C3082AA on 31 March 2010 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately three years after the last dose. On 09 September 2013, the subject developed a cough without whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 05 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 05 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 10 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
States she was unable to lift arm the vaccine was given in for 1 week after the vaccine. Was not able to lift higher that shoulder.
08/26/22 presents to ED for "generalized weakness". PMHx of "CABG, DMII, CAD, HTN"
This is a spontaneous report from a contactable consumer, reporting for herself. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 13Sep2017 at single dose for immunization. Medical history included diabetes and blood pressure. The patient was taking diabetes and blood pressure medicines and everything like others do at her age. The patient received the vaccine in the pharmacy as they give the vaccine to senior citizens. The patient experienced a certain area of her mouth had blown up on 25Sep2017. The patient stated "Let's say a week later, I ended up going to the dentist, so I go to a periodontist and she noticed that a certain area of my mouth had blown up". No treatment was provided for the adverse event. Outcome of the event was unknown.
the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, frequency and route of administration) lot # R026722 and expiration date: 17-MAR-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No additional adverse event information was provided.  The vaccine was stored in between 6 Fahrenheit degrees (F) to 14 F for 8 hours and 14 minutes. There was no previous temperature excursion. The storage was recorded by digital data logger.
Patient age 13 yr. 4 months seen for follow-up on acne and allergic rhinitis. Given HPV2 - sat in room for 5 minutes then on way to lobby stopped in bathroom - fainted while washing hands and again en route to exam room. Full recovery in 30 minutes.
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially  associate  with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating.  Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life.  I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
Persistent acid reflux (unusual for me)( didn't respond to TUMS) followed by severe but short term vomiting lasting about 5+ minutes.  I feel fine now (30 minutes later)  Last thing I ate before vaccination was 2 pieces of toast with butter and a banana for breakfast eight hours earlier than the vomiting..
feels her arm sore; body aches; feels her arm sore, had a low grade headache and body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches). At the time of the report, PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
LEFT LEG MUSCLE CRAMPING 9/20/21. SHORTNESS OF BREATH 9/25/21. EVALUATION IN DOCTORS OFFICE 9/28/21. STAT PVL AND STAT CTA CHEST SCHEDULED 9/28/21 3PM. HOSPITAL ADMISSION 9/28/21- CURRENTLY ADMITTED AWAITING SURGERY. CTA RESULT WAS DIFFUSE BILATERAL MULTIFOCAL MAIN SEGMENTAL AND SUBSEGMNTAL PULMONARY PE TO ALL LOBES WITH SLIGHTLY DILATED PULMONARY ARTERY
Two days after injection, the injection site was a small bump and itchy.  Six days later, the area below the site was bumpy and very itchy. The following morning a small area about 1/2 in in length was red and the tricep was swollen. itchy, and hot.
At about midnight on 9/5/02. Parents heard pt cry out. Parents went to pt's room, picked pt up, pt's lips were blue and pt went limp in arms of parent. Mom called at 0900 to office. Pt was seen at 0940 by FNP.
Woke up at 6 AM, got into shower.. passed out, woke up then called out for my boyfriend to help. He ran into the bath to assist me and said that I passed out again and had no breath. I do remember having a difficult time breathing before I went down. He proceeded to call an ambulance which brought me to the ER.  All which resulted in a reaction from the Modern shot. I felt perfectly fine after the shot the day of but not the following morning and the day after that as well. In my 60 years I don't remember ever passing out. Ironically the morning I passed out I was to go and have blood work done for my annual physical which is tomorrow 5/13/21. We shall see what the results are...
51-year-old female with history of intermittent asthma presented to the ED with 1 week of intermittent fevers, myalgias, arthralgias and headache.  Patient reports receiving first dose of moderna vaccine last week.  She initially developed arm soreness followed by chills and body aches.  Subsequently developed frontal headache, photophobia, back pain, nausea and vomiting.  She was seen in the ER on 1/1/21, when her work-up including labs, CT spine, chest x-ray were negative therefore she was discharged home. She continued to have symptoms and also developed bilateral intermittent ear pain.  She also developed rash in her extremities and torso. Rash is pruritic but not painful. reports ongoing history of neck pain for which she sees PT.  Denies sore throat, cough, chest pain or shortness of breath.
loss of smell; lost his sense of taste; difficulties listening; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration as first dose on 13Jan2021 and second dose on 3Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of smell, lost his sense of taste and difficulties listening. The events assessed as non-serious. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was in the office for her vaccines.  After patient received the vaccines she was leaving the office and got dizzy.  Patient had an episode of Vasovagal syncope
Information has been received from a receptionist referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route were unknown; lot number was reported as N05077 with expiration date 30-SEP-2017), which were exposed to unspecified temperatures outside of the recommended range. No adverse event was reported. The reporter had not been information of an adverse experience. No product quality complaint was involved in the report. Additional information has been requested.
Narrative:  73 yo male with Parkinson's, cirrhosis, gout, HTN presenting with malaise and fever after obtaining his second CV19 vaccine yesterday and being admitted with weakness most likely related to being one day out from his 2nd CV19 vaccine. Neuro exam with no deficits except 4/5 weakness in bilateral lower extremities, so low suspicion for CVA. He is unable to ambulate on his own and required 2 people to use the bathroom. Per daughter, weakness has been progressing over last 6-9months. 100.3F on presentation, now 99F. Most likely due to CV19 vaccine. No infectious symptoms of cough, no leukocytosis, CXR without consolidations so less likely pneumonia. CV19, flu, RSV negative. No abdominal pain or TTP on exam, so low suspicion for an underlying biliary pathology that could explain the elevated total bilirubin. Most likely it is elevated due to hypoperfusion from poor PO intake after feeling poorly from his 2nd vaccine. He was admitted overnight for rehydration and discharged with resolution of acute symptoms.
Vaccine may have been store under condition that depart from the manufacture's recommended specification, so the manufacture deem vaccine not viable and recommends a repeat dose of vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing), notes: Other medical history: MCAS; "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Ibuprofen, reaction(s): "known allergies: ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
EXTREMELY FATIGUED; ARM AT INJECTION SITE HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced arm at injection site hurting. On an unspecified date, the subject experienced extremely fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm at injection site hurting and extremely fatigued was not reported. This report was non-serious.
Redness in that area as well; Wednesday morning, I felt it and it felt weird; A blister on the back side of her arm; It's still a little warm to touch after 2 weeks; Itching on back side of arm where I got injection/ it was still itching the next day; thought it was a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks) and VACCINATION SITE ERYTHEMA (Redness in that area as well) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX), TELMISARTAN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced ARTHROPOD BITE (thought it was a mosquito bite) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm) and VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in that area as well). At the time of the report, ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks), VACCINATION SITE ERYTHEMA (Redness in that area as well) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported by the reporter.
On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, but it did not interfere with activity. Then 5/21 PM she noted a discomfort in her chest. By yesterday she had marked chills, felt burning hot, c/o a mild ST and mild nausea and abd pain. Her chest discomfort (poorly characterized in location) worsened and she was brought to ER with concerns that she had another effusion. At the hospital, she had 24 hours of fever and hypotension.
progessively worsening purpura on feet, legs, thighs, buttocks; itching; pain/swelling of legs, hands; sx described by MD as idiopathic hypergamma globulinemia (woldenstrom type), mild lupus vavient (sjogren's synd), ideopathic monoclonogam
cellulitis area devel in a 10 x 12 cm area around inject site of DTP lt thigh; placed on ATB, warm soaks;
Patient developed erythema, swelling a few hours after receiving ZOSTAVAX on right arm, subcutaneous site (back of arm). Erythema spread and pt. developed warmth to touch. Pt. was treated with BACTRIM 7-day course on 6/15/17 and then was seen 6/15, where BACTRIM was stopped and Tx with KEFLEX 500 mg due to spreading of rash.
2 hrs after vaccination, developed severe chills, shakes, fever, called 911, went to ER, had IV acetaminophen and neg labs and CXR.
heart pain within a day of the shot and continuing now to 1 week after; Tightness of chest; Shortness of breath, especially with mild/normal activity; This is a spontaneous report from a non-contactable consumer or other non hcp. A 39-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration, administered on Arm Left on 22May2021 14:15 at SINGLE dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included None, except maybe PMDD. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included fluoxetine 5 mg daily (FLUOXETINE). On 23May2021 the patient experienced heart pain within a day of the shot and continuing now to 1 week after, tightness of chest, shortness of breath, especially with mild/normal activity. Patient did not receive any treatment. Since the vaccination and post vaccination, patient has not been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt sat in store for 30 minutes after injection (20 minutes after feeling faint).  Was feeling well when she left.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-DEC-2012. The reporter stated that they GAVE A DOSE OF EXPIRED FLUMIST which started on 11-DEC-2012. The outcome of the event of GAVE A DOSE OF EXPIRED FLUMIST is unknown. According to the reporter the report was considered to be non-serious. Follow-up of insignificant information received on 29-JAN-2013 from a healthcare professional case opened during log step, no new information to add.
Headache, Flu- like symptoms, low grade fever sore throat, nasal congestion, SOB fatigue, aches, etc.
10 minutes after administration note tightness in throat with swallow which was not there on administration. Rated as a medium discomfort. 153/88-73-12- 99% on room air.
60 y/o male with left arm swelling from mid upper arm to mid lower arm. After speaking with provider possibly cellulitis not associated. However starts at site of injection.
The pt showed mom the area at the right arm injection site evening of 8-3, the red area was about the size of a quarter and was itchy. Today the area that is red is 9cm long, about 9cm wide at the top, tapering down to 6cm on the bottom. The reaction has been assessed this afternoon and is a large local reaction, no treatment given.
shortness of breath, swollen and numb upper lip on right side, swelling and numbness on left side of neck and waste
tightness on one side of neck; tightness of shoulder; A report was received from a consumer concerning a 91-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and developed tightness on one side of neck and tightness of shoulder.  The patient's medical history was not provided. Concomitant medications reported included atorvastatin and omeprazole.  On 30 Dec 2020 at 16:30,, approximately 14 hours and 30 minutes prior to the onset of the events, tightness on one side of neck and tightness of shoulder, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020 at 7:00 am, the patient woke up and felt a bit of tightness on one side of her neck and shoulder, mostly neck. She said it could be because of the way she slept. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcomes of the events, tightness on one side of neck and tightness of shoulder, were unknown  The reporter did not provide an assessment for the events, tightness on one side of neck and tightness of shoulder.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
pt recv vax; rash & pharyngitis, stomatitis devel w/in 4-6  hr p/ immun;
A company representative reported that a female child received an injection of Prevnar and subsequently, became irritable. The irritability resolved after 24 hours. The child also developed an injection site reaction characterized by swelling and pain. She recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar.
Patient received both doses of COVID vaccine ( 1st dose 12/21/20 and 2nd dose 1/12/21). Patient was admitted to  Medical Center on 1/24/21 and tested positive for COVID.
first dose in 2019, second in 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in September 2019).   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient asked, about the Shingrix vaccine, the shingles vaccine and the gentleman wasn't quite sure, he just kind of quoted something from the Disease Control, because he had two of the doses, one in 2019, and one in 2022. But he was kind of unable to tell that, whether he should schedule a second dose in 2022, or whether the 2019 and 2022 already made that the two doses, and he didn't need any more. So he referred me to other areas, other numbers for him to talk to.  But that was the only thing, he didn't know that he quite gave a yes or no.  He didn't need to schedule any more, that was the only negative comment he had received. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.