chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 45-year-old female with past medical history of multiple sclerosis, hypothyroidism, pseudoseizures, conversion disorder, who presents to the emergency department from COVID-19 vaccination clinic after having a reported allergic reaction and seizure-like activity.  She presents by EMS who reports that she was given intramuscular epinephrine as well as IV Benadryl for her symptoms.  EMS reports that they saw generalized convulsive activity while the patient was alert and oriented, he reports this as "pseudoseizure-like activity".  She was receiving her second dose of the COVID-19 vaccination today, she reports that she immediately thereafter got a rash to her torso and became short of breath.  She was feeling well prior to the vaccination.  She denies any other recent acute illnesses including fevers, chills, nausea, vomiting, diarrhea, chest pain.  She says that she is currently undergoing a relapse of her multiple sclerosis and has been wheelchair-bound for 1 month.  This is a 45-year-old female with past medical history of multiple sclerosis, hypothyroidism, pseudoseizures, conversion disorder, who presents to the emergency department from COVID-19 vaccination clinic after having a reported allergic reaction and seizure-like activity.  She presents by EMS who reports that she was given intramuscular epinephrine as well as IV Benadryl for her symptoms.  EMS reports that they saw generalized convulsive activity while the patient was alert and oriented, he reports this as "pseudoseizure-like activity".  She was receiving her second dose of the COVID-19 vaccination today, she reports that she immediately thereafter got a rash to her torso and became short of breath.  She was feeling well prior to the vaccination.  She denies any other recent acute illnesses including fevers, chills, nausea, vomiting, diarrhea, chest pain.  She says that she is currently undergoing a relapse of her multiple sclerosis and has been wheelchair-bound for 1 month.
Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.
PT.felt like he was going to pass out, water given, breathing techniques used, paramedics Arrived,  VSS. Pt waited extra 15 mins & left stable
I received Moderna vaccine. After 1st dose I had slight headaches; after 2nd dose I have significant hearing loss, like someone put sound attenuating ear muffs over my ears, this occured about 4 hours after the 2nd dose (March 29). This feeling went away but now I have constant buzzing in both ears, constantly.  Did not have these problems before the vaccine.
Pt c/o subjective fever, muscle aches, chills, fatigue, and nausea which started the day after injection.
Received 2nd dose of Moderna COVID-19 vaccine on 1/26/21 at around 1300 (unknown lot info). Had a headache that lasted 5 days, resolved. This past Monday headache reoccurred and felt fatigued with body aches and nausea. On Wednesday developed non painful sores (x2) at the back of mouth with LUQ pressure. No trauma or injury. Currently not pregnant.
BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 30-MAY-2021, the subject experienced bodyaches. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, chills, and bodyaches. This report was non-serious.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. The patient has not been sick since the vaccine occurred and appears to be in good health. No symptoms or signs after the patient received the vaccine. The family is being contacted to inform them of what happened and advise them to have the patient get the covid-19 bivalent booster as the patient is due for it and should be revaccinated after the incident.
Given MMR vaccine 3/3/15. Did well until 3/12/15 when rash appeared. Rash maculopapular, generalized, on exam 3/13/15. Per mother lower lip swollen, eyes swollen prior to BENADRYL shot 3/13/15.
High fever after 2nd dose (103.7); This is a spontaneous report from a contactable pharmacist(patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:ELI283), via an unspecified route of administration into the left arm on 19Jan2021 09:30 at a single dose for covid-19 immunisation. Medical history was reported as none.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and gabapentin (GABAPENTIN). The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EH9899), via an unspecified route of administration into the left arm on 29Dec2020 11:00 AM at a single dose for covid-19 immunization. The patient experienced high fever after 2nd dose (103.7; units unspecified) on 20Jan2021 03:00. The event was reported as non-serious and the patient did not receive treatment. Outcome of event recovered on an unspecified date.
mom called 23DEC93 9AM stated pt vomited 3x-large amounts, no fever, or other sx; It started 8PM-930PM @ which time went to sleep; feeling better this morning; mom called MD who felt was the flu;
HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A  and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient supposed to get fluzone high dose but received the FLUBLOK QUADRIVALENT/no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (GMI) (Reference number- 00356636) and transmitted to Sanofi on 12-Nov-2020.   This case is linked to case 2020SA322386 (same reporter).  This case involves a 63 years old female patient who supposed to get fluzone high dose but received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: QFAA2054 and expiry date not reported] via an unknowns route at an unknown administration site for prophylactic vaccination [wrong product administered].  The patient medical history included brain tumor.  The patient past medical treatment(s), concomitant medication and vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing multiple sclerosis.  It was an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  At the time of reporting, patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
covid vaccine given 5/5/2021: pt experiencing mild dizziness and weakness. Patient denies any urgent concern at this time. pt to see PCP (external to system)
Went to go get the vaccine a little after 10am, later that night after 10PM the adverse event began. She started wheezing and coughing sounding very congested, she did take her inhaler that evening. On the following Sunday she was still congested and the coughing wasn't getting better which lead to taking cough syrup. That Monday she went to work however she was coughing later that night and  mucus was coming up. On Tuesday she went to the doctor and was told she was okay and that everything will be fine. Two days later she had a fever running into that Saturday which lead to going to the hospital following speaking to her pediatrician. She was giving antibiotics and Prednisone at the hospital visit.
This is a spontaneous report from a contactable consumer. This 67 year old male consumer was administered with PREVNAR 13, (Lot Number: F80381) unknown dose prefilled syringe intramuscular injection as single dose on left arm at 10:15 AM as a pneumonia vaccination on 26Feb2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. Relevant past product history included an unspecified Flu shot vaccine for an unknown reason in Dec2012. On 26Feb2013 he experienced local reaction at the site of administration, pain at the site of injection, burning sensation and pain in muscles. It was unknown if he had any siblings. Relevant lab data was none. The patient had not recovered from the reported events at the time of the report. Follow-Up (01Mar2013): New information received from the same consumer includes: outcome of events (changed to not recovered for all the events). Follow-up (10-APR-2013) Follow-up attempts completed. No further information expected.
Slight temperature elevation and appetite. Rash on body occuring within 3 days of immunizations. Adenovirus versus Rubella.
16 hours following vaccine administration, patient had vomiting and low grade temp (100 F).  Approximately 28 hours post vaccination, skin rash was noted- a fine papular erythematous rash which became generalized and was pruritic.  No visible lesions involving mucosa.  Possible atypical target lesions on upper extremities.  10 days post vaccinations, skin began peeling, including palms and soles.  Peeling may also have involved tongue.  Currently, still has some peeling of palms and soles. Patient evaluated by the patient's primary care physician who referred the patient to me.  Rapid strep test and strep DNA probe negative.  Pruritus treated with antihistamines. Regarding prior adverse events,  the patient received the DtaP (Aventis C1385AA), Act-HIB (Aventis UA847AA), MMR (Merck 10807) and IPV (Aventis W0869) on 7/9/03.  Within 48 hours she developed a fever to 103-104 F.  She also developed a fine papular rash on her chest which resolved within 3-4 days without exfoliation.
Started sweating profusely, then freezing and shivering. Went to the ER. Given and EKG, Stress test, CT Scan, Ultrasound with inconclusive results. Went to my primary doctors and had an MRI. Was never able to get a diagnosis.
tested positive to SARS-COV2; tested positive to SARS-COV2; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive to SARS-COV2 on 08Jan2021. Today (18Jan2021), he got his appointment to get the second dose. He just wanted to know if he should go to get it or not. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Information has been received concerning a pt who on 03/27/96 was vaccinated with one dose of varicella vaccine. On 06/49/00 the pt experienced a chickenpox out break. Blisters started in the mouth and on the head. The rash was also on the chest and back. She was diagnosed with varicella and treated with calamine lotion. It was noted her father had shingles 2 weeks prior the pt's onset of chickenpox.
No swelling, redness, pain or fever. No abnormal signs or symptoms per mother. Hepatitis A given instead of HIB.
At 11:20AM Patient returned to vaccination room to show that she had developed hives on the right side of body (back, side, and legs).  Patient was experiencing redness and itching--no shortness of breath.  Patient was given 25mg of diphenhydramine.   At 12:30PM Patient returned to show that the rash had cleared considerably and was not having any other issues.  Patient was instructed to be observed by a healthcare provider for 30 minutes, rather than 15, for her second dose.
Moderna, Date: 02Oct2021 / Pfizer, Date: 26Sep2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: 6J6739) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: 011L20A), in left arm, on 11Mar2021 as dose 2, single (Lot number: 031a21a), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 047cZ1a), in left arm for immunisation. The patient's relevant medical history included: "Penecillin" (unspecified if ongoing), notes: Known allergies: Penecillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023 at 21:00, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Date: 02Oct2021 / Pfizer, Date: 26Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day 7; Positive, notes: positive this morning 20Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was taken as treatment for COVID-19 from 04Oct2023 to 09Oct2023
Achy; headache; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), HEADACHE (headache) and FATIGUE (Tired) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: flu in 2023. Past adverse reactions to the above products included No adverse event with flu.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PAIN (Achy), HEADACHE (headache) and FATIGUE (Tired). At the time of the report, PAIN (Achy), HEADACHE (headache) and FATIGUE (Tired) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745339:Wife's case
The night of her PNEUMOVAX vaccine, the patient reported shivering, being "freezing", teeth chattering, and right hand contracting with it being hard to pull her fingers back down. Patient took TYLENOL 1000 mg with some relief. The next morning she reported a fever of 99.8 F and felt weak and hoarse. The following day she reported a light pinkish/red mark/line that was hard under the line and burned/stung. Reported that it was hard to move arm using shoulder muscle. Pain was relieved by TYLENOL and icing.
On 5/2/21, 5/5 or 6/21, and 5/8/21 during my usual/normal active/fast walking I had extreme pain and tightness across my chest, with radiating pain from my breastbone through to my back and pain down my left arm to the point of either causing me to slow my steps or stop walking completely and sit down. After 5-10 minutes the pain subsided enough to allow me to continue walking at a slower pace until I reached my destination. At the same time and continuing I had "fluttering" in what seemed to be my heart but was never confirmed so perhaps it was my breathing. This fluttering would occur after exercise or exertion and eventually I called my doctor about it and was directed to the ER at Hospital. on 5/17/21. An EKG was done which showed irregularities from one done five weeks previously.   I was given a bed and a heart monitor was attached to me.  A troponin test was done showing 60, which was up from 20 five weeks previously.  I was told this most probably indicated a heart blockage.  An ultra sound on my legs and chest area were performed with no blood clots found.  A heart catheterization was done 5/18/21.  Instead of finding arterial blockage, a Spontaneous Coronary Artery Dissection (SCAD) event was identified. A CT scan was performed, looking for arrhythmia's with negative results. The heart monitor data was reviewed and my heart was working normally. A baby aspirin per day was prescribed. I was discharged on 5/20/21 and have no ongoing symptoms of the SCAD event. I have no personal or family history of cardiac issues. Furthermore, the fluttering sensation I was experiencing from 5/2/21 through approximately 5/23/21, which I termed a "heart flutter" never showed up on the heart monitor data from the hospital. A pulmonologist was consulted and found no irregularities. Note: I received my first dose on 3/30/21 at 2:30pm. I received my second dose on 4/28/21 at 12:30p. The heart pain described above began just 4 days after this.
Hives began on 2/1/22. Appeared on extremities and head progressed to entire body over the next few days.  Has continued since that date. Is controlled with antihistamines and topical ointments. If combinations of antihistamines are not taken hives reoccur quickly.
Initial report received on 18 December 2009 from a consumer who is also a health care professional. A 21 year old female patient with a history of asthma, food, and environmental allergies (concomitant therapy included Albuterol and ASMANEX) complained of an upper respiratory infection 1-2 days later and severe gastroesophageal reflux disease an unspecified amount of time after she received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP006AA) on 04 November 2009. The patient was seen in the emergency room and was started on ZANTAC and PRILOSEC on an unspecified date. A few days later, during the morning hours of 15 November 2009 or 16 November 2009, she started developing tingling and swelling, also described as a "tight feeling", in her extremities. The symptoms have been getting worse with episodes throughout the day and night. According to the patient, these symptoms were worse in her feet than in her arms. The patient was scheduled for a visit with the neurologist on 21 December 2009. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Mild symptoms similar to those of a flu vaccination but a little stronger. Injection site was sore for about 3 days maybe a bit still on the 4th. Also felt tired and spent more time sleeping than usual. All symptoms were gone within 5 days of the vaccination I would say.
This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is first of 2 reports for patient 2. A 20-year-old female patient received, on 05Jun2015, the first single dose of TRUMENBA. Relevant medical history included pink eye form 2015 (ongoing). Had no allergies. Concomitant medications included birth control pills and antibiotic for Pink eye. On 05Jun2015, the patient experienced minimal pain at the injection site. No treatment was provided. Laboratory tests were not performed. The patient recovered from the adverse event on 05Jun2015. The same reactions occurred to her sister after first and second vaccination with TRUMENBA performed respectively on 05Jun2015 and 04Aug2015.
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead  with mild erythema including eyelids,  mild circumoral numbness with occasional burning/stinging sensation.
Red swollen left arm from shoulder to elbow.  Feverish & sore under arm & side of left breast.
mom states slept several hrs-hard to wake up-cries while sleeping as if in pain;
Lymph node swelling as large as an egg. Pain in underarm and shoulder, neck area as well as injection site in arm. Fever, chills, muscle aches. Started within 24 hours. Lasted more than 72 hours. Lymph node is still swollen.
Patient felt pain at injection site at the time of injections and states pain is still there at night. Told patient local pain is normal and called pt later to see if ok. Stated she still had a little pain. Instructed her to take TYLENOL. To this date she says she still feels pain.