chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine in the morning. She started to experience chills that evening. The next morning she felt dizzy, lightheaded, continued chills, temperature 101.5-102 F. Systemic symptoms resolved after 48 hours. Local reaction of red stripe at or just below injection site, resolved in another 48-72 hours.
I will definitely not be getting the 2nd shot. Swelling and pain in arm. Itching; Bright red rash from elbow to shoulder; Nausea. Lasted 2+ weeks.
Patient years ago had a flu shot which resulted in her arm burning very reddened swelling. On 12/20/13 received FLUBLOK 24 hrs later redness, swelling 4-5 c area peaked at 48 hrs. Redness/pain severe about 6-7 days.
lost some diluent while drawing it up, technique issue; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   Additional Information: GSK Receipt Date: 6-Jun-2022 Reporter's Comments: The reporter was a pharmacist who works for a retail pharmacy. One of the pharmacists lost some diluent while drawing it up for a vaccine and she had to use another diluent bottle.  So, at the time of reporting they had 1 vaccine bottle without a diluent. The pharmacist spoke to the reporter and asked her if she thought there was a quality issue with the vial. She said no. She said that she thinks that it was a technique issue. No patient involvement as they were able to prepare the full dose using a different adjuvant vial (from the same box). The vaccine administration facility was the same as primary reporter. Reporter provided limited information.  No further questions were asked because reporter was not sure if this was considered an adverse event or not.  Reporter was not aware that a report was being filed. Additional Supportive Information: Pharmacists lost some diluent while drawing it up for a vaccine and she had to use another diluent bottle, which led to Wrong technique in product usage process.
Breakthrough case after 3 vaccines Moderna 2/10/21 Lot# 0M1520A ; Moderna 3/10/21 Lot#044a21A;  Moderna 11/30/21 Lot# 004F21A
I am extremely fatigue thinking slower moving slower not getting any better; I am extremely fatigue thinking slower moving slower not getting any better; I am extremely fatigue thinking slower moving slower not getting any better; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 13Jul2021 at 15:45 pm (age at vaccination was 44 years) as dose 1, single for COVID-19 immunization. The patient's medical history included hypothyroidism, high blood pressure, diabetes and lumbar spine surgery (just had lumbar spine surgery). The patient received concomitant medications or other medications in two weeks. The patient previously took morphine and experienced known allergy to it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if post the vaccination, the patient has been tested for COVID-19. On 13Jul2021 at 15:45 pm, the patient was extremely fatigue thinking slower moving slower not getting any better. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if any treatment was received for the adverse events. The outcome of the events was not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Started with neck pain right side on 7/26. Shingles rash broke out 7/29/14.
High fever up to 103 degrees Fahrenheit, body aches, shortness of breath, shivering. He took Tylenol every 2-3 hours, felt better by next morning.
Had severe arm pain which I medicated with Tylenol which became significant body aches overnight. Caused difficulty sleeping even with Tylenol. Continued through the next day but subsided in the evening. Also experienced fatigue and dizziness that same day which also both subsided.
Patient is fully vaccinated and boosted x2  . COVID positive on admission. 77y.o. male with history of lymphoma, pulmonary embolism (June 2021), unintentional weight loss, CAD and glaucoma who presents with hypoxic [SPO2 80%] and tachypneic with conversational dyspnea while performing a 6-minute walk test.  Positive for cough, sputum production, fatigue and weight loss.EKG was negative for acute ischemic changes with negative troponin. D dimer, 1,255.  No significant electrolyte abnormality. A CTA PE study was was obtained and it showed no signs of pulmonary embolism. PET CT, Multiple foci of ground glass opacity with increased metabolic activity in bilateral lungs likely due to infectious or inflammatory process. Malignancy is less likely.  DX: COVID pneumonia. Treatment: oxygen, lovenox, decadron. Patient currently remains hospitalized at this report
This case was reported by a nurse and described the occurrence of not responding to therapy in a 51-year-old female subject who was vaccinated with Hep A + Hep B recombinant vaccine (GlaxoSmithKline) for prophylaxis. On unspecified dates, the subject received the full series of Hep A + Hep B and in 2008 she experienced not responding to therapy. On the morning of 6 October 2008, the subject received 1st dose of repeat series of Hep A + Hep B (1 cc, unknown, right arm) and that afternoon, she experienced a headache described as a dull throb in head. The nurse stated a female subject was vaccinated on the morning of 06 October 2008 with Hep A + Hep B and that afternoon developed a headache, which was further described as a dull throb in her head. These events did not require any treatment and did not last long. The reason Hep A + Hep B was being given was that she had the Hep A + Hep B series before but her body titers were negative when taken in 208. The timing of the previous series was not known. The subject did not have any reactions to Hep A + Hep B during her initial series. The nurse has consulted with the clinic physician and he did not feel this headache was a reason not to continue  the Hep A + Hep B series. Thus the Hep A + Hep B series will be continued as long as the subject is comfortable continuing. At the time of reporting the headache had resolved, the not responding to therapy was unspecified. The healthcare professional considered the events were possibly related to vaccination with Hep A + Hep B.
This spontaneous report as received from an approximately 7 months old physician refers to a patient of unknown gender. The patient's relevant medical history and concurrent conditions were not reported. On 03-MAR-2015, the patient was vaccinated orally with a first dose of ROTATEQ, (dose, lot # and expiration date not reported). On 12-AUG-2015, the subject received ROTARIX as a second dose in rotavirus series (dose, route of administration, lot # and expiration date were not reported). On 04-DEC-2015, the patient received a dose of ROTATEQ, lot # K003208, expiration date 15-DEC-2015, orally (dose not reported) and as the third dose in the rotavirus series. No concomitant medications were reported. The patient was 11 months old at the time of vaccination with the third dose in rotavirus series, which was older than the recommended age for last dose of ROTATEQ. No adverse effects were reported. Additional information has been requested.
Received vaccine (HPV) GARDASIL at 10:05. returned to clinic at 2:45. States she felt flushed and nauseated. States she had a granola bar  to eat today. Unsure if related to vaccine.
Soreness in shoulder, cannot pick up anything. Pain when driving that shoots up to my neck. Pain when moving my arm in certain positions.
Right after receiving the vaccine she started having shooting pain radiating down to her fingertips. she is experiencing muscle and joint pain and hasn't been able to lift her arm. she has been taking tylenol and icing
Information has been received from a healthcare worker referring to unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ lot # K014826, expiration date 28-MAY-2016, orally (dose and dose # were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
injection site pink discoloration; injection site itching; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site pink discoloration), VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE SWELLING (injection site swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection site pink discoloration), VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site pink discoloration), VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
This spontaneous report was received from a registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 07-APR-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # 014587 with expiration date of 15-JAN-2016 (anatomical route of vaccination and dose number were not provided). The patient's concomitant medications were not reported. There was no adverse event reported due to vaccination with VAQTA and no product quality issue was involved. Additional information has been requested.
Patient got vaccine on 9/9. Came to pharmacy on 9/12 complaining of swollen arm and "unable to move it." Did not complain of other symptoms. Stated that she saw PCP 9/12 and was prescribed ADVIL. We had not received it yet.
Puffy left eye (vaccinated on left arm) first 3 days post vaccination. Spotting day 5-7 post vaccination. Not normal to be spotting as it?s only been 1 week post last cycle. Day 7-8 (currently on day 8), puffy right eye. This is more extreme and difficult to open right eye.
Received vaccine at ~5pm. on 1/12/2022,   Noted full body pruritus at ~10 pm.   Diffuse hives noted, but not until 1/15/22 by grandmother.  Improved with topical calmoseptine cream.  Contact dermatitis also at site of bandaid.
Dizziness, slight confusion, lightheadedness severe wheezing (asthma attack) not relieved by rescue inhaler, nausea and vomiting.
Left side facial droop, left side body weakness especially left arm and leg numbness, unable to close left eye, difficulty eating and drinking. hearing loss all on left side.  Eventually diagnosed as Bells Palsy.
Approx 4-5 days p/DTP/OPV/MMR/HIB pt devel temp, & had seizure; 911 called & pt taken to hosp;
Patient was sitting in observation after receiving first dose of Moderna and within 5 minutes began to feel dizzy and visual disturbances.  We gave the patient some bottled water and ice pack and she started to feel better, but ultimately her mother wanted me to call EMS. Ems instructed no food or drink until they got there.  The EMS took her blood pressure which was in the 80s/50s.  The patient said she was feeling better but was fearful of another dizzy spell and wanted to go with EMS out of an abundance of caution.  From the time she received the vaccine to the time she left with EMS it was no more than 30 minutes.
Swelling at site [(R) arm sq] from injection given 9-21-10 - Swelling noted the following day.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced a bad reaction/bad flu. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. Patient recovering from bad flu; outcome of bad reaction: not reported. This case (same patient) linked to 20220412017.
The inj. was administered at 9am on Saturday, April 3, 2021.  I felt fine through lunch. After lunch about 1:30 I started having abdominal pain that peaked every minute or so and increasing with time and intensity with nausea.  At 4:30pm I vomited x 3 what appeared to me my entire lunch.  Abdominal pain continued with nausea and I vomited again x2.  Contents in toilet was all liquid, moss green in color and left a noticeable sweet taste in my mouth.  Pain decreased throughout night and diminished by next morning.  Feeling weaker than normal and will stay on liquids today. Otherwise ok.
Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm ) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm ). At the time of the report, PAIN IN EXTREMITY (Very very sore arm ) outcome was unknown. Not Provided  :Mother case- dose 1
Patient received vaccination without incident. Developed red mark shortly after vaccination which resolved after approximately 3 days. Developed Bell's Palsy on 8/2/2022, 16 days after vaccination. Went to ER and was provided neurological test by two MDs who confirmed the diagnosis, then he followed up with his PCP. Gum, tongue, and lip area were most affected. Slight involvement of the eye and eyebrow. He reports that all symptoms of Bell's Palsy have resolved as of 8/22/2022.
As he was administering the shot in my left arm liquid squirted out and the needle broke; my arm has a lump and it hurts; my arm has a lump and it hurts; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EW0172), via an unspecified route of administration on 24Apr2021 at 13:15(at the age of 49-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public health clinic/facility. Medical history included allergies to Sulpha drugs from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin calcium (ATORVASTIN); lansoprazole (PREVACID); Vitamins (all taken for an unspecified indication, start and stop date were not reported).The patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: ER8730), via an unspecified route of administration on 03Apr2021 (at the age of 49-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public health clinic/ facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 24Apr2021 at 13:15 PM, it was reported that As he was administering the shot in my left arm liquid squirted out and the needle broke, he immediately said uh oh that has never happened, I asked if one the needle was broke in my arm and if I got the vaccine and honestly they weren't sure, my arm has a lump and it hurts and I don't know if I should get an X-ray to see if the needle or part of the needle is in my arm. No treatment was given for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
I passed out on the 5th, went to the ER. I stayed over night, they did their tests and put heart monitor and all tests but never tested me for covid. Because I fell in my office I had bruises, cut and sore arm. They discharged me the next day and gave me heart medication because I had wolf Parkinson white disease back in 2010. So they were checking my heart quite a bit and were concerned because I also had heart palpitations over night. When I got home I was tired and didn't think much of it. The next day on Monday I didn't feel well like I had a fever, normally its 99 degrees when I'm tired but it was 101 and had a gut feeling I should get tested, the next day I got tested and the next day it came back positive with covid. I only had a stuffy nose and fever the first day and after that it was horrible mind-numbing aching pain in my left arm radiating up and down my arm. Eventually I got the monoclonal antibodies within the first week the arm pain didn't subside so the doctor gave me muscle relaxers and that helped. It took a good 2 weeks to get past the left arm pain and came out of quarantine and the arm was very weak.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately January 2016, the patient was inoculated by a pharmacist or physician with the ZOSTAVAX vaccine at drug store as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In approximately February 2016, the patient was treated at a physician office for the onset of a rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Had area 4x6cm that was red, warm and swollen to L upper arm. Cellulitis in affected area.
local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; local reaction with redness, red dots and tenderness in her left thigh; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 10-month-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOCAL REACTION (non-serious), ERYTHEMA (non-serious), RASH MACULAR (non-serious), TENDERNESS (non-serious), outcome "unknown" and all described as "local reaction with redness, red dots and tenderness in her left thigh".  Additional information: It was reported that this call was regarding a ten-month-old female patient. The caller refered that when the patient got their 2-month dose of Prevnar 13, she had what was deemed a local reaction with redness, red dots and tenderness in her left thigh within 24 hours and has been holding off the patients third dose due to the reactions and wants to know if something like what the patient experienced has been reported and if there is any recommendation.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300005752 Same patient and drug, event separated in time;
no additional adverse event reported; expired VAQTA was administered to a patient; This spontaneous report was received from a nurse concerning a 27 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot# S024396, expiration date 12-OCT-2020 (dose and route were not provided) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024396; expirationdate: 12-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Shot was given at 11 a.m. . Adverse symptoms started at 5 p.m. . Maximum fever 102.3, chills, shivering and shaking, body aches, headache, fatigue. I had to call a telemed doctor for advice on reducing the fever as Tylenol was not working. He instructed me how to take Advil and Tylenol together to lower the fever. Also instructed to increase fluids. After a few hours by 9 p.m. fever is 100 and chills have subsided. Still have mild headache and general discomfort.
Woke up middle of the  night with bilateral arm numbness/paralysis and then shooting pain on both  arms and neck.  Lasted up to 5  minutes.  Next day -- pain in both  hands and periods of bilateral arm numbness.  Following evening woke  up in the  middle of the night with bilateral arm numbness/paralysis and pain shooting up fingers to shoulders in both  arms and neck.  Pins and needles on spine and arm and bilateral hand pain and numbness followed for 27 days.
In the evening of 04/11/2023, I started with a postnasal drip and sore throat. I thought was my allergies, so I started taking some allergy medication and started feeling a little better. On 04/13/2023, I developed a fever that got up to 102. It still felt more like sinus congestion. I woke up on 04/14/2023 with fever, aches, and chills. I took an at home COVID-19 test. The results were an abnormal reading. I called my doctor who did an additional COVID-19 test. He prescribed a Z-Pack for me. After taking that for one day, along with Tylenol, the fever subsided. I then lost my sense of smell. I was still having a lot of fatigue and nasal congestion, as well as some diarrhea. By Monday, I was taking Tylenol and Tylenol Sinus and Claritin. My sense of smell came back that day. A few weeks later, and I still have some postnasal drip. congestion, and coughing. I saw my doctor again, who said that the symptoms might continue to linger and to take antihistamines.