chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA; Ever since 3/8/21 I've experienced consistent nausea (over a month duration as of today). I have not had any new medical conditions, nor has anything changed with my medical history, before or after the vaccine.
States she had hepatitis b vaccine at another facility and then came to health department for Td on 9/1/04. Within 3-4 hrs had flu like symptoms with aching, cough, runny nose and sore throat with lethargy. Right deltoid very tender to touch but no swelling or redness at this time. Unable to lift arm over head or behind back. Very stiff. States she did move arm alot yesterday to try to keep stiffness down but could not even move arm this morning when she woke up. Took Motrin with some relief of pain.
Information has been received from a female who a year ago was suppose to get ZOSTAVAX (Merck), but by mistake the prescription was written for VARIVAX. The consumer reported that she had then received three doses of VARIVAX. No AE involved. Consumer did not want to provide physician information. Further information is not expected.
Pt reported "bone pain",  pain behind eyes, sore throat, malaise, severe dry cough, sweating. Pt was advised to take acetaminophen, but declined. Pt asked about epsom soaks, and was told they would be ok.
History: Influenza vaccine RUE 10/30/2019. The patient also complained of burning over the lateral aspect of her right proximal arm extending up to the shoulder in the area where she had a flu shot. She states that this started up 1 or 2 days after her flu shot and continues to be a problem nowat 6/10 in severity and burning in nature.   Activity does not seem to make it worse she denies any recent fevers or chills there's no evidence of any drainage or acute infection within the skin or the site of her injection.   Exam right proximal arm laterally over the should and the deltoid.    Palpation elicits no fluctuance or induration there is no redness or deformity no evidence of infection whatsoever although she notes tenderness to palpation  Assessment: Right upper extremity localized  neuropathic pain reaction to influenza vaccine  Pan:  At this point patient is able to tolerate the discomfort and I doubt additional medication would be particularly useful.   If symptoms worse she is to report back to me.
Had pre op testing for surgery on Jan 6, 2010.  Platelet levels found to be low @ 120,000. [down from physical done in October, 2 days after immunization].  Redraw of platelet count 11 days later (12/28/09) shows level now down to 105,000. Asymptomatic other than blood count.  Seen by Hematologist suggests H1N1 vaccine is only new addition in last 2 months and I have an immune thrombocytopenia.  Redraw of blood and further testing to be done Monday 1/4/2010.
received a dose from a vial that had been punctered more than 12 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that vaccine was administered after puncturing for more than 12 hours.
This child had 4 small lesions, and a rash. Diagnosed on 02/23/01 with chicken pox. Treatment: Atarax.
Face has been brilliant red since shortly after receiving 2nd vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medications includes atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), timolol (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and  B all for unknown indications from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247) via an unspecified route of administration in the left arm on 17Feb2021 at 12:00 as a single dose for COVID-19 immunisation. On 19Mar2021, shortly after receiving 2nd vaccine, the patient face had been brilliant red. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face has been brilliant red was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Trouble breathing, high fever, chest tightness, severe headache, nausea and vomiting
2nd day after taking the vaccine her arm started to swell. Arm became itchy, feverish and swollen.
IBS flare up; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS flare up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IRRITABLE BOWEL SYNDROME (IBS flare up). The patient was treated with VEDOLIZUMAB (ENTYVIO) for Irritable bowel syndrome, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS flare up) had not resolved.            No concomitant medications were reported.  The patient started treatment with Moderna COVID-19 vaccine on an unreported date in Feb-2021 and Mar-2021, and then summer and then winter 2022/2023, every 6 months for a total of 5 shots with Moderna for COVID-19 immunisation. It was reported the patient had IBS, and a month after each shot, she would flare up. The patient reported that the doctor said lymphocytes are asked to generate antibodies and there is no wonder that's when the flare ups happened. Her gastroenterologist said it was a different cause and she started to flare in the winter of 2021. The individual was on Entyvio for IBS and had her second dose on 19-Sep-2023. The patient reported an IBS flare up comes every 30 days after she stops the steroid. She started to flare 3 days before taking Entyvio.   This case was linked to US-MODERNATX, INC.-MOD-2023-745444, US-MODERNATX, INC.-MOD-2023-745439 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745444:Same Patient. US-MODERNATX, INC.-MOD-2023-745439:Same Patient.
Numbness/tingling on right side of body and right side of face as well as soreness in right arm where shot was taken continues three days after shot was given.  Some ill feeling/fatigue a day after the shot but went away after one day.
pt recv vax OCT96 & 1DEC96 pt exp fatigue, h/a, & stomach pains for 2wk;4JAN97 pt started having a sore throat, h/a, fever, aches all over & fatigue;pt has not yet recovered;
Mother stated small hives at site of Menactra injection (Lt deltoid).Less then ten hives appeared approx. six hours post injection. Hives disappeared spontaneously. Mother stated large hives generalized over body appeared four days post vaccine administration of Menactra (Lt. deltoid) & Hepatitis B (Rt. deltoid.) Mother stated gave Benadryl hives are gone, no other reaction reported. Instructed mother to have child seen by MD.
When drawing up several doses of the above vaccine from a multi-dose vial, I attached 25g, 5/8" needles instead of 1-1 1/2" needles. 2 injections were given with the sub-Q needles. The error was noted within 5 minutes of the 2nd injection. Both clients were called and a second flu vaccine was given today, 11/16/2022. Both clients denied any side effects from the initial injection. This nurse will follow up via phone on 11/17/2022 to again evaluate any adverse reactions. Syringes/needles have been re-labeled as well as re-education to all staff.
did not feel well, achy all over, serious upper resp problem-chest got tighter, constriction in throat;DPH, breathing sxs, pred x 5 days w/tapering dose;
WARMTH, RASHING FORMING LOWER ON ARM...CELLULITIS DIAGNOSED.
This spontaneous report  was received from a office manager refers to a 6 month old patient. The patient's current condition, medical history, drug reactions or allergies and concomitant therapies were not provided. On 26-NOV-2018, the 6 months old patient was vaccinated with GARDASIL 9 (lot # R009614 and expiration date 30-NOV-2018) at a dose of 0.5 ml once (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was reported.
Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure.  Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional reported that the patients have some reactions after receiving the 1st dose that makes them hesitant to get the 2nd dose. The healthcare professional was not comfortable giving patients information. The healthcare professional was a student on rotation so not able to provide long term data from the pharmacy's patients, but assured that they have documented correctly and reported as needed. The healthcare professional looked for data or resources to answer questions came from providers rather than patients. The healthcare professional did not consent to follow up.
Patients 3rd dose of COVID Pfizer monovalent was not documented. Patient then received a dose of Pfizer bivalent. (Fourth dose not indicated).
p/vax pt devel irritability, crying, dec appetite, sl able to console when crying;did have ?twitching episodes also;no fever, no rash;lasted throughout afternoon;
Rapid response called at 16:47, Care escalated to ED. Dizziness, Headache, Rash & diaphoresis
Booster; have Pfizer vaccine and booster, and today test positive for covid; have Pfizer vaccine and booster, and today test positive for covid; This is a spontaneous report received from a contactable reporter from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: immunization, outcome unknown; drug ineffective, COVID-19 both with onset 31Dec2021, outcome unknown and both described as have Pfizer vaccine and booster, and today test positive for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
down in bed for three days; This case was reported by a consumer and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got Shingrix shot and was down in bed for three days. The patient got the second shot last week.  And had no reaction to it at all.
Moderna COVID-19 Vaccine EUA  Rash near the injection area 1 week after receiving 1st dose of the vaccine.  Itchy and appears to be patchy/legions.
NO KNOWN REACTION. MOM WILL MONITOR PATIENT AND MD IS AWARE OF SITUATION.
Information has been received from a consumer concerning her 12 month old daughter with no drug reactions/allergies and "unremarkable" pertinent medical history who on 09-MAR-2006 was vaccinated with a first dose of MMR II. Concomitant therapy included several other vaccines given concomitantly (names not provided). On 17-MAR-2006 the patient experienced a seizure that caused brain injury and liver failure. The consumer stated that her child was virtually brain dead. The caller was informed by physician that the injury was due to vaccine. The patient was hospitalized for several days. The consumer stated that her daughter was completely disabled and was hospitalized. Lab diagnostics studies performed included: CT scan, MRI-Anoxic Brain Injury. The outcome was reported as not recovered. The adverse event was considered to be disabling. There was no product quality complaint. Additional information has been requested.
Started itching 4 days after receiving vaccine. Broke out with rash in patches all over body. Feet , legs, arms and back itch. Symptoms haven't worsened or subsided in 3 hours.
Swelling, redness, hot to touch, hospitalization. IV antibiotics clindamycin, home on oral Rx BACTRIM.     10/23/09:  Emergency Department Records and Dischrage Summary received for Date of Service 9/20/09.  Dx:  Cellulitis of the left thigh. Assessment:  Presented with 1 1/2 day of left thigh redness and pain to left thigh injection site.  Site warm to the touch.  Decrease level of activity noted.  IV antibiotics initiated.  Admitted for inpatient treatment.  Discharged in improved condition, Bactrim to be continued for an additional 5 days  Follow-up: Hospital stay x 4 days IV and oral meds.
Syncope and collapse. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Right after receiving the vaccine, I experienced chest discomfort. I could feel this discomfort constantly for the next two weeks. Sometimes it was worse than others, but it was always present. I would describe the discomfort as feeling heavy, fragile, hot (and sometimes cold), or like something just felt wrong in my central chest region. After two weeks of this, I had an EKG, x-ray, and labwork done. One doctor said that the joint between my rib and sternum (on the left side) seemed to be possibly inflamed or at least in pain as well as possible pain in my esophagus (due to worse acid reflux) so he had me taking Ibuprofen and a higher dose of my usual Omeprazole.
Local Rx in L thigh. Warm, no erythema, slight swelling, all decreased from last night. Was limping - is no longer. Child playful and active.
pt recvd vax & devel rash, itchy patches on chest, legs & arms; patch of pimples as indicated by pt; pt recovered;
Expired vaccine kept on refrigertaor; no adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date), PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jan-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date), PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date) and PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor).    No concomitant medications was reported. HCP states that when they had received the Moderna monovalent vaccine, the expiration date stated 31-DEC-2069 and they did not realize that they had to check for the manufacturer expiration date. As a result, on 26-JAN-2023, one patient was administered a dose which had expired on 27-NOV-2022. Patient had not reported any adverse reactions to this invalid dose administration. Vial size was 5.5 mL. The vial was initially stored in the refrigerator on 26-JAN-2023. The vial did not undergone any temperature excursions. No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2023: Non Significant follow up appended
Fainted; extreme dizziness and disorientation since; extreme dizziness and disorientation since; metallic taste in mouth; smell metal coming out of pores; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (not pregnant, age at vaccination 39-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand=Pfizer, Batch/Lot number was not reported), via an unspecified route of administration in the left arm, on 12Mar2021 09:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to contrast dyes. She reported of Covid prior vaccination. She had her first dose of bnt162b2, 09am (lot unknown), left arm on 19Feb2021. Concomitant medications was antibiotics (unspecified) in two weeks. On 12Mar2021 09:15, the patient experienced faint/fainted, extreme dizziness and disorientation, metallic taste in mouth and had a smell metal coming out of pores (no treatment for the events). She had a clinic visit and Emergency room/department visit. The patient was hospitalized for 2 days due to the events. The patient underwent laboratory test Sars-cov-2 test: negative on 01Apr2021. The outcome of events was recovering.  Information about lot/batch number has been requested.
Severe pain in left elbow joing about 6 inches below injection sight, elbow became sore and very painful to move. Administered naproxen sodium which did little to aleviate pain and stiffness which lasted approx. 24 hours.
Administered 0.5 mL of vaccine instead of 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 45-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Vaccine 04/26, 05/03 rash trunk right.  Atoxia - incortination. Improving 05/07/2003
Narrative: Pt developed symptoms after 2nd Covid- 19 (Pfizer) vaccination.
Patient got shot in the afternoon of Aug 9th, the next day on the 10th after shower her husband noticed her left arm had a rash on it where SHINGRIX shot was given. Patient says it is not itchy or painful. When she came to pharmacy on Sat the 11th, she states she does have a lot allergy to meds and food. She is currently on ZYRTEC and takes one each day. The area is not swollen but red about 3 inches in length. Icing it is too late but suggested she take a BENADRYL tonight at bedtime and not take a ZYRTEC tomorrow but instead take another BENADRYL in the am and afternoon on Sunday. I asked if she has any facial or tongue swelling and the answer was no. I suggested topcial hydrocortisone cream on area too. Asked to please call or contact us again if any further issues or concerns. Cautioned her on 2nd shot to warn RPh and probably take a BENADRYL before the next shot.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 24-APR-2013, the patient was inoculated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-AUG-2016, the patient was treated at a physician office for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir and LYRICA for management of her painful symptoms. As a direct an proximate result of the ZOSTAVAX, 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, pain and suffering and other damages. Additional information has been requested.