chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna covid vaccine and during the time she was in observation she developed a rash on her back and neck. No sign of hives. Rash developed 15 minutes after injection. Patient stated that she had developed new allergies to many different things recently. She also stated that she had talked to her doctor and he recommended taking diphenhydramine if she had any reaction to the shot. Patient reported taking 50 milligrams diphenhydramine PO at first sign of rash. Patient observed for 30 minutes and released to self. Patient signs and symptoms included nausea, anxiousness, rash, dizziness. Patients BP, heart rate, respiratory rate, and pulse oximeter readings were normal during this period.
Started with lower lip swelling, followed by urticaria arms, legs, hands, then joint pain. Resolved within 24 hours with BENADRYL.
it was only one shot; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (in 2011). Previously administered products included Shingles vaccine (received 1st dose on an unknown date and had troble with the dose than the shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not applicable for this report. The patient stated that he/she only had one shot and knock on wood had not had it again.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient suggested that, it was highly contagious, so you must really careful around someone who had it. The follow-up would not possible as no contact details were available.
Fatigue and  body ache started approximately 6.5 hrs after shot. Low fever (1.5 degrees f above normal) started 10 hours after shot at which point I took 1 200mg ibuprofen capsule. High fever (5 degrees f above normal) and chills were experienced at 12 hours after shot at which point I took 2 200mg ibuprofen capsules. By 22 hours after shot fever was back to a low level. Fever was gone approximately 30 hours after shot and fatigue and body ache continued until approximately 48 hours after shot.
This spontaneous report was received from a other health care professional (Registered nurse) regarding a patient of unknown age. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 28-DEC-2018, the patient was vaccinated with improperly stored PROQUAD (strength, frequency and route not reported) lot # R015742 and expiry date: 02-DEC-2019 for prophylaxis. The vaccine PROQUAD was reconstituted with properly stored diluent. No adverse event was reported. Temperature at which vaccine was stored was reported as -14 °C to -10 °C (-12.3 °C) with a time frame of 30 minutes. There was no previous temperature excursion reported. Digital data logger was present.
RASH FROM ELBOWS TO WRISTS ON BOTH ARMS; This spontaneous report received from a patient concerned a 55 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 and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced rash from elbows to wrists on both arms. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash from elbows to wrists on both arms on 12-APR-2021. This report was non-serious.
Patient received Moderna for their first shot, received Pfizer for their second. Patient filled out form stating she needed her 2nd Pfizer shot, however, after receiving shot and checking her information, she actually received Moderna (LOT 023c21A, exp 10/21) as her 1st. Patient has had no ill effects.
Feeling like flu; Feeling like bad cold; Feeling like chills; Head ache; Body ache was horrible; Pain; Hand and arm hurting; Hand and arm hurting; Low grade fever having temperature of 100 degree; side effects took her to bad, "did not leave the bed except for bathroom; A spontaneous report (United States) was received from a healthcare professional concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  The patient's medical history was not provided. Concomitant medications reported were Statin for drug use for unknown indication.  On 23 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNK) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Feeling like flu, Feeling like bad cold, Feeling like chills, Head ache, Body ache was horrible, Pain, Hand and arm hurting, Low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feeling like flu, feeling like bad cold, feeling like chills, head ache, body ache was horrible, pain, hand and arm hurting, low grade fever having temperature of 100 degree, ide effects took her to bad, did not leave the bed except for bathroom was unknown.
Information has been received from a nurse concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2013 (reported as: 4 years ago at age 70), the patient was vaccinated with PNEUMOVAX 23 (dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included PREVNAR 13 administered to the patient in October 2013. On an unspecified date, the patient had a titer ran and was not immune (antibody test negative). On 30-JAN-2017, the patient was vaccinated with another dose of PNEUMOVAX 23 (drug use for unapproved schedule). At the time of reporting, the outcome of the antibody test negative was unknown. Additionally, the relatedness between the event and PNEUMOVAX 23 was not provided. There was no product quality complaint involved. Additional information has been requested.
Redness and induration 9 cm at injection site of VARIVAX 48 hours after administration.
Enlarged axillary lymph nodes, ( left), left side of neck swelling, fever ( 100.5). Patient evaluated in ED on 07/18/2021, f/u at Health Center on 07/21/2021
getting it, mild case/suspected vaccination failure; getting it, mild case; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and just had a mild case of shingles which was recovered in a week and it had not come back. The patient stated that the Shingles shot did not prevent him/her from getting shingles. The patient stated that if this was mild then he/she sure would not want a full blown case of it, so yes get the shot. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Received Varicella immunization and influenza vaccine at the same time. Caused massive guttate psoriasis outbreak which had previously been dormant for at least 10 years. Had chickenpox as a child, found no need for chickenpox  (not shingles) vaccination in a 40 y/o person.
BODY ACHES; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, headache and fatigue was not reported. This report was non-serious.
headache (approximately 13 hours later) , shoulder pain (8 hours later) , slight blistering from band aid adhesive (~10 hours)
Report 20010141421 described swelling and itching (eyes) in a 33 year old female who received hep B vaccine (Engerix-B) for the prophylaxis of hep B. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee is allergic to penicillin. Her medical history was not specified. She received the tuberculin tine test on 04/30/2001. On 04/30/2001, the vaccinee received her first left arm dose of Engerix-B. That evening, she experienced itching of the eyes. On 05/01/2001, she woke up with "marked" swelling of the eyes. She "consulted" with the physician and was told to call back if the situation worsened, or alternatively to seek emergency medical attention. On 05/02/2001, the swelling was "the same"; she went to see the physician. The physician consulted with an immunologist who reportedly said that swelling occur as a side effect of the vaccine; he advised that she receive no more immunizations with this vaccine. As of 06/11/2001, the outcome of the events was unknown.
hitting his head and "cracking it open" upon the fall; syncopal episode; This spontaneous report was received from a pharmacist refers to a male patient (reporter's step son) of unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were unknown.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were unknown) for prophylaxis.         On an unknown date the patient developed a syncopal episode after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient's syncopal episode resulted in the patient hitting his head and "cracking it open" upon the fall. The patient was taken to the hospital but unsure if he was admitted to the hospital. The patient had sought medical attention. It was unknown whether any treatment was given for the events. The outcome of both events was unknown. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and both events was unknown.   Upon internal review, syncopal episode and hitting his head and "cracking it open" were determined to be medically significant.
Pt died on 3/7/22 in hospital.  The patient  developed significant debilitation due to his prolonged illness and severe pneumonia needing prolonged and focused rehabilitation efforts.  He appeared to show some improvement and were able to wean his oxygen to nasal cannula. He subsequently developed melena with no significant drop in hematocrit.  He was started on IV Protonix.  He subsequently developed worsening hypoxia requiring non-rebreather face mask.   Chest x-ray showed findings suggestive of nosocomial pneumonia with secondary bacterial infection. Patient was started on IV cefepime/Vancomycin and IV Solu-Medrol. He continued to deteriorate and was intubated emergently on the 7th March 2022 and was started on mechanical ventilation support.  Patient's brother was contacted and he stated that the patient did not want to continue aggressive care under the circumstances and requested to change his code status to DNR.
Her fibromyalgia flared up for about 10 days starting 3 days after the vaccination. She developed cold sores/fever blister and had the chills; Her fibromyalgia was especially bad in her feet, hands, and elbows where her most troubled areas are.
the next day after my second dose ,I felt dizzy,nauseated,weak and some chills. no tx administered except rest.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 67-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 30th March 2018). On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, 7 days after receiving SHINGRIX, the patient experienced vesicular rash and discomfort. On an unknown date, the patient experienced feeling of warmth. On an unknown date, the outcome of the vesicular rash and discomfort were not recovered/not resolved and the outcome of the feeling of warmth was not reported. It was unknown if the reporter considered the vesicular rash, discomfort and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a shingles type of reaction under the skin by the area on the rib cage after the 2 doses of SHINGRIX. The reaction was reported as rash and discomfort that goes away and comes back as well as less than a year after receiving SHINGRIX, the patient experienced warm feeling in the same place. The patient stated the reaction started about a week after the 2nd dose. This had not been diagnosed till the time of reporting by a physician.
This spontaneous report as received from a registered nurse via a company representative refers to a 67 years old female patient with no medical history and drug reactions or allergies. On an unknown date in 2007 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot number not reported). Concomitant therapies included AMBIEN also reported as 'AMBIAN', PROTONIX also reported as 'PROTOICS', an unspecified inhaler and unspecified creams. On 26-FEB-2014 the patient experienced rash that has been diagnosed as a mild case of shingles. The outcome of the event was reported as not recovered. The patient sought medical attention by the office visit. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Redness, induration, tenderness worsening after third injection. Neck and shoulder ached on day of injection. Pending recovery.
numbness fingers Narrative:  numbness 2,3,4th finger (left hand)
arm swelling; redness; Pain in arm; fever; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix on left deltoid. From her elbow to her shoulder there was redness, swelling and soreness or pain on the left arm.  Also reported 3 hour fever.  At the time of the call the pharmacist reported that symptoms were resolved or resolving.  No additional details were provided at the time of this call. There is an unclear information provided in the source document regarding to the event fever. It seems that the fever has resolved in 3 hours (Also reported 3 hour fever), hence the 3 hours has been considered as a duration of the event fever and not the time to onset. For further clarity the clarification has been requested for the same.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date, route of administration and dose were not reported). Other suspect therapies included FLUMIST (dose, route and lot # were not reported). The vaccines were administered two weeks apart on unknown dates. The physician stated he did not remember which vaccine was administered first. He received a letter from the health department stating these doses were administered too close together and were therefore invalid. No adverse effect was reported. Additional information is not expected, because the reporter declined any further contact.
redness at the injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Dizziness, lightheaded, headache, body ache, seizure or loss of consciousness with odd vocal noise.
1-2 days after 2nd dose Pfizer covid vaccine administered, developed significant hives reaction on torso and right leg. Right leg rash biopsied at dermatology visit on 1/21/21 with biopsy results urticarial tissue reaction.  Given topical steroid with improvements and started on Zyrtec. Rash finally started improving on Day 11 (1/24/21). Hives rash nearly resolved but then new rash started shortly after on right hip/buttocks. Saw provider in clinic and diagnosed with shingles on 1/28/21. There had been no new changes other than vaccine during time of start of rash (for example no changes in usual lotions, soaps, laundry detergents, new clothing, etc and no new foods had been introduced).
Fever up to 101.9 varying throughout  the day and lasting into next day (today) @ 100.1 this AM.   Tx - Tylenol  and fluids, rest, observ.
Patient fainted following physical - had received #3 HPV vaccine - (Pt fell to floor  - hit her head and required treatment in ER).
tingles down arrm, not constant, some feeling of numbness in fingers - not constant site not red, not warm to touch, not swollen above symptoms totally resolved after 3 days. treatment: none had her check in each day for an update
a patient was administered a expired dose of MMRII; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-APR-2022, the patient was vaccinate with an expired dose of measles (+) mumps and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T012807 with an expiration date on 14-APR-2022) administered for prophylaxis (strength,  dose, and route of administration were not provided) (expired product administered).  No other issues or concerns were noted.   .
Pharmacy technician called the patient at home and reported that the pharmacist on duty, had given the patient a Covid-19 vaccine on 07/05/2021 from a vial that was punctured on 07/03/2021 at approximately 11:30. The punctured vial was stored in the refrigerator for the entire time after puncture however it does not meet the CDC temperature storage guidelines of discarding any unused vaccine after 12 hours of puncture.
After receiving HPV vaccine/Gardasil (her 3rd dose) patient felt lightheaded; she reclined on exam table. No loss of consciousness, took sips of water, waited about 15 min, B/P monitored. Left ambulatory.
This spontaneous report as received from a 40 years old pharmacist refers to himself. The pharmacist reported that he felt that he developed shingles from administering live ZOSTAVAX last summer (late summer 2012, date unspecified). The pharmacist did not report any needle stick or direct contact with the vaccine (pharmacist wore gloves), but had just completed a vaccination clinic in which he administered numerous doses of live ZOSTAVAX. The pharmacist stated that shingles was diagnosed and he took an unspecified antiviral within 72 hours of the start of the shingles. The pharmacist describes the shingles as a mild case and reported that he was recovered. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Hypertension was first noticed a little over a week after the vaccine. Hit a high almost 2 weeks after. Had to go to the emergency room after testing at 183/122. Now with high dosage medications, it's still high averaging 170/110! With no known catalyst.
Slightly red, lump with mild itch and mild pain at injection site.  This was not noticable until today, although there was a mild pinpoint pain when touched prior to today.
Swollen tongue.  Had to go to the ER and received and EPI shot, prednisone and two antihistamines via IV.
w/in 1st hr p/vax pt c/o abdominal discomfort & h/a; during the following 3-6 hrs pt blood sugars fell below 70 & pt felt warm & was confused;
Syncopal episode lasting approx. 2 minutes immediately following vaccine adm. Recovered fully within 2 min.
This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 18-JUN-2014, was vaccinated with a dose of (Oka/Merck) PROQUAD (lot number K005648, Exp. Date: 17-OCT-2015) (dose and route not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.