chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 65 year old female with no known drug reactions/allergies, who on 05-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 663177/1413X). Concomitant therapy included NEXIUM, TARKA and CELEXA. On approximately 19-JAN-2009, 2 weeks after getting the vaccine, the patient experienced shingles on her hand (she noticed 2 spots on her hand). At the time of the report, the patient had recovered (unspecified date). The patient did not seek medical attention. Additional information has been requested.
Information has been received from a physician concerning a 50 year old female with a history of splenectomy who "6 years ago" was vaccinated with a dose of Pneumovax. When she was vaccinated the patient experienced local redness at the injection site. No other symptoms were noted. Subsequently, the patient recovered. Additional information has been requested.
Red, swollen area at injection site. Hot and itchy. Approximately 3 inches by 6 inches. Applied ice packs and anti-itch cream (hydrocortisone and Sarna).
This spontaneous report has been received from a physician (internal medicine) via a company representative, referring to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unspecified date (reported as a couple years ago), the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that on an unspecified date in May 2018 (reported as sometime this month), the patient developed a mild shingles breakthrough further described as three blisters above his eye which was red and irritated (ophthalmic herpes zoster). The patient received an unspecified dose of VALTREX as treatment for the event. At the time of this report, the outcome of ophthalmic herpes zoster and the causality between the aforementioned event and ZOSTAVAX was not reported. Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
brain fog immediately after vaccination, 2 hours later blood pressure and heart were elevated. Around 11:00 pm went into extreme Atrial Fibrillation and risk of stroke for 10 hours. Heart rate went from 55 bpm before vaccine to 90 bpm after vaccine. Blood pressure went from 120/70 to 145/80.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 17:00 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Sep2021 17:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovering", described as "intense pain under my left arm". Additional Information: The patient received the booster dose, within the 24 hours after receiving the vaccine, patient started to intense pain under his left arm, the same where he received the shot. It had mostly resolved, the intensity was not as bad, but he still feel it. The lot number for bnt162b2 was not provided and will be requested during follow up.
5 minutes after receiving flu vaccine pt fell from chair-unclear if syncope or pt just fell, landed face first, split upper lip and bleeding from both nares-sent to ER for further evaluation of nose.
Became shaky and dizzy. Nail beds on right hand appeared blue which resolved after heating pad was applied and shakiness resolved after drinking orange juice. Had just drank 3 water bottles of cold water.
Severe muscle cramps 48 hours following injection.  Muscle cramps resolved then severe joint pain in all the large joints (ankles, knees, hips, shoulders, elbows), malaise, headache, nausea, diarrhea.
Headache, muscle pain, nausea, shivering, tiredness, unsteady feeling
(B) eyes puffy since 7/27/10, c/o pain on (R) thigh. Apply ice pack.
On 06/28/2021 i received the vaccine. I was sitting in a chair at the pharmacy, unsupervised. Within 5 minutes of receiving the shot I began to feel light-headed, lost consciousness and fell onto the floor and hit my head (according to a witness). I came to and there were staff members/medical personnel present and talking to me. I spoke with them and was immediately brought  to the emergency room for further examination. An EKG was administered and a urine sample was taken. Results were normal. I was given acetaminophen and ibuprofen and discharged.   Since being vaccinated on 06/28/2021 to today, 07/01/2021 I have experienced the following symptoms: muscle aches/soreness, headache, joint pain, fatigue, nausea, diarrhea
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies. Concomitant therapies included the sterile diluent. On an unknown date, the patient received "on time" the first and second dose of GARDASIL 9. On 03-APR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # M014929 and expiration date 27-MAY-2017) for prophylaxis (dose and route of administration were not reported). However, the third dose was given too early since it was supposed to be administered on 23-MAY-2017. No adverse effects were reported and no further information was provided. Additional information has been requested.
Headache, Nausea, Hot Temperature (sweating profusely), coughing (damage to chest), body aches, lethargic, sleeping 16 hours, blurriness, large amount of mucus. Tired, results similar to pnumonia.
cellulitis; other zoster related injuries; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On unknown date (reported as 41891), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles, cellulitis and other zoster related injuries. The outcome of these events was unknown.   Upon internal review, cellulitis was determined to be medically significant.
Moderna 2/13/21, 3/14/21, 10/25/21, 5/5/22. Positive on 5/30/22
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 10-AUG-2017 the patient was vaccinated with an expired dose of ZOSTAVAX lot # L029482 for prophylaxis. No adverse event were reported. Additional information has been requested.
Pt received Varicella Vaccine (2nd dose) on 8/14/2006 around 10:30 AM.  Patient had a headache that afternoon.  Patient awoke the following morning with itching around his injection site, which progressed to pain and swelling.  Pt returned to our office on 8/15/06 at 1630 and he had a 6 cm X 6 cm swollen, pink-red firm mildly tender and warm patch on his upper right arm with a cluster of vesicles in the center.  The vesicles appeared to be more like those one sees secondary to edema rather than varicella-like.  Pt was given Ibuprofen by his mother prior to the 2nd office visit, and was instructed to take Benadryl liquid 12.5mg to 25 mg q 6-8 hours prn, and to continue to take Tylenol or Ibuprofen as needed for pain.  And he was instructed to apply ice/cool packs prn to the affected area.
Pt was administered AstraZeneca 5/1/21 and Janssen 10/16/21 before Pfizer Booster  Pt reported dizziness.  Pt had not eaten all day.  Last meal was 8pm 2/11 Vitals: 12:00 118/71, 70, 20, 98% RA -- > 12:09 HR 62, 99% -- > 12:15 HR 66, 97-98% Pt was given water and snack.  Pt stable and released from the vaccination site @12:15.
Chronic diarrhea started after MMR- watery stool 3 times a day for 3 months completed by UTI 2 hour diarrhea with pyelonephritis
MEDICATION ERROR NOTE   5/30/2021 Patient is a 17 y.o. the young man who on 5/03/21 per chart review received the Moderna vaccine, despite being 17 years old. I was notified by the site lead and pharmacist lead that this patient would receive the second dose of Moderna today, given that he has already had one dose, he does not have low weight, and is almost 18 years old. I concur with this decision.  The mother agreed with the decision.
pt recvd vax 27JUL;ran high fever (104.4), thurs, Fri-Sat;devel rash on face worse on Monday 1AUG to PMD
pt recv vax & 1 to 2 days later pt devel an inj site rxn characterized by erythema, edema & warmth;the edema & pain have progressed upward;also had mild fever & myalgia which resolved in several days;tx w/ice & anti-inflam agents;
pt recv vax & woke up in middle of noc trembling w/fever; did not take temp; gave APAP & fever came down; pt was sleepy & difficult to arouse-didn't want to wake up; no redness or swelling @ inj site; diarrhea started 2 days p/vax;
Approximately 1 week after the vaccine, I developed an itchy pink, raised rash on several areas of my face.  These still persist.  I have used no new facial products for many months.  There are no other areas of my body affected.  I am using castile soap for cleaning and aquaphore ointment on the areas with no change yet.
lump rt leg 1 1/2 diameter w/purplish discoloration;
This spontaneous report was received from a healthcare worker referring to a 2 week old baby patient. Concurrent conditions or pertinent medical history were not reported. On 15-JUN-2015, the patient was vaccinated with a first dose of VAQTA 25/0.5 (lot #, expiration date, dose, route of administration and frequency were not reported) (inappropriate schedule of drug administration). No adverse events were reported. Concomitant medications were not specified. Additional information has been requested.
After shot was administered, the band aid was filled with blood. I was feeling a great deal of soreness immediately. my arm at the injection site is tender to the touch and my shoulders and neck are sore too. I started with 99 fever Monday night and Tuesday night  I experienced sweats and clamminess. I couldn't sleep. When I awoke Wednesday morning, I had 100.5 fever. I took Tylenol and a couple of hours later, fever went  to  99. 2. I will continue to take Tylenol every few hours.
Temperature: 100.9;  shaking, fatigue-severe, vomitted x1
Employee came in with complaints of red itchy eyes - feel a tickle in throat - questions difficulty/itchy throat - developed these signs at 13:00 given flu shot at 09:00
Nausea, dizziness, diarrhea, headache--got worse as day went on. Took Excedrin and Tums and went home and slept for 3 hours at about 12:30 pm. Felt better once I woke up.
chills./She lie dawn for 6 hours wrap in blanket; redness; itching allover body including scalp; bumps under skin; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills./She lie dawn for 6 hours wrap in blanket), ERYTHEMA (redness), PRURITUS (itching allover body including scalp) and VACCINATION SITE MASS (bumps under skin) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Allergy to antibiotic (It is reported that patient cannot take Antibiotics, as allergic to it.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced CHILLS (chills./She lie dawn for 6 hours wrap in blanket), ERYTHEMA (redness), PRURITUS (itching allover body including scalp) and VACCINATION SITE MASS (bumps under skin).   At the time of the report, CHILLS (chills./She lie dawn for 6 hours wrap in blanket), ERYTHEMA (redness), PRURITUS (itching allover body including scalp) and VACCINATION SITE MASS (bumps under skin) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a pharmacist concerning a female with allergy to "mycins" who "many years ago" was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported) and her ears swelled. Subsequently, the patient recovered from her ears swelled. The patient sought medical attention by contacting the office. Additional information has been requested.
leaving room fell to floor apparently passed out; eyes rolled back, picked pt up & laid on table ammonia given; awoke but pale would not talk;20-30min a/color returned to face shaking of extremities x 2-4sec p/falling to floor;
Having not had an HSV-1 outbreak in the genital area since 2009, after receiving dose 2 of vaccine, I experienced an outbreak. I received dose 2 on 2/5/21 and by 2/7/21, I began to experience symptoms. I saw primary care doctor who confirmed this and was prescribed anti-viral medications.
Info has been received from a licensed practical nurse concerning a female patient with a history of lupus and pancreatitis who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M). One day post vaccination, the pt developed a red, hot and painful 6.5 by 7.5 site around the injection site. The pt also developed a fever. Unspecified medical attention was sought. The nurse also reported a 2nd patient that had a similar experience after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M) (WAES #0207USA01683). Additional info has been requested.
6-13-16 Received Tdap prior to moving. At PE on 9-29-16 got second dose as part of "11 year old" vaccines.
Vaccine Vial stored longer than recommended, potentially stored up to 28 days post puncture. No adverse effects, no illness
Booster dose given early. Prior dose given 12MAY2020. No symptoms/signs of adverse reaction or consequential treatment. Patient notified of early booster dose administration.
We were extremely busy after lunch. I was working by myself. I was trying to be extremely cautious. I had 2 different patients getting vaccinations at the time. I had this patients vaccines in one tote labeled separately(she was to receive a varicella and MMR). I had administered the varicella in one arm already and when i had taken the label off the MMR to administer the other syringe, i prepped her arm, then mistakenly grabbed the Moderna syringe from the other basket for the other patient. We both noticed at the same time that I had administered the wrong syringe. I apologized profusely. She had not received the COVID shot before. I had observed her and called Moderna to find out the reaction to her getting it subcutaneously. Patient was monitored and did not have a reaction at the time
Severe headache, muscle ache, nausea, tiredness, lack of appetite, extreme thirst, high fever for first 2 days.  Could not get out of bed.   5 days later, still moderate tiredness, mild headache.
DIAGNOSED WITH COVID-19 AFTER BINAX NOW TEST ON 12/21/2021
delayed onset cellulitis at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (delayed onset cellulitis at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Vaccination site cellulitis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced CELLULITIS (delayed onset cellulitis at the site of injection) (seriousness criterion medically significant). At the time of the report, CELLULITIS (delayed onset cellulitis at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient visited to the emergency room on 8 Apr 2021.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I felt back pain and  on Apr. 26th.  Then I thought it will be ok soon. But in the next 2 or 3 days, I felt weak, joint pain and cold. Then I test my body temperature.  It was over 100.  Today, I still felt back joint pain, a little headache and have low fever. But I did not cough and was not shortness of breath.
pt began not eating well, had diarrhea x 1 day, devel sl rash on face & on vaginal area;pt put down for a nap-was found in bed not breathing, pronounced dead @ hosp;
Moderna severely worsened my tinnitus after all 3 shots, and every joint in my body hurt, I had 103 fever for 3 days after 2nd shot, and 99 fever for 3 days after booster.
Ear is red; Ear is swollen; Ear is draining a lot of fluid; Left neck is red down to his shoulder; Severe body aches; Left side of his face swelled up; Injection site arm is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Ear is red), EAR SWELLING (Ear is swollen), OTORRHOEA (Ear is draining a lot of fluid), ERYTHEMA (Left neck is red down to his shoulder) and MYALGIA (Severe body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS (Has a lot of allergies).   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ERYTHEMA (Ear is red), EAR SWELLING (Ear is swollen), OTORRHOEA (Ear is draining a lot of fluid), ERYTHEMA (Left neck is red down to his shoulder), MYALGIA (Severe body aches), SWELLING FACE (Left side of his face swelled up) and VACCINATION SITE PAIN (Injection site arm is extremely sore). At the time of the report, ERYTHEMA (Ear is red), EAR SWELLING (Ear is swollen), OTORRHOEA (Ear is draining a lot of fluid), ERYTHEMA (Left neck is red down to his shoulder), MYALGIA (Severe body aches), SWELLING FACE (Left side of his face swelled up) and VACCINATION SITE PAIN (Injection site arm is extremely sore) was resolving.            No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.
Pounding headache in left temporal lobe and left eye; Pounding headache in left temporal lobe and left eye; Fever; Fatigue; Injection site pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an intramuscular route of administration in the left arm on 03Sep2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included intracranial ventricular peritoneal drainage and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-vaccine. Concomitant medications were not reported. On 03Sep2021 at 10:00, the patient experienced pounding headache in left temporal lobe and left eye that was still present 12 days after receiving the vaccine. Patient also experienced fever, fatigue and injection site pain lasting 1-2 days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, fatigue and injection site pain after the injection were recovered with sequelae on an unknown date in Sep2021 (reported as lasting 1-2 days), while the clinical outcome of the event pounding headache in left temporal lobe and left eye was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme exhaustion. I had to leave work early and take the next day off. I slept 14 hours on that day off.
Severe low back pain, intermittent paralysis, severe joint pain. All diagnosed as ankylosing spondylitis.  Treatment is Lortab, Meloxicam and muscle relaxers.
Fever - high per mom. Headache. Malaise - slept the entire day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Nov2023 to 06Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367599 Same patient, different product, different dose/event;
Alopecia. This case describes the occurrence of hair loss in a 10 year old female patient who received hepatitis A vaccine inactivated (Havrix) for prophylaxis. This report was received from the patient's mother and has been verified by a physician. The physician reported that the patient was a "well child." The patient's medical history and concurrent medications were not reported. On 26 August 2003 the patient received the 1st dose of Havrix. Four days post-immunization, on 30 August 2003, the patient experienced hair loss. The hair loss improved on 31 August 2003. The reporting physician considered the hair loss to be unlikely to be related to vaccination with Havrix.