chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via Pfizer, Inc. and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of unspecified HPV vaccine (lot #, expiration date, dose and route of administration were not reported). Administered doses of vaccines experienced the highest temperature of 9.1 degrees Celsius and "out of range for five days, was at 8 degrees Celsius". It was not specified if a digital data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011907: US-009507513-1703USA011908: US-009507513-1703USA010426: US-009507513-1703USA011910.
Patient received 1st dose of Gardasil vaccine on 8/8/08 in Dr. office, since having the vaccine she has had recurring headaches, severe joint pain, chronic fatigue syndrome, and chronic swollen glands, chills, fever, sore throat, ear pain, numness in arms. On 12/2/08 she received her 2nd MMR and Menoccical vaccine at her pediatrician.  3/11/09 MR received from PCP from 8/7/08-2/15/09. Seen 9/28/09 with c/o sore throat and congestion. DX:  sinusitis. Pharyngitis. Seen again 10/6/08 after falling off horse with c/o neck pain. DX:  Spasm-R SCM muscle.  URI and BSOM 10/13/09.  Sinusitis 11/12/08.  MCV4 and MMR given 12/2/08. Seen again 2/5/09 for c/o ear pain, chills, fever with congestion.  DX:  allergy.  RSOM. Seen 2/12/09 for c/o fever, scratchy throat,cough, lip swelling,congestion and achy joints.  DX:  Pharyngitis.  Bronchitis. Seena 2/15/09 with c/o difficulty breathing, cough, wheezing, H/A.  DX:  URI.
urticaria kind rash; urticaria kind rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria kind rash) and RASH (urticaria kind rash) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (urticaria kind rash) and RASH (urticaria kind rash). At the time of the report, URTICARIA (urticaria kind rash) and RASH (urticaria kind rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pt stood to leave and loss consciousness, caught by nurse and lowered to floor, legs elevated. Pt regained consciousness, oriented x3, diaphoretic, pale. Admits to not having anything to eat since breakfast. Cool compress applied BP lying 112/64, HR 67, SaO2 97% RA. Moved from floor to chair in Trendelenburg BP 108/71, HR79 SaO2 97% RA, Sprite given. After 5 mins placed in sitting position BP 111/67 HR64, SaO2 98%, PulseOx Dc'd. BP standing 102/66, HR 76, Pt lightheaded returned to sitting. Reattempted standing after 5 mins BP 114/76 HR82, denies dizziness. Discharged with Boyfriend ambulatory to home with instruction to eat and f/u with PCP if problems.
The area got very thick, pretty much the entire circumference of the deltoid was affected; Had some bumps; The area got very red; The area got very hot; Was itchy; Really bad headache; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and PACLITAXEL (PAXEL) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HEADACHE (Really bad headache). On 03-May-2021, the patient experienced PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot) and PRURITUS (Was itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (The area got very thick, pretty much the entire circumference of the deltoid was affected), PAPULE (Had some bumps), ERYTHEMA (The area got very red), FEELING HOT (The area got very hot), PRURITUS (Was itchy) and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-Jun-2021 contains non-significant information.
Patient received the first shot on 2/17/21. Nothing seemed unusual during the following days; no complaining of soreness or anything. He hadn't introduce any new medicine or food into his routine. On the morning of 2/21/21, he woke up around 5 AM as usual. He spoke with his wife for a bit. Around 7:00 AM, he started having trouble breathing. He asked for help from family members. 911 was called. EMT's preformed heart compressions for about 45 minutes before pronouncing patient deceased. During EMT's initial encounter, EMT's struggled getting a tube down patient's throat due to his tongue being swallon
w/in 2 minutes p/shot had odd feeling hard to explain feeling; 21OCT93 had sight problems, bright spots and blacks-felt faint, high blood pressure @ ER;
Large erythematous indurated blanching over 12cm diameter region on deltoid on left.
Tdap injection admin IM on 8/5/08 at 1300.  Immediately after injection R arm site became reddened & swollen.  Resp event unlabored.  8/7/08 R arm with erythematous 8cm macular rash, swollen, warm to touch, painful at injection site-mod reaction to Tdap.
The patient's mother called on 08/21/18. She specifies that at the vaccination site for the TRUMENBA vaccine on the right arm, the area is red and swollen. We recommended to the mother to use cold compresses in the area and in case no improvement is observed to take the patient to the pediatrician so the area is evaluated and they can determine if treatment is needed. The mother brings the patient to our site on 8/22/18 so that we can evaluate her arm. The area where the TRUMENBA vaccine was administered previously has a slight erythema and the area is also slightly warm to touch. The mother took the patient to the doctor who prescribed antibiotics for 7 days and BENADRYL to treat the side effects the patient experienced after the administration of the TRUMENBA vaccine. The doctor recommended the administration of the 2nd dose of the vaccine against Meningitis B (TRUMENBA) according to schedule on the opposite arm where the prior vaccine was administered.
05/08 evening pt complained of pain L arm with small area of erythema. 05/09 evening L upper arm more painful, larger area of redness, continued to increase in size and pain level increase 5/10. Pt has been afebrile, no signs of anaphylaxis. L upper arm in clinic with 20cm x 20cm area of erythema, induration, encompassing approx 2/3 circumference of upper arm. 1cm x 1cm well demarcated patch of increased erythema at injection site. Treated to cover both allergy and infection. Received Benadryl and IgM IV Ancef in clinic.
This spontaneous report was received from a physician via Pfizer's field representative and refers to a 57 year old female patient. There was no information about the patient's concurrent conditions, medical history and concomitant therapy. Past drugs included HUMIRA discontinued 4 weeks before vaccination. On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) (dose, route, site of administration, lot # and expiration date were not reported). On an unknown date, reported as 6 weeks after vaccination, therapy with XELJANZ extended release (XR) was initiated (dose, frequency, route of administration and indication were not provided). On an unknown date (reported as 9 weeks later), the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and zoster vaccine live (manufacturer unknown) was not reported. Additional information has been requested.
arm still very sore / suffering severe arm pain 3 months after my shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still very sore / suffering severe arm pain 3 months after my shot) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm still very sore / suffering severe arm pain 3 months after my shot). At the time of the report, PAIN IN EXTREMITY (arm still very sore / suffering severe arm pain 3 months after my shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. The patient had a Family History of fall (Fell and cracked head open was bleeding, got knocked out). Previously administered products included ZOSTAVAX with an associated reaction of loss of consciousness. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and feeling unwell. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's past medical history was got ZOSTAVAX injection. The first and second shot were both given in the left arm in the same spot. The patient experienced after receiving the 1st shot in left arm she got a fever and felt sick. She said the fever was 102 degree F and her physician told her to alternate between Tylenol and Ibuprofen. The fever resolved after a day and a half. The reporter did not get permission to contact them. For tolerance to next dose, refer case US2018GSK224418. Lab Comments: On unknown date, Body temperature was measured.
8 days after injection, injection site is swollen, hot, itchy, redness extending out from injection site about 4 inches.  Body aches, tired, headache.
ACHY; SORE; SLUGGISH; COLD; SWEATY; FOGGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 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 2021, the subject experienced achy. On 2021, the subject experienced sore. On 2021, the subject experienced sluggish. On 2021, the subject experienced cold. On 2021, the subject experienced sweaty. On 2021, the subject experienced foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, sore, sluggish, cold, sweaty and foggy was not reported. This report was non-serious.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. The Public Health District, per guidance from the Department of  Health (ODH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid
Developed a red circular spot on left arm; approximately 3 inches across; warm to the touch; extremely itchy; put Benadryl cream on the spot twice a day for 2 days; spot lessened in severity; by 3rd day spot had disappeared and was no longer itchy or warm to the touch
pt recvd vax for prophylaxis;20 mins later exp swelling of arm,hands, & fingers & was dizzy; tx w/ dph; resolved;
Palpitations; Shortness of Breath; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory). At the time of the report, PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood pressure measurement: dropped (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
After a few minutes patient lost consciousness; hit head on table ; unable to rouse; phoned 9-1-1 for EMS transport to Hospital;patient remains hospitalized on date of this report
Adverse reactions began as fatigue and joint soreness, and soreness at the injection site in the afternoon and evening. These in an of themselves would not have prompted me to file this report. By the time I went to bed, though, it had advanced to marked achiness and feeling feverish. All night I had difficulty sleeping well, culminating in chills in the middle of the night. At 4:30 I took my temperature, which read 100.6, at which point I took two ibuprofen. The rest of the night was still pretty rough but my temp was normal by morning and I've had no fever recurrence. I am, more than 48 hrs. later, still somewhat fatigued and my arm is very sore. An area bigger than a silver dollar is still quite red as well.
Felt very faint like I was about to pass out; Dizzy; I had really fast heartbeat; Shaking of hands; It was a wave that came over me; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (at the age of 36-years-old) (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from 2003 and ongoing, Seasonal Environmental allergy, Acid reflux. Concomitant medications included  (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etonogestrel (NEXPLANON) taken for contraception, start and stop date were not reported. On 19Mar2021, the patient experienced some symptoms 9-10 min after receiving the vaccine some of which are listed on the severe allergic reactions possibility here so I just wanted to report that and if anybody could provide me any suggestion as to whether or not I should be receiving my second round which is due for next week and I am not sure to get that. Felt very faint like I was about to pass out. It was a wave that came over me, I was very dizzy and my heart rate was racing, I had really fast heartbeat. In couple of minutes my hands were shaking. The patient did not receive treatment for the events. The outcome of the event It was a wave that came over me was unknown while recovered for the other events.   Information on the lot/batch number has been requested.
Employee experienced weird feeling in left arm (arm of injection); knot developed on top of left hand.
Patient began to complain of "itching all over" about 20 minutes after receiving her vaccination. Shortly after that, she complained of feeling unwell. BP was 152/100.  Patient began to complain of tingling around her mouth. Rph observed mild swelling on bottom edge of lower lip. Pt began to cough and kept trying to clear her throat. EPI 0.3 was administered. Paramedics arrived 4 minutes and 30 seconds afterward. Patient had developed a pink rash on arms that was noted by EMS and Rph.. Patient taken to ER.
A child came in with approximately 50 spots on trunk and back. Pt also had fever was dx with mild case of chicken pox. Pt was vaccinated on 7/5/98.
Patient had Varicella & MENACTRA injection to (R) arm 1-11-12. On 1-12-12 at school arm became swollen, itchy & red & warm. Continued to swell. Mother took to physician 1-12-12 - cellulitis vs allergy. On CLARITIN, BENADRYL, Cephalexin. Swelling worse & at night. Better 1/13/12.
This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was vaccinated with a dose of VAQTA lot # L048460 that expired 14-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Hypotonia noticable within about 6 hours of shots, within 18 hours muscle tone at the worst, a few days later muscle tone slowly started to recover.  Antibiotics and acyclovir given as a precaution for the first 48 hours, when all test results came back negative medications discontinued.  No other treatments given.  Stayed in hospital approximately 4 days until he seemed stable and not getting worse. 60 Day Follow up: One of the neuro pediatricians theorized he had a bad reaction from the immunizations because since I have lupus he was born with some bad antibodies from me and maybe those w/ the immunizations were too much for his system.
Mouth blisters; Mouth was bleeding from blisters; Mouth is so sore, hard to eat; Mouth is so sore, hard to eat; Lips were itching extremely bad; Face was swollen; UTI; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen) and ORAL MUCOSAL BLISTERING (Mouth blisters) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Soft tissue sarcoma (Treated with radiation) and Breast cancer (Treated with radiation).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). On 08-Mar-2021, the patient experienced LIP PRURITUS (Lips were itching extremely bad) and SWELLING FACE (Face was swollen). On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 06-Mar-2021 to 08-Mar-2021 for UTI, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), URINARY TRACT INFECTION (UTI), LIP PRURITUS (Lips were itching extremely bad), SWELLING FACE (Face was swollen), ORAL MUCOSAL BLISTERING (Mouth blisters), MOUTH HAEMORRHAGE (Mouth was bleeding from blisters), ORAL PAIN (Mouth is so sore, hard to eat) and DECREASED APPETITE (Mouth is so sore, hard to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used was not provided by the reporter.  Concomitant therapy administered included radiation treatment  The patient went to see her physician and was prescribed "miracle swish" for the blisters.
Narrative: Admitted on 2/27 for COVID-19 pneumonia with fever and cough. Received 4 days of dexamethasone and remdesivir. He improved with treatment and was discharged on 3/2
Patient developed tactile fever and shingles rash near the L arm, below the L axilla and the L upper back about 2 days after receiving the  vaccine.   Rash appears like vesicles in clusters. Patient describes rash as itching and has burning sensation at the site of the rash.  Of note, patient had chickenpox infection around 1 year of age.  Denies any recent illnesses.
No adverse effects reported; patient was administered M-M-R II intramuscularly instead of subcutaneously; This spontaneous report was received from a licensed practical nurse and refers to a 66-year-old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On 25-SEP-2019, the patient was vaccinated with properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) injection, lot number S010706, expiration date 08-APR-2021 (dose and site of administration were not reported) for prophylaxis. The patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) intramuscularly instead of subcutaneously, which was considered to be a medication error. The vaccine was reconstituted with properly stored sterile diluent (STERILE WATER), lot number S015086, expiration date reported as 06-FEB-2022. The patient was receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin (rHA))(M-M-R II) as she worked with college students and it was a job recommended vaccine. No adverse events were reported.
After a week of receiving vaccines, lt upper arm noted with bruising and tender to touch. 1/15/15 in clinic noted bruising to injection sites. Fresh large bruise noted to left inner arm and elbow area. Tender to touch. Instructed to apply ice pack to area. If symptoms worsen, report to private Dr or ER.
Urticaria developed about 2cm distal to the injection site on the L thigh. No systemic allergic response was noted during subsequent observation. Benadryl 6.25mg given po.
Case number PHEH2015US020238, is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to an 81 years old male patient. Medical history and concomitant medications were not reported. On 02 Oct 2015 the patient was vaccinated with FLUCELVAX (batch number: 161211) that were expired on 01 May 2015. No adverse event was not reported.