chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness in arm; This is a spontaneous report from a contactable consumer or other non-HCP (measurable supplier, patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced soreness in arm on an unspecified date in Mar2021. Event took place after use of product. The outcome of the event was unknown.  Follow up letter has been generated for further information.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Redness, slight swelling, firmness & warmth & tenderness at injection site (R) upper posterior arm. W/ecchymosis radiating inferior to injection site.
Within 5 minutes of receiving the vaccine got lightheaded, malaise, blurred vision, heart palpitations, chest tightness, SOB/Assessed - monitored.
PT. rec'd 0.25 QUAD FLU at O.V. on 9/27/16. Mom reports fever began 9/28/16AM; 102.1 Max. No cough, vomiting. No site reaction noted at return O.V. for fever on 9/28/16. Tx with supportive care.
Myalgia, Arthralgia, Fever, migraine, sore thorat Narrative:
Patient has been experiencing prolonged pain in arm after vaccine. Also pain when raises arm or lifts anything, on 12/1/16 patient asked about when to take to help or if need to see doctor.
Patient reports waking up next morning with pain, swelling and a knot where she received the vaccine (injection site reaction). No other adverse effects away from injection site reported
injection site itching; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 18B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness) 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. Treatment information included ointment.
pt had a terrible headache , started sweating, upset stomach, felt faint, then passed out and had a seizure according to husband and he called 911 she is alright now but wanted us to document
Mother called to clinic to report her daughter called from school to report that here left arm near the injection was very itching and was red and swollen.
15SEP97 macular-papular gen rash;started on the face & neck first & then spread;no fever & not itching;no URI;
Treatment of Covid-19; Treatment of COVID-19; . This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; MUCINEX D; ACETAMINOPHEN. Past drug history included: Nsaids, reaction(s): "Intolerance to NSAIDs". The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an 18 year old male patient. On an unknown date, when the patient was one week of birth, approximately in 1995, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (Lot #, dose and route not reported) for prevention of hepatitis b. The second through fourth doses of RECOMIBVAX were administered at 6 weeks of age on an unspecified date, the third dose was administered at 9 months of age on an unspecified date and the fourth dose was administered at 5 years of age on an unspecified date. No adverse effect reported. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a registered pharmacist concerning to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose and route not reported) (Lot#H011332, no exp. date given). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that when reconstituting ZOSTAVAX it bubbles too much. The pharmacist was administering vaccine after this occurred. Also stated that she was able to get the bubbles out prior to injection into patient(s). No adverse effect reported. Additional information has been requested.
22SEP90; vaccinee experienced non-pruritic rash on head, neck & arms p/first vax (deltoid). Rash resolved w/out treatment.
On 8/17/01, mother reported red, hot and puffy area, the size of a half dollar, on the right deltoid area. No complaint of discomfort.
pt recv vax 19JUL96 & 29JUL96 pt exp a measles-type rash w/a few red spots on scalp, trunk & lower extremities;pt recovered w/in 2-3 days;
Patient stated on 7/26 in the evening her arm started to become sore and then over the next several day up today (7/29) she has become achy, feeling pressure in her head and headache,  lightheaded, dizzy when she moves too fast and legs feel weak.  She reports her bp is normal and has no fever.
loss of appetite; injection site soreness; lower body soreness/stiffness; Lower body soreness/stiffness; nausea; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL 3247) via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:30 as dose 2, single (age at vaccination 38 years old) covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not received any other vaccine in four weeks. The patient had not received any other medications in two weeks. The patient had not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL 3247) via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:30 as dose 1, single (age at vaccination 38 years old) for covid-19 immunisation. On 24Feb2021 at 09:00 patient experienced loss of appetite, injection site soreness, lower body soreness/stiffness, nausea, chills and fatigue. The patient did not received treatment for adverse events. The outcome of events was recovered on an unspecified day in 2021.  Follow-up attempts completed. No further information expected.
Started menstrual bleeding/Started a week before my regular period which usually last four days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Sep2021 16:45 (Lot number: EC3184) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 17Sep2021 04:00, outcome "recovered" (04Oct2021), described as "Started menstrual bleeding/Started a week before my regular period which usually last four days". The event "started menstrual bleeding/started a week before my regular period which usually last four days" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Patient stated that menstrual bleeding started three days after receiving the vaccine which was one week early. Her menstrual cycle has been every 28 days and last about four days. After the first vaccine she started her monthly menstrual period, it lasted 18 days, stopped on the day she got her second covid vaccine. Till 13Dec patient did not had a menstrual period. She did not receive any other vaccine in four weeks and no medications received within two weeks. She was not tested positive for Covid prior to vaccination and was not tested positive since the vaccination. She also stated that the Pfizer product had a causal relationship to the adverse event.  No follow-up attempts are possible. No further information is expected.
chills; fever; fatigue; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis and diabetes. The patient had a history of known allergies to amoxicillin, septra ds and penicillin.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, the patient experienced chills, fever, fatigue and joint pain. The patient did not receive any treatment for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, fatigue and joint pain was resolved on Mar2021.   No follow-up attempts are possible. No further information is expected.
Numbness of right side of face x3 days (started 12/1/10), draining ear with crusting in right ear canal.
FEELING A LITTLE NAUSEOUS BUT NOT BAD; This spontaneous report received from a patient 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 14-MAR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 17-MAR-2021, the subject experienced feeling a little nauseous but not bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling a little nauseous but not bad was not reported. This report was non-serious.
A non-serious spontaneous report of sinusitis has been received from a mother concerning a five-year-old female patient subsequent to FLUMIST administration. The patient has no relevant medical history and does not use concomitant medications. She did not receive any other vaccinations with FLUMIST. On 24-Oct-2009, the patient received FLUMIST. At 6:00 PM on the same day, the patient developed a fever of 102.9, a bad cough and runny nose. On 26-Oct-2009, the patient was seen by her physician. She was diagnosed with sinusitis and treated with an antibiotic (name unknown). On 30-Oct-2009, the events resolved and the patient returned to school. The outcome of the event sinusitis, was resolved. Additional information was received on and incorporated into the narrative: event term changed to sinusitis, event details, treatment and medical history.
After dose number one I have been suffering with severe abdominal cramping. After dose number two the abdominal cramping has continued and I had 48 hours of the chills and fever
On 8/27/12 pt called & reported on Fri, 8/24 he developed pain in (B) arches of feet/calves/hamstrings that got worse on 8/25 & 8/26. On 8/27, pt reported feet, calves, hamstrings pains pretty much gone but now with pain on top of (B) forearms with stiffness, On 8/28 at approximately 1:30 pm pt called to report inside of (B) forearms with pain & weakness, states can't grip, stated could not pull up socks or zipper this AM. Also now with discomfort in (B) Biceps & front on neck. Instructed to go to ER/Immediate care. On 8/29 I called pt. Pt reports, seen by MD in urgent care on 8/28 who referred him to hospital ER to see neurologist. Pt states told symptoms are 'Atypical' & to continues to monitor - if worse to return to ER if no resolution --> FU with PMD. Pt as of 8/29 states still with (B) arm pain, weakness with grip.
No adverse effect; the patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 23-JUL-2019, the patient was inadvertently vaccinated with the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number N019120, expiration date: 22-JUN-2019, albumin status: rha; dose and route of administration were not provided). No adverse effect was reported.
Dreadful pain in arm, felt like it was broken. Onset 3 hours after shot. Chills and fatigue the following night.
Patient reported erythema, inflammation, and pain at the injection site. She described it has, "a red circular rash that is swollen and warm to touch at the injection site, the pain is mild" I instructed her to use tylenol/ibuprofen to help reduce the pain and inflammation and also use an ice pack to reduce inflammation and the warmth. I also instructed her to contact us if anything changes.
By the evening that day, my son had a 3 hour screaming episode. Nothing would calm him and he nonstop screamed/cried. That night, he slept for about 15 hours straight. Then, in the months following developed chronic constipation and diarrhea. One week he would have constipation, the next he would have diarrhea. His diet was consistent and healthy. He continued to have screaming fits that were so abnormal for him. He also developed splenomegaly in the months following these vaccines and the ones given in May, July & August.
Had sore arm a few days after vaccine.  Headache lasted a week, fatigue.  Then sore arm came back on 4/9 along with warmth and redness.
Diagnosed with chickenpox on 3/21/2006, received Varivax on 8/11/1998.
Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system. During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.    The CDC requires continuous temperature monitoring of all VFC vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness. We want to reassure you that there is no potential harm to your child from
Chest pain, non continuous, on the right side of the chest, at the level of the heart. Started 5 or 6 days after the vaccine. Still ongoing today albeit very mild now. It was strong enough that it would wake me up at night.
cough; Short of breath; Losing 30 pounds / weight loss; high eosinophils; This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 1 and 2 months after receiving Shingles vaccine, the patient experienced cough, shortness of breath, weight loss and eosinophil count high. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the cough, shortness of breath, weight loss and eosinophil count high were not recovered/not resolved.   It was unknown if the reporter considered the cough, shortness of breath, weight loss and eosinophil count high to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed a cough and had become short of breath.   The reporter reported losing 30 pounds, but it was unclear if that was prior to the onset of breathing problems or after, or if the weight loss was deliberate.  The patients doctor has told her she has high eosinophils and was recommending treatment with Nucala and had not started taking Nucala. This call was regarding questions about Nucala, a medication the reporter has not started taking it yet.  The potential AE for the shingles vaccine was not recognized until after the call ended, so additional information was not available. The patient received Shingrix 2nd dose in February 2020.
Fainted, pale, skin felt cold and clammy, patient reported nausea, BP was 107/73, pulseox: 98%, Pulse: 65 bpm. Patient given a lollipop, cookies, and water as well as an ice pack. Patient sat and rested for approximately 20 minutes after event after which he reported feeling much better and left.
11-10 Developed mild "light headedness" developed fine, macular eruption on 11/11, had to abort incipient migraine (has by history) on 11-11. Rash has persisted with some itching, but no excoriation. On 11-12, onset of mild discomfort with swallowing and some ill defined tightness in upper airway -No wheezing, evertional dyspnea - Prescribed PREDNISONE 40 mg QD x 2 days then 20 mg x 3 days.
Patient reports that 24 hours after vaccination she experienced a "redness" on face and chest and then had a fever up to 103 degrees F. The redness resolved approximately 24 hrs. later. Then she started having nausea & vomiting, joint aches and headache on day 5 after vaccination. I advised a medical evaluation but the patient declined.
Within 2 hours of the shot, he became clumsy and began falling frequently. By the next day, he began taking less weight on his left leg and demonstrating a significant limp. The limp became progressively worse over the next two weeks. He was taking almost no weight on that leg and the leg was also observed to buckle if he did put weight on that leg, up to 8-10 times per hour, resulting in falls. After 1 week of symptoms, I took him back to the pediatrician, and bilateral hip, knee, and ankle xrays were ordered, but no abnormality was found. There was also no redness or swelling or obvious pain to palpation. I am his mother and a pediatric occupational therapist, and I can tell you from my professional perspective that there appeared to be peripheral nerve/sensory involvement. It was as if he could not feel or move his leg when ambulating. I called Pfizer, who stated that his symptoms are consistent with the known adverse event of "limitation of limb movement". It is slowly resolving, but it is not yet fully resolved. In addition to his limping, he also had a severely reduced appetite and diarrhea for 14 days.
c/o generalized itching; feeling of fullness in lips; feeling of puffiness in eyes;
Rash; Inflammation; Swelling; Itchy; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced a rash, inflammation, swelling and itchy after receiving the vaccine. She stated it was not uncommon for her to get. The patient wanted to know if she could take a Benadryl. Limited information was available. The clinical outcome of rash, inflammation, swelling and itchy was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Localized urticaria on lt UE 5-10 secs p/inject intense itching;
On both ends of the bandaid that was applied I developed a blister. One was much larger than the other and one burst and blistered again.
Vaccination related malaise; Vaccine administered to patient of adolescent male patient; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination related malaise) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination related malaise) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient). At the time of the report, IMMUNISATION REACTION (Vaccination related malaise) was resolving and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced did not feel well from covid Injection. Moderna vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approximately five minutes after being vaccinated the patient described what she felt was a hot flash and then became dizzy with sweating, rapid breathing, and pale skin.