chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO. Concomitant products included FLUARIX TETRA. On 29th September 2017, the patient received BEXSERO. On 29th September 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient was the daughter of the reporting pharmacist. The patient received BEXSERO and FLUARIX TETRA in an unknown arm. The patient experienced injection site pain that had not resolved. FLUARIX TETRA was administered in opposite arm but the patient had not complained about pain in that arm. The healthcare professional did not had lot number or expiry information for either vaccine administered.
Persistent moderate to severe headache, fever and myalgia immediately following second vaccination progressing over days to neck stiffness, nausea and vommitting, personality change and irritability, ataxia involving dysarthria, extremities and gait leading to hospital admission on 6/19/21
Pt. received flu vacc. on 12/8/12. Developed chills, weakness & tiredness. Now (1/23/13) c/o coughing up white mucous, nasal discharge & still feels weak/tired.
Insomnia; Headache; Left Shoulder Pain; a little dizzy; anxiety at night; This is a spontaneous report from a Regulatory Authority via medical information team. A contactable male consumer (patient) reported.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient experienced insomnia, headache, left shoulder pain, a little dizzy and anxiety. The 1st week, the patient had insomnia, Headache and left shoulder pain. "He took Naprosyn and the headache went away but he became dizzy." The 2nd week his "headache came back and also dizziness, he went to the doctor and was told he was fine." The patient asked Are these normal side effects and will my shoulder go back to normal "Is the dizziness normal and how long does it last". The patient also asked Can I take pain meds after the 2nd vaccine dose for my shoulder and anxiety at night which will help me sleep" He saw his doctor and doctor told him he was fine. The patient wanted to know if he should still get 2nd dose of vaccine." The patient took Naprosyn as therapeutic measures for event headache. The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a consumer regarding to her 17 years old daughter, who had no concomitant medication, pertinent medical history or drug reactions/allergies. On 12-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date and dose were unknown; intramuscular). On an unknown date in July 2016 (reported as a few days later), the patient experienced itching all over her body and also developed pimple like blisters all over her body. It was reported that the itching got worse when the patient was outside and she was hot and sweating. The patient sought medical attention by visiting the physician's office. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
I experienced intense chest pain (thought I was having a heart attack), went to the hospital and they diagnosed it as pericarditis, took Ibuprofen on a near hourly basis for the next several weeks. In the following months, I also experienced intense musculoskeletal pain on and off, sometimes lasting a week, sometimes several days. No medication worked to make it subside. Currently it has faded to almost nothing, but it lasted around 6 months.
Dose 1 gave me a tremondous an extremely sore arm, extreme exhaustion.  Dose 2 gave me a smashing headache, severe nausea, severe ehaustion, couldn't eat, temp 102.5, total body aches,  sever cough.  Ice and heat  packs to break fever, tried to drink water. Stayed in bed.
Reaction started with itchy and red eyes at 6:30pm.  Sx worsened to include rapid heart rate and breathing difficulties.  She was seen at 11:15pm and given #1 EPI, #2 STEROID, 3# BENADRYL.  Given PREDNISONE 50mg X5 to take home.
Patient has had the flu shot many times in the past but has never had the shingles shot. Pretty sure her reaction is related to the Shingrix vaccination. She broke in a rash on her whole body.
Approximately 2 days after the vaccine, I started experiencing shortness of breath, fatigue, profound muscle weakness in my lower legs and lower arms, and tremors. The symptoms got worse over the next 3-4 days and then started to gradually lessen. I'm now 2+ weeks post vaccine and I still have arm weakness and some leg weakness.
migrane; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health professional and describes the occurrence of MIGRAINE (migrane) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (She just finished chemotherapy for lymphoma.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migrane). At the time of the report, MIGRAINE (migrane) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided
she had received an extra injection; I did find out that I am allergic to the Covid vaccine; This is a spontaneous report from a Non-Contactable consumer. This 42-year-old female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had no changes to her health. She did find out that she was allergic to the Covid vaccine on unknown date in 2021. She reported that she had received an extra injection (took 3 in one month) cleared the breakout due to the vaccination. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event "she had received an extra injection" recoded to "extra dose administered".
Patient reported arm swelling after shot. She iced it and took BENADRYL/APAP which didn't help much. I referred patient to doctor. Doctor prescribed MEDROL dose pack. Patient was counseled on use and ok.
ACHY JOINTS; FATIGUE; CHILLS; PERIODIC HEADACHE PAIN/PAIN NEAR LEFT EYE AND EAR; SWELLING ON THE LEFT TOP AREA OF SKULL/ FLUID BETWEEN SCALP SKIN AND SKULL BONE; BIT OF TENDERNESS ON THE LEFT TOP AREA OF SKULL; This spontaneous report received from a patient concerned a 61 year old male. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling on the left top area of skull/ fluid between scalp skin and skull bone. On APR-2021, the subject experienced bit of tenderness on the left top area of skull. On APR-2021, the subject experienced periodic headache pain/pain near left eye and ear. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced achy joints. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy joints, fatigue, periodic headache pain/pain near left eye and ear, swelling on the left top area of skull/ fluid between scalp skin and skull bone and bit of tenderness on the left top area of skull was not reported. This report was non-serious.
difficulty walking; Shooting nerve pain from hip to foot on right side.; Intense pain; fever; chills; shortness of breath; nausea; chest pain; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female consumer(patient) reported that:  A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 21May2021 at 10:00 (at the age of  54-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included known allergy to epinephrine, MRI dye (MRIBUTIN) and Penicillin from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on 30Apr2021 at 10:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Ambien within 2 weeks of vaccination. On 21May2021 at 21:00 the patient experienced difficulty walking, shooting nerve pain from hip to foot on right side, intense pain, fever, chills, shortness of breath, nausea and chest pain. Since vaccination patient not tested for covid-19. This case assessed as non-serious as per reporter. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovering.  Additional information is requested.
Febrile reaction 12-7-05 to 12-12-05, temp ranged from 101-105 degrees.
Fever of 102, fussy, diarrhea, not eating, vomiting, not sleeping, crying, can't put him down, fussy, non interactive-not playing, cooing, babbling. Fever  and diarrhea gone after 5 days but still fussy, won't sleep and non interactive.
Chills, shaking, soreness all over, over 2 days. Rest, Ibuprofen, TYLENOL for treatment.
This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-DEC-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
She is having diharrea, severe headache, pain at injection site, strong fatigue, soreness, nausea  My fiance is 37 weeks pregnant, estimated delivery date is April 8th
The patient reports same-day symptoms including redness, warmness, and swelling around the injection site. Lasted for approx. 4 days, then self-resolved. Now has a fluid-filled blister at the injection site (pencil eraser size).
Information has been received from a registered nurse concerning an 11 year old female who on 16-JUN-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 619271/1338D). On 05-NOV-2007, the patient developed a breakthrough of chickenpox. The patient had rash on shoulders, chest, head, abdomen and legs. The patient also had fever and had less than 50 lesions. On an unspecified date the patient had recovered. Additional information is not expected. This is one of several reports received from the same source.
Patient DOB 09/16/2009 presented to the Center on 2/9/2022 for a first dose of Pfizer COVID vaccine for ages 12 and up. Client presented with her mother and 10 year old brother. Upon sitting at the pediatric vaccination table, both patient and her brother were vaccinated at 4:18 pm with Pfizer COVID vaccine for ages 5 to 11 in her right arm. (Lot FL8095 exp 3-16-22). PHN called Clinical Project coordinator and discussed CDC guidance for error. PHN informed client?s mother on CDC guidance to administer the Pfizer COVID vaccine 12 and up formulation in 21 days to complete the primary series. Client?s mother verbalized understanding. Client waited in observation area for 15 minutes and left with mother and brother in stable condition with no complaints. PHN reeducated vaccination table on Pfizer COVID vaccine ages 5-11 and Pfizer COVID vaccine for ages 12 and up formulation. Vaccination table verbalized understanding.
Information has been received from a pharmacist concerning a female (age not reported) who on an unspecified date in September 2007 during a vaccination clinic, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). In September 2007 one or two days following vaccination with pneumococcal 23v polysaccharide vaccine the patient developed an injection site reaction described as a infection and was referred to her physician. The patient was given a prescription for CIPRO and BACTRIM antibiotics. The physician considered hospitalizing the patient but had not hospitalized her yet. The relationship of the event to therapy with pneumococcal 23v polysaccharide vaccine was reported as unknown. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-July-2021 contains Significant information new reporter details added, updated patient details and medical history.
Patient noted extreme hearing loss in right ear beginning  two weeks after 2nd Pfizer Covid Vaccine dose. The next day hearing loss was total in both ears. Patient reports he cannot even hear himself talk.
Again like the first dose, I felt burning sensation in my chest half hour. As day progressed, I felt worse. Intermittent muscle spasms all over my body, thighs, back, arms, chest area, bad headaches, muscle aches, joint pain, chills.
Pain/I feel severe pain; I can not even walk; Fever; Muscle pain; I can not even bend my neck towards my face; This is a spontaneous report from a contactable consumer (patient). This is the second of 2 reports. Only this case is serious. A 41-year-old patient of an unspecified gender received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FA6780), dose 2 via an unspecified route of administration, in the left arm on 30Jul2021 (at the age of 41 years) as a single dose for COVID-19 immunisation. The patient had no medical history and took no concomitant medications. The patient previously received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, in the left arm on 09Jul2021 (at the age of 41 years) as a single dose for COVID-19 immunization and experienced muscle pain. The patient had no prior vaccination before four weeks. The patient got the vaccine, the full dose and since one week almost a week they were feeling fever, pain and muscle pain. The patient was trying to take Tylenol as soon as the time closing about 6 hours, the patient felt severe pain, could not even walk, could not even bend their neck towards their face. The muscle pain started before the patient took the second dose. The outcome of fever, pain, muscle pain, could not even walk, could not even bend their neck towards their face was unknown.  Follow-up attempts are completed. No further information is expected.
Case previously recorded as MA2009-3085. Initial case report received from a registered nurse via MedCom, on 15 OCT 2009. A patient, age and gender unknown, was vaccinated i.m. with S-OIV FLUVIRIN (batch no. 3P003AA) in left deltoid. The caller stated that during administration, approximately half of the vaccine leaked out of the prefilled syringe. The caller was unsure about the batch number. No adverse event was reported. Reference no.: NA09-006349.
pt c/o fever,aches,knot in arm;inj site was enlarged,hard,& warm to touch;went to MD & was prescribed Anaprox
1215AM fever, chills (extreme) cont 8AM;fever 102, chills this cont until 530PM & then disappeared
out in the sun and broke out in hives; pain in her back; a headache; out in the sun and broke out in hives; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. It was reported that, on an unknown date, her friend got the second shot and two days later was out in the sun and broke out in hives and took benadryl and it went away but every time she is in the sun she broke out in hives. It was also reported that, when the hives come out it gives her an adrenaline rush, pain in her back and a headache. Her friend was driving in her car and the sun hitting her hands and forearms made her break out in hives and she had to turn around and go home and her friend has had photosensitivity for at least four weeks. Also enquired that, how long the photosensitivity will last. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness at injection site. Itching at injection site. Knot at injection site.
Per the documentation on our company consent form and the patient's COVID-19 Vaccination Record Card, the patient was given Moderna 0.5mL for her booster dose. The patient is not immunocompromised and therefore should have been given the booster dose 0.25mL. Upon speaking with the pharmacist who vaccinated the patient, she is confident she gave the correct booster dose, however, this cannot be confirmed with 100% certainty. The patient's caregiver, was notified and the patient did not have any adverse effects following her Moderna Booster dose. The caregiver was informed to contact us with any issues or concerns in regard to this matter.
severe headache; palpitation; shortness of breath; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), PALPITATIONS (palpitation), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 HEADACHE (severe headache), PALPITATIONS (palpitation), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy). At the time of the report, HEADACHE (severe headache), PALPITATIONS (palpitation), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-098962 (Patient Link).
This spontaneous report was received from a registered nurse refers to a 8 year old child patient. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On 23-FEB-2018, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), (dose, frequency, lot number and expiry date not reported) instead of Oka/Merck VARIVAX (wrong drug administered), subcutaneously for prophylaxis. No adverse effects were reported in the patient. No further information was provided. A product quality complaint was not present.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown deltoid and experienced warmth, achiness, soreness, and redness on her entire deltoid for six days. The symptoms had since resolved. The reporting pharmacist had declined to provide further information. The batch number reported for SHINGRIX (C5Z3T) did not exist and was updated to C523T as per sales database.
Left arm redness, swelling , warm at touch, and painful. Cetirizine given. MOC  informed  to apply cold compress.