chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced severe pain and loss of mobility in the injected arm. That evening I had a temp of 99.6 and severe fatigue, the following day (Thur. 8/23/18) I continued to feel ill. Temp still elevated and severe fatigue. I went to bed early that night (6:30 PM) hoping to sleep the reaction away. At 12:30 AM I was awakened by a severe pain in my right hip. I was unable to stand or put any weight on the right leg. I spent Saturday with this severe pain and hobbled around the house using furniture as a crutch. On Sunday the pain relented slightly and I was able to limp around, but still experiencing severe pain in right hip. It has been that way till today, I called the Dr. and went in to see the PA. She sent me for x-ray and it showed no mechanical damage. I was prescribed meloxicam. I have not started this treatment yet. I can only guess, as well as the PA, that this is a severe reaction to this vaccine.
Pt states had dizziness, 2 hours, post vax. He had difficulty focusing on day 2. Went to ER and was referred to a neurologist, who dx'd him with diplopia. Immune mediated event due to immunizations.
Sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in arm left, administration date 09Mar2021 14:30 (Lot number: ENG207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerant" (unspecified if ongoing); "Type 2 Diabetic" (unspecified if ongoing), notes: Type 2 Diabetic. Concomitant medication(s) included: OZEMPIC; FARXIGA; SIMVASTATIN; UBRELVY. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional Information: The patient was also taking vitamins for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372707 same drug/reporter, different dose and events
mom described sz 10OCT93 @ 3PM & 12OCT93 @ 630AM reports as pt fell down, eyes rolled back, had shaking movement; did not respond to verbal calls-lasted 4-5 mins; then opened eyes staring & then went to sleep; transported to ER;
This spontaneous case reported by a consumer, describes the occurrence of maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031A21A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine). At the time of the report, maternal exposure during breast feeding (breastfeeding and received her 1st dose of the Moderna COVID-19 vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Notice that he had 2" x 1 3/4" then went up to 4"x4" Rt thigh. 7/8/07 Put on antibiotic BID x 10 days. Topical cream and Epsom salts.
Patient was administered their 2nd dose of the influenza vaccine 5 days early. Provider was notified. Patient was monitored for post-immunization reaction and none noted.
4 days p/vax severe urticaria w/swollen joints & fever to 101; rxn took 3 days to resolve
Localized rash around site of injection that quickly spread to the back of her neck; itchy, red, inflamed. Treated with Triamcinolone Acetonide cream 0.5% twice a day x14dys, treatment still ongoing.
Patient presented to the ED and was subsequently hospitalized for Acute respiratory failure with hypoxia and hypercapnia within 6 weeks of receiving COVID vaccination.
Acutely and abruptly ill on 12/31/2020, early afternoon. Short of breath, dyspnea, mental fogginess, and dry cough.  Spouse took me to ED.
Injection site pain; On 25-SEP-2022, a serious initial non-interventional study safety report was received from a consumer via study and was received by Novavax on 25-SEP-2022.  An individual of an unspecified race,age and sex was vaccinated with intramuscular Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced injection site pain (PT: Injection site pain) (Serious: Hospitalization).  At the time of reporting, the event outcome of Injection site pain was unknown.  The reporter assessed the causality between vaccine and reported events: Injection site pain as Not Reported.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Injection site pain after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Injection site pain was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Injection site pain was assessed as related.
Dose dripped while administering the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Dose dripped while administering the second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Dose dripped while administering the second dose). At the time of the report, UNDERDOSE (Dose dripped while administering the second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
UNUSUAL TINGLING SENSATION FELT DURING AND POST VACCINATION. AFFECTED ARM (LEFT) IS ARM THAT RECEIVED VACCINE. DENIES PAIN, SHORTNESS OF BREATH, SECONDARY/NEUROLOGICAL EXAMS NORMAL. REFUSED TRANSPORT.
sinus infection; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): GL-011822-1190 (Reference Number).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid (RESTYLANE), from 14Jan2022 17:00 (Batch/Lot number: unknown) to 14Jan2022 17:00 at 1.2 mL (1.2 ml(received 1 ml of restylane kysse 0.75 ml in the lips and 0.25 ml around the mouth)). Relevant medical history included: "dental cleaning" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), administration date: Dec2020, when the patient was 46 years old, for covid-19 immunization; Bnt162b2 (2nd Dose), administration date: Jan2021, when the patient was 46 years old, for covid-19 immunization. The following information was reported: LIP SWELLING (non-serious) with onset 14Jan2022 20:00, outcome "recovering", NASAL OEDEMA (non-serious), CIRCUMORAL SWELLING (non-serious) all with onset 14Jan2022 23:30, outcome "recovering" and all described as "lip swelling/swelling was huge, up to my nostrils and round my mouth/could feel a ridge up by my nostrils"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of lip swelling, nasal oedema, circumoral swelling, sinusitis. Additional information: She received the injection around 5:00 PM and by 8:00PM the same night she started to experience lip swelling and by 11:30 PM the same night nurse reports the swelling was huge, up to her nostrils and round her mouth. She could feel a ridge up by her nostrils. Patient was given an injection of Kenalog and prescription for prednisone on 15Jan2022. Patient reported that Kenalog helped a lot and prednisone helped even more. Patient reported on Sunday 6Jan2022 the swelling had decreased to the normal expected swelling, she still has slight swelling. Patient had Restylane kysse about a year ago and did not experience this swelling then. Denies any other vaccines within the past year. Nurse reports she recently had a sinus infection but no other illnesses reported. Nurse reports she has had a routine dental cleaning in the past 6 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Recipient states that approximately 2 hours or less after vaccination her left arm began to hurt.  As of today she states radiating pain, weakness, and inability of full use of left arm.  I advised her to not receive 2nd dose of COVID vaccine and to see PCP.
Full body rash 2 days after vaccines and 1 week after amoxicillin. Questionable vaccine vs. allergic reaction. Very prominent rash at.
Patient received adult formulation of Pfizer vaccine rather than pediatric formulation.  No adverse effects noted.  F/U call ot patient's mom on 12/23/2021.  Mom reports only complaint of pain to injection site.
Information has been received from a physician's office staff concerning an approximately 17 year old female who on approximately 05-AUG-2009 (two weeks ago) was vaccinated with her second dose of GARDASIL (Lot # was not provided). Concomitant vaccine therapy included VARIVAX (Merck) and meningococcal vaccine (unspecified) (manufacturers unknown). On approximately 07-AUG-2009 (two days after receiving her second dose) the patient experienced headache and nausea. On 18-AUG-2009 the patient fainted and went to the emergency room but it was unknown if she was admitted to the hospital. The patient's headache and nausea and fainted persisted. The outcome of the events was unknown. Additional information has been requested.
PATIENT IS AFRAID OF NEEDLES, HE WAS ANXIOUS AT TIME OF VACCINATION. AFTER VACCINE WAS GIVEN, PHARMACIST TOLD PATIENT TO BE SEATED AND WAIT 15 MINUTES. ABOUT 10 MINUTES LATER, PHARMACY STAFF HEARD PATIENT SAYING 'GOING DOWN' HE WAS SLIDING DOWN THE CHAIR. PHARMACIST RUSHED OUT TO THE PATIENT AND SECURED AREAS AND HELD PATIENTS ARM AND SHOULDER MAKING SURE HE IS NOT HITTING ANYTHING WITH HIS HEAD. PHARMACIST ASKED ANOTHER PHARMACIST TO CALL 911 AND MANAGEMENT TO THE PHARMACY.  ALSO CALLED PATIENTS FATHER TO COME IN FROM PARKING LOT, HE SPOKE TO PATIENT AND MADE SURE HE IS FINE AND AMBULANCE CREW CAME VERY QUICK AND CHECK ON PATIENT. PATIENT WAS AWAKE AT THE TIME, NO INJURIES. CREW TOOK HIM TO EMERGENCY ROOM FOR FURTHER EXAMINATION.
flu like symptoms; pain; redness; fever; chills; swelling; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, erythema, fever, chills and swelling. On an unknown date, the outcome of the influenza-like symptoms, pain, erythema, fever, chills and swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, erythema, fever, chills and swelling to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. he patient received Shingrix  and experinced pain redness, swelling, and flu-like symptoms with fever and chills following Shingrix vaccination.
Pt reports, redness, swelling, warmth and pain in the are of the deltoid, ~5cm oval. Still painful and mild swelling 7 days later. Improving. Denies, itching, hives or throat swelling. Pt reported to different clinic when he presented for suture removal.
Blood pressure went up, usual BP is 128/85 and had 147/100; Period became irregular, went from happening every 29 days to being completely off and unexpected; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EW0171), via an unspecified route of administration, administered in left arm on 03May2021 at 15:00 (age at the time of vaccination was 21 years) as dose 2, single for covid-19 immunisation at hospital. Medical history included, covid-19 from an unknown date and unknown if ongoing (the patient had COVID prior vaccination) and birth control from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for birth control, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient was previously administered bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EW0162), via an unspecified route of administration, administered in left arm on 14Apr2021 at 16:15 (age at the time of vaccination was 21 years) as dose 1, single for covid-19 immunisation at hospital. It was reported that no other vaccine was administered to patient in four weeks. On 10May2021, the patient(s) blood pressure went up, usual bp was 128/85 and had 147/100, period became irregular, went from happening every 29 days to being completely off and unexpected. Also her blood pressure went up, usual BP is 128/85 and had 147/100 for a full month before it went away and came back down to normal levels. On 10May2021 the patient underwent lab tests and procedures which included blood pressure measurement: 147/100 (Usual BP is 128/85). The patient was not tested for COVID post vaccination. No treatment was received for AE. It was reported that the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
A non-serious, spontaneous report of administration to 20 month old was received from a health professional concerning a 20-month-old male. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Itchy left arm, redness, swelling under left arm, painful and tender. Still sore and swollen today 01/25/2021.
VARIVAX was ordered by MD / ZOSTAVAX given by error; Both meds side by side in freezer shelf / Merck contacted / Observe child / child was without any side effects after 24 hours. Follow-up Information 17-JUN-2008: Mother reporting some headache but improving over time and red area at site of injection is also improving over time.
At 2pm pt got Zostavax shot. By the time she got home, she noticed her feet and ankles swollen.  She called us to report the side effects and called her dr.  Later on she was in the emergency room.  ER Dr couldn't find out why she had this reaction.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored MMR II injection, lot # K005574, exp. date: 17-APR-2016, lot# K003822, exp. date: 14-MAR-2016 and lot# K009192, exp. date: 27-JUN-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
8 hours post vaccination: severe arm pain, severe chills, severe body aches, fever 100; 13 hours post vaccination: fever 101, shortness of breath, headache; 21 hours post vaccination: migraine, persistent fever 100
Later that evening, my arm began to hurt. The next symptoms were intermittent very sharp pains first on the left side of my face between my ear and teeth and the next day my right side as well.  Throughout the night I had very severe nausea, body aches muscular and bone.  I had fever for 3 days exhaustion and  brain fog for 4-5 days.  By Wednesday I felt normal again.
Rash on left Arm around shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 08:00 (Lot number: EW0150) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Batch/Lot No: ER2613 , Location of injection: Arm Left , Vaccine Administration Time: 08:00 AM), administration date: 17Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 09Apr2021 08:00, outcome "recovered" (17Apr2021 08:00), described as "Rash on left Arm around shot". Therapeutic measures were not taken as a result of vaccination site rash.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Cold; chills; Discomfort; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration on 08Feb2021 (at 79-years age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284), on Jan2021 12:00 PM as single dose for covid-19 immunisation. The patient medical history were not reported and no known allergies. The concomitant medications were reported. The patient was not tested positive to covid prior and post vaccination. The patient had not received any other vaccines within prior to the COVID vaccine. The patient experienced cold chills and discomfort occurs intermittently throughout the day and night on 09Feb2021. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The patient consider the Pfizer product had a causal effect to the adverse event. The event outcome was not resolved.  Follow-up(27Apr2021): This is a follow up-spontaneous report from a contactable Physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: event details and narrative description. Follow-up attempts completed. No further information expected.
3 Hours after injection patient started to "not feel like himself."  Several hours later he vomited and was profusely sweating. Patient still reports vomiting and sweating the day after injection.
abnotmal neut; abnotmal monos; abnotmal eos; This case was reported by a consumer and described the occurrence of neutrophil count abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 2nd dose of Shingrix. On 22nd November 2019, 3 days after receiving Shingrix, the patient experienced neutrophil count abnormal, monocyte count abnormal and eosinophil count abnormal. On an unknown date, the outcome of the neutrophil count abnormal, monocyte count abnormal and eosinophil count abnormal were unknown.   It was unknown if the reporter considered the neutrophil count abnormal, monocyte count abnormal and eosinophil count abnormal to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient had abnormal neutrophil, monocyte eosinophil count. The reporter inquired if this could be related to the vaccine. This case has been linked to another case reported by the same reporter US2019AMR211840.
he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning; he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning; he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning.; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning), DECREASED APPETITE (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning) and NAUSEA (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ONDANSETRON for Nausea.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FOOD POISONING (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning), DECREASED APPETITE (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning) and NAUSEA (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning.). At the time of the report, FOOD POISONING (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning), DECREASED APPETITE (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning) and NAUSEA (he got very nauseous and he could not eat or drink anything, and he felt like he had food poisoning.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.