chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours after 2nd vaccine intermittent numbness to right arm; Swelling, redness, pain and warmth at injection site; Swelling, redness, pain and warmth at injection site.; Swelling, redness, pain and warmth at injection site.; Swelling, redness, pain and warmth at injection site.; This is a spontaneous report from a contactable nurse, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 30Apr2021 at 19:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit-hyperactivity disorder (ADHD) and anxiety. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), sertraline hydrochloride (ZOLOFT), hydroxyzine (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 04Apr2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 22:00, 24 hours after second vaccine, the patient experienced intermittent numbness to right arm, swelling, redness, pain and warmth at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen and ice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness to right arm, swelling, redness, pain and warmth at injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vasovagal Reaction. Vital signs taken at 3:15 91/44  HR 69.  Feet elevated, cool pack applied, another  set of vitals taken at 15:24  109/54  HR 54. Patient rested lying down with feet elevated. Cold water given. Third set of vital signs taken at 15:27  108/65  HR 83.  Patient feeling better. Set upright. Patient stated that he had had the same response in the past with a vaccination. Educated patient to always inform a provided about this response in the future.
On 12/28/1999, the pt received the first IM-left deltoid dose of Lymerix.   One hour later on 12/28/1999, the pt experienced chills, fever, body shakes and body aches. No treatment was given. Symptoms resolved on 12/28/99.   The most recent information received on 12/29/99 reports the condition of the pt is resolved.
Pt developed bilateral optic neuritis within 1 month, no etiology found. She has since recovered and mother just brought timing to my attention.
Aching began day after injection, nausea, dizziness, shaking, general flu-like muscle and joint pain, fever, no appetite. Lasted approximately 4 days. Patient could not drive. Day after patient was seen by Dr and received Benadryl, steroid (methylprednisolone dosepack), after 4-5 days from the injection it resolved.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 09-FEB-2013, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot number reported as 0364AE, expiry date 16-MAR-2013, route was subcutaneous) that had been previously exposed to 71 degrees Fahrenheit for possibly 16 to 24 hours. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Injection site reaction raised red bump golf ball site slightly larger over night to orange size, hard in center to touch. Pt used ALEVE.
I received the vaccine and took a nap and woke up and felt paralyzed on the right side and I got up out of the bed and started walking around and that went away and two days later I developed a fever and the next day after that I developed a boil and I went to see the primary care doctor, I thought it was a blood clot and I went to see the Dr and she said that it was a cyst and she gave me an antibiotic to take for 10 days and a suave for 5 days and then I went to the urgent care and they decided for me to have a full evaluation and they wrote a report that I gave to my PCP and saw my cardiologist and they took meds away.  I just had another boil come up last week.  I am in physical therapy now and he works on my knees.  It started to aggravate me and  Sunday night it busted and the doctor gave me more antibiotics.  The doctor said it was the best thing that could happen because the other one never ruptured and none of this was going on till I taken the shot.  I had no reverse things till this came about.  I told the doctors they are going to have to work with me and I have never seen a heart doctor till this came about.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt felt dizzy after 10 minutes of sitting in the store. We decided to have the patient laid down for 10 extra minutes and she felt better after 20 mins. Pt was okay to leave the pharmacy with her parents.
Woke up morning after injection with chills and fever. A few hours later had horrible body aches, fever around 102. Highest temp was 104.  Chills again that night, could not get warm. Body aches lasted into the next day as well. Extreme fatigue, thirsty,  achy. By day 3 felt back to normal. Did have headache for a few days too.
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
Baby started projectile vomiting repeatedly, which was followed up by diarrhea.  Symptoms lasted approximately 12 hours.
The pt experienced minor muscular aches and a shooting pain from the injection site down into the elbow. Shoulder is very painful at night.
Patient was administered shot and shortly after (couple days) began having pain down arm and in joints of fingers, saw DR got Voltaren gel but hasn't had relief. Forgot to mention shot at visit.
Red swollen eyes. Throat swollen, hard to swallow. Gave 50 mg benadryl and told I would get checked out at ER.
Information has been received from a physicians assistant concerning a 25 year old patient who on 02-OCT-2007 was vaccinated with a first dose of Gardasil vaccine (Lot #658488/1264U). On 05-OCT-2007, the "patient experienced generalized rash all over the body." At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 25 year old female who on 04-OCT-2007, at 15:58, was vaccinated IM, into the left arm, with a first dose of GARDASIL (lot #658488/1264U). On 04-OCT-2007 the patient developed "itchy rash all over body." On 05-OCT-2007, the patient still had the rash. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Right arm lymphedema; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: unknown), intramuscular in the right arm, on 11Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included migraines and penicillin allergy. Concomitant medication included rizatriptan. The patient took first dose of bnt162b2 (lot number: EL0140) on 23Dec2020 via intramuscular in the left arm for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 12Jan2021, the patient experienced right arm lymphedema. Event was not treated. Outcome of the event was not recovered.
syncope, swelling to upper arm where recieved injection, nausea and dizziness
I contracted Covid; I contracted Covid; Dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FH8028) at the age of 58 years as dose 3 (booster), single, administered in arm left, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM; HYDROXYCHLOROQUINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovered" and all described as "I contracted Covid"; IMMUNISATION (medically significant) with onset 15Nov2021, outcome "unknown", described as "Dose_number=3". The event "i contracted covid" and "i contracted covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Patient had no known allergies. Since the vaccination the patient has been tested for COVID-19. Patient did not receive any other vaccines in 4 weeks and prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
01/05/23 presents to ED for "corona virus concern". PMHx of "current stage IV cancer, history of DVT, liver and renal transplant, hepatitis C, coronary artery disease, A. fib, GERD, gastric varices and cirrhosis"
Approximately 7-8 hours after receiving the vaccine I was awakened with uncontrolled shivering and feeling cold. After about 90 minutes the shaking subsided and I was able to continue sleeping for a short time.  When I got out of bed I had moderate lower back pain and some dizziness, neither of which is normal. I felt weak and tired for the next 24-30 hours and finally felt normal after 48 hours.
12/29/2021- History of Present Illness: The patient presents with episode of syncope during physical therapy at the house PTA. Daughter denies patient hitting her head or trauma. Patient had vomiting and diarrhea. Yesterday patient was doing OK with no vomiting or diarrhea. Patient has had a dry cough starting today. Patient got COVID test for the cough for which she sometimes has. Patient had no fever at home. Per EMS: BP 62/38, 100.4 F, 1200 mL saline given. Patient says she is now feeling fine. Associated symptoms: nausea, vomiting, fever, denies chest pain, denies abdominal pain, denies headache, denies dizziness and denies back pain.
abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Feb2021, the patient experienced abdominal pain. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered.     No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Onset of redness, swelling, pain, itch within 4-5 hrs of receiving her first 6 AVA SQ.
Fever. Large area approximately size 1/2 dollar of redness, swelling, induration, excruciating pain to left upper arm - site of injection.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever of 103F to 104F), CHILLS (Bad chills/ rigours at nights), VOMITING (Vomiting) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 021B21A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), CYANOCOBALAMIN (VIT B 12) and TESTOSTERONE for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever of 103F to 104F), CHILLS (Bad chills/ rigours at nights), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever of 103F to 104F), CHILLS (Bad chills/ rigours at nights), VOMITING (Vomiting) and HEADACHE (Headache) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 103 to 104 (High) 103F to 104F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After receiving paracetamol it took 6 days for the symptoms to disappear completely. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. This case was linked to MOD-2021-102002 (E2B Linked Report).; Sender's Comments: MOD-2021-102002:Dose1 case.
Pt recv vax on 10/2/97; on 10/3/97 pt exp urticarial rash; tx=Prednisone & Benadryl.
Patient received 3 full doses of Moderna Covid vaccine (2 shot series as well as an addition dose due to immuno-compromising  conditions) and also received the booster dose at an offsite clinic. Patient has reported no issues or adverse events related to this additional dose.
Patient received moderna vaccine on 3/18/21, 4/15/21, and 1/6/22. Presented to ER on 7/13/22. COVID positive on 8/6/22. Admitted on 7/13 for lethargy and patient lying on floor. The patient was ready to be discharged but then he had  a positive COVID test without any COVID symptoms.  He was kept in hospital  for 3 more days and observed.  He has not developed any fever, chills,  diaphoresis.  Discharged on 8/8/22
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (the patient had a reaction to vaccine). On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, general body pain and injection site pain. On 3rd June 2018, the patient experienced injection site itching. The patient was treated with paracetamol (Tylenol) and crisaborole (Eucrisa). On an unknown date, the outcome of the fever, injection site itching, injection site erythema, general body pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, injection site itching, injection site erythema, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a fever, body aches, injection site pain and redness the evening after receiving SHINGRIX. Four days later, the patient experienced severe injection site itching. The patient took Tylenol and Eucrisa to treat her symptoms. Her symptoms lasted about 7 days and resolved. The reporter given permission to contact physician.
Pt reported dizziness after receiving vaccination.  Resolved with no treatment or transport.  Vital signs within normal limits.
Patient showed up to the hospital after her 2nd Moderna vaccine with AFib w/RVR and failed cardioversion. Patient was recently diagnosed with AFib  a couple of days after receiving the first dose of the Moderna vaccine
My left arm hurts every time I move it, I cannot move my arm back or out away from my body without pain. My vaccine was on 2/10/21 and I am in still in pain.
A nurse reported that a 49-year-old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated on 04/09/2001. The next day, she developed an injection site reaction measuring 4-inches in diameter characterized by being raised and red. the patient also experienced weakness and body aches. The reporter indicated that 2 pt experienced these events.  (See HQ 2658928JUN2001)  No further information was available at the date of the report.
UPPPER RIGHT-ARM: REDNESS SPREAD-OUT 7"x5" BELOW THE INJECTION SITE, SWELLING, SKIN FLUSH AND HOT TO THE TOUCH, MULTIPLE NICKLE AND DIME SIZED HIVES ON SHOULDERS AND ON THE BACK OF THE UPPER RIGHT ARM.
Swelling, redness, small blisters stretching over a large area surrounding the injection site...told to try Benadryl and possible an ice pack...doctor out of town today.
facility gave an expired vaccine shot (expired by 4 days) of Daptacel to a patient; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used. It was reported that the facility gave an expired vaccine shot (expired by 4 days) of Daptacel and reporter did not know any information about the patient.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS  LATER IT BECAME REALLY SORE TO THE POINT OF HURTING. HE SAID HE HAS A PHYSICAL JOB AND HE COULD HAVE EASILY INJURED HIS SHOULDER AT WORK THE DAY HE GOT HIS VACCINE, BUT DOES NOT REMBER INJURING ARM/SHOULDER. THE PATIENT PRESENTED TO THE PHARMACY FOR HIS SECOND VACCINE (OVER A MONTH LATER) AND HIS SHOULDER IS STILL HURTING. HE SAYS IT HURTS WHEN HE LIFTS IT UP, IF FEELS WEAK, AND HE HEARS/FILLS A 'POP'.
20Jun1997 recv 1 dose vax. 23Feb98 devel varicella w/approx 50 lesions behind ears, on back & trunk. No fever.
This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
speeding heart rate from the Pfizer vaccine; This is a spontaneous report from a contactable consumer. This reporter reported similar events for four patients. This is the second of four reports. This case is non-serious.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. When reporter did reporter's EKG, it was reported that she was the 4th person to come in with a rapid heartbeat after the vaccine. The patient experienced speeding heart rate from the pfizer vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350648 same reporter/drug, similar event, different patient
Pt had agreed to wait post Covid IM for observation due to history of allergeries.  After 30 minutes post observation, pt reported an onset of "sinus headache" and noted redness and itching on left index finger.(injection site was in left Deltoid) Pt immediatly took her own dose of Benadryl 12.5mg ( pt stated "I have to take children's dose). Pt denied SOB, no hives noted at injections site or in left hand. Denied Nausea, denied heart palpitations (Pulse 88) no dizziness. No tightness in throat or chest. BP at 3:30 137/94 after 10 minutes 148/68. Pt sated, " I feel normal" ER visit was encouraged but Pt and husband decided to not go to ER for evaluation.  "I am there for hours and they never find out what is wrong with me." Pt remain in Covid clinic under observation until 4:10pm. Upon departure, patient reports headache subsided and redness disappeared. Pt left with instructions to call 911 if she worsens. Pt and her husband agreed. Also advise patient to contact PCP for guidelines for second Covid IM.
Injection at 9 am . By 2pm experienced stomach/intestinal cramps, headache and leg muscle pain.  Saturday morning got up at 7 am with severe stomach/intestinal cramps, headache and leg muscle pain.  Took ibuprofin and vicodin to relieve symptoms. Felt bad all day. Sunday morning woke up at 4 am with same symptoms. Same ibuprofin/vicodin pain relief. Felt bad all day. Moday morning woke up midnite, 2am, 4am with severe headache. At 2am had severe abdominal pain. Same ibuprofin/vicodin pain relief. Still hurt at 4pm Monday.