chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 31-JUL-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
Patient is a 11 Y female who presents with redness on right arm. Next day after the immunization, patient noticed small, quarter sized red bump at infection sight. Today after picking up from daycare, sight was significantly larger, erythematous and "hot".
was very sick after shot but told that was normal with people who have had covid.  Took abut 8 days to feel "normal" then today woke up to a rash on the arm of the injection site that was quite large, red and sore.
cold; sore throat; cough; sinus issues; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown", described as "cough"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The female consumer was over the age of 65. Patient states that she received her first dose of the Pfizer COVID 19 vaccine in Mar2021 and received the second dose as well. Patient is on day 18 of the cold and thinks that it is subsiding or "waning". She described a sore throat, cough, and sinus issues. Patient was told by the nurse that it was okay for her to receive the booster dose since her cold was going away. The pharmacist told her that she should wait at least a week after her cold is gone to get the booster dose. Patient would like to know how long she should wait or if she needs to wait for the cold to subside completely before getting the dose. Her appointment is this Thursday to receive the dose.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sore upper left arm for about 3 days, starting during the afternoon after getting the shot around 10 AM.  Soreness decreased with each day.
43 hours after receiving vaccines pt developed tennis ball sized red area that was hot and tender to touch. Red area was at location of ZOSTAVAX shot.
Rapid heart rate 180bpm, AFIB, Graves? disease caused by vaccine, lost 16 lbs in two days. Hospitalized for three or four days.  On blood thinner, methimazole, atenolol for life. Hoping to get cardioverted  back to sinus rhythm soon.
PATIENT HAD A PNEUMOVAX INJECTION IN RIGHT ARM.  PATIENT CALLED THE MORNING AFTER INJECTION AND STATED: THERE IS A LARGE PONE IN THE AREA OF THE INJECTION.  ARM IS SWOLLEN AND WARM TOO TOUCH. SWELLING AS NOT REACHED THE ELBOW.  ARM IS NOT RED.  HAD FEVER AND CHILLS AND WAS UNABLE TO SLEEP THE NIGHT AFTER INJECTION DUE TO THE PAIN. PATIENT WAS CALLED BACK BY THE NURSE LATER THAT DAY AND STATED THAT HIS ARM WAS BETTER, NO FURTHER SWELLING, NO HEAT NOTED.
p/vax pt devel abd pain& vomiting; hosp w/dehydration & hematuria; during hosp devel purpuic rash & Dx Henoch-Schonlein Purpura made; disch 9/25
Loss of balance persists; Loss of balance; Diagnosed with Benign Bilateral Positional Vertigo; Vertigo; Discomfort on injection arm; A spontaneous report was received on 25 Feb 2021, from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vertigo, loss of balance, discomfort on injection arm, diagnosed with benign bilateral positional vertigo, loss of balance persists.  The patient's medical history was not provided. Concomitant medications reported were High Blood Pressure Medications, Diabetes Medications, Cardiac Medications for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the event(s) vertigo. On 30 Jan 2021, the patient experienced the event(s) loss of balance. On 30 Jan 2021, the patient experienced the event(s) discomfort on injection arm . On 7 Feb 2021, the patient experienced the event(s) diagnosed with benign bilateral positional vertigo. On 18 Feb 2021, the patient experienced the event(s) loss of balance persists.  Treatment details included Physical Therapy.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), vertigo was unknown.The outcome of event(s), loss of balance was unknown.The outcome of event(s), discomfort on injection arm was unknown.The outcome of event(s), diagnosed with benign bilateral positional vertigo. was unknown.The outcome of event(s), loss of balance persists was unknown.
Pain in shoulder joint starting the morning after I received my first dose. Continued till date of my second dose and got worse after 2nd dose given in same arm due to medical recommendation for better vaccine response. Have pain on lifting arm. Can?t raise it more than 75 degrees without great pain. Trouble pulling or pushing with that arm or carrying heavy things.  Have not had issues with this arm before vaccination.
2 days a/f vaccine administration, HA (general HA 6/10; occular pain 7-8/10).  6 days a/f vaccination abdominal pain; R side sub costal, 6/10; stabbing; intermittent; associated dizziness).  sleeping and analgesics help to relief s/s.  Denies: V, diarrhea, hematuria, melena.  RN Scheduled visit w/ Provider.
Patient vaccinated and within a few minutes after vaccination, patient with syncope. Able to stabilize patient in chair and bring to first aid. Patient recovered quickly. MD at bedside. Discharged without difficulty.
Patient did not feel any pain during the vaccine. The next day (9-29-18) the patient reported her arm was bruised and swollen. A few days later the arm was still swollen and warm. The patient began feeling numbness and tingling along her forearm and in 2 fingers so she went to urgent care. They completed xrays and scans and told the patient everything looked fine and if it worsened to come back. They estimate the reaction may have occurred with the needle placement from the vaccine being too high.
right arm was hurting; Tenderness; right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 2. At the time of the report, PAIN IN EXTREMITY (right arm was hurting), TENDERNESS (Tenderness) and VACCINATION SITE PAIN (right arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 59-year-old female who experienced NS events of unexpected pain in extremity and expected vaccination site pain, tenderness.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
three days after vaccine was administered, a "quarter-sized" bruise developed that was multi-colored. Patient emailed doctor regarding and pharmacy will follow-up with patient on 04/05/2021.
Manufacturer of COVID booster and RSV vaccines administered on 9/28/2023 are UNKNOWN at this time. Patient had his seasonal influenza vaccination "3 to 4 weeks" prior to receiving a COVID booster and RSV vaccine.  He was in his usual state of health on 9/28/2023 when the COVID booster and RSV vaccines were administered in his deltoids.  According to his wife (who is my sister) his arms were sore afterward, then 24 to 48 hours later on Saturday, 9/30/2023, he "didn't feel well" and felt worse as the evening progressed, so she took him to their local hospital ED for evaluation.  On arrival, he was triaged immediately and his vital signs were checked and an EKG was done which was grossly "abnormal".  As they rushed him back to an ED treatment room, he slumped in his wheelchair and he was transferred to a stretcher in cardiac arrest.  ACLS was initiated and he was unable to be resuscitated, and he was pronounced in the ED.  To my knowledge, he has no cardiac history and he had a "routine" cardiac work up "a couple of months ago" which was unremarkable.  He had routine follow up scheduled in the coming months.  I will attempt to obtain further details at his funeral on this Friday, October 13 including the name of his PCP and the hospital where he was taken.
Fever 99.5F; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 12Feb2021 13:00, the patient experienced fever 99.5f. The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on 12Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
Hard time breathing; A spontaneous report was received from a consumer who is a 76 year old female patient who received Moderna's COVID-19 Vaccine and experienced a hard time breathing.   The patient's medical history was not provided. Concomitant medications, provided by the reporter, include Labetalol 200mg and Propafenone 150mg.  On 31 Dec 2020, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 037520A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient had a hard time breathing. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, hard time breathing, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SWOLLEN LUMP ON THIGH; SWOLLEN LUMP ON THIGH; IT WAS HOT AND ITCHY; IT WAS HOT AND ITCHY; Allergic skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY), PRURITUS (IT WAS HOT AND ITCHY) and DERMATITIS ALLERGIC (Allergic skin reaction) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY), PRURITUS (IT WAS HOT AND ITCHY) and DERMATITIS ALLERGIC (Allergic skin reaction). At the time of the report, SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY) and PRURITUS (IT WAS HOT AND ITCHY) outcome was unknown and DERMATITIS ALLERGIC (Allergic skin reaction) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.
itchy hives throughout body on evening of 5/16/2022, treated with OTC Benadryl and Prednisolone x 3 days, outcome unknown at this time
After the first shot I woke up the next day really tired and achy, stayed in bed three days.  However, after the second vaccine, I was in bed five days and still tired and achy for the next eighteen days which is a bit much.  Today is the first day I woke up with just my normal aches and pain and not quite as totally worn out as I have been since getting the second shot on May 7.  I just wanted to report it because it seemed like a whole lot of tiredness and aches and pains like I had not experienced before.  Some is normal for me but not that much.  Oh, and after the second shot I had a lot of feet and ankle swelling, could not even wear shoes.  That has not lessened but is getting better if I just wear sandals.  Did not go to a doctor and am happy to be feeling better today and more awake.  Maybe it affects people who live at high altitudes more?  I live at 7800'
I developed a painful knot under my left ear the evening on my booster vaccine.  I noticed it around 7:30pm.  Also had temp of 99.7.  Took a shower and 2 Tylenol.  Went to bed around 9:30m.  When I woke up at 5:30am, the knot had grown to be 1 1/2 in long and painful.  No fever.    I did not have this reaction to my first and second vaccine.
Confusion; Falling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Lot number: EN6199) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Pituitary gland removal Caller states that she had this procedure done 25 years ago. Concomitant medication(s) included: HYDROCORTISONE taken for hypothalamo-pituitary disorder. Vaccination history included: BNT162b2 (Dose number: 1, Lot Number: EM9810), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization. The following information was reported: CONFUSIONAL STATE (hospitalization) with onset Mar2021, outcome "unknown", described as "Confusion"; FALL (hospitalization) with onset Mar2021, outcome "unknown", described as "Falling". The patient was hospitalized for confusional state, fall (start date: 06Mar2021, discharge date: 09Mar2021, hospitalization duration: 3 day(s)).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050007 same patient/drug/event, different dose;US-PFIZER INC-202201050008 same patient/drug/event, different dose;
This spontaneous report as received from a immunization official refers to an unknown number of patients of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with VAQTA injection (lot # not provided) route, dosage and frequency were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patients may have received VAQTA that was improperly stored from 11-JUN-2013 to 22-APR-2014. No adverse effects were reported. This is one of several reports from the same reporter MARRS CASE #1405USA004444, #1405USA004445 and #1405USA004446. Additional information has been requested.
administered after a temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 27-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), dose 0.5 (unit not provided), once, lot # T024281 (valid lot #), expiration date was reported and also validated as 15-JUL-2022 (strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). It was reported, that the vaccine before administration was stored at the temperature of 7.1 Fahrenheit degree (F) for 59 hours and 45 minutes. There was no previous temperature excursion detected. The data logger was not involved. No product quality complaint (PQC) was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA000622: US-009507513-2102USA000364: US-009507513-2102USA000435:
Moderna vaccine administered to wrong patient. Patient monitored for 30 minutes. No s/sx reported of adverse reaction. Followed up with patient and the patient denies adverse reactions or lingering effects.
This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain for three days post vaccination. The reporter did not agree to follow up from GlaxoSmithKline. This case has linked to case US2018GSK155665, reported by the same reporter.
6/9/03 (6 PM) tenderness at site; 6/10/03 Tenderness, erythema, warm to touch, warm compresses applied by parent, and Tylenol. 6/11/03 (AM) redness area enlarged, tenderness increased - Tylenol only by parent. 1:30 PM to PH Center, evaluated (Tylenol and cold pack). Parent will see family MD 6/11/03.
Redness & warmth noted to the left thigh.  No induration noted.  No infection or De noted.
Fever night of getting the shot.  Severe abdominal pain for weeks. GI Dr. visit on April 7, 2021 and the PA ordered an abdominal CT with contrast.  CT exam on April 13, 2021 which showed total occlusion of the superior mesenteric artery (SMA) and a clot in the thoracic aorta.  Went to emergency room on April 14, 2021.  Doctor determined that a SMA embolectomy is needed via exploratory laparotomy.  Post operation had an event and returned to the ER but was released with all normal blood and heart values.
Rec'd first shot on April 12,2021 minor reaction rec'd second dose on May 3, 2021.  Left arm pain within 48 hours and has never stopped.  Pain ranges from throbbing to ache from shoulder to forearm and into fingers.  Loss of range of motion can not lift arm above my head and can not reach out to the side or forward severe radiating pain occurs.  Also experience Left breast pain. Sharp shooting and throbbing pain in left breast intermittently.  It has been 6 months with no reduction in symptoms chronically tender and sore. Visited my PCP in June, stated that she is aware that breast  pain can happen as it gets in the lymph nodes and most likely the shot might have been injected in a nerve.  Stated that could recommend PT but probably would not work due to the pain was coming from a nerve and that it takes a while to heal.  Breast pain has subsided for the most part with an occasional flare up.  ORec'd first shot on April 12,2021 minor reaction rec'd second dose on May 3, 2021.  Left arm pain within 48 hours and has never stopped.  Pain ranges from throbbing to ache from shoulder to forearm and into fingers.  Loss of range of motion can not lift arm above my head and can not reach out to the side or forward severe radiating pain occurs.  Also experience Left breast pain. Sharp shooting and throbbing pain in left breast intermittently.  It has been 6 months with no reduction in symptoms chronically tender and sore. Visited my PCP in June, stated that she breast  pain can happen as it gets in the lymph nodes and most likely the shot might have been injected in a nerve.  Stated that could recommend PT but probably would not work due to the pain was coming from a nerve and that it takes a while to heal.  Breast pain has subsided for the most part with an occasional flare up.  Is having and adverse affect on my life and creating many inconveniences.
Information has been received from a consumer referring to his wife, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On 10-OCT-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 mcg/ml (lot #, expiration date, dosage and route were not provided). The second and third doses were vaccinated on 07-NOV-2014 and 10-MAY-2015 respectively for the same indication (both lot#s, expiration dates dosages and routes were not provided). The reporter stated that in approximately 2015, the patient experienced an anti-HBs antibody negative, reported as "she was not immunized for hepatitis B", which was considered as very unusual by the physician. The outcome of the anti-HBs antibody negative was unknown at the time of this report. This is one of two reports received from the same reporter. Additional information has been requested.
immediately following inoculation the individual complained of left arm soreness with alternating cold and hot sensation; he also told the observation nurse that during his 15 minute observation he had "3 seizures." none of the seizures were observed by any of the clinic staff. The individual requested to be taken to the emergency department. The rapid response team assisted him to the ED.
Tested positive for COVID on 5/5/21 prior to travel to. Retested on send out and still positive. Is asymptomatic.
Secondary transmission of adverse event. I administered the vaccine to pt on 12/8/2010 I wore gloves while mixing vaccine & administering vaccine. 12 day after I have come down with shingles. (I am on steroids for chronic condition). This also happened to me last year - which I considered coincidental and did not report.