chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: patient felt faint after receiving vaccine.  did not faint but still not feeling well.  paramedics were called.  paramedics performed assessment.  advised patient her blood pressure was low. @83/60.  patient refused transport to hospital. patient remained at pharmacy.  took patient bp with electronic bp monitor. bp read 103/67.  patient stated that she intended to go to the ER for further evaluation. patient left with friend and child.
Patient states that about 26 hours after vaccine he had a seizure which led him to the emergency room. He states that it took about 2 days for him to recover and feel back to normal. No further follow up is required per patient.
Severe joint/bone pain; Severe joint/bone pain; Body aches; Low fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, recovered on an unknown date in Jun2020.Concomitant medication were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was 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. On 09Apr2021 at 07:00 the patient experienced severe joint pain/bone pain, body aches, low fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events joint pain, bone pain, body aches, low fever and chills was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received her 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine: At approximately 18:00 by RN. Patient walked out of the vaccination room after her 15 minutes observation period and did not complain of any symptoms. She walked to the main entrance and notified a clinic manager at the check-in desk that she was experiencing "chest pain." Clinic RNs came to observe and assess the patient. The patient communicated with no displays of distress. When asked what type of chest pain, she stated "heaviness pressing on her chest, localized on the left side and on the upper chest area." Patient denied pain radiating down arm and denied jaw pain. Patient denied SOB and had no signs and symptoms of respiratory distress. She was escorted to the ED via wheelchair at 18:33. The ED note states that symptoms were most likely related to anxiety (patient mentioned she was anxious about receiving her second dose) and as patient reported symptoms completely resolved, she was discharged home from the ED at 19:01.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of minus 40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
MUSCLE CRAMPS; BODY ACHE; PAIN TO ARM; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight was 185 pounds, and height was not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. patient had no history of drug abuse or illicit drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on left arm 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced muscle cramps. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced pain to arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps on 10-MAR-2021, body ache, fever, and headache on 12-MAR-2021, pain to arm on 17-MAR-2021, and fatigue on 24-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
A report was received from a health care professional on 12/11/03 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on an unknown date in November 2003. On an unknown date in November 2003, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
no other AE reported; improperly stored vaccine administered to the patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 17-SEP-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # t002847, expiration date 23-JAN-2022 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 10 hours in the temperature of -9.19 degrees Celsius (C). There was no previous temperature excursion. Digital Data Logger was involved.  There were no adverse experiences to report as a result of the temperature excursion.
5/5/2002 @ 0600 woke up with (bad) headache, body aches everything hurt (all joints), cold could not get warm used heating pad, slept 12 hours, felt physically weak. It is now 2:25 p.m. and most symptoms have eased up. I have now had similar reactions lasting 24- 30 hours after both my second Pfizer and  1st Pfizer booster.
upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced upset stomach.  The patient asked how long did the upset stomach last. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Confirmed Breakthrough case COVID-19 (Pfizer) 1  04/15/2021 Pfizer ER8732   COVID-19 (Pfizer) 2  05/06/2021 Pfizer EW0150
intentional administration of FLUZONE HIGH DOSE QUADRIVALENT to a 64-year-old, high risk patient, with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 64-year-old, high risk patient of unknown gender who had intentional administration of influenza quadrival A-B high dose HV vaccine [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (lot number, expiry date: not reported) via unknown route in unknown administration site for Immunization.  On an unknown date there was intentional administration of fluzone high dose quadrivalent to a 64-year-old, high risk patient, with no reported adverse event (off label use, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.
About four hours after his six month wellness appointment, patient awoke from sleeping and was high-pitched screaming until around 11:30p.m. that evening. His body was also extremely warm and was sweaty. Patient refused to be put down or let anyone else but me hold him. My husband and I were not able to find our child thermometer in a hurry and chose to try and comfort patient instead. We had called our pediatrician?s office and spoke to the individual on call who mentioned that his symptoms were normal.  At his nine month wellness appointment, I brought up my concerns of his vaccine reactions three months prior, however, the pediatrician noted that there were no records of us calling on 11/6/20 describing patient's reaction. He noted in that visit?s note of patient's severe reaction. Since his six month appointment, Patient has had extreme difficulty sleeping and staying asleep. He is also extremely irritable and has regressed in his progress towards walking on his own.
Patient received Shingrix Vaccine, number one, in right arm on 10/25/2019 by CMA.  Patient presented to the office 1/24/2020 to be seen by Dr. for right arm drooping.  Dr. suspects patient may have a rotator cuff injury related to vaccine administration.  He prescribed NSAIDs and referred the patient to sports medicine.  He is looking for their opinion, then will possibly move to MRI.
"Moderna COVID 19 Vaccine EUA."   Pt received second Moderna vaccine and proceeded to Observation. Shortly thereafter, pt summoned EMT and said, through a translator, that her eyes "felt warm".  Pt denied any other chief complaint, no respiratory involvement, no redness or swelling. Pt was monitored and pt stated that her "warm eyes" were getting better. No visual problems noted, no swelling or redness to eyes.  Pt advised to seek further medical care, but pt refused transport and met AMA criteria. Pt signed AMA, witnessed by friend/translator. Pt advised of signs and symptoms of allergic reaction to look out for and pt went home with friend,
Injection site redness and raised welt, progressively spread to surrounding tissues of arm and down left side of torso; itchiness and soreness; no headache or respiratory symptoms; reported adverse reaction started morning after injection, worsened over next two days, and started subsiding in severity day 3 post injection; recommended Benadryl oral 25-50 mg q6h prn discomfort / itching.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
diarrhea; really tired/Tiredness; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 15:00 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing), notes: Verbatim: Type 2 diabetes mellitus; "tested positive", start date: 28Dec2020 (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "fever" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "headaches" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time; "diarrhea" (unspecified if ongoing), notes: Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 06Mar2021, outcome "recovering", described as "really tired/Tiredness"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovering", described as "headache"; DIARRHOEA (non-serious) with onset 07Mar2021, outcome "not recovered", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, diarrhoea.  Additional Context: Caller received the first dose of Pfizers' COVID vaccine on Friday, 05Mar2021. On 06Mar2021, he started feeling really tired and had a little bit of a headache which is continuing now but has improved. For the past 3 days he had persisting diarrhea and was wondering if that was an expected side effect. Caller asking will the 2nd shot have the same side effects. Caller stated he tested positive back on 28Dec2020 and was quarantined for 3 weeks and had fever and headaches, which all went away in 3-4 days and then developed diarrhea during that time. After receiving the vaccine, he's having these symptoms again and having diarrhea again on Sunday.  No follow-up attempts are possible. No further information is expected.
He head a rash, fever of over 102 for 3 days and he had a seizure at 4:00 pm that lasted almost 10 minutes. We call 911 and an ambulance came and took him to the ER. After he was checked he was hospitalized for 2 days for some tests that were done by the doctors. He was sent home after 2 days but he still had some fevers that ended on the next day after giving him several doses of Tylenol for infants. Per review of hospital discharge summary the discharge diagnoses were febrile seizure, glucosuria, hyperglucosemia and head trauma.
Four days following the first does I had sudden onset: -Tinnitus -Ear pain -Muffled hearing
Pt observed 1/2 hour after Japanese encephalitis vaccine; and was fine. Two hours later she experienced acute chest pressure and sob. Chest pressure lasted 15-20 minutes and sob lasted 5 minutes. She stated her heart rate time increased  5-10 minutes, beat seemed regular. She went to bed and sought no medical attention, slept and felt fine though she did not notify me of these events until 1 week later on 11/22/05.
Pt recieved the prevnar 20 at a local pharmacy.  That night she noticed redness and pain at injection site.  As the days went on she noticd the site became increasing red, warm to touch, and firm.
moderate, and intermittent nausea; lack of appetite; fatigue; malaise; sometimes chills; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A couple of hours after she received the Pfizer-BioNTech Covid-19 Vaccine last 21Dec2020, she started to experience moderate, and intermittent nausea, lack of appetite, fatigue, malaise, and sometimes chills; all on 21Dec2020. She said that the worse of all side effects she's experiencing was nausea. HCP also said that she was still experiencing the side effects until now. She also mentioned that she got tested for Covid, and results came back negative. However, she said that she will get tested again just to make sure she did not have the virus. The events were reported as non-serious. The outcome of events was not resolved.  Information on the Lot/Batch number has been requested.
fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN, FLECAINIDE, FUROSEMIDE, VALSARTAN and APIXABAN (ELIQUIS) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Treatment included Over the counter medicine Action taken with mRNA-1273 in response to the event was not applicable
Large oval shape rash at injection site 7 days later ? itchy, hot and burning sensation? raised bumps on the rash day 1 ? day 2 smooth rash
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no known allergies and a history of bacterio vaginosis who on 02-SEP-2010 was vaccinated intramuscularly with her first 0.5 mL dose of GARDASIL (lot number not reported). Concomitant therapy included metronidazole. The nurse stated that the patient received the dose of GARDASIL after having a negative urine pregnancy test. On 06-SEP-2010, the patient had a positive pregnancy test . On 09-SEP-2010, the patient visited an unspecified emergency room complaining of vaginal bleeding. The patient was diagnosed as miscarrying at that time. Gonorrhea and Chlamydia tests were performed with no results provided. The nurse also reported that the patient visited an unspecified emergency room on another unspecified occasion since 09-SEP-2010, complaining of vaginal bleeding. At the time of report, the patient had not recovered from vaginal bleeding. Last menstrual period 02-AUG-2010. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
TINGLING ALL OVER BODY; CHEST PAINS; MUSCLE SPASMS; WEIRD HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced tingling all over body. On APR-2021, the subject experienced chest pains. On APR-2021, the subject experienced muscle spasms. On APR-2021, the subject experienced weird headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling all over body, weird headaches, chest pains, and muscle spasms. This report was non-serious.