chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I feel really bad; Sore throat; Chills; Fever; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "unknown", described as "I feel really bad"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "Sore throat"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "Fatigue".  Additional Information: When probed for the concern, consumer stated, "he took the Pfizer second shot and feel really bad since then, patient had sore throat, chills, fever headache and fatigue. And asked was the sore throat a side effect of the vaccine?". Patient also wanted to know whether he should take booster dose. Response was provided, consumer was informed Pfizer Medical Information Department for the concern. Upon follow-up consumer also reported in response to Non-HCP telephonic  and asked, 'how many people had died because of the vaccine?', consumer stated he was doing alright now. Consumer does not want to continue with the follow up process with the pharmacovigilance team. Consumer does not wish to be contacted any further.  Follow-up attempts completed. No further information is expected.
patient stated the day after her pfizer booster shot, she started having trouble sleeping at night and experienced muscle pains. she seemed confused about when she was given the shot. she said she received the shot the previous week, but our records show it was 29 days ago. she wanted the pharmacy to help her feel better. the pharmacy recommended she seek medical attention from a doctor. she said she does not have a doctor so could not seek medical attention.
Patient found unresponsive in crib by parents. No symptoms prior - autopsy revealed intussusception. Pronounced dead at ER.  1/23/09 Autopsy report states COD as complications of intussusception. Also states: six areas of IS of small intestine; changes of distant intestine present; early pneumonia; inflammation of lung tissue & small airways.  Patient had been found unresponsive in crib after recent history of cold like symptoms with fever.
This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a female patient who received FLUARIX QUADRIVALENT (batch number 2MA5F, expiry date 30th June 2019) for prophylaxis. On 11th October 2018, the patient received FLUARIX QUADRIVALENT (intramuscular). On 11th October 2018, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the tingling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient received FLUARIX in left deltoid. The health care professional (HCP) reported that minutes after administering FLUARIX to the patient, patient had tingling in her ring and pinky fingers and on the left side of her face. Adverse events were still occurring when HCP called in. The HCP did not want to disclose the patient demographics.
Reports pain in L upper arm immediately after vaccination.  Pain increased that evening and during the night.  Seen in ER early AM on 10/13/12, given "a shot for the swelling" and released home.  Pain continued and she was seen by her PCP on 10/15/12.  MRI done and WNL per client.  Given pain medication and antibiotic which she did not continue due to side effects.  Lack of appetite resulting in 8# weight loss.  Also reports lethargy during this time.  Pain did seem to subside temporarily, but client contacted writer on 10/31/12 to report that pain and inability to move arm continues.  Referred to her PCP for continued medical care.
Patient stated that upon waking up the next day should felt ill, she experienced dizziness, and her left leg should could not feel at all. She made her way to the bathroom and after 25 minutes she could feel her leg again.  She was tired for 3-6 days. Dizziness resolved first day. Then on 4/9 (9th day) she stated that the dizziness was back and she was having trouble walking. She also complained that she had lymph nodes behind her ears that were swollen. She mentioned no treatment or medication taken. She was advised to make an appointment with her provider for evaluation.
throwing up, diarrhea, migraine, dizziness, tingling feeling in my mouth, fingers, toes for 8 days, 2 weeks felt weak, migraines, hard to swallow, cant sleep, pain in my legs. 2 more weeks loss of coordination, no feeling in toes fingers mouth, went to emergency room and diagnosed with GBS
This spontaneous report as received from a certified medical assistant refers an unspecified number of patients of unknown ages and genders who on an unknown dates were vaccinated with included LIQUID PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017) (dose and route were not reported) which was exposed to temperatures as low as 34.1 F unspecified amount of time. The vaccine was not exposed to a previous temperature excursion. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Arm pain; Felt like having a mild case of covid-19; Feeling hot and cold; Having chills; Fever; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache). At the time of the report, VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.            Treatment medication was not provided    This case was linked to MOD-2021-246784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 2 July 2021 contains no new information
Symptoms about an hour AFTER injection, facial numbness and mild soreness at the injection site.  A few hours (~8hours) symptoms started with fatigue, body soreness, chills, low fever, malaise, mild chest pains/tightness, headache, dizziness
01/03/2020: Last night staff having chill and fever 101. Feeling better now. Covid test for her department will be on 01/06/2021.  No exposure.  Already schedule 2nd dose appointment on 01/15/2021.
Patient received fluzone HD and pnemovax23 on Friday 9/11 and came by on Monday 9/14 reporting swelling and bruising on right arm. She stated she could not move the arm much on the weekend but can move it now. Swelling is still presenting but seems to be getting better
Fever up to 102 few hours after 2 months old vaccination. Develop fever with seizure on 06/29/02 (2days later), Seizures -ER 06/27/02 -Fever 102degrees F, 06/29/02 -Feverile seizure.
Rash to both antecubitals, behind both knees & entire back which persisted for 2 weeks.
Patient states 9/19/18 that since vaccinated on 9/17/2018 very severe site reaction including redness, hotness, purple/black/blue bruising the size of a hand stated looked worse than felt. No allergy symptoms.
So you took nap the  day of and when I woke up my arm hurt. The next day I felt very tired and had a hard time doing my daily activities and this continued into the next few days.  7 weeks,  due date August 27th.  I am also breast feeding.
Headache and body aches on the next day, March 3rd, after receiving 2nd Moderna vaccine, on March 2nd.   Symptoms went away on March 4th.  No problem with the 1st Moderna vaccine on Feb. 2nd. However on the 18th of March a headache started that was like the one I had after the 2nd Moderna vaccine.  It has continued until today, March 30th.  I have taken Extra Strength Tylenol 4-6 per day which controls the headache but it comes back before I have to take another 2 tablets.  I emailed my doctor on March 29th and he said it probably is a result of the Moderna vaccine.  He advised me to switch to Aleve, 2 tablets each day.     I really do hate feeling these headaches and I want to know if it will ever end and what you recommend. Thank you.
Blurred vision; dizzy; This is a spontaneous report from a contactable healthcare professional. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. It was unknown prior to the vaccination whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient tested for COVID-19. It was unknown if any other vaccines were taken within four weeks prior to the vaccination. On 31Mar2021, the patient experienced blurred vision for 30 minutes and was dizzy for 20 minutes. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events blurred vision and dizzy was resolved.  No follow-up attempts are needed. No further information is expected.
inadvertently administer  the vaccine 11 days after expiration date; nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A and 005C21A) for COVID-19 prophylaxis.     Patient had no medical history. Patient had no allergies to medications, food and other products. Patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccine on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022). On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Biomedical ID for the flu vaccine was reported as JX223. It was unknown whether the patient had COVID positive test or diagnosis. It was reported that HCP had inadvertently administered the vaccine eleven days after expiration date. Vial was initially stored in refrigerator on 27-May-2022 and did not undergo any temperature excursion. No treatment drug information was provided.   This case was linked to MOD-2022-593722 (Patient Link).
received 1st dose of Covid vaccine and then both of them got Covid.; received 1st dose of Covid vaccine and then both of them got Covid.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for two patients. This was the first of two reports. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient and her husband received 1st dose of COVID vaccine on 23Feb2021 and then both of them got COVID on unspecified date. Lab data included COVID-19 was positive on unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331602 same reporter, drug and event; different patient.
patient that fainted today.  She reported on her screening questionnaire of passing out after receiving a injection.  She was placed for 30 minute observation.  The patient fainted several minutes after being seated.  It was observed that she fell over from the chair and hit her head.  Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable.  VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services.  She was with her husband and he agreed to drive her home.
Cant fall asleep due to pain; Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test; Constant Throbbing pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test), PAIN (Constant Throbbing pain in arm) and SLEEP DISORDER (Cant fall asleep due to pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21) for COVID-19 vaccination.     The patient's past medical history included Heart attack (had two heart attacks in the past) and Stent placement (he has had two stints put in in the past) since an unknown date.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test) and PAIN (Constant Throbbing pain in arm). On an unknown date, the patient experienced SLEEP DISORDER (Cant fall asleep due to pain). At the time of the report, PAIN IN EXTREMITY (Arm pain that has moved from top of arm to bottom arm/pain in hand/feels like a constant blood pressure cuff test), PAIN (Constant Throbbing pain in arm) and SLEEP DISORDER (Cant fall asleep due to pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.
feeling tired; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. An 8-decade-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunization. On an unspecified date, the patient experienced feeling tired after receiving the second vaccination which did not last long, maybe half a day. It was reported that the patient was not tired after the first vaccination. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Began to have jaw pain and muscle weakness still having severe jaw pain can't chew food, fatigue, lower back and leg pain. Today has been 15 days and she feels awful jaw is very painful.
Progressive loss of balance, ataxia and speech abnormal. Lumbar puncture and clinical picture Guillain Barre. Ruled out intracranial lesion/process, metabolic, etc. From Discharge summary, discharge summary states celebellar ataxia, GBS disproven, WBCs found in CSF.
I received the flu shot at my place of employment and it has left my immune system super sensitive. I have Steven Johnson Immunocomplex disease and the reaction mimicked my post hospitalization recovery. My lips peeled massively and completely. I also have HPV1 and it caused a breakout all over my lips. I've had rashes. I've had midnight fevers/chills, I have NEVER had this type of reaction before and I am refusing to take anymore from now on. When I was initially post hospitalized we (my PCP) and I worried about this happening but given my hyper-sensitive immune system the concern is more long term clearly. Disclosure: I am a nurse and did not see my PCP. I monitored myself.
I had flu like symptoms the next day, fever, chills, body aches, headache etc... and then on 4/9 I woke up with a red swollen and itchy rash ALL over my body. Other than all this I feel ok.
Chills, elevated heart rate, fever, nausea, dizziness, back pain, body aches
Immediate abrupt diminution of eye contact, loss of words (all) already learned. Marked speech delay.   The 60 day follow up received on 9/5/03 states extent of persisting effects is hard to determine. however there continues to be some speech/language abnormality. Does not use speech conversationally-more innitative, songs, rituals with words.
Developed back pain and pain in her torso that spread to the extremities, starting on 7/8. She then developed paresthesias, dysesthesia, and shortness of breath. LP showed elevated protein. The patient has been diagnosed with AIDP/Guillian-Barre.
Red swollen lump 6? across 3? down.  Warm to touch and little pain.  Got worse today.
For 4 weeks I was unable to use my left arm without extreme pain. Sharp/shooting pain through entire arm, difficulty sleeping through pain, occasional numbness in arm. Pain is still present.
SHORTNESS OF BREATH (WORSE IN THE MORNING); TREMBLING HANDS INTERMITTENTLY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath (worse in the morning), and trembling hands intermittently. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath (worse in the morning) and trembling hands intermittently was not reported. This report was non-serious.
Patient was administered 0.25ml of the  moderna vaccine ndc 80777-282-99 instead of 0.2ml of the moderna vaccine ndc 80777-283-99 as booster dose. Patient had completed primary series with moderna.
Slight body aches and headache day of second injection.  Moderate body aches and headache the day after injection. Night after second day had severe headache, severe confusion, severe dizziness, severe nausea, unable to walk unassisted.
Cellulitis. Initially 2" diameter swollen, red, hot. Next day whole upper arm puffy, red. Treated with antibiotics.
Received Hep B vaccine on 6/30/11. She called Dr. office on 7/2/11 stating that she was experiencing numbness and tingling from elbow to wrist in injection arm. She denied any other symptoms.
Red, ringworm looking circles all over body 1-2 days after vaccination /severe chronic urticaria-rash then furious weals, lasting 9 months/shivering temp 100, sweating-bed clothes soaked/red eyes, swollen eyelids, body rejecting sun screen lotion, lotions, watch band (metal), stomach (9 months pregnant- looking swollen), diarrhea, depression, anxiety, food sensitivities-kidney beans, banana, sun flower and pine seeds (never allergic before flu shot).
he also had delta in December of last year; he also had delta in December of last year; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "he also had delta in December of last year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive. The report's brother had high fevers when he got his booster, but he also had delta in December of last year, right around , he got it because he travels for work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201252016 same patient, different AE;