chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose COVID-19 Pfizer vaccine on 10/02/2021 and had came to pharmacy on 10/23/2021 for second dose of COVID-19 Pfizer vaccine. Patient did not have her CDC vaccination card at the time and returned back to the pharmacy to have the card fill out for the second dose. Upon checking patient's profile image for the VAR form for the second dose of COVID-19 Pfizer vaccine, it was discovered that a Fluarix Quad 2021-2022 vaccine label was on the VAR form. It is unknown whether patient had received the COVID-19 Pfizer vaccine or the Fluarix vaccine on 10/23/2021. Patient had discussed situation with her physician and no lab test is available to determine whether she had the Fluarix vaccine or the COVID-19 Pfizer vaccine.
Woke up in the night with chills and body shivers; Headache; Dizziness; Low grade fever; genaral body pain; Joint pain; No appetite; Generally felt ill; Pain at injection site; This is a spontaneous report from a non-contactable consumer. A 69-years-old female patient received second dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in right arm on 03Feb2021 on 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history included High blood pressure and thyroid. The patient concomitant medication was not reported. The patient historical vaccine included first dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in left arm on 13Jan2021 on 3:30 PM as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, has the patient been tested for COVID-19. On 04Feb2021 04:30 AM, the patient woke up in the night with chills and body shivers, head-ache, dizziness, low grade fever, body ache, joint pain, no appetite, generally felt ill and pain at injection site. On an unspecified date, the events were resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea Vomiting running hot, runny nose Narrative:  Called in sick for work
kidney infection; urine turning a different color/urine was an orange color/urine was a tea color; This is a spontaneous report from a contactable Nurse reporting for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated earlier this afternoon (07Jan2021) urine turning a different color, her urine was an orange color, and this afternoon her urine was a tea color. She had no other symptoms as if she had a kidney infection. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event kidney infection cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Left sided scalp and facial numbness 5 minutes after vaccine. Left sided arm numbness 10 minutes after. Seen in ED at Hospital with normal saline iv, Benadryl iv and solumedrol iv. Head ct completed which was negative. No improvement in symptoms. Discharged home. 1/9 woke up with left sided body numbness. Seen at Hospital MRI brain completed, 1/10 numbness and pain to left side of body. Start medrol dose pack. 1/11 saw PCP. 1/14 MRI brain with iv contrast. 1/15 completed medrol dose pack, continued symptoms
I experienced fever, headaches, fatigue. I still have these symptoms  and I have pain at the injection site.
PATIENTS HUSBAND CALLED THIS MORNING STATED SHE IS APPROXIMATELY 3 WEEKS PREGNANT, COMPLAINS OF HEADACHE AND STOMACH ACHE
80-year-old gentleman, has coronary artery disease, hypertensive heart disease, as well as diabetes mellitus.  Presented to the emergency department yesterday with complaints of coughing, diarrhea, headache, myalgia, as well as fatigue.  He has no energy.  He wants to sleep all the time.  He also has aches and pains all over the body with unsteady gait. His symptomatology has been going off and on for the last 4 days. patient underwent workup in the ER, which revealed unremarkable hemogram, although his creatinine was 2.00 with a glucose of 182.His COVID test was done also, which was positive. Antibodies positive. Admitted to COVID unit, started on decadron.
This spontaneous report was received from a 73 year old female patient with asthma, many allergies (unspecified), and allergies to beta blockers and iodine. The patient's medical history included cancer (not further specified) and shingles twice before receiving ZOSTAVAX. On 16-MAR-2013, the patient was vaccinated with ZOSTAVAX one dose via "injection". Concomitant therapies included DEPAKOTE, ZOMIG, and several unspecified medications. On 18-MAR-2013, the patient developed severe migraine headaches after receiving ZOSTAVAX. Treatment included acupuncture therapy and physical therapy. An MRI of the brain and blood tests described as ESR/CRP (erythrocyte sedimentation rate/C-reactive protein) were performed (results not provided). She went to a neurologist. The migraine headaches have not recovered. The patient also reported that DEPAKOTE and ZOMIG (unspecified manufacturer) did not work (dates not provided). Additional information has been requested.
Pt developed itching evening of injection which became "bad" per pt and did develop "little red bumps"-both were generalized over entire body per pt report.  Was instructed to take benadryl at night and zyrtec or claritin during day and was given rx for prednisone 4/29/2022 due to continuation of itching.
DELAYED TYPE HYPERSENSITIVITY; This spontaneous report received from a patient concerned a female 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced delayed type hypersensitivity. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from delayed type hypersensitivity. This report was non-serious.
Patient walked over to observation table and complained of nausea and light headedness.  He then walked back to his chair .  I took his blood pressure at 1313: 165/123 (L), P - 77. , BP @ 1322 - 143/118 (L), P - 82.  Patient was given cheese cracker and water after her reported that he hadn't eaten that morning, since he is intermittently fasting.  BP was attempted a third time; however, the patient was very agitated therefore the BP couldn't be read.  The patient complained of headache and anxiety.  Another attempt was made for the third BP @ 1335 - 168/104 (R), O2 - 97%.  The patient was encouraged to finish his crackers and have another bottle of water.  The final BP at 1350 - 147/104 (R).  Patient reported no headache and feeling less anxious.  Patient left with cousin and advised to report to PHCP for follow up of blood pressure.
On day 2 i had a severe rash covering my legs starting to my feet my left arm face and starting at neck
Patient called 9/18/20 and stated: Woke up in the middle of the night with heart racing for greater than 30 minutes, also experienced night sweats. Patient went to Emergency Room and potassium levels were 1/10 of a point reduced from 2 days prior at last blood work check.
In the process of giving / second dose / had a needle failure /unknown amount was injected /the rest leaked from the syringe; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, In the process of giving a patient their second dose of Shingrix, had a needle failure. An unknown amount was injected while the rest leaked from the syringe, which led to incomplete dose administered.
My initial vaccines were Pfizer. My first booster was Moderna. After the first Moderna booster, I noticed that I had persistent tinnitus, but thought it was probably a coincidence. Then, after my second Moderna booster, my tinnitus immediately got worse and has not abated.
Pt received booster dose of Pfizer. First 2 doses were Moderna. No adverse reaction or outcome.
Initial misuse report received from a health care professional on 03 October 2013.  The patient had received FLUZONE HD on 03 October 2013 and then received another FLUZONE HD dose on 03 October 2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
MOTHER MESSAGED CLINIC : AFTER APPT ON 4/19/21,  CHILD DEVELOPED A HARD LUMP AND RED SPOT ON RIGHT LEG . NOW LOOKS ANGRY. IT'S BEEN 2 WEEKS SINCE THAT VISIT. RED CIRCLE AREA ON RIGHT LEG
This spontaneous report was received from a 74 year old female consumer referring on herself with collagenous colitis and atrial fibrillation. On 24-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), TIKOSYN, ASACOL, colestipol hydrochloride, zorelto and diclofenac. In approximately January-2013, (also reported as two weeks after injection) the patient broke out with shingles around the waist and back area left side. She sought medical attention and was treated with gabapentin 300 mg three times a day and with ointment fluocinonide. Patient stated blisters have healed but was still experiencing the nerve pain and wants to know how long this would last. At the time of this report the outcome of shingles was not recovered/not resolved. Additional information has been requested.
The evening of her shots, she experienced a red, raised rash on her trunk that traveled over a 1 week period of time, to extremities and back and has resolved. She had a fever of 101F X 3 days and was seen in ER. The MD stated "it's from the shots".
Fatigue, nausea, body aches, chills, fever, hot/cold sweating, headache, ear ache and dizziness.
onset high pitched cry 3 hrs p/vax; fussiness off & on x 24 hrs;
Pt fell forward, seizure-like movement.  I leaned her back against chair.  Her head came up and eyes open.  She started to cry and was upset.  She had seizure-like movement a second time.  BP was 76/51 at 4:15pm.  She reported stomach hurt and chest hurt.  Feet put up in chair.  Paramedics arrived and took over.
broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to case 2022SA410416(CLUSTER).  This case involves a 82 years old female patient who broke out in hives , after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to 15 drugs and is severely allergic to sulfa drugs.   On an unknown date of 2012 followed by unknown date of 2013,( in later years received a 1/2 dose) the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date, the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " she received the Pfizer Covid vaccine. She had platelets. She got sick with Covid from 15Dec2021 to 09Jan2022. She had one Covid booster and then was sick for 7 days from it. The sickness from the booster was just like having Covid."  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.; Reporter's Comments: 1/2 dose
skin rash (cherry hemangioma or petechiae); also with intermittent headache since vaccination above left eye radiating to right side
Patient stated that a couple of hours after receiving the vaccine she lost almost all of her hearing. She stated it sounded like her head was under water. A few hours later once her hearing came back everything sounded very loud. This morning when she woke up she started hearing ringing in her ears. She stated that she started feeling much better around 11am this morning, however, wanted to make the pharmacy aware.
approx 7 days p/vax pt had poor feedings, cough, fever, emesis x2; admitted to hosp; dx intussusception w/perforation, rt hemicolectomy performed; unremarkable post op course
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data).  Patient acknowledged recommendation but not currently interested in revaccination. Will consult with primary care and may seek blood titer.
fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 15Apr2021, outcome "recovered" (Apr2021), described as "fatigue". It was unknown if therapeutic measures were taken as a result of fatigue. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Extremely swollen lymph nodes in left axilla. Unable to press arm down against side due to the swelling.  Very painful.
Information has been received from a registered nurse and a physician concerning a female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced breakthrough chickenpox. On 24-Aug-2004 the physician saw the patient who had about 15 lesions and no fever. The patient was not treated with any medication. There was not product quality complaint involved. OMIC
lymph swelling right side of neck; headache; Pain body; Fatigue; A spontaneous report was received from a healthcare professional concerning a 20-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lymphadenopathy, headache, general body pain, fatigue.  The patient's medical history included OVID-19 positive prior to receivingvaccine and autoimmune disease lupus kidney disease. was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event(s) lymph swelling right side of neck . On 16 Jan 2021, the patient experienced the event(s) headache. pain body, fatigue.  Treatment details included medical center: 2 ultra sounds and CAT scan preformed February 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) headache was considered resolved on 17 Jan 2021.The outcome of event(s) pain body was considered resolved on 17 Jan 2021.The outcome of event(s) fatigue was considered resolved on 17 Jan 2021. The outcome of event(s), lymph swelling right side of neck,  was unknown.
Stopped talking/making noises, regression in speech and eye contact, and developed Apraxia
tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Flu shot received 9-25-13. Later that evening she felt area between nose and throat was swollen. She has celiac disease and has this problem when she eats wheat but she did not have any wheat that day to her knowledge. The injection site was warm to touch, swollen, and very red. The next day all of her joints hurt. She could barely walk or use her hands.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 33 months old female patient who accidentally received the child 0.5ml instead of the 0.25ml dose while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ069AA via intramuscular route in the left thigh after receiving the 0.25 ml first dose on 23-Oct-2018. It was a case of actual medication error due to overdose. No adverse event were noted at the time of the event. 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.
Developed an 102F for two days; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNISATION SERIES COMPLETE, UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "Covid-19". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Developed an 102F for two days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Physician is calling about a 72 year old female who received the gray cap formulation of the Pfizer BioNTech Covid 19 vaccine as a booster about six months ago and she developed an 102F for two days. Does this mean that she cannot receive the new bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports that her arm became sore immediately after injection. The soreness has not gone away ever since and she now suffers from limited arm movement and range of motion. She has sought treatment from her primary care doctor who advised her to exercise the arm. However, the effect (soreness) remains, although it has improved slightly.
Janssen Lot #1805031 Approximately 2 1/2 hours after injection experienced chills for about 45 minutes. Approximately 3 hours later had a much more severe episode of the chills along with leg aches.  I used heating pads and took an Advil when I could not stop shivering . Second episode lasted over an hour.
A pharmacist reported that a 2 month old male received Prevnar, Comvax, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk), and Polio vaccines in November, 2002. Two days post immunization, the infant developed encephalopathy and was admitted to the hospital. He was hospitalized for "about a week," Encephalopathic and sepsis tests (not specified) were performed at the hospital and the results were negative. The encephalopathy resulted in "no sequela." No additional info was available as of the date of this report. A copy of this report has been forwarded to manufacturers of concomitantly administered vaccines.
Patient started to feel light headed, then fainted with 1-2 minutes of receiving the vaccinations.  Patient was unconscious for less than one minute.  Patient was hot, pale and sweaty upon regaining consciousness.
symptoms of lupus; sjogrens syndrome; immune system goes wacko; The vaccine woke/caused a disease to flare that was already in her; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient received first dose of BNT162B2 on Feb2021 (lot Number: en6201, expiration date: 30Jun2021) and second dose on Mar2021 (lot Number: en6199, expiration date: 30Jun2021): both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had side effects to the first and second dose but not as bad to the first. The vaccine woke/caused a disease to flare that was already in her. She had symptoms of lupus and sjogrens syndrome and right after the vaccine she got it. Patient got the shot and her immune system went wacko. She had been monitored for rheumatoid factor. There was no other causation for her experience. Reporter thought the reaction was due to her condition and not the vaccine. The outcome of events was unknown.