chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHEST PAIN; TINGLING; SWELLING; NUMBNESS; MOBILITY ISSUE; SHOULDER ISSUE; STIFFNESS IN LEFT SIDE OF NECK/STIFFNESS; SWELLING IN LEFT LEG; EMOTIONAL DISTRESS/SUFFERING; PAIN; EXTREME HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-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 chest pain, tingling, swelling, numbness, mobility issue, shoulder issue, stiffness in left side of neck/stiffness, swelling in left leg, emotional distress/suffering, pain, and extreme headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, stiffness in left side of neck/stiffness, swelling in left leg, extreme headache, chest pain, emotional distress/suffering, pain, numbness, swelling, mobility issue and shoulder issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Fever over 101.5; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 as a single dose for COVID-19 immunisation. Medical history included asthma, hormonal imbalance and thyroid disorder. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication, Progesterone (MANUFACTURER UNKNOWN) for an unknown indication and Bioidentical hormone replacement therapy (HRT) (MANUFACTURER UNKNOWN) from an unknown date and it was unknown if ongoing. The patient was allergic to Sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Mar2021, the patient experienced pyrexia. The patient had fever over 101.5 (unspecified units) for one day after the administration of vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as result of the event fever included antibiotics (unspecified). The clinical outcome of the event pyrexia was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Hearing loss; Fluid in middle ear; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4471789-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for  rheumatoid arthritis. The patient's relevant medical history included: "MODERATE TO SEVERE RHEUMATOID ARTHRITIS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "recovering", described as "Hearing loss"; MIDDLE EAR EFFUSION (non-serious), outcome "recovering", described as "Fluid in middle ear". The action taken for adalimumab was unknown.  Clinical course: Solicited report from a consumer of an elderly female with events of  HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR and non-serious HEARING LOSS DUE TO  BUILD UP OF FLUID IN EAR with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset and  HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.  RA's opinion is that there is no reasonable possibility that the event of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset is related to HUMIRA(ADALIMUMAB). RA's opinion is that the event of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset is not assessable.  The reporter considered "hearing loss" and "fluid in middle ear" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. 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.
The First vaccination was received on Saturday, July 3 at 1pm.  Patient experienced common injection site soreness that lasted approximately 48 hours with no other symptoms.  New symptoms appeared approximately 80 hours post-injection (approximately 8pm on July 6), including left ear ache, fatigue, sore throat and muscle aches.  By the following morning additional symptoms appeared  including nausea, chills, and headache.  Symptoms persisted up to bed on July 18 and by the morning of July 19 all symptoms were gone.  Temperature readings were normal throughout symptom period.
pt recv vax 13FEB98 & w/in 8hr arm swelled, was sore to touch, was red & extremely warm;swelling was pronounced & lasted about 2 days;pt husband recv pneumonia vax @ same time w/no adverse event;
Normal mammogram in 3/07. During physical in 4/07 was given Zostavax-shingles vaccine. Days later developed symptoms on chest. Was told it was shingles-from the vaccine. Did not improve and was biopsied. Diagnosed as Inflammatory Breast Cancer.  5/16/08 Death certificate states COD as metastatic inflammatory breast cancer.  5/16/08 Reviewed PCP medical records of 4/19/07-7/10/2007 which reveal patient experienced good health on 4/19/07 w/a normal breast exam.  Returned on 6/15/07 with rash on right breast x 2-3 weeks.  Vesicular rash in T8 dermatome that was crusting over but had been pruritic & tender.  Dx w/shingles.  Returned 7/10/07 because rash was not healing.  Exam at that time revealed a keloid type rash over the anterior chest & right breast into the axilla.  A biopsy was done & started on antibiotic for surrounding erythema.
Sore arm within a few hours. About 7 hours after the vaccine pain got worse significant swelling and red and heat at injection site. Chills and shaking. High fever. Nausea.
Patient describes that she experienced a fast heartbeat after receiving the vaccine that started within the 15 minute monitoring period.  She continued to have this symptom throughout the day and ended up being monitored in the ED later in the day.  Symptoms did resolve for her.
Pt. received PCV-13 in clinic today at 11:00 am. Reports that he felt shaky after injection. About 4 hrs later while walking around store, his "eyes blacked out" and he dropped to floor. No LOC. One hr. later he feels better but still shaky.
Pt started vomiting immediately within 60 seconds of vaccines given. Pt was also sweating profusely. After 10 minutes, pt stated she felt fine and she could stand up and walk fine.
This spontaneous report Was received from a physician concerning a 19 year old male patient who on unknown date was vaccinated with 3 pediatric doses of RECOMBIVAX HB 0.5 mL (route and lot # not provided) as a child. The physician stated that the now 19 year old patient required evidence of immunity for college. On an unknown date, the physician drew titers which showed negative immunity and the patient as then administered 1 pediatric dose of RECOMBIVAX HB 0.5 mL (route and lot #not provided) on 10-MAY-2012 and 1 pediatric dose of RECOMBIVAX HB 0.5 mL (route and lot # not  provided) on 16-JUL-2012. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
Not an adverse event. Patient was given 2017-2018 version of flu vaccine in error. Patient was notified immediately upon discovery (same day) and offered revaccination with current formula. An old version of afluria was transferred from another pharmacy to ours along with current formulas, and this was given during a chain of several flu shots. Patient experienced no adverse events. states she will come in for revaccination in upcoming weeks.
This spontaneous report as received from a 93 year old patient of unknown gender, referring to him/herself. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis. The patient stated that had had quite a few ZOSTAVAX shots over the years given him/her age. No adverse effects reported.
A report has been received from a Health Professional concerning a 4 year old, patient of unknown gender, who had been receiving nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, once/single administration. FLUMIST Quadrivalent (Intranasal) started on 09-Mar-2016. It was reported that the patient received an expired dose of FLUMIST on 09-Mar-2016 that expired on 03-Mar-2016. The outcome of the event of expired FLUMIST administered to patient is unknown. The reporter's description of the event(s) was as follows: None reported. The report was considered to be non-serious.
Inconsolable crying, refusal to eat, decreased urine output, rectal fever of 100.3
Client verbalized feeling lightheaded.  Client was evaluated by onsite Fire Rescue and released to go home at 11:28 am.
sick; feeling hot; sweating; cant eat; massive headache; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took first dose of Pfizer covid vaccine on 31Mar and still sick. She was told side effects would last only 2 days but she was still sick as though she just had the shot. Reported feeling hot; sweating, can not eat, massive headache since received shot. The outcome of the events was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Deep bone pain and aches in lower half of body around 12hr after injection; arm injection site pain started around 2 hours after injection
tiny little rash; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (tiny little rash) and MYALGIA (little soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Jan-2021, the patient experienced RASH (tiny little rash) and MYALGIA (little soreness). On 23-Jan-2021, RASH (tiny little rash) and MYALGIA (little soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Unknown. No relevant concomitant medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound COVID 7 days after treatment of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccines on 7/17/13. Came to office on 8/8/13 reporting indurated areas on bilat thighs beginning 1 week after injections.
red, blotchy rash over joints 2 days p/vax; itchy, painful in joints;
Around the end of January, I experienced a sudden onset of chest pain and high BP that lasted for about one hour. And high PvC I went to the doctor a few days later and was rx'd which helped w/ the chest pain and BP.
Patient turned Greenish blue and fell face first into the floor within a few minutes of having these vaccines. I tried to get the vaccines as close as possible with the information on her vaccine records. Patient continued to feel weak and have nausea and frequent headaches in the weeks following these vaccines. Patient had severe weakness also that seemed to grow in strength over the next few months. On January 29th 2016, patient had a seizure and All of the symptoms worsened after this. An EEG showed swelling on her brain. An MRI done after that did not show the swelling anymore. Patient was diagnosed with POTS after a visit with the head of Pediatric Cardiology. Patient still suffers from POTS today.
Severe pain in upper and mid left arm. Numbness in fingers hand and wrist. Weakness in grip and strength of wrist and hand. Very painful
A week after my first dose I noticed bumps in my middle arm (front). I thought they were mosquito bites. Then the area grew with more bumps with fluid. Very itchy. I also got a few on my chest and back as well as the back of my left arm.
I had the vaccine on 01/07/2021  and in 01/23/2021 I started to have pain. I went to urgent care. They thought it was a UTI. They put me on some medications. They said that I probably not have cancer, it is probably a tumor and I am having it removed.  It is in my left ovary. They are going to remove the ovary, fallopian tube and tumor.
Case number PHEH2014US002563 is an initial spontaneous report received from a health care professional (office manager) on 02 Feb 2015 and with a follow up report received from physician on 17 Mar 2015. This report refers to a 16 year old female patient. The patient was vaccinated with MENVEO (batch number: unknown) into the left deltoid at a dose of 0.5 ml on 21 Oct 2014. The patient received the vaccine that had a temperature excursion of 30 degree Fahrenheit for 17 hours. The vaccine was not frozen. The reporter stated that the dose of MENVEO was reconstituted and pre-drawn into a syringe and then administered after the temperature excursion. No adverse event was reported. No further information was provided. Follow up report received from physician on 17 Mar 2015: updated patient demographics, date of vaccination and site of vaccination.
Feelings of mental fogginess, disorientation, mental detachment, near syncope. Started 6 days after vaccine was given. Intermittent spells continue.
12-24 hours after 4th Tdap, pt developed redness, swelling of (L) upper arm at site of injection. Increased in size over next 24 hours to encompass 2/3 of length and 1/3 circumference of (L) upper arm.
After dose two, platelet count was much lower than normal on routine lab draw.  I suspected vaccine may be contributing factor.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101820680 (Pfizer).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 10:00 (Lot number: FF2593) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; EXCEDRIN PM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 17Apr2021,when the patient was 60 years old, for Covid-19 immunization, reaction(s): "much lower than normal".The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 10:00, outcome "unknown", described as "booster"; PLATELET COUNT DECREASED (non-serious) with onset 10Dec2021 11:00, outcome "not recovered", described as "After dose two, platelet count was much lower than normal on routine lab draw.  I suspected vaccine may be contributing factor.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased.  No follow-up attempts are possible. No further information is expected.
As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than  she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD.
11 YO received Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number ABXCO888, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient went to a facility to receive a Menveo dose, but instead he received a Bexsero dose, which led to wrong vaccine administered.
Mother states when child had hepatitis B vaccine #2 on 09/10/01, the child had a low grade fever and fatigue for one week after vaccination. She never consulted a doctor or reported it until now to us. Mom doesn't want child to have hepatitis #3.
Encephalitis. Fever, lethargy, extreme irritability, stiff neck, somnolence. The discharge summary states contusion of skull, thrombophlebitis, altered level of consciousness, bacteruria, and meningoencephalitis.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: "It is unknown of the pt recovered from the adverse events."
7 PM night of injection whole right shoulder was throbbing, shooting tingles down back from shoulder blade, unsteady on feet, took Tylenol with some relief. Next day much better. Still taking Tylenol, still having muscle soreness as of 11/30/2001.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient herself) via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date in Feb2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On an unknown date reported as three months ago since the second vaccine, the patient experienced metallic taste in mouth. The patient still has the metallic taste in her mouth. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a nurse refers to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose of (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the events was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 4 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 28-APR-2014, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperature warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that a new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.
Headache with onset of about 30 minutes after vaccine administration.  Moderate pain not relieved by Aleve.  Headache progressed to more severe pain with nausea and sensitivity to light.