chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of swelling injection site in a 69-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included acid reflux, allergies, high blood pressure and high cholesterol. Concurrent medications included LOPID, LIPITOR, NEXIUM, PAXIL, XANAX, BENICAR, TOPROL, Nifedipine, CENTRUM SILVER, Vitamin B, ECOTRIN, ALLEGRA and NASACORT. On 3 September 2009 at 14:07, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, hot flush, and fever. On 4 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced chills. At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. The subject was treated with EXTRA-STRENGTH TYLENOL. At the time of reporting the hot flushing, fever and chills were resolved and injection site swelling was unresolved. The outcome of injection site pain was unknown.Tthe subject is a retired physician. He took 500mg TYLENOL extra strength upon laying down to help with the pain at injection site on his left arm. He spiked a temperature at 102 that night and turned his air conditions to 62 degrees. He took a shower in cold water. This morning he had chills at about 5 am and covered up with sheet and to coverlets to keep him warm. He slept from 5 am until 2 pm. He feels better now in the afternoon, but not 100 percent.
1/25/21 @ approximately 2000 began to chill and shiver.  Continued throughout the night waking up intensely shivering, and body aches.  Temperature 105.1 at the highest. 1/26/21 fever subsided after ibuprofen and tylenol, body aches and fatigue continued. 1/26/21 @ 2055 no fever but continued body aches and fatigue.
Difficulty breathing.  Painful to breathe. Reported feeling like her throat was closing.  Didn't seek any medical treatment.  Reports she "paced" until symptoms subsided to a tolerable level approx. 1-1.5 hours later.
Pt. got a COVID-19 on 4/20/21 around 5;15 PM and fainted after a few minutes. He gained conscious after 4 minutes. He just complained that he feel felt  light headiness and very nauseous but never thrown up. He laid down on floor and then moved to 3 chairs to lay down and rested for over an hour before his wife drove him home.
This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 09-AUG-2017 to 30-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 expiration date 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 89 hours. Data logger was not involved. There were no previous excursions reported.
Adverse Event: patient had swelling, bruising and pain at injection site. Treatment: patient periodically applied cold compress. Outcome: patient's swelling and bruising has gotten better and most of pain is gone.
Flu-like symptoms: Fever, chills, arthralgia, myalgia, sensitive to touch, fatigue, headache, nausea
Pain, increasing swelling and redness spreading down into elbow and up into neck area increasing from 10/19/17-10/20/17. Seen at Medical Clinic on 10/20/17 due to increased swelling, warmth, redness, and discomfort.
Narrative: Patient received two doses of covid vaccine. Patient on hospice with active malignancy. No additional details of death noted. Reported per facility instructions.
dizziness/vertigo, feeling unstable; have fallen twice in past two weeks, 2nd time resulted in broken hand requiring surgery
Initial report received from a health care professional (nurse) on 16 Dec 2010: This patient was vaccinated with only the MenCWY liquid component (C, Y and w-135) of MENVEO (batch number: 022011) intramuscularly on an unspecified date. The outcome was reported as unknown. No other information was provided.
Received COVID-19 "booster" shot on 11/11/2021. Received original doses in December 2020 and January 2021 respectively. When had the first two doses nothing out of the ordinary occurred other than short typical side effects within 24-48 hours of receiving the vaccination.    After the booster dose, however, there was a change in my menstrual cycle, I did not get a period for the month of November, the expected start date was 11/20/2021. I do not have irregular periods so this is very odd. Had all the normal symptoms of a menstrual cycle (moodiness, cramps, etc.) but no blood. Took multiple urine pregnancy tests and all were negative. Also took urine ovulation tests around the time I was predicted to ovulate which did show ovulation during the predicted window after a menstrual cycle.
pt fussy & had low grade fever evening p/vax according to MOC; approx 8AM on 29APR93 both parents noticed that pt was staring, did not respond to their voices this cont for approx 1 hr;
very sore, stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (very sore, stiff neck) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (very sore, stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (very sore, stiff neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
No Adverse reaction occurred, Learned Moderna had been approved. Believed this was from the CDC.
SM who received multiples doses of ENGERIX-B within a one year time period, later diagnosed with MS. Symptoms: Loss of vision (CN II), weakness, headache, migraine. Prior to receiving multiple doses of the ENGERIX-B, Lt was in excellent shape and usually ran 6-12 miles almost everyday. Although he received his last ENGERIX-B in Feb 2007 and did not develop any acute symptoms until Jan 2008, he notes that in May/June of 2007 that he had a pins/needles sensation in the L leg, when it was scratched on the back. On his last PT test in Sept/Oct time frame of 2007, he received his lowest PT score ever. His usual score was a 270-280, he received only a 220.  1/23/09 Received medical records. FINAL DX: multiple sclerosis Records reveal patient experienced pins & needles sensation in legs, decreased energy, sudden onset blurred vision, mustle weakness in legs, loss of taste sensation.  Hospital admit 1/08.  Developed migraine HA after LP.  Continued w/decreased vision, unsteady gait & poor muscle coordination.  Tx w/meds including interferon.  Prior AD Army, now out of service on disability retirement due to progression of his MS. This case was reviewed at at neurology teleconference on 1/14/08 and assigned a WHO Causality assessment of "unlikely" because neurologists felt that there was no close temporal association between the last vaccine and onset of symptoms.
Pneumonia Hypoxemia; Pneumonia Hypoxemia; exacerbation of Chronic Obstructive Pulmonary Disease; Metabolic Encephalopathy; frontal lobe seizures; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 03-MAR-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered chest pain, shortness of breath, altered mental status and was diagnosed with pneumonia hypoxemia, exacerbation of chronic obstructive pulmonary disease, metabolic encephalopathy and frontal lobe seizures. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  All the events were considered to be disabling by the lawyer. Upon internal review, pneumonia hypoxemia, metabolic encephalopathy and frontal lobe epilepsy were determined to be medically significant.
Arm soreness still persisting 2 wks later. Hurts all the time, especially at night while trying to sleep.
I have been telling the doctors since he was 1 year old he has been acting autistic. Soon after the 1 year old shots he was intolerant to noise/music. He is now getting diagnosed with Aspergers and will be going to hospital on January 20th 2006. Per 60 day follow up report- He has been diagnosed with Aspergers -an autistic spectrum disorder. He has been acting Autistic since his 1 year old shots. He remains autistic  He started his Authistic behavior after his one year old shots (noise intolerance etc...) the last shots he received just hapended to be his 4 y/o shots.
Patient lost conscious x 7. Pt laid down during vaccine and waited 15 minutes after given, walked to checkout and lost conscious, laid on floor legs elevated. Sat back up, water given, pt lost conscious again, laid on floor, legs elevated, soda and food given.
Slight sore right arm in shot location; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL9267), via an unspecified route of administration in the right arm on 10Feb2021 at 00:30 (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to latex and penicillin, Afib, asthma and diabetes (under control with diet). Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Feb2021, the patient experienced a slight sore right arm in the shot location. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of slight sore right arm in shot location was unknown.
Pain in hand; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PAIN IN EXTREMITY (Pain in hand) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 24-Jul-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in hand). At the time of the report, COVID-19 (COVID-19) was resolving and PAIN IN EXTREMITY (Pain in hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported. It was unknown if the patient was enrolled in a COVID-19 Vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax 23JUN95 & NOV95 pt devel cold urticaria p/hands & face were exposed to the cold while jogging;pt devel angioedema;lab test were done indicating a positive elevated ANA of 1:16 speckled & a positive elevated IgE of 580;
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involve 16 years old female patient who received IPOL (batch number P1A371M, expiry date 27 April 2020) in left deltoid which had been stored outside of acceptable ranges. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included second dose of HEPATITIS B VACCINE for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) for Immunisation. It was an actual medication error due to incorrect product storage and Deteriorated drug administered as patient given from the same IPOL vial that was unacceptable for use due to prior temperature excursion. Patient had emergency department visit on 09 Jan 2019. On an unknown date, the patient was performed PPD test, where the result was unknown. It was unknown if any adverse event occurred. 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. List of documents held by sender: none.
Bell's palsy over one month later. Right side facial paralysis.; Bell's palsy over one month later. Right side facial paralysis.; This is a spontaneous report from a contactable consumer.  A 55-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 at 11:00 (at the age 54-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included hypothyroidism and patient had known allergies gluten, bee or wasp venom. Patient took 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207) administered in right arm on 11Mar2021; administration time at 11:00 AM. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient's concomitant medications were not reported. The patient experienced bell's palsy over one month later and right side facial paralysis on 25May2021 at 12:00. The treatment medications include prednisone and Valtrex. The outcome of the event was not resolved.  Follow-up attempts are needed. Further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Age group was not reported, but was captured as adult as per vaccine indication. The healthcare professional (HCP) stated that the patient developed shingles 2 weeks after a dose of SHINGRIX. The HCP was a retail pharmacist, stated that the had SHINGRIX at another location, and on the day of reporting was presented for dose 2 of SHINGRIX. The HCP did not have vaccine information and declined to provide patient information for this adverse event.
The pt received the vaccines on 4/11/00. That evening the pt experienced swelling of right leg. It swelled to the site of a tennis ball and has remained swollen and red since.
This spontaneous report as received from a physician refers to an 11-year-old female patient. The patient's pertinent medical history included seasonal allergy. They had no any drug reactions or allergies. She did not take any concomitant medications. On 11-JUN-2018, the patient was vaccinated on the right arm with an unspecified dose of GARDASIL 9 (injection, intramuscularly, lot # N013698 and expiration date 19-DEC-2019), MENVEO and, on the left arm, with BOOSTRIX (dose, route of administration, lot# and expiration date were not provided for both). On 12-JUN-2018, at home, the patient developed urticaria on the right arm. On 13-JUN-2018, she was seen by physician at the office, who confirmed the event. No lab diagnostics or studies were performed. There was unspecified treatment given for the urticaria. On 14-JUN-2018, the patient's urticaria was resolved. Causality assessment was not provided.
Per Fire EMS on site client reported "tightness in her chest and flushed feeling" after receiving COVID vaccine. She sat in observation for 25 minutes and then was in the eval room for another 30 minutes. Symptoms resolved and she went home accompanied by husband.
No issues with shot #1 or 2. This was a booster for immunocompromised yesterday (#3).  Was fine until around 1900. Because extremely nauseous and vomited. Otherwise ok. Went to bed. Work up at 0530 today (9/1) and it felt like a RA flare. My symptoms have been pretty controlled with meds but today feels like day one. I hurt in every joint and back. Mild headache, dizzy, lack of appetite (I can taste). Chills, mild numbness in hands/feet.
Chills followed by an icy feeling in my body.  Slight headache.  when the chills stopped my nerve endings felt like they were on fire.
Guest came in today 10/7/14 stating she had a localized, red swelling near vaccine site for 1 week duration.  Now resolved.
4" knot at injection site. Large, hard, red lump on left shoulder. It is sore and tender to touch, with a slight burning sensation. It hurts when my arm is moved at all, especially if reaching. It first occurred the night of the 2nd injection. About 8-9 hours after the shot. It has gotten larger as the day goes on. It is now 12:25pm the following day.
Left knee swelling and pain 3 days after 2nd injection.  No injury.  Pt was not on medications prior to the vaccination.  Her knee pain has not improved with PT, xrays are normal other than mild OA.  She has been taking Motrin and using Voltaren gel without improvement.  Pt is having difficulty ambulating.
seeing people/things that are not there; having psychosis issues; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. This consumer reported for a patient (father) that: A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unknown date in Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states that his dad had the first dose of the COVID-19 Shot a little over two weeks ago in Feb2021. Caller stated that lately in Feb2021, his dad was having psychosis issues, and was seeing people/things that are not there. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
VACCINE ADMINISTERED 35 MINUTES AFTER 2 HOUR LIMIT AT ROOM TEMPERATURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 59 year old male. 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced vaccine administered 35 minutes after 2 hour limit at room temperature. On 02-AUG-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 35 minutes after 2 hour limit at room temperature and incorrect product storage was not reported. This report was non-serious.
Muscle twitches and tics, mostly in stomach; Muscle twitches and tics, mostly in stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MUSCLE DISORDER (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Oct2021, outcome "recovered" and all described as "Muscle twitches and tics, mostly in stomach". The events "muscle twitches and tics, mostly in stomach" required physician office visit. Therapeutic measures were not taken as a result of muscle disorder, abdominal discomfort.  Clinical information: No known allergies. No covid prior vaccination and covid tested post vaccination. Facility type vaccine was pharmacy or drug store. BNT162b2 was administered on an unknown date in Oct2021 at 3:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had erythema on L deltoid area around injection site. Appt 8/13/02 at 1:30pm.
began having chest pain and tightness, pain/swelling/tenderness left anterior neck, bouts of dizziness/light headed, extreme fatigue,  approx 2 days after injection, and on day 5 i tried to make appts at local urgent cares, were all full. i was placed on a waiting list and told i would receive a text when i could come in, but was never contacted.  i attempted to make appt with PCP on day 7, was told to go to ER. all Ers are full, with 15+ hours wait with covid patients.  on day 9 i am still having some chest tightness, dizziness, headache, but starting to feel better.  still planning to make appt with PCP to discuss reaction.
Heart palpitations and dizziness. Followed by swelling in the left calf and bruised vein in the back of the knee which hurts in that area when walking. The leg also becomes tight and swollen from walking. Sharp/pinching pains in the left thigh and behind the knee when resting or sitting.