chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to his mother who was an 89 year old female patient with hearing impaired and osteoarthritis. On 18-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route not reported) for prevention of shingles. The patient developed injection site reaction after receiving ZOSTAVAX on 18-NOV-2014. The patient reported to the pharmacist that she had "heat at site", general malaise, worsening of pre-existing osteoarthritis, more trouble walking with "aches in all her muscles" since 18-NOV-2014 (reported as 6 days ago). The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered (ongoing). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from  a medical assistant concerning a 46 year old female patient. The patient had no medical history and drug reactions or allergies. The patient's concurrent conditions were not reported. On 23-DEC-2016 ( reported as "today"), the patient was inadvertently vaccinated with an expired dose of M-M-R II injection, 0.5 ml-once, subcutaneous route in his left arm, expiration date: 02-DEC-2016 (also reported as "02-OCT-2016") (strength and lot number were not reported) for prophylaxis(reported as "for school"). The patient's concomitant medications included vitamin D, hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), amphetamine aspartate (+) amphetamine sulfate(+)dextroamphetamine saccharate(+)dextroamphetamine sulfate (ADDERALL) and nicotine patches. On the same date, after vaccination, the patient experienced burning in his left arm  where she was injected. The medical assistant provided her treatment to the patient described as rubbing the site and the patient recovered from the burning, on the same date. No laboratory diagnostic studies were performed. The causality assessment between the Injection site burning and the was not reported. Additional information has been requested.
Pt reports reaction started several days after the injection.  She reported a rash starting around right hip and traveling up her torso.  It then started around right wrist and moved up arm to vaccine site area.  Pt had pictures of injection site as well as the  swelling of her arm.   Site was a deep red, that appeared to be width of her upper arm,  with a darker red edge.  Swelling of arm visible in picture also. She reported calling an office and was told to take Benadryl for several days.  Seven days after injection she called her PCP and a Medrol Dose Pak was prescribed.  Unknown as to whether she was seen in office or not.  We were not notified of reaction until pt came for 2nd Covid injection.  Pt was advised to seek advise of PCP as to whether she should get vaccine or not, and return to vaccine site if PCP was in agreement to get 2nd dose.  Pt did not return.
the excursion occurred in the fridge that the products are normally stored in, The highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event; products were administered post excursion with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA145332.  This case involves a 3 years old female patient who had products were administered post excursion with no reported adverse event and the excursion occurred in the fridge that the products are normally stored in, the highest temperature reached 52.5 f and the total excursion lasted 1 hour 30 minutes with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (infanrix) for Immunisation.  On 18-Apr-2023, the patient received a dose 3, 0.5 ml once of suspect IPV (VERO) Suspension for injection, unknown strength, expiration date and lot V1B89M via intramuscular route in the deltoid nos for Immunization.  On 18-APR-2023 the patient developed a non-serious products were administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). On an unknown date the patient developed a non-serious the excursion occurred in the fridge that the products are normally stored in, the highest temperature reached 52.5 f and the total excursion lasted 1 hour 30 minutes with no reported adverse event (product temperature excursion issue) (unknown latency)   Action taken was not applicable.  Outcome: Unknown   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 the 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.
This case was reported by a other health professional via call center representative and described the occurrence of headache in a 65-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 17th July 2018, several hours after receiving SHINGRIX, the patient experienced headache and discomfort. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the discomfort was unknown. It was unknown if the reporter considered the headache and discomfort to be related to SHINGRIX. Additional information was reported as follows: The reporter was a pharmacy student reporting that the patient received SHINGRIX at their pharmacy and within a couple of hours developed headache. The headache experienced by the patient had gotten worse progressively. The reporter stated that the patient started to limit the daily activities due to discomfort from the headache. The reporter also stated that, the patient had used over the counter medications as treatment and they had not helped out for headache.
This spontaneous report was received from a nurse referring to a multiple unknown number of patients of unknown age and gender. No medical history, allergies nor concomitant therapies were provided for these patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot #, and the expiration date were not reported) for prophylaxis. On multiple unspecified dates, the patients were vaccinated with an improperly stored ZOSTAVAX and reconstituted with the properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to at -9 to -8 degrees Celsius for an hour and 15 minutes. There was no previous excursion and there was a data logger. No adverse effects were reported. This is one of multiple reports from the same source. Sender's Comments: US-009507513-1706USA007593.
extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest.   Information on the lot/batch number has been requested.
Body started to feel tingling and numb; Body started to feel tingling and numb; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), polycarbophil calcium (FIBER), ascorbic acid, vaccinium spp (CRANBERRY), ginkgo biloba (GINKGO) and D all for unknown indications, from an unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021 about 10 minutes after injection the patient experienced body started to feel tingling and numb (like patient was given novicane at the dentist). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event body started to feel tingling and numb was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a medical assistant concerning a 26 year old female who on 08-MAY-2009 was vaccinated with her first dose of GARDASIL. Subsequently the patient fainted. The patient has sought medical attention and had recovered. Follow up information has been received from this medical assistant concerning this 26 year old patient who was vaccinated with her first dose of GARDASIL (Lot# 660555/0279X). The patient did not received ant concomitant vaccines at report time. After receiving GARDASIL the patient stool up an fell down and lost consciousness. In the same day the patient regained consciousness. The patient had a "bump" on the right side of her forehead. The patient was nauseous. The patient has a "skull x-ray" which revealed no fracture. An ice-pack was applied to the right side of the patient's head. The physician's office contacted the patient on 09-MAY-2009. The patient stated that she felt fine. Additional information has been requested.
Fatigued and achy in evening; woke at 10:30 pm with fever, chills, achy all over, EXTREME back pain: became very diaphoretic, dizzy, started sweating profusely, VERY nauseous: vomited for hours. Violently.  2 days later I stared itching, woke up with hives, my face was one huge hive. Very red, swollen to the pint it was hard, very hot to touch, extremely itchy.  Had to go to urgent care   BP was elevated, had to get a steroid shot, on steroids for five days. And  OTC antihistamines.  Noticed change in eye color today.  Much better but still somewhat puffy, pink and itchy.
This is a prospective pregnancy case. This 29-year-old female subject was enrolled in a study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during  pregnancy or within 28 days preceding conception. The subject received BOOSTRIX on 5th March 2015. Concomitant products included LOVENOX and prenatal vitamin. The subject's estimated date of delivery was 19th April 2015. The subject received BOOSTRIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 5th March 2015, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included intramuscular formulation administered by other route on 5th March 2015, injection site erythema and injection site swelling. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included injection site erythema (unknown), injection site swelling (unknown) and intramuscular formulation administered by other route (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy and intramuscular formulation administered by other route to be related to BOOSTRIX. The investigator considered that there was reasonable possibility that the injection site erythema and injection site swelling may have been caused by BOOSTRIX. Additional details provided as follows: The reporting nurse reported that after review of site it appears the vaccination was given further down on the arm and anterior to the deltoid. so she believed it may have been given subcutaneously. The nurse was not able to determine the onset of the redness and swelling. She also added that the patient was at 35 weeks 4 days gestation.
I woke up the next morning after receiving the injection with  body muscle aches, headache, and fatigue.  I felt like I had influenza.  I did not have a fever.  I was unable to go to work as I felt very ill.  The RN that gave me the shot thought that I would most likely have a very sore arm the next day.  My arm was not sore.
I couldn't hardly lift my feet and to feel numb all over.  My neck wouldn't hold my head up and I could hardly speak. I began to heave and got sick at my stomach. Since I hadn't eaten anything, all that came up was bile.  I had the pharmacy call my daughter and she came and called the paramedics.  They took me to the ER at the hospital. They gave me something to settle my stomach and I was so cold and shaking that they piled heated blankets on me. I was told that my blood pressure went down to 35.  They said they were going to admit me to the hospital and did. There they got an IV Drip going for my blood pressure, took blood samples and did a couple of EKG tests on me.  They also put me on a liquid diet becasue of the vomiting.  I was there a day and a half.  The Dr. released me the next day.
Fever, loss of appetite on 11/17/2021 followed on 11/18/2021 by non-intractable emesis with blood, lethargy. Two ER trips (11/17/2021, 11/18/2021), second ER trip resulted in admission to hospital. Unable to reduce intussusception with air or fluid enema attempts, surgical intervention required to reduce intussusception. Pt has recovered from surgery with no recurrences or complications.
Patient stated that she was having weakness/numbness/tingling of the legs. She went to her PCP office and was diagnosed with Guillain-Barre. She has been taking TYLENOL which has been helping with the pain. Spoke to patient 11/4/2016 and symptoms were diminishing/gone.
Headache, Fever, NauseaVomiting,  inj site sore, chills, leg nerve pain, fever 101.4, fatigue Narrative:  inj site sore, nausea, chills, headache, leg nerve pain, fever of 101.4F self medicate with OTC meds, symptoms lasted from Day 1 through 3; Day 4 - headache
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous potential legal report received from a health care professional concerned a male of unspecified age and ethnic origin.  The race of the patient was white (health care professional was not sure). 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. (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808486, and expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported. The lot number provided was 1808486, however, the attorney thinks that there could be an error in writing the lot number as 1808986 so the reporter wanted to confirm if the lot number is valid. On an unspecified date, it was reported that the patient was diagnosed with Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure), however, had no information on the type of test that was performed. The patient passed away due to Covid-19 (dose number in series 1). On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000211973.; Sender's Comments: V0:V0: 20220127738-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220127738-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
muscle pain in the arm where patient got the Pfizer shot; weakness; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose at arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle pain in the arm where patient got the Pfizer shot, and weakness that faded after a day on an unspecified date. Outcome of event muscle pain in the arm was unknown, and outcome of event weakness was recovered.   No follow-up attempts are possible. Information about Lot/Batch can not be obtained. No further information is expected.
Low grade 1(100-101) temp  and fatigue persistently every day since vaccine (20 days and counting). Transient headaches.
Patient stated he started having fever the day after vaccine.  Highest temperature was 101 degrees, Deep chest pain that lasted 3 days with a 6/10 on pain scale that was worse in the evenings.  Experienced burning in his head, feet and lips. Patient does work outside, but did have a sunburn before vaccine. Also, described visual disturbances that included blurry vision. Patient did have Covid 1/21.
No additional AEs or PQC reported; Caller reported expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 09-JAN-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 ml, at left (L) deltoid, lot# U003306, expiration date 15-OCT-2022, (strength, dose # and route of vaccination were not provided) for prophylaxis (expired product administered). No additional adverse events (AEs) was reported (no adverse event)
I started to feel tired but I did not attribute it to COVID-19. A friend contacted me to advise that they tested positive. I then took an at home COVID-19 Test and it was positive. I contacted my doctor and asked for Paxlovid and I started taking it yesterday. I am having sleeplessness, headache, loss of appetite and taste.
Leg cramps, and muscles, anxiety, dizziness, sleep disturbance, weakness, pain joints, decrease sexual ability, skin rash.
Late Localized Reaction; redness swelling; and tenderness to injection site 8 days after vaccination
I got my vaccination on 2/24/2021 and sat down for the my face started tinging and I felt like I was panic. The nurse gave me water and advised me to sit in the office until I felt comfortable. I sat at the office for 45-mins to an hour. I took a Benadryl and drove home. The morning of 2/25/2021 I woke up and felt lightheaded, my hands started tingling, and my face was numb . I tingling in my hand felt like an electric shock. On 2/25/2021 later that day the lightheaded feeling stopped completely. The tingling lasted periodically for a few months. April 4th, 2021 I was at my sister house and all of a sudden felt my fingers tingling again and my fingertips were extremely painful. I took my blood pressure and my blood pressure was a  little high to the point I was concerned. On April 4th, 2021 around 12:00pm I went to the Emergency department and was given a EKG, blood panel, chest x-ray and it was normal. The DR advised I was having a allergic reaction and I was given an IV of Benadryl. The symptoms never came back but I was concerned on receiving the 2nd dose.
Patient got very sick with the flu.; Patient got very sick with the flu.; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involved unknown demographic patient who  got very sick (illness) with the flu (influenza), while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that the patient had taken the flu shot one time in 74 yrs. Patient got very sick(sickness) with the flu(influenza). Since then Patient have had the flu twice in 40 yrs.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.