chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for  a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term  prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
according to mom, pt became pale, limp & unresponsive 5min post vax;13NOV95 sx lasted 30min;pt was taken to MD ofc;EEG the next day was nl;pt did not notify clinic until 8JUL96 about episode
approximately 5 hours after receiving the vaccine, I became very ill, nasua, diarrahea, shortness of breath, severe headache, body aches, extreme fatigue
On the day of I was fine but the day after, I had flu symptoms meaning headaches, fatigue, fever. On the third day I kind of lost my voice and the day after that there was a tingling that started. It started on my left side, from arm to hip to leg to foot. And now from knee to foot and a little bit in my left elbow to my left middle finger as of today. I saw a neurologist on June 3 2021.
1st dose: Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:00 (Lot number: ER8736) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: wasps" (unspecified if ongoing), notes: Known allergies Bactrim, wasps; "High blood pressure" (unspecified if ongoing), notes: other medical history High blood pressure, Mild asthma; "Mild asthma" (unspecified if ongoing), notes: other medical history High blood pressure, Mild asthma. The patient took concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim", notes: Known allergies Bactrim, wasps. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "1st dose: Arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. Other medications was taken in two weeks. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
12 hours after shot - Woke up in middle of night with severe pain in arm of shot. Hurt to raise arm. Forced self to move it, hoping to loosen it up, immediately broke out into a cold sweat and became extremely nauseous from the pain. Iced arm and took Tylenol, which reduced the pain. Nausea and arm pain lasted all day. Fatigued. Day 2 after shot  - still very nauseous and have arm pain (not as bad, but still hurts to move), and tired.
Swelling from above his shoulder to below his elbow; redness; Itching; Soreness to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling from above his shoulder to below his elbow), VACCINATION SITE PAIN (Soreness to touch), ERYTHEMA (redness) and PRURITUS (Itching) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATENOLOL and BENAZEPRIL HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (BENAZEPRIL/HYDROCHLOROTHIAZIDE ACTAVIS) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness to touch). On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling from above his shoulder to below his elbow), ERYTHEMA (redness) and PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swelling from above his shoulder to below his elbow), VACCINATION SITE PAIN (Soreness to touch), ERYTHEMA (redness) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Ten days after the vaccine injection my arm started hurting and swelled to the size of a baseball at the injection site. The lump was hot to the touch and had a large red circle about 3" in diameter. I had tightness in my chest and a headache.  I had took two Benadryls every eight hours for three days, since it seemed to be an allergic reaction to the vaccine.  At this date/time I don't have any further signs of an allergic reaction.
Pt received 2 scaly, circular areas near injection site (one above bandaid and one to side of bandaid.  Both were dime to nickel's in size.  "Pimple's" appears on forehead and on both cheeks. Not itching/no fever.  Pt still has area
Given LA SQ. Hives at the site and redness only at the site. Hive size of dime.
met resistance/felt pressure; only "about 1/2 a dose was administered"; Poor quality device used; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions included anxious/tense. There was no information about the patient's drug reactions, allergies, medical history, and concomitant therapies provided.   On an unknown date in August 2020 (reported as on unspecified date "last week"), the patient only received a partial dose of a prefilled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T009744, expiration date 28-JAN-2020; exact dose and route of administration were not reported) for prophylaxis by a healthcare professional, because the nurse administering it "met resistance/felt pressure" when administering the vaccine (reported as feeling resistance and only about 1/2 a dose was administered) (resistance to movement in device, inappropriate dose of vaccine administered and poor quality device used). The prefilled syringe looked normal prior to the administration and after the partial administration. The plunger appeared to be working normally once withdrawn. The reporter confirmed no additional adverse events as a result of the partial dose. The patient was not anxious/tense after vaccine and no site reactions reported. The reporter had syringe available for retrieval. The sample had been received. No further information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T009744; expirationdate: 28-JAN-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: Returned to Manufacturer; productreturndate: 11-SEP-2020; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
PATIENT WAS GIVEN FLU VACCINE INTENDED FOR CHILDREN ABOVE AGE 3. FAMILY WAS NOTIFIED OF MISHAP, ACCORDING TO GUIDELINES THERE IS NO NEED TO REVACCINATE.
Developed Shingles - first symptom 8/21 (pain - right side of body), rash appeared (lower right side of back) 8/28, diagnosed 8/30, medication started 8/30
dizzy; Just extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Jul2021 11:00 (Lot Number: Unknown) as dose number unknown, single at the age of 34-year-old for covid-19 immunisation.  Medical history included MS multiple sclerosis, migraines, seizures and known allergies to Ibuprofen, naproxen. Concomitant medications included gabapentin, glatiramer acetate (GLATOPA) and oxybutynin all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced just extremely tired and dizzy on 08Jul2021 11:00. The outcome of the events was recovering with no treatment.  Information on the lot/batch number has been requested.
Site: Pain at Injection Site-Severe, Additional Details: see pt written statement attached.  pt complained of site too high above normal injection area.
vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypereosinophilic syndrome" (ongoing). Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: EOSINOPHIL COUNT INCREASED (hospitalization, medically significant), HYPEREOSINOPHILIC SYNDROME (hospitalization, medically significant), CONDITION AGGRAVATED (hospitalization, medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms". The patient underwent the following laboratory tests and procedures: Body mass index: Unknown results; Eosinophil count: increase in eosinophil count or eosinophil-related, notes: symptoms; SARS-CoV-2 antibody test: Unknown results. Therapeutic measures were taken as a result of eosinophil count increased, hypereosinophilic syndrome, condition aggravated. Additional information: only 1 case did this lead to a change in Hypereosinophilic syndromes therapy (a transient increase in prednisone dose 2 weeks after the second dose of the Pfizer vaccine).  The reporter considered "vaccinated participant reported an increase in eosinophil count or eosinophil-related symptoms" 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: A possibly contributory role of BNT162B2 in triggering the onset of clinically significant exacerbation of HES requiring alteration of therapy cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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
Pt describes body aches, sore throat, congestion. Reaction reported to this provider on 8-9-16, states he is feeling better.
Tingling of both arm, back, tongue,  right leg and both feed, chills high heart rate in the 160's
Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Daily headaches have been occuring. Since the second shot (3/23/2021), migraines have increased in frequency and intensity.; Slurrred speech; Sound sensitivity; Lack of cognition; Debilitating; It affected her job/work; light sensitivity; Auras; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 32-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in left upper arm on 23Mar2021 15:00 as dose 2, single (at the age of 32-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) intramuscularly in left upper arm on 03Mar2021 15:26 as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other (Civic Center). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Prior vaccinations within 4 weeks was reported as none. Vaccine was not administered at Military Facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history was reported as None. The concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000) daily. Patient experienced headaches that had been occurring daily since 23Mar2021 20:00. Since the second shot (23Mar2021 20:00), migraines had increased in frequency and intensity. Headaches occurred the evening of the second dose (23Mar2021 20:00). The headaches persisted and series of migraines set on 23Mar2021 20:00. This caused slurred speech, auras, light & sound sensitivity, lack of cognition on an unspecified date in 2021. It affected her job/work and was debilitating on an unspecified date in 2021. She sought help from her primary care and also a second opinion in Apr2021. It had continued, despite medications (multiple trials), massaging to try and release tension, and physical therapy. The headaches were daily and migraines occur frequently. Patient was prescribed with sumatriptan and Topomax for migraines along with physical therapies. Medications to try and disrupt migraine patterns had not worked. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The lab tests and procedures included COVID-19 (Rapid PCR test) with result as negative on 06Feb2021. The outcome of the events was not resolved.
Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 28Jan2021 at 14:30 (at the age of 65-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history (as reported). The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications included levothyroxine from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 01Feb2021, the patient experienced low-grade fever, headache, cough, fatigue, and diarrhea. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcomes of low-grade fever, headache, cough, fatigue, and diarrhea were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
pt recv vax 31MAY95 & pt exp a local inflammatory rxn w/inflammation & swelling the size of a grapefruit, redness, severe itching, throbbing & pain @ the inj site;pt felt did not have full ROM in rt arm; presented to ER & tx w/med;
daily headaches worsening thru out day and  low grade fever since booster,  also severe l eye pain for 30min on 2/2
I received the vaccine in February and in June I had severe diarrhea for two days and then it went down to once a week. I had a colonoscopy done and it showed hemorrhoids. I then had blood work done from the doctor. I have lost 25 pounds and the doctors cant find anything wrong. It has sense lessened to two times max a month.
Myalgia flushed skin Narrative:  sore arm 2nd day after receiving the vaccine. 1 hour after receiving the vaccine had a small feeling of being flushed that lasted only 2-3 seconds.
Rt upper arm 7 x 5cm redness and swelling. No pain from shoulder to elbow.
55 year old female with PMH significant for temporal arteritis diagnosed in 2020, who presented to the Ed for evaluation of headache. Pain is mostly on the right temple and right side of head, described as feeling like someone is grinding on her temple, associated with blurry right eye. Patient reported that she is under the care of a neurologist Dr. outpatient. She reported that her headaches have been on and off but worse since Saturday, hence she came to the Ed for further evaluation. She was given IV solumedrol in ED. .
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 21-APR-2016 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
My arm started to swell up where the shot was. It was red, and really warm. It was really painful. These symptom lasted 3 days after my shot. I had a fever and body aches as well. I went the CVS Minute Clinic. They just asked my question about my symptoms. I took Benadryl and it went away.
Widespread hives all over body, under hair, raised bumps--especially on the back. Over 2.5 days, hives remain.
Per mom - pt received Hep A vaccine on 7/17/06 at former PCP - pt developed high fever. Was admitted to hospital day after vaccine.
Pt c/o trouble breathing about 15min after receiving vaccine. Cough noted by staff, Patient received 0.5mg of epinephrine IM in RD while seated.  She we then moved to a stretcher to lay down.  Paramedics arrived to evaluate patient.  Breathing improved and patient refused transport to hospital.  Husband is a paramedic and patient has a history of anaphylaxis. Vitals: 1st: BP: 151/104 HR:80 RR:22 O2: 98% on RA 2nd: BP:150/72  HR:79 RR: 20
10 to 15min post vax experienced pain @ inject site & spasms of the deltoid & trapezius muscle; Tx included the application of ice;
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
She noticed an increase every day of a burning sensation happening in rectum 24 hours a day and then lymph nodes in neck were swollen and then many bumps came out in the entire neck area as well as the entire scalp area along with itching in the stomach area. Had a biopsy but they diagnosed her with an explosion of hives.
Swelling; Anxiety attacks; Palpitations; Chest pains; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CL8729) via an unspecified route of administration in the arm left on 29Apr2021(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus syndrome, hypothyroidism, hypercholesterolemia and sulfonamide allergy. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EL00171) via an unspecified route of administration in the arm left on 07Apr2021(at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021 the patient experienced anxiety attacks, swelling, chest pains and palpitations. No therapeutic measures were taken as a result of the events. The clinical outcome of the events anxiety attacks, swelling, chest pains and palpitations were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
had pain; extremely fatigued; administered with an extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th March 2019) and Shingrix (2nd dose recieived on 20th May 2019).   In June 2020, the patient received the 3rd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain, fatigue and extra dose administered. On an unknown date, the outcome of the pain, fatigue and extra dose administered were unknown.   It was unknown if the reporter considered the pain and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient received 3rd dose of vaccine, which led to extra dose administered. The patient had pain and was extremely fatigued after receiving the third dose of Shingrix and it was very hard for him to get out of bed. The reporter did not consent to follow up.