chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for herself and from a contactable other HCP. A 78-year-old female patient received PREVNAR 13 (Lot# L77777, Exp: 31Jan2017) intramuscular in right arm at 0.5 ml single on 22Jul2015 at 2:00 PM and sulfamethoxazole, trimethoprim (SMZ-TMP DS, Exp date 27Aug2015) 800-160 mg tablet at 2x/day from 22Jul2015 and ongoing for bladder infection. Relevant medical history included ongoing bladder infection on 22Jul2015. Concomitant medications were not reported. On 23Jul2015 patient woke-up at 07:00 am and experienced the following adverse events: difficulty moving, very weak, stomach ache, arm itching like crazy, arm red, arm swollen six inches wide, hurt when touch it hard, feeling very ill. The AEs required urgent care and the patient was admitted to hospital. No tests and/or treatment were required. Events difficulty moving, very weak and stomach ache recovered on 24Jul2015. Outcome of feeling very ill was unknown. Outcome of other events was not recovered. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered there was a reasonable possibility that the event is related to suspect product. The reporter was not willing to be contacted again by Pfizer on the reported adverse events. Follow-up (28Jul2015): New information received from a contactable consumer includes: confirmation of the outcome for the event "Stomach ache" (recovered). Follow-up (21Sep2015): New information received from a contactable other HCP on behalf of a Physician includes: suspect data; event onset date; medical history; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability. This case contains a Hospira co-suspect product and may have qualified for regulatory reporting for this product. This case may therefore be a duplicate report.
Pt was given combination vaccine containing Hep B & Hep B wasnt due.  Vaccine (Hep B) before minimum interval.
Right hand has gone numb after each injection. Right arm numb after 3rd booster injection. Became allergic to peanuts after 2nd injection where I need to carry an EPi pen at  all times.  Now, right hand is numb 2-3 times a week mostly felt at night causing me to wake up in pain
This spontaneous report as received from a pharmacist via the publicist representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, indication not reported), dose and frequency reported as one shot dose, route reported as injection, a dose of influenza virus vaccine (manufacture unknown) (lot#, expiration date, dose, frequency, route and indication not reported) and a dose of PNEUMOVAX 23 (lot#, expiration date, dose frequency, route and indication not reported) at the same time by the pharmacist manager. She first injected the patient in an unspecified arm with influenza virus vaccine (manufacture unknown). Then in the same arm, the patient was injected with ZOSTAVAX (but not in the same injection site as influenza virus vaccine (manufacture unknown)). Then on the other arm, the patient was injected the PNEUMOVAX 23. On the same day, on the arm that was injected with the influenza virus vaccine (manufacture unknown) and the ZOSTAVAX, the patient developed an injection site reaction or the patient already had a rash there previously and now it had worsened because of the vaccines being given. The patient sought medical attention and spoken with the pharmacist. The outcome was unknown. Additional information has been requested.
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
Fever 99.2  (normal temp 97.6), chills, headache, body aches, back pain. Lasted until the morning of 1/24/21. Took extra strength acetaminophen about 8 hours after symptoms began and then took Maxalt for migraine evening of 1/22/21 and 1/23/21.
Pulsatile tinnitus; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on 30Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that on 02Apr2021, Pulsatile tinnitus occurred 2 days after the 2nd dose on 30Mar2021. The tinnitus does not go away and the symptom persists. Patient visited physician office. The outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.
Shingles and subsequent nerve pain, nerve pain continues. Initial treatment Meloxicam, Tramadol and then gabopentin and acetaminophen
Chills. Headaches, stomach pain, nausea, fatigue, and back pain. Symptoms have been 15 days now.
Information has been received from a health professional concerning a 6 year old white male who on 10-MAY-2000 was vaccinated with a dose of varicella virus vaccine live.  On 14-Jan-2006 the patient experienced breakthrough chickenpox with less than 50 lesions and no fever.   At the time of the report the patient was recovering.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided. Follow up information from a health professional indicated that the patient recovered.  The patient's sister had a similar experience after vaccination with varicella virus vaccine live (WAES 0601USA01839).  Additional information is not expected.
Itchiness; Sore arm; Redness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness) and INJECTION SITE ERYTHEMA (injection site redness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PRURITUS (Itchiness) and INJECTION SITE ERYTHEMA (injection site redness) had resolved and PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Redness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   Treatment information was not provided.  Patient did not experienced any adverse events after taking second dose of vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 contains outcome of the events as recovered.
This spontaneous report as received from a pharmacist refers to an 88 year old female patient. The patient did not have pertinent medical history, concurrent conditions or concomitant therapies. On 09-JAN-2017, the patient was vaccinated with PNEUMOVAX23 (dose and anatomical location were not reported), lot # M038216, exp date 09-MAY-2018, intramuscular for prophylaxis. The pharmacist reported that the patient went back into the pharmacy on 10-JAN-2017 and presented with "redness and swelling at the injection site." On an unspecified date after administration, the patient went to the hospital because it was unresolved and was hospitalized for "2 nights" and was diagnosed with cellulitis around the injection site. The patient was treated with "antibiotics". The pharmacist reported that the patient is fully recovered on an unspecified date, but did not know the date of recovery. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of VAQTA (exact dose and route were not reported, lot # L039659, expiration date 15-MAR-2017), that experienced a temperature excursion of 32.7 degrees Fahrenheit for 3 hours and 49 minutes. No adverse events were reported. Additional information has been requested. It has been determined that case # US-009507513-1602USA0005212 is a duplicate of case # US-009507513-1602USA004961. The case # US-009507513-1602USA004961 has the earlier aware date 08-FEB-2016. There fore, case # US-009507513-1602USA005212 is being deleted from our files and the cases are consolidated into case # US-009507513-1602USA004961.
COVID-19 POSITIVE; This spontaneous report received from a patient concerned a 52 year old white male of unspecified ethnicity.. 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered to left arm on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-FEB-2022, the patient mentioned having tested positive for Covid with a rapid test after receiving the vaccine. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious. This report was associated with product quality complaint (PQC): 90000218866.
2/12 pain and erythema at and around injection site which spread on 2/13. Associated with mild headache 2/13. 2/14 am erythema measured 94mm x 100mm, area indurated. 2/14 pm intense itching, burning at and around injection site and erythema. 2/15 erythema spread beyond markings of 2/14, area now hot to touch.
Sudden onset severe, unrelenting vertigo and nausea, vomiting with any movement. Staggering while ambulatory. Facial Pain left side from temple down to jaw (not headache pain). Symptoms began Fri June 4th, continued through June 8th. Unable to move without triggering vomiting, symptoms progressively worsened. Taken to ER on June 8th at suggestion of patient's Neurologist. Patient given CT scan (negative), had previous MRIs in early May (stable for MS lesions), and given IV reglan and benadryl without relief. Diagnosed with "vertigo" and stayed overnight in observation unit . Given Valium and Meclizine in Observation Unit with minimal improvement. Finally solumedrol 250mg was given with resolution of vertigo and sent home.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Current condition of patient included osteoporosis and thyroid. No relevant medical history was reported. Drug reactions or allergies were reported as none. On 09-OCT-2014, patient was administered with ZOSTAVAX (subcutaneous, lot # K008880, expiry date 09-SEP-2015). On an unknown date approximately in 2014, 4 weeks prior to administration of ZOSTAVAX the patient was administered with a dose of an unspecified Influenza virus vaccine (manufacturer unknown), in an unspecified arm. Concomitant medication reported was unspecified osteoporosis and thyroid medication. Patient began to experience severe pain in the elbow of her injection arm, on an unspecified date, following the vaccination. Pharmacist reports that the patient cannot sleep because of the pain. Also patient clarified that she was not actually having pain in her elbow, she believes that she can pinpoint the nerve in which she feels the pain. The patient was seen by unspecified physician on an unspecified date due to the severe elbow pain. The physician administered a cortisone (manufacturer unknown) injection to the patient's elbow to treat the pain and also an x-ray of her elbow was performed, on an unspecified date. Pharmacist reported that the cortisone (manufacturer unknown) injection did nothing to treat the patient's pain and nothing was found on the x-ray. Sought medical attention was reported as yes. The pharmacist does not know if the patient had consulted the physician since she realized that the cortisone (manufacturer unknown) injection did not relieve her pain in her elbow. The patient had not recovered, and no additional information was provided. The outcome of cannot sleep because of pain, severe pain in elbow of her injection arm and she can pinpoint the nerve in which she feels the pain was reported as not resolved. This is one of the 2 reports from the same source related via same patient link (MARRS case # 1411USA012759). Additional information has been requested.
-symptoms: left arm is red, hard and warm; it is very itchy, no pain "at all"  -duration: was there for about 3 days after the vaccine, then faded, then came back 2 days ago
No additional clarifying statements or AE details were provided; The patient was administered a dose of VARIVAX that was involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # W021740, which had been verified to be a valid lot #, expiration date: 10-JUL-2024) (strength, dose, and route of administration were not provided), administered for prophylaxis. The vaccine was stored at 14.7 degrees Fahrenheit (F) for 1 hour and 3 minutes. No previous excursions were reported. No additional clarifying statements or adverse events (AE) details were provided (no adverse event).
Have had long COVID symptoms since October 2020. I felt tiredness after second vaccine two hours later for a day - not super tired but just like I hadn't slept enough. I had sore arm. I have had these symptoms: Dizziness, brain fog, fatigue, food sensitivity testing before the vaccine and with Long COVID symptoms. - End of April about the 30th I had food sensitivity testing: I'm now sensitive to honey, beef, gluten intolerant  - found those results out after I was vaccinated. The dizziness, brain fog and fatigue have slowly gotten better since the initial onset of long COVID .  I did do a two week (10 day) taper of Prednisone in May due to Inflammation  - ordered that.  I also have anxiety and I never was anxious before all this. Noticed it in back in November  - when I start feeling faint than I start to feel anxiety symptoms and I have noticed it more now.  - nurse practitioner - she has been my second doctor I'm seeing -
CHILLS; SHAKING; This spontaneous report received from a patient via a company representative (and wife of the patient) concerned a 56 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included non-smoker, and no alcohol use. The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, JNJ 1802068) dose was not reported, administered on 05-MAR-2021 at 4:00 PM to left deltoid for prophylactic vaccination. Concomitant medications included lisinopril.  On 06-MAR-2021, the patient experienced chills and shaking. A wife reported that her husband had side effects from the JnJ Covid-19 vaccine. He received the vaccine and experienced chills and shaking about 12 hours later. He was fine now. Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and shaking on 06-MAR-2021. The reporter considered the causality between the events (chills and shaking) and Covid-19 vaccine ad26.cov2.s as related. This report was non-serious.
I had Covid diagnosed twice - July 2021 and December 2021 Symptoms  after vaccine - shortness of breath- leg fatigue - occasional chest pain - April 7th severe chest pain, admitted to hospital, lab values off, fluid and inflammation noted around heart.
Intense shaking; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 14:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, psoriasis and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13May2021 at 14:00 as a single dose for COVID-19 immunisation. The patient had known allergy to tree nuts. On 03Jun2021 at 00:00, 10 hours after injection the patient experienced intense shaking and could not stop and it was continuing at the 11th hour after injection. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intense shaking was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative: Patient received his COVID booster and flu vaccine on 11/5/21. On 11/25/21, he had c/o a severe headache, LUE weakness and was diaphoretic. His  family called EMS and he was taken to a non hospital facility and was intubated and  then transferred to a different facility for a higher level of care for treatment of a  hemorrhagic stroke and hydrocephalus. SCr at this time was 6.10 (not on dialysis  prior to this event but was being evaluated for the need for dialysis). He was  extubated on 11/27/21; however had to be re-intubated on 12/5/21. He did receive  dialysis as well. On 12/10/21, family requested home hospice services as he was  unable to be weaned from the ventilatory and dialysis did not help his neurologic  status. On 12/13/21, he discharge home with home hospice and on 12/15/21 he  passed. There were 40 days from date of vaccine to date of death. No autopsy  reports available.
Itches all over body, hives, large reditching blotches all over arms, legs, back. Followed by a non-stop cough, blurry vision.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:37 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and  traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Patient under age 18 was vaccinated with Johnson and Johnson, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away.
Extreme fatigue and cold intolerance. One previous pregnancy (unremarkable with no complications). Expected due date: May 19, 2022. Tested thyroid. Treatment plan is to retest hormone levels in 6 weeks. 20 week ultrasound showed no fetal abnormalities.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was provided. Patient stated that she has been icing the injection site but wanted to know if it can use Aspercreme or muscle rub.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated to resolved.
On 12/29/00, that night, post vax, pt developed redness on face, worse the next AM but getting better. It also itched and he had mild URI symptoms. No SOB.