chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the 1st, 2nd and 3rd doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (Dose, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) (Dose, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, after receiving her 3rd vaccination, it was noticed that her hair had fallen out. Approximately on an unknown date in 2017 (Also reported as over the past year), the patient's hair had completely fallen out and had not grown. The patient had then been diagnosed with alopecia. It was reported that there was nothing wrong with her before. All her labs had not suggested any disorders. It was reported that there were others who like the reporter had determined that the Human Papilloma Virus (HPV) vaccine was the main cause of their daughter's hair loss. It was reported that the patient went from donating her hair every 3 years to needing a wig of her own. This had caused so much stress in her life as she was then in high school and felt embarrassed. The reporter stated that something needed to be done about that situation. The outcome of the event of alopecia was not recovered. The outcome of the events of stress, emotional distress and product origin unknown was unknown. The causality assessment was not provided.
Burning, numbness, tingling, throbbing both feet and sometimes coming up legs. Muscle weakness. These symptoms are daily and continue today 3/31/23. Arm pain/hand grip pain July 2021. Tinnitus in both ears began January 2022.
Received Pfizer on 2/26/21 & 3/19/21. Admitted 4/25/21 for acute respiratory failure with hypoxemia, COVID 19 pneumonia
fainting episodes; This spontaneous report was received from a registered nurse via a company representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis.   On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given.   The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of fainting episode was considered to be medically significant.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA007327: US-009507513-2107USA007519:
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 39 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.
DIFFICULTY BREATHING WITHIN  3 MINUTES OF ADMINISTERING VACCINES. 911 CALLED - EPIPEN DOSE 0.15MG ADMINISTERED 1 TIME, DIPHENHYDRAMINE 50MG/1ML ADMINISTERED 1 TIME, 1 PUFF ALBUTEROL ADMINISTERED BY PATIENT COMPANION.  EMS ARRIVED 5 - 10 MINUTES LATER TO EVALUATE PATIENT. PATIENT WAS REFERRED FOR MEDICAL EVALUATION BUT REFUSED. PATIENT STABILIZED AND LEFT UNDER HER OWN POWER.
Approximately 48 hrs after vaccine developed 1in (+ or -) in circumference red, raised/indurated area and over next 1.5 days increased to 4inches (+ or -).  Less today at approx. 8cm diameter.
Vaccine was given on 11/06/2013, 12/18/2013 & 04/08/2014. On the morning of 04/09/2014 after the 3rd vaccination I went to the emergency room with symptoms of an allergic reaction (difficulty breathing and swallowing felt like my throat was closing, swelling eyes and face, hives rash and tingling burning sensation on the skin).
The  day after I got the vaccine I woke up with a rash all over my stomach and severe pain in my lower back area. This turned into a rash with bumps and severe pain in the area. I went to the doctor and I was diagnosed with Shingles. I am in severe pain and can't sleep or eat.
Vaccine give to left upper arm 11/05/14 at 16:30 at Health Dept. to HU on 11/06/14 left upper arm red from shoulder to elbow, hot, and hard to touch at 08:44 ice pack applied. Parent contacted. Verbal MD referral given. Appt made for 11:00 on 11/06/14.
Could not move it; Real sore arm/ Really painful; Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move it), VACCINATION SITE PAIN (Real sore arm/ Really painful) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could not move it), VACCINATION SITE PAIN (Real sore arm/ Really painful) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle). On 08-Nov-2021, HYPOKINESIA (Could not move it) had resolved. At the time of the report, VACCINATION SITE PAIN (Real sore arm/ Really painful) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle) had resolved.            No concomitant medicines were reported. No treatment medicines were reported.  Patient had real sore arm because the pharmacist at Costco put the needle way high on shoulder into acromion joint. Patient believed that injection was not given into the muscle. Patient could not move it until just current morning. It was really painful.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received contains no new information.
After 2 days of getting vaccine, on Feb 22, my arm had a huge rash and was very tender where my shoulder was sore.  I took a picture.  I didnt notice any redness prior to this but wasn't looking for it.  Do you know when it will go away.  It is larger than when a baseball hits you in an arm and the same amount of tenderness.
Fever 103, rigors, body aches, sever headache, generalized weakness,  fatigue
The patient started to feel swelling, redness on the interior of  upper right leg.It was a swollen vein.  She went to the physician on 2-15-2021. She was diagnosed with having a blood clot and had to have it removed. She is wearing compression stockings now 24/7.
Narrative:  Per Patient's Spouse was at PCP visit 6/25, patient received J&J vaccine on same, 5days later 6/30/21 dx with Hemorrhagic stroke, was transferred to MED CENTER-DISCHARGE SUMMARY-6/29/21-07/05/2021. Case reported to this writer on 7/23/21 during post d/c follow-up. Per spouse unsure if J&J vaccine caused recent CVA -given patient had had a previous stroke. However, says timing concerning.
No adverse event; adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.).    No concomitant medication was reported. The dosage text of the suspect was reported as unknown. It was reported that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine, 21-Jun-2023. The vaccine had expired on 18-Jun-2023. The HCP was looking for guidance for these patients on whether they need to be revaccinated or not. Vial size was reported as 5 ml. Vial was initially stored in the refrigerator was unknown. Vial did not undergo temperature excursion. No treatment medication was reported.  This case contains information about patient 2nd  out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730167 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730167:Master Case
Slight redness and swelling on (L) arm where KINRIX and Varicella given. No warmth or pain/itching present. Advised Children's BENADRYL and Ibuprofen - In if sx worsen.
0840-Received Typhoid Immunization 0910-Developed a rash in mouth 0910-Rash, hypersensativity, feels like sunburn all over. 1300- Present at ER for treatment
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 51-year-old female patient who received FLUARIX QUADRIVALENT (batch number 34CY2, expiry date 30th June 2015). In 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be related to FLUARIX QUADRIVALENT. Additional details were as follows: This case was previously reported to a doctor. The reporter was told by her physician that a patient received the FLUARIX QUADRIVALENT vaccine last fall (2014) and she experienced an allergic reaction. The reporter did not have any details because the patient was new to their practice and she did not received the vaccine from them. The reporter was told by her physician to call GlaxoSmithKline to determine which flu vaccines do not contain egg products.
Pt presents with a fever up to 103.5 F., chills, body aches, joint pain, cough. These symptoms started the days after her booster. Treatment is Tylenol, Ibuprofen, hydration, rest and a short course of Prednisone.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 17-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016, (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache,  rash to arm , light headedness, mental fogginess - resolved with rest , Benadryl , tylenol
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 2nd of 8 patients.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   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.; Reported Cause(s) of Death: expired before receiving the second dose
p/vax pt rt deltoid on arm was red & swollen; end of wk arm was swollen; advised warm compresses & call FMD; still itchy; arm at inj site red & swollen w/red line from site to hands; T103;
4 DAYS AFTER 1ST DOSE MODERNA HAD SEVERE ABDOMEN PAIN WITH NAUSEA, TO THE ER WITH CT SCAN AND LABS DONE. DOSE 2 MODERNA 2/18/2021 AND 2 DAYS LATER HAD SAME SEVERE ABDOMEN PAIN AND NAUSEA .FIRST EPISODE LASTED ABOUT 3 DAYS AND SECOND EPISODE LASTED 2 DAYS
Approximately 3 weeks after the injection, my neck got very stiff and sore on the left side. The stiffness/soreness extended own my back, chest and shoulder on the left side. It lasted 1 - 2 weeks. The pharmacist told me she has had other people say the same thing. She encouraged me to fill out this form.
32 weeks pregnant woman received a Tdap from a local pharmacy.  Estimated Due date is 9/26/2019. Unknown pregnancy history as she  sees an OB for that care.  She called the Primary Care Clinic due to continued L arm pain 7 days after receiving Tdap shot in L arm. She states that it is so painful she has a hard time lifting her arm or putting clothes on. Also L arm is painful to touch. This RN scheduled patient for visit today (7/31/2019) with PCP.  Patient reports that immunization was given 4cm inferior to acromium and 2cm posterior and final diagnosis to be determined after ultrasound per physician.
No adverse event; Immunocompromised patient received first booster after second dose; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 010M20A and 012L20A) for COVID-19 vaccination.     Patient did not had allergies to medications, food and other products.  Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Asplenia (15 years ago), Idiopathic thrombocytopenic purpura and Immunocompromised.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Immunocompromised patient received first booster after second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-647028 (Patient Link).
Information has been received from a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed stabbing pain and itching for months after vaccination. It was unspecified if medical attention was sought. The patient's outcome was not reported. Additional information is not expected.
Arthralgia, Fever, weakness, injection site pain Narrative:  Other Relevant History:
positive COVID test 2/16/2021 after 2 Pfizer doses; patient asymptomatic other than ear pain which she presented to the ED for on the same day (ED presentation was not for COVID symptoms although she was positive at time of presentation)
Local tissue reaction with area of swelling and erythema.  5 cm x 10 cm . Non tender.
Temp 103. Profuse sweating. Severe Headache. Achy joints, muscles. Runny nose, sneezing.
Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a consumer, who is a 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sustained atrial fibrillation and elevated diastolic blood pressure.  The patient's medical history or concomitant medications were not provided.  On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (037M20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection.  On 14-Feb-2021, the patient experienced the sustained atrial fibrillation and elevated diastolic blood pressure, which were considered medical significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event was unknown.  The patient believe the events, sustained atrial fibrillation and elevated diastolic blood pressure, may be related to the vaccine.  Consent given for Safety Division to follow up with her, if needed.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Bruising occurred in the area from itching so much; Itching at the site that was intense started very mild and then it increase; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder NOS (Patient stated she has a "skin condition"), Dry skin and Itchy skin.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase). At the time of the report, CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment medication not provided.  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.
Client was administered Janssen vaccine with an expiration date of 09/08/2022. Lot # 211D214 on 09/12/2022.
Vaccine expired on 4-17-22, reported to Moderna, internal testing done and this was the result: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for Covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing), notes: known allergies Shell fish; "red dye" (unspecified if ongoing), notes: known allergies red dye; "Idiopathic intracranial hypertension" (unspecified if ongoing); "Hasimoto's" (unspecified if ongoing), notes: Hasimoto's; "chronic back pain" (unspecified if ongoing); "degenerative disk disease" (unspecified if ongoing), notes: degenerative disk disease; "fibromyalgia" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: TYLENOL; ACETAZOLAMIDE ER; CITALOPRAM. Past drug history included: Brevital, reaction(s): "Known allergies: Brevital", notes: Known allergies: Brevital. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: The patient received other medications in two weeks included Tylenol 3, Citalopram and Acetazolamide ER. Antiviral details: The drug Paxlovid (Lot number: GA8778) started on 05Jun2022 and stopped on 09Jun2022 was taken for indication as treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.