chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Arm where the vaccine was given became red, swollen, itchy, hot, and sore. I noticed it on March 1, 2021, 8 days after the vaccination.  The size of the red spot is 2.5 inches by 1.5 inches today (March 2, 2021).
Mild headache and light headed for around 2 hours.  Dry mouth for around 4 hours.  I took 500mg Naproxen for the headache, and drink water for the dry mouth
This spontaneous report was received from a pharmacist, referring to a 17 year old female patient. She did not have relevant medical history, concomitant medications or drug history. It was reported that the patient had been receiving GARDASIL in a course of three injections over six months and that the first injection was administered on 18-OCT-2016. On 23-NOV-2016, the patient was vaccinated with the second dose of GARDASIL (lot # L007531, expiration date 04-NOV-2016) 0.5 ml for prophylaxis (route of administration was not reported). After she received the injection, it was discovered that the vaccine had already expired. At the time of this report, the patient had not experienced any adverse effect. The reporter stated that she did not have any relevant laboratory data. At the time of the report, it was unknown if the patient would continue GARDASIL, but the next injection was scheduled sometime in April 2018. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 20, 2021, patient experienced pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day). At the time of the report, pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and  musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient was vaccinated with first and second dose of GARDASIL on 02-AUG-2011 and 02-JUL-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Incorrect vaccine was given for the 2nd dose, instead of Moderna, Pfizer was administered
Ischemic stroke; Right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke; A spontaneous report was received from a consumer concerning an 89-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced ischemic stroke and right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke/thrombosis.  The patient's medical history included hearing issue. Concomitant medication included losartan.  On 24 Feb 2021, approximately 12 days prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 001A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 08 Mar 2021, the patient got ischemic stroke. The patient was in hospital for 3 days and doctor put him on blood thinner. MRI (magnetic resonance imaging) of his upper body revealed his right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke. Treatment for the event included blood thinner.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events ischemic stroke and right side of brain and blood vessels affected badly and found blood clots because of ischemic stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Employee states flu shot was more painful than previous years. Site was bruised, arm was stiff and sore, had difficulty moving arm for 2 wks. At this time pain improved but still she (4 wks after vaccine.
Right nostil has bloody scab; Everytime blow nose, blood comes out; Stomach is upset; Severe pain; Loose stools; Severe spinal pain/headache; Severe spinal pain/headache; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset) and PAIN (Severe pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SPINAL PAIN (Severe spinal pain/headache) and HEADACHE (Severe spinal pain/headache). On an unknown date, the patient experienced NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHOEA (Loose stools). At the time of the report, SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain), DIARRHOEA (Loose stools) and HEADACHE (Severe spinal pain/headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported. Patient received 2nd dose 03/20/21(Batch no.002B21A). Reporter stated that Right Nostril had a bloody scab that won't heal for a month and 1/2.
Product storage error; Received vaccine with expired BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product TETANUS VACCINE for an unknown indication.    It was reported that patient had not been diagnosed with/tested positive for COVID-19. It was reported that patient had no acute illnesses at the time of vaccination and upto one month before.  Concurrent medical conditions included Drug allergy (Cefdinir), Drug allergy (Codeine), Drug allergy (Doxycycline Hyclate), Drug allergy (Erythromycin), Drug allergy (Lamictal), Drug allergy (Lisinopril), Drug allergy (Lithium Carbonate), Drug allergy (Peniillin drugs), Drug allergy (Tramadol), Drug allergy (Wellbutrin), Drug allergy (Amitriptyline), Type 2 diabetes mellitus (No recent change), Bipolar disorder (No recent change), Major depression (No recent change), Hyperlipidemia (No recent change) and Asthma (No recent change.). Concomitant products included ATORVASTATIN, CELECOXIB (CELEBREX), GABAPENTIN and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 05-Apr-2022, the patient received dose of TETANUS VACCINE (Intramuscular) 1 dosage form. On 05-Apr-2022 at 10:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Apr-2022 at 10:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication included Ability 30 mg/daily by oral route of administration. It was reported that vial was initially stored in refrigerator between 2-8 degree Celsius on 18-Feb-2022. It was reported that vial did not undergo any temperature excursions. It was reported that patients did not have any symptoms or side effects. It was reported that this was patient's first moderna booster dose. No treatment medications were reported.   This case was linked to MOD-2022-536509.
Blood clot in right lung; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204; Expiration date was not reported) on the right arm on 26Mar2021 (18:45) as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 31Mar2021, the patient had blood clot in the right lung. The event resulted into doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care, and the patient was hospitalized on an unspecified date in 2021 for two days due to the event. The patient did not receive any treatment for the event. The outcome of the event, 'blood clot in the right lung', was recovered on an unspecified date in 2021 with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination, and had tested negative for COVID-19 nasal swab test on 01Apr2021.
Says that 3 days after receiving the flu shot, her right upper extremity became so sore she could barely move it. Said it gradually improved but still had some soreness when seen in office 1/24/2020.
A few hours after receiving vaccine patient noticed slightly raised red bump at site of injection. A few days later the red area enlarged to a couple inches in diameter. Site is slightly painful. Advised patient to take Benadryl, and if pain or red area gets larger to seek urgent care for treatment.
I have been getting unusually dizzy and my heart has had more frequent episodes of increasing rate when I stand up or do anything physical.
No additional adverse event reported; patient was administered a fourth dose of GARDASIL 9.; patient was administered a fourth dose of GARDASIL 9.; This spontaneous report was received from a nurse referring to a  patient of unknown gender, age reported as "16" (units not reported).. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with the fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (mL) as prophylaxis (frequency, route of administration, and anatomical site of vaccination were not reported; lot number S020254 had been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), with an expiration date on 09-DEC-2021) (inappropriate schedule of product administration and extra dose administered). It was reported that the patient completed the three-dose series on January of 2017. No additional adverse event was reported. At the time of this report the outcome of inappropriate schedule of product administration and extra dose administered was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
TIRED; NEEDLE TOO SHORT; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced needle too short. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and needle too short was not reported. This report was non-serious. The case was associated with a product quality complaint number. The suspected product quality complaint has been confirmed to be this complaint does not describe a product quality issue. therefore, it will be forwarded to pqv management for review for void approval. based on the PQC evaluation/investigation performed.
High blood pressure 150/107  high consistent; Hand and arm rash with lesion; Hand and arm rash with lesion; Chest pain; Headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old patient of an unspecified gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ed7533) in the left arm, at single dose, on 24Apr2021, at 02:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Relevant medical history and concomitant medications were unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. On 24Apr2021, at 23:00, the patient experienced headache, chest pain, hand and arm rash and lesions and high blood pressure 150/107, high consistent. No treatment was received. The patient did not recover from the events at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Information has been received from a health care professional concerning a 43 year old black female pt who on 8/3/98 was vaccinated with the 1st dose of Hep-B vaccine recombinant. That same day, she developed a headache "which lasted for 3 days". The pt sought unspecified medical attention. On 9/25/1998, the pt received the 2nd dose and "again developed another headache which lasted until the following day". On 2/5/99, the pt was vaccinated with the third dose and that same day she "developed a minor headache". On 2/7/99, she developed a "major headache". Subsequently, the pt recovered. No further information is available.
A report has been received from a Health Professional concerning a 6 year old, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on an unknown date. The nurse reported, that they administered expired FLUMIST QUARDIVALENT which started on 14-Jan-2014. The outcome of the event of administered expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious by the reporter. Corrected report on 22-Jan-2014: Case was suppressed.
Bleeding from the left arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site) in a 49-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On an unknown date, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site). On 22-Sep-2023, VACCINATION SITE HAEMORRHAGE (Bleeding from the left arm at the injection site) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient was bleeding a little in the arm. Not bleeding currently, He also received his flu shot today.  No treatment information was reported.   This case was linked to MOD-2022-693251, MOD-2021-066255 (Patient Link).   Reporter did not allow further contact
Family reported today 3/17/2021 that patient passed away 3/12/2021, they did not indicate that it had anything to do with the vaccination or give medical history.
Patient with diagnosis of Chicken Pox (varicella) on 03/14/2005. Pt had diffuse vesicles and crusted papules.
She developed headache a few minutes after Vaccine administration.  After her 15 minutes she left and went to her office. within 15 minutes after being in her office, she reported that she was having chest pain, swollen tongue, and not feeling well.  I checked her throat and she said she has had this kind of reaction in past and doctors have not found out the reason to her reactions.  She said she was told she is showing some symptoms of pre-development of Lupus.  She has not done Allergen's testing for food or environmental factors due to Insurance not paying for it.  Her blood pressure and pulse were taken a few times as follows and she was gradually getting better until 4:13 pm where she felt normal again.  She said her chest felt better, fogginess was almost gone, her throat felt normal, and her headache was less.   3:44 pm, Blood pressure:  157/97, Pulse 82. 3:47 pm, Blood pressure:  149/92, Pulse 78 4:00 pm, 150/104, Pulse 73  (she was talking to me while her blood pressure being taken) 4:05 pm, 149/96, Pulse 71; 4:13 pm:  150/95,  Pulse 72  She felt okay at the last vitals being taken and I asked her to call us again if her symptoms get worse.
A non-serious spontaneous report of FluMist administration to a child on aspirin has been received from a physician concerning a child subsequent to FluMist. On unknown date, FluMist was given to a child on chronic aspirin therapy. The patient's medical history was not reported. On 21-Sep-2009, the reporter confirmed there were no adverse events after FluMist administration. There was not adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with the post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.   All follow-up attempts have been made per company SOPs.  No additional information available.