chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A medication error occurred.  The patient was administered 0.8 cc of the Pfizer Vaccine.  The patient was notified.  The patient denied experiencing any adverse reactions 30 minutes post vaccination and again 3.5 hours post vaccination.
Within 2 weeks started with hearing loss. Resulted in hearing aides bilaterally which helped initially. Hearing continued to decline with multiple adjustments made to hearing aides until complete loss in left ear and only about 18% in right with hearing aide. Ultimately resulted in bilateral cochlear implants.
well i hope it works. but right after i got the 3rd shot  i got COVID; well i hope it works. but right after i got the 3rd shot  i got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "well i hope it works. but right after i got the 3rd shot  i got COVID".  The patient wanted to know what makes the Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines. He wanted to be as specific as possible. The patient wanted to know why he got COVID right after 3rd shot.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient visibly nervous about getting vaccine. No issue at time of injection. After about 3 minutes developed sweats (patient attributes potentially to nervousness) and tingling/numbness in extremities. Assessment of patient did not warrant epinephrine administration or contact EMS. Advised patient may take benadryl/acetaminophen. Contact MD if symptoms are not resolving.
He reports he was unable to sleep the evening of immunization. Symptoms include fatigued, restless, legs restless. All complaints resolved as of 21 July 2010.
PATIENT PASSED OUT 5 MINUTES AFTER VACCINE ADMINISTRATION.  PATIENT WAS SITTING ON THE PHONE WITH HER MOM- FELT DIZZY AND STOOD UP TO WALK TO FRONT OF PHARMACY.  PASSED OUT IN FRONT OF PHARMACY INTO DISPLAY AND CUT FOREHEAD
Dizziness and faintness, sinking feeling immediately after, tiredness, body aches, chills in the first few days, then extreme tiredness, body aches, a warm, sickly feeling in chest, throat and head, nausea and difficulty eating, mild fever, poor sleep in this past week
pt fainted p/the 5th inj loss of consciousness for 10-15 seconds;pt was choking for about 3 seconds;no eye rolling or stiffness noted;regained consciousness then loss consciousness again for 10 seconds;pt was pale & diaphoretic;pt felt weak
Coughing; She was dizzy; She experienced a rapid heart beat; She experienced weakness of both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (She experienced weakness of both legs), COUGH (Coughing), DIZZINESS (She was dizzy) and TACHYCARDIA (She experienced a rapid heart beat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (She experienced weakness of both legs). On 05-Mar-2021, the patient experienced COUGH (Coughing), DIZZINESS (She was dizzy) and TACHYCARDIA (She experienced a rapid heart beat). At the time of the report, MUSCULAR WEAKNESS (She experienced weakness of both legs), COUGH (Coughing), DIZZINESS (She was dizzy) and TACHYCARDIA (She experienced a rapid heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported.
6/10 chest pain and pangs around 36 hours after 2nd Pfizer dose (Saturday night). Shortness of breath, potential heart flutterings, and chest pain that comes and goes. Intensified around midnight. Sunday, increased around noon.  Decided to get checked out at ER.   Doctor said no evidence of a blood clot, and diagnosed me with ******"costochondritis"******   has not gone away, although slowly subsided by day 4. I still have shortness of breath, inability to breathe deeply, bend over. Got intense saturday night but is mild now.
I was diagnosed with Dysautonomia a few years ago and feel that my condition has been exacerbated since receiving the 4th dose of the vaccine. On (12/13, 12/14, 12/16) I experience high blood pressure; rapid heartrate and extreme shivering to the point that I can't even talk. After my episode is over I feel tired; hypertensive and fatigued for a few days. There is currently no treatment but will be following up with my physician.
patient is tired all the time now; experienced itchiness/itchiness started all over again; whole body redness (arms, legs, neck, and his left cheek); This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder soreness (pre existing condition) and neck pain (pre existing condition). Previously administered products included Zostavax (On an unknown date patient received Zostavax) and Covid Vaccine and Boosters (On an unknown date patient received Covid vaccine and Boosters). Concurrent medical conditions included drug allergy.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a day after receiving Shingrix, the patient experienced pruritus and redness generalised. On an unknown date, the patient experienced tired all the time. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and tired all the time were not recovered/not resolved and the outcome of the redness generalised was recovered/resolved.   It was unknown if the reporter considered the pruritus, redness generalised and tired all the time to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comments: The reporter was the daughter of the patient. The reporter stated that the patient had received his first dose of Shingrix 2 weeks ago. He had received the injection in his left arm. About 8-9 hours after the injection, the patient had experienced itchiness, and the next day he had whole body redness (arms, legs, neck, and his left cheek). The patient had took Benadryl to alleviate symptoms, and the symptoms resolved. However, the patient woke up this morning and the itchiness had started all over again. The reporter stated that the patient was tired all the time now too. The reporter had given consent to follow up with Healthcare Professional (HCP) (pharmacy)
12/17/2021 Around 4:15pm I got a headache and was red/flushed on face and chest. Also, my lips were a little swollen and puffy. 12/18/2021 I had a headache, joint and muscle soreness, nausea, no vomiting, but fatigue. Toward the end of the day fever and chills. 12/19/2021 I had a headache, fatigue no joint pain. In the evening I started getting chest pain. 12/20/2021 Chest pain and tightness continued; 12/21/2021 Chest pain got worse.
pt recvd vax 25FEB94 states around 7PM that evening pt started crying/screaming for about 5 hrs; would go to sleep & awake @ intervals crying/screaming; t102.9;
Fever, chills and body aches. Pain in the arm where the shot was given. Aleve and tylenol taken and was relieved.  Occured 12 hrs after shot and lasted  24hrs.
On 9/8/99, the pt experienced a mosquito bite on her left forearm which swelled to 3/4 the circumference of her forearm. The bite was red and hot to the touch. After the bug bite, the pt experienced joint aches and Bell's palsy-like symptoms which left the pt's eyelids swollen, slightly itchy, and at times impairs her vision. Additionally, the pt noted a gurgling sound in her left ear and she noticed that her skin color was shallow. The pt reported that the inflammation has subsided but she noticed that the injection site is still tender to the touch. The pt noted normally react to mosquito bites but never to this extent before.
At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.
Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Patient experienced swelling of lymph nodes, severe headaches, a reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that bum and itch very badly, hot flashes, and insomnia.; Skin rash; breakouts of hives from head to toe that bum and itch very badly; bum and itch very badly, hot flashes, and insomnia.; bum and itch very badly, hot flashes, and insomnia.; This spontaneous report was received from a consumer, referring herself, a female patient of unknown age. The patient's historical conditions, medical history, concurrent conditions, drug reactions or allergies were not reported. It was reported that the patient used a concomitant medication mentioned as: "birth control".   On 23-DEC-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.   On 24-FEB-2019, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  On 03-JUL-2019, the patient was vaccinated with the final and third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for cervical cancer (route of administration reported as "injection') (dose, strength, lot number and expiration date were not reported.  It was reported that "some time shortly after 03-JUL-2019, the patient experienced swelling of lymph nodes, severe headaches and reoccurring skin rash that gets way worse in the sun, breakouts of hives from head to toe that burn and itch very badly, hot flashes and insomnia. It was reported that a biopsy of lymph nodes was performed, and the result was not provided. At the time of this report, the patient was still not recovered from the events. The patient visited "multiple physicians".   At the time of this report, the causality assessment between of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events, was not reported.
dyslexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSLEXIA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller mentioned that she took the Pfizer COVID19 vaccine last year. The caller said that she was negative now and that she will go to her sister-in-law's birthday party. The caller would like to know if she can get the vaccine, and she wants to know if the vaccine was effective. caller said that she had dyslexia and that she took the Pfizer vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1975 pt vax; failed to induce antibodies.  Recv 2nd dose on 15May90 & devel induration & fever (WAES90051288).
Tear in the eye; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Tear in the eye) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced LACRIMATION INCREASED (Tear in the eye). At the time of the report, LACRIMATION INCREASED (Tear in the eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: TCR report where the patient denied further calling.
Started with weakness and clumsiness in R arm.  Progressed to loss of use of arms and legs.  Neurology says "GBS symptoms, possibly vaccine related".  Currently being treated with IVIG.
Fever, tachycardia, dyspnea, fatigue, orthopnea, headache, chest pain. Current working diagnosis weeks later: pericarditis. Management is still ongoing.  Initially meds were reduced, later patient's chest pain and dyspnea sent her to the ED.  Notes available for review if ok'd from patient.
Fever, chills, headache - 13 hours after injection and continuing  for 48 hours Fatigue - 13 hours after injection and continuing for 72 hours Nausea - 25 hours after injection and continuing for  33 hours Injection site reactions:  pain, tenderness, swelling, hot to the touch - 8 hours after injection and continuing  (75 hours to this reporting)
Patient needed to repeat the Hep B series with adult dosing as her titers showed she did not have immunity. A pediatric dose was given in error instead of the adult dose needed.
Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient's death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen.
Arm was sore and red for two day following vaccine. Got better and now today is day 8 and arm is sore again and red, warm to touch. I also I have a headache.
pt recvd 1st MMR vax in 1988 & was revaxed on 18MAR91; On 30MAR91, pt was dx w/measles; spots were identified as koplik's spots; no further details were provided;
PT PASSED OUT FOR LESS THAN 20 SECONDS, EMS CAME. NOT TREATMENT RECOMMENDED BY THE EMS
Patient received an undiluted pfizer vaccine (6 times the dosage).   Patient reported no adverse side effects after  24 hours
Cold hands at 1700 pm same day of vaccine, chills, by 3 am  (Jan 20,2021)severe aches/pain in joints, difficulty moving arms and legs,  Neuropathic -like pain, pins. needles with burning sensations.  Aching throughout body, headache.  Extremely fatigued, slept for hours.  All came on quite suddenly. Every joint in body hurt.  Jan 21st, runny nose, stomach ache mid morning.  Mild aching, still with headache.
Started having sharp pain in right flank area and shortness of breath on 11-28-2021. Went to doctor on 11-30-2022,  CT done on 11-30-022 which showed bilateral pulmonary emboli. Admitted to Medical Center overnight. Discharge on 12-1-2021 with Eliquis. Takes Eliquis 5mg twice daily now. No longer on birth control pills.
No reactions occurred. Vaccine administered on 5-4-22, however due to it being kept in fridge it should have expired on 4-8-22, therefore pt received expired vaccine.
Patient said she felt ill upon getting the flu shot last 8/4/16. She said she has itching all over her body (no rash) and itchy eyes. She also said she felt tired in the evening, off balance, dizziness. She went to the doctor on 8/5/16 and doctor gave her CLARITIN 10 mg and ZADITOR eye drops. She said she felt better now.
24 hours after getting flu shot left arm starting itching and sore like a bruise, NKA, on 1 med Hypertension Zelnorm, and another med Enalapril. No SOB, no rash/hives. 4x2 cm red raised tender to touch left deltoid.
54 y.o. male, immunized with Td booster upon beginning employment at hospital in 11/2004. Suffered finger laceration at work on 5/3/2005. Was given another Td booster. Pt c/o marked pain, with mild swelling, and fever and chills beginning about 1 day after vaccine administration, and continuing until today. Mild relief with OTC ibuprofen x 2 tablets yesterday. No facial/oral swelling, no SOB/cough, no distal swelling, no arthralgias/rash. On exam, no lymphadenopathy anywhere. Mild bogginess with mild erythema and tenderness to injection site left medial deltoid.
Patient with history of asthma and recurrent respiratory infections requested a Fluvirin and Pneumovax immunization. Patient had no known allergies and no prior pneumococcal immunization. Patient was vaccinated by standing order and SOP in opposing arms.  A 0.5ml dose of Pneumovax was given SC in the right lateral arm. Patient 48 hours later developed a large erythematous patch around the Pneumovax injection site along with myaglia, chills, malaise, low grade fever and asthma exacerbation. Patient went to her physicians assistant and was given a Medrol dose pack for the allergic reaction and albuterol inhaler for her asthma symptoms.  Currently taking Medrol dose pack.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX, (lot #s N012134 expiry date 17-APR-2019, N000682 expiry date 06-JAN-2019, N012486 expiry date 20-APR-2019, and M045204 expiry date 11-NOV-2018) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date, the VARIVAX vaccines were stored with a temperature excursion of 15°F to 46°F during 40 hours (incorrect product storage). The sterile diluent (STERILE DILUENT) did not undergo any temperature excursions. No adverse effects reported. The medical assistant was call because of a data logger. The outcome of incorrect product storage and no adverse event was unknown. Additional information is not expected as no information to obtain follow-up was provided.
Patient had received a 3rd dose; 1st dose Oct2020, 2nd dose Sep2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose had been administered in October 2020).  On 01-MAY-2023, the patient received the 3rd dose of Shingrix. In SEP-2021, the patient received the 2nd dose of Shingrix. In SEP-2021, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Oct2020, 2nd dose Sep2021). On 01-MAY-2023, the patient experienced extra dose administered (Verbatim: Patient had received a 3rd dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional Information: GSK Receipt Date: 03-MAY-2023 A pharmacist called to inform that a patient had received a third dose of Shingrix. According to the reporter, the patient had already received two doses of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. At the time of reporting, the patient had received the third dose of Shingrix vaccine, which had led to extra dose administered. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Rash on her chest; Mild headache; A spontaneous report was received from a consumer concerning a female patient of unknown age who experienced a headache and rash on chest/rash.    The patient's medical history included viral infections and allergic reaction to flu vaccine. Concomitant product use was not provided by the reporter.   On 08JAN2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Beginning on 09JAN2021, the patient experienced a headache.  On 10JAN2021 the patient developed a rash on her chest.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, headache and rash on chest were unknown.; Reporter'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.
Patient reports on 1/13/2020 at 1130pm she awoke from her sleep in severe left arm pain. She could not raise her left arm. She then noted on Wednesday 1/15/2020 her arm was able to raise and move better but she noted a rash all over her torso from her neck to bottom of back and it was "like severe sunburn" she went to emergency room and was given oral Benadryl After she took Benadryl orally her rash had resolved and she was able to return to work on 1/16/2020 with no further concerns. Today she reported as of 1/16/2020 her symptoms had resolved.
Ten days started having bleeding gums with mouth sores. Saw doctor and was given chlorhexidine gluconate oral rinse, but the rinse only made sores worse. Gums are still too sore to wear partial.
Peri-rectal abscess that required surgery. Pain in the anal area that prevented sitting, walking and lasted 2.5 days (until surgery)
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 23-MAY-2013 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J000783, expiration date: 30-APR-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.