chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effects including headaches, muscle aches, fever/chills, which lasted 2 days. On 4/19, he presented to the ED with 2 days of R sided pleuritic chest pain, dyspnea, and was diagnosed with PE based on CTA. He was started on treatment with apixaban and his symptoms of pleuritic pain and dyspnea have resolved.
Pt returned on 10/03/2014 with right arm hot, red and swollen.
Upper Right Abdomen Pain, occasionally radiating to the back. No outcome, taking a watch and wait approach if symptoms worsen
got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactable consumer nurse assistant (patient).   A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EH9899) at single dose on 28Dec2020 for covid-19 immunisation, administered at the hospital she worked at.  Medical history included cholesterol. The patient reported taking unspecified concomitant medications. The patient got lightness in my head, had been dizzy and experienced headache in Dec2020. No treatment received. The outcome of events was unknown.
L arm SQ swelling, redness, hot to touch measured 5in x 5in
Skin rash,head and nerve pain back of head severe, bells palsey 3 days later
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient of an unknown age who was received vaccine FLUBLOK QIV (batch number, expiry date, dose, route and site of administration were unknown) on an unspecified date, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 9 months pregnant when she received vaccine. It was unknown whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Medical history and concomitant medications were not provided.  On or about 10-OCT-2912, the patient was vaccinated with ZOSTAVAX at a pharmacy as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 07-JUL-2016, the patient was treated at a Family Practice for a rash that was diagnosed as shingles.  He was prescribed valacyclovir to manage his symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome was unknown. Additional information has been requested.
Patient received wrong vaccine. Patient received a Moderna vaccine as a first dose but was accidently given Pfizer as a second dose
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 12-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Information has been received from a registered nurse concerning a 1st grade elementary school male student who on 04/29/1998 was vaccinated with a dose of varicella virus vaccine live.  In mid December 2004 the student developed chickenpox.  According to the school nurse, there were 58 other students who developed chickenpox in mid December 2004 and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live.  Unspecified medical attention was sought.  There was no information regarding the present status of the first grade student.  No product quality complaint was involved.  Additional information has been requested.
Pt received both doses of the Pfizer COVID vaccine, on 1/21/2021 and 2/11/2021.  Pt then had unspecified symptoms of covid and was tested via clinic on 7/24/2021.  Pt hasn't needed additional medical care at this time.
near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; chronic pelvic pain; prostatitis; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; He stated that he received 3 doses of Gardasil/Caller confirmed multiple times, and was adamant, that he received GARDASIL and not GARDASIL 9; This spontaneous report was received from 38 years old male patient, who was referring to himself. The patient's medical history included heart attack 10 years ago. His concomitant therapies included levofloxacin, cipro and other unspecified medications. His drug reactions/allergies included corticosteroids.    On 20-OCT-2020, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis (product administered to patient of inappropriate age). The patient confirmed multiple times, and was adamant, that he received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and not HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On 25-NOV-2020, he received zoster vaccine live (ZOSTAVAX) lot # S039272 was confirmed to be valid, expiration date was reported as 20-JUN-2021, but upon internal validation was established as 30-JUN-2021 for indication of vaccination. Exact dose, anatomical location and route of administration were not reported for both vaccines.  Near the end of December 2020, the patient experienced urethra burning and testicular pain during ejaculation. His physician initially thought he had prostatitis but currently believes that he has had chronic pelvic pain.  On 29-DEC-2020, he was vaccinated with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis. On 29-APR-2021, the patient was vaccinated with a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T030356, expiration date was reported as September 2022 and upon internal validation was established 30-SEP-2022 for prophylaxis. Exact dose, anatomical location and route of administration were not reported for both vaccines.  On an unknown date, the patient sought medical attention and received treatment: antibiotics and anti-inflammatory medication but continued to have symptoms. Also on an unknown date, Magnetic Resonance Imaging (MRI) of prostate and pelvis area, tests of urine and semen and tests for sexual disease were performed - all test were negative. The outcome of the events was reported as not recovered/not resolved.   The causality assessment between the events and the suspect therapy was not provided.
Right thigh red and swollen area 16 cm x9.5cm, pt told by Dr to use ice and Benadryl
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Pregnancy is current condition).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Sep-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis and LIQUID PEDVAXHIB lot#R005116, expiration date 28-NOV-2020, lot#R004963, expiration date 21-NOV-2020 (dose and route of administration were not reported). There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636, US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636.
Client has fever of 102, body aches, swelling of Rt. arm increasing diameter of Rt. upper arm  approx 2 inches, erythema only to Rt. upper arm, and decrease limb mobility.  Client saw her Dr. on the afternoon of 10-10-14 to have him check for allergic reaction. No treatment given.  Client recovered with mild tenderness to Rt. arm on 10-14-14.
Flu-like symptoms began 8 hours after vaccination. Chills and body aches and lasted until 28 hours after vaccination
Developed heart arrythmia which worsened over the month and was hospitalized end of march with PVC, PACs and non sustained run of ventricular tachycardia.
Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.
Arm, face & neck w/ sl erythematous/edematous plaques & papules;
Pain in my hole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in my hole body) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in my hole body) and PYREXIA (Fever). At the time of the report, PAIN (Pain in my hole body) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication was  reported.   A nurse advised patient to take paracetamol in case of fever and pain. It was unknown if the patient took the medication.
Vaccine was on a thursday migraine level  headache that started about 4 hours after the vaccine followed by extreme vertigo for 12 hours where i could not move my head  with out nausea and vomiting  then it started to improve but lasted moderately throughout the next day ( friday) Fever total body pain - like sever flu symptoms, fatigue etc the injection site was very red and hot for 10 days and remains slightly itchy. Headache and fatigue did not resolve until late sunday night and virtigo was resolved 100% sunday am
8AUG94 approx 315PM pt sent to occup hlth to recvd vax & repeat PPD; pt was fine the remainder of the day 9AUG94 woke up 8AM & states had difficulty moving legs; seen in ER was xrayed & given something for pain & swelling; dx serum sickness
Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a head cold. Some chills etc. by the time I went to work right side hearing was severely affected with what sounded like phase shifter in my head. No relief through weekend, too dangerous to work due to my job in a busy kitchen. Saw my Dr. on Tuesday 04/13. Treated as an ear infection. 3 day steroid with nasal spray. No relief. By now the ringing, whooshing, roaring and chirping in my right side are extremely disorienting! Started antibiotics on 04/15 with wait and see effectiveness.  Today is 04/16 at 10:15am. To date no relief of symptoms.
Patient developed paresthesias and progressive weakness 1-2 weeks after vaccination. Was hospitalized and had neuro consult. MRI Brain neg but lumbar puncture revealed elevated protein level consistent with Guillan-Barre Syndrome.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on Monday and still having fever (101 degree F).
Within a couple of days of receiving vaccine, developed dyspnea and palpitations. Stress test negative for ischemia (3/20/21). Event recorder started 3/19/21 - reported long episodes of supra-ventricular tachycardia.  Covid-19 positive on 12/16/20 and received monoclonal antibodies. Did well, then received first dose of Covid-19 vaccine on 3/4/21. (Received the vaccine a few days earlier than the recommended 90 days following monoclonal antibody treatment, due to potential loss of vaccine supply)
massive heart attack; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "massive heart attack". The patient died a few weeks after receiving COVID vaccine from massive heart attack. The patient date of death was unknown. Reported cause of death: "massive heart attack". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: massive heart attack
Around 7pm on 3/13/21 I went to use the restroom to urinate when I felt a severe pain that felt like my bladder and uterus wanted to fall out. I could hardly stand to get help. I took Ibuprofen to try to relieve the pain so I could care for my injured toddler. The severe pain lasted most of the night with little relief. In the morning I went to the emergency room where they ran labs and did a CT scan. I had slightly elevated white blood cells and the CT scan showed a possible appendicitis. The appendix wasn?t presenting with the normal signs of appendicitis but it was inflamed. I had surgery to remove my appendix that evening at 9pm 3/14/22. The resident surgeon mentioned she believes the vaccine was causing appendicitis in some patients but at that time there was little information on this. Now it has been listed as an adverse side effect and I believe this is what caused mine. I?ve had reactions such as lip and tongue swelling/ tingling, brain fog and vertigo after my 1st and 3rd Pfizer vaccines. I had the normal side effects such as sore arm, swollen lymph nodes and fatigue from each dose of vaccine as well.
Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Pimple-like rash; Anxiety; Felt a little odd; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma from 1993 to an unspecified date (diagnosed when she was 5). Concomitant medication included tetanus vaccine (Lot number: U6830A; Expiration date: 17Sep2022) on 06Jan2021. On 20Jan2021 (15:00), the patient had reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot. In Jan2021, the patient had pimple-like rash; anxiety; and had felt a little odd. The patient had received diphenhydramine (BENADRYL) as treatment for the events, 'reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot' and 'pimple-like rash'. The outcome of the events was unknown.
the needle would not fully go into the patient's muscle due to minimal muscle mass (patient was very thin ) and toughness of the tissue .  therefore , I took the needle out without injecting any vaccine component and prepared a new syringe/dose , then I successfully injected the patient with a dose the second time.
VERY PAINFUL INJECTION SITE, BRUISED, NUMBNESS IN ARM AND TINGLING DOWN TO FINGERS. BLEED A LOT AFTER THE SHOT.
CHILD RECEIVED ADULT DOSE 0.5 ML OF FLUZONE MULTI-DOSE VACCINE.  SHOULD HAVE RECEIVED 0.25 ML.  NO ADVERSE EFFECTS KNOWN AT THIS TIME.  CONTACTED SANOFI PASTUER.  THEY STATED THAT THERE WASN'T ANYTHING THAT NEEDED TO BE DONE, AND THAT THERE SHOULDN'T BE ANY ADVERSE EFFECTS.  PARENT NOTIFIED OF INCIDENT.
Swollen neck, sore throat, ear pain beginning 2 days after vaccine.  Symptoms still present after 2 weeks. Received antibiotics and steroids.  Over 1 month after vaccination still have inflamed left sinus and feels like clogging in left ear. Went to ENT doctor and currently on stronger antibiotics and steroid.
Covid Vaccination on 14 March at 2:45 pm, left arm. Itch began 22 March evening (11:00 pm) at injection site. Swelling 23 March morning at injection site. Redness 24 March morning at injection site. Swelling and redness spread over next several days, then cleared over subsequent days.  Pacemaker on that side.
pt recv vax 11FEB96 & exp stinging sensation;pt arm was uncomfortable for 24hr;no tx was given;
the patient experienced CORONA VIRUS; the patient experienced CORONA VIRUS; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4053032-00) from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 20Jul2021 (Batch/Lot number was not reported) (age at vaccination 53 years) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free for psoriasis. Medical history included psoriasis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. In 2021, the patient experienced Corona virus. Pfizer-BioNTech COVId-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Jul2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The outcome of event was recovering. The action taken in response to the event for bnt162b2 was not applicable, for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CORONA VIRUS was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(Injection): Causality as per reporter (Drug/Vaccine): Probable.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Pt c/o bilat. arm pain, chills, achy all over and h/a. Onset at 1:00am on 10-6-10. Has just taken Ibuprofen.
red marks and a spot around the injection site; A spontaneous report was received from a 54 year old male patient, who received  Moderna's covid 19 vaccine (mRNA-1273) and experienced red mark and a spot around the injection site. They are getting bigger and bigger.   The patient has previous medical history of high blood pressure and high cholesterol. Concomitant medications were reported.    On 06 Jan 2021 prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (Batch NO:041LZ0A ) injection on left upper arm for prophylaxis of covid 19 infection.  On 17 Jan the patient experienced red marks and a spot around the injection site. They are getting bigger and bigger. Denies allergies.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  Outcome of the event, red marks and a spot around the injection site,  unknown.
This spontaneous report was received from a nurse, concerning a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 20-APR-2018, a dose of ROTATEQ was improperly stored. The temperature of excursion was reported as 9C, during a time frame of 1 hour 50 minutes. There was no previous temperature of excursion. On 26-APR-2018, the patient was vaccinated with the improperly stored ROTATEQ first dose, 1 tube orally, for prophylaxis, lot #N02200 and expiration date reported as 31-OCT-2019 (strength was not reported). There was a Digital Data Logger involved.
Swollen glands, body aches, disequilibrium , chills, sweats.
pt c/o h/a, chest congestion tx'd w/Amoxicillin, Motrin;