chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/20/21  he is a nurse and works in the emergency room at Hospital downtown.  He comes in today because he has had a cough for 2 days.  Overall otherwise feels well.  No headache no fever chills, no nausea vomiting diarrhea, no myalgia, little to no rhinorrhea.  He has been immunized against coronavirus.  Presently not taking anything for his symptoms.  He has a 4-month and a 2-year-old home and wanted to be checked especially because of concern for them. Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Positive for sore throat (Seems to be more from his coughing than actually having a sore throat per patient). Negative for rhinorrhea (Very mild) and voice change.    12/20/21     Respiratory: Positive for cough. Negative for shortness of breath and wheezing.   Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Musculoskeletal: Negative for myalgias.  Neurological: Negative for headaches.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/18/2021 and 4/7/2021. Patient admitted to hospital on 1/2/2022 with complaints of worsening dyspnea. Patient received dexamethasone, remdesivir, enoxaparin, and antibiotics. On 1/4/2021, patient was transferred to hospital. Patient developed agonal breathing and required mechanical ventilation and vasopressor support. Patient expired on 1/5/2022 at 1325.
Induration and swelling R thigh where received Hib and Prevnar 2 mo immunizations
INJESTION SITE UPPER LEFT ARM- HIVES RAISED TO .25 INCH TALL X 3.0 INCHES LONG X 1.0 INCH WIDE. CHIN - SHOWS TO HAVE TWO OCCURENCES OF RED RAISED AREAS WITH ONE WHITE BLISTER LIKE SPOT IN EACH OCCURENCE. LOCATED UNDER BOTTOM LIP CENTER OF CHIN.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient and pharmacist both were standing while receiving the shot. The patient experienced pain and soreness at the injection site which lasted for 24 hours. For tolerance after 2nd dose of SHINGRIX, refer case US2018176482.
Patient on 12-23-22  evening, had a 5 second chest pain episode (Familial history of similar event).  Described as very sharp pain, like being stabbed in the heart. Patient following up with prescriber to discuss event on regular check up within 7 days of this report.
Night of shot- upper arm painful, tight feeling as if encircled with a band, extreme thirst, headache, sleepless.  Next day - upper arm in area of shot had a reddish rash, arm painful, very tight feeling, headache.  Second day - upper arm bright red, very hot, painful and swollen as if filled with liquid.  Third day - redness, swelling as if filled with liquid, and hot down to mid-forearm, entire arm painful.   Fourth day -  same as third day.  Fifth day - swelling and redness started to subside, upper arm still tight and painful.  By the end of a week swelling and redness subsided, upper arm still tight and tender.  Based on advice from the pharmacist I had taken Benadryl and Advil several times early in the week, did not seem to be having any effect so I quit taking them.  My right upper arm muscle still seems slightly sore, other than that I feel fine.  I had had bronchitis and a slight touch of pneumonia according to an x-ray in May of this year which prompted me to get the pneumonia shot this fall.
On 01/19/05, I noticed red bumps covering my back and chest, around 25 or 30 of them.
mouth sores and swelling of tongue, gums, neck. redness on neck and upper chest. bleeding and soreness of gums. pain of tongue.
Left deltoid, redness, warm to touch, no swelling or fever, T-97.0, vomiting, less active, Referred to MD, MD gave RX. Phergan supp 12.5 mg, Suprex & Pedialyte.
Acute appendicitis; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EH9899), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient received the vaccine in a hospital. The patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced acute appendicitis which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had appendectomy as treatment. The patient had no other vaccine in four weeks, no Covid prior vaccination and was not Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event appendicitis is likely an intercurrent medical condition and unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
After receiving the injection, I moved my right arm around.  While driving home I noticed that my right wrist began hurting a great deal.  I made an appointment with my orthopedic physician.  I was examined by him and he said the pain was as a result of receiving the Moderna Injection. Through recent months since receiving the Moderna injection, i have pain in the right wrist from time-to-time. Presently I am having  slight pain in the right wrist.
The patient was requesting to receive 1 dose of MMR and 1 dose of Hepatitis B vaccines. I drew up both vaccines and administered the MMR in the left deltoid IM instead of subcutaneously. I then gave the Hepatitis B in the right deltoid IM. No adverse outcome occurred. I realized after the patient had left as I was charting the vaccine administration. I immediately called my direct supervisor and our regional supervisor. I then contacted the patient with the information. The patient was very understanding.
Severe headache, minor chills and body aches.  Took ibuprofen and tylenol every 6 hours.
shortness of breath and chest tightness experienced on evening of 7/25 and took multiple hours to resolve; another case of shortness of breath and chest tightness occurred on 7/28 evening; patient also had headache and muscle pains
The Pfizer vaccine was kept in the refrigerator past the date of removal/expiration. The patient was notified about the expired dose given, had no signs of an actual adverse reaction to the vaccine, and did not want to receive an additional booster. The patient requested antibody testing to test the efficacy of the dose given.
cataplexy attacks; hallucinatory dreams; sleep paralysis; extreme tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003551.  A female patient received BNT162b2 (BNT162B2), on 19Sep2022 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: CATAPLEXY (medically significant), outcome "unknown", described as "cataplexy attacks"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "hallucinatory dreams"; SLEEP PARALYSIS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness". Clinical course: It was reported that the patient started treatment with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported the patient had 5 days of cataplexy attacks, hallucinatory dreams, sleep paralysis, and extreme tiredness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
expected symptoms started at 24 hours: vague abdominal cramping, nausea, diarrhea, fatigue. and continued for 72 hours, then progressed to chills, sweats, intractable vomiting, severe abdominal pain and severe diarrhea.  Visit to clinic required - IV fluids. Technical problem getting laboratory evaluation so return visit tomorrow if still symptomatic.  Currently improved, but still with abdominal cramping and diarrhea.
Chest pain and tighness, generalized with stabbing pain intermittently elevated blood pressure 180/95
PT states active lymphoma, sees Doctor. Did not discuss vaccine with PCP. Received verbal permission from Pt to contact D=providers. TC to Doctor's office, spoke with nurse, who states, spoke with Doctor who gave permission to vaccinate. 14:22 - After vaccination patient stood and stated he felt dizzy. Mentioned has a history of anxiety with vaccination. Rested while seated. After 5 minutes, c/o nausea, denies SOB, urticaria, or other SX anaphylaxis. Escorted via WC to first aid area. 14:33 VS: BP- 162/78 P 56 O2 Sat 98%. Provided rest / H2O. 14:45 - States SX resolved. VS - BP 164/72P - 52, O2 Sat 97%. Escorted to driver @ 15:00.
Recurrence of COVID symptoms, along with positive antigen test; Recurrence of COVID symptoms, along with positive antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: 16Mar2021, stop date: 20Apr2022. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 12:00, outcome "not recovered" and all described as "Recurrence of COVID symptoms, along with positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Other medication in 2weeks. Anti-viral details included that Product was COVID 19 Treatment, brand Pfizer, treatment start date 20Apr2022, treatment stop date 24Apr2022. Patient had not received any other vaccine in four weeks. Patient had received Paxlovid as a treatment medication. patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HIB and Prevnar given in right leg. Leg swollen and red. Baby inconsolable crying.
At approx 5 PM client experienced faint/dizziness, was eased to a waiting room chair, where she was treated: VS taken. 94/50 P-66 R- 20, skin was pale and clammy, provided cold wash cloth and crackers and juice, she admitted to not having eaten that day, within 5-10min she felt OK.
Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed deep vein thrombosis and pulmonary emboli.    The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Jan 2021, approximately 3 weeks prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient reported she was hospitalized for deep vein thrombosis and pulmonary emboli. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, deep vein thrombosis and pulmonary emboli, were considered unknown.; Reporter's Comments: This case concerns a 64-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of Deep vein thrombosis and pulmonary embolism. The events occurred 22 days after the first dose of mRNA-1273 (Lot number: 037K20A) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Additional information has been requested for further assessment.
few hrs p/vax pt had swelling @ shoulder & inject site; c/o pain, aching & redness; no temp; called MD & rx w/APAP w/Codeine but no pain relief; 2 hrs later went to ER & recvd pain med inject & blood work; dx w/infect;
pt recv vax; maculopapular rash gen; mild fever; T 100.5;
Shingrix series completed, get shingles/Suspected vaccination failure; Shingles; Rash; PHN; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles, rash and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and post herpetic neuralgia to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter inquired about after a series of Shingrix had been completed, the patient get shingles. The patient asked that it was possible for the actual rash could look different since the patient was vaccinated as opposed to a non-vaccinated patient. There patient also asked that there was any outcomes data that show the actual reduction of post herpetic neuralgia if vaccinated with Shingrix. Due to medical information guideline, this adverse event was reported even when another GlaxoSmithKline representative was first to hear around them. The reporter consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
pt recv vax 2PM 16SEP96 & was fine through noc;8AM today daycare provider felt that pt was not feeling right-t103, fussy;pt seen by MD, t101.7, fussy, lethargic;language was dec;
After a few minutes, noticed or felt a rapid heart beat.  Waiting 15 minutes and left  the facility but still felt the rapid heartbeat for the a few hours. Had some fatigue by Wednesday. (Injection given on Sunday). Chest/heart still  felt achy  after a week.
Swelling under left eye Swelling on left eye li Swelling on left side of face
Administered booster dose of Moderna (blue top). Person should have received Moderna Bivalent booster (blue top).  No adverse event occurred.
I have had A-Fib and I seem more tired than I was before the vaccination. My heart started racing and fluttering. I went to the hospital and they said I had A-Fib. I was prescribed several medications.
Malaise, fatigue, red rash over entire abdomen, inner arms, chest and inner thighs
Woke up with very stiff neck and a lot of soreness.. 2adjustments by a Chiropractor  Exrays to check for abnormalities Currently rehabbing with physical rehab  Started neck rotation at 35* to the right and left. Currently improved to 45* with a goal of 60*.
Arm is tight where they got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm is tight where they got the shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE INDURATION (Arm is tight where they got the shot). At the time of the report, VACCINATION SITE INDURATION (Arm is tight where they got the shot) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-369479, MOD-2021-369499 (Patient Link).
inconsolable crying for 3 1/2 hours, treated with infant Tylenol
Headache, joint pain, nausea, mild fever, moderate to severe pain in lymph nodes on right side of body, including underarm into breast, clavicle, and down right side of ribs, right side of groin, right side of upper back, and right arm down to wrist area.  Underarm/clavicle lymph node pain is most severe.
Pain, redness and swelling of the left deltoid. Physician advised pt to treat with ice and BENADRYL.
36 cm sore, pruritic, erythematous rash and swelling starting at injection site on left upper arm x 5 days, resolving slowly.
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and with a dose of PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported) (both vaccines were administered on the same day). Since the day of vaccines administration (unknown date), the patient felt a little sick for a week. The patient did not seek medical attention. The outcome of the event was unknown at the time of the report. The relatedness between the aforementioned event and the vaccination with PNEUMOVAX 23 and PREVNAR 13 was not assessed. Additional information has been requested.
Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021; No adverse event; Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021), PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021), PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021) and PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021).    No concomitant drug was reported. Vial size was reported as 5.5 ml. The vial did not undergo any temperature excursions. No treatment drug was reported.
Two hours post vax, the pt experienced intense injection site pain that radiated down her arm to her hand, and the pt returned to the physician's office. The pain worsened and the fingers of her left hand began to tingle. Her left hand became numb. After 12 hours, she experienced a deep aching muscle pain that extended from her shoulder to her wrist. Treatment included codeine. After 2 days the numbness and tingling resolved and the pain was slowly getting better, if she avoided sleeping on her arm. On 5/16/00, the pt was seen for follow-up and it was noted she had atrophy of the left deltoid and heat and a circular swell like smallpox vaccine leaves after injection.
The day following the Moderna  injection with severe headache and sensitivity to light which lasted for 3 days. then followed by low level confusion and forgetfulness, loosing words during conversation until 2/23/2021 when had grand mal seizure. I have a history of epilepsy since 13 yrs old and had been seizure free for 8+ years until 2/23/2021. Since that seizure with continued forgetfulness , foggy feeling in head, and eye fluttering. Seen by epilepsy specialist on 4/12 and was admitted to hospital for video EEG and MRI and found to have significant both focal and generalized seizure activity despite my usual anti-seizure medications that had been working for 14 years. My medications were changed and I was discharge home after 6 days.
Felt a little achy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) and FATIGUE (Extremely tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Prophylaxis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Felt a little achy) and FATIGUE (Extremely tired). On 16-Mar-2021, PAIN (Felt a little achy) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-390023 (Patient Link).