chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone exposure during pregnancy with no adverse event; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/non healthcare professional.  This case involves a 29 years old female pregnant patient who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [exposure during pregnancy].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 45 weeks of pregnancy and the patient was exposed to QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) at 45 weeks of pregnancy, during unknown pregnancy trimester for the vaccine.  The date of last menstrual period was reported as 26-Feb-2020.  The estimated delivery due date was 02-Oct-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Jan-2021, the patient received first dose of suspect FLUZONE QUADRIVALENT (suspension for injection, lot UT7325JA and expiration date 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
I had had problems with pain and mobility in my left shoulder since getting the second dose of my vaccine. I got the third dose in the other arm and I experienced the same pain in my right arm. The pain started at the injection site and then it spread to the top of my shoulder I went to Urgent care and they told me it was a soft tissue reaction to the shot. I was prescribed Prednisone for four days and it did improve a little. It is very sore to touch and I can't raise my arm or lift things. It is hard to reach for anything and I can't turn my arm. It even hurts to drive.  It is the top of my shoulder at the head of the Bicep. It is extremely tender to touch.
Pfizer-BioNTech COVID-19 Vaccine EUA  Itching and hives on upper arms, upper legs, and sides of torso x48 hrs thus far, controlled with oral otc Benadryl and pep I'd.
sarcoidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown". Clinical course: A reporter said that they got their Pfizer vaccine at (withheld), but they only had the Moderna for this year. So her mother and she are trying to find out where they can get the Pfizer vaccine this year, and they both had several vaccines. She mentioned her mother is diabetic, and she had sarcoidosis. They had several vaccines, their cards full front and back, because they both had the extra boosters, they wanted to continue with Pfizer and did not want to get a different brand, and they wanted to stay consistent. Provided the website for vaccine appointments.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331501 Same reporter/product, different patient/event;
Developed substernal chest pain on 1/2/22. Sought ED treatment on 1/3/22 and was diagnosed with myopericarditis.
Arm became numb; Tingling; Achy sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H0A) for an unknown indication.     The patient's past medical history included No adverse event (The patient's medical history was not provided.  ). Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, WARFARIN.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation). On 17-Feb-2021, HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Within 24 hours of injection - complained of pain, swelling - 3.5 x 4.5 cm, tender, non-erythematous. Denies CP/SOB/problems breathing or swallowing.
The patient received her COVID booster vaccine this week.  The reporter did not provide details on which vaccine she received. Since then she has been feeling under the weather and had fatigue.
Routine Influenza vaccination as requested per patient. (Extensive ecchymosis left arm) PMHx - HTN, Long Term Anticoagulation Tx for DVT/PE.
This spontaneous report was received from a medical assistance and refers to a multiple patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a GARDASIL (dose, route of administration, frequency, lot # and expiration date were not reported). Immediately, after receving a GARDASIL, while the patients were still in the office, they developed episodes of syncope, which usually lasted for about 45 minutes. No treatment was given to the patients for the event. There was no product quality complaint involved. Subsequently, the patients were fully recovered and went home. The causality between event of syncope and GARDASIL was not provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA007023.
Patient had a vasovagal episode immediately after receiving Vaccine- Janssen Lot # 1808609 injection on the Left deltoid. Vitals were taken every 15 mins 116/61, 89/48, 100/57. 12 Lead EKG taken, patient found in Sinus Brady Cardia. Patient was isolated from other patient. Focus head to toes assessment completed by doctor and EMT. 911 contacted. Paramedic and Fire Dept. Arrived on site. Patient offered to be taken to the hospital. Patient refused.
PRODUCT STORAGE ERROR; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 54 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 212A21A expiry: 20-MAY-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 18-NOV-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537532, 2005084289, 20220537548, 20220538238, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220538666, 20220537688, 20220538693, 20220540524, 20220540474, 20220538890, 20220540853, 20220540611, 20220538292, 20220538316, 20220540688, 20220540420 and 20220540570.
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling  of face/arms/chest,  and feeling like moving through water.
Started with a fever on 5/24/21.  Rash came and vomited on 5/26/21.  Entered hospital on 5/27/21 and had jaundice.  Liver numbers were sky rocketed.  Every liver number went down except for the ALT that is continuing to rise.
Fever began four days following immunization. After about three days, fever subsided and a rash appeared on my arms. Very itchy. Became severely dehydrated and kidneys were assaulted. Only treatment IV fluids, adjusting medications, and closely monitoring labs. Over four weeks later still having symptoms but they are improving.
Patient who was previously administered the 1st GARDASIL 9 dose in 2013 experienced an interruption in completing GARDASIL 9 schedule and had never received 2nd GARDASIL 9 dose.; No additional AE; This spontaneous report was received from a pharmacist and refers to a currently 25-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2013, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. The patient experienced an interruption in completing hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) schedule and had never received the second dose. The pharmacist requested medical information.
Narrative:  COVID infection following COVID vaccine series 09/09, Pfizer, dose #1 09/30, Pfizer, dose #2 12/27 COVID Swab, result: detected 1/3 COVID Swab, result: detected 12/26 pt cc: cough, exposure: unknown 12/31 clinically resolved
pt recv vax & mom called & said pt has hard pea size lump started the day p/shot given & has been there 9 days now;no tx given;
Light menstrual spotting within first full day (less than 24 hours) of receiving first dose of vaccine. Occurred again two days post-vaccination just over 24 hours after first occurrence. Intermittent abdominal cramping noticed as well. I am a female that regularly tracks menstrual cycles, has a consistent 29 day cycle with a period lasting an average of 5 days. I have good knowledge of my ovulation window and am certain this is not related to any ovulation/implantation occurrences. It is too early in my cycle for that to occur.  I am reporting so that you have this information but also out of concern that this could represent the onset of any other bleeding issues that may be developing as a result of getting vaccinated.
First wheal was not created. Had to repeat ID injection. Pt left in No Distress.
ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 100 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up The patient received macitentan (form of admin unknown, oral, batch number: ZE019B0101 expiry: UNKNOWN) 10 mg, 1 time, therapy dates were not reported for an unspecified indication. Non-company suspect drugs included: epoprostenol sodium (intravenous, batch number: MM248M0101 expiry: 30/JUN/2022, form of admin was not reported) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included warfarin non-company for drug used for unknown indication, and riociquat non-company. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of arm pain was not reported. This report was non-serious.
had SOB, shakiness, dizziness 45min p/ vax;used inhaler for asthma helped dec sx;that PM had h/a, neck pain, nausea;inc urination (has this problem w/APAP);had blister like rash on arms & shoulders x few days;
After administration of 1st Shingles shot developed the following - headache joint pain/body-aches fever localized swelling and warm welt developed at injection site.
Large area of erythema warmth pain entire L deltoid extenidn to triceps and down to mid upper arm.
a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm with some force and I felt a jolt in my arm; fatigue; body aches; coughing; headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 15:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, exercise-induced asthma and penicillin allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), estradiol and progesterone, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 in the left arm on 23Mar2021 04:00 PM (at 58 years of age) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. The patient had no covid prior vaccination. She has not been tested for Covid post vaccination. The patient reported that the shot was put in the arm with some force and she felt a jolt in her arm and a big jolt immediately following in her heart. She mentioned that her heart felt sore off and on in that spot the following day 14Apr2021. No other unusual symptoms just the expected ones including fatigue, body aches and some coughing and headache. The events started on 13Apr2021 15:30 with outcome of recovering. The patient did not receive any treatment for the events.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information, and on a plausible temporal association, the Company considered that a reasonable possibility could not be completely excluded that the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to the occurrence of the reported event Big jolt immediately following in my heart. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
intermittent chills; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (intermittent chills) and INJECTION SITE SWELLING (injection site swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Apr-2021, the patient experienced CHILLS (intermittent chills) and INJECTION SITE SWELLING (injection site swollen). At the time of the report, CHILLS (intermittent chills) and INJECTION SITE SWELLING (injection site swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment for the events, were not provided
About 5 days after my 1st vaccine I experienced breakthrough bleeding, well after my monthly period ended.  This has continued every month, about 4-5 days after my period has ended. It's 1 day of bright red blood spotting and then it stops.
36 yo F with allergies to wheat (unk rxt), peanuts (anaphylaxis and metaxalone (abd pain) and history of constipation, LLQ abdominal pain, upper abdominal bloating and cramping, poor appetite, nausea and intermittent low grade fevers presented for Covid-19 vaccine on 4/29.  Moderna was given in left deltoid at 1132.  Lot # 044B21A in left deltoid.  After 15 minutes observation, patient left the clinic but returned at 20 minutes post vaccination with reports of throat soreness and swelling and voice changes.  Treated with an Epipen at 1224 and then with methylprednisolone 125mg IM and diphenhydramine 50mg IM prior to arrival of EMS at 1252.  No records available regarding transfer or an ED visit.  On 4/30 ~0900,
pt recv vax 19MAR93 & p/vax pt exp chronic fatigue synd;
Narrative:  Patient with breakthrough COVID infection after vaccination with 2 doses of Moderna COVID vaccine Symptoms:  & covid breakthrough infection Treatment:  CASIRIVIMAB/IMDEVIMAB (EUA) 600mg/600mg MG ONCE
Initial report received from a consumer on 15 June 2012. A female patient, whose age, medical history and concomitant medication were not reported, received a dose of Rabies vaccine on an unspecified date (Lot number, route and site of administration were not reported). It was reported that the patient was effected by the rabies vaccine. As of 15 June 2012 the outcome was not reported. Documents held by sender: none.
Information has been received from an RN and a physician concerning an 81 year old Caucasian female who on the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, on 4/11/02, the pt experienced redness, edema and severe throbbing pain from her right shoulder down her right arm below her elbow. It was reported that the experiences were severe and the pt was placed on over the counter Benadryl and was treated with warm compresses. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected. The nurse also reported that 3 other female pts experienced injection site pain, swelling, itching, redness and warmth following vaccination with pneumococcal vaccine 23 polyvalent (see WAES 0104USA0158, 0204USA02063 and 0204USA02064).
had very bad side effect with second injection; became really ill; had an attack had to run out and get air; dizziness; weakness; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness) and ASTHENIA (weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
10 mg of Hep B vaccines were given to 70 newborns because the GSK products requires 10 mcg dosage, but MERCK product required only 5 mcg for the same effects. Therefore, 70 patients received "double dose" of vaccines (10 mg vs 5 mg) when the GSK product was temporarily unavailable.
per patient family report, patient was hospitalized in intensive care unit on a ventillator the day following covid-19 vaccination
1 of 3 adult pts vaxed from the same pnu-immune lot# who devel an adverse event;pt immunized 15FEB95;16FEB devel high fever,feeling weak,head congestion,chills & large local redness around inj site;also flu-like sx x 1wk;recovered
Vaccination adverse reaction; Tiredness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), the first episode of FATIGUE (Tiredness) and the second episode of FATIGUE (Tiredness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 16-Oct-2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram every three months. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced the first episode of FATIGUE (Tiredness). On 30-Aug-2021, the patient experienced the second episode of FATIGUE (Tiredness). In September 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and the last episode of FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had reaction to covid-19 vaccine and tiredness.  Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the events of Vaccination adverse reaction was not reported and for Tiredness was possibly related. No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
101.8 fever, body aches, cold sweats, chills, pain at injection site, sore arm (arm where injection was), fatigue, headaches, joint pain, whole body in pain to the touch, starting around 9pm day of shot 2/11/2021. Continuing until today 2/12/2021 fever still at 101 unable to go to work
Diffuse erythematous based sand paper like rash with urticaria.  Given solumedrol, benadryl and famotidine with improvement