chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has received bone marrow transplant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: BONE MARROW TRANSPLANT (medically significant), outcome "unknown", described as "Has received bone marrow transplant".  Clinical course: Caller stated that they had a patient who had received bone marrow transplant and had received the Pfizer COVID-19 vaccine primary series and booster dose over a year ago. He mentioned that the patient can now be able to get the vaccine again and the doctor informed the patient to restart the primary series. He also clarified that the patient has not yet been re-administered with the primary series. He wanted to know, for this particular instance, what formulation should the patient receive, the monovalent primary series or the bivalent formulation? What interval, 3 weeks apart or 2 months?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the event BM transplant.  The reported event is likely associated with intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
-2021-069799, MOD21-071455 (E2B Linked Report).; Sender's Comments: Rash (neck,behind  knee,lower back); sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash (neck,behind  knee,lower back)) and VACCINATION SITE PAIN (sore injection site arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 RASH (Rash (neck,behind  knee,lower back)) and VACCINATION SITE PAIN (sore injection site arm). At the time of the report, RASH (Rash (neck,behind  knee,lower back)) was resolving and VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-069799, MOD21-071455 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069799:Case for second dose MOD21-071455:cross linked case
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     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 (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.     This case was linked to MOD-2021-392458 (Patient Link).
No adverse event; 6 Patients received the vaccine past the beyond used date; Accidental underdose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient had allergy history or diseases.     On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 2nd child patient of the total 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-705086 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705086:Master
Child presented to clinic 6-4-09 w. cc "crying a lot", 7 cm reddened swollen LAT at site of 4th INFANRIX. Mom advised to warm packs, return to clinic 3-4 days.
pt recv vax & w/in 48hr pt devel outbreak of hives;the hives resolved w/o tx in several days;it was noted that the pt also had an outbreak of hives p/a tetanus shot & may be sensitive to thimerosal;
The following day in the morning, I felt weak and my blood pressure was low, than  same day I felt nauseated and felt like my head was spinning inside. It was like that all day. 2nd day I felt nauseated and also my head was  like  spinning inside and than had a very terrible headache  later in the day &I was not hungry. I was just in bed. 3rd day, all my body felt sick, had mild running nose, mild cough, mild soar throat and just felt ache, I felt like that all day and till the 4th day.  I started feeling myself in the evening of the 4th day.  5 th & 6th day, I just felt on and of  light headed and nauseated.  It was the most miserable days I?ve had.
I woke up 2/26/21, 8 am,  the morning after the vaccination. I had a low key headache, some muscle aches, and tiredness. Around noon I walked downstairs to eat something. I felt about the same as in the morning. Around 1 pm I went back to bed and started shaking uncontrollably. I got up out of bed and walked about ten feet and couldn't walk any further. I had severe cramping/rigidity in  my legs. I called out to my husband and he came upstairs to the bedroom. I thought we should go to an outpatient clinic but I couldn't walk on my own. My husband walked/helped me to the  bathroom. I felt short of breath. I vomited into the sink. I still felt short of breath but I could talk some. My anxiety increased because I was concerned my shortness of breath may get worse. I decided my husband should call 911. An aide unit came to the house. The team was reassuring. My symptoms subsided.
Two weeks after Dose 2, given on 4-17-21, woke up with persistent muscle twitching in legs, somewhat migratory to upper body as well. This lasted from approx. 5 -9 AM, and receded as I started activity (or I didn't notice it.)  This persisted for 2 weeks, every morning. Also, at this time developed clonic muscle jerks-- of legs, one hand curling, chest jumps, pelvic/lower abdominal bilat jerks, shoulder or arm jerks.  This disturbed sleep on a couple occasions.  Mild AM headaches for 2 weeks, and for last 3 days sharp R-sided head pains, scalp itching, and discomfort in the evening.   Myoclonus seems better today after 3 days of taking NAC (N-acetyl cysteine) and herbs.
LOC, dizziness, fainting, twiching & rigid arms for 20 seconds.
Client proceeded to an upstairs restroom post-vaccination, rather than to observation area. Upon exiting rest room, client experienced weakness, mild light-headedness with elevated BP of 203/98.  She was evaluated by paramedics on site who recommended further evaluation.  Client declined stating she felt better and would take her medication when she arrived home. RN encouraged her to call her physician when she got home. A friend drove her home . A follow-up call was made at 1:46 p.m. by reporting RN.  Client stated she took medication, was resting and BP was 168/70, and she was planning to call her doctor.  She felt the episode was due to the exertion of going directly upstairs to the rest room, rather than sitting down in observation area.
Dark circles and puffiness under both eyes when woke up the day after the booster shot was given, and those effects are still here today.
throat became tight; eyes were full of blood; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional via Medical Information (reference number- 00405372) and transmitted to Sanofi on 23-DEC-2020.  This case involves a 76-years-old female patient whose throat became tight (throat tightness) and eyes were full of blood (ocular hyperaemia) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   Concomitant medication include intravenous (IV) contrast cause neck swollen, eyes swollen; antibiotic causes thrush; steroid shots gave her hot flashes  In 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2016, the patient's tthroat became tight (throat tightness) and eyes were full of blood it was not like just blood vessels in eyes, much more than that(ocular hyperaemia) 15-minutes following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory details were not reported.  The patient was treated with intravenous (IV) DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) took it by mouth for a week.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Information has been received from a consumer concerning her 4 year old daughter with n allergy to PCN who on 03/03/2004 was vaccinated with a dose  of varicella virus vaccine live. There was no illness at the time of vaccination. On 08/30/04 the pt developed lesions on her abdomen which was reported to be chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the pt had no adverse events following prior vaccination. Follow up information from a physician indicated that the morning of 08/30/2004 the pt had mild breakthrough case. Subsequently the pt had recovered. It was also reported that on 03/29/2000 the pt was vaccinated with a SQ first dose of MMR live vaccine on her right side, an IM 3rd dose of poliovirus vaccine inactivated on her lower left side and an IM first dose of diphtheria toxoid + Hib conj vaccine (tetanus toxoid) + pertussis whole cell vaccine + tetanus toxoid (ACTHibDTP), on her left side. It was reported that the pt had no adverse events following prior vaccination. No further informtaion is expected.
Patient came in 2/16/23 for Boostrix vaccine and prior to administration, complains of radiating, left arm soreness that she states originated from her previous 3 vaccines she received on 8/27/22. She states she experiences pain when elevating her left arm and is unable to sleep in certain positions on her left side.
racy feeling; extreme headache; fatigue; lymph node swelling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew 0180), via an unspecified route of administration, administered in right arm on 14May2021 at 10:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included allergy to medications (some past prescription medications). The patient stated that she was sensitive person and had the uncommon side effects. She had no chronic conditions, no illnesses. She was a healthy person. Concomitant medications included unspecified multivitamins and unspecified magnesium supplements. On 14May2021 in the evening the patient experienced experienced a racy feeling and a bit of needing to take deep breaths. She had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
This patient has noted prior events with other unknown influenza vaccines in prior years. Her most common reactions have been fatigue, headache, fever, and nausea. This time around, she noted severe balance issues and coordination issues that caused her to avoid driving and walking around much for 3 days. She also noted that she had recurrent episodes of idiopathic tachycardia (>120/minute rate). She would wake up with a racing heart and this would also happen during waking hours.  The cardiovascular events were noticed for 3 weeks post vaccination and then resolved.
Subject occasionally notes (3 times since 5/31/06, dates unknown) that area surrounding injection site on left deltoid becomes hot, red, itchy, swollen (approx 2 in. x 2 in.) with bumps. No treatment required. Symptoms resolve within 24 hours of appearance. He also states that when the symptoms occur he also feels aching of his left arm and hand. The aching resolves with the injection site symptoms.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, PAIN Narrative:
This case was reported by a consumer via call center representative and described the occurrence of electric shock sensation in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose of SHINGRIX in November 2018 refer case (US2019GSK001363)). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced electric shock sensation, fever, increased blood pressure, urine discoloration and nausea. On an unknown date, the outcome of the electric shock sensation, fever, increased blood pressure, urine discoloration and nausea were unknown. It was unknown if the reporter considered the electric shock sensation, fever, increased blood pressure, urine discoloration and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The second shot went like this when needle hit muscle felt like electrical jolt and all downhill after got home. Temperature was 100 degree C and blood pressure elevation to 150/90 mmHg and no rapid pulse but kidneys had very dark urine output for 2 days, now okay after 3rd day but still a little nauseous. The patient writing because 1st shot went so well and had no negative effects to prevent for 2nd return. The patient did not go to emergency room because of heartbeat stable but did call doctor, just for information exchange. This case linked with US2019GSK001363, reported by same reporter for the same patient. Lab Comments: Lab test performed on unknown date.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for Cholesterol blood excessive, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and PIOGLITAZONE for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) and NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (B-100 COMPLEX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Soreness). On 19-Mar-2021, PAIN (Soreness) had resolved. Not Provided      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.   Patient treatment information was not provided.
On 12/31/03 Approx. 8 hous after receiving Twinrix Hep A and Hep B vaccine lot YK-BF, patient states he broke out with a rash and hives on his chest, neck, behind his ears.  He went to the ER on 01/01/2004 and received "some little green pills."  Patient had returned today for 2nd Hep A and Hep B vaccination and reported this . Second injection not given.
Pt., age 15, received her second Pfizer dose 6/10/2021. On 6/11/2021 acute pain onset in her hip region that caused considerable pain when walking or climbing stairs. We made arrangements for her to come home early if needed from plans on Friday 6/11/2021. By Monday 6/14/2021 I sent a message on record to her pediatrician's office reporting the vaccine side effect and asking if we should be seen by them or a specialist. The pain never went away.  We visited the pediatrician for this issue; we were referred to physical therapy; we were escalated to sports medicine. Sports medicine took an MRI and blood test in November 2021 when the pain persisted.  We were referred to Hospital where pt. received a diagnosis of juvenile autoimmune spondyloarthropathy. Her immune system is attacking her joints and the vaccine was the environmental trigger for this genetic predisposition, as shown with the acute onset within <24 hours of the second vaccine dose. The pain just never went away after that date and is now a chronic condition.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Was reported as 80777027399. Completion date was reported as 24-Aug-2022. No treatment information was provided.
both Shingrix in March2019; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2019, the patient received the 2nd dose of Shingrix. In March 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix in March 2019. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter asked if needed booster dose.
Child became pale, clammy, diaphoretic, BP decreased, c/o dizziness, slightly nausea. VS taken, applied cool cloths, provided H2O.
Diarrhea, vomiting, loss of apetite, no energy. Mostly recovered by 9/13.
pneumonia; bronchospasm; Sick; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Sick). On 25-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and BRONCHOSPASM (bronchospasm). At the time of the report, PNEUMONIA (pneumonia), BRONCHOSPASM (bronchospasm) and ILLNESS (Sick) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Although a temporal association exist, based on the known etiology of pneumonia being of an infective etiology, a  causal relationship between the event and the administration of mRNA-1273 is unlikely.  However, the relationship between the other events and mRNA-1273 cannot be excluded.; Sender's Comments: Although a temporal association exist, based on the known etiology of pneumonia being of an infective etiology, a  causal relationship between the event and the administration of mRNA-1273 is unlikely.  However, the relationship between the other events and mRNA-1273 cannot be excluded
pt devel a fever up to 39.5;pt recovered from the fever p/symptomatic therapy;11SEP96 pt devel a temp up to 37.7 & exp sz like movements of the head;12SEP96 pt hosp because movements recurred;CSF,EEG & MRI nl;dx focal cerebral convuls
Draining in my mouth. Have been to many specialists including ENT, GI, Dentist and nobody can figure out why or where it is coming from. This all started very soon after my first dose of the vaccine. It tastes terrible and is burning my mouth.