chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness; mild headache; mother received the Pfizer vaccine in December and a dose of Moderna vaccine on 29-Jan-2021; A spontaneous report was received from a consumer concerning a 58-year-old, female patient who received Moderna's COVID vaccine (mRNA-1273) and who experienced the events contraindicated product administered, vaccination site pain and headache.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 29-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the left arm for prophylaxis of COVID-19 infection.    The reporter states that, patient had received Pfizer vaccine in December and then received the Moderna vaccine on 29-Jan-2021. The patient experienced soreness and mild headache following administration of the Moderna vaccine.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, contraindicated product administered, was considered recovered/resolved.  The outcomes of the events, vaccination site pain and headache, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report also refers to a case of wrong product administered for mRNA-1273, lot # unknown, with no associated AEs.
Pt recvd DT/HIB TITER & w/in 12 hrs mom reported an ax t94 which lasted 4-5 hrs; Pt was not seen by MD; w/prior DTP, pt had some fever & crying for up to 4 hrs following DTP, so DT was given;
Had a fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0158 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 19May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19May2021, the patient received vaccine and about 3 hours after she had a shot. She had a fast heartbeat and then the following day on 20May2021 it happened again and she had a fast heartbeat about 12:45 in the afternoon. When she talked to the nurse, nurse said that the second dose was a little stronger. Outcome of event was recovered on an unspecified date in May2021.   Information on Lot/Batch number was available. Additional information has been requested.
Diagnosed with Cellulitis of the Left upper extremities; describes the masses as abscess-like and diagnosed with subcutaneous edema; Mass growing on the injection arm (left side); mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema). 11-Jun-2021, the patient experienced VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth"). On 19-Jun-2021, the patient experienced CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities) (seriousness criterion medically significant). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, CELLULITIS (Diagnosed with Cellulitis of the Left upper extremities), OEDEMA (describes the masses as abscess-like and diagnosed with subcutaneous edema), VACCINATION SITE MASS (Mass growing on the injection arm (left side)) and LIMB MASS (mass growing on the injection arm (left side), then it spread to her left leg, and now the right arm is also having mass growth") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, Blood test: normal (normal) normal. On 19-Jun-2021, Ultrasound scan: abnormal (abnormal) findings: subcutaneous edema. On 19-Jun-2021, X-ray: normal (normal) normal.         Concomitant product use was not provided by the reporter.  The patient reported the masses as "abscess-like" and "hard-lumps." She was sent to the emergency room (ER) on 19-Jun-2021 and discharged the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt ran t103 was given APAP & died; pt had epicardial petehchiae, pleural petechiae; there was pulmonary congestion & edema, & congestion of the abdo viscera;
Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in left arm on 10Mar2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFUTURER UNKNWON), allopurinol (MANUFUTURER UNKNWON) and famotidine (MANUFUTURER UNKNOWN) all for unknown indication and from an unknown date. On 11Mar2021 at 09:00, patient experienced sore arm. On 12Mar2021, the patient experienced moderate headache which lasted for 15 hours and on 13Mar2021, the patient felt hungover. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of sore arm, moderate headache and felt hungover was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
received an expired Infanrix vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 19-JUN-2023, the patient received Infanrix. On 19-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired Infanrix vaccination). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2023 The nurse reported that the patient received an expired Infanrix vaccination. The reporter did not consent to follow-up. The patient received Infanrix beyond the expiration date, which led to expired vaccine used.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 31Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 03Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ZICAM COLD AND FLU, start date: 11Nov2022, stop date: 12Nov2022; ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE], start date: 10Nov2022, stop date: 12Nov2022. Past drug history included: Bactrim, reaction(s): "Known allergies"; Erythrimiacin, reaction(s): "Known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient used Paxlovid from 12Nov2022 to 16Nov2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
dizziness; lightheaded; nausea; nauseated; Initial information received on 19-Dec-2022 regarding an non-serious case received from via consumer/non-hcp.  This case involves a 26 years old male patient who was diagnosed with dizziness; lightheaded and nausea; nauseated after receiving influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] and vaccines covid-19 vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Nov-2022, the patient received a dose suspect influenza quadrival a-b high dose hv vaccine at dose 1 (batch number: UT7701MA) (strength, frequency, formulation, expiry date: unknown) via intramuscular route in the right arm for Influenza immunization.  On 21-Nov-2022, the patient received suspect covid-19 vaccine produced by unknown manufacturer at dose 2 in injection form (batch number: 4302MF023) (strength, expiry date: unknown) via intramuscular route in the left arm for COVID-19 immunisation  On 21-NOV-2022 the patient diagnosed with a non-serious events of dizziness; lightheaded (dizziness), nausea; nauseated (nausea) (same day latency) following the administration of influenza quadrival a-b high dose hv vaccine and following the administration of covid-19 vaccine.  Action taken was not applicable for both suspects.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both events.
Pt developed rash on abdomen that started 2:00 pm on 11/11/99.  At 11:00 p.m. she noticed rash over entire body.  Pt instructed to take benadryl.  11/15/99, pt improving, she never picked up benadryl, but rash is leaving.
2 very heavy and long menstrual periods that occurred right after vaccination and the month after.   Painful cramping for 1-2 months
I experienced chest pains off and on a week after receiving the vaccine; then, a couple of weeks later and the pain stopped but returned the following week. I went to the ER three or four weeks ago. The ER personnel asked me some questions, took my blood and did a EKG to find out why I was experiencing chest pains. The ER doctor said that I was experiencing heart inflammation as a result of the vaccine (dose 2). I was give a prescription for a 6-day pack of prednisone upon being released from the ER. I am under orders from my PCP to refrain from any rigorous activities until further notice.
Developed extreme anxiety symptoms after the vaccination, thought it was normal until the onset of extreme chest pains on or around 4/24/2021.   Was diagnosed with Pericarditis on 4/29/2021.
This is a spontaneous report from a contactable Pharmacist via a Pfizer sales representative. An elderly female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling at injection site larger than normal a little bit spread out on an unspecified date with outcome of unknown.
Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Pt. woke up at night 11 pm with soreness, and fever, stiffness in left arm/should and leg. Said left arm feels almost paralyzed. Site of injection red and swollen. Pt. also complaint of severe headache and neck ache. Now getting better after 3 days. (11/9/17).
Booster; Had this weird dizzy feeling in my head; Started getting a lot of pain in my you know like lower back and then the pain got worse at night; My back, my both legs were in severe pain; My back, my both legs were in severe pain; Have been running fever; Cough; Not feeling well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Oct2021 11:00 (Lot number: FF2590) as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), administration date: 2021 for COVID-19 immunisation, Bnt162b2 (Dose no: 2), administration date: 2021 for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 23Oct2021 11:00, outcome "unknown", described as "booster", DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Had this weird dizzy feeling in my head", PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Started getting a lot of pain in my you know like lower back and then the pain got worse at night", BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "unknown" and all described as "My back, my both legs were in severe pain", PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Have been running fever", COUGH (non-serious) with onset Oct2021, outcome "unknown", described as "Cough", MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Not feeling well at all". Therapeutic measures were taken as a result of pyrexia.  Additional Context: Consumer stated, Patient had the Pfizer COVID Vaccine Booster yesterday and after the shot patient had this weird dizzy feeling in my head and later on patient started getting a lot of pain in my you know like lower back and then the pain got worse at night, like really bad, my both (incomplete sentence) my back, my both legs were in severe pain and also I have been running fever. Patient had the shot at 11 am yesterday. Patient still running with fever tonight and I also developed a cough, that was really concerning me, Patient was taking Tylenol (Treatment) but the fever is been going up and down (Further clarification was unknown) and patient started coughing and from what I have read, I do not see anything of that being a side effect to the COVID booster.  QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default.  Follow-up (18Nov2021): Follow-up attempts completed. No further information expected.
administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included allergic rhinitis (on 24th December 2016) and constipation (on 18th July 2018).   On 24th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 24th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The registered nurse reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was revaccinated on 1st September 2022. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. Nurses to check all vials for vaccines prior to administration. The reporter did not consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131228:Same reporter US-GSK-US2022AMR131200:Same reporter US-GSK-US2022124956:Same reporter/ original report
24 hours after injection. Warmth, induration, erythema, pain at injection site around 8 cm. Myalgia, tactile fever. Treated with Ibuprofen, ice. 8/13/04: sx improved.
I woke up the next day after getting vaccinated and had a 30 second seizure at 10:30 a.m.
She got the second vaccine at 1 pm on 12/3. At 4:45 am on 12/4, she started vomiting. She had a slight fever that morning, 99.5.   She reported a headache and sore arm the morning of 12/4 at 8 am.  She was given Tylenol.  That evening at 4 pm, she had a 101.5 Fever and tired.   Has woken up today, 12/5 and seems to be acting normal.
After receiving dose of COVID 19 vaccine patient reports the following: rash to both arms, right neck. Heart rate increased to 102. Reports slight shortness of breath. ER visit- administered Benadryl/Solumedrol IM
erythematous rash 4cm, began @ site (lt arm) of inj 72hr p/vax given;rash persisted for several days;
Covid Arm.  I woke up on the 7th day after my covid shot with an itchy, red, swollen arm. No other symptoms.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Medium
SORENESS AT INJECTION SITE FOR A DAY OR TWO; This spontaneous report received from a consumer concerned a 76 year old female. 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, batch number: Unknown) dose was not reported, administered on FEB-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced soreness at injection site for a day or two. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site for a day or two. This report was non-serious.
When I got the vaccination I was 32weeks pregnant and on Saturday I had spontaeous rupture of the amnotic fluids and went immediately to the hospital and was immediately given steroid, magnesium for the baby.  And on Sunday around 3:45PM I got a second round of the steroids and was transferred for observation.  On Monday, at 8:06am I went into early labor I delivered my baby at 33weeks gestation and she weighed 3lb 11oz.  Expected Date of Delivery-2/8/2021.  I was a high risk patient d/t Fibroids but have experienced no issues the entire pregnancy and my last ultrasound was 12/17 and baby was healthy with no complications at that time.
Swelling redness (R) deltoid advised ice, rest. BENADRYL 50mg IM: KENALOG 40mg DECADRON 10 mg} IM. Call in am.
shoulder pain  Narrative:  Patient is an 87-year-old man with castrate-resistant prostate cancer, HTN, essential tremor (DBS), OA, HLD, SNHL, and lung CA (RUL lobectomy) presenting with left upper extremity pain. He was last admitted in 1/2021 for generalized weakness and fall (c/b L radius hairline fracture) thought to be from possible medication-induced rhabdomyolysis (prednisone and abiraterone held). He received the second dose of the Moderna COVID vaccine in his L shoulder on 2/10/21 and began having L shoulder pain about 12 hours later (8pm on 2/10) that continued to worsen and limited his range of motion and ability to bear weight in his L arm significantly. Patient was admitted for evaluation and management of monoarticular inflammatory arthritis concerning for septic joint given increased risk of infection in the context of steroid use and underlying malignancy.
Shortness of breath requiring oxygen, chest (heart) heaviness and discomfort, extreme lack of energy and extreme fatigue (bedridden), edema from toes up to abdomen (2+), a feeling of impending doom.  I received the second Pfizer COVID vaccine on October 1, 2021. The symptoms started on October 2, 2021 and never eased up until October 19-20, 2021. I was bedridden the entire event.
Shortly after receiving the vaccine (approximately 5-10 minutes).  She felt "warm" similar to how she felt when she had received an epidural for labor pains.  She developed a metallic taste (mouth full of nickels) which subsided 15 minutes later without treatment.