chrisvoncsefalvay/vaers-outcomes huggingface dataset:
early DVT; cellulitis; Presumed superficial phlebitis; moderate swelling; severe erythema; tenderness to left lower leg radiating to groin.; D Dimer mildly elevated along with white blood cell count; D Dimer mildly elevated along with white blood cell count; This is a spontaneous report from a contactable physician. A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) intramuscularly in the left arm on 03Aug2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were reported as None. Patient did not have any known allergies. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications within 2 weeks of vaccination as received by patient was reported as None.  On 04Aug2021 (1 day after vaccination), patient had early DVT (deep vein thrombosis), cellulitis, presumed superficial phlebitis and developed moderate swelling with severe erythema and tenderness to left lower leg radiating to groin and D-Dimer mildly elevated along with white blood cell count. No preceding injury or explanation. The adverse events were DVT and Cellulitis were reported to be serious. The adverse events result in visit to emergency room. Treatment received were antibiotics, steroids and anticoagulation. Lab test included ultrasound scan and evaluation showed no evidence of DVT, D Dimer test shows mildly elevated along with elevated white blood cell count, on 04Aug2021. The outcome of all events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis and cellulitis cannot be totally excluded 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.
Pt reported hearing loss in left ear (10/22/16)-I reported to Seqirus next day. There data says nobody ever had hearing loss. I filled out adverse event form and faxed to seqirus 11-7-16. Talked with pt 10 days later says hearing coming back. 11-7-`6-pt says muffled hearing came back 2x but today 11-7-16 hearing back to normal. 11-21-16 follow-up-pt hearing normal. Follow-up 11-30-16-pt says hearing normal. Hearing normal checked with Dr. Pt says dr. said hearing of I reported to Dr office 2x about hearing.
R09.02 HYPOXIA 3/23/2023 ASPIRATION PNEUMONIA
felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt sleepy). At the time of the report, SOMNOLENCE (felt sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2022-460300 (Patient Link).   Reporter did not allow further contact
Symptoms were much worse after the first two doses; 104 fever for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms were much worse after the first two doses) and PYREXIA (104 fever for 6 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third 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 (Symptoms were much worse after the first two doses) and PYREXIA (104 fever for 6 hours). The patient was treated with IBUPROFEN for Adverse event, at a dose of 2 cycles 40mg. At the time of the report, VACCINATION COMPLICATION (Symptoms were much worse after the first two doses) outcome was unknown and PYREXIA (104 fever for 6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fever (High) Had a 104 fever.   Patient mentioned that his symptoms were much worse after the first two doses. Patient had Flu vaccine at the same as the booster. No concomitant medications were mentioned.   This case was linked to MOD-2021-407187, MOD-2021-407170 (Patient Link).
Upon administration of vaccine, Havrix, the patient's eye's rolled back in his head and began getting very flushed. His then began producing dystonias and then developed syncope. Patient recovered in about 3 minutes.
Pt. states that after the 1st dose of Shingrix 01/26/2022, started experiencing symptoms that evening of a severe headache on the Left side of the head continuing. No noted Primary visit/communications.
neck pain; muscle strain on the left side of her back-- muscle strain super tight; feel super depressed; hardly sleep last night; achiness in her chest; burning under her skin; shortness of breath-; heartburn; can't lay on her left side because it is too tight; Swollen lymph nodes on her collar bone; vaccination site started to itch; neck is also swollen; soreness on left side of throat; felt hot under skin; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021. The most recent information was received on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck pain), MUSCLE STRAIN (muscle strain on the left side of her back-- muscle strain super tight), DEPRESSED MOOD (feel super depressed), INSOMNIA (hardly sleep last night) and PAIN (achiness in her chest) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced SWELLING (neck is also swollen), OROPHARYNGEAL PAIN (soreness on left side of throat) and SKIN BURNING SENSATION (felt hot under skin). On an unknown date, the patient experienced NECK PAIN (neck pain), MUSCLE STRAIN (muscle strain on the left side of her back-- muscle strain super tight), DEPRESSED MOOD (feel super depressed), INSOMNIA (hardly sleep last night), PAIN (achiness in her chest), SKIN BURNING SENSATION (burning under her skin), DYSPNOEA (shortness of breath-), DYSPEPSIA (heartburn), DISCOMFORT (can't lay on her left side because it is too tight), LYMPHADENOPATHY (Swollen lymph nodes on her collar bone) and VACCINATION SITE PRURITUS (vaccination site started to itch). At the time of the report, NECK PAIN (neck pain), MUSCLE STRAIN (muscle strain on the left side of her back-- muscle strain super tight), DEPRESSED MOOD (feel super depressed), INSOMNIA (hardly sleep last night), PAIN (achiness in her chest), SKIN BURNING SENSATION (burning under her skin), DYSPNOEA (shortness of breath-), DYSPEPSIA (heartburn), DISCOMFORT (can't lay on her left side because it is too tight), SWELLING (neck is also swollen), OROPHARYNGEAL PAIN (soreness on left side of throat), SKIN BURNING SENSATION (felt hot under skin), LYMPHADENOPATHY (Swollen lymph nodes on her collar bone) and VACCINATION SITE PRURITUS (vaccination site started to itch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. Treatment information included  Epson salt bath ,Hot and Cold Therapy and Ibuprofen   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: significant follow-up has been appended
I was positive for COVID-19 on 01MAR2023, I was traveling and I had a sore throat and when I came home I tested and it was positive. I didn't have a fever or body aches but I did feel tired and joint pain. I did have a constant cough. I contacted my doctor and he prescribed me Paxlovid, I started feeling better 10 days after.
Felt her left ear draining; Bleeding in the left ear, "a little clotting" in the left ear; Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of OTORRHOEA (Felt her left ear draining), EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear) and PAIN IN EXTREMITY (Pain in the left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included IBUPROFEN for Headache.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm). On 30-Jul-2021, the patient experienced OTORRHOEA (Felt her left ear draining) and EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear). At the time of the report, OTORRHOEA (Felt her left ear draining), EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear) and PAIN IN EXTREMITY (Pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter. patient takes ibuprofen occasionally to treat occasional headache. he caller stated that she is scared to receive the second dose in the series. The caller stated she is concerned scheduled an appointment for evaluation. The appointment is scheduled for 02Aug2021 with her HCP.
Headache, Myalgia, Fever, Tachycardia, Chills with fever, seen in ER for Tachycardia Narrative: Tachycardia - went to RE for evaluation. MD told her it was unrelated to vaccine the day before.
This spontaneous report was received from a pharmacist via company representative regarding a 60 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with VARIVAX (Merck) followed 1 month later by administration of ZOSTAVAX (inappropriate schedule of drug administration). No adverse event was reported. The outcome of the event was unknown. Additional information is not expected because the reporter does not wants to get contacted.
Right after getting my first dose of the Moderna vaccine, my throat and back of my tongue started tingling. After a few minutes I asked one of the nurses if it was normal. They took my vitals, and gave me a Benadryl  25mg, my vitals were fine. Also, my throat and tongue looked fine.  After getting home my body started hurting, especially my arm where the vaccine was administered and my calfs.
LOW PLATELETS/PLATELETS OF 50; 3/4TH OF BODY COVERED IN BRUISES/BRUISES ARE GETTING WORSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 205 pounds, and height was 61 inches. The patient's past medical history included: surgery, and concurrent conditions included: type-2 diabetes mellitus, hypertension, sulfa allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: Platelet count (NR: not provided) high/above average at that point. On 13-MAR-2021, the patient experienced 3/4th of body covered in bruises/bruises are getting worse. On 15-JUN-2021, the patient experienced low platelets/platelets of 50. Laboratory data included: Platelet count (NR: not provided) LOW. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 50. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 3/4th of body covered in bruises/bruises are getting worse, and the outcome of low platelets/platelets of 50 was not reported. This report was non-serious.
Patient received a dose of Menveo reconstituted with sterile water; Patient received a dose of Menveo reconstituted with sterile water; This non-serious case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVA721A) for prophylaxis.   On 09-AUG-2023, the patient received Menveo. On 09-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Patient received a dose of Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Patient received a dose of Menveo reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received an incomplete dose of Menveo vaccine. The reporter reported that the patient received Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR121420:same reporter, drug and event US-GSK-US2023AMR121420:same reporter, drug and event
Breakthrough case admission after three vaccines; Pfizer 7/23/21 Lot# FA6780; Pfizer 8/20/21 Lot# FC3182;  Pfizer 2/21/22 Lot# NOT NOTED.
Arm and shoulder pain. Some loss of movement. Symptoms have lasted for several weeks without recovery or improvement.
I contracted COVID-19 on 03JAN2023 I went to an urgent care locally. It was confirmed I had Covid, I was prescribed PAXLOVID and took this for five days I tested negative 11JAN2023 I flew home and rebounded with COVID-19 on 16JAN2023 and did not test negative until 26JAN2023. As a note I did test positive pneumonia on 28JUL2022 and had a hip replacement 04AUG2022.
Information has been received from a counselor concerning a 21 year old female who was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a rash. The patient recovered on unspecified date. Additional information has been requested.
Tingling and tightness in face that felt like face being pulled Redness and swelling in face  Rush of heat down midline and out to arms  Unusually increased blood pressure (baseline is 100/60, I was up to pre-hypertension levels for a bit)
No additional adverse events were reported; Patient who was already immune received a dose of RECOMBIVAX on 10/4/2022.; This spontaneous report has been received from a nurse prescriber referring a 49-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-OCT-2022, the patient was already immune and was vaccinated with 1 dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number K9H5S with reported expiration date 03-OCT-2024 is not valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB)), (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (extra dose administered). No additional adverse events were reported.
Information has been received from a 67 year old consumer reporting on herself with type 2 diabetes, multiple sclerosis, neurogenic bladder, lichen planus, allergy to amantadine hydrochloride, KEFLEX, BYETTA, LEVAQUIN, lovastatin (manufacturer unknown, WAES#1105usa02111), MOBIC, CRESTOR, sitagliptin phosphate (MSD) (WAES#1105usa02112), BACTRIM DS, DESYREL and BEXTRA who in June 2009, was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (lot number not reported). Concomitant therapy included PRISTIQ, hydroxyzine (manufacturer unknown), GLUCOPHAGE, nitrofurantoin (MSD), DIOVAN, KLONOPIN, baclofen, DITROPAN, ALLEGRA, AMARYL, modafinil (MSD), lorazepam (MSD), ACTOS, spironolactone (MSD), LANTUS and XYZAL. "On 20-APR-2011 or 21-APR-2011" the consumer developed lower right quadrant abdominal pain. On 23-APR-2011 the consumer stated the pain became severe and she went to the emergency room, where the consumer was evaluated and discharged with a prescription for TYLENOL with codeine. On 25-APR-2011, the consumer saw the physician and was sent to the emergency room. On 28-APR-2011, the consumer developed a rash on her abdomen, the consumer saw the physician at that time and was diagnosed with shingles. The patient received acyclovir as treatment for the event. On an unknown date, were performed a Computerized Axial Tomography (CAT scan) and unspecified blood tests (no results were provided). At the time of the report the patient had not recovered. Additional information has been requested.
An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00609798) and transmitted to Sanofi on 20-May-2021.  This case involves a 3 years old male patient who received fourth dose 0.5 mL HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (frequency: once, batch number: UJ207AA and expiry date : 30-Apr-2021 via an intramuscular route at an right thigh administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  Reporter want to know what need to know and which actions to take for the affected donors. Caller requested information to provide to mother of patient.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A report was received from a healthcare professional on 11/21/2002, concerning a 54 year old male vaccinee who experienced an injection site reaction after receiving Fluvirin on 11/19/2002. On an unknown date the vaccinee experienced an injection site reaction after receiving Fluvirin on 11/19/2002.  The vaccinee's upper arm became red and swollen, and the area around the injection site was swollen.  At the time of reporting the outcome of the event was unknown. There was insufficient information to determine the reporter's causality assessment.
pt recv vax 20JUL94 & 20JUL95 pt exp soreness @ inj site which lasted 1yr;f/u info reported that pt exp pain w/arm movement & was seen by an orthopedic MD;pt had numerous therapy tx;x-ray taken of the shoulder was negative;
Bruising and redness following day of shot. Redness/swelling subsided after 3-4 days, however 8 days following the shot started up again. Red and itchy.
-started feeling generally sick within three hours  -fever over 101 within  six hours -fever over 102 by evening and not controlled well with fever reducer  -shakes -chills -back ache
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 11-Jan-2021, the patient experienced PYREXIA (Slight fever). On 12-Jan-2021, VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (Slight fever) and ARTHRALGIA (Joint pain) had resolved.        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.   The patient reported using ice packs and over the counter Acetaminophen as treatment medication from onset date of symptoms until last night (11-Jan-2021).  Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the events, a causal relationship cannot be excluded.