chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In May 2022, the patient experienced PNEUMONIA.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4400131-00.  An 80-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Unknown), administration date: 2021, for COVID-19 immunization, reaction(s): "Pulmonary thrombosis"; Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Not recovered/not resolved), administration date: 2021, for COVID-19 immunization, reaction(s): "Persistent cough"; Bnt162b2 (DOSE 1(single), Route of Administration: Intramuscular, Event onset Date/Year: 2021., Outcome of Event: Recovered/ Resolved, Start Date : 2021), administration date: 2021, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19". The following information was reported: PNEUMONIA (medically significant) with onset May2022, outcome "recovered" (2022), described as "In May 2022, the patient experienced PNEUMONIA.". The event "in May 2022, the patient experienced pneumonia." required emergency room visit. The patient underwent the following laboratory tests and procedures: Bone densitometry: Unknown results; Computerised tomogram: Unknown results; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of pneumonia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737), on 22Apr2021 as dose 2, single (Lot number: EW0164), on 24Oct2021 as dose 3 (booster), single (Lot number: 32030BD) and on 15Apr2022 as dose 4 (booster), single (Lot number: FT4989) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: then tested positive again 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti viral COVID 19 Treatment from 02Feb2023 to 07Feb2023.   No follow-up attempts are possible. No further information is expected.
This spontaneous case, initially received on 28-Nov-2016, was reported by a health professional and concerns a(n) 49-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On an unspecified date in Nov-2016, the patient experienced Bloodshot eyes (outcome: Recovered / Resolved), Excessive sleep (16 hours) (outcome: Recovered / Resolved), Migraine (outcome: Recovered/ Resolved), Sweats (outcome: Recovered / Resolved), Vomiting (outcome: Recovered / Resolved). Follow-up information received 30-Nov-2016: This case concerns a 49 year old non-pregnant female patient. Concomitant medications: omeprazole, alprazolam, dicyclomine, diphenhydramine, metronidazole and hydrocodone / acetaminophen. This was the patient's first flu shot.
warm for like 15 minutes; migraine for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL, FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours). At the time of the report, FEELING ABNORMAL, FEELING HOT (warm for like 15 minutes) and MIGRAINE (migraine for 12 hours) had resolved.            The concomitant medication was reported as antidepressant and sleeping pill.  The patient had second dose of Moderna.  No treatment medications were reported.
PFIZER COVID VACCINE #3 GIVEN 10/1/21, LOT #FF8839; pt transported from a residential facility to hospital due to not tolerating BiPAP well; when EMS arrived O2 saturation was 70%; placed on NRB 15L O2; found to be positive for COVID; given ABX and IVFs; ICU; respiratory failure; condition worsened; multiorgan failure; pt passed away in the hospital
Low Estrogen; can't sleep; can't focus; depressed; has anxiety; can't concentrate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD OESTROGEN DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Low Estrogen"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "can't sleep"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "can't focus"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "depressed"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "has anxiety"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "can't concentrate". Relevant laboratory tests and procedures are available in the appropriate section.  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-202101533632
Information has been received from a physician concerning a female patient with a penicillin allergy and no medical history who on 06-JUN-2007 was vaccinated IM with a dose of Gardasil. There was no concomitant medication. On the morning of 07-JUN-2007, the patient developed a rash that was red, erythematous, and itchy. It was on her trunk, neck and arms. She also felt faint or dizzy as the rash began. The treatment was Benadryl. No diagnostic laboratory studies were performed. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Additional information is not expected.
Swollen arm for over 4 days. Very painful to touch. Aches, fever, chills and lethargic for 36 hours.
Hives and itching on right forearm and above right eye. started 3 hours after vaccine and cleared and resolved with topical Benadryl.
Hiccups; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:1, Lot Number:  EN5318), administration date: 08Jan2021, when the patient was 67-year-old, for Covid-19 Immunization. The following information was reported: HICCUPS (non-serious) with onset 2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hiccups.  Additional information: Reporter states that he was a nurse. Says he went from Risk Management to Infectious Disease and worked Infectious Disease during Covid. Reporter states that he took both vaccines when they first came out. He has also had the two boosters. Reporter verifies that he was calling about the Pfizer Product: Covid Vaccine. Reporter that shortly after the vaccine he started having hiccups. he didn't relate them to the vaccine at first. Reporter mentions knowing others with hiccups, does not provide how many people or any identifiers. Reporter states he wants to know if anyone else has report the same problem? What are they doing for it?. Reporter states that he has taken every drug on the market for chronic hiccups and had procedures. States now he was on the last medical procedure, for when nothing else will help. Reporter states that he takes Thorazine three times a day, after about a week it will not work for his hiccups, and he will take Lyrica twice a day. Caller states that after about a week the Lyrica will not work for his hiccups. Reporter states that he has almost had to overdose to get something to work for a week. Reporter states that the hiccups started for him shortly after he got the initial series, the first two vaccines. States that the hiccups has gotten worse, and it has been about 2 years now. Seriousness Criteria: When probed for specific seriousness criteria related to all of his symptoms the caller states no and that he has not been hospitalized. Reporter states that he was now trying to see a neurologist to either paralyze or sever the phrenic nerve. Reporter states this was the last resort for intractable hiccups. Reporter begins hiccupping during call, states that the hiccups he was having during the call aren't as bad as the ones he normally has. Reporter states that he takes Thorazine three times a day, after about a week it will not work for his hiccups, and he will take Lyrica twice a day. Caller states that after about a week the Lyrica will not work for his hiccups.
24 hrs p/2nd dose exp fever, diarrhea, nausea, & vomiting; pt was not seen by MD; full recovery in 1 1/2 wks; decision was made to discontinue Engerix-B vax;
Itching that was like pinpricks all over the body, including the ankle, face, legs, and nose in particular. (No itching at the injection site.) Developed a rash on face. These all developed within 15 minutes of receiving the vaccine. Took a benadryl to be safe shortly afterwards. Itching lasted for approximately 2 days. The rash is still about the same.   There was also swelling at the injection site, plus a rash that developed at the site about a day later. Other symptoms, such as fatigue, tiredness, and achiness, seem to be more typical outcomes.  Also developed a swollen lymph node under the arm that received an injection. This occurred two days afterwards.
This spontaneous consumer report (initial receipt 08-Sep-2015) concerns a female patient. On an unspecified date in Nov-2014, the patient received an unspecified influenza vaccine (manufacturer and batch number not provided). On an unspecified date during summer 2015, the patient experienced influenza. No further information provided. The outcome was not reported.
Inflammation of knee joint. Aspiration of knee 7 day hospital stay - IV antibiotics. Child could not walk or crawl. Fever and pain in Knee. Fever spiked to 103.7 Events occurred 16 hrs after injection.  07/02/2007 MR received for 7 day hospitalization for an child with refusal to bear weight/walk on the left leg. Initial exam showed some swelling and initial dx was of toxic synovitis. Pt later developed fever and increasing swelling and warmth. Admitted to r/o septic knee and begin IV abx. Discharge DX: Resolving L knee arthritis, septic vs inflammatory.
PATIENT CLAIMS PAIN RADIATED FROM ARM ACROSS BACK, AND EVENTUALLY ALL OVER. PATIENT REMAINED IN BED FOR 2 DAYS, DUE TO BODY SORENESS. ALSO DEVELOPED METALLIC SWEET TASTE IN MOUTH.
Numbness and tingling on left side of face. severe joint and muscle pain that is still ongoing
patient is 14 and received the vaccine inadvertently. our clinic does not administer to any individuals under the age of 16. no issues to minor at this time.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her left arm, like 3 inches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. 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 ERYTHEMA (redness on her left arm, like 3 inches). At the time of the report, ERYTHEMA (redness on her left arm, like 3 inches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.
NORMAL FEELING LIKE TRASH FOR 24 HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and 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, and batch number were not reported) dose was not reported, administered on 07-MAR-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 normal feeling like trash for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from normal feeling like trash for 24 hours. This report was non-serious. This case, involving the same patient is linked to 20211116405.
Felt pain at left ( injected side) axilla and breast in the morning on Jan 13 and then had pain, swelling, warm, itchy at left arm in the evening at the same day.  Symptoms become better without taking any other treatment since Jan 15.
Dizziness; BP 208/68 (pulse 64). Monitored 30 minutes, BP 190/68.
Throat swelling and chest tightness three days after administration of vaccine. Symptoms were managed with over the counter antihistamines until 1/11 when the antihistamines were not working and my throat was swollen and tight, my chest was tight and my voice was horse. I got prescribed prednisone on 1/11 and have been on a long taper of that, with scheduled benadryl, pepcid and zyrtec.
Itching , redness, swelling of left upper arm, was warm to touch ; Taking benadryl and ibuprofen.
Awakened by extreme nausea at 2am. Vomited violently until stomach empty. Cold sweat and intestinal discomfort. Digestive symptoms eased after stomach was empty. By 9am, headache and fatigue for 12 hours.
After receiving the moderna vaccine at 2:30PM yesterday, I immediately had soreness in my arm of the injection site and had difficulty raising my arm without pain as the day went on. I woke up this morning with chills, 101.4 fever and aches.
Initial report received from a consumer on 11-November-2013. The five patients whose medical history and concomitant medications were not reported., received a dose of FLUZONE HD (lot number: UT4721AA, expiry date and site of administration was unknown) via intradermal route. Doctor stated that he administered FLUZONE ID to 27 patients and 5 of those 27 patients experienced reactions at injection site ranging in size from 1-2 cm up to 5 cm area at injection site that was red, had induration, was warm to touch, and painful. Outcome of the events was unknown. List of documents held by sender: none
Patient c/o nausea, fever, HA, fatigue 3 days, cont. sxs.
5 YO received Boostrix, when 3YO received Infanrix; 5 YO received Boostrix instead of DTap; when 3YO received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 13th September 2017), pediarix (received 2nd dose on 16th November 2017), pediarix (received 3rd dose on 13th February 2018) and Kinrix (received dose on 17th Oct 2021).   On 18th January 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 13th May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th May 2021, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 18th January 2023, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate age at vaccine administration were 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: 23-JAN-2023 Reporter's Comments:  Nurse reports 5-year-old male patient was administered a dose of Boostrix on 18th January 2023 instead of DTaP.   The patient had Infanrix on 13th May 2021. The reporter consented to follow up.  The Vaccine Administration facility was the same as Primary Reporter. Additional Supportive Information: The 5 year old patient received Boostrix on 18th January 2023 instead of DTaP, which led to inappropriate age at vaccine administration, wrong vaccine administered. The patient received Infanrix vaccine at age of 3 years, which led to inappropriate age at vaccine administration. Infanrix captured as a suspect as per conservative approach an more clarification has been raised.
Sore arm day of injection. A few days later fatigue along with joint and muscle pain.
Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which resolved over a few days, then she developed  bilateral ankle swelling and pain 80 hours later with a rash and swelling spreading up to her thighs and down through her feet.  hands also swelled and turned white (sounds like Raynaud's). knee pain resulting in difficulty sleeping at night. tachycardic on exam. evaluated in clinic on 6/11 and follow up on 6/15. noted loss of appetite for a week and fatigue. Myalgias made ambulation painful. instructed to use NSAIDs and elevation and she improved over the next few days
jittery; WEAKNESS; Feels very tired; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (jittery), ASTHENIA (WEAKNESS) and FATIGUE (Feels very tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Brugada syndrome. Concomitant products included QUINIDINE, METOPROLOL, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced NERVOUSNESS (jittery), ASTHENIA (WEAKNESS) and FATIGUE (Feels very tired). At the time of the report, NERVOUSNESS (jittery), ASTHENIA (WEAKNESS) and FATIGUE (Feels very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: fast (High) Fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Knot in arm; Swollen arm at injection site; Nausea; Severe arm pain; fever; Fatigue; Flu like symptoms; could barely move arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain) and PYREXIA (fever) in a 53-year-old male patient 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm).   At the time of the report, INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants are provided No treatments are provided
chills, 24 hours;  painful joints, 24 hours; lethargy, 4 days; lack of appetite, 5 days.   By day 6 was back to normal.