chrisvoncsefalvay/vaers-outcomes huggingface dataset:
coughed all night; broke up his chest congestion; coughed up a lot of phlegm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm). On 31-Mar-2021, COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm) had resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Significant Right arm pain Deep bone/joint pain Muscle pain Fatigue Mild headache Heartburn
Case previously recorded as MA2009-5227. Initial case report received from a physician via MedCom on 19 Oct 2009. A 10 month-old female patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no.: NA09-008308.
Patient said he was running fever and felt fatigued for 2 days, no other symptoms.
Starting experiencing throat soreness on 5/19. I tested positive for Covid on 5/20. I started experiencing extreme fatigue which persisted throughout the weekend accompanied by chills and high temperature. Experienced headaches and coughing. Tele doctor on 5/23. Sore throat started to fade on 5/23 and feeling better on 5/24.
Headache; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided
Initial report was received from a consumer, who was also the patient, on 15 August 2012. A 42-year-old female patient had received a dose one intramuscular injection in the left deltoid of IMOVAX Rabies, Sanofi Pasteur SA (lot number not reported) on 13 August 2012 for pre exposure. Right after the vaccination, the patient felt soreness at arm at the injection site. On 14 August 2012 at 3:00AM, the patient experienced severe abdominal pain, diarrhea, blood in stool, fever and chills. Corrective treatments included rest and fluids. The patient was to return to the physician if symptoms continued. The patient had no illness at the time of vaccination and an allergy to sulfa. The patient's outcome was unknown. Documents held by sender: None.
I got the Pfizer?BioNTech COVID-19 vaccine Monday 8/2/21 and woke up Wed 8/4/21 at 4:00 am with a pounding heart and very fast heart beat.  It lasted about 20 seconds after I woke up.  I called my physician and she told me to get rest and if it happens again and lasts longer to go to the ER.
Significant tinnitus 8 hrs after the 2nd dose.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10May2021 at 16:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. On 11May2021 at 01:00, 8 hours after the second dose, the patient experienced significant tinnitus. The patient had first dose 3 weeks prior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant tinnitus 8 hours after the 2nd dose was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.
Very severe restless leg syndrome and sleeplessness the first night. Subsequently, and at night for almost a month now - sleeplessness, restless leg syndrome and itchy skin. (The sleeplessness can endure just a couple of hours or until almost 6 a.m. some nights.) This is the first time I have had a reaction beyond the usual arm pain/feeling like you're coming down with the flu at the very beginning.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Patient had redness/swelling/pain in the upper left arm. She said it never worsened or spread, but did last for 7 days. Patient never had a fever or systemic symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: G49694) and on 25Apr2023 as dose 5 (booster), single (Lot number: GJ3268) for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9266) and on 16Apr2022 as dose 3 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measure taken as a result of drug ineffective, covid-19 included administration of Paxlovid.
This spontaneous report was received from a pharmacist regarding a 63 years old female patient. The patient had a previous history of cold sores. On 06-JAN-2013, the patient was vaccinated with dose 1 live ZOSTAVAX(lot#, dose and route not reported). No concomitant medications were reported. On an unknown date in January 2013, the patient experienced a flare up of her cold sores following vaccination with live ZOSTAVAX. It was unclear how soon after the vaccination with live ZOSTAVAX the cold sores flared up. The patient wanted to take VALTREX for the cold sores which she had previous episodes of cold sores. The patient sought medical attention (contacted the pharmacist). No laboratory diagnostics studies were performed. The outcome of flare up of her cold sores was reported as not recovered. The relatedness for flare up of her cold sores was unknown for live ZOSTAVAX. Additional information is not expected.
Extreme burning sensation starting over a week after second dose and has continued throughout the entire body and has increased in intensity. It feels like a sunburn under the skin or as if I had shingles all over my body. Pain level 8/9.
Painful arm and warm to touch at injection site the day of injection, March 5,  that continued through March 15 Extreme joint pain on March 10 & 11,  mild joint pain through March 15 Headache on March 10 continued through March 14 Sleepless nights began on March 10, lasting through March 15
anaphylaxis requiring intubation, stable after extubation and discharged from hospital intubation required the morning after he got the vaccine at around 11am the previous day
Fever - 24hrs Fatigue - 24hrs Vomiting - once around 7:00 PM on May 16 Headache - about 9 hours starting at 1 on May 16
My symptoms included severe chills, 100 degree fever, nausea, headaches, and fatigue.  These symptoms lasted approximately 48 hours.  The headaches, however, continued for six days.  I did not go to an emergency room or urgent care clinic.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported   This case was linked to MOD-2022-551714 (Patient Link).
Severe chills starting 11 hours after administration.  Severe fatigue entire day after administration, milder fatigue for 2 days thereafter.  Swelling of injected deltoid muscle noted 3 days after injection, swelling reduced over following 4 days.  Bruising 3 to 4 inches in diameter noted 3 inches below injection site (at approximate location of deltoid insertion) developing 5 days after injection and still noticeable 2 weeks after injection.    Bruising still noticeable at time this report submitted
I took the call from the patient & she proceeded to say that she "by no means" wanted to complain about her experience but she got a vaccine from a pharmacist on 9/26/22 who "doesn't know how to give vaccines." She said the vaccine was given way too high on her arm & her husbands was given way too high also, but he is fine & she is injured. She said she went to the Dr & the Dr confirmed it was high based on her pointing to where it was given & referred her to physical therapy which she now is going to. I explained that when errors like this are reported to us, we follow a procedure of filling out a VAERS report & internal incident report to document the incident. She immediately objected saying she didn't want to be part of ANY reporting or give any more information. Patient refused to give which arm or which vaccine was involved & didn't want to be contacted so I don't have any other information. The clinical pharmacy specialist & privacy specialist from our company confirmed that we still have to report this information despite her objections & despite their being a lack of information as she wouldn't give any more necessary information.
Projectile Vomiting, no bowel movements. Saw P.A. Sent to emergency room where he received an xray, then transferred to Hospital. He was given a barium enema to reverse intussusception.
It has been more than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Itching, swelling in a square shape around injection site and tender to touch.  15 days after injection.  Still there and on day 3.  I have read they are calling this Covid arm.
received her 1st dose of our COVID-19 vaccine last 03/08 but dated 03/11 she tested COVID-19 positive; This is a spontaneous report received from Pfizer sponsored program  via contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Mar2021, the patient experienced received her 1st dose of our covid-19 vaccine last 03/08 but dated 03/11 she tested covid-19 positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hives all over body.  Took Benadryl. Then nausea, vomiting and diarrhea. Symptoms resolved about 10 hours later.  Then about 4 hours later he began to lose peripheral vision in his left eye.  This resolved after about 30 minutes.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal nasal solution (frozen) was received from a 41-year-old female consumer who experienced severe joint pain. At 41 years of age, the patient received a dose on 18-Dec-2003. Medical History: The patient's concurrent illness includes rheumatoid arthritis. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 18-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included ibuprofen (manufacturer unknown). Event Details: on 18-Dec-2003, hours after receiving Flumist, the patient developed severe joint pain. She took ibuprofen with no relief. As of 19-Dec-2003, the pain continued. Related case(s): See related case(s): HQWYE914824DEC03 (In 2002, the patient received a flu shot (manufacturer unknown), and in the first 24 hours, she experienced severe joint pain.) No additional information was available at the time of this report.
Headache; Fatigue; Swollen knee joint; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0183) via an unspecified route of administration in the left arm on 10May2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). Prior to 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. On 11May2021 at 13:00, the patient experienced headache, fatigue and swollen knee joint. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events headache and fatigue were recovered on an unknown date in May2021. The clinical outcome of the event swollen knee joint was not recovered (as of 6 days later as reported) at the time of this report.   No follow-up attempts are possible. No further information is expected.
Major diarrhea, vomiting, body ache, chills for first day. Milder for day two.
pt rcvd vax; pt devel sinusitis & upper respiratory infection; was treated w/ antibiotics;
First my bp my who life has been 130/80 I first noticed I was feeling very flushed, didn?t make much of it. I don?t take my bp,often, dr offices etc. 4 weeks ago, I felt pressure around eyes, in back of neck, weak, dizzy. My bp had spiked to 203/104, my husband called the ambulance. I went to ER. Bp went down, I came home, same thing happened the next day. Back in again.... Since then, I have had just about every test possible. I am perfectly healthy on paper. I just don?t know what to,do.... have now taken some bp meds and beta blocker. I can feel my bp spiking several times a day. 170/93 and then after a while back down again. I feel like I might be allergic to whatever is in my body. My hands and face tingle, I feel hot and then cold.  I am praying this will ease it way out after the vaccine wears off. Needless to,say I am super concerned. I have ALWAYs been very healthy, fit and happy with a busy life.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned a male of unspecified age. 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested.. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
I lost vision mainly in my right eye, could not understand letters/words, could not think of or properly form words/sentences, experienced numbness in the arms, hands, mouth and face.  I was taken to the ER and treated for a stroke.  Within about 2 hours my normal faculties were back to normal and then experienced a headache for several days.  I spent the night in the hospital and was released with what was assumed to be a complex migraine but they could not rule out a TIA (mini stroke).  I saw a neurologist in the hospital and had a follow up appointment with another neurologist within a week of my release from the hospital.
Adverse Event: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed. loculated pleural effusion in the left long, worse than previous scan in June(has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed. on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 80, 416, 1172, 24, 336, 168 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sudden severe abdominal cramps and heavy diarrhea; after several minutes, problem subsided and has not recurred.
Felt feverish, chills, muscle aches, cough, chest pain, headache, loss of taste and smell.
3 mo infant rec'd DTP/HIBTITER/ORIMUNE 1MAR91; had no sx; Next morning 2MAR91 infant was found dead in crib by mom; autopsy is being performed;
Sore arm getting worse after 3-4 weeks having difficulty lifting arm higher than shoulder.
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with the second doses of GARDASIL. A week after the patient experienced herpetic lesions at the the front of her legs where the underwear touches. Patient denied having any sexual history. Unknown medical attention was sought. Patient outcome is unknown. no product quality complaint was involved. Additional information has been requested.