chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a Not Serious Spontaneous case from a Pharmacist in the USA of stuffy nose, achiness, and cough. The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety surveillance accelerated reporting agreement for FluMist. An 8 year old female who received on 1/06/06 with family reported stuffy nose, achiness and cough. No history of close contact with flu or a cold. The pt's physician did not creat symptoms. The symptoms are still ongoing.
Experienced sudden hearing loss 4 days after first vaccine dose, hearing loss did not worsen after second vaccine dose. An MRI brain was done, no evidence of ischemic or hemorrhagic event.
03/07/03 Chest pain 03/10/03 Saught medical care, heart cath done, revealed right bundle branch block
Severe Fatigue in first week - lengthy sleep and actually slack-jawed at times.  Fatigue has lingered, with brain fog - difficulty finding words, difficulty staying awake, difficulty staying focused.  Feeling of slight numbness/fatigue from shoulders up.   Similar feeling to jet lag.   It's been 4 weeks.    Blood work was done - vitamin b12 deficiency is all - all other measurements were fine.
SORE ARM AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Surgery (botched surgery from 30 years ago) in 1992. Concurrent medical conditions included Diarrhea (Since 1992, the patient had ongoing diarrhea that had gotten worse in 2022.) since 1992.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE). In March 2021, VACCINATION SITE PAIN (SORE ARM AT INJECTION SITE) had resolved.            Concomitant information was not provided.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was linked to MOD-2022-584794, MOD-2022-584726, MOD-2022-584796 (Patient Link).
Big red patch on left arm. Patient described that female was itchy, hot & little painful. Patient tried taking TYLENOL, BENADRYL and Hydrocortisone cream but not a significant difference. Going to see MD next.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). The physician reported that the patient "developed a zoster type infection 4 days after injection and was now blind in one eye". The patient sought unspecified medical attention. Unspecified treatment was given for the events. At the time of the report, the patient had not recovered. Blind in one eye was considered to be disabling. No further information is available.
This spontaneous report was received from a 69 years old female patient with chronic obstructive pulmonary disease (COPD), sulfa allergy, KEFLEX allergy and penicillin allergy. The patient who had a prior episode of shingles was vaccinated with live ZOSTAVAX (dose, route and lot not reported) on 14-MAR-2011 on the recommendation of her physician. No other co-suspects were reported. Concomitant medications included: steroids (unspecified). The patient developed a second case of shingles on 21-JAN-2013. The patient exhibited a red burning rash on her left butt cheek. The patient felt it may be triggered from all the medications especially the steroids. The patient was treated with valcyclovir 3 times daily. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
This spontaneous report was received on 29-JUN-2017 from a registered nurse concerning a male patient of unknown age. No information regarding the patient's concurrent conditions, concomitant therapies, allergies or medical history was provided. On 26-JUN-2017, the patient was vaccinated with an improperly stored dosage of M-M-R II (route and dosage not reported) lot # L040960, expiration 16-OCT-2017 for prophylaxis. Concomitant therapies included sterile diluent lot number 041248, expiration 27-JAN-2018. No adverse event was reported. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004049.
04/19/22 presents to ED for "bilateral lower extremity cellulitis". PMHx of "hypogonadism, and past surgical history of lipoma resection and cholecystectomy"
31Aug90 pt vax; also vax w/ ProHIBit; 10Sep90 devel fever 102-104F, tonic clonic seizures of 1 1/2 min duration, rash.  Fever lasted 48-60 hrs.
Onsite reaction (redness, swelling) where ZOSTAVAX was administered. (left arm)
SYRINGE MALFUNCTION. LOOSE NEEDLE CAUSED 90% OF VACCINE TO SPILL OUT OF NEEDLE AT LUERLOK CONNECTOR. <50% DOSE ADMINISTERED. PT. REDOSED W/O ISSUE.
07/03/22 presents to ED for "abdominal pain". PMHx of "type 2 diabetes, hydrosalpynx, and recurrent UTIs"
eyes wouldn't focus well; fever; headaches; back felt sore; eyes stuffy; This spontaneous case was reported by an other and describes the occurrence of OCULAR DISCOMFORT (eyes wouldn't focus well), EYE DISORDER (eyes stuffy), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EYE DISORDER (eyes stuffy). On an unknown date, the patient experienced OCULAR DISCOMFORT (eyes wouldn't focus well), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore). At the time of the report, OCULAR DISCOMFORT (eyes wouldn't focus well), EYE DISORDER (eyes stuffy), PYREXIA (fever), HEADACHE (headaches) and BACK PAIN (back felt sore) outcome was unknown.            This case was linked to MOD-2021-169804 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up document received on 25 May does not contain any new information
pt recvd vax & was instructed to take apap q 4 hrs;par didn't give apap,awake w/ high pitched scream;purple lips; limp; hard time breathing; purple under eyes & moaning;given apap;pt taken to ER & adm for observ; t 103;lethargic
Headache; Injection site pain; haziness; lack of focus; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) via an unspecified route of administration on 16Feb2021 at 11:15 AM (at the age of 23-year-old) in left arm as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) via an unspecified route of administration on 26Jan2021 at 11:15 AM in left arm as dose 1, single for COVID-19 immunisation and experienced felt very dizzy, severe headache for 2-3 days, lips turned blue but returned to normal color an hour later. No COVID prior vaccination. Not tested for COVID post vaccination. On unspecified date in Feb 2021, the patient experienced haziness, lack of focus, headache and injection site pain. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering.  Follow-up attempts was completed. No further information was expected.
Information has been received from the father of a 16 year old female consumer with no medical history and/or drug reactions/allergies who on 04-Sep-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot not reported).  There was no concomitant medication.  During the first part of October, 2007, the patient experienced swollen ankle.  The patient went to the ER and was diagnosed with ankle sprain.  "A couple of days later" her other ankle swelled.  At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arms and legs."  Unspecified blood work was performed (results not provided).  At the time of the report the patient was recovering.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/7/2008. Information has been received from the father of a 16 year old female (119 lbs., 62 inches) with no medical history and/or drug reactions/allergies who on 04-SEP-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine (Lot #657872/0515U). There was no concomitant medication. During "the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arm and legs." Unspecified blood work was performed (results not provided). The patient recovered from her experiences on 17-DEC-2007. No further information is expected.
After the second dose of the vaccine, I got a large welt on my arm which swelled up around the shot. It was puffy and red. I have Fibromyalgia and about a week after the vaccine my muscles felt like they were a little atrophied. I was a little weak and tired. It was a subtle feeling and it lasted for about a week. I have that feeling very rarely and it does not last that long. They felt like they were shrinking.
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K012457, expiration date 04-JUN-2017; lot M011116, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1610USA010976:
Mother brought child back into clinic at 11:40 AM. Reports she is crying and not making any sense with words. Ex: saying he when she should be saying she. Not knowing where she is. Reports right hand numb, right side face=tongue numb. Didn't feel right after vaccine gave but, didn't report to RN. Client reports numbness gone at 12:00 PM when left with mother, ambulating without assist. RN scheduled appt. today with PCP to evaluate.
A 19 year old male pt had received an IM, left deltoid, first dose injection of Menactra, lot number U2057AA, on 6/12/06. The following day, the pt developed a small pea sized lump in his left collarbone area and a twinge pinch felling. At the time of this report, the pt had not recovered.
5 hours after vaccine - Headache, muscle soreness, fever, chills, sweating due to fever. Fever lasted about 8-10 hours during sleep. Tylenol was taken every 6 hours after vaccine. Minor Headache and muscle weakness lasted for 2 days post-vaccination.
After HPV (third vaccine given during visit) patient became pale and stated she felt like she was going to "pass out". Patient lost consciousness for 30 seconds, nurses provided ammonia inhalant and patient regained consciousness and was monitored for 15 minutes after event before she was released.
pt reported sx of nausea & vomiting;also reported has frequent bouts w/elevated BP that result in nausea & vomiting;c/o inc BP p/vax;
sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reported for herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly on 16Dec2020 at single dose at right upper arm for COVID-19 immunization. Medical history included Asthma: She explained she had seasonal asthma as a kid and as she got older, it got worse, she couldn't remember when. The patient's concomitant medications were not reported. The patient received the first COVID vaccine on 16Dec2020. She clarified further with the first vaccine, she was fine. She had a sore arm and that's it in Dec2020. With the first COVID vaccine, she had a sore arm but has recovered completely from it. She got the first vaccine and it didn't hurt or anything. Her arm started to get sore in the early hours of the morning like 1am. She thought it took her 2 days to recover completely and then she was fine. Investigation Assessment was no. Vaccination Facility Type was Hospital, not Administered at Military Facility. The outcome of the event was recovered on an unspecified date in Dec2020.
This is a spontaneous report obtained from a non-contactable Health Care Professional through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history was unknown. On an unspecified date, the patient experienced swelling and infection in arm after co-administration with flu vaccine. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are possible, information about lot number cannot be obtained. No further information expected.
Pain in arm; Itching; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced pain in arm/pain in extremity and itching/pruritus.   The patient's medical history included osteoporosis. Products known to have been used by the patient, within two weeks prior to the event, included denosumab.  On 11 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route in arm for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient experienced pain in arm and itching.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event pain in arm and itching was unknown.
she has not gotten the second one; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment products were reported.   Reporter did not allow further contact
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 07Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2022 as dose 4 (booster), single (Lot number: 062F22A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "overweight" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Sep2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective COVID-19 which included as PAXLOVID as prescribed from 30Aug2023 until 04Sep2023.  No follow-up attempts are possible. No further information is expected.
Approximately 3 hours after injection I had the following symptoms: difficulty breathing, cold sweat, body aches and weakness. Then in another two hours turned into severe nausea, dizziness. Symptoms lasted 12 to 15 hours. Was very close to going to the emergency room when I fell asleep.
w/in 1min of inj pt exp severe pain in rt arm elbow to middle of the humerus;that same day exp fever, congestion & edema, tenderness & warmth from the elbow to the shoulder of the rt arm;congest & edema;t101.2;cough;sputum w/blood;
administered dose, expiration of 08Feb2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were provided as follows: The patient was administered an expired dose of Twinrix, which led to expired vaccine used. At the time of reporting, the dose had not been repeated.  The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Tingly-numb on left pinky finger, and tingly on left ring finger, and numb on 1/3 of left palm towards my pinky; headache; left eye (reading eye) was tired.; bedtime tingly left pinky finger/left side of thigh felt tingly; full left hand felt limp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 17:00 (Lot number: 301308A) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "breast cancer", start date: 2015 (unspecified if ongoing); "osteoporosis", start date: 2020 (unspecified if ongoing); "cataract surgery" (unspecified if ongoing); "Monovision" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; ALENDRONATE. Past drug history included: Taxol, start date: 2016, for breast cancer, reaction(s): "my feet felt tingly", notes: 5 years ago I had chemo for breast cancer and my feet felt tingly from Taxol/paclitaxel. It felt like that except chemo was multiples worse; Paclitaxel, start date: 2016, for breast cancer, reaction(s): "my feet felt tingly", notes: 5 years ago I had chemo for breast cancer and my feet felt tingly from Taxol/paclitaxel. Vaccination history included: Jj vax, administration date: 12Mar2021, when the patient was 59 years old, for Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 07Oct2021 23:00, outcome "unknown", described as "bedtime tingly left pinky finger/left side of thigh felt tingly"; MUSCULAR WEAKNESS (non-serious) with onset 07Oct2021 23:00, outcome "unknown", described as "full left hand felt limp"; HYPOAESTHESIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Tingly-numb on left pinky finger, and tingly on left ring finger, and numb on 1/3 of left palm towards my pinky"; HEADACHE (non-serious) with onset 08Oct2021, outcome "unknown", described as "headache"; ASTHENOPIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "left eye (reading eye) was tired.". Therapeutic measures were not taken as a result of paraesthesia, muscular weakness, hypoaesthesia, headache, asthenopia.   Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: letrozole, alendronate, store vitamins (various). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. known allergies: no.   No follow-up attempts are possible. No further information is expected.
PT BEGAN ITCHING ALL OVER BODY, AND THE VACCINATION AREA BEGAN TO BECOME WARM TO THE TOUCH. THE PATIENT THEN STATED THAT THE SIGHT BEGAN TO ITCH MORE SEVERLY. PT STATES THAT THE SIGNS AND SYMPTOMS HAVE WORSENED AND SHE IS BEGINNING TO FEEL "TINGLING" IN THE HAND OF THE ARM THAT THE VACCINE WAS ADMINSTERED. PATIENT TOOK ALEGRA AND BENADRYL THIS MORNING ALONG WITH TOPICAL HYDROCORTISONE. THE PATIENT HAS SCHEDULED AN APPOINTMENT TO BE SEEN BY HER PRIMARY CARE PROVIDER.
"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021.  On Jan. 21st, 2021, I woke up feeling feverish.  I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy.  Suddenly, I passed out and hit my head and upper neck on the tile floor.  My parents heard the sound of my fall and luckily rushed to the bathroom.  They found me lying  unconscious on the floor with my eyes rolled up for what felt like more than a minute.  I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in.    I felt too weak to get up and walk, and the back of my head and upper neck were in pain.  I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area.  I went to the local hospital in an ambulance.  I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm
Pt came to clinic on 12/30/08.  After leaving PCP's office (in clinic at approx. 5pm) - had tennis ball sized area of inflammation, redness at left arm - above antecubital area.  Was prescribed KEFLEX by PCP.