chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SOME CHILLS; FELT LIKE CRAP FOR A LITTLE BIT; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some chills, felt like crap for a little bit, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some chills, headache and felt like crap for a little bit was not reported. This report was non-serious.
Reported symptoms to Facility 1/11 directed to PCP, F/U with PCP 1/12 Dx Allergic reaction  and Follow up Labwork
the side effects were worse than when I had COVID; I felt like I was going to die; achy all over; difficulty breathing; coughing; tired; really bad headache; temperature of 102.4F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing) and COUGH (coughing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included BISOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, ROSUVASTATIN CALCIUM (CRESTOR), CITALOPRAM and ALLOPURINOL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE, CITRIC ACID, SODIUM BICARBONATE (ALKA SELTZER [ACETYLSALICYLIC ACID;CAFFEINE;CITRIC ACID;SODIUM BICARBONATE]) at a dose of 1 dosage form. On 02-Apr-2021, COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) High.     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.
Patient received vaccine to R Deltoid at 10:20am, by the evening developed moderate pain to entire right arm extending from right side of neck to fingers, to side of right breast. Patient also reports entire area is tender to touch. Patient reports "quarter dollar" sized redness to injection site with lump, and "quarter sized" redness, lump to anterior axilla near shoulder. Patient with no N/V, no fever/chills, no red streaks.
Patient given an adult dose of Pfizer diluted using 1.3mL of sodium chloride and drawn up to administer 0.2mL dose. Patient observed for 15 minutes with no signs of allergic reaction.
Pt had received vaccines and 10 minutes, post vax, as family was leaving clinic, they returned because pt became red with hive-like blotches on face, neck and back of arms. No respiratory distress. Doctor was notified and ordered Benadryl and cool compresses. 24 hours later there were no hives.
pt was given DPT & arm immed turned red, warm to touch, 6.5cm wide by 7.5cm long; MD ordered DPH & instructed pt to stay in clinic 1/2 hr; redness dec pt sent home; mom to given DPH x 3 days;
a patient received a dose from a FLUZONE QUADRIVALENT multidose vial (MDV) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no A/E; Initial information was received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via a physician Inquiry Number: 00899139).  This case involves a 54 years old male patient who received a dose from a INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multidose vial (mdv) that was opened and exposed to 22 Fahrenheit for 23 hours due to a refrigerator malfunction with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ713AA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "The caller reported a temperature excursion on FLUZONE (MULTI-DOSE VIAL, UNPUNCTURED) and wanted to know if the products are still suitable for use. Caller reported she needed to confirm, but a patient may have had received this vaccine and wanted to know if they would need to re-administer. She asks if the dose was valid or needs to be repeated."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, 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.
Patient is  9 years old and received purple top pfizer 0.3ml dose without dilution
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a currently 81-year-old female patient (pt). No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dose, vaccination site and route of administration were not provided) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.  Additional information has been requested.
Patient red 4 year immunizations at WIC office 11/29/06. Rash began left arm where mom states DTaP was given.
C/O heart beeping and throat hurting. Noted irreg heart rhythm. Sent to ER.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 10-MAY-2012 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 15-OCT-2013, the patient was treated at a health care facility for a painful rash that was diagnosed as Herpes Zoster with ophthalmic complication (a strain of shingles that has spread into the eye and caused vision loss). On or about 05-DEC-2013, the patient was treated at the same facility for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia, a chronic and permanent condition involving nerve damage and pain that occurs as a residual effect of shingles. While shingles and post-herpetic neuralgia are an incurable conditions, the patient has been prescribed VALTREX to manage his symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, the events of Painful rash diagnosed as Herpes Zoster with ophthalmic complications (a strain of shingles that has spread into the eye and caused vision loss) were determined to be medically significant. The event of treated for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia was considered to be disabling. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009733.
Dizziness; Vertigo; This is a spontaneous report from a contactable consumer reported for a patient. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not provided) via an unspecified route of administration, administered in left arm on 22Feb2021 09:15 am (age at vaccination was 52 years) as single dose for COVID-19 immunization.The patient's medical history included known allergies: Penicillin. Concomitant medications included Prilosec Omeprazole Magnesium, Crestor and Bystolic.On 23Feb2021 at 02:00 am, the patient experienced dizziness and vertigo. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse concerning to multiple unspecified patients. Patients' medical history, concurrent conditions, drug reactions and/ or allergies, and concomitant therapies were not provided. It was reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # M036059 and expiration date 03-JUN-2019  on multiple unspecified dates (the frequency, strength, and route were not provided). No adverse effects were reported. The storage conditions were reported as follows: temperature: 13.7 °C; time: 1 hour; there was no previous temperature excursion and a data logger was not involved. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a 67 year old female patient. On 04-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015), 0.5 ml, intramuscular in the left arm for vaccination. On 04-DEC-2013, the patient experienced swollen left arm, white colored at the injection site, and red around the edges of the injection site. The patient sought medical attention in the office doctor. The patient received treatment over the counter with oral BENADRYL (manufacturer unknown). The reporter stated that the patient's arm was still swollen but "going down" she was on the mend, and feeling good. This is one of several reports from the same source. Additional information has been requested.
What hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 as dose 2, single (Lot number: FT1614) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Known allergies: some preservatives" (unspecified if ongoing), notes: known allergies:some preservatives; "Known allergies: latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulphur, reaction(s): "Known allergies: Sulphur". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot No: 33130BA; Anatomical location: Arm Left), administration date: 07Jan2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset Jun2022, outcome "not recovered", described as "What hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip". The event "what hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal distension.  Additional information: The patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 3 (booster), single (Lot number: FP7135) in left arm for covid-19 immunisation. The patient did not received other vaccine in four weeks. The other medication in two weeks included OTC Supplements, Don't Know which ones, not taken daily. It was unknown whether the patient had covid prior to vaccination. The patient had been tested negative for covid post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201117095 same reporter/patient/product, different dose/events;
Mild to Moderate Stomach Cramping began approximately 3 hrs after vaccine and were off and on for about 36 hrs. Also had mild Lightheadedness during the 36 hours.
Patient stated felt mildly short of breath, shakiness and diaphoretic Patient vitals stable, refused medical transport and signed ama form
Shingles outbreak after 1st dose; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The nurse reported that the patient wanted to be administered with the 2nd dose of Shingrix. The nurse reported that this patient suffered a shingles outbreak after the 1st dose.  The patient did not administer the second dose of Shingrix. The reporter gave consent to follow up.
VERTIGO; RACING HEART; BLURRED VISION; CHILLS; FEVER; BODY ACHES AND PAIN; HEADACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced body aches and pain. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced vertigo. On 03-JUN-2021, the subject experienced racing heart. On 03-JUN-2021, the subject experienced blurred vision. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, chills, body aches and pain, vertigo, and racing heart, and the outcome of blurred vision was not reported. This report was non-serious.
symptoms began the next day (April 3) and continue to the present... exhaustion, difficulty staying awake / falling asleep during the daytime, confusion, disorientation, severe headaches, sensitive to sound and light
sz-like activity 30JUL97 has been on apnea monitor;neuro work up by ped neurologist negative;
Received GARDASIL # 2 9-17-10. LMP 10/4/10. Pt was using NUVARING. Pregnant now. 1/11/11 Pt terminating pregnancy.
Patient passes out with LOC during.  Patient states onset of feeling of chills 12hrs (2100) post vaccination and during time of onset of symptoms.  Patient denies hospitalization after event or signs of an anaphylactic reaction.  Patient denies shortness of breath or difficulty breathing post vaccination.
Pt vaccinated w/FLU developed difficulty walking out to the car, BP & Pulse normal. Felt clammy & blood sugar was 21. Also difficulty getting 1/2 cup coke swallowed was shaking & moaning,took to Hosp treated & observed in ER,admit for 1 day
did have a kind of a long term reaction / that's the way my body reacts.; i'm fine, it is nothing serious, just not feeling that great; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great). At the time of the report, ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She stated that's  she had bad reaction to shots and that the way her body reacts.   Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a registered nurse via a company representative referring to an 11 year old male patient. Pertinent medical history and drug allergies were not reported. On an unspecified date in July 2015 (reported as "last week") the patient was vaccinated with GARDASIL 9 (lot # and strength not reported, 0.5 ml, intramuscular injection) with 3 other vaccines: DTaP and MENACTRA (dose, strength and route unknown) (manufacturers unspecified) and hepatitis a vaccine (dose, strength and route unknown) (manufacturer unknown). The patient turned white and complained of being woozy right after receiving the 4 vaccines. No lab diagnostics studies were performed. Nurse observed him in the office for 15 minutes and gave him cold compress on injection site and some juice. Patient fully recovered within 15 minutes and was sent home. Causality was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Increased Tinnitus 9 days after injection. Has not subsided as of today.
Woke up 1/29 with body aches, chills, and fever over 102 until 10 pm. Called out sick for 1/30 due to symptoms. 1/30 symptoms improved but lethargy continued for the remainder of the day
Severe tinnitus. Sounds like cicadas or hissing in eight year all the time. Left ear also has tinnitus but not as loud. Has nothing gone away since it started in February. Some days it gets so loud I get a headache.
4"x5" large red raised painful bump  which was hot to the touch flu like symptoms-lethargy, sore throat, stomach upset The symptoms increased in intensity over three days, beginning to see decrease on fourth Treated with ice and Tylenol.  Antihistamin on first day.
PROLONGED INJECTION SITE PAIN. PATIENT REPORTS DOCTOR DIAGNOSED TENDONITIS.
Vaccine administered in the morning, baby was fussy all day, that evening at midnight she awoke with a fever of 100F, extremely fussy and irratable.  Unable to comfort.  We gave her infants tylenol.  Shortly after she awoke, she started to jerk (like she was being startled).  This lasted about an hour.  The fever broke about the same time the jerking stopped and she fell into a light sleep.  She slept the night but was very restless, she had some congestion.  She awoke alert and active with a low grade fever but fell back to sleep again after about an hour and slept very sound for 3.5 hours. When she awoke around noon, she was alert and active.
Patient misses the 2-6 month window; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The customer relationship management (CRM) request sent by sales representative on behalf of health care professional, would  like to know if the shingrix should re-started if patient misses the 2 to 6 month second dose window. The representative was unable to confirm if a specific patient was involved or if this was only a general inquiry.  This may be a duplicate adverse event. No other information available.  Could not confirm mailing address was current in health care professional's profile or if follow up was permissible.  Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The case was kept valid with worst approach considering that the patient was involved and missed the second dose.
Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and asked was it possible to still had muscle aches a week after having the vaccine. Additional Supportive Information: Follow-up would not possible as no contact details were available.