chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer who reported for herself, enrolled in a Pfizer-sponsored program, (Pfizer RxPathways); this report regards an event part of the medical history of the patient. A currently 68-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunisation, ADVAIR, (lot 7DP5590, exp date Feb2019), on unspecified dates, at unknown dose and route, for an unspecified indication and SPIRIVA, via an unspecified route of administration from 2013 and ongoing at 1 breathing capsule in a handheld deal once daily every morning for longer bronchodilator. The patient medical history included ongoing COPD and emphysema. Concomitant medications were not reported. The patient previously received a pneumococcal vaccine on unknown date for immunization. The patient experienced pneumonia while taking tiotropium bromide and fluticasone propionate, salmeterol xinafoate on an unspecified date in 2015 or 2016 with outcome of recovered. The patient was hospitalized due to the event. The action taken for fluticasone propionate, salmeterol xinafoate was unknown, for tiotropium bromide was dose not changed. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Information was received from a female consumer of unknown age. On an unknown date the patient was vaccinated with GARDASIL. The patient reported she was vaccinated in her 27th week of pregnancy. She did not specify which dose this was. She reported that she experienced no adverse events. No other information was provided. Additional information is not expected.
Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 05-FEB-2007 was vaccinated with a dose of HPV (lot# 654540/1162F). On 05-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-activated because of her reactions which were she "felt woozy" and her eyes were fluttering, and her whole body was shaking. It was noted that the patient did not lose consciousness. The patient will come back in two months to get re-vaccinated. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 01-FEB-2007 was vaccinated with a dose of GARDASIL (lot# 654540/1162F). On 01-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-vaccinated because of her reactions which were that she "felt dizzy" and her eye rolled upward, and her whole body was jerking. Upon calling the patient's name, her eyes opened wide and focused on her mother and the nurse. Her body stopped jerking and she stated, "I just feel dizzy." It was noted that the patient did not lose consciousness. The patient rested a while on the exam table and walked out of the office on her own. The mother was instructed to call the office if anything appeared to be out of the ordinary. No call was received. The patient will come back in two months to get re-vaccinated. On 01-FEB-2007, the patient recovered. Additional information is not expected.
I have something like them / Really nasty; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I have something like them/Really nasty). The outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-MAR-2023 This case was reported by a consumer via interactive digital media. The patient had something like them (shingles), which started shortly after his/her first shingles vaccine.  The patient stated really nasty. Seeing doctor tomorrow to find out what it was.  Follow-up would not be possible as no contact details were available.
I have been experiencing internal heat on Left shoulder, where the flu shot was given.  The heating in my shoulder has expanded toward my back part of the same shoulder. I some times feel very hot in cold temperatures and if I lay my left arm on a cold table. it feels hot internally. If that make sense. I talk with my doctor and explained it to her and nothing she could do to help. There is no bruising, rash or pain. I have full mobility of my arm.
Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning slow; Chest felt heavy; Flu-like symptoms; Weakness; felt like i couldnt move; Chills; Arm pain; Fever; Nauseous; Fatigue; A spontaneous report was received from consumer concerning a 63-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, nausea, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, hypothermic, alternating sweats and cold, tingling in hands and fingers, functioning slow.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of mRNA-1273 (batch number: 025J20A) on an unknown date. On 2 Feb 2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the consumer experienced the events arm pain, nauseous, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms. On 4 Feb 2021, the patient experienced the events hypothermic 93 f, alternating sweats and cold, tingling in hands and fingers, functioning slow. The event hypothermic 93 F was considered medically significant.  Treatment details included paracetamol and ibuprofen to relieve symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, fever and alternating sweating and cold, was considered recovered/ resolved on 04 Feb 2021.  The outcome of the events, arm pain, nausea, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, tingling in hands and fingers, functioning slow, were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Patient received flu vaccine on 8/18/21 in the morning around 10 AM. Patient reported pain and discomfort in arm/shoulder on 8/23. Patient shared with pharmacist a picture of her injection site which included the location as evident on the upper deltoid and without apparent redness or swelling. Patient was counseled to use over-the-counter NSAID's such as ibuprofen, icing, and light stretching. Patient stated that she has felt improvement in her arm discomfort and pain, but not full relief. Patient returned to her normal physical activity including hot yoga. On 8/30, patient still reported sharp pains recurring especially at night still.
Patient was given Pentacel vaccine that did not get reconstituted thus ended up getting the Dtap and IPV only and missing the ActHib.
The mother put the current date instead of the child's birth date.  When checked in MICR her birth date is 3 days from now.
Pt woke up day after injections with small red nodule at site of injection, was sent to school and when arrived home, area had gotten bigger with multiple bumps.  On the second day, are was red, firm to touch, warm and he was taken to the ER.  He was diagnosed there with allergic reaction and given PREDNISONE and BENADRYL.  FU in the office on 8-31 showed continued resolution of the area.
Patient admitted to hospital with multiple PEs, started on heparin drip and discharged on oral anticoagulation. Received vaccination covid booster dose 10/27/2021, has onset of chest pain and sob on 11/2/2021. CT PE showed multiple PEs
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
PT started experiencing itching at 9:30pm that evening in opposite arm (right).  The following  day, had "spots"/rash developed. around 6pm on that arm and both sides of neck and face.  "spots" were itchy.  upon talking to mom, she looked and noticed spots on chest and back.  Nothing below waist line and nothing really on left arm (vaccinated arm).  no breathing issues.  Patient instructed to be given benadryl, watch rash, and page pediatrician.  Pediatrician said same...benadryl and watch rash
We were conducting a booster clinic at a facility. We were told by medical staff that everyone showing up to the clinic was eligible for a booster, per their Medical Director. Individuals receiving boosters did not have access to their Covid-19 record cards for nurses to verify before giving the vaccine. Afterwards, when inputting doses into the database, it was discovered that this individual had received their booster dose too early per CDC guidelines, they were eligible to receive their booster on 12/06/21 but received it on 11/18/21. They were monitored afterwards per CDC guidelines and no adverse events occurred.
Fever (103 deg), inconsolable, fussy, restless sleep, abdominal distress
Irritation in RIGHT EYE (like corneal scratch). Visited ophthalmologist, and his diagnosis was IRITIS (rheumatoid arthritis (RA). He prescribed PREDNISOLONE AC 1% OPTH SUSP eyedrops for 1-month. Irritation cleared up (on both occurrences).   Patient was referred to rheumatologist, who ordered a battery of blood tests for RA. Test results for ANTI-CCP Ab. IgG/IgA was 39 - ABNORMAL.   2nd dose Moderna received 3/11/2021 ADVERSE EVENT: IRITIS in right eye occurred 04/05/2021. 3rd dose Moderna (Booster) Received 11/05/2021 at pharmacy. ADVERSE EVENT: IRITIS in right eye reoccurred 01/08/2022.
This is a 75 year old male with a PMH/PSH as noted below. r. Per daughter, the patient's home caretakers are ill with presumed Covid. Patient also goes to HD T, Th and Sat. Approx 2 days ago, patient seemed to be more somnolent and less verbal than his baseline which is answering simple questions. Today, the daughter called the HCF to evaluate and his pulse ox was in the 80s, oxygen was applied and he came up to over 90% per daughter. In the ED, he was initially on NRBM by medics and then to 4liters with sats of 94%. Patient is vaccinated.
About 6 weeks after vaccine I was diagnosed with a breakthrough case of COVID-19. Symptoms were extreme fatigue, headache, and mild chills. No fever, sore throat, or cough. Doctor prescribed PAXLOVID.
1350 Feeling anxious and weird, HX seizures as a child,  1413 Zyrtec given laid down Semi Fowlers position 1444 Report feeling nasal congestion throat swelling has improved.  Vitals 124/84, P-79 SPO 97 % Exited and in stable condition.
started (@12pm) with a low headache, then increased throughout the day. Very tired, chilled, and achy about 2 hrs after the headache started. Started to itch all over, along with a rash that was blotchy all ver body. temp was low grade @99 degrees. as evening became closer, the temperature started to rise. achiness and be chilled was rotating with achiness and being warm all evening. still had headaches at bedtime. the itchiness was bearable with Benedryl. about 1 am body temp jumped to 104 with a laser thermometer. a running fan and cold washcloths were applied for at least 4 hours to bring it down.  by morning, temp was about 100 and slowly going down. most of the day was exhausted, tired, and dealing with itchiness, headaches, chills, and achs. kept fluids, OTC pain meds, Benedryl, and sleep for the next 3 days.  seem to take 4 weeks to get close to normal.
A week after receiving a vaccine of Hep A peds and varicella on the left thigh. Pt presented with redness and a small bump of a size of a nickel. Negative for fever, pt advised to put a warm compress on the site and monitor the child for any sign of fever and increase of the site, and on any case of that to go to the closest urgent care.
Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023; No adverse event; Dose was administered after more than 12 hours post first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture), PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered after more than 12 hours post first vial puncture) and PRODUCT STORAGE ERROR (Initially stored on 20-Feb-2023, First punctured on 21-Feb-2023 and administered on 24-Feb-2023).    The concomitant medication was not reported.  The date of last administration was 24-Feb-2023.  The treatment medication was not reported. The dose was administered more than 12 hours post puncture. It was confirmed that the vial had not undergone any temperature excursion issue. The information about individual vial used was unknown. The vial was initially stored in the refrigerator on 20-Feb-2023, first punctured on 21-Feb-2023 at 06:00 am.  Administered on 24-Feb-2023 at 07:45 am and 8.45 am  respectively. None of the patients had reported any adverse events after the vaccination.   Treatment medication information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712701 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Non-significant follow up received, updated reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712701:60 years old patient
Diffuse maculopapular rash on face, exerting, trunk, back starting on 29 May 2009.
Parent reports lump at inj site after inj that is now gone but has 1.5 inch pink mark with a few raised areas that appear hive like. No streaking, fever or pain.
4-5 days after shot patient had extreme fatigue for three days, a frontal headache and no temperature. The fatigue caused her to stay in bed for one full day.
Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAY-2016, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In December 2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Can not eat; severe nausea; very weak; wife was aching and out of sorts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Diabetic and Kidney disorder (kidney issues). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (wife was aching and out of sorts) (seriousness criterion hospitalization prolonged). On 27-Mar-2021, the patient experienced NAUSEA (severe nausea) (seriousness criterion hospitalization prolonged) and ASTHENIA (very weak) (seriousness criterion hospitalization prolonged). In April 2021, the patient experienced FOOD INTOLERANCE (Can not eat) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to ASTHENIA, MYALGIA and NAUSEA, and then on sometime in April 2021 due to FOOD INTOLERANCE. At the time of the report, MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown (Inconclusive) unknown. In 2021, Laboratory test: unknown (Inconclusive) unknown.         On 27-MAR-2021, the patient had severe nausea, was very weak and went to the emergency. The patient was admitted for 3 days. Reporter stated his wife was transferred to another hospital for 7 days and then transferred to a rehab for 3 days. The patient was currently back at the first hospital with severe nausea and can not eat. The doctors who had examined the patient could not figure out from where the severe nausea coming from or how to stop it. The patient was given nausea medication. Action taken with mRNA-1273 in response to events was not applicable.  Company comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-081839, MOD-2021-081707 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-081839:Case for dose 1 MOD-2021-081707:same reporter
Ear pain; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed ear pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on (date of vaccine not provided) intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist called to report that she has received an email from HR at her work facility asking if ear pain is a common side effect of the Moderna vaccine due to a "couple people experiencing it".  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, ear pain, was considered unresolved.   The reporter did not provide an assessment of the event, ear pain.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
On 9-16-09 small, itchy, fluid filled lumps appeared entire body except for face, palms of hands and soled of feet; pt self treated with OTC hydrocortisone cream. Pt is a retired RN and did not seek medical care. Areas remain on body 9-30-09 but healing scabs
C/O injection site soreness, swelling and increasing pain that was worse on Saturday (7-28).  Then diarrhea on Sunday with headache on Sunday night.  Went to local ER 2 AM Mon morning with c/o "throbbing" headache.  ER staff noted photophobia, PERL, neck supple.  Pt was given IVF and IV MS, with relief of headache.  CT of head showed no acute process.  Pt discharged to home with Rx for lortabs, instructions to stay off work for 2-3 days, and apply ice packs to injection site.