chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced headache, confusion, slightly blurred vision, dizziness, decreased ability to concentrate, and generally unclear thinking.
Awakened by dry mouth, , hoarseness, swelling in throat and difficulty swallowing, weakness, tiredness, headache, shaking and blurry vision. Used home medications--Trelegy inhaler, Albuterol inhaler, Benadryl, and Tylenol.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site for 3 days after getting the vaccine on an unspecified date. The patient recovered from the even on an unspecified date. Information on batch number has been requested.
immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.
hypotonic, hyporesponsive event w/in 24 hr of vax, no apnea noted; no CPR required;
Second dose received 24 days after the first dose; had a rash from his feet to his neck,stated it was hives./big welts; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose) and URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had covid some time ago). Concurrent medical conditions included Hearing decreased and Allergy.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose). The patient was treated with PREDNISONE for Hives, at a dose of high dose. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose) and URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts) had resolved.            Caller stated he had covid some time ago. It could not be clarified if it was from before or after the vaccine.  No Concomitant medication information was reported.
sick; Sneezing; Coughing; Runny nose; clogged nose; has a head cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program.  This consumer reported for himself that a 57-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported, caused problems with urination so he stopped it. Stated that it dried up his urination, he was told that it could have been both which dried it up and it resolved when he quit taking it. On an unspecified date, the patient was sick; had sneezing; coughing; runny nose; clogged nose and has a head cold. Stated that he was scheduled for his second shot on Wednesday and just wanted to make sure if he was sick if he was supposed to go to take a second shot or not. Stated that his nose was clogged up again and he has a head cold. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I have never had an adverse reaction to a vaccine other than sore arm or body aches for 1 day and I am not afraid of needles. I walked out of the pharmacy and experienced brief vertigo. I then went shopping and had extreme soreness in my hips and thighs and had trouble walking. I noticed a tingling sensation on my right shoulder and pain in my right arm about 24 hours later as well as body aches. The body aches improved but my arm had pain that extended down my right arm into my right hand. I saw a doctor a week later about something else but mentioned my arm and they told me to take  800 mg of ibuprofen every 3 hours and to move my shoulder regularly which I did.  The pain in my arm and shoulder increased and I had extreme pain doing everyday activities. I developed pain in both arms, elbow joints and hands and sometimes my thighs and hips. I noticed that I no longer could extend my right arm fully and made an appointment with an orthopedic doctor in Dec 2020 who said he sees the problem fairly regularly as a result of immunization and I was diagnosed with frozen shoulder and I now in physical therapy to help heal it. I know I have thyroid issues and diabetes which make me more likely to have this problem but the issues started within 24 hours of the immunization. I really didn?t believe people who said they had reactions to flu shots. I was told it could take up to a year or more to regain full motion in my shoulder. This past weekend I began to have pain everywhere including my feet.  I also developed abdominal pain in November.
ankles along with feet swelled up; inflammation; chest pain; difficult breathing; This is a spontaneous report received from a contactable other healthcare professional (patient). A 38-year-old female patient (also the age at vaccination time) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 12:00 (Batch/Lot Number: Ew0175) as dose 1, single; dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 12:00 (Batch/Lot Number: Ew0177) as dose 2, single for Covid-19 immunization. Medical history included Covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19? - Yes). There were no concomitant medications. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her ankles along with feet swelled up after 4 days of receiving Pfizer Covid 19 vaccine and continued to swell and inflammation occurred with chest pain and difficult breathing. Side effect continued for two months. Blood work was drawn, and inflammation marker were very high. Adverse event start date was 10May2021 (12:00 PM). The patient was treated with Prednisone 10 mg tab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) (as reported). The patient has not been tested for COVID-19 since the vaccination. The patient recovered with lasting effects on an unspecified date in 2021. The events were reported as serious with seriousness criteria of life threatening.
A non-serious spontaneous report of bright red rash has been received from a nurse concerning a 48 year old female, subsequent to receiving FLUMIST.  No medical history or concomitant medication information was provided.  The patient received FLUMIST on 25-Nov-2008 nasally.  Within 4 to 6 hours after receiving FLUMIST, the patient noticed two bright red spots on her face, both on the right cheek.  One spot is 1/2 inch in diameter the other is 1 inch in diameter and the spots do not itch.  The patient reported the rash resolved by 01-Dec-2008.
At 11:30pm, She became hot, had blurred and blotchy vision, vomited, fainted, and fell. The episode lasted 20 minutes.
no additional AE's were reported; The HCP reports that an adult patient was administered a dose of PROQUAD; This spontaneous report has been received from a physician concerning an adult patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 21-APR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, administered subcutaneously (lot # W028568, expiration date 06-MAR-2024) (anatomical location was not provided) for prophylaxis (product administered to patient of inappropriate age). No additional events were reported (no adverse event).
Patient says that her arm has been in a lot of pain since receiving the shot and that she can hardly move it. She says that she tried Tylenol and Advil and it helped a little, but still couldn't move her arm. She went to the doctor and they ordered MRIs and an X-ray and diagnosed with tendonitis.
Patient presented to clinic on 2/28 with fluttering in chest. EKG showed potential atrial fibrillation. Patient subsequently admitted to hospital on 3/2 for new onset a fib and pulmonary embolism and VTE in right leg and was inpatient until 3/6/21.
cold sores; This case was reported by a consumer and described the occurrence of cold sores in a adult 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 cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had cold sores since then.
Passed out for a little bit; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a little bit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for a little bit) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Patient passed out for a little bit after his shot. After he came to, he felt thirsty and got some food.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
After the booster, she only had funkiness for one day; Booster dose was after 7 months of her first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination). In September 2021, FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  Patient got the booster dose after 7 months past her first vaccination.   This case was linked to MOD-2021-339239 (Patient Link).
On 3/12/01 pt called to report that she was having a lot of pain and soreness in her right arm. She received TD and MMR on 2/8/01. Instructed to take an OTC pain reliever of her choice (no ASA) and compress the area as a comfort measure. If no relief, she should call her family doctor. On 3/14/01, pt called to report family doctor refused to see her. Is taking ibuprofen for pain. Pain from shoulder to fingers for several days, per pt report. Is able to move arm with effort. Directed her to call doctor and explain that our facility is not set up to treat-is a free standing IZ site. Pt was seen by a PA at hospital minor treatment center on 3/15/01 at 09:15. PA feels it may be an inflammation of the bursa and will start her on Anaprox this evening. If no better in 3-4 days, she is to follow-up with her family doctor.
Edema, itching, erythema, hot to touch, tenderness of entire arm of injection lasting for 3-4 days.
Inflamation, Bulging and herneated discs (they could been there before, but didn't feel them) 5 L1-L5
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swelling injection site in an adult male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 30 July 2010 the subject received a dose of BOOSTRIX (unknown route, unknown deltoid). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site. At the time of reporting the outcome of the event was unspecified. Follow-up received on 27 August 2010 from the reporting healthcare professional: The subject was 30 years-old. On 06 August 2010 the subject received a dose of BOOSTRIX (0.5 ml, left deltoid). On 08 August 2010, approximately 48 hours after vaccination with BOOSTRIX, the subject experienced cellulitis, allergic reaction to vaccine, injection site redness, injection site pain and injection site induration measuring 100mm x 70mm. The healthcare professional reported the diagnosis as cellulitis vs allergic reaction post TDAP immunization in left deltoid. This case was assessed medically serious by GSK. The subject returned to the clinic on 09 August 2010 due to induration and pain at injection site. He was treated with doxycycline, MOTRIN and BENADRYL. On 15 August 2010, the events were resolved. The subject was instructed not to take Tdap again. The healthcare professional did not consider that the events could have been associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent.
had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am.    Dr. did the autopsy over the weekend.  At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct.  Quick tox was negative for drugs.  No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing.  F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such.  Covid swab is negative
Headache, HYPERtension, Tachycardia, arm pain/swelling Narrative:
Patient went to the DR. for a check up and was told that he had elevated caridinary  and kidney stones in both kidneys.
Stiffness, very painful and swollen wrists, hands, and knee for duration of close to 2 weeks, appearing 2 weeks and 5 days after administration of vaccine.
Pt presented to the ED with c/o chest pain and SOB.  She received vaccine on 7/20.  CT scan of chest showed extensive extensive bilateral PE, right >left.  She is currently hospitalized receiving anticoagulation and is in stable condition.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
PAIN LEFT ARM , BACK  AND NECK. FEVER AND DRY MOUTH , LEFT ARM EDEMA  AREA OF INJECTION, HEADACHE, MALAISE, WEAKNESS, HOARSENESS, NAUSEA AND DIZZINESS TOOK PANADOL
she received the second dose of gardasil 9 14 months later; This spontaneous report was received from a physician, refers to a 15 year old female patient. Information regarding patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, dose, frequency, route of administration and anatomical location were not reported) first dose for prophylaxis. On an unknown date (reported as 14 months later), the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The physician wanted to know, if the patient needed to start the series over. The outcome of the event was unknown.
No adverse event; patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 01-Oct-2022, the patient experienced UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml) 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 assessment was provided for UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml).    No concomitant drug was reported. No treatment drug was reported.
This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a 32-year-old female patient who received FLUARIX QUADRIVALENT (batch number A9SY5 ?, expiry date 30th June 2016). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 25th September 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced migraine and injection site pain. On an unknown date, the outcome of the migraine and injection site pain were not recovered/not resolved. The reporter considered the migraine to be probably related to FLUARIX QUADRIVALENT. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On 25th September 2015, at 9.30, the patient received FLUARIX QUADRIVALENT (intramuscularly in left deltoid). The patient experienced migraine and sore arm. The reported batch number for FLUARIX QUADRIVALENT (A9SY5), did not exist as per sales base, however no clarification could be obtained.
Information has been received from a RN concerning a pt who on 13Sep95 was vaccinated with a dose of varicella virus vaccine live (lot 609289/0433B).  Subsequently, on 21Dec01, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
Within 15 minutes post injection patient developed redness, swelling, 30 mm in size4 with warmth and hardness at the injection site.  Dr. notified, and Benadryl 7.5 ml dgiven along with cold compress.  Area inproved in appearanceafter treatment.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on an unknown date. The patient experienced patient pulled back some and a little bit of FLUMIST got into his right. The patient recovered from the event of patient pulled back some and a little bit of FLUMIST got into his right on an unspecified date. Assessment of the serious criteria for the report was as follows: important medical event.