chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity receive PREVNAR 13, (Lot # S74423, Expiry Date Nov2019, NDC # 00005197101) via an unspecified route of administration at 0.5 ml, single into left deltoid on 24Feb2018 around 13:00 for immunisation, administered at pharmacy/drug store. No other vaccines were given the same day. The patient medical history, concomitant medications or investigations were not reported. The patient initially had a low grade fever the first day or two after the vaccination on 24Feb2018 and has gone away completely recovering in Feb2018. On 27Feb2018 also began experiencing nausea and diarrhea and had continued (outcome was unknown). She also experienced pain, significant swelling and tenderness, at the injection site and that it is warm to the touch, like elevated temperature in that arm, all on an unspecified date in Feb2018 with outcome of not recovered. Patient did not information the reporter of time of onset of the AEs reported and whether her symptoms had improved, worsened, or persisted. The reporter had already advised the patient to speak with her doctor. Information about lot number already provided.
bodyache, chills, upset stomach, h/a started on 17OCT & lasted x 5 days; pt was unable to work
-Swollen lymph nodes near clavicle and in armpit in left arm (same arm as injection site) - occurred on 12/29/2020- 6 days after receiving vaccine
headache; muscle pain; diziness; flu simptoms; Runny nose; pain in shoulder; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported) in pharmacy or drug store, via an unspecified route administered at an anatomical site of right arm on 04Apr2021 at 12:00 (at the age of 48 years) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient stated that she only felt pain in shoulder on the second and third day of getting the first dose while also reported like the first and second day and it went away but today she was having a lot of symptoms. She read that getting the symptoms at the beginning of vaccination is normal but she had it after six days of vaccination. The patient experienced headache, dizziness, muscle pain and flu symptoms on 10Apr2021. The patient also experienced runny nose on an unspecified date in Apr2021. No treatment was received by the patient for headache, dizziness, muscle pain and flu symptoms. She wanted to know if it is normal to get the symptoms after 6 days and was informed about Pfizer medical information department. The outcome of headache, dizziness, muscle pain and flu symptoms was not recovered at the reporting time. The outcome of runny nose was unknown at reporting time. The outcome of pain in shoulder was recovered in Apr2021.   No Follow-up attempts are needed. No further information is expected.
Moderna Covid-19 vaccine EUA Muscle aches, fatigue, fever, headache, chills, joint aches Started when I woke up and fever got worse throughout Day 1
Information has been received from a physician concerning a male patient "in his 60's" who at the end of December 2006 was vaccinated with a dose of Zostavax. Three months later at the end of March 2007, the patient experienced encephalitis. It was reported that the patient had no other history of precipitating factors for the encephalitis. Upon internal review,the encephalitis was considered to be an other important medical event. Additional information has been requested. 6/27/07-records received from facility for DOS 5/30-6/15/07-DC DX: Dysphagia unknown etiology. BPH and Anxiety. Generalized weakness, intubated for respiratory failure and PNA. Subsequently extubated. Developed right sided facial numbness then progressed with flu symptoms and vertigo three weeks prior to admission. Admitted with extreme weakness, vertigo and nausea.
My other three shots - no problem except a little bit of soreness from my shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Lot number: EW0186), on 12Jun2021 as dose 2, single (Lot number: EW0186) and on 14Jan2022 as dose 3 (booster), single (Lot number: FL320PN) at the age of 71 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "My other three shots - no problem except a little bit of soreness from my shot." Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: There was no other conditions, Other Products. Patient stated her other three Pfizer Covid shots she had no problem with and the sores she had with she thinks probably all three of her prior vaccine doses and it was very little soreness. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No Emergency Room and Physician Office visit. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant was None. Relevant Tests was None. Caller states she was thinking from the fact that there were two separate lot numbers of her Pfizer Covid vaccine and it was sort of like the 1st had one lot number and the 2nd had one lot number and maybe it was a different lot and somehow that lot was something different; states her question for the previous agent was what are the percentages of people that come out of trial that have had these symptoms and she was also wondering if they do trials on each lot of the vaccine or how does that work; caller was offered transfer regarding her question.  No follow-up attempts are needed. No further information is expected.
flu symptoms; aching in arms; chills; cold; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single for COVID-19 immunisation. The patient's medical history included Rheumatoid arthritis with rheumatoid factor from an unspecified date in 2015 and unknown if ongoing. The patient's concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]), ibuprofen, metoprolol tartrate (PROLAT). On an unspecified date the patient experienced, the patient recently had COVID-19 vaccine administered and developed flu symptoms, aching in arms, chills and cold. The reporter classified the events as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had got bad infection last year (infection),  after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious got bad infection last year (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The case received from Social media. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Got bad infection last year antibiotics for seven days never again."   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Angioedema of the lips which resolved within an hour.  Diffuse redness and warmth of the skin, starting with the ears and face, moving down to cover entire body. Diffuse itching.  Seen in office about and hour after onset.
CHILD HAD C/O PAIN IN UPPER BICEP AND THAT ARMPIT HURT.  MOTHER FELT SWOLLEN NODES IN ARMPIT ON THAT DATE.  WATCHED OVER NEXT COUPLE OF DAYS.  ON 11/23/2009 MOTHER REPORTED THAT CHILD DEVELOPED RED STREAKS DOWN SKIN OF ARM FROM BICEP PAST ELBOW, SO SHE BROUGHT HIM TO THE ER ON THAT DATE.  THEY TOOK XRAY, CBC, AND BLOOD CULTURES.  GAVE HIM ONE COURSE OF IV ANTIBIOTIC AT THAT VISIT AND WAS SENT HOME WITH ORAL ANTIBIOTICS ( AMOXICILLIN AND AUGMENTIN)
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient was diagnosed with pneumonia.
15 hours after injection started with vomiting, diarrhea, fever, and chills. Symptoms lasted 32 hours.
Patient was given a high dose flu vaccine which is approved for patients 65 or older. this patient was 63 at the time of vaccination.
30 minutes after the shot staff start having headache.  At night, headache, bodyache (mostly back), fatigue.  Staff had Covid positive in March, feel the same now. Also had fibromylagia and asthma.
Prolonged uncontrolled status migrainosus, not controlled with triptan or even IV medications in the hospital; severe and painful muscle spasms in neck/shoulder area.
Felt very sick; chills; This is a spontaneous report received from a Sponsored Program a contactable female consumer (patient self). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: unknown), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced chills and felt very sick on the 3rd or 4th day after the second dose of BNT162B2. It was unknown if the patient received treatment. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Mom states that she noticed a rash around injection site and a couple "papules" on the body.
feel just a little pain in my forearm/a little bit of pain; My index finger got purple, looked black blue mark, massaged it and purple; itching; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. A 71-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in the right arm on 01Oct2021 (at the age of 71-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient stated, that she received the booster shot at 6 o'clock. She came home, she ate, she took a shower and then in the shower, the arm she got her booster shot started to feel just a little pain. Patient described it as it 'tinged' something in her forearm and then she got out of the shower and her index finger on a same side, the right side where she got the shot, her inside hand at the base of the index finger got purple. She thought well maybe she hit it because she don't remember hitting it. It looked like a black blue mark so what she did was she started massaging it. The purple went away and the pain went away because there was itching and it turned purple and a little bit of pain. So she massaged it and it went away. So she was worried if that was a blood clot, and If so she mean it disappeared after she massaged it. No treatment were given for the events. The patient recovered from pain in forearm and index finger got purple, looked black blue mark on 01Oct2021, while outcome of itching was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
I received my 5th shot on 10/11, the morning after my vaccination was just the sore arm.  On the morning of 10/26 I was brushing my hair and my left side went completely numb except my hands and feet. I went to the doctor and it still hadn't resolved so I went to the ER to get checked for a stroke. No signs of stroke but they had found evidence of two previous strokes that I wasn't aware of,  but nothing active. I had a neuro consult and other than the numbness my muscles were fine. They gave me a neuro referral which is scheduled in a few months. They prescribed baby aspirin to help prevent clots. I am still numb a week later and I did see a pain clinic this morning for another issue but they didn't want to weigh in until I see neurology.
Pain in left arm whereas mobility is limited. Unable to extend arm independently without pain, difficulty with daily tasks (ie shutting car door, sleeping on left side, difficulty dressing etc.)  Pain on upper shoulder/joint.  Took ibuprofen for pain.  Saw PCP who diagnosed it with bursitis.  Prescribed prednisone (4mg tabspak).  Pain started immediately following shot, no pain or issues prior.
COLD SENSATION ON NOSE, FINGERS AND TOES; SORE ARM; HEADACHE; nausea; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced cold sensation on nose, fingers and toes. On 07-MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced nausea. On 08-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and nausea on 08-MAR-2021, and had not recovered from cold sensation on nose, fingers and toes. This report was non-serious.
I am completing this to the best of my ability. I registered for the CDC's V-Safe mobile app, but the links no longer allow me to log in. Shortly after receiving the 2nd vaccine, an itchy rash appeared on the top of my feet. I also noticed areas of redness on my gums. For the rash, I used over-the-counter cortisone which seemed to only help with itch, not the lesions. Over the next few months, the rash persisted, but my gum became more and more inflamed.  Finally, I saw my doctor who was unsure of the cause. I saw my dentist a few days later who diagnosed me with Oral Lichen Planus and suggested I see a rheumatologist. In researching, I discovered that a possible trigger for LP is a pre-existing autoimmune disorder and a flu vaccination.  My doctor is scheduling me for a punch biopsy and we are awaiting results from bloodwork.
Pt. had severe shoulder pain which effected her mobility in that arm, to the point of needing Cortisone injections. Luckily injections helped. Sought help from Ortho Doc.
Patient had sneezed and blood came out. The patient had a bloody nose that lasted for about 30 minutes.  Patient sat down at the pharmacy and tilted her head forward. She had tissues and pinched the bridge of the nose to help clotting. She also received a cup of water. She had no other reaction to the vaccine.
Body Itching and swelling of the lips Started taking Zyrtex and still taking.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was received as follows: The patient experienced injection site pain which lasted for about 3 days and then resolved. The reporter did not consent to follow-up. This case is linked to the case US2019210496 by same reporter. The outcome of injection site pain as recovered/resolved in the system however in source document, it was mentioned as recovered/resolved with sequel.
Dad reports that he is exhausted, achy, and has an upset stomach and food does not taste or sound good. He said he?s feeling a little better right now but he feels he got a second setback from the vaccine
Warm, tingling & numbness 10 minutes post injection. Monitoring indicated elevated HR & BP. Team member released after 50 minutes. TM was driving to her clinic and developed left side numbness to her cheek, upper arm and lower left back areas.  Supervisor completed incident report and had team member go to urgent care and then went to ER.  TM drove herself.  ER provider Dr. contacted EH and informed us that TM did not have anaphylaxis and has no known allergies.  She also drew CBC, Mag, Urine pregnancy & performed a CT scan w/o contrast to rule out kidney stone. No significant findings were noted.
Acute chest pain, fever approximately 30 minutes after 2nd Hepatitis B shot. R/O allergic reaction to  Hepatovax. Advised not to get Hep third shot until discussing with MD.
This is a spontaneous report from a contactable registered nurse who reported on behalf of a physician. This is first of two reports. A 49-year-old male patient received while he was in the dialysis clinic, a dose of PREVNAR 13 (Lot J90092; Expiration date May 2016; NDC number 005197105), intramuscular in right arm on 11Nov2014 approximately 7 am at 0.5 ml single. He was diabetic, had high blood pressure, high cholesterol and chronic renal failure. He had a catheter in his left arm for dialysis. Concomitant medication included PNEUMOVAX 23 (lot K007773; expiry date of May2015) administered on 11Nov2014 in right arm, aspirin at 81 mg daily, FLONASE as needed, clopidogrel at 75mg daily, carvedilol at 12.5mg twice a day, lisinopril 20mg daily, pantoprazole 40mg daily, pravastatin 40mg at bedtime, LANTUS on a sliding scale, vancomycin 1g IV for planned shunt placement and VELPHORO 500mg four times a day. On 13Nov2014 patient complained of severe pain during administration of PREVNAR 13 and discomfort. On the same date he experienced cellulitis of arm: cellulitis was above his right elbow and did not require an emergency room visit. Always on 13Nov2014 patient had pain and tenderness in right arm and redness, swelling and warm of right arm. The outcome of discomfort was unknown, the other events recovered on unknown date.
MMR vaccine administered 8/14/07 and Hepatitis B vaccine 8/22/07 - developed nausea and diarrhea, joint pain (knees, wrists, elbows, hands), joint swelling (rings too tight to remove) ? low grade fever, no rash slowly improving 9/13/07.
Stroke. It was a stroke to the cerebellum area of the brain. I was treated at the hospital after the stroke occurred on January 18/January 19, 2022 and remained in the hospital until Sunday, January 23. I am virtually fully recovered as of Tuesday, January 25, 2022.
TOOK VIVOTIF ON CONSECUTIVE DAYS; This spontaneous case report (PVX2019-2500) was received from a nurse on 07-Oct-2019. It described a female consumer who "took Vivotif on consecutive days" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer stated that, she took Vivotif yesterday and today continuously. She had two doses left.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.
in the noc p/immun pt devel temp, inc to 103, temp dec p/2nd dose of APAP; pt was very fussy w/periods of inconsolable;
JANSSEN COVID-19 VACCINE WAS ADMINISTERED AFTER THE VIAL WAS PUNCTURED AND LEFT IN THE FRIDGE AT 4C FOR OVER 6 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a consumer concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced janssen covid-19 vaccine was administered after the vial was punctured and left in the fridge at 4c for over 6 hours. On 22-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine  was not applicable. The outcome of the janssen covid-19 vaccine was administered after the vial was punctured and left in the fridge at 4c for over 6 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210947074.
Pt called us at 8/13/22. He received the vaccine  on 8/4/22.  He was asking if the knot/little bumps reaction from the vaccine is normal. It is also itchy. It started with swelling with acute pain around the area of injection and a day after it went away but was replaced by the knot and little bumps, not a rash, little bumps. I informed the patient to not scratch the area because it will make it worse, to apply cold compress around the area for 15mins and if it is not relieved, then take Benadryl OTC. And if it gets worse to have a Dr check up on it.
CHILDS DOB WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS FATHER. CHILD IDENTIFIED IN SYSTEM WITH A DIFFERENT DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE.
Robust immune (flu-like) response within 12 hours of dose. The week following 2nd dose felt tired & achy.  Beginning 3 weeks after 2nd dose: total exhaustion, muscle fatigue, joint pain & tenderness and overall weakness which has continued to persist. The main complaints are sore shoulders, wrists, and hips. Dr suspecting Polymyalgia Rheumatica.