chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age. The reporter reported that RECOMBIVAX HB (lot# reported as 0020AE, exp JUN 2014) which had been exposed to 31 degrees Fahrenheit for 62 hours were administered to multiple unspecified patients on 20-OCT-2012. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Pt admitted to hospital on day after immunization for possible seizures.  All work up was negative & pt was thought to have Sandifers syndrome (GE reflux). 5/9/08-records received for DOS 4/6-4/9/08-DC DX: Seizure disorder. Leukocytosis, resolved. Sepsis ruled out. Fever and sudden onset of seizures. Episodes of cyanosis with seizure. Developed loose stools.  Second admission 4/10-4/12/08- DC DX: Gastroesophageal reflux. Continued to have seizures occur when patient is placed on back.
pain and slight swelling at injection site. Patient sought treatment at an emergency room as a result of discomfort continueing 1 week post vaccination received
Red, feverish, rash about 3 inches in diameter on back of left arm where vaccine was administered.
Left arm indurated; Left arm hot; Left arm red; Left arm itchy; Left arm painful rectangular area measuringabout 3X4 inches; This is spontaneous report from non-contactable nurse, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 03Mar2021 at 07:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol, degenerative joint disease and osteoarthritis. Concomitant medications included rosuvastatin calcium (CRESTOR) for unknown indication from unknown date. The patient did not have any allergies to medications, food, or other products. 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 had not been tested for COVID-19. On 10Mar2021 at 11:00, the patient's left arm was red, hot, indurated, itchy and had painful rectangular area measuring about 3X4 inches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of left arm red, left arm hot, left arm indurated, left arm itchy, left arm painful was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient had an episode of vomiting with a syncopal episode shortly after leaving  the clinic. Resolved with no further vomiting or syncopal episodes.
Myalgia, Arthralgia, Fever, chills, sweats Narrative:
She got her vaccine in her left wrist.  The following morning at 6:00 AM she noticed a grape sized lump inside her elbow on the left.  Slowly as the days, weeks and months have progressed the symptoms have exacerbated.  She initially noticed increased pain in the joints and muscles on the left.  Increased swelling that is increasing more and more.  At first she thought it was her post-polio.  She then started running low grade temps, chills, nausea, headaches which she never gets.  Also has coughing, red spots on her arm, red spots under the arm, and red spot on top of the wrist and under the wrist.  She went to her doctor for her symptoms, and he was most concerned for the swelling under the arm.  He sent her
At approximately 2:45AM-PST child vomits.  Around 4:20AM-PST child vomits a 2nd time.  About 6:15AM-PST child vomits a 3rd time.  Around 8:35AM-PST child vomits a 4th time, and again for the 5th time at approximately 11:15-AM-PST.  Vomiting is accompanied by abdominal pain on the belly button area.  The pain is dull at first, then increases right before the child vomits, subsides thereafter but then increases back to a dull pain and then the ebb and flow pain pattern continued with vomiting until the 5th incident.  After the 5th incident, pain in abdomen would come and go.  There appeared to be some sleeplessness as well.  No other appearance of side effects were present (i.e., no fever, diarrhea, headache, rashes, soreness, swelling, chills, etc.)
Information was received on 26-MAY-2017 from a lawyer regarding a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) in 2012, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles.  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 and pain and suffering and other damages. Additional information has been requested.
Sudden rash and slight swelling when I woke up the morning of January 3rd, I applied benedryl cream once in the afternoon and right before bed. When I woke up the next morning, January 4th, the injection site was swollen to the size of a softball, hot to the touch, red and very hard and painful. No treatment successful as of yet. I have not seen a Healthcare professional because I haven't found one that knows what to do for it yet. Just spoken to nurses over the phone.
3/13/12 Pneumonia vaccine given in left arm. In the evening of 3/13/12 pt developed pain. On 3/14/12 pt developed erythema about 5 inches round, painful and warm to touch. Doctor evaluated pt, apply ice, TYLENOL and Loratadine, erythema outlined and if sx/sx worsen to call for further treatment.
Patient received second dose of COVID-19 vaccine series, 1 day early. Her first vaccine was given on 2/1/21 and she received her second dose on 2/17/21, 16 days apart. No adverse event reported by patient.
At the time of the injection (date is uncertain) and soon afterward only pain at site were a problem.  Within a week or so, a stubborn yeast infection started that is still recurring and never quite clears up even today, 4 months later, with agressive physician care and prolonged internal and external medical treatment.  As the HPV vaccine is yeast based, I believe there is a definite correlation.  There is no history previously of recurrent yeast infections in her.
11/18/22 presents to EC ED for "abnormal imaging" "shortness of breath, cough". PMHx of "
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, nausea and felt faint. On an unknown date, the outcome of the injection site pain and nausea were recovered/resolved and the outcome of the felt faint was unknown. It was unknown if the reporter considered the injection site pain, nausea and felt faint to be related to SHINGRIX. Additional details were provided as follows: The patient experienced extreme pain at the injection site, and nausea on the evening of receiving the SHINGRIX vaccine, due to the nausea, patient felt like she almost passed out but she did not pass out. The patient had now recovered.
losing the voice; very achy, with severe body aches and headaches /Soreness; very achy, with severe body aches and headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. In February 2021, the patient experienced APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue). At the time of the report, APHONIA (losing the voice), PAIN (very achy, with severe body aches and headaches /Soreness), HEADACHE (very achy, with severe body aches and headaches) and FATIGUE (fatigue) outcome was unknown. Not Provided          Treatment medications were not provided Action taken with mRNA-1273 in response to the event was not applicable; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the product known safety profile.
Dry, non productive cough with throat irritation, tongue feeling "fuzzy" progressed into swelling, slurred speech and difficulty swallowing.
Moderna Booster administered 10/26/2021 around 1 pm.  Approximately 11 pm i started feeling feverish.  It was bedtime so I took 2 pm tylenol and slept until 5:30 am.  I woke up to severe nausea, chills, abdominal pain.  These symptoms lasted until 4:30 pm.  I assumed it was a reaction to the vaccine since husband and I had eaten exactly the same foods. On 11-8-21, I woke up about the same time with the same problems except more severe and went to ER where it was determined through testing I had  gall stones.  So not a reaction to the vaccine!!
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male 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) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No medical history was provided. No concomitant medication provided.   Reporter did not allow further contact
7 days after vaccine, R arm around injection site became acutely itchy and red, blotchy.  over next 4 hrs, itchy rash spread to R shoulder, chest, neck and R cheek.
Patient reported feeling overly fatigued, abdominal pain and elevated liver enzyme results on lab work.
Post vax, the pt broke out in hives on 10/21/00 followed by severe headaches and burning itchy watery eyes. Pt came in to ER on 10/25/00 and was treated with Atarax.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 25-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
First vaccine- immediate pain down left arm. Within 30 minutes- blurred vision, tingling in lips, hands and feet. Treatment- pharmacist instructed drink pedialyte and rest at home 7 days after first vaccine- dry mouth, tremors, racing heart. Went to ER twice.  Family Dr tried adding buspirone to medications. Symptoms improved after approx 2 weeks. However, became shaky/tremors with exertion. 2nd dose 5/3/21- Woken in middle of the night with racing/pounding heart, pain and burning in feet/legs. No treatment sought. Continued to have tremors/jittery feeling with exertion. July- muscle twitching began in legs. August- jittery feeling increased, insomnia and night dizziness began. Woke mid august with racing/pounding heart. Heart rate 50 when lying and 130-150 when upright. Also had increased urination, 5 lb weight loss, diarrhea, flushing/redness after eating and near syncope. Referred to a cardiologist, then referred to autonomic neurologist for tilt table testing. November 2021- diagnosed with pots.  December 2021- started on corlanor Referred to allergist for continued flushing/jittery/tremors with eating March 2022- diagnosed with Mast Cell Activation Syndrome. Treatment- singulair, xyzal, famotidine
I faint anf fell twice hurt my back once; I faint anf fell twice hurt my back once; hurt my back once; Dizzy spells; Constipation; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration in Jan2021 (a week before reporting) at single dose in left shoulder for COVID-19 immunisation. Age at vaccination was 91 years. The patient's medical history and concomitant medications were not reported. About 24 hours after shot he started having some dizzy spells and then fainted and fell a couple of times and hurt his back once. He stated he also had had constipation since the shot and do not know if that is related or not. The patient wanted to talk to see if he could get his second shot. He is taking some pain killers for his back. With regards to Physician Office/ Emergency Room: patient stated, 'This for my back and nothing else of that'. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
soreness since 9/29, 10/10 numeric pain scale, sharp, burning, sore pain in L shoulder that radiates to hand, now radiated to elbow in termittently. only occurs at night. 11/9 chills, bull body spasms
About 10 hours after the shot, started to encounter the same type of symptoms I had when I had Covid, low grade temperature, chills, generally felt lousy all night.  Symptoms subsided about 12 hours later.
Pt developed hives approx. 1day after receiving the vaccine. Took a CVS allergy tab (unknown generic) She contacted the Dr to call her. Attempt to contact no answered.
Swelling, stiffness and pain in elbow of arm that received shot.  No traumatic or other injury to that arm or elbow.  No pre-existing elbow issues.  Unable to fully bend elbow and nerve issues in hand and fingers.
the following day: chills, rigors, headache, nausea, vomiting, fatigue.  Took 1 gram Tylenol  one week later: 8/24/2021 4;10 pm left foot tingling, numbness and persistent numbness and tingling left arm and called 911 /ambulance with numbness and tingling left face and lip/head and went to ER with CT head/MRI normal and no stroke,  Diagnosed ? complex migraine . continued until now  headache cocktail given in ER wihtout relief.  Neurology consult.  worse with Depakote one dose , Continued symptoms when due for 2nd covid 19 dose and worsening left leg numbness 7 hours later.
Face became very hot, vision blurred momentarily; I continued to feel very hot although the car window was down and it was a cool day; then I realized that my nasal passages were swelling.  First symptoms subsided after 10 min, nasal passages were returning to normal after 15 min.  No treatment given.  I didn't even report it as I didn't see anyone to report it to until I was pulling out of the Fairgrounds.
December 1, 2021 Vaccine moved from Freezer to Fridge January 6, 2022 Vaccine administered.
The patient received Pfizer Covid vaccines on 1/20/21, 4/27/21, and 5/18/21. Patient was diagnosed with Covid and received IV antibody treatment after the first vaccine. She thought she needed to restart the series.
8days after the vaccination, at the site of the injection (left upper arm), a bright red, raised, hot and itchy rash appeared out of no where. I feel itchy all over and achey. My arm is extremly sore and feels hot/burning. Now two days since the onset of the ?rash? the affects area has expanded to my entire left upper arm (shoulder to elbow) still bright red and raised and itchy, all symptoms have remained the same. It is not improving with time.
given to a patient with another diluent; given to a patient with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 333TE, expiry date 15th April 2023) 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 wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was Nurse and Clinic Manager. The age at vaccination was unknown. The reporter called in because she reviewed vaccine records and found that a first dose of Shingrix had been given to the patient with another diluent than the one in Shingrix pack. which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. She stated that, she was unsure what solution was used at this point and needed to investigate further from her staff. She stated, if any additional information was uncovered she would call back and provide it. The reporter requested additional guidance on how to proceed after this administration so Medical Information number was provided to her. The reporter did not consent to follow-up.
Midnight, vomiting, diarrhea, heart palpitations, hot skin, shaky, headache stomach cramps
This spontaneous report was received from a pharmacist technician concerning three unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (Lot # K010337, expiration date: 22-JUL-2016) that on an unspecified date were exposed to a temperature excursion. It was reported that the doses of VARIVAX (Merck) were exposed to temperatures of 60F for 1 hour, then less than 46F for 3 hours. No adverse experience had been reported. Additional information has been requested.
Pt developed cellulitis on administration site (L) arm. She went to her MD and prescribed her AUGMENTIN 875mg and TYLENOL 500mg. She had fever, pain, headache, itching, redness, swelling; is under treatment.
Symptoms started with blurred vision within  30 minutes had full double vision ,  dysarthria and aphasia .  Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but  movement was very ataxic and labored.  Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days.  Still having word finding difficulty, but mild.
Wednesday, Oct. 6, went to Urgent Care for rash. Prescribed Clotrimazole-betamethasone cream for fungal infection.   Thursday, Oct. 7, Pfizer COVID booster (both my husband and I received the same Lot # Pfizer vaccine). I used Clotrimazole-Betamethasone cream 3 times before booster. Two applications on Wednesday, Oct. 6, and one application day of booster. Also, I had never heard of not using Tylenol or Motrin before a COVID vaccination. I cannot remember if I might have been taking Tylenol for tooth discomfort after a dental implant September 1, 2021.  Friday, Oct. 8, mild discomfort. Took Tylenol.  Saturday Evening, Oct. 9, extreme reaction to what I believe to be the Pfizer booster. Symptoms appeared severely and suddenly. From my neck to my waist, front, sides, and back of my torso, what felt like piercing, debilitating muscle spasms with any extremely small movement. With movement, even breathing the wrong way, must have lasted only seconds but felt like minutes of torture. I do not remember my legs or arms having, for lack of a better word, spasms, but I could not put my leg on a small step stool without my husband?s help. Perhaps because the leg movement could not be achieved without some mid-body movement. I felt weakened to the point of not being able to perform the smallest task, but I think it was from the pain, not that my muscles could not move. When my husband helped me into bed Saturday evening, I could not budge, one way or the other, the physical suffering was too much. One other prominent symptom that appeared quickly, my right knee that had meniscus surgery several years ago ballooned with swelling.  Sunday, Oct. 10, misery. Continuation of Saturday evening symptoms. No relief. Tylenol and Motrin could not touch the pain.  Monday, Oct. 11, Dr. appointment with primary care physician. Doctor?s notes ?acute myalgia after COVID vaccination.?  RX, Prednisone, 20 mg, 3xday, for 5 days. After 2nd dose of Prednisone, symptoms began to dissipate quickly with each passing hour and day.   Sunday, Oct. 17, I feel fatigued and weakened, some joint stiffness in my left foot and right knee, however, pain is gone, and agony is over.   I hope my reporting can help in a small way to help advance COVID vaccines.
Dizziness & NauseaVomiting  Narrative: From email: ". On Thursday I was fine with simply a sore arm. Starting Friday I started feeling terrible. I have had fever till yesterday. No fever so far today but have had constant nausea, dizziness, all over body ache and super drained. Today I feel real shaky."
shivering; fatigue; headache; A restless night; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivering in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (first was a breeze).   On 30-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 31-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced shivering (Verbatim: shivering), fatigue (Verbatim: fatigue), headache (Verbatim: headache) and difficulty sleeping (Verbatim: A restless night). The outcome of the shivering, fatigue, headache and difficulty sleeping were not reported.   It was unknown if the reporter considered the shivering, fatigue, headache and difficulty sleeping to be related to Shingles vaccine.     It was unknown if the company considered the shivering, fatigue, headache and difficulty sleeping to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the second shot on Thursday. The first was a breeze, but that second had him/her shivering and fatigue plus a headache at 2:00am Friday morning. A restless night it was. The follow-up could not be possible as no contact details were available.
Tingling sensation to left hand, traveled up to elbow and upper arm. Then tingling sensation traveled to right hand to upper arm. Both shoulders started to feel achy. Then tingling sensation switched to pins and needles sensation. Later on the day, left foot noted to have tingling sensation. Symptoms noted around 11am to current time 7pm, and continues to have tingling, pins and needles sensations.