chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since 12/27/2021 I have been breaking out in chronic hives daily. If I don?t take a daily antihistamine ? my doctor prescribed Cetirizine ? the hives return. If I gently touch or scratch skin the hives show up. I have also gained 6 lbs of weight since then even with little change to my diet and exercise routine. I have not had my period since the vaccine (I am on the mirena IUD).   I recently came across this study which lead me to fill out this report and feel like I?m not the only one have these side effects. My doctor aggressive that my hives could be a side effect from the vaccine booster.   On the night of vaccination I vomited, almost fainted, and had severe body aches. I?m an extremely healthy person and struggled to get myself from my bedroom on the second floor to my kitchen on the first floor.
Fever, chills by 7 pm.  Felt better until Sunday 10/24/2010.  Fever returned, severe body aches.  Went to hospital 10/26/2010.  Released next evening.  Severe pain continued for 5 days returned to Dr.  Further test performed.  Results all negative.  Dr. felt it was still the reaction to flu shot.  Aches much improved but still continue as of this date.
Physician order in EHR for DTap, nurse administered Tdap. Pt tolerated vaccination without incident - mother made aware of incorrect vaccination having been administered. Advised to monitor for side effects.
Patient tested positive for Covid on 12/18/2021.  No interview was completed in the disease reporting system, no charting was updated.  Symptoms and pre-existing conditions unknown.
105 degree temp for 4 days Softball-size lymph node under left arm for 6 days Vomiting/diarrhea for 2 days Headache/migraine for 3 days Whole-body spasms for 4 days Chills/sweats for 3 days Dizziness for 1 week Lethargy for 6 days Complete numbness in pinky  and ring finger and side of palm for 5 days Throbbing arm for 7 days Metallic taste in mouth for 1 week Excessive watery eyes for 4 days Hard cough for 5 days Chest tightness/pain for 5 days
Admission for labor and delivery - 9/28/2021. This visit was within 6 weeks of receiving the COVID vaccine.
Pt recvd 3rd dose of vax 15OCT92 & 1 wk later exp diarrhea (1 day) & sinus infect;  also exp severe malaise, lethargy, weight loss of 10 pounds over 10 day, fatigue, exhaustion, severe insomnia, restlessness, nausea & anorexia;
The same day she developed an injection site reaction characterized by a golf ball sized area of redness, swelling and warmth. This is 1 of 3 patients from this who developed an injection site reaction.
Erythema around site approx 3 inch diameter surrounding injection site. Petechiae on forearms bilaterally. Given Rx for oral prednisone.
Patient stated that it started off as a small rash but spread towards her armpit. Red, several inches out from the shot and now it seems to be warm to the touch and starting to worry her
Caused my blood sugar to run very high. Stated within 2 hours following the second shot and continued for 3 days. Every time I ate anything my blood sugar would jump to the 300+. I would have to aggressively up my insulin amount to control. I am still having high blood sugars following meals.(I have been an insulin dependent diabetic for 30 years and have always kept my A1C at 7 or below.) It does not seem to matter what I eat the result is a very fast rise in my blood sugar. I wear a Dexcom PDM and use OmniPod pump to manage my diabetes.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On 18-APR-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J009788, Expiry: 17-MAR-2016). It did not had any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
This spontaneous case, initially received on 19-Sep-2016, was reported by a health professional and concerns a patient of unknown age/gender. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 12-SEP-2016 to 12-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54507. No additional suspect drugs. On 12-Sep-2016, the patient received AFLURIA PFS (which had been) exposed to fluorescent light for an unknown duration of time - no adverse event (special circumstances: drug administration error without adverse event, outcome: unknown). The reporter considered the event non-serious (medication error).
6 days after injection and recovery of arm soreness, pain and itching at injection site started again and hasn?t went away
pt recv vax & 5 days p/vax in OCT9996 pt to hosp w/a severely swollen face;pt was dx w/serum sickness & tx w/atarax;also devel joint pains & rash;MD felt sx were a rxn to thimerosal; Follow-up from the patient's physician stated that two weeks later, the patient recovered. Follow up from the consumer indicated that "I have and still am being treated for post-traumatic stress disorder. From this incident as the shot made me hypersensitive to other products that I have always been able to use. I have also become chemically sensitive to anti-depressant medication for anxiety after this incident triggered a fear of many things that have caused sever facial swelling and hypersensitivity". No further details were provided.
patient received a dose of VARIVAX following a temperature excursion; no adverse event; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX), lot # R035222  and expiration date 04-DEC-2020, subcutaneously, for prophylaxis (dosage schedule, anatomical location, were not reported) . The administered dose of the vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 29 minutes, as recorded by a data logger. There was previous temperature excursion that was 6 degrees Fahrenheit  to 14 degrees Fahrenheit (multiple excursions)  for 25 minutes. No adverse effect reported.
Patient described as a red ring around injection site. She did apply ice packs. Now presents with redness and swelling starting half way down upper arm extending to elbow.
Pain in the right arm; Swelling in the right arm; Difficulty moving the arm for a week/Difficulty lifting the arm for a week / Difficulty raising her arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past). Previously administered products included shingles vaccine (had the previous Shingles vaccine in the past).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site swelling and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional information received were as follows: The patient woke up at middle of night with swelling and pain in the right arm. She had difficulty moving and lifting the arm for a week. After a week it was getting better, but she was still having difficulty raising her arm.  No further details were provided, caller disconnected call prior to gathering any further information.
Immediately after the vaccine, the patient felt faint, lightheaded, with moderate to severe headache.
10 days p/vax t103 for 3 1/2 days then got diarrhea & fever was 101;diarrhea for 2 days on 4th day began to get measles from head to toe;was extremely itchy;5th day measles were @ its maximum;started fading on the 6th day;
Uncontrollable shaking and twitching in entire body. Looks like an all day seizure. Symptoms began at approx 2pm, 27 hours after second Moderna injection
Patient received Flulaval pediatric flu vaccine instead of adult Fluarix. Per pharmacist: "Flulaval and Fluarix are both influenza vaccines made by GSK. They are both indicated for 6months and up.  The dose (0.5mL) is the same, for a kid and an adult.  I do not believe the adult patients should not need to be revaccinated."
Mom called 3/17/06 (Imm given 3/16/06) explained pt broke out with small bump at injection site, no itching just irregular shaped raised area.
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female with no pertinent medical history and no drug reaction who on 07-OCT-2011 was vaccinated with first dose of VARIVAX (Merck) (lot# unspecified). There was no concomitant medication. The patient was found to be pregnant on 31-OCT-2011 by a urine pregnancy test. The date of last menstrual period was 15-SEP-2011. The estimated delivery is 21-JUN-2012. On 08-OCT-2011 (the day after received the vaccine), the patient developed a rash at the injection site and on her back. The patient sought medical attention by office visit. No treatment was given for her adverse events. At the time of reporting, the patient's outcome was unknown. Follow up information has been received which reported that the patient suffered a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Within five minutes, I experienced extreme lightheadedness, and over the course of two hours my symptoms worsened and included irregular heartbeats with some of them feeling like stronger beats, Diarrhea, nausea, feeling like I was going to throw up, Flushing heat on my chest, chills
Fever, onset approx 8-10 hors post vaccine -> 104 degrees; Rx with TYLENOL and cool bath; recurrence on 3/27/14 T 102 degrees. Advised to take ibuprofen alternating with TYLENOL. Fever resolved on 3/28/14.
Information has been received from a 62 year old female registered nurse who is the patient. The patient's medical history included in 2012 right arm and leg were paralyzed, and right arm and right leg could not move them by herself and right arm and right leg were numb, right arm and right left felt they were asleep after vaccinated with PENUMOVAX23 (MARRS#1312USA011693). On 25-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm, lot # J007301, expiration date 20-SEP-2014). Concomitantly, the patient annually has been administered with FLUVIRON (manufacturer unknown) since 1993 (dose, route, and lot number were not provided). On 18-OCT-2013 or 19-OCT-2013, the patient received her most recent dose of FLUVIRON. On 25-NOV-2013, she was vaccinated with ZOSTAVAX and reported developing "flu like symptoms" on 05-DEC-2013 described as a fever ranging from 101 Fahrenheit to "almost 103" Fahrenheit, chills, lethargy and confinement to bed from 05-DEC-2013 to 07-DEC-2013. "Flu like symptoms" resolved completely on 10-DEC-2013. Nurse additionally reported that on 13-DEC-2013 she developed a rash which began on the left side of her chest and described as pimples which progressed to "V" of chest and then to right side of neck and a cross the median line. The pimples were itchy and red. Nurse stated that she thought the rash may have been chickenpox. Treatment for the rash was over the counter 1% hydrocortisone cream. The rash was resolving and described as most are dried up with some areas that are still itchy and red. Laboratory test was not performed. The patient did not seek medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same patient. Additional information has been requested.
(R) thigh - area of redness, warmth and tenderness measuring 10 x 8 cm.
Could not see out of it for a little; Head was pounding; Eyes were clouding up again in right eye; She also had temperature of 103; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and had no reaction. Patient received Covid shot and first injection she had no reaction but with second one her head was pounding, eyes were clouding up again in right eye and could not see out of it for a little. She also had temperature of 103 F. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
slight rash; Severe stomach pain; nausea; my back, shoulders, and neck to hurt; my back, shoulders, and neck to hurt; my back, shoulders, and neck to hurt; nightmares; feel like my bones are trying to come out of my body; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 45-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in arm left on an unspecified date (Batch/Lot and Expiration date was not reported) (at the age of 45-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included immune system disorder, Von willebrand's disease, high blood pressure, arthritis, allergies: Latex and related foods, all from an unknown date and unknown if ongoing. Concomitant medications received within two weeks of vaccination included duloxetine hydrochloride (CYMBALTA); levetiracetam (KEPPRA); lisinopril (LISINOPRIL); lisdexamfetamine mesilate (VYVANSE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took paroxetine (PAXIL), blood pressure medication with Diuretic, Penicillin, and experienced drug hypersensitivity. The patient did not receive any other vaccine within 4 weeks of covid vaccine. The patient did not have covid prior to vaccination. The patient was tested for covid post vaccination. On an unspecified date, the patient experienced slight rash, severe stomach pain, nausea, my back, shoulders, and neck to hurt, nightmares, feel like my bones are trying to come out of my body. Adverse events were reported as Severe stomach pain with diarrhea and nausea, feel like my bones are trying to come out of my body (I wish I had a zipper to release the aliens) causes my back, shoulders, and neck to hurt, nightmares, slight rash with first dose, yeast infection with 2nd, brain feels bigger than my skull, chest fullness like heart trying to come out of chest, stomach bloating. Laboratory tests on 08Mar2021 included sars-cov-2 test was negative (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 4NOV98 355PM & had temp >101 evening p/vax;didn't want to go to bed;finally to bed 10PM asleep then up 2AM & up all noc afterwards;3:30 or 4:00AM vomited;runny nose;viral;
Hives on wrist, later her eyes and lips swelled and started getting hives by eyes, hives also on back and hip, started about 5 PM, took zyrtec at 7:00 pm.  Seems to slow progression.  Called  nurses desk and was told to give Zyrtec.  Went to bed about 8:30 pm.  Slept all night.  When she woke up in the morning, her hives were gone, eyes and lips a little puffy still.  Went to school.  Dad picked up at 10:55 and she looked a lot better but tired. Slept the car ride.  (They were in contact by phone with the nurse, but did not go in for a visit)
PT states he began to feel itchy about 3 hrs after vaccine administration. 9/16 he noticed rash on arms legs groin area with swelling of feet, hands. He also noticed tightness in his throat. But not severe. He applied BENEDRYL spray to rash. On 9/17 he has noted decreased swelling of hands feet and improvement of rash. No resps x or swelling sens in throat.
no adverse event; GARDASIL 9 vaccine that underwent a temperature excursion was administered to a patient.; This spontaneous report as received from a registered nurse  refers to an identifiable patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 05-NOV-2021 the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(unknown dosage; lot # T025369 expiration date: 01-DEC-2022 for prophylaxis) which underwent a temperature excursion. No adverse event was reported.
This case was reported by a consumer via call center representative and described the occurrence of rash mouth in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash mouth. On an unknown date, the outcome of the rash mouth was unknown. It was unknown if the reporter considered the rash mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter called GlaxoSmithKline to inquire if there has there been any incidence of getting an oral rash after getting the SHINGRIX vaccine because she had one. The reporter declined to answer any reporting questions. The patient was referred to her health care professional before the call ended. This caller chose to end the call after the package insert was discussed and declined to answer further related questions, so no further information beyond what is documented above was provided during the call.
Mother noticed lymph nodes on her neck swollen on 7/19, with rt side of jaw pain, rt side of neck pain. On 7/25 was seen again by another doctor and was prescribed an antibiotic (AUGMENTIN).
I felt like I was hit by a truck; Shortness of breath; anxiety; chest palpitations; side effects, tenderness at injection site; felt really sick for about 36 hours; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season. On 8th December 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell. In December 2021, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by the nurse herself. The patient was now due for second dose of Shingrix this month and she was worried because she reported side effects from dose 1. The patient stated that she received dose of Shingrix in right arm and a flu shot (did not know name) in the left arm.  She stated that she had tenderness at the injection site with Shingrix .  The patient mentioned the next day, she felt like she was hit by a truck. She stated that she had shortness of breath, anxiety, chest palpitations, and felt really sick for about 36 hours. The patient was referred to health care professional and medical information department phone number was provided. Spoke per content.
This spontaneous report was received from a pharmacist referring to a 63 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received form the same reporter. Additional information has been requested.
swelling; chills; redness; This case was reported by a consumer via call center representative and described the occurrence of swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In 2020, less than 6 months after receiving Shingrix, the patient experienced swelling, chills and redness. In 2020, the outcome of the swelling, chills and redness were recovered/resolved.   It was unknown if the reporter considered the swelling, chills and redness to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix on left deltoid. The patient had a few side effects from her first dose of Shingrix in January of this year. These included chills, redness and swelling but all resolved within 2 to 3 days. The patient received second dose in July (for tolerance of second dose refer linked case US2020AMR157877). The reporter did not consent to follow up. This case was linked to case US2020AMR157877 by same patient.
Headache, Sedation, Myalgia, NauseaVomiting, CHILLS AND PAIN Narrative:  Other Relevant History:
Information has been received from a consumer concerning her 4 month old daughter who on 03-APR-2007, was vaccinated with a dose of PEDVAXHIB (OMPC).  Suspect concomitant therapy included ROTATEQ, for the treatment of prophylaxis (duration and dose not reported).  Other concomitant therapy included polio virus vaccine, DTAP (unspecified) Hib conj vaccine (unspecified carrier) and hepatitis B virus vaccine (unspecified).  On 04-APR-2007, the patient developed a huge red bump that was hard to the touch at the injection site.  The physician saw the patient within a week and thought it was a typical injection site reaction that should resolve on it's own.  It was reported that weeks went by and the patient's injection site reaction was still red.  In mid May 2007, the patient was seen by the physician and it was recommended that she start massaging it and hot packing the injection site area and within a week it ended up bursting with green goo coming out.  The reporter took her daughter to the emergency room where they evaluated the injection site and ran some tests.  The patient was then put on a series of antibiotics at that time.  It was reported that shortly thereafter the patient saw a new physician and she was again prescribed more antibiotics for about a month.  It was reported that the patient's leg was lanced to get the infection out.  The patient is now seeing a surgeon because the injection site reaction left a scar on her leg but it's no longer a large bump under the site.  At the time of this report, the patient's abscess is small but still had a red bump that's half the size of a penny.  It was also reported that the patient did not have a reaction from her 2 month immunizations.  No product quality complaint was involved.  Additional information has been requested.