chrisvoncsefalvay/vaers-outcomes huggingface dataset:
you took two shots and I still got them / Suspected Vaccination failure; got them; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received years before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In March 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingle shot years ago, then had them again many years later when they took two shingles shots and still got shingles this past March. The patient took every precaution and still get shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
6May-7May-low grade T. Sore @ injection site. 7May-24May cranky. 24May began runnning T to 102F. Would break w/APAP. Became limp, uninterested in surrounding & cried all the time. Took to MD, SX abating 31May.Still running T @ time of rept.
Student came to the health office at 10:45 with numbness and tingling of the left upper arm. The arm she had received the flu vaccine in. Also, some discomfort noted when extending the arm outward from the side. The arm was warm with +pulses and good hand movement. School nurse is  monitoring this and has notified her Mom.
Left arm hurt; And stuff; Felt tired/a little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm), VACCINATION COMPLICATION, and FATIGUE in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 041B21A, and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Cataract (Taking eye drops to treat). Previously administered products included for Drug use for unknown indication, flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Seasonal allergy, Overweight, Depression, Myalgia, and Stress. Concomitant products included NAPHAZOLINE HYDROCHLORIDE for Cataract, FISH OIL, ZINC, and VITAMINS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (Left arm) and FATIGUE. December 2021, the patient experienced VACCINATION COMPLICATION. At the time of the report, PAIN IN EXTREMITY (Left arm), VACCINATION COMPLICATION, and FATIGUE outcome was unknown.            Concomitant medication includes using eye drops to treat cataract. Patient reported sometimes she gets depressed, has muscles aches in arms and legs. Caller stated she goes to the dentist and her teeth are normal. She also reported she gets stressed out occasionally.  Treatment information was not provided.    This case was linked to MOD-2021-420631, MOD-2021-420621 (Patient Link).
Developed Shingles 4 months after receiving the 2nd dose of Pfizer vaccine for COVID
I got sick a month ago, I was exposed to COVID-19 positive people. I got sick I was having a scratchy throat that progressed to dripping in the back of my throat. I had nasal congestion and then the cough came. I took some cold capsules and the cough got worst and about five days later I went to see the doctor. I did test for COVID-19 twice and they both came up negative. The doctor prescribed an antibiotic which I took for ten days. I went back to the doctor cause of the cough, it was for a dry cough so it did not help. I still and suffering from the cough and itchy throat. It's lasting not as bad but its still there.
Recurrent vestibular neuronitis vertigo; unsure which vaccine she received; symptoms are improved but not fully resolved
Hives started about 5 minutes after immunization. Gave 50 mg of Benadryl and ice to apply to skin. No progression of symptoms. Stayed in store about 45 minutes total. Said she felt fine and left with person she came with. Said she wanted to take cool shower and he promised to watch for any other symptoms. Phone calls confirmed she is fine.
tested +for covid - symptoms: headache, mild cough, head congestion started Paxlovid on Day 1
Headache, Myalgia, Arthralgia, Diarrhea, injection site pain Narrative: diarrhea ongoing for four days, headache lasting more than a few days. Taking OTC medication. Advised to speak to her pcp if symptoms persist.
13 days after my 2nd Pfizer dose, my period started on May 14, 2021. Today is June 21, 2021 and my period has continued this entire time (38 days), with either heavy bleeding (bleeding with clots, using more than one Super tampon every two hours) or at least spotting on every day except for two days (not bleeding on June 12 and 13).
Provider on call received a p/c from parent reporting arm red and hot where shot was given on 05/13/05- no fever.
PARENT CALLED AND REPORTED HIVES STARTING 30 MINUTES AFTER DTAP WAS ADMINISTERED.BENADRYL WAS GIVEN.  CONTINUED TO HAVE HIVES OFF AND ON OVER NEXT 72 HOURS.
Patient received vaccination and was sitting on dad's lap. Dad told her to stand up. She rose but fell to the floor face down. Dad turned her over and picked her up. She said she felt like "she was dreaming.." She said she had a headache.
Fever, headache, nausea, body aches, joint pain, started day after vaccine.
Fever 101 degree Day 7-10 post MMR, Varicella. Varicella type rash started day 9.
fever, at 103°F; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as Age: 28, Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient received the vaccine on 05Jan2021 and experienced fever at 103 F on 05Jan2021. She then asked if she should be alarmed or was it a reported side effect of the vaccine. The outcome of the event was unknown.   Information about lot/batch number has been requested.
pt recv vax 3JAN97 & on 4JAN97 fever of 102.3, chills & redness on lt arm;5JAN97 fever of 101.0, redness traveled upper arm & to elbow;seen @ ER 6JAN97;arm was hot & redness was traveling on the arm;
Vaccines administered were exposed to a low temperature and invalid for administration. Patient has not reported an adverse effect.  Revaccination plan to be addressed.
~24 hours after receiving second dose of vaccine, patient experienced acute tinnitus of the right ear canal.  Level of tinnitus subsided to a more tolerable level the following day but has continued since receiving vaccination.
Mom reports toddler got MMR at health dept on 06/22/01 at 4:00 pm. Mom states three days later the child had "hives" all over his body and she took him to the family physician. Mom reports child saw the doctor three times in three weeks and he prescribed Benadryl. After the third episode the child was referred to the pediatrician around 7/09/01. The mom stated the pediatrician stated the child had an allergic reaction to the MMR and he also had an ear - sinus infection. The pediatrician prescribed an antibiotic and Zyrtec. Mom states the child's temperature at the physician's office was 101.5 F. Mom reports while at the local pharmacy for the prescriptions, the child had a seizure. The child's temperature was 103.7 at that time. Mom stated the child was taken by ambulance to the ER, where he had a spinal tap and was in the hospital for 2 days. Mom reports the child still has hives in the mornings and he is on Zyrtec 3/4 tsp on a daily basis.
Rash, redness shoulder back pain/back pain/under arm pain tender to touch injection site. Red from shoulder.
Patient decided not to second dose so there is a time lapse, First dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL DOSE OMISSION (Patient decided not to second dose so there is a time lapse, First dose > 35 days ago) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Patient decided not to second dose so there is a time lapse, First dose > 35 days ago). On 22-Feb-2021, INTENTIONAL DOSE OMISSION (Patient decided not to second dose so there is a time lapse, First dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received with No New Information On 24-Sep-2021: follow up received contains no new information
Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 75% of facial skin that was painful / burning sensation for 24 hours and itchy after that.  Still have the rash 60 hours after onset of rash, but it has subsided to approximately 50% of facial skin.
Fever up to 104.4 starting approx. 45 minutes after receiving flu shot.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, Fatigue Narrative:  Other Relevant History:
Initial report received on 31 Oct 2005 from a health care professional. A 48 year old female patient with a medical history on no known allergies and diabetes experienced vertigo approximately 4 hours after the influenza vaccine (Fluzone SV '2005-'2006) administration on 25 Oct 2005. She was sent to an emergency room, where she was evaluated by the Emergency room physician. The glucose test was within normal limits at an unspecified time. She was concomitantly administered with insulin pump and some other unspecified medications. Outcome was not reported. Follow up information received on 20/Mar/2006 from a health care provider. The patient has a medical history of insulin dependent diabetes mellitus type 1, hypertension and hypothyroidism. Per the reporter, the patient had received a double dose of the Fluzone vaccine on 25/)ct/2005. The site of administration was in the upper left arm. The patient has not had any recurring symptoms since October 2005. It has been recommended to the patient by her treating physician not to to received the Fluzone vaccination again. No follow-up appointments have been completed.
Rash started appearing on my arm a day after the first shot. (Aug 18th). The rash went away after a couple of days (Aug 21) But now this rash is back again (Aug 25 at 7:00 PM) and it is itchy and red and about the size of a baseball.  Other symptoms are soreness, hardness in arm, and nausea.
This spontaneous report received from a patient concerned a 72 decade old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced confusion, numb hand, brain fog, not sleeping good, very sore arm and it extends downwards, nausea, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, brain fog, confusion, very sore arm and it extends downwards, numb hand, fatigue, and not sleeping good. This report was non-serious.
Within 1 minute of receiving HBV, MMR and Varicella became dyspenic, nasal flaring, wheezing and neck retractions (11:21 AM). 11:23 AM Epinepherine 1:1000/0.25 ml SQ. 11:24 AM Benadryl 50 mg/ml 1cc IM given. 11:30 responded well. Symptoms subsided. Sent directly to PMD office (after notifying office). Office call x2, doing well. 7/10/03 T/C doing well.
Donor states at approximately 1700 on 12-20-06 started to itch (with hives) after tetanus injection, she started to take Benadryl. Is still taking medication at this time for itching, no longer has hives.
Red, itchy rash at site of injection on left arm, started noticing it on Saturday 5/1, which was 3 days after the vaccine was administered. Worse today, on Monday 5/3.
Patient complained of pain in left upper arm.  Left arm elbow to shoulder reddened, with slight swelling, warm to touch.
Pt was given Moderna COVID-19 vaccine on 2/11/21 with no adverse reactions.  Pt later died on 3/08/2021 with lung cancer being cause of death.
After my injection I started to get a rash from my arm and on the left side of my chest.  It's a bit itchy, red and weird  it's Friday and still noticeable.
became sick due to other issues; did not get his second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot). At the time of the report, ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided.  Treatment information was not provided.
h/a (all around) throbbing; nausea no vomiting; tx @ ER Tonadol/Compazine; pt had just recovered from pneumonia bout 2-3wk;
Fever of 102 degrees, headache, chills, aches, skin hurt, tired.  Hard time doing anything.  Took Ibuprofen all day.  Lasted approx. 36 hours.  Was okay by Friday, Jul 4.
patient experienced a "quarter sized lump"at the injection site; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case (GMI reference number: US-SANOFI-00314166) received from a pharmacist.  This case involves a 32 year old male patient who experienced a quarter sized lump at the injection site (injection site mass), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication, family history were not provided.   On 12-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7005MA and expiry date 30-June-2021] via an unknown route at right arm site for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious quarter sized lump at the injection site (vaccination site mass) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was injection site mass.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome was reported as not resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 64 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), on 08Apr2021 as dose 2, single (Lot number: ER8737), on 03Nov2021 as dose 3 (booster), single (Lot number: FH8028) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9894) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 22Mar2023 to 26Mar2023.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 84-year-old patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Lot number: EN6210) for covid-19 immunisation. The patient's relevant medical history included: "canker sores in mouth and on tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot# EL1283), administration date: 01Feb2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "only had 3 Canker sores/a potential solution to the treatment of canker sores". Additional information: it was reported that in all the patient's life had canker sores in mouth and  tongue on a constant basis. This began as young as 4 years old. Through in childhood was examined and treated by several dentist. There were times the dentist had told the patient and the parents that the patient had as many as 21 canker sores with some of them as large as a dime. They could never eliminate them. Through adult life this continued and caused extreme discomfort. Patient always had at least 4 to 5 canker sores in the mouth. On 28Oct2021, patient received a 3rd booster lot# 320308D. Since the vaccinations patient only had 3 Canker sores and all 3 occurred where the patient bit the cheek or tongue while eating. Patient thought that this might be interesting  potential solution to the treatment of canker sores.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : FIZER INC-202201049932 same patient/product/event, different dose; PFIZER INC-PV202200038491 same patient/product/event, different dose;
PATIENT HAD PFIZER VACCINE ON 12/30/2020, and 01/20/2021, AND TESTED POSITIVE TO COVID.
Foster mom brought pt in on 8/19/04 with left thigh swollen approx 3 1/2 in. in size, induration with red splotchy area. He had received Pediarix in left thigh on 8/17/04. She said it had been that way for 2 days. He received 12.5 mg of Benadryl IM. Dr. spoke with mom on 8/20/04 and his left thigh area had turned completely red, told to bring back in, mom didn't. Spoke with foster mom this AM said doing great, redness gone.
Oct. 21, started out with chills and fever that went up to 102.7. Fever lasted 5 days. Monday, Oct. 25. we called PCP, He said it was a side affect of booster, it should pass.  Monday night Mom started to have a cough and hard time breathing. she could not catch her breath after coughing. she was getting worse. Oct. 26, her left hand and fingers started to turn black and very painful, while getting worse with the breathing and coughing. Took her to ER. she had multifocal pneumonia and very low pulse in left arm and wrist. So then she was transfered to Medical Center OCt. 27, had angiogram done then Life flighted Oct. 28. then died Nov. 2, 2021
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:08 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.41 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Vial was moved to fridge on 05-Oct-2021. Product moved to clinic on 27-Oct-2021. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 39, 32 Fahrenheit from 09:00 AM TO 10:00 AM. Beyond use date for the vial was reported as 04-Nov-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A report was received from a health care professional on 11/04/02, concerning a female vaccinee in her 30's who experienced a tingling sensation on her lips and cheeks 30-45 minutes after receiving Fluvirin intramuscularly on 11/04/02. The symptoms had not resolved at the time of the report. It was reported that the vaccinee had not been exposed to influenza vaccine before nor had any allergy to eggs. The reporter has assessed the relationship of the vaccine to the event as probable.
On 6/2/2021 11 year old was administered Pfizer .3ml  On 6/28/21 11year old was administer a 2nd dose of Pfizer .3ml