chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced shingles after dose two of Shingrix; Shingles; blister on the leg; her legs jumping like they were in pain; her legs jumping like they were in pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included paraplegia (T10 Paraplegic).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: she experienced shingles after dose two of Shingrix) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), blister (Verbatim: blister on the leg), leg pain (Verbatim: her legs jumping like they were in pain) and leg discomfort (Verbatim: her legs jumping like they were in pain). The outcome of the vaccination failure and shingles were unknown and the outcome of the blister, leg pain and leg discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister, leg pain and leg discomfort to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, blister, leg pain and leg discomfort to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter reported that she experienced shingles after dose two of Shingrix.  The reporter did not leave lot number, expiration date or date of birth. The reporter described shingles as a blister on the leg and her legs jumping like they were in pain.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
sore left arm shot area  chemosis- thought I had something in  my eye, a cat hair since I had been petting put cat.  skin around right eye slightly swollen.  Realized the liquid was under clear part of eye.  Looked like some bubbled coming from top of eye, so weird.  Could feel the liquid moving in eye when moving head.  Touched the eye, liquid spread around iris and pupil not going over it.  Was so weird.  No pain.  Felt that it had to be a reaction to the shot.   My body seems to be pretty sensitive.  I have had cold sore a few times back to back due to stress.  My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child.  Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction.  The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data.  Blah blah blah.  I disagreed and left it at that.  Had a benedylt last night and put  a pataday drop in eye as recommended by PA
This spontaneous report as received from a medical assitant, refers to a currently 16 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9),  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Body aches. Fatigue. Nausea. Headache. Earache. Couging. For 1 week
WARMTH, RASH, REDNESS, INFLAMMATION BELOW THE DELTOID ON THE LEFT ARM.
pt recvd 2nd vax 20JUL93 same sx feverish?, chills, loose BM x 3d, tiredness;
redness on whole arm from elbow to shoulder; itchiness at the injection site.; rash at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on whole arm from elbow to shoulder), VACCINATION SITE PRURITUS (itchiness at the injection site.) and VACCINATION SITE RASH (rash at the injection site.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (redness on whole arm from elbow to shoulder), VACCINATION SITE PRURITUS (itchiness at the injection site.) and VACCINATION SITE RASH (rash at the injection site.). At the time of the report, ERYTHEMA (redness on whole arm from elbow to shoulder), VACCINATION SITE PRURITUS (itchiness at the injection site.) and VACCINATION SITE RASH (rash at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications given by reporter.  No treatment information given by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Additional information received
Patient came in for covid vaccine and administered at the moment of vaccine no symptom occurred at the time.
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were provided.
Patient at 11 year old well child check.  Seconds after receiving Tdap vaccine, patient felt lightheaded and became pale,  but never passed out. Patient laid flat on exam table. Ice pack applied to head Dr. came in shortly after and assessed patient. Apple juice provided Blood pressure taken and was 92/56.  Patient felt much better after this and walked out office with mom and brother with no symptoms after being reassed by Dr.
Staff received vaccine and sat in observation area at 1405. At 1420, staff complained of right arm pain (4/10) at injection site. Vital signs WNL. Patient was assessed by onsite MD at 2:35 PM and returned back to work at 2:37 PM. Advised by MD that he could use ibuprofen and he should monitor site.  No redness or swelling noted at injection site. Normal range of motion
This spontaneous report as received from a pharmacist referring to a 69 years old female patient who on an unknown date was vaccinated with 0.65 ml ZOSTAVAX, SQ (Lot # not provided) on 20-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 29-SEP-2012 the patient experienced burning sensation, itching and eventually developed cellulitis after receiving ZOSTAVAX. The physician mentioned that "just to be clear there was no rash", MOTRIN, BENADRYL and an unspecified antibiotic were given as a treatment for the events. The outcome of cellulitis, itching and burning sensation was reported as recovering/resolving "it's a vaccine". The relatedness for cellulitis, itching and burning sensation was unknown for ZOSTAVAX. Additional information has been requested.
The pt received 3 injections of Lymerix. Some time later, he sustained a tick bite. He then developed headaches and "tight" joints; his joints were not red. The tick attached itself on the pt's right hip, approximately four inches "below the belly button". A "nickel-sized" are of redness surrounded the tick, a "quarter-sized" are of discoloration surrounded, the area of redness. On 11/22/00, the pt was seen by a nurse, who reportedly made a "possible diagnosis of recovering Lyme disease". The pt was to have the tick removed by a physician on 11/27/00.
Large pink egg sized swelling in the area of injection. Patient informed to apply a cold compress to area and take TYLENOL for pain.
mom asked MD if was nl for child to cry like this;mom states child been crying since 11AM;told to give DPH;pt still crying;told to take pt to ER;pt went to sleep & woke up fine did not go to ER;cont labeled allergic to pertussis;
Glands had swollen; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's glands had swollen. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient was seen in the Emergency Department on 07/28/21 for frequent falls.  He was swabbed for COVID-19 in anticipation for possible hospital admission.  Pt tested positive for COVID-19.  With no upper respiratory or GI symptoms.  He did not want to stay in the hospital and was discharged home.  Pt previously tested positive for COVID-19 on 05/07/21.
Localized Pain ((L) Deltoid), Redness, Swelling, Shoulder Pain, Cellulitis Axillary Adenopathy, Sore Throat Keflex 500 mg once po QID/Day
Increased BP, dizzy, frontal headache 1 1/2 hr. after Boostrix 0.5 ml IM
Boostrix was inadvertently administered  that was stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2EC5G, expiry date 13th January 2023) for prophylaxis.   On 5th April 2021, the patient received Boostrix. On 5th April 2021, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter was a clinical supervisor. The age at vaccination was not reported. The reporter called in to check stability of Boostrix vaccine stored at minimum 29 Fahrenheit temperatures for 48 hours.  The reporter stated that they had inadvertently administered Boostrix vaccine that was stored outside of normal range and needed to be discarded of the patient, which led to incorrect storage of drug. The reporter was unable to provide additional details of vaccine and patient. The reporter did not consent to follow-up. This case is 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102718:Same reporter US-GLAXOSMITHKLINE-US2021102717:Same reporter US-GLAXOSMITHKLINE-US2021102716:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
Ear infection; delayed the second dose vaccination/beyond the 6 weeks period, 60 days after; Patient has not received 2nd dose, received first dose 1Jun2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021), EAR INFECTION (Ear infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021). On an unknown date, the patient experienced EAR INFECTION (Ear infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after) had resolved and EAR INFECTION (Ear infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  Patient had taken the antibiotic for treatment of ear infection hence delayed in 2nd dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up  received on 30-JUL-2021: New event of Ear infection and treatment medication were reported.
I am really upset; I got the first shot and I got a reaction through that; sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9263) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Medical history included AFib, breathing problem. Concomitant medications were not reported. On an unspecified date, patient got the first shot and patient stated I got a reaction through that, I got all the symptoms. Patient stated I am really upset from that shot so patient was calling about should I go tomorrow to get the second shot.The patient also experienced sick. Patient stated thatI am alright now, I come out if it, right now. It lasted for a few days and it left. The outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
reported she had 8 days after her first Moderna shot (/702021) a thick red, raised, itchy and painful rash. Rash was also hot to touch. Rash started 8 days after injection to Left Deltoid. It started from injection site and spread down to abover her elbow-grew to 4 by 6 inch long rash. It was most painful te 15th, 16Th, and 17 Th.  She also reported feeling faint, dizzy, and weak/ unsteady gait at the time of the rash.  By Jan 19 the she started to feel better. By 2/4/21 when seen again in clinic rash still ad some redness and rash was 1.5 by 1.5 inches but no longer raised and painful. All other symptoms had resolved.  She was not given a second dose of the Moderna vaccine . She was instructed that the rash is not an absolute contraindication for the second Moderna vaccine dose but that she should see her primary care provider to discuss the rash/other symptoms and make a medical plan if she were to get the second dose.
Herpes zoster symptoms start around April 17th. Diagnosed on the 30th and was prescribed with IC Gabapentin 100 MG. Was given an OKAY to take the second dose of vaccine (taken on May 2nd) and have not been having much side effect. The Herpes zoster symptom has been almost cured now on May 7th.
had reaction to Dtap L Deltoid 8cm x 5cm - redness Ibuprofen  5/ml 2 tsp po x1 @ 11am
Hour or two after the vaccine, increased anxiety due to fear of what the vaccine would do to my body. Dizziness and tiredness, arm pain on 10/29/2021 and today 10/30/2021. Slight headache on 10/29/2021. Also decrease in appetite both days.
Severe muscle pain / joint pain worse, irritability / crying, chills, night sweats, fluttering or pounding of heart, Headache, Breathing affected and swollen lymph nodes
Pt experienced immediate reaction of nausea, headache, muscle and joint pain with a fever of 100F, lasting approximately 72 hours. Pt had an onset of tendonitis in right elbow approximately 2 weeks - 3 months, treated with rest and an anti-inflammatory. Pt experienced an onset of bilateral carpal tunnel syndrome approximately 6 months to date of report, continued with rest and anti-inflammatory therapy.
COVID-19; Sore throat; Runny nose; Diarrhea; Coughing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021. The most recent information was received on 05-Feb-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder on 01-Mar-2021.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On 03-Feb-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were reported as Xarelto, Sotalol and OTC Vitamin in description.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 22-Jul-2021, dose 2 removed (not received, only scheduled), Vaccine derived SARS-CoV-2 infection removed, COVID-19 event added, updated action taken to unknown.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.
Information has been received from a consumer concerning her currently 5 year old nephew with no medical history who was vaccinated with a dose of MMR II when he was 17-18 months old. There were no concomitant medications reported. "Shortly afterwards," he developed the symptoms of autism. He started "flapping his hands and going into his own world." Unspecified medical attention was sought. It was reported that there were no diagnostics studies performed. The outcome was reported as not recovered. Upon internal review, it has been determined that autism is an other important medical event (OMIC). The reporter also reports that "a friend's child had the same experience with the vaccine." (WAES0305USA02474). No further info is available.
Headache, Sedation, Myalgia, Fever,  Cold sweats, Difficulty sleeping, Back pain,   Narrative: Pt experienced headache, cold sweats, difficulty sleeping through the night, back pain, myalgias and fatigue the day of the second dose 1/20/21. Continued body aches through 1/22/21. Missed work x 1 day. Pt has no known prior COVID infection.   Other Relevant History:
I experienced brain fog, itchy throat, sore arm, fever, diarrhea, headache, poor appetite, hard to concentrate and memory loss. My memory loss is so bad I had a GPA of 3.9 now I'm failing in my studies. I'm experiencing daily headaches taking me 2 hours each day to get out of bed, experienced 10 lb  weight loss, going hours without eating. I have memory loss this has affected my studies and job duties as a nurse. I have seen a Neurologist and PCP running more tests (MRI) has recommended me to see another Neurologist. In my everyday, example: instead of using the coffee pot I picked up a flower vase. Another example, as a travel nurse I administer medication I thought I gave one of my patients her medication however I didn't only because the computer recognized it. This is very unsafe for me at work being a nurse I have to give patients narcotics. My grades are failing in school I have 66% now. I have an appointment on next Wed to get blood work done.
I have a fever of between101.7 and 102.5 and its keeps going up and down with extreme chills, and overall headache with fatigue and bad body aches.
Dizziness followed by her Eyes sight spontaneously going completely to a blackout state. Migraines.
Information has been received from a nurse concerning a 14 weeks old female who on 01-JUN-2010 and 27-JUL-2010 was vaccinated with the first and second dose of ROTATEQ respectively. (Lot number is 665276/0302z for the first dose and 668041/0510z for the second dose). Concomitant therapy included PENTACEL and PREVNAR. On 28-JUL-2010, the patient experienced facial swelling after receiving her second dose of ROTATEQ on 27-JUL-2010. Her right cheek was swollen and bright red. She did not have a fever but experienced an increase in sleep. The patient was seen in the office on 28-JUL-2010 and 30-JUL-2010. By 30-JUL-2010, her face had improved. On unknown date, the patient recovered. Additional information has been requested.
09/19/22 presents to ED for "hypertension, shortness of breath". PMHx of "Afib, COPD, lung cancer, ascending aortic aneurysm and obesity"
Cold symptoms 10/17-18.  Headache, chills, fever, achy, runny nose, coughing, difficulty breathing, extreme fatigue - 10/19-10/20 Runny nose, extreme fatigue - 10/21-10/23
Information has been received from a physician, via a company representative, concerning a 15 year old female patient who was vaccinated "during the last couple of weeks" (February 2007), with the first dose of Gardasil. Concomitant suspect therapy included other vaccines (therapy unspecified) that were administered at the visit. The physician reported that the patient "fainted after getting Gardasil and several other vaccines were administered at the same visit. Subsequently, the patient recovered. The patient sought unspecified medical attentions. Additional information has been requested.
Right deltoid area inflamed, hard and swollen.  Benadryl, Cortaid, ice pack, Tylenol recommended.  If symptoms persist to return to clinic ASAP.
p/vax pt eyes are swelling & skin is very red on arms & legs;no breathing problem;pt taken to ER;given epi & ready for discharge;