chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included cold sores. Previously administered products included varicella vaccine (booster vaccine received before 2010). Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin, PRAVAXHOL, PROTONIX and SYNTHROID. On 26th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th April 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018, the patient experienced blood sugar increased. On 28th April 2018, the patient experienced cold sores, malaise, fever, tingling lips and tiredness. On an unknown date, the patient experienced bumps lip, scab and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the cold sores was recovering/resolving and the outcome of the pain in arm, blood sugar increased, malaise and fever were recovered/resolved and the outcome of the tingling lips, bumps lip, scab, pain and tiredness were unknown. The reporter considered the cold sores to be possibly related to SHINGRIX. The reporter considered the pain in arm, blood sugar increased, malaise and fever to be related to SHINGRIX. It was unknown if the reporter considered the tingling lips, bumps lip, scab, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cold blisters. The patient received SHINGRIX vaccine in the right deltoid. The patient reported that she received the SHINGRIX vaccine on a Thursday around 7:30 PM and on Saturday she woke up with a tingling feeling on her upper lip on the right side. On Sunday she had a cold blister and she used Acyclovir cream and she still had the blister. The patient could feel the little white bumps and they were larger than normal and they hurt and then she got a scab and it crusted over. The blister did not really get that big as it was the size of a frozen pea. The patient still had the scab with white underneath the blister. She also experienced a low grade fever which lasted a day or two and then resolved. Her blood sugar went through the roof at 212. She claimed that her blood sugar started to creep up on Friday and leveled back down again. She increased her Metformin at the advice of her physician during this time. She had a hurt and sore arm after injection which resolved by Sunday. On Saturday she felt tired and by Saturday night she had a fever of 100.4 and then it went to 100.7 and by Monday it was gone.
Information has been received from a physician concerning a 60 year old male with no known medical history or allergies who on 12-JAN-2007 was vaccinated with a first dose of Zostavax (lot#652947/1212F). Concomitant therapy included amoxicillin, Valtrex, Triglide, Diovan. The patient showed symptoms of diabetes one day after vaccination on 13-JAN-2007. The patient's sugar levels were "A1C" 10.6 and sugars 355. The patient experienced fatigue, blurred vision and frequent urination. The patient previously showed sugars of 132 in December 2005 and 109 in December 2004. Unspecified medical attention was sought. Addition information has been requested.
Patient came with a red and itchy arm. We directed the patient to see a doctor and her doctor said it was an infection and she was treated with antibiotics.
Patient had a syncope episode due to MMR vaccine administered at facility, hit his nose no bleeding. Lot S023656 Exp Date 30 Jul 2021 Left Arm.
bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (bell's palsy) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FACIAL PARALYSIS (bell's palsy) (seriousness criteria medically significant and intervention required). At the time of the report, FACIAL PARALYSIS (bell's palsy) outcome was unknown.        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.   Products known to have been used by patient, within two weeks prior to the event, included cholesterol and blood pressure medications. Patient received his 1st dose of Moderna on 18Mar2021 and on 22Mar2021 he started having bell's palsy. He went to ER. Treatment included steroids.  Patient was concerned regarding his second shot of Moderna vaccine which is due on 14Apr2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mild reaction, Covid arm; Red arm; Itchy arm; Hot; Swollen; Tender; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Mild reaction, Covid arm), ERYTHEMA (Red arm), PRURITUS (Itchy arm), FEELING HOT (Hot) and PERIPHERAL SWELLING (Swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Mild reaction, Covid arm), ERYTHEMA (Red arm), PRURITUS (Itchy arm), FEELING HOT (Hot), PERIPHERAL SWELLING (Swollen) and TENDERNESS (Tender). At the time of the report, VACCINATION SITE REACTION (Mild reaction, Covid arm), ERYTHEMA (Red arm), PRURITUS (Itchy arm), FEELING HOT (Hot), PERIPHERAL SWELLING (Swollen) and TENDERNESS (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include blood pressure medication and cholesterol medication
Big lump near my shoulder blade; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MASS (Big lump near my shoulder blade) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced MASS (Big lump near my shoulder blade). At the time of the report, MASS (Big lump near my shoulder blade) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Reporter did not allow further contact
2/17/23 I woke up and felt horrible with a very bad cold and was freezing. I had a negative COVID test. On 2/18/23 I had a positive COVID test and still felt horrible. I called my doctor's office and she prescribed PAXLOVID. I started taking it that day and took it for the 5 days. On 3/3/23 I spoke to my doctor's office and discussed the positive results I continued to have even though I felt better. On 3/6/2023, I tested negative. By then I had lost my sense of taste, but I did feel better. I still do not have my sense of taste.
positive COVID test, nasal swab/ developing a cough/fatigue, sore throat, lost sense of taste/smell; positive COVID test, nasal swab/ developing a cough/fatigue, sore throat, lost sense of taste/smell; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247) intramuscular in left arm single dose for COVID-19 immunization; second dose on 09Feb2021, first dose on 19Jan2021, at 25-year-old. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received a positive COVID test on 17May2021. COVID test post vaccination via nasal swab tested positive on 17May2021. On 12May2021, the patient started developing a cough/fatigue. On 15May2021, the patient developed a sore throat. On 15May2021, the patient lost sense of taste/smell. Outcome of the events was unknown.
Patient requested Moderna booster #1 and presented with Covid card with two primary doses already given.  Booster dose administered as requested.  After checking Tenniis, it showed three doses given prior to today.
Information has been received from a registered nurse concerning an unspecified number of unspecified patients of unknown age and gender. On 22-AUG-2015 the patients received improperly stored doses of PNEUMOVAX 23 (lot #: L003188 and expiration date: 06-JUL-2016; dose, route, frequency unspecified). No adverse effect reported. Additional information has been requested.
Hospitalized for severe vertigo, nausea and disrupted eye sight. Dizziness and tinnitus continuing past hospital stabilization.
pt recv vax 17AUG98 & pt exp n/v & dizziness;20AUG98 pt stated that white of eyes were yellow w/bloody blotches & also had a low grade fever;
Patient reported having arm pain and a hard time raising her arm/moving her shoulder about 2-3 days after receiving 2nd Moderna booster. She said she was applying heat and went to her doctor and was prescribed prednisone, but said that it didn't help and she is still having issues weeks after receiving. Advised patient to contact dr again and to apply ice to help with the pain.
Patient reported redness, pain, & swelling the night of the injection. She reported to the ER and was told it was cellulitis and given acetaminophen. Her primary doctor gave her an antibiotic.
My left arm became very swollen, red and itchy and remained that way for 3 weeks.  In addition, I was very congested, coughing, extremely lethargic and had no appetite.  I struggled to complete the simplest task, and then had to rest for a lengthy period of time before attempting another errand.   To date, I continue to be very tired, more than is normal for me, which is far worse as the day progresses.  Some days are much worse to the extent I'm largely unable to do any tasks or chores around our home; others are pretty good in the morning with the tiredness growing much worse as the day goes on.
08mar90 pt vax 3rd hepta B.  next day pt devel pruritic rash on her trunk.  12mar90 pt adm to er w/ maculopapular rash on upper and lower extremities, chest and back.  pt devel arthralgia in all joints but maintained full motion. See worm..
Redness around injection site with mild swelling.  Redness measured 7cm x 3cm 2 days after injection given on left upper, anterior thigh.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash at the injection site and on her body a few days later. The rash at the injection site consisted of 15 red, raised bumps with a slight itch and the rash on her body consisted of 12 spots on her back and chest. The pt sought unspecified medical treatment. The physician noted that the rash resolved after 10 days, however, the pt is still experiencing a red itch. On 05/19/1999 the pt was vaccinated with the second dose of varicella virus vaccine live. It was noted not reaction as of 06/23/1999. No further information is available.
This child had swelling and tenderness in her left arm it hurts to lift her arm, very painful redness. The patient instructed to take Tylenol and use warm compresses 15-20 minutes every 2 - 3 hours. Call if not better.
After vaccination patient was walking - lost consciousness for 5-10 seconds and fell- hit head.  911 called and patient monitored. pulse low
3 days p/inj pt devel redness, fever 101 & area was hard;taken to MD 1 wk p/inj & ear infect was dx;
RECURRENCE OF LYME DISEASE/FLARE OF LYME DISEASE POST VACCINE; RECURRENCE OF ROCKY MOUNTAIN SPOTTED FEVER/FLARE OF ROCKY MOUNTAIN SPOTTED FEVER POST VACCINE; This spontaneous report received from a patient concerned a 42 year old white, hispanic or latino male. The patient's height, and weight were not reported. The patient's past medical history included rocky mountain spotted fever, lyme disease, hernia repair surgery, esophageal stricture repair, hives and left ventricular hypertrophy and concurrent conditions included non alcohol user, non smoker, poison ivy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was previously treated with levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 vaccination at left arm 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced nerve pain in extremities, numbness to arms/extremities. On 17-APR-2021, the patient experienced recurrence of lyme disease/flare of lyme disease post vaccine, recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever and generalized muscle aches. On 19-APR-2021, the patient experienced tingling in bilateral hands/arm and fatigue. On 20-APR-2021, the patient experienced generalized joint pain throughout body, shoulder, arms, hands, legs. Laboratory data (dates unspecified) included: CBC (complete blood count) (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrence of lyme disease/flare of lyme disease post vaccine and recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever post vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210505559-COVID-19 VACCINE AD26.COV2.S- recurrence of lyme disease/flare of lyme disease post vaccine and  recurrence of rocky mountain spotted fever/flare of rocky mountain spotted fever post vaccine. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Pt  presented in clinic to receive second dose of Moderna COVID vaccine.   One vaccination station was responsible for providing both Moderna and Pfizer vaccines.  The Moderna vaccine was kept on a separate station and handed off to the vaccinator only when the need arised.   The Moderna vaccine was placed on the table near the Pfizer vaccine by  another nurse.   The vaccinator did not see the Moderna syringe and inadvertently used the Pfizer vaccine.      No immediate reactions were noted.   The patient was notified of the administration error.
Itchy body rash beginning 6 days after vaccination and worsening at day 7 and 8. Contacted telemedicine  and was prescribed an oral steroid and Benadryl.
No adverse effects reported from immz, however child was admitted to hospital 4/10/14 w/ flu like sym and tested positive for flu. Treated for dehydration etc...unsure if child is still in hospital or discharged.
Moderna for 12+ given to a 10 year old. Parent informed, encouraged to watch for extra side effects and call or have the child be seen if have any concerns. Parent reported child was doing fine at time of call; had been about 2 hours since shot administration.
Severe left arm pain. Body aches that started 30 hours after vaccine and lasted 24 hours. Decrease in the amount of breast milk I was producing for 3 days. Congestion.
Information has been received from a medical assistant in a physician's office concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough chicken pox. The case was reported to be mild. Unspecified medical attention was sought. A product quality complaint was not involved. No further information was available. The medical assistant also reported a male toddler who had a similar experience after therapy with varicella virus vaccine live (WAES0404USA00169).
The pt states that on 12/19/01, she noticed a large reddened area at the injection site 4" X 4" approx. It was warm to touch but no lump or other side effects present. No generalized difficulties.
Since I had a shot for anthrax #1 my neck become stiff and aching. He has had 2 subsequent doses in his RA. He complains of ? since that time. Pt on meds for Monopril, Lipipor, Gluphage, Ameryl, and Allopusive.
1st dose end of Jan2022, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient reported that received first dose of Shingrix at the end of January of 2022 (26th January to be exact) and having not yet received the second dose. The patient had realized that gone past the 2-6 month window to get the second shot. The patient asked that was that ok or did they have to start over again. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, patient did not receive the 2nd dose of vaccine which led to incomplete course of vaccination.
Itchiness and hotness on upper left arm down to elbow, gave patient one Benadryl and water, patient recovered after 10 min
Broke out with several cold sores on my chin. Have never had them on my chin before.
Patient arrived to our Emergency room here at Medical Center 4 days after receiving his 2nd Booster of the Moderna Covid-19 Immunization.  He arrived at the ER with complaints of a headache and numbness in his left arm radiating to his feet.  He told the nurse his pain was 5/10 for the headache and that he also had visual disturbances.    He has been to the ER with these same complaints previously with the most recent one on 2/26/22 .  He says that they are from his Atypical Migraine diagnosis.  He had a follow-up on 8/3/22 with his primary care physician after the ER visit to discuss a referral to his neurologist at Clinic who initially diagnosed him with Late Life Atypical Migraines.  He had been doing very well for about 2 1/2 years until over the course of the last 6 months he has had now 2 episodes of these headaches with numbness and at this point has had no evidence of any stroke activity.
Chills, fever, body aches, fatigue, head ache. Most lasting 24 hrs
On 3-29-14 it started with tingling and numbness in my hands and feet.  Over the next week, I had pain in my face and when I moved my eyes. Was unsteady on my feet and beginning to fall. I went to the doctors a few different times and finally after another trip to the Drs. they decided I had GBS. 4-9-14 they sent me to the hospital. I was there for 3 days and sent me home and said it was not GBS. Once I saw an Orthopedic Dr. on 4-14-14 they sent me to a Neurologist who diagnosed me with GBS, and sent me back to the hospital on 4-15-14. I remained there until May 1-2014. It's now 4-5-16 and still have weakness in my legs and still have extreme fatigue.
Erythema & swelling @ injection site in the evening post receiving imms.  It now extends to entire upper arm- Instruction on cool compress, BENADRYL + return if no improvement
client DOB 7/3/88 Boostrix given client turned 19 (38 days too old for Boostrix)
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 20-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Severe flushing, fever, headache, dizziness, rapid heart rate, hives and rash. Sent home, BENADRYL 50mg - & continued BENADRYL x 2 day.
PATIENT CALLED REPORTING THAT SHE HAD DEVELOPED A FEVER OF 102 DEGREES AND BODY ACHES IN THE EVENING.  SHE STATES THAT SHE HAD TO USE HER RESCUE INHALER AND HER CHEST TIGHTNESS IMPROVED AS IF SHE WERE HAVING A REACTION TO HAYFEVER (WHICH SHE IS BEING SEASONALLY TREATED FOR), SHE ALSO TOOK HER EVENING SINGULAIR DOSE AND TIGHTNESS EASED.  RPH INFORMED HER IT SOUNDED LIKE A TYPICAL VACCINE REACTION COMBINED WITH A TYPICAL RESPONSE TO SEASONAL ALLERGY, HOWEVER PATIENT INSISTED IT BE REPORTED TO VAERS
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient had some redness at the injection site. The patient had denied permission to contact their physician.
Developed shingles after receiving 6th dose AVA.  Had received primary series of immunization in July 1997.  Then in 2000, subject was administered the primary series again because the original paperwork couldn't be found.  Sought treatment for shingles on 11/27/2000.  Around this same time he developed severe headaches, depression with sobbing uncontrollably and an inability to think clearly.  He began to self medicate with alcohol and street drugs 2 1/2 years ago.  His wife left him 06/01/2005.  His father realized he needed help and took him to the emergency room to ensure immediate treatment.  Substance abuse is no longer a problem following an outpatient treatment program that the subject attended.  At this time the expectation is that there is no need for further treatment.  The patient was evaluated and sent for psychological and medical referrals.  The patient has also been receiving counseling for post traumatic stress disorder and the counseling is expected to continue.  The patient had diagnostic workup in mid-June and is now taking Bupropion HCL to correct his serotonin levels and he sees his doctors frequently.  His father reports that the patient had improved 3000% since beginning the medication and his headache have improved drastically.  This information was received from the patient. Follow-up information received May 2, 2006. BioPort has not further informatino on this case. In the event that additional relevant medical information is received, a follow-up report will be submitted.