chrisvoncsefalvay/vaers-outcomes huggingface dataset:
area is red; hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix in upper arm and area was red and hot to touch.
Patient experienced symptoms of rash, hives, swelling, and itching all over his body, within the first 24 hours of injection. His eyes were almost swollen shut and the hives were red and blotchy all down arms, legs, and body. He went to urgent care on 10/01/2018 and was prescribed prednisone 20 mg tablets by mouth twice daily for 5 days, as well as famotidine 20 mg tablets twice daily by mouth for 5 days. He also followed up with his primary care physician on 10/02/2018, After 24 hours of the prescribed treatment, his symptoms were noted to have improved, however, the rash, hives, and swelling were all very prominent.
pt recv vax 29MAY97 & 5hr later pt devel a maculopapular rash on forearm & elbow of the arm where vax given;there was no itching;w/in 12hr rash resolved;the redness persisted until 1JUN97;
Swelling and rash at injection site, fever, cough, runny nose, headache
This spontaneous report as received from a pharmacists via a company representative refers to a female in her late sixties to early seventies. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient experienced injection site redness and injection site swelling for 6 days after receiving PNEUMOVAX23 concurrently with an unspecified Flu vaccine. The outcome of the events injection site redness and injection site swelling was not reported. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Pt developed severe pain in (L) shoulder a few hours after Tdap injection. Pain limits ROM and makes it difficult for pt to pick up infant daughter. MRI showed fluid in subdeltoid bursa, likely b/c injection was given to high. Pt treated with subacromial bursa injection of KENALOG and physical therapy.
On 8th day after injection, a large red rash appeared around the injection site.  Itching at injection site that continues now - 18 days after injection. Rash subsided after 6-7 days.
Thurs 09/15/16: Pain at injection site; (left thigh) and would not move left LE at night. Fri 09/16/16: Fever to 102: reluctant to walk. Sat 09/17/2016: Exam by MD; back to normal; mom agreed.
Follow-up info received on 12/9/02 provided pt details, dates of vaccination and event onset, recovery status, and treatment. A medical assistant reported that a 49 year old received an injection of Flu Shield on 10/15/02. Within two minutes of immunization, clamminess and lightheadedness. An electrocardiogram was normal. The pt's blood pressure was 152/95mm Hg and his pulse ox was 98% on room air. He was treated with Benadryl, oxygen, Proventil, and unspecified steroids. The pt was seen in an ER where he was treated with methylprednisolone. The pt also developed a 3 inch by 1 inch area of edema at the injection site. He recovered. Dyspnea, tongue edema, and throat tightness were considered medically important (OMIC) in this case. As a result of follow up info, this report has been reclassified as serious, unlabeled. This is one of two reports concerning pts from this facility who experienced an adverse event following receipt of Flu Shield. See related case HQ4782423OCT2002.
Case number PHEH2015US016929, is an initial spontaneous report from a nurse received on 27 AUG 2015. This report refers to a 24-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2015/2016 (batch number: 157403, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 27 AUG 2015. It was reported that patient received FLUVIRIN that had a temperature excursion of 10.39 degrees Celsius for up to 25 minutes. No adverse event was reported due to the  maladministration (incorrect storage of drug).
pt recv vax 5JAN98 & pt exp a full blown case of varicella w/30+ vesiculopapular lesions;
This spontaneous report as received from a medical assistant (MA) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 cm rash, are vesicle, left arm skin over deltoid with itching. Likely mild Varicella
Dry mouth, started about 2 hours after vaccine. Symptoms - dryness/coarseness of mouth and tongue, tongue has lost some color, mild discomfort from dryness. Feel overall dehydrated despite attempt to drink sufficient water. Symptom is ongoing.
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a elderly male patient who received SHINGRIX. Concomitant products included Atorvastatin, AMBIEN, clonazepam and LEXAPRO. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician who reported for himself. This case was previously reported to a doctor. The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced red and swollen area about 3 inches in diameter on his arm near the injection site which resolved after a few days. The patient was unable to provide full demographics of his personal physician. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK080047.
This spontaneous report as received from nurse refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the unspecified patients were vaccinated with liquid PEDVAXHIB (dose, lot#, not reported. No concomitant medications reported. The nurse reported that since 01-JUL-2014, unspecified patients may have been administered with liquid PEDVAXHIB, that were not stored properly. No adverse effects reported. This is one of the several report received from the same reporter.   Follow up information has been received. On 23-JUL-2014, a phone call was placed to Licensed practitioner nurse. The office admin answered the phone call.  A message was left with the admin requesting that the L.P.N, return the phone call. Additionally, a request was made for patients identifiers, lot numbers and expiration date and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Information has been received from a physician and the office manager concerning a 12 month old female patient who on 05-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported. The patient did not seek medical attention.  This is one of several reports from the same source.  Additional information is not expected.
Bell's Palsy; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included ongoing blood cholesterol and ongoing nephropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Device Date was reported as 11Jul2021.Concomitant medication within 2 weeks of vaccination included rosuvastatin (ROSUVASTATIN). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 05Jul2021 at 09:00, the patient experienced bell's palsy. The case assessed as serious (Disabling/Incapacitating, medically significant). There was no Prolonged hospitalization. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of event and treatment included with Prednisone, Valacyclovir and Systane. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Inconsolable crying for about 2 hours. Redness on injection site (R thigh).
2 shots and still got shingles started behind my left ear/suspected vaccination failure; shingles; Still have scabs drying up 3 months now; still hard to get sleep; This serious case was reported by a consumer via interactive digital media 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.   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: 2 shots and still got shingles started behind my left ear/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), scab (Verbatim: Still have scabs drying up 3 months now) and trouble falling asleep (Verbatim: still hard to get sleep). The outcome of the vaccination failure was unknown and the outcome of the shingles, scab and trouble falling asleep were not resolved.   The reporter considered the vaccination failure, shingles, scab and trouble falling asleep to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure, shingles, scab and trouble falling asleep to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 This case was reported by the patient via interactive digital media. The patient had two shots of Shingrix and got shingles started behind left ear and still had scabs drying up 3 months now, still hard to get sleep. The patient reported that might be without shots could been lot worse. The patient reported that she had friends who had shingles.  The pain they described sounded unbearable. The patient educated herself about the risks and what she could do for prevention. The reporter thought event might not had been related to drug. 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. Follow-up would not possible, as no contact details were available.
Rash on face and neck developed - md has her on Benadryl qid.
swelling in left arm / swelling still present; pain in left ear was terrible; headache on left side; left foot felt like needles in it; pain all over her body; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, SPIRONOLACTONE and HYDROCODONE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN (pain all over her body), PYREXIA (fever) and FATIGUE (fatigue). On 29-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it). At the time of the report, PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it) outcome was unknown.        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 treatment medication was provided
Confirmed Breakthrough Case COVID-19 (Moderna) 1 04/01/2021 Hospital Moderna 002B21A   COVID-19 (Moderna) 2 04/29/2021 Hospital Moderna 007B21A   COVID-19 (Moderna) 3 10/25/2021 Family Phys Moderna 017F21A   COVID-19 (Moderna) 4 10/30/2021 Pharmacy Moderna 017F21A
pt recvd vax; w/in 24 hrs exp a fever of 101-102 & was cranky & fussy; apap;
2nd dose given 2 weeks earlier- did not meet 6 month interval in between dose 1-2. no adverse effects.
having significant diarrhea intermittently; This is a spontaneous report from a non-contactable consumer. A male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced having significant diarrhea intermittently on an unspecified date and wanted to know if diarrhea is a common side effect of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse event. Dr was notified. Family is aware. Patient given wrong dose of Pfizer Biotech, patient given Pfizer Biotech 12 and up.
60 YOM with PMH T2DM received PREVNAR-13 vaccination on 11/18/2015 and reported having a very painful reaction with headache, erythema, and swelling the night of his vaccination.
Severe leg cramps.   It felt like many muscles in my legs and toes were cramping at once.  Legs were painfully bending and twisting Could barely walk.   Very difficult to try to relieve them as motion to relieve one cramp made others worse.   Lasted about 45 minutes.   After about 15 minutes I took a cyclobenziprene I'd had for a back spasm about a year ago.    After seeing a report of a woman with severe seizure-like leg spasms I decided to report my experience.   I am concerned about taking dose #2 scheduled for March 4.
A 48 year-old male patient had received on 18 August 2014 an intramuscular injection of Tdap vaccine, lot number FL2P2 (not a valid Sanofi Pasteur lot number, site of administration not reported) and one day later on 19 August 2014, the patient reported passing out. The patient's last Tdap was over 10 years ago. The patient's has a history of multiple vaccinations (illegible). Other medication, illness at time of vaccination and pre-existing conditions were none. No further information was provided at the time of the report. Outcome was recovered. Documents held by sender: none.
After applying the band aid following the last immunization (Tdap), Patient fainted in her chair for about 3 seconds. Other nurses were called by CMA and mother. Patient was waking up but confused. Patient was diaphoretic and pale. Blood pressure was monitored as well as O2 and heart rate. Patient was given sips of coca cola and a couple bites of a muffin. Patient started to feel better and was complaining of arm pain. Mom was asked if she would like an ambulance called to transport to the ER and she opted to drive her herself. Patient was helped into a wheelchair and was taken to ER by parents. The next day, we called mom to find out how she was. Mom said the Doctor didn't think it was a vaccine reaction. They thought it was a vasovagal reaction. They gave her the ok to continue getting he vaccinations but to lay down in the future to prevent this from occuring.
LETHARGIC, MEMORY LOSS, DROP FOOT OCCURED 2 WEEKS AFTER SHOT,  BALANCE OFF, FALLING, LOSS OF INTEREST IN DOING THINGS, NUMBNESS IN FINGERS ON BOTH HANDS AND TOP OF BACK,  DROPPING THINGS, LOSS OF FEELING FEET, HANDS AND BACK,
Red bump appeared on right side of abdomen adjacent to the naval the next day after receiving second covid-19 vaccine. Patient initially assumed it was a bug bite. Red bump grew in size and smaller bumps appeared around the initial bump three days later. Patient made a doctors appointment on sixth day and diagnosed with shingles. Doctor prescribed Famciclovir and Gabapentin TID for seven days. Prescription is still in progress.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 28-MAY-2016, the patient was inadvertently vaccinated with a third dose VAQTA. The patient completed the series several years ago. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
site of vax red, swollen (size of grapefruit) war to touch;tx ice, DPH ointment to site, DPH tablets;
She had redness, over upperarm from shoulder to elbow.  It was painful, itchy, and swollen.  She took ibuprofen for the pain.  The area had increased in size from bedtime to morning.  She reported it to me 2/7/17 in the morning and I told her to take oral Benadryl and to watch if the size of the area kept increasing.  She reported back on 2/8/17 that symptoms were improving and report if any relapse.  I haven't heard from her.
Swelling - throat, tongue, eyes, gums. Ears ringing. Body pain; arms-back-legs.
On 7/31/01, pt had pain in upper right arm, down to fingers of right hand with swelling in upper right arm, down to fingers of right hand. This began, post vax, yesterday. Applied ice the evening of 7/30/01 and had less swelling in arm today (7/31/01) but hot and hand still swollen. Referred to PMD for follow-up today. Pt went to ER on 8/1/01, due to hand swelling and states had loss of use of hand and area of hand with decreased blood flow. Calan 40mg Rx given and referred to surgeon.
Pt. fainted after receiving 2 vaccines (BOOSTRIX and Typhoid). Paramedics were called and they found pt. had low blood sugar and they gave glucose. When she fainted, she did fall and hit the left side of her face.
Pt. states received injection in (L) arm. States since then she's had a dull pain in her (L) shoulder.
suspected vaccination failure; developed shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for asthma.   On an unknown date, the patient received Shingles vaccine at an unknown dose and Nucala 100 mg at an unknown frequency. On an unknown date, unknown after receiving Shingles vaccine and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Nucala was continued with no change. 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. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was vaccinated for shingles prior to starting Nucala. The patient started Nucala few years ago from the date of reporting. The patient recently developed Shingles. Till the time of reporting, the patient has not discontinued Nucala. The reporter was not sure if shingles was related to Nucala. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, time to onset for the event and lab test confirming varicella zoster virus infection was unknown at the time of reporting. The reporter consented to follow up.
Miller Fisher Syndrome, with ophthalmoplegia and ataxia, without areflexix. GQ1b positive.
Pt recvd vax & exp prolonged crying duration 3 hrs p/vax; mom instructed to contact PP ASAP;
Severe hair loss on scalp within a few weeks after vaccine. Tried to decrease stress and increase supplement with vitamins (multivitamins), more sleep and rest. Notified doctor and had lab work to check thyroid, which came back with normal result. Continues to lose lots of hair daily.
Itching - mostly on chest - arm and head.  This lasted 3 weeks small bumps and uneven skin.
Pt's mother called and stated 2 days after his shots he got a fever and his left deltoid became hot and red with bruising. She also states his neck and ears are swollen and he still has a low grade fever so she has a Dr's appointment today.