chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deep intense pain in area of injection, bicep/tricep area followed by acute impingement feeling of shoulder joint - certain, specific movement cause pain - pain started 5 days after injection and has persisted. Dr recomended I see shoulder specialist. Treatment has been Motrin or Oxaprozin. Follow up received 05/15/2007. Saw specialiast MD. "Frozen Shoulder" from tetanus shot. Annual followup 01/4/2010 Left shoulder is 50%. Permanent damage is likely. Pain free to some extent, but have limited range of movement in left arm. 02/01/2010 Still has impngement in shoulder MRI done on 6/28/07 showed stage III impingement syndrome left arm still has limited range of motion. Patient has received oral methylprednisolone for 6 days not much change.
unusual sensation of sharp tinny sound when she was talking/ hear someone talking nonstop causing her irritation; Tinnitus like symptoms; mild headache; mild sinus irritation; This is a spontaneous report received from a contactable consumer(patient).   A 53-year-old female patient(not pregnant) received BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 02:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was none. Concomitant medication included estradiol, progesterone (BIJUVA) taken for hormone replacement therapy. There was no covid prior vaccination, no covid tested post vaccination, no known allergies. Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 15:00, She experienced tinnitus like symptoms, unusual sensation of sharp tinny sound when she was talking. First time was in a restaurant and she could hear someone talking nonstop causing her irritation and onset of a mild headache. She was also feeling mild sinus irritation. There was no treatment. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on the date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/2021 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
12:10PM 'CHEST TIGHTNESS AND SOB' PALE, RESP SHALLOW. 12:13PM EPI PEN GIVEN LT LATERAL THIGH. NEAR SYNCOPE - PLACED ON FLOOR WITH FEET ELEVATED. BP 77/68, HR118, R 20 02 SAT 97%. 12:20PM IV STARTED PER SQUAD.  NO WHEEZING PER AUSCULTATION - BREATH SOUNDS DIMINISHED.  BP 182/90, HR 110, R 16,  02 SAT 95%. TO ER PER SQUAD.  4-2-21 10:20AM: STATES TREATED/RELEASED FROM ER. NOW HAS RASH TO FACE/CHEST, HEADACHE AND FATIGUE. HAS APPT WITH PCP TODAY.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown date in 2016 (reported as "since 03-OCT-2016"), the patients were vaccinated with doses of improperly stored VARIVAX (dose and route were unknown; lot # M004662 with expiration date 27-JAN-2018 and lot # M025870 with expiration date 24-MAY-2018). On 03-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. On 17-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. There were no previous temperature excursion and no data Logger. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose) 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.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose). In December 2021, ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
day 1 - headache, fatigue day 2 - headache, fatigue, fever day 3 - headache, fatigue, fever day 4 - severe constipation, fever, shaking chills day 5-7 - diarrhea
4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had wheezing in his lungs, short of breath on exertion and productive cough. Voice also sounds "harsh" per patient. He has used his inhaler and it is not helping.? Nurse recommended Urgent care tonight. Patient agreed. 4/6/21 went to  urgent care. CXR no acute airspace process. COVID-19 PCR: neg. Given Prednisone. Sent home 4/13 allergy appointment cancelled. 2nd vaccine 4/20/21 received. Reports difficulty breathing, dizziness and weakness and headache on survey. Calls Nurse triage 4/20/21 and reports extreme fatigue, headache, nausea, vomiting, and chills.  Calls Nurse triage phone on 5/6/21 reporting shortness of breath, phlegm and cough. Recommended to go to ED. Went to ED.
Red at site; Hot at site; Swelling at site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2022, the patient received Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix on Friday (the day before reporting) and still had red, hot and swelling at site after 4 days. The patient asked how long did side effects last. Additional Supportive Information: Follow-up would not possible, as no contact details were available.
Was a bit dizzy even sitting quiet. About 3 hours later she happened to notice that her right upper arm deltoid area where she had received her influenza vaccine yesterday is now covered with small pimple like spots that are raised and itchy if touched. They are located above the injection site and up to her neck line and across top of back. Pt has taken her BP several times and the highest it was was 180/100.
Swollen arm; Bruised Arm; Sick to the stomach; Neck Pain; Lethargic; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2022, the patient received the 1st dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy were unknown.   It was unknown if the reporter considered the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy to be related to Shingrix.     Additional Information: GSK Receipt date: 6th December 2022. Reporter's Comment: The reporter was the patient. The patient received her first dose of SHINGRIX yesterday (5th December 2022). The patient experienced a swollen and bruised arm, felt sick to her stomach, neck pain, and felt lethargic. The patient used a heating pad to her neck to alleviate the neck pain.  The reporter did not consent to follow-up
developed headache 3 weeks later of the second shot; developed fever 3 weeks later of the second shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (developed headache 3 weeks later of the second shot) and PYREXIA (developed fever 3 weeks later of the second shot) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced HEADACHE (developed headache 3 weeks later of the second shot) and PYREXIA (developed fever 3 weeks later of the second shot). At the time of the report, HEADACHE (developed headache 3 weeks later of the second shot) and PYREXIA (developed fever 3 weeks later of the second shot) outcome was unknown.            No concomitant medication was reported.  Treatment medication was not provided.
Patient developed clinical "chicken pox" (varicella).  The patient has classical rash with fluid fluctal vessicles in multiple stages of development.  Diagnosis on 09/08/2003.  Rash started on 09/07/2003.  Suspect vaccine failure.
Pt developed redness, warmth 8-27-09 at MMR site, itching, swelling, developed 8-28-09. Developed blister and oozing. On site on 8-31-09. Came to health Dept on 9-1-09 for assessment noted approx 1cm red revised area with blistery surface, no Benadryl at this time - Her surrounding swelling, hot to touch. Referred.
Headache Fever Muscle pains Fatigue  All appeared simultaneously, and reasonably strongly. Went to bed, fever-sweat, body aches, head pains stayed strong for 6 hours, began to subside.   After 14 hours from initial symptoms, body aches subsided, mild fever, mild headache persisted and remained.  After 20 hours from initial symptoms only a  verymild headache persisted.  After 30 hours all symptoms were gone.
One day later, large edema, vomiting, fever and diarrhea. Swelling to toes.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # J013394 with expiration date 25-AUG-2016 and lot # K019502 with expiration date 04-FEB-2016; dose and route of administration were not reported. No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of MMR II, (Oka-Merck) PROQUAD, (Oka/Merck) VARIVAX and ZOSTAVAX, but none of these vaccines have been administered to the patients. This is one of several reports received from the same reporter. Additional information has been requested.
abnormal pap smear; HPV strains 6 and 7; HCP reported an adverse event for GARDASIL. Caller explained a patient who was vaccinated with GARDASIL had three abnormal pap smears. Caller said the first abnormal pap smear was on 21FEB2021; she did not provide any additional dates for the other a; This spontaneous report was received from nurse and refers to a 24-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2010, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 10-MAR-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 18-JUL-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, HCP reported an adverse event for GARDASIL. Caller explained a patient who was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  had three abnormal pap smears. On 21-FEB-2021, the patient experienced first abnormal pap smear. Caller did not provide any additional dates for the other abnormal pap smears. On unknown date, the patient experienced abnormal pap smear, the patient experienced abnormal pap smear and the patient had HPV typing which detected HPV strains 6 and 7. No treatment was given for HCP reported an adverse event for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 22-APR-2023, the patient had a Colposcopy, but the results were still pending. Caller was unable to provide any further clarifying details. No additional AE or PQC reported. No additional information provided. The action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) regarding events was reported as Not Applicable.  The causal relationship between events  and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Immunization status after inadvertent inoculation in the eye and any consequences thereof. The outcome of the event of inadvertent inoculation in eye is unknown. The report was considered to be non-serious by the reporter.
Patient received one dose of Pfizer biotech vaccine on  10/12/21 .Morning on 10/15/21 at approximately 6:00 a.m. patient complained and told parents stated"I feel different can't explain it feels weird"within an hour the patient began to act very bizarre ticking  his  hands head and facial gestures. repetitive speech and loss of short term memory.Pyschotic like behavior laughing whispering to self  but no delusions or hallucinations .He has good personal insight but is unaware of his current mental status.Patient is currently still the same no changes treating with Risperdal 0.5mg
Right arm swelling, redness, itching (1 inch x 2 inches) at injection site. No need for emergency room, no visit to MD. No problems breathing.
Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history and no allergies or drug reactions who on 23-JUL-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 ml, intramuscularly. Concomitant therapy included YAZ. On 24-SEP-2008, the patient was vaccinated with the second dose of HPV vaccine (lot# 661044/0548X), 0.5 ml intramuscularly. The nurse practitioner reported that the patient developed intermittent nausea 1 and a 1/2 hours after receiving her second dose. The nausea was mild and intermittent, and had not caused emesis. At the time of the report, the patient had not recovered. The patient sought medical attention by phone. Additional information has been requested.
Pt. received ZOSTAVAX on 4/11/11. She contacted us late in the afternoon on 4/12/11 to report a raised, red area at injection site, which was warm to the touch. She came in and was instructed to take diphenhydramine for the reaction and if it gets worse to contact her physician. She contacted us on 4/13/11 and indicated it was improving. Pt stopped by on 4/14 - still improving according to patient. She reports taking cetirizine as she cannot tolerate diphenhydramine. According to pt. on 4/20/11, reaction has subsided.
Pts biceps became red and swollen, still a little red today. He also said he spent the day in bed with a low grade fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 12:00 as dose number 1, single (Lot number: EH9899), on 12Jan2021 at 10:00 as dose number 2, single (Lot number: EL1283), on 09Nov2021 at 10:00 as dose number 3 (booster), single (Lot number: FF2590) and on 06May2022 at 03:00 as dose number 4(booster), single (Lot number: FP4554) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "WPW" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High Chol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nkma, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
it was rpt fr pt who in 1995 & then 8mos later was vax. In 1999 the pt lab eval revealed a lack of response. pt noted she was exposed to chickenpox & may be infected. pt titer test was meant for pre-vax not post vax.
Patient reported back to the immunization center approx. an hour after vaccination with bilateral erythema below injection sites. Patient otherwise stable assessed by provider, monitored ibuprofen ordered for inflammation. Patient released with mother. Attempts to contact mother for follow up have been unsuccessful at this time. Mother given strict instructions of signs and symptoms, and when to seek emergency care if symptoms worsen.
In 2 weeks after the second shot I felt muscle twitching (mostly in my calves), vibration in different parts of my body, painful pins and needles, severe insomnia, jerk movements while falling asleep, internal tremor, burning in legs and arms. I visited 8 neurologists, 2 immunologists, took Lyrica, Gabapentin, Medrol, Miaser, Magnesium, VitB complex and many other supplements. All my symptoms did not change, I am straggling every day, can not work and live normal live. Desperately need help.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients (unknown age and gender). The patients current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (lot # L046900 and expiry date 23-FEB-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further details were provided. Additional information has been requested.
Pain at injection site, pain lasted 3 days, aching and cramping radiating down arm to hand, cramping is not constant last episode was 1 wk ago, has not seen physician.
In dec2021 - 9dec2021 - I woke up intense headache , I was fixing breakfast, In my right eye, I saw flashing, there was a blank spot on my eye and couldn't read anything. I took Tylenol , pain and flashing stopped and slept and woke up from my nap. Woke up and the flashing started again but no headache. 10dec2021 - I called the ophthalmologist and I explained to them although I felt fine and said I should see the doctor.
started having blurred vision that afternoon, severe nightmares for a few weeks after vaccination, and erythema, pain, hot and swelling at the injection site for a few days
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, starting on or after 02-FEB-2017, the patients were vaccinated with doses of improperly stored VAQTA lot # M033611 with expiration date on 02-MAR-2018 (dose of administration were not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 2 hours. Digital data logger was used to record the excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014611:
Information has been received from a physician via a company representative referring to an unspecified number of patients of unknown age and gender.  Concurrent conditions and medical history of the patients were not reported. On unknown dates, the physician administered PNEUMOVAX23 (lot#, expiration date, dose and route unspecified) every five years to the an unspecified number of unspecified patients. It was not specified how many doses the unspecified number of unspecified patients had received. No adverse effects reported. Additional information has been requested.
Child taken to see doctor on 8/1/01. States arm warm, red and swollen. The doctor gave order for Tylenol and warm packs.
Fever 104, HA, neck pain, back ache. Took ASA x1, fever went down to 103. Next day Fever started at 102, took ASA x2, reduced it to 101. Today temp 99.3.
Pfizer vaccine vial punctured at 0825 gave Pfizer vaccine to Patient at 1555. Vaccine was expired by 90. No symptoms seen and no tx given at this time. Observation of 20 minutes
Patient complained of "tingling tongue" and "numb lower lip" about 10-15 minutes after immunization. RPh spoke with ptn., observed and administered 25mg Benadryl (po) at about 1 hour post imm. (Ptn declined 50mg so she could drive) No further signs of allergy but ptn. wsa concern so 911 called and EMT's checked BP & vitals and released ptn upon her signature and ER doctors verbal approval. Patient had flu shots in the past and had no history of allergic rxn to flu vaccine. We paged her PCP but did not receive a call back. Ptn went home on her own after shopping about 2 hours post imm.   Upon follow up there was no worsening of allergic like symptoms but the ptn did complain of flu like discomfort, but is now feeling fine (10/18/05).
Pt developed cellulitis starting evening after vaccine administration, was seen by Dr on 8/25/2017 and prescribed a course of antibiotics.