chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered nurse regarding a 20 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
1st shot standard side effects, low fever, chills, lethargic for several days.  The constant feeling of tiredness came and went after that. No immediate side effects to second shot. When went to doctor for physical because was still lethargic and having chills at night and running fever on and off of 99-100 Blood screen showed slightly higher than normal Alkaline Phosphate numbers 138 and several abnormal items in urine screen which would indicate urinary tract infection. Primary prescribed Ciprofloxin and 4 days into the treatment a rash (later diagnosed from biopsy as Perivascular Dermatitis) began from head down arms and through torso and lower abdomen. Dr prescribes Prednisone for two weeks in separate packs. 60 mg 4 days, then step down. That did not work and then second week 60,50,40,30,20,10. That did nothing,. When cortiosteroid wore off numerous autoimmune issues arose. Arthritis in both ankles and finger, high liver enzymes and Alkaline Phopshates shot up to 198 indicating liver issues, dry mouth and tear ducts, rash got worse and bells Palsy set in causing droop in left side of face. MRI, 2 cat scans showed no Neurological issues and most rheumatological disorders were ruled out. Dr. put allergic reaction to  Ciprofloxin as cause but attributed without certainty the autoimmune response potentially from vaccine. Have taken Ciprofloxin in past without allergic reaction.
Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number A5449, expiry date 13th November 2022) and (batch number 7JG74, expiry date 13th November 2022) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Hiberix. On an unknown date, the dose was an unknown dose. On 3rd December 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Hiberix, which led to expired vaccine used. The reporter consented to follow up.
Patient stated she got the vaccine 5-11-21. Three days after, her arm had red blotches; and was itchy, swollen and hot to the touch. She went to the MD office. They told her there was an infection at the injection site, however they did not give her any antibiotics. She was told to call the pharmacy to report the reaction. Patient believed it was an allergic reaction to the shot. She stated she will follow up with MD.
Vaccine given right upper arm 5/7/03. Child has multiple severe environmental allergies - on immunotherapy and multiple allergy meds. Seen 5/12/03 with 5 x 5cm area red, hot, indurated, tender. Treated with oral Augementin. Improved within 36 hours.
Felt warm and later started having fevers Tmax of 102F. Seen on 08/15/16 for persistent fevers with chapped lips, desquamative rash. Later Dx as Kawasaki disease. Admitted at medical center for 3 days with IVIG and Aspirin treatment. Normal Echo findings. Discharged home on 8/18/16.
Within 30 seconds of receiving the 1st Rabies vaccine, all fingers became numb on arm of injection and radiated up to the shoulder. Had pain at injection site - several days of constant pain and numbness in arm. These symptoms recurred with Rabies vaccine #2. Since then, symptoms have worsened: now has pain in upper left arm daily - lasts anywhere from 15 minutes to several hours.
Initial report received on 17 Nov 2005 from a health care professional. A patient with no reported age and gender experienced chills, shaking, eyes were running and sore throat almost 5 hours following the influenza vaccine (Fluzone SV '2005-'2006), lot no: U1916AA administration on 15 Nov 2005. On 17 Nov she had laryngitis. The patient was not recovered at the time of the report. Follow up information received on 26/Jan/2006. Per the reporter, the patient coincidentally contracted an upper respiratory disease at the time of the vaccination. The patient realized that the injection had no connection with her flu vaccination. No further information is expected.
aches for 24 hours; Chills; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 27Apr2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously did not receive any medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 03:00 the patient experienced Chills, fever, aches for 24 hours. The clinical outcome of the event Chills, fever, aches for 24 hours was recovered on 29Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd MMR on 14NOV91; On 19NOV91 devel a measles-like rash; had no fever & no Koplik's spots; no further details were provided;
Swelling, pain at site of previous growth on upper back. Now it has pain in arm, shoulder and neck. Itching at times. I have had three doses and three visits related to problem.
1. Dizziness 2 hours after injection. On and off dizziness 24 hours after injection.  2.  Minor Right arm pain at injection site.
I began to experience itchiness around 08:00PM. At around 03:00AM I noticed a breakout of a rash from head to toe. I went to the doctors on the 28th for symptoms. They stated that I was having an allergic reaction to the vaccine. I was given hydroxyzine, and then an injection of Benadryl and Pepcid, and was then prescribed to go home with Pepcid, and hydroxyzine. I have not seen much progress from the prescription, and I used vinegar to help with the itchiness. Rash is now pretty much gone, and itchiness is beginning to subside. Arm is still sore and swollen.
pt recv vax 27AUG96 & 18SEP96 pt began to exp ascending numbness from feet which climbed over 7 days to umbilicus;found to have ascending myelopathy;sx are improving but persist;numbness has descended to knees as of 27NOV96
Light headache since Monday (09/13/2021) and it does not go away. I been taking Tylenol and is not helping at all. And also I started to have hip pain on the right side. I never experienced this pain before.
Friend got the Moderna vaccine and he got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Friend got the Moderna vaccine and he got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Friend got the Moderna vaccine and he got sick). At the time of the report, ILLNESS (Friend got the Moderna vaccine and he got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
11/12/2021 UC started presenting of Flared up talked with the Dr. who provided with directive of care but problem persisted so contacted and received a doctors appt. 12/16/2021, then he prescribed a depositor of  Hydrocortisone suppository 25mg once daily. Flare up is still present and ongoing in worsening condition. Upcoming doctor appointment, provider is given present dosage time to activate or work. Another infusion coming up.
Random swollen lips, worse the first time, randomly every couple months. i also get hives on my eyelids randomly. only since the covid 19 vaccines.
Day 1 through Day 4:  systemic hives, mild to moderate, treated with Zyrtec antihistamine;                                                  some muscle soreness at injection site Day 2-3: periodic hives and itching throughout the body continued; sweats and chills, body aches, extreme fatigue Days 1-5:  unusual fatigue requiring naps ***Day 7:  rash, swelling, and soreness at injection site
Arm twinges on occasion; Broke out particularly around the eye and nose; Arm became spotty, swollen just below the injection site; Arm became hot, just below the injection site; Arm became spotty just below the injection site; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4C493, expiry date 20th March 2023) for prophylaxis.   The patient's past medical history included shingles (10 years before the date of reporting).   On 29th October 2021, the patient received the 1st dose of Shingrix .5 ml. In October 2021, 2 days after receiving Shingrix, the patient experienced local swelling, skin warm and spot-like rash. In November 2021, the patient experienced shingles. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the shingles, local swelling, skin warm and spot-like rash were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the shingles, local swelling, skin warm, pain in arm and spot-like rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: This case was reported by the patient. The patient stated that she had shingles approximately 10 years ago which started at the top of her head and spread to the right side of her face around the eye and nose. She stated she had no lasting symptoms after that. The patient received her first dose of Shingrix in her left upper arm. About 2 days later, her left arm became spotty, swollen and hot, just below the injection site. These symptoms subsequently abated. Less than 9 months after vaccination, her left arm twinges on occasion. About 1 week after receiving the Shingrix vaccine, the areas where she had shingles prior, she broke out particularly around the eye and nose. These also subsequently resolved. The reporter also stated that due to these effects, she declared she was not going to receive her second vaccine. The consented to follow up was given. The reporter gave consent to follow up with the healthcare professional (pharmacy).; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072608:Same reporter.
This is my third Novavax shot.  My 2nd shot was on 08/27/2022.  Within four hours of receiving the third shot, my left arm began swelling with discomfort.  I began having severe headaches and chills.  The injection site and about two inches around were deep red and hot.  On Tuesday, the swelling had increased to my entire shoulder and my bicep.  Today, Wednesday, the area is still swollen, warm and itching.  I have been using cold compresses as well as taking over the counter pain/fever reducers.
Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headache on left side of head. Would sit up and move around and headache would dissipate with 30 minutes.  Am not able to lay on back or on side.  Received booster on 1/26/2021 and have had same  events.  OTC pain killers are not working.  Once I initially wake up I move to recliner and fall asleep.   We have a sleep number bed and have not had this issue in the past, although don't know if it is the vaccine or a unknown subtle change in day to day activities.
I had vaccination on 09/12/2022. On 11/25/2022 I had Subchorionic hemorrhage on 11/25/2022. I was about 6 weeks pregnant and my due date is 07/19/2023. I was on aspirin and I was told to stop. I am on medication to support the IVF.
1:00 after getting vaccine the day before, woke up to chills, body aches, temperature of 99.1 and extreme right arm pain. Fell back to sleep at 6:30 woke up at 11:30 with same symptoms but no fever and an additional strange occurrence of brain fog, felt out of it and disoriented.
Could not lift right arm overhead, pain and wekaness of right shoulder persisting for three months. Just reported to provider on 10/10/12.
Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand - unable to open our close hand. Lasted until next morning.
Slept the month of July away; extreme fatigue. really bad headache, a few days my urine turned brown, my daughter said I smelled sickly sweet, my whole body ached, exp. my joints in shoulders, arms, wrists, knees, ankles and feet no appetite, nausea, the fatigue still haunts me on side of mouth and below lip blistery, stinging achy rash that oozed and swelled.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "PVC arrythmia" (unspecified if ongoing), notes: other medical history: PVC arrythmia; "several food" (unspecified if ongoing), notes: known allergies: several food; "seasonal allergies" (unspecified if ongoing); "vaccine dose number:unknown Johnson and Johnson, vaccine dose number:unknown Pfizer" (unspecified if ongoing), notes: vaccine dose number: unknown Johnson and Johnson, vaccine dose number: unknown Pfizer. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other medication Paxlovid in 2 weeks for COVID 19 Treatment. Treatment start date was reported as 06May2022 and stop date was 07May2022 and lot number included FY6859. Reported Event was Allergic reaction. itching swelling in mouth and throat, and asthma like breathing problems. stopped taking after 2 doses. Reaction began 16 hours after first dose. Adverse event start date was 07May2022, 12:00 AM and it was reported that AE resulted in none of the above if patient recovered and adverse event recovered on 08May2022. Treatment received for the adverse event was Benadryl, Alburterol, PepsideAC and Zertec. Device Date was 09May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 20 year old female patient who on an unspecified date was vaccinated with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed injection site swelling and pain. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Patient claims she had flu-like symptoms the day after vaccination. She felt sore lymph nodes in the head/neck area (not enlarged though). Two days later, she woke up wheezing. This lasted several hours. She had a enlarged lymph node under her right arm and a "tennis ball sized sore area under her arm. This lasted several hours. At 4:45pm, today, there is a 4 inch round, red rash surrounding the vaccination area; she says it was not there yesterday. It also started itching today. She says she will not seek medical help. She is currently feeling better.
Vaccination/Flu shot betw 4:00 and 4:30 on 10/18. By 9:00 pm very scratchy eyes, w/in the next 1.5 hours - swollen eyes (almost closed), lips and tongue; throat constricted, difficulty breathing. Took antihistamine (CLARITIN) - symptoms improved - still hoarse, puffy, red crusty eyes.
Information has been received from a health professional concerning a patient (22 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
The pt was given a 0.5mL Janssen vaccine in his R deltoid by an RN. The RN called the charge nurse over due to "half of the dose coming out of his arm." The provider on call, , was called and said to give the pt 0.2mL of another dose of the Janssen vaccine. This was discussed with the pt, and he was agreeable to this. The same administering RN gave the addition 0.2mL dose in the same arm. The pt was given strict ER and follow up precautions. He then ambulated himself to the observation area. Site manager Will aware of the situation.
She had the normal side effects of fatigue, drowsiness, aches, but also was had nausea and bloody stools and a blood clot in her stool.  This happen only once and the next day she was fine.  She was alarmed about the bloody stool and 1 blood clot.
Received vaccine on 06/09/2022 at 19:00PM, tested positive for COVID-19 vaccine on 07/06/2022. Started feeling a scratchy sore throat and fever on 7/4/2022 at 19:00pm. Took a home test and it was positive, then I went to a remote site for  and tested positive as well. Currently quarantined. Called Dr and was prescribed Paxlovid, started taking this on 07/08/2022.
still his legs are sore; left jaw is hurting; hardly walk; myalgia; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2020SA346513 and 2020SA346488.  This case involves a 87 years old male patient who experienced still his legs are sore (pain in extremity), left jaw is hurting (pain in jaw), hardly walk (gait disturbance) and myalgia, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Past vaccination included FluBlok (he got the same thing last year and he did not have any side effects).  Medical history, medical treatment, concomitant medication and family history were not provided.  On 08-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route in the left arm site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious still his legs are sore (pain in extremity), left jaw is hurting (pain in jaw), hardly walk (gait disturbance) and myalgia (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was also reported that He consulted a rheumatologist and the rheumatologist said it might last for 2-3 months. The rheumatologist also said he only sees about 1 or 2 cases like this a year so its not common.  Details of laboratory data not reported.   On 10-Oct, the doctor then prescribed prednisone 15 mg (milligram). Couple of weeks ago he cut it to 10mg, and then 5mg. Recently he tried 5mg but that didnt work as he really started hurting again so he is back on 5mg.   The patient was treated with PREDNISONE (PREDNISONE).  At the time of reporting, the outcome of events were reported as unknown.  There will be no information on the batch number to be requested for this case.
12:05 PM 8 y/o male student rec'd H1N1 Nasal vaccine-waited 15 min., returned to class-went to lunch, ate lunch and returned to class. Student told teacher felt 'sleepy'-was sent to vaccination clinic area-c/o feeling sleepy, face flushed, P-90, BP 100/60. Instructed to lie down, elevate feet, placed cool, wet cloth on forehead, gave apple juice to sip. 12:10-call placed to grandmother.
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg  for blood pressure and my Bp always stated 130/80s