chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 5 month old male patient who on 21-JUL-2008 was vaccinated with the first dose of ROTATEQ (Lot # 660600/0281X) and did not have any reactions at that time. On 22-SEP-2008 the patient was vaccinated with the second dose of ROTATEQ (Lot # 661034/0470X). The physician reported that one month after receiving his second dose on approximately 22-OCT-2008 the patient experienced intussusception. The patient received surgery because of the intussusception and also had his appendix removed at that time. It was noted that the patient did not have appendicitis at the time. The patient sought unspecific medical attention. At the time of the report the patient was currently recovering from surgery. Additional information has been requested.  12/15/2008 Reviewed hospital d/c summary of 11/21-11/22/2008. FINAL DX: ileocolic intussusception, surgically reduced; appendectomy. Records reveal patient experienced colicky abdominal pain, pallor, green diarrhea, & lethargy x 2 days.  Admitted to outlying hospital for dehydration, had bloody stool & transferred to higher level of care.  Did well postoperatively, tolerating full feeds & d/c to home w/clinic f/u.
Increasing pain and aches throughout entire body.  Heavy breathing, sharp pains in lower back.  Chills. Then, by 7 PM vomiting.  No vomiting after 8, but severe aches and pains all night.  Pains are still present, but not as strong the next morning.
She has a fever of 102.9; She is so exhausted; She can barely walk across her bedroom; Diarrhea; She is sick; Headache; barely walk across her bedroom; This is a spontaneous report from a contactable consumer. A 79-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient took patient 11Jan2021 to get the Covid vaccine and the patient just called reporter on 12Jan2021 and the patient had a fever of 102.9 and she was so exhausted and she could barely walk across her bedroom. She had like diarrhea and like she said she was sick, and headache. The reporter wanted to know what the reporter do, Is that normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
It was reported that a 50 year old female patient received a Fluzone SV vaccination on 12/01/2000 in the PM. Reportedly the day after the vaccine was administered, the patient developed a 5" area of hardness, heat, redness and pain. The patient had no fever. The symptoms lasted for 3 days. the hard know remained through 12/05/2000. Reportedly the patient recovered from this experience. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time. This case is closed.
Client reports at 15 minutes after being vaccinated with first dose COVID vaccine, she experienced tingling in left arm and across chest, itching and red specks in both arms, dizziness, blurred vision and migraine headache.  She was observed for 30 min and all symptoms resolved except migraine and sore arm which lasted total of 24 hours.  Client did not take medication at home for symptoms, did not follow up with primary care provider for second dose guidance.
clamminess; looks awful / feels awful; headache; she couldn't sleep; fever; whole body aches; chills; fatigue; abdominal cramping; Migraines; weakness; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (clamminess), FEELING ABNORMAL (looks awful / feels awful), ABDOMINAL PAIN (abdominal cramping), MIGRAINE (Migraines) and ASTHENIA (weakness) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ABDOMINAL PAIN (abdominal cramping), MIGRAINE (Migraines), ASTHENIA (weakness), PYREXIA (fever), MYALGIA (whole body aches), CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced COLD SWEAT (clamminess), FEELING ABNORMAL (looks awful / feels awful), INSOMNIA (she couldn't sleep) and HEADACHE (headache). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA-SELTZER) for Adverse event, at a dose of UNK, bid. At the time of the report, COLD SWEAT (clamminess), FEELING ABNORMAL (looks awful / feels awful), ABDOMINAL PAIN (abdominal cramping), MIGRAINE (Migraines), ASTHENIA (weakness), INSOMNIA (she couldn't sleep), PYREXIA (fever), HEADACHE (headache), MYALGIA (whole body aches), CHILLS (chills) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Doctor prescribed a headache medicine.
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
Information has been received from a licensed practical nurse concerning a 6 year old male who on 09/13/96 was vaccinated with a dose of varicella virus vaccine live (site unknown). On 11/23/01, the pt developed a few lesions of chicken pox on the trunk and scalp. It was reported that the pt had no fever and "no problems". The pt was seen in the dr's office on 11/28/01. The pt reportedly had no problems and the lesions were in the drying stage and almost gone. The pt sought unspecified medical attentions. Additional information has been requested.
Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision,  weak muscles, lack of thirst and  appetite, fever
Pt recv vax on 9/22/98; within 2 to 3 hr pt exp inconsolable crying & vax site redness, swelling & rash
About 5 minutes after given the GARDASIL 9, patient confirmed of dizziness and later became pale. Patient was asked to lie down and after 15 minutes recovered completely.
On 3/19/2003 I became very lethargic. I was unable to keep my eyes open for more than a few minutes to converse with anyone. I slept for over 48 hours and felt tired for a few days after this. I also had severe swelling under my left arm, pain under my left arm down to my hand. My left arm swelled to twice its size for two days. The swelling decreased but my left arm and hand are still swollen. I am also still having alot of pain in my left axilla, arm and tingling in my hand. My left breast is also swollen. Prior to my period of lethargy I had pain originating from my left axilla that spread across my chest into my Rt Axilla and arm. I still get some shooting pain into my chest but this is not constant. Slept for 48 hrs after 2 days after vaccine administration. Developed swelling and pain in left arm and axilla 2 days after vaccine administration, this is not resolved. Unable to use left arm to do any type of heavy lifting or pulling.  The medical records received on 12/4/03 states lymphedema and neuropathy.
Pt reports having a bad headache, nausea an her eyes are black and blue and swollen, she states she had some eye issues before getting the vaccine but seems it has trigger eyes to get worse. Pt reports taking Claritin daily for allergies. Pt denies swelling around  mouth or lips, denies any difficulty swallowing.  Dr. diagnosed pt with EYELID DERMATIITS FLARE Pt also reported lichens planus in mouth on 10/19/21.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.70 for dose administered on 13-Feb-2021 and 67.80 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and  37 degrees Fahrenheit at 10:00 AM . This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Induration and erythema on right lateral deltoid measuring 15cm x 8cm.
FEEL SICK; PAIN IN MUSCLES/HOT IN MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular) 0.5 ml, on 04-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Mar-2021, the patient was feeling sick, had pain in muscles, and hotness in muscles. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The outcome of the feel sick, pain in muscles and hot in muscles was not reported. This report was non-serious.
Fever 101, chills, sinus pressure, headache, loss of appetite, soreness injection site without redness or swelling
09/15/23 48 yr old woman known to service for ESRD on HD MWF, respiratory failure on chronic tracheostomy on collar, severe obesity but remains fairly functional and ambulatory presented to ER yesterday with syncopal episode, found to have COVID positive. Recently treated for PNA with Levaquin with no improvement.  Last HD 09/13 Wed with 5.2L fluid removal, left at 129 Kg(1 Kg below target weight). She was dialyzed on 2K bath.    Chart reviewed.
first injection / 06/22/2018 but then there were supply problems and I never got the second dose.; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, there were supply problems and I never got the second dose. The patient was going to a new primary care physician. The patient asked did he or she took the second dose now or start over with the first dose.
Stiff neck, headache, joint and muscle aches. Some tightness in chest and mild cough.  Treated with Tylenol.
Chronic urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 immunization.     The patient's past medical history included COVID-19.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (Chronic urticaria). At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Patients got in the sauna every other day for half an hour and worked up a bad sweat, he controled it 90% so it was tolerable. He tried all the antihistamines. He had the reaction after the second dose and the first booster. He also did got COVID.
pt had redness in left eye.  He had a small bump in his eyebrow and more redness around his nose.  The redness was spreading on his face.  On 6/1/21 he went to PCP.  He was diagnosed with Herpes Zoster.  He was prescribed Valtrex.  He says the headaches are getting worse and has deep internal face pain so he called doctor and will have a FU phone appt on 6/2/21.
PATEINT WAS GIVEN DILUTED DOSE FOR PFIZER VACCINE. RPH HAD MIXED OLD USED PFIZER VACCINE LEFT IN TRAY WITH DILUENT. PT WAS INJECTED VERY DILUTED DOSE/ SALINE SLOUTION AT APPOINTMENT. WE FOUND ERROR IN THE LATE AFTERNOON. WE CALLED PATIENT AND SET UP APPOINTMENT FOR 3/21 TO GET RIGHT DOSE.WE ARE ALSO REPORTING THIS TO VAER SITE.
This is a spontaneous report from a contactable consumer, the patient. A 47-years-old Caucasian male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the left arm in Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. The patient medical history included Benign prostatic hyperplasia (BPH); Eagle's Syndrome, bilateral styloidectomy; and previous paraesophageal hiatal hernia repair. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 since the vaccination. The patient had not tested for COVID-19. No allergies to medications, food, or other products. Concomitant medication included tamsulosin 0.4mg (MANUFACTURER UNKNOWN). On 07Mar2021 08:00, the patient experienced arthritic-like pain in multiple joints beginning in the days preceding the second dose of the vaccine and becoming more severe following the second dose. The pain was specifically in hands, feet, ankles and knees, but originating in the hands bilaterally. This might be coincidental timing, but could possibly be related to vaccine. The adverse event led to doctor or other healthcare professional clinic visit. The patients blood tests showed C-reactive protein at 14 mg/L, negative ANA and negative RF. The patient was prescribed diclofenac. The clinical outcome of arthritic-like pain was not recovered. No follow-up attempts are needed. No further information is expected.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4487105-00. A 56-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (ongoing) (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 11Jul2022, outcome "recovering" and all described as "COVID-19". The action taken for upadacitinib was dosage not changed. Clinical course: On 11Jul2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. On 11Jul2022, the patient had COVID-19. She was recovering from COVID-19 and felt better just had congestion. Physician advised to keep taking Rinvoq. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Pt was given 0.5ml dose instead of 0.25ml booster dose. In-service and further education has been done prior to given anymore vaccinations.
States had red rash all over left leg and right leg. Lots of swelling and took several weeks to resolve
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, oral (dose, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Minutes after vaccine given rash various flat red macules on (B) legs only. No other symptoms. Lessened within 20-30 minutes -> gone by hours. No recurrence.
Dizziness Narrative: felt lightheaded 10 min after the vaccine. Resolved at the end of the observation period of 15 min
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified by reporter. On 03-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J004332, dose, route of administration and anatomical location was unknown) which was expired on 26-SEP-2014. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Within 35 minutes of the vaccine administration I experienced discomfort in my jaw (left) and numbness and swelling in my cheek (left).  I was driven directly to an clinic who directed me to the ER. Clinic performed bloodwork and observation.  Bloodwork considered normal.  Discharged with information on paresthesia and told to contact primary physician or return to the hospital if symptoms worsened.   No symptom change at the time of this report, 4 hours post vaccination.
Immediately after injection employee felt numbness and tingling down arm on the same side of the injection. Symptoms subsided approximately 10 minutes after vaccine was given.
I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving.  However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face.   The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.
Three days after receiving vaccine, patient noticed rash, which turned to whelps on joint areas.  This included patient's wrists, knees, buttocks and ankles.  She noticed that where pressure was applied and bending was occurring, the itchy whelps would show.    Patient  took oral Benadryl which calmed itching and redness and saw primary care Dr. as well as rheumatologist for reaction.  Triamcinolone was prescribed and patient used to calm itch.  This reaction continued to occur for two weeks after the first vaccine.  She received her second dose and the same reaction occurred and continues to occur at this time.   Lot# for second Moderna vaccine is 013M20A, given on 2/12/2021.
Low grade fever,  exhaustion, arm pain started approximately 20 hours post administration  Mild chest pains 10 min post injection
Chills, Fever, Body Aches, 5:30 AM, Tylenol
STIFF NECK; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced stiff neck. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stiff neck and headache was not reported. This report was non-serious.