chrisvoncsefalvay/vaers-outcomes huggingface dataset:
J&J Dose 6/21/21 (043A21A) COVID Positive 1/5/22  1/5/22: Patient is irritable, states that she has not slept throughout night.  She preferred that we ask very few questions, do very limited examination so that she can get some rest.  She has type 1 diabetes mellitus, chronic kidney disease stage 4, dilated cardiomyopathy, impaired vision, eye surgeries, gastroparesis and other medical problems.  She reportedly has not taken  insulin for a week.  Significant other called EMS for mental status change.  She reported severe generalized weakness.    She was found to have a blood glucose level of 954, bicarbonate 3, anion gap 38, venous pH of 6.990 and potassium level of 6.5.  She was given IV fluids and was started on IV insulin.  I was advised to admit the patient for diabetic ketoacidosis. Subsequently she tested positive for  SARS-CoV-2.  Reported nausea.  Denied fever or chills.  Renal function appears to be at baseline.  She was previously hospitalized in November 2021 for diabetic ketoacidosis and elevated troponin.  1/10/22: 30-year-old female patient with a history of uncontrolled type 1 diabetes, hypothyroidism, diabetic nephropathy with chronic renal failure stage 4, retinopathy-patient is legally blind was admitted to the hospital because of vomiting and not taking the insulin as prescribed.  Patient was admitted for treating her DKA, placed on insulin drip and monitored closely in the ICU. Patient also tested positive for SARS-CoV-2 infection. Patient was admitted for DKA management in November 2021. During the course of hospitalizations, the patient developed a GIB and hemoglobin went down to 5.3gm for which she had required PRBC transfusions.
ITCHY ARM; HOT ARM; HEAVY ARM; PAINFUL ARM; RAISED AND RED RASH ON ARM; This spontaneous report received from a patient concerned a female 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced itchy arm, hot arm, heavy arm, painful arm, and raised and red rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy arm, itchy arm, hot arm, painful arm and raised and red rash on arm was not reported. This report was non-serious.
Paient was given vaccination on 3/26/2021 and he said he had fever, nausea and headache which lasted for two days. He took Tylenol OTC.
On 6/2/10 around 4PM, client noticed redness "blotchy" on (L) arm where received TDAP & VZV vaccines.  On 6/3/10 upon wakening at 9AM, client noticed hardness and swollen (L) deltoid area, continued redness, warm to touch.  Back of upper (L) arm (where VZV given) is redness and small knot under the skin.  Client placed cold rag on areas for 5 minutes 6/3/10 around 11AM.
dizziness, bradycardia HR50 patient was monitored for 30 min v/s 126/49 HR was 58 SPO 100% patient was DC after issue resolved
Pt has  swelling in Lt arm 50mm that istarted day after receiving SHINGRIX. Pt states it is warm to touch, stiff arm with some discomfort. Pt denies having any further symptoms post vaccination. Pt was concerned since this is not a live vaccination.
Patient called in at 10:30am on 10/31/2022 stating that her son was experiencing an adverse even following an influenza vaccine on 10/29/22. She followed up with a doctor and the stated the patient is experiencing a vaccine reaction including, Swelling, rash, blistering of the skin.
Breakthrough infection 04Aug2022; Breakthrough infection 04Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 35 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no Known allergies. Patient did not have covid prior to the vaccination. The patient's concomitant medications were not reported. Patient did not received any other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04Aug2022, outcome "not recovered", COVID-19 (medically significant) with onset 04Aug2022, outcome "not recovered" and all described as "Breakthrough infection 04Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 04Aug2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient called and stated she woke up at 4:00 am on 05/29/21 with vomitting that lasted 2 hours. She is still feeling nauseated. She also is experiencing uncontrollable sharp leg pain, restlessness, throbbing of legs. She said she cannot sit still. The patient sounded very anxious and stressed over the phone. I advised her to seek medical attention to be monitored.
Pt C/O pain in (L) arm at time of injection. Reaction was 3-4 Hrs after vaccination. She developed pain and aching from Left mid arm to shoulder. Lost ROM and strength in (L) arm. No swelling or redness at injection site. Returned to office 2 wks later and still C/O Left arm pain and ache, but had regained some ROM and strength back. Pt showed injection site was below the deltoid muscle. After 6mos no pain in Left arm but continues to have ache in certain positions. Was given a taper dose of Prednisone 10mg and Tramadol 50mg 1 tab every 6 hours.
Patient is having blood build up under the skin. Looks like bruising/blood thinning. Multiple blood blisters that come and go.
Expired vaccine administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021 at 7:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        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 concomitant medications were reported. No treatment medications were reported.
No additional AE reported; Temp excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a health care professional and referring to a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (lot #W006596, expiration date: 11-OCT-2024; dose and strength were not provided) administered intramuscularly in right thigh for prophylaxis.    The administered dose of the vaccine experienced a temperature excursion since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes (product storage error). Digital data logger was involved. No additionally adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA001029:
started feeling spaced out & boxed in 10 mins p/shot; presented to ofc 20 mins p/shot; BP 118/82, P80, R20; went to eat @ 1300, to return if further problems;
My 5 year old daughter was dosed incorrectly at Pharmacy and we are awaiting guidance from Pfizer, the CDC and the Dept of Health as to whether this first dose will count of if she will need to repeat the first dose.
pt recv vax 1OCT97 & presents 3OCT97 w/rt upper arm is now swollen, red, & warm to touch;current dx r/o cellulitis vs local tissue rxn;
LATE PERIODS; HEAVY BLEEDING DURING PERIOD/LONGER PERIODS/LASTING 7-9 DAYS EVER SINCE THE VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patients normally periods would last for 5 days.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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from late periods, and heavy bleeding during period/longer periods/lasting 7-9 days ever since the vaccine. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Child cried, inconsolably, for 7 hours starting approximately 45min after administration of the vaccination.  Child returned to doctor's office and was re-evaluated by another physician.
slight headache; Nauseated; Palpitations; This is a spontaneous report from a contactable consumer (co-worker). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that her co-worker reported having a slight headache the first day and then started feeling nauseated. She stated she felt something about her chest like she felt palpitations in her heart. The patient declines she taken any treatment. The reporter stated that her co-worker was ok. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018865 same reporter/drug, similar events, different patient
A Pfizer Pediatric dose (.2 ml) was administered undiluted on 2/1/22 to the patient. This was the patients second dose in the series. The first dose was administered on 1/1/22. The patient's mother stated injection site pain with the first dose.  Patient is experiencing inject site pain and headache at this point in time following the second dose administered 2/1/22.  Patient's mother kept the patient home from school and is going to consult with the patient's primary care physician.
Severe tender/sore breasts. No other symptoms.  breasts didn?t start hurting until 2nd full day after vaccine dose.
Patient incorrectly received a 3rd full dose of Moderna. Patient received doses on 12/21/2021, 1/8/2022 and 2/4/2022. Her intake form did not specify she was immunocompromised.
Case number PHEH2014US003662, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
COVID-19 symptoms started on 04/27/2022, tested positive on 04/30/2022. Symptoms were stuffiness, but not runny nose, sore throat, severe headache, and a little heaviness in chest. It was the sore throat that tipped me off to get tested. I've been fatigued but that's about it. Symptoms lasted for 6 days. I'm still fatigued but they put me on Paxlovid and I've had side effects. I also had a dry persistent cough for several days and diarrhea.
1st dose Oct2022, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Oct2022, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-APR-2023 The caller was the patient.  The patient had not yet received the second dose. The reporter did not consent to follow-up.     Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that the vial was punctured on 28 Dec 2021, and was used for up to 17 hours post puncture that is till 29 Dec 2021. No patients have reported any side effects from this dose. Did the vial undergo any temperature excursions? No. No concomitant medications and treatment details were reported.   This case was linked to MOD-2021-435992 (Patient Link).
Pt experienced redness about the size of a baseball around the injection site, with itching and soreness.
Headache localized right frontal area 2 days after MENACTRA was given. Sharp pain lasted for few minutes to an hour about 2-3X per day. Improved after taking Ibuprofen.
large fibrous knot @ site of inject initially w/extensive pain & swelling which resolved on Pediaprophen althoughfibrous knot @ 1 1/2cm still present @ f/u;
11MAY93 pt became lethargic, had fever of 103 R w/elevated pulse, foul smelling stool; hospitalized for dehydration & dx resp viral synd; neg spinal tap; sl fever
Two weeks of sporadic headaches followed by four days of constant tension headaches behind ears, followed by Bell?s Palsy of the right side of the face.
Patient stated that 1 or 2 days after vaccination, she couldn't stand up or walk for more than 2-3 minutes on her left leg. She can lift her leg but no muscle strength to stand up.  She is doing physical therapy right now for this incident.  Her doctor is still trying to find out the diagnosis for this. She has to use a wheel chair right now to get around because she can't stands up.  No other symptoms associated with her left leg.
I awoke around 1200 am last night (11/12) with sharp chest pain that radiated to my back. It was slightly more noticeable on the R side. It made it difficult to breathe. I was able to sleep through the rest of the night and for the most part today a more dull version of the chest pain has been present, at times radiating to my back again.
Body ache a little that day, night time - chills, fever, body aches, next day - all body aches, fever, chills, really tired.  Monday - slight body aches
was at work and can't remember much about it . they told him that he was walking and he went down and was on the ground and whole body was shaking . They called ambulance and they transported him to the hospital. he thought that they gave him fluid and antinausa medication
Patient was given varicella vaccine 3 days prior. Came in with complain of off balance. He was able to walk but tilts to side, sits down and seems off balance. MD consulted with neuro and agrees with diagnosis of cerebellar ataxia due to varicella vaccination. To monitor home. No treatment needed.
pt got dizziness, fainted, shaking after 5 minutes of vaccine administration. His heart rate dropped to 60 and his blood pressure 105//70. pt was conscious and breathing on his own and felt normal after 30 minutes and went home with his family members.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: Patient had a small rash of red bumps around the injection site and the maculopapular rash had spread to a site near wrist also. Still reporting pain at injection site 2 weeks post immunization
I was 6 weeks 4 days pregnant 4 days post vaccination I began cramping and spotting and ultimately miscarried my pregnancy.  I had an normal and healthy ultrasound at 6 weeks 2 days.  A strong heart beat was readily detected.  There was no evidence of an unhealthy pregnancy.  11/16/09 Medical records received for DOS 110/21-11/8.  OB recodes.  Final DX: Missed abortion. 1st trimester spotting.  FHT noted on 11/2. 11/8 bleeding continued. Missed AB. LMP 9/9/09, EDD 6/22/10.
Skin rash starting on lower left leg 6 days after injection. Telemedicine doctor incorrectly diagnosed rash as Shingles. Rash gets progressively worse for 4 more days and appears on right leg with less severity. Primary doctor diagnoses as bacterial skin infection and prescribed oral antibiotic. Rash continues to get worse covering most of back of right leg and ankle swelling appears. Went back to primary for Antibiotic injection. 3-4 days later rash began improving. Slow and steady improvement for the next 5 weeks with second prescription of antibiotics. As of today 4/29 still small remnants of rash but healing continues. I had a bacterial skin infection 15 years ago and was given antibiotic injection and oral antibiotic. 48 hours later rash was dissipating, 5-6 days later rash/infection  was completely gone. This reaction 6 days after Moderna is still present 6 weeks after first appearance.
Parent called 3/21 to report child's left arm at injection site was red and swollen - no systemic reaction - parent gave child Benadryl - RN advised reaction not uncommon - Put ice on site
"About 24 hours after vaccination with TDAP, began having: headache, ringing in ears, fever 102 (stayed at 100 for 24 hours), generalized pain, generalized rash, red, itchy hives-face, neck, chest, arms and legs, abdomen." Presents 3/1 to Employee Health-feels drained, other sxs gone except for bumpy, rough, red rash neck and arms.
The patient presented to the vaccination site on 10/25/21. The client notified RN that he received (Sputnik) COVID vaccine, first dose in May 2021 and second dose on September 23, 2021. RN  submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen first dose. Per CDC guidance, approval to proceed with COVID vaccine Janssen first dose was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Janssen first dose Lot# 1822809 on 10/25/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1145.
Agitation, Headache, Myalgia Fever, Angioedema, Tachypnea, UrticariaPruritus, HYPERtension, Tachycardia Narrative: SYMPTOMS STARTD DAY OF VACCINE SEVERE HA, PRURITIS, NAUSEA ,HIVES WAS SEE IN ED 3/31 WITH HYPERTENSION TACNYCARDIA AND ANGIOEDEMA TREATED AND RELEASED ON 4/1 SYMPTOMS STARTED AGAIN WENT TO ED AGAIN AND TREATED AGAIN WITH STERIODS AND H2 BLOCKER HIGHER DOSE GIVEN EPI PEN
22 patients vaccinated using old vial from 03/08/2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/08/2021) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/08/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/08/2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-208074, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-208074 (Patient Link).
Large, swollen red circle on left arm at site of injection.   Tender to the touch.  It lasted several days.  Decreased each day after 3rd day, until it was gone.
He received his first dose as pfizer, and was given moderna as a second dose. The first dose was 1/27/21, then pt had back surgery.  Today he verbally said and checked off on consent form that he had received moderna for first dose, but did not have his vax card.  So he received a second dose of moderna. Nurse practitioner was made aware and will follow up with him. observation time 30 minutes and no reaction noted.