chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a 3rd dose of vaccine, 1st dose given 1/12/21 2nd dose 2/2/21 and patient had titer done at rheumatology specialist and said her level was 0 so her specialist wrote an order for her to have a 3rd dose and her pcp agreed,  contacted patient today and said she was not having any side effects what so ever.
Patient is a 73 y.o. male patient of MD with history of hypertension, stroke, and diabetes mellitus type II who presented to Hospital with shortness of breath.   Acute Hypoxemic Respiratory Failure Covid-19 Virus Infection Date of onset of symptoms: 9/15/2023 Symptoms present on admission: dyspnea, fever, tachypnea Date of covid positive test: 9/18/2023 Vaccination status: vaccinated Imaging: Chest x-ray with bilateral atelectasis Oxygen requirements on admission: 4 L Current oxygen requirements: RA Medical therapy: steroids, remdesivir; will discontinue both as he is now stable on RA Consultants following: None Anticipated special isolation end date: 9/25/2023   Severe Sepsis Lactic Acidosis 2/2 COVID 19 infection Initial lactate was 2.2, improved to 1.8 with IVF Low suspicion for concomitant bacterial pneumonia Urine sample was collected off of chronic indwelling SPC Blood cx x 2 with NGTD Will stop CTX and azithromycin at this time Management of COVID as above   Acute on Chronic Renal Failure Cr 3.22 on arrival; baseline is 1.8-2 Received IVF Renal US with asymmetric kidneys but no hydronephrosis Cr peaked at 3.5; improving to 3 Cr stabilized, suspect he has ATN due to AKI Repeat BMP in 1 week Outpatient nephro follow-up  Elevated troponin Initial troponin 106, repeat 101 EKG without acute ischemic changes Suspect elevation due to demand ischemia with hypoxia, concurrent infection Continue to monitor on telemetry   Neurogenic Bladder Bacteriuria Pt with indwelling SPC catheter, last exchange was on 8/24 per family UA grossly contaminated Clinically low suspicion for UTI at this time Urine cx positive for pseudomonas, likely due to colonization Urology performed SPC exchange on 9/20 No antibiotics indicated   Positive Blood Culture 2/2 blood cx with growth of coag neg staph 1/2 blood cx with growth of MSSA Repeat blood cx 9/20 with NGTD Suspect positive cultures are result of contaminant Given presence of S. Aureus however, will consult ID He has not had any fevers or evidence of clinical decompensation Discussed with ID, will plan for doxycyline for 7d   History of CVA with residual right-sided hemiplegia Chronic aphasia Dysphagia In wheelchair at baseline, lives with family at home Known chronic dysphagia, pt refuses to eat modified diet and will not work with SLP Family agreeable to regular diet at this time   Diabetes mellitus type 2 Continue home basal + SSI
Mother noted that evening post vax, left arm became very red, warm to touch, itchy and bruised. Had lump sizw of 50 cent piece. Redness and bruising size of baseball. Noted symptoms approx. 3 1/2  hours after. Treatment warm compresses, Tylenol and Benadryl cream.
Mom states pt started w/fever 30JAN92 that night 101; APAP was given every 4 hrs @ approx 5AM 31JAN92 fever to 103; Went ot see MD @ clinic was told not to give DTP only DT next time;
Severe rash for over a week,  over entire back, chills, body aches, started about a week after the 2nd shot.
Numbness un lower lip. Soar throat Headaches, patient allegedly took Maxal 10 mg at 9:00am. Erythema in the neck area.
Mom states she and pt left the building post vaccination and pulled around the block and pt "went into a full blown seizure." Immediately drove to hospital ER. Mom states pediatrician there did not feel seizure was caused by vaccine.
Initial report received from a health care professional on 16 October 2013. A 70 year old female patient (date of birth not reported) had received FLUZONE HD vaccine on 14 October 2013 of lot number U4530AA expiry date October 2012 at left deltoid by intramuscular route. The patient had no relevant medical history and no known allergies. The subject had no concomitant medications. On 16 October 2013, the patient experienced redness and swelling at injection site. Corrective treatment was not reported. The outcome of the event redness and swelling was unknown. No more information available. Documents held by the sender: none.
Herpes simplex, rt. Lower lip Treated with Abreva Cleared within 6 days
1/15/14 Swelling at and below injection site - 7" - 3 1/2" area started swelling warm to the touch. No fever, pain 3 out of 10 on pain scale. Instructed to take CLARITIN and ice - no other symptoms - reported.
Pt rec'd the Men B vaccine by Trumenba. Shortly after pt began to vomit, complain of stomach pain, and chills. Pt was monitored in the office and given water to drink.
Woke up at 2:30 am with elevated temperature and a heart rate of approximately 130 bpm
GARDASIL 9 and verbalized that it was administered after the temp excursion had ocurred; This spontaneous report was received from a medical assistant and  refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 29-DEC-2020, the patient was vaccinated with an improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # 1687292 and expiration date on 25-AUG-2022 for prophylaxis (dose and route of administration were not reported).  The administered dose experienced temperature excursion on 22-DEC-2020 at 22.7 F for 35 minutes and a previous temperature excursion was reported for 07-DEC-2020 at 32.6 F for 30 minutes. This call was because of a data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA001792: US-009507513-2101USA001777:
Heart palpitations. Resting heart rate is now 90. Before vaccine was 60.  Sudden episodes now making heart rate 140 to 150.
my sister felt horrible after getting her 4th booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (my sister felt horrible after getting her 4th booster) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced FEELING ABNORMAL (my sister felt horrible after getting her 4th booster). At the time of the report, FEELING ABNORMAL (my sister felt horrible after getting her 4th booster) outcome was unknown.            No Concomitant medication were reported. No treatment drug were reported.   Reporter did not allow further contact
Patient had no adverse event. Patient received VARIVAX 7-15-09 and that evening developed temp 99-100 and  fine bumpy rash and she continues to have symptoms - Patient's mother, 22 weeks pregnant, broke out with rash 7-21-09 confirmed by doctor as chickenpox on 7-22-09, and she was treated with ZOVIRAX.
body aches; arm soreness; couldn't breath; throat was closing up; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A male patient of an unspecified age (Age: 58, Unit: not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient just has a question while he was waiting on his doctor to call him. Says he had the first dose of the Covid Vaccine on 03 or 04 Apr2021. He was fine all day. He went to bed around 01:00 and woke up at 06:00 am with body aches and his arm was sore/arm soreness. States that he could not breathe; felt like his throat was closed up. Stated it wasn't like when you have a chest cold, it was like the air didn't want to go in his throat. He states he took a Benadryl and about 10-15 minutes later it had went away. The patient wanted to know about taking the second dose. He said he got tested for antibodies and he was positive for it. He wanted to know about the result/reading of the antibodies level from the test. States that a parent at his daughter's volleyball team said they had the same problem that happened to them overnight. No further information or identifiers for this person provided by caller. States that he was wary about getting the second shot because he heard that it was stronger, and the side effects are worse. Says he does not know what to do and nobody seems to have any information. The patient was declining to complete report. He states he has been on hold for an hour, and he was in the car and has to pick up his kids from school. He states that his next vaccine was scheduled for tomorrow and he just want to transfer to Medical Information. States he can call back or go online to do the report. States he will go online to file the report; he heard he could do that while he was on hold for call handler. The outcome of the event throat was closing up was recovered on Apr2021 and outcome of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained  Follow-up attempts are completed. No further information is expected.
Patient experienced a metallic taste in her mouth approximately 15 minutes after receiving vaccine. She was to then be observed longer. Vitals at 4:10pm= BP 142/90mmHg, PO2 96%, and heart rate 88 beats/min. Patient reports she had already been having an asthma exacerbation earlier during the day and walking into the facility from the cold makes her asthma worse. Upon the metallic taste in her mouth and the need to be observed longer she states she had some anxiety and that this contributed to her wheezing. Patient took one puff of her albuterol inhaler and was feeling better. At 4:25pm the nurse noted lungs were clear with no wheezing detected. After approximately 30-45 minutes of observation, she was then walked by a nurse outside and due to the cold bothering her lungs she took a second puff of her inhaler in her car. Her wheezing lessened and the patient felt fine to go home.
Reaction to the Covid shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the Covid shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the Covid shot). At the time of the report, VACCINATION COMPLICATION (Reaction to the Covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075607 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075607:Same reporter/ Different Patient
had  shot dose #1 in August 2020 has not yet received shot #2 AFTER the Shingrix shot she received her covid-19 shot(s); This case was reported by a consumer via call center representative and described the occurrence of social problem in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020,1 intramuscularly in unspecified upper arm). Concomitant products included covid-19 vaccine and prednisone.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingrix, due to covid-19 shot, which led to social problem. The reporter did not have the exact date of the shot or the lot/exp but did provide the contact information for the pharmacy who administered it. The medical director said did not have an internist and had been without one for years. The reporter stated that, the patient received  prednisone tablets in January or February 2021. The reporter stated that, an unspecified time after the Shingrix shot, the patient received covid-19 shot(s).
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient began to experience tingliong in her extremeties about 5 minutes after vaccine was given. She experienced the same feeling last time and was given 1 tablet of benadryl. She was also given 1 Benadryl capsule this time and already had water. Patient was asked to wait for 30 minutes. Pharmacist was notified. After 30 minutes had past the patient stated she was feeling better and wnated to leave with her husband.
mom reported that pt felt very ill-aching muscles, h/a, throat ache 1/2hr p/vax;taken to MD ATB prescribed;
Child became nauseated and arm became red and tender, followed by a papular rash which spread from the arm to the back.
now its in my palms and different parts of my body; itching sensation; tingling in my fingers like pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my fingers like pins and needles), PARAESTHESIA (now its in my palms and different parts of my body) and PRURITUS (itching sensation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy and Allergy.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PARAESTHESIA (tingling in my fingers like pins and needles) and PRURITUS (itching sensation). On an unknown date, the patient experienced PARAESTHESIA (now its in my palms and different parts of my body). At the time of the report, PARAESTHESIA (tingling in my fingers like pins and needles) and PARAESTHESIA (now its in my palms and different parts of my body) had not resolved and PRURITUS (itching sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
24 hours later - measles-like rash (red, oval like, not elevated)  on inner thighs and under arms on both sides of the body, worse on the side of injection. No rash at injection site
Became dizzy, warm, tachycardic. Lost consciousness (fainted?), quickly regained consciousness and was taken to the Emergency Department. Before transfer, Benadryl IM 25mg administered.
Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks) 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.    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 MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks). At the time of the report, MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
pt recv vax 9AM 11MAR96 w/no problems noticed until 12MAR96 lt arm was noted to be red,hot & swollen approx 5" by 2",no fever,no pain,no change in activity or behavior,no tenderness;cool soak reduced edema & erythema;ice pack started;
states w/in 24hr had general malaise, inc temp;soreness-tender to touch-hot to touch @ site w/swelling;
States he has problems with hypoglycemia and began to feel lightheaded.  No loss of consciousness.  VS at 11:20, BP=138/100, HR=81, O2 sat=98%.  He was able to eat a granola bar and some fruit snacks with out nausea or vomiting.  C/o of hypoglycemia sxs.  Prior to leaving the recovery area after about 30 minutes, his blood pressure was 128/80, 96% o2 sat, and 92 pulse.  Contact information given to wife to text me when they arrived home and to rest; push fluids.
Case number PHEH2015US026565, is an initial spontaneous report received from a pharmacist on 03 Dec 2015. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) subcutaneously instead of intramuscularly on an unknown date. No adverse event was reported following this administration error.
Very fatigued; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (17Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lowers the immune system" (unspecified if ongoing), notes: Lowers the immune system; "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for immune system disorder, osteoporosis. Past drug history included: Bnt162b2, start date: 12Mar2021, stop date: 12Mar2021, for COVID-19 immunization, reaction(s): "numbness". Vaccination history included: BNT162b2 (Dose 1), administration date: 12Mar2021, for COVID-19 immunization, reaction(s): "she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms", "she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Very fatigued". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3 hours after immunizations, pt with localized hives all 3 injection site with raised, erythematous hive, hives spread over upper legs and trunk.
This spontaneous reprot has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of RECOMBIVAX HB (lot number J014855 - expiration date 16-APR-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010883, 1507USA010884). Additional information has been requested.
Palms of hand and feet very itchy with small welts on arm. Back of neck itchy. General overall body itchy and creepy/crawly for 2 1/2 days. Took Benadryl.
3 days after administration of ADACEL pt felt warm & soreness at site at 1 cm x 3/4 cm of injection Pt to apply ice/BENADRYL at hs prn.
Child was done for 2nd Hep A, DTaP and IPV, MMR #2. RN gave DTap-IPV-Hep B. Mother notified and will come in for second Hep A. No adverse effects imm. given out of range.
On 7/19 I was experiencing  fatigue and tested positive on 7/20.  I was prescribed paxlovid the same date and eventually began to feel better.  On 7/30 I began to feel a lot worse with cold symptoms including sore throat and body aches.  Doctor would not re-prescribe paxlovid.  After about five days I began to feel a little bit better.
Received Varicella injection and the next day noted swelling and redness at the injection site, along with body aches and headache.
Self-reporting as pharmacist and patient. After Moderna vaccine, injection site reactions developed for 48 hrs following administration (moderate pain, swelling, warmth to touch). Injection pain then subsided. At 10 days after injection, large swollen lymph node under arm on injection side was noticed. The swelling of lymph node seems slightly diminished today (day 14 post injection #1). In conjunction with swollen lymph node, experiencing generalized malaise, fatigue, and neck lymph nodes seem slightly swollen. Routinely taking ibuprofen and acetaminophen for some symptomatic relief.
Ongoing pain at the injection site that comes and goes.  Inflammation and frozen shoulder that came on slower over time after progressed after second shot resulting in continued loss of mobility with the left arm.
Information has been received form a registered nurse concerning a female patient who on 14DEC1998 was vaccinated with a dose of varicella virus vaccine live (lot number 0668M). On 31-MAR-2003 the patient broke out with chickenpox. It was noted as a mild case and there were 6 lesions on her stomach and some on her back. Unspecified medical attention was sought.  Follow up information revealed that the office could not provide further information without the patient's name. No further information is expected.
Varicella Information has been received from a consumer concerning a 9 year old male with down's syndrome and a penicillin allergy who in approximately 1999 "at a little over two" was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included levothyroxine NA (Synthroid), omeprazole (Prilosec) methylphemidate HCL (Metadate) and "risperdal". On 23-FEB-2006 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Tested positive for COVID-19 on May 18, 2022  -  approximately 2 months after second booster shot. Asymptomatic. Treated with Paxlovid for 5 days. Fully recovered with no side effects.
Pt became anxious & started to shake during vaccination.  Mother witnessed pt vomiting.  Laid down in Observation area.  Quickly began to feel better. Escorted to car with parent.