chrisvoncsefalvay/vaers-outcomes huggingface dataset:
69-year-old male with history of CAD s/p MI 6/2/2022 (unable to stent LAD -- recommended DAPT for one year, then aspirin only), HFrEF (last EF 30%), HTN, CKD 3, OSA on CPAP, hypothyroidism, who presented with acute onset lightheadedness and slurred speech while exerting himself on a ladder at 12PM on 6/7.  On arrival to ED, NIHSS = 0 and slurred speech had resolved.  CT head was negative.  At 4:45 PM, patient developed sudden left facial droop and slurred speech again. NIHSS = 3 in ED.  Stroke alert called.  No TNKase given outside window from initial symptoms.  CTA head and neck showed no LVO, no ICA stenosis, but noted soft plaque at the right ICA origin without stenosis.   Admitted for acute stroke.  MRI brain showed small volume cortical ischemic infarct at the lower right precentral gyrus. Spoke with Neurology, Dr on 6/8 -- > recommended okay to start apixaban 5 mg BID sometime after 6/11 -- if CT head shows no acute bleed -- for secondary stroke prevention in the setting of new Aflutter.   Notably, patient had new atrial flutter with slowed ventricular response and bradycardia to the 20s to 30s and 4-6 second pauses intermittently (mostly while sleeping) throughout admission.  Asymptomatic throughout admission.  TTE showed improved EF from prior but severely dilated left atrium. Cardiology consulted and recommended holding nodal blockers and no indication for pacemaker. Discussed again with Cards Dr. on 6/9; says he no longer needs to see the patient, and patient is stable for discharge home from his perspective. Said pauses of up to 5 seconds were acceptable as long as asymptomatic. Recommended to discharge with Ziopatch to monitor persistence of the bradycardia and f/u with home Cardiologist. Recommended okay to stop Plavix from cardiac perspective, but should continue aspirin with anticoagulation long-term.
Tested positive for COVID-19 by PCR on 3/15/2021. Asymptomatic for COVID-19 Immunized on 1/21/2021 and on 2/11/2021
Extreme Hive/Rash Spreading all over body. Very Swollen, very painful, and very itchy.
red spot on arm, dots above it, around injection area; warm to the touch, arm warmth; The spot is deeper red and spotty; Sore Arm; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) 50 µg. On 20-APR-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore Arm) and fever (Verbatim: Fever). On 21-APR-2023, the patient experienced injection site erythema (Verbatim: red spot on arm, dots above it, around injection area), injection site warmth (Verbatim: warm to the touch, arm warmth) and red spotty rash (Verbatim: The spot is deeper red and spotty). On 24-APR-2023, the outcome of the fever was resolved (duration 4 days). The outcome of the injection site erythema, injection site warmth, pain in arm and red spotty rash were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, pain in arm, fever and red spotty rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site warmth, pain in arm, fever and red spotty rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2023 Reporter was the wife calling on behalf of her husband who received his dose of Shingrix, and that same evening developed a sore arm and a fever. The morning after receiving the vaccine, the husband noticed a red spot on his arm about the size of a dollar bill, 6 inches long and 3 inches wide, with dots above it, all around the injection area. The spot was deeper red and spotty in the spot where the injection was given, and the area was warm to the touch.  The patient was still experiencing the arm warmth and large red spot on the day of reporting. The patient also developed a 105 degree F fever the evening of receiving the vaccine, that went down and came back each day until day of reporting. The reporter consented to follow up. This case is linked with US2023059936, reported by the same reporter.; Sender's Comments:  US-GSK-US2023059936:Same reporter
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions or concomitant medications.  On approximately 22-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for long-term prevention of shingles and zoster-related conditions. The vaccine was administered by a healthcare provider. The patient was approximately 74 years old at the time of the vaccination. On an unknown date, the patient experienced shingles and was treated by a healthcare provider. The outcome of the event was unknown.  The reporter considered the event to be related to the zoster vaccine live (ZOSTAVAX).
Within 10 minutes of receiving DTaP, Hib, IPV and Prevnar pt began to develop about 7 bright red spots on face. Small blotched rash noted to neck and chin.
heavy migraine; full body soreness; a fever over 100 F; fatigue; loss of strength; This is a spontaneous report from a contactable 25-year-old male consumer reported for himself that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 2 via unspecified route in left Arm on 25Feb2021 10:00, as dose 2, single for COVID-19 immunization (age at time of vaccination 25 years). The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 1 via unspecified route in left Arm on 04Feb2021 10:00, as dose 1, single for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 02:45 AM the patient experienced a heavy migraine, full body soreness, a fever over 100 F, fatigue, and loss of strength. The patient was did not received treatment for the adverse event. On 26Feb2021 he had lab test Body temperature result was fever over 100 F. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Very loud tinnitus occurred along with ear fullness and hearing loss mostly in right ear (same side as sinus surgery 9 years ago). ENT advised of inflammation and clogged Eustachian tube. He prescribed Flonase and advised to take Mucinex. I did that for 2 weeks and the ear fullness went away. I then started Allegra which I have been on daily and the tinnitus went away after about 2 months.
pt exp aching lt arm deltoid area extended to numbness finger tips & dorsum of hand, sensory changes w/o weakness;
Son states patient started having chills and was shaking approximately 1 hour after receiving PREVNAR. No other reported adverse event.
mom called c/o redness & swelling, no temp; began 2 hrs p/vax lt leg began quarter size that noc very red, became swollen to knee from mid thigh; very painful, limping tried ice & APAP did not resolve; to ER, dx w/infection, rx ATB;
Information has been received from a physician concerning a 6 year old male who on 15-JUN-2001 was vaccinated with a dose of Varivax. Subsequently, on 16-APR-2006 the patient experienced a "mild" case of breakthrough varicella rash. Unspecified medical attention was sought. No further information available. There was no product quality complaint involved. Additional information received that there was no further information available. No additional information is expected.
Admit for COVID and DKA, new onset DM. Given O2, steroids, lovenox, singulair, zinc, remdesivir. Weaned to RA and discharged home
Received 2nd booster shot on 03/30/2022. My adverse event started on 05/02/2022 in the morning at around 2:00PM my throat started to hurt and I became congested. I started having cough and sore throat for 3 days. On Tuesday I took  home test for COVID-19 and test came out positive. Then I called my doctor he prescribed me Paxlovid for 5 days. I took it 3 days so far I feel great.
Breakthrough case admission after three vaccines 2/12/21 Moderna 031M20A 3/12/21 Moderna 040A21A 11/10/21 Moderna 039F21A
Her HCP thinks she has COVID; Her HCP thinks she has COVID; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (59-year age at Vaccination). The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of Pfizer covid vaccine on 19Mar2021. She was not been feeling well so she did a covid test. Her results still pending and her 2nd shot was due tomorrow. States she had been feeling tired and depleted. Her HCP thinks she has COVID. Asking if she should get her second shot tomorrow. she already reported it to Pfizer safety dept yesterday. Outcome of the events was unknown.
9 Months  old  Male BIB mother  with fever, runny nose and congestion x 2 days.  Symptoms viewed as moderate by parents. Better with nothing, worse with nothing.  No history of other contacts with same symptoms. No travel overseas.  Mother last gave Tylenol at 0120 and states that fever did not break so she got worried and brought the patient in.  Upon initial contact, patient is afebrile.
patient got the flue; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient (gender and age unspecified) who got the flue (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flue (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reporter that, patient had never taken shot since.   Details of laboratory data not reported.     It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
uncontroable convulsions for 4 hours; 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 SEIZURE (uncontroable convulsions for 4 hours) 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 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced SEIZURE (uncontroable convulsions for 4 hours) (seriousness criterion medically significant). At the time of the report, SEIZURE (uncontroable convulsions for 4 hours) outcome was unknown.            No concomitant medication information was provided. Treatment information was not provided, but the patient would've gone to emergency room  if he could've made it. Action taken with mRNA-1273 in response to the drug was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded
Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 08:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and allergy to sulfa drugs. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), bupropion (MANUFACTURER UNKNOWN), drospirenone, ethinylestradiol (GIANVI) and spironolactone (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 11:00, the patient experienced joint pain several hours after injections. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient administered with expired vacciine, no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid  non-serious case from a consumer/non-healthcare professionals via Medical Information (under reference number 00849947).  This case involves a 60 years old female patient who was administered with expired IPV (VERO) [IPOL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  No other vaccines was given to patient.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (once in total, lot number RIF917 and expiry date- 03-Oct-2021) via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported that "Caller stated that medical assistant administered poliovirus vaccine inactivated (IPOL) to patient and it expired on 03-Oct-2021. Caller asking if there is going to be a reaction, do they need to revaccinate? Caller asking what they should do. Caller declined to provide email. Agent transferred caller to management. Call transferred without email address."  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial unsolicited report received from a non-healthcare professional (office staff) on 30 JUNE 2015. A female patient (age not reported) whose medical history and concomitant medication was not reported, had received intradermal 0.5 ml prefilled syringe of FLUZONE QIV, (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, approximately three days post-vaccination, patient's toes went numb, she experienced headache and the symptoms lasted about 3 weeks. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (lot number, dose and frequency were not reported) orally. On an unknown date the patient experienced abdominal cramps after receiving ROTATEQ. The action was not provided. The outcome of abdominal cramps was reported as recovered/resolved. The patient had sought unspecified medical attention. Additional information is not expected.
Low degree fever (99.8 F) in the night of 01/02 until the afternoon of 01/03. Sore left arm and feeling unwell throughout the day.
This spontaneous report was received from a registered nurse and refers to a 9-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Severe body aches, chills, and lethargy for two days following injection. Soreness and bruising at injection site. Non-injected shoulder joint pain with rotational movement since 1 day after vaccine. Has not stopped.
Pt. states that her left upper arm felt sore the night after the vaccine was administered on 8/5/19 and the next day she noticed bruising and a "lump" which hurt to touch at the injection site. Pt. self treated with massaging area and symptoms improving and resolving slowly but taking longer than expected and came in to clinic to report and get evaluated. Pt. did not report symptoms to provider until 8/14/19 and with a 1cm mildly tender, hard lump in the left deltoid site which pt. states has decreased in size since she first noticed it. Pt. with no other pain or discomfort and overlying skin normal without any bruising or rashes. Pt. with full ROM of her left upper extremity and shoulder and her strength and sensation intact.
So the next day I started feeling the chest tightening, and postal nasal drip. And also developed a cough. I called the minute clinic and they gave me nebulizer treatments and steroids and by the next day I was feeling fine.
Normal side effects until it came time for my period. It?s 3 weeks late and I?m not pregnant.
severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine; stood up and tumbling; He couldn't stand up straight and kept falling to right hand side; He couldn't stand up straight and kept falling to right hand side; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side). At the time of the report, DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Moderna booster vaccine administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in database lookup tool is 12/31/2069. Patient contacted on 12/4/2021. No adverse effects reported.
Confirmed Breakthrough - 4/15/2022  1st Dose - J&J - 6/15/2021  2nd Dose - Moderna - 4/1/2022
Pt states "flu-like reaction", decreased physical activity and use of arm due to extreme pain. Fever. Tennis ball size redness around injection site with swelling. Instructed her to call her physician as well.
felt a lump on the arm of injection; swelling; redness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE MASS (felt a lump on the arm of injection), INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE MASS (felt a lump on the arm of injection), INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness). At the time of the report, INJECTION SITE MASS (felt a lump on the arm of injection), INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 7AUG97 & 21AUG97  pt exp approx 20 small 1/2cm red spots, kind of elevated on rt torso;reported that none have broken or crusted over;