chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/29/2021 @ 1:00 PM Light persistent headache on same day of vaccine, feeling better next day.
The day before I was extremally tired, but it was Christmas and we had just got our kitchen redone so I was very tired naturally giving it was the holiday season. The next day I was still tired but had a scratchy throat. I had a weird feeling, so I took a COVID-19 test and it was positive. I started to get chills and lots of fatigue and it felt like I had the flu. Then I went and told my family. I was also having muscle pain in my legs, brain fog. I then reached out to my doctor which prescribed Paxlovid (that had a really awful after taste). It took about two weeks for me to start to recover. I had some lingering symptoms such as headache, couch, sever muscle pain and vile taste (everything had a weird taste).
C/O 'off balance' as walking out of waiting area he felt off balance and was leaning to the right side, face was flushed and gait unsteady  Vital signs were monitored every 10 minutes for half hour, given benadryl by mouth @ 6:15 PM Left to go home with wife who was able to drive him home. Instructed to F/U with PCP  to have second dose on 3/4/21
Information has been received from a pharmacist via a field employee referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and concomitant medications were not specified. On unknown dates the patients were vaccinated with ZOSTAVAX (lot number, expired date, dose and route unknown). On unknown dates the patients experienced a red spot at the injection site after administering ZOSTAVAX. The outcome of the event and causality with ZOSTAVAX were not provided. It was not reported if the patients sought any medical attention and there was no product quality compliant (PQC). Additional information has been requested.
severe diarrhea 3 days after his second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea 3 days after his second vaccine) in a 44-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea 3 days after his second vaccine). At the time of the report, DIARRHOEA (severe diarrhea 3 days after his second vaccine) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up report received included no new information. On 15-Jun-2021: Reporter's Email address was updated.
allergy to mRNA vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003888 (Novavax).  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergy to mRNA vaccines".  Additional information: On 17Oct2022, it was reported that a patient started treatment on an unspecified date with mRNA vaccines (COVID-19 Vaccine mRNA) at unspecified dose for an unspecified indication. It was reported the patient had allergy to mRNA vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NO additioanll AE details available; improperly stored vaccina administered/ temperature above 46 F (62.8 F); This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023; route of administration defaulted to oral, dose was not reported), that was improperly stored.  Storage and temperature excursion details: Temperature: above 46 degrees Fahrenheit (62.8 degrees Fahrenheit) Time frame: 8 hours 0 minutes and 0 seconds Previous temperature excursion? No  No additional adverse event (AE) details available.
Less than 36 hours following vaccine in left arm, I awoke in the middle of the night with sore, stiff left jaw with loud popping in my jaw whenever opening my mouth. My left jaw has popped loudly every time I open my mouth or chew ever since. It is so loud that others can hear it. Upon wet weather, it became very achy. I have never had any symptoms at all with my left jaw before the vaccine. In addition, it has been accompanied by occasional dizziness.
She got her vaccine, and by evening her arm was swollen, puffed up and she can barely move her arm.  It is very painful and she is not able to use it.   Her husband said that she was moaning and crying out in the night.  She took 2 hydrocodone/Acetominophen 5/326 which did not alleviate her pain, which she has taken twice, but not relief of the pain.
Approximately two hours after receiving vaccination, I began to have chills. I felt hot and cold and weakness, muscle spasms, and muscle pain. I had arm pain but not at the injection site. I did have bruising and hardness at the injection site. I had a rash and below my knees. A cream was applied and it went away. It took me about three days to recover. I went into day procedure venogram due to DVT which turned into an emergency surgery and an artery was nicked and I was bleeding so much I required a blood transfusion. I was discharged on December 24th, 2022.
Large local reaction to left deltoid after vaccination (may be due to DTaP), diagnosed with cellulitis at outside emergency room
Truncal rash started 12 days after immunization (hep A, varicella, flu, MMR). Mother brought child to office visit with health care provider. Immunizations given on 2/7/12. Office visit is was 12/21/12. Diagnosed as hypersensitivity MMR reaction possibly delayed.
Generalized flushing, Urticaria upper torso and sparse to uppe thighs, No SOB,NO STRIDOR Lungs clear  Treated with Epi 0.5mg IM, and Benadryl 50mg IM Right Deltoid  Sent via EMS to the ER
Right upper thigh with knot (3cm diameter) and 2cm redness at site. 1tsp (5cc) Benadryl 12.5mg given and mother advised to apply ice pack to site. Directed to call office, if symptoms worsen.
Knee stopped popping; Started hurting again; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Knee stopped popping) and ARTHRALGIA (Started hurting again) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Knee stopped popping) and ARTHRALGIA (Started hurting again). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Knee stopped popping) and ARTHRALGIA (Started hurting again) outcome was unknown.            Concomitant medication reported as blood pressure medication. No treatment medication reported.   This case was linked to MOD-2021-405067, MOD-2021-405732 (Patient Link).
12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date; 12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (12 people were vaccinated with the Moderna Covid 19 vaccine past its best use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The vial was initially stored in the refrigerator on 13Jun2022. A total of 12 doses were given to 12 patients from 3 vials. The vial didn't undergo any temperature excursions. Dates of administration of vaccine were 16Jul2022- 3patients, 23Jul2022-5patients and 24Jul2022-4patients. No treatment information were provided. This case contains the information of the fourth of 12 patient.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up - Significant Information contains reporter's email updated and  narrative updated.
This spontaneous report as received from a medical assistant refers to a 2 months old patient of unknown gender. On 19-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K024700 (dose, route and frequency unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
14APR94 830PM rash appeared on rt arm very itchey rash spread to lt arm, face, chest & legs; lotion applid;
ARNP Note 10/16/18 1100 48 yo male Clinical Technologist presented to EH with c/o left sore deltoid x 10 days. Reported receiving yearly flu shot on 10/5/18 in EH and denied problems with administration. However a couple of hours later developed an achy pain at injection site with now resolved tingling in left hand 4th and 5th digits. Endorsed occasional sharp pain from deltoid to elbow but overall the pain is in the left deltoid. Today pain 3/10 but increases 5/10 with sharp pain. Will have increased discomfort to area when lying on left side or leaning against sofa after 30 min. This past weekend thought the pain was less but then it seemed  to return to 3/10 yesterday. No prior LUE injuries. Taking ibuprofen 200 mg po q 4-6 hours prn. No f/c. No erythema or warmth to site; no ecchymosis. No HA. No numbness, tingling or extremity weakness. O. In NAD; MSK: Neck: No midpoint tenderness; FROM w/o pain elicited Shoulder: No SC or AC joint tenderness; no bony deformity. No erythema, edema or warmth to deltoid; supple FROM with only slight discomfort elicited in left deltoid with maneuvers. 5/5 strength with sensation intact. Sensation test to lateral arms intact for axillary nerve 2++ tricep/bicep DTRs. Strong bilateral radial and ulnar pulses with cap refill < 3 sec Back: No spinous process tenderness; no step offs; no paravertebral tenderness. A. Left Deltoid Pain No overt pathology. Most likely deltoid soreness r/t trauma of injection needle into the muscle, leading to muscle contusion P. Increase ibuprofen to 400-600 mg po q 8 hours; take with food Moist warm compresses to area 10-20 min on; 30 min off repeat qid/prn Return in 2 weeks if no improvement or sooner if pain increases, decrease extremity function, numbness, tingling. Verbalized understanding ARNP. 10/22/18-- c/o shoulder pain persisting over the weekend, has appt with PCP, enc f/u Seen by Dr. on 10/23/2018 and diagnosed with bursitis. per pt "I saw my primary care provider last week and he has diagnosed me with acute bursitis due to improper placement of the vaccination. He wanted me to make sure that your department had filed a VAERS report ".
In 1997 the patient developed modified varicella. On 01/02/2001 the patient developed a second breakthrough rash of approximately 35 pustules and was confirmed to have chickenpox. The patient sought unspecified medical attention. The patient was not on steroids, and had no history of steroid use or asthma. Additional information has been requested.
During previous admission, patient completed the Moderna Covid series on 2/8/21 and 3/8/21.  During current admission  patient received a third dose of the Moderna covid vaccine in error. Patient's medical consultant informed this writer that the patient has been under close observation for any side effects, including  checking vital signs every shift.  So far, no side effects noted.
Persistent vomiting x 3 days. Dx with Intussusception on 3-31-14.
Tiredness throughout the day; slight lightheadedness; slight headache; This is a spontaneous report from a contactable pharmacist (reporting for himself). A 38-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), intramuscular on 21Dec2020 09:30 on the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Dec2020, the patient experienced tiredness throughout the day, slight lightheadedness and slight headache.  There was no treatment that was received for the events. The events were considered non-serious. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.   Information about Batch/Lot number has been requested.
This spontaneous report as received from a pharmacist regarding herself refers to approximately 62 year old female patient with drug reactions/allergies to salicylic acid topically. Concomitant therapies included SYNTHROID, EVISTA, CRESTOR, bupropion hydrochloride, estradiol (manufacturer unknown) and progesterone (manufacturer unknown). On 23-JUN-2014 the patient was vaccinated with ZOSTAVAX lot # J014568 expiration date 18-FEB-2015, dose 0.65 ml, route subcutaneous in the left arm. The reporter stated that on 23-JUN-2014 after receiving ZOSTAVAX, she developed redness, soreness at injection site (back of left arm) and injection site was hot also. The pharmacist stated that she developed chicken pox. The reporter stated that area is improving but still a little tender. The reporter also stated that she had chicken pox 25 years ago then her child recently (time frame unspecified) brought them (chicken pox) home. The outcome of events reported was reported as recovering/resolving. The patient sought no medica attention. No product quality complaint was involved. Additional information has been requested.
1.5 hours post vaccination, developed reddened appearance of arms and face and started to feel "itchy". Has history of receiving FLUZONE in past without reaction.
pt brought to ED via EMS; c/o generalized weakness, SOB, fever, diarrhea; O2 sats in 40s on RA per EMS; O2 supplementation; admitted to hosp; positive for COVID; transferred to ICU; dexamethasone, ABX; required intubation with maximum ventilation support; continues to be hypoxic; family decided to make pt DNR/DNI with comfort based approach; extubated and pt died in the hospital
This case was reported by a other health professional via call center representative and described the occurrence of vesicles in a 54-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicles, pruritus and burning sensation. On an unknown date, the outcome of the vesicles, pruritus and burning sensation were unknown. It was unknown if the reporter considered the vesicles, pruritus and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient developed pruritic burning vesicles on index finger. The reporter gave consent to follow up.
REACTION TO IMMUNIZATIONS, VARIVAX AND/OR PEDIARIX. LARGE SWOLLEN, VERY PAINFUL, RED LEFT ARM WITH BLISTERS IN IJECTION SITE
numbness and tingling in right leg below knee, pain in big toe off and on some numbness in left leg
Swelling from ankles to knees, worse at 12 hours post injection, now improved but still an issue for patient.
Left arm, shoulder, pectoral swelling, redness, warmth, malaise, fever within 48 - 72 hours of vaccination.
On 06/17 of receiving vaccines patient fell asleep.  Mother noted he didn't awaken when expected.  He was very difficult to arouse and limp.  Mother called 911.  It took about 45 minutes before he was "back to himself".
Lower lip began to swell up; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar II disorder and OCD (obsessive-compulsive disorder). The patient did not have any allergies. 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. Concomitant medications included lithium (MANUFACTURER UNKNOWN), olanzapine (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and were unknown if ongoing. On 02May2021 at 16:00, approximately two weeks after the vaccination, the patient's lower lip began to swell up. It was reported that the patient's lip ballooned up 2 times its normal size over the course of three days and then the swelling went away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event lip swelling which included treatment with unspecified steroid cream and pills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lower lip began to swell up was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Intense pain and burning sensation at injection site that occurred 3 hours after vaccination was given. Pain and burning made me dizzy and nauseated. The discomfort lasted about 30 minutes and the injection site remained sore for 4 days.
pt recv vax 20OCT98 & 30min p/vax had a rxn @ 12noon;difficulty breathing, paleness, weakness, fast heart beat, dry mouth, dizziness;
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that GARDASIL of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number H021861 and expiry date 09-OCT-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practitioner nurse refers to a patient (age and gender not reported) who on 01-MAY-2013 was vaccinated with an expired dose of VARIVAX (Lot No. 0098AA, exp. 12-JAN-2013) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Heart attack; This serious initial spontaneous safety report was received by Novavax on 05-SEP-2023 from a consumer, via the contact center.  A 78 year-old female of was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 26-OCT-2022, and dose 2 on 16-NOV-2022 on the right side at a clinic.  The following medical history was reported: Blood cholesterol abnormal, Diabetes mellitus, Drug hypersensitivity (Antibiotics that ends with -illin), Food allergy (nuts, berries, and anything from the ocean), Hypertension, Neoplasm malignant, and amoxicillin drug allergy. Additionally, the individual had never received any other Covid-19 vaccination and never tested positive for Covid-19.   The individual's reported concomitant medications included an unspecified blood thinner, an unspecified diabetes medication, and unspecified painkillers.  On 18-JAN-2023, 2 months 2 days after vaccination with dose 2, the individual experienced a heart attack (PT: Myocardial infarction) (Serious: Hospitalization and Medically Significant) which was reportedly "due to preexisting cholesterol issues." The individual was hospitalized on 18-JAN-2023. Subsequently, the individual underwent a stent operation as treatment and the symptoms resolved.  On 18-JAN-2023 the event outcome of Myocardial infarction was recovered/resolved.; Sender's Comments: This 78 year-old female experienced: Myocardial infarction after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Myocardial infarction was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Patient under 16 years of age.  No s/s of adverse reaction.  NO treatment required
Hives started in October. Saw doctor in November and referred to allergy specialist, who diagnosed with chronic spontaneous urticaria in December. Prescribed famotidine, montelukast, and zyprexa. Has not improved to date.
Patient recieved a dose 9/12/21 and 10/13/21 patient had no side effects
No adverse event; Nurse reported that GARDASIL 9 was administered following temperature excursion. Consent to contact obtained. No additional AEs/PQCs reported.  ?    Names of vaccines involved (including lot/exp) GARDASIL 9         ?    Temperature 52.86F; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2023, the patient was administered a temperature excursion therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot number W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error ). A temperature was 52.86F for time frame of 96 Hours.