chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold sensitivity; flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds; headache; body aches; severe fatigue; overreaction to loud sounds; This is a spontaneous report from a contactable physician (patient). A 72-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), via unspecified route of administration in left arm, on 16Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient medical history included postural orthostatic tachycardia syndrome, depression and hypothyroidism. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) on 01Mar2021 and resulted in negative. The patient concomitant medication included levothyroxine sodium, morphine and sertraline. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3249) via unspecified route of administration in right arm, on 25Jan2021 (at the age of 72-year-old) and had no initial reaction. It was reported that a week after the second dose that was on 24Feb2021, at 08:00 the patient developed flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds. The patient underwent laboratory tests and results were as follows on an unknown date in 2021, the patient had no fever, blood pressure and pulse normal, chem panel, tsh and crp all normal. The patient received increase in pain medication as a treatment to events. The outcome of the events was not resolved.
pt suffered severe h/a beginning about 3:30 the day p/vax;about 1hr later pressure started in neck & pain on underside of muscle where inj was given;relates having chills as well;
Hives with red itchy painful rash on right leg within 30 minutes of vaccination. Did not resolve with Benadryl or hydrocortisone after 72 hours.  Periodic bleeding and difficulty sleeping.
ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Baby began to run a fever the same day the vaccines were given, no other symptoms presented, fever continued to next day
Went to bed w/o evidence of fever or irritability; found dead by mom in morning;
ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
FOR ONE WEEK FOLLOWING INJECTION OF HER 2ND DOSE OF ENGERIX-B ON 01-DEC-89 PT FELT SORENESS,NAUSEA,VOMITING,MALAISE.CONSTANT PAIN IN LEFT ARM(INJECTED ARM)
Pain at site of inject for more than 1 month. Extreme pain. Can't lie on it.
Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Legs ached the day of the shot and the day after but ok now
Case number PHEH2016US001006, is an initial spontaneous report received from a healthcare professional on 11 Jan 2016. This report refers to a 34 years old male patient. Past medical history and concomitant medications were not reported. Patient prior vaccination history included as, he vaccinated with FLUVIRIN in last year without adverse event (well tolerated). He was vaccinated with FLUVIRIN (batch number: 1516601, expiry date: not reported) intramuscularly on an unknown date. On 08 Jan 2016, he experienced lost consciousness, mild seizure and went to the hospital after receiving FLUVIRIN. The patient records show as a child, he had an egg allergy, but current records do not show that. The outcome of events was reported as complete recovery on 08 Jan 2016. The seriousness of events was reported as serious (hospitalization). The causality of the events was not reported.
Pt received vaccine 3/1/21; states that initial soreness occurred 3/4/21, and progressed into red, itchy rash by 3/5/21. Rash is red, raised, and warm to the touch, and sore ("like a bruise" according to patient). Rash area is roughly 5 inches long by 2 inches wide starting at injection site. Pt reported to pharmacy 3/6/21 to report concern. Pt was instructed to contact her primary care physician, or proceed to emergency department if rash continues to spread or worsen.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:03 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.06  for dose administered on 27-Oct-2021 at 09:03 AM.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 29-Sep-2021, 05-OCT-2021 and beyond use date for the vial was reported as 29-Oct-2021, 04-Nov2021. Product moved to clinic on 27-Oct-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.   Vaccines were not frozen at time of administration.   It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  No treatment medications were reported.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (Headache). In 2021, HEADACHE (Headache) had resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event(s) of SECOND COVID VACCINE RESULTED IN A HEADACHE was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/3/2022,  5/1/2022,  5/2/2022 --  RECURRENCE OF SAME SYMPTOMS
Fainted approximately 5 minutes after receiving flu vaccine, fell to floor. No injury noted, conscious immediately after falling, pale. Recovered after laying down w/ feet up x 5 minutes.
Patient received his first dose of the Covid-19 vaccine.  After 5 minutes of sitting, he decided to walk around the store to shop.  The patient experienced syncope and fell face first to the floor, cutting his lip.  The patient was bleeding from his lips.  Customers and pharmacy technicians tended to the patient.  He was alert and responsive the entire time.  The pharmacist called 911 and an EMS team was dispatched.  The patient rose and sat in a chair.  He was given water.  He stated that he just felt overheated and that the store was very warm.  EMS arrived, evaluated the patient, and stated that the patient just experienced a bout of syncope.  They asked if the patient would like to go to the hospital and the patient declined.  EMS left and the patient remained seated, resting for an additional 20 minutes.  The patient left the pharmacy.  The pharmacist spoke with the patient several hours later and the patient reported he was doing fine at home resting.  The pharmacist counseled the patient to contact his primary care provider regarding the incident.
The patient was at work and  felt that  he could not hear a coworker  in the middle of the conversation , the hearing went off as turning off a  switch . The patient had to visit his ENT Doctor on an Emergency Visit and he was giving a prescription for prednisone but the Doctor wanted him be seen by another Doctor to get second opinion because he could not believed how much hearing he  had lost in such  a short time. As of today the patient continues suffering the lost of hearing and had to have hearing aids prescribed. His emotional stability has been tremendously affected since he can no longer enjoy things that he liked such as tones and music and not only this has affected him but this condition has been detrimental for performing his daily job duties. His quality of life has deteriorated at a rapid pace.
we jut tested negative aftr a long bout with covid; This case was reported by a consumer and described the occurrence of covid-19 in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 12-DEC-2022 Reporters comment: The reporter reported we just tested negative after a long bout with covid, yesterday (one day before the day of reporting) was six month after our first injection of shingrix and asked was it too late. Additional Supportive information: This case has been linked to the case US2022AMR186444 reported by the same reporter for single patient.; Sender's Comments:  US-GSK-US2022AMR186444:Same reporter.
Approximately 1week after injection I developed a large red area at injection site. The red area is 2 in long and 5 in wide on multiple right arm, at and below injection site. The area is raised slightly, itching, sore and has small welps.  Present for 3 days, ice, Benadryl helped to decrease, then return after 2 more days. Large area is still present. I have not seen physician for reaction.
Red blotchy, hot, and itchy face; Red blotchy, hot, and itchy face; Red blotchy, hot, and itchy face; This is a spontaneous report received from a non-contactable consumer, the patient. A 29-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 29 years old) for COVID-19 immunisation. Patients past drug history included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not known) via unspecified route of administration in left arm on unspecified date for COVID-19 immunisation. Medical history was not reported. Patient received concomitant medications, However names not specified (although it was stated that patient had received medications within 2 weeks of vaccination). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  The patient experienced red blotchy, hot, and itchy face on 19Mar2021 at 16:30. Treatment was not received for the adverse events.   Clinical outcome of the red blotches, feeling of warmth facial, facial pruritis was recovering.  No follow-up attempts are needed. No further information is expected.
Pt recvd 1st dose Hep B vax (recombinant) in May of 1991 & exp severe pain in shoulder on the same side as the inject site; pt recvd 2nd dose in mid JUN91 & exp worsening of shoulder pain which was felt to be arthritis & later dx tendinitis
Lymphadenopathy in inguinal area developed on 11-12-07. On 11-14-07 she developed a rash and was more fussy. Rash on thighs and spread to torso, was scattered, maculopapular, erythematous. No vesicles or fever appeared to be measles-like rash.
Rash around vaccination site on day 10 after injection.  Itchy, red, hot to touch.
Suspected left foot thrombophlebitis in a varicose vein. Treated with warm compress and NSAID. Patient was seen on the day of onset of the 'lump' in the foot.
Extreme pain in bones of right foot; Couldn't walk or move foot; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 15:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known 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 COVID-19 vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified vitamin (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 26Apr2021 at 18:45 (reported as 18:30), 3 hours after the vaccination, only reaction the patient experienced was extreme pain in bones of right foot which lasted 12 hours and gone. It was reported that there was no visible bruising or swelling but no way to alleviate pain and couldn't walk or move foot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme pain in bones of right foot and couldn't walk or move foot was recovered on 27Apr2021 at 06:45.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
c/o left red and swollen arm on 07/15/2002, c/o right Jaw pain began am 07/18/02
She was vaccinated on Monday morning.  On Tuesday, she woke up with a painful swollen lymph node at the base of her neck.  On Wednesday she woke up with a painful swollen lymph node under her arm.  Both swollen lymph nodes are on left side.
coughing; Issues breathing; Couldn't sleep; terrible wheezing; "had a bad reaction"; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (MSG and red dye #40 (carries epi pen)).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Issues breathing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction"). At the time of the report, COUGH (coughing), POOR QUALITY SLEEP (Couldn't sleep), WHEEZING (terrible wheezing) and ADVERSE REACTION ("had a bad reaction") outcome was unknown and DYSPNOEA (Issues breathing) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-06-2021 contains No significant information
Patient presented to clinic for rashes all over body, developed 2 days after 1st dose of Pfizer. Patient had J&J prior. No resp./CV adverse symptoms, NAD, no fever or drainage, c/o itchiness. Symptoms persists ~1wk, not getting better or worse. Did not seek PCP as no insurance. Advised patient to seek higher level of care @ urgent care &/or ER, info provided. Patient agreed with plan.
Chills, cold sweats, syncopal episode resulting in fall, unable to see when experiencing syncopal episode, extremely painful left arm, unable to move arm secondary to 10/10 pain and stiffness. Vasovegal episode.
Subsequent to receiving first and second doses of varicella virus vaccine live a serum varicella zoster virus antibody test revealed a titer of 0.74
Approximately 3 weeks after the first Moderna vaccine dose, I experienced sloughing of the skin on my hands that eventually cleared.  After the second dose, I began experiencing sloughing of the skin on my hands several weeks later, then subsequently began experiencing sloughing of the skin on the soles of my feet.  It has lasted for quite some time, but now appears to be clearing.
booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). In November 2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. All booster doses were injected intramuscularly in deltoid muscle.
feeling like tachycardia in my left side in my heart, arm then go up; took the two dose but I feeling like something wired after that; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0187, and Expiration date: Aug2021), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced "feeling like tachycardia in my left side in my heart, arm then go up" was really wired and "took the two dose but I feeling like something wired after that". The caller stated that, the effect was in her body, that was why she was afraid to put third vaccine and she wanted to know what will happen if she put third vaccine. The patient received no treatment for tachycardia. The outcome of events was unknown.
cc: tachycardia; Joint aches, malaise, fever, chills and tachycardia. She presented on the 11 Feb saying the malaise/fever/chills had cleared after 5 days or so but the tachycardia persisted - consistently 110+ during clinic visit. Sinus rhythm on EKG
2 days post vax started sz @ 18mo of age;from 18mo to 2yr pt has pro aggressive sz, sz grand mal, clonic-tonic & petite mal varies daily tx through ped neuro physician depakote, topomax, lamictal;
Received tetanus injection on 8/28/09 in E.D. Returned on 8/30/09 c/o arm/neck pain. Dr diagnosed pt with acute allergic reaction to tetanus injection.
Developed fine rash on trunk, front and back and a little on face 7/31/06, on 7/29/06 ran high fever up to 103.4.