chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reports of children that were dying. I know of one mother who breastfed her child after she was vaccinated herself and her child got very very sick.; Reports of children that were dying. I know of one mother who breastfed her child after she was vaccinated herself and her child got very very sick.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "Reports of children that were dying. I know of one mother who breastfed her child after she was vaccinated herself and her child got very very sick.".   Additional Information: They are medical healthcare health care workers exemptions. Women who have been breastfed and their children have died transfer of spike protein to the child. Think how strange this was. Reporter called companies and organizations and every single of them tell them to call your health care provider. Reports of children that were dying. Reporter knew of one mother who breastfed her child after she was vaccinated herself and her child got very very sick. Genocide of the country. That is what is about to happen. Is there a transfer of spike protein in breastmilk to the infant who was not vaccinated but the mother was.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101043747 mother case
23JUL91 began vomiting blood, pale, lethargic was hospitalized; woke screaming like had never heard a/; pt died 25JUL91 10 days p/shots;
swelling and severe pain. went to urgent care and received prednisone and pain medication. swelling and pain subsided about 30 hours after.
left arm soreness; extreme fatigue for 4 days; severe headache day 3,4; This is a spontaneous report from a contactable physician, who is also the patient. This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 18Dec2020 at 07:00 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. Relevant medical history included penicillin allergy. There were no concomitant medications. On 18Dec2020 at 15:00, the patient experienced left arm soreness and extreme fatigue for 4 days and in Dec2020 she experienced severe headache day 3, 4. The patient did not receive corrective treatments. She recovered from the events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
SHORTNESS OF BREATH, LABORED BREATHING COULD NOT LIE IN SUPINE POSITION; TIGHTNESS IN CHEST; SWELLING IN LEFT ARM, PALM, RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; REDNESS IN LEFT PALM, RIGHT HAND, LEFT AND RIGHT SOLE; ITCHY IN LEFT PALM, ARM,RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; TIP OF TONGUE REDNESS; WEIRD FEELING ON TONGUE-TINGLING; LEFT ARM PAIN/ACHY COULD NOT MAKE A FIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 119 pounds, and height was 64 inches. The patient's past medical history included autogenic dental bone graft, and concurrent conditions included hypothyroidism, non-smoker, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. The patient experienced drug allergy when treated with clindamycin, and minocycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium.  On 14-MAR-2021, the subject experienced shortness of breath, labored breathing could not lie in supine position. On 14-MAR-2021, the subject experienced tightness in chest. On 14-MAR-2021, the subject experienced swelling in left arm, palm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced redness in left palm, right hand, left and right sole. On 14-MAR-2021, the subject experienced itchy in left palm, arm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced tip of tongue redness. On 14-MAR-2021, the subject experienced weird feeling on tongue-tingling. On 14-MAR-2021, the subject experienced left arm pain/achy could not make a fist. On JUN-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Ultrasound Doppler (NR: not provided) Negative blood clots. On 08-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 16-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 17-JUN-2021, Laboratory data included: Antibody test (NR: not provided) low by 4%. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in left arm, palm, right hand, sole of foot right and left, redness in left palm, right hand, left and right sole, itchy in left palm, arm,right hand, sole of foot right and left, tip of tongue redness, weird feeling on tongue-tingling, and left arm pain/achy could not make a fist on 15-JUN-2021, and had not recovered from shortness of breath, labored breathing could not lie in supine position, and tightness in chest. This report was non-serious.
Took 2 doses and had third; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 7gm34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dsoe on an unknown date).   On 21st September 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 21st September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The pharmacist reported that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter stated that, consumer forgot that they had already received both first and second dose previously at another pharmacy. The reporter consented to follow up.
patient was adminstered flublok on left deltoid, shortly after about 1 hour patient noticed itchy, red, swolleness to administration site. the redness is spreading to her elbow
Patient was expecting COVID19 Pfizer BioNTech BiValent and instead received COVID19 Pfizer BioNTech
UNKNOWN IF REACTION WAS RELATED TO VACCINE:  Patient received his Pfizer COVID-19 booster in the clinic (he received Moderna for his initial series).  Shortly after, he  developed intermittent episodes of being verbally unresponsive.  Episodes lasted between 30-60 seconds.  He also developed spasms of his upper extremities.  The muscle spasming and jolting resolved in less than 30 seconds.  Family said these were the full body spams he had been experiencing and that they were NOT new to patient (family said he experienced 8 or 9 full body spasm episodes the day before).  After full body spasms, patient was immediately alert and noted to be back to pre-spasm cognition; vital signs within normal limits for patient and oxygen saturation adequate on room air.  Patient became unresponsive, was given epi pen, and became immediately responsive.   Emergency Medical Services  was called.  5 minute vital signs within normal limits for patient.   Shortly after, patient became unresponsive again. Epinephrine administered, and patient immediately began full body spasm, lasting approximately  30 seconds. When spasm was complete, patient was back to pre-level of conscious cognition. Emergency Medical Services arrived and patient was taken by ambulance to an emergency department (where diagnosis was ?tremors of nervous system?).  Patient also has a known seizure disorder, has been on Keppra, states he is compliant, but misses his meds sometimes.
pt recvd vax; itchy, prickly sensation in legs around ankles & calves; tried dph & topical cream w/out relief; to see md;
I want to start by saying I am a vegan. I never had a problem with cholesterol. I eat no meat, no cheese, no oil, etc. I had a heart problem 7 years ago. For the last 4 years I been on top of it, especially being a vegan. After the vaccine, my left arm felt tired. Which was weird because it had been 4-6 weeks since I had the shot. After feeling this and just run down through the day, I knew I was having a heart attack. It was the week before the November holiday when it hit me, around 11/14/2022. I was admitted into the hospital for 5-6 days. They did an angiogram and noticed I was blocked.
Notice abnormal soreness in arm of immunization and redness below injection site after getting out of shower in the evening of 9/22/17.
Blinding headache, nausea, weakness. Reporting this because it has continued until today 10/09/2011 2:37 PM.
her head is stopped up; feels really weak; has "gook" in her eyes; cold; headache; sore throat; nausea; feeling sick for the last week; She can't do anything; gastroparesis; sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 30Mar2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. She reported having only a sore arm after getting the vaccine (in 2021) however she has had to cancel the appointment (twice) for her second dose on 20Apr2021. She was feeling sick for the last week (Apr2021) as her head was stopped up, has gastroparesis, felt really weak, has "gook" in her eyes, a real bad cold, headache, sore throat, and nausea.  She can't do anything and has stayed in her bed. Outcome of the events were unknown. She doesn't think the first shot caused it because she didn't get sick until days later.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Narrative:  93y.o. MALE Patient with a h/o CKD stage 4, CAD, HTN, HLD; presented to ER with report of fall on 1/9/2022. Per 1/11/2022 MD H&P note regarding covid infxn: "*COVID-19 infection, POA - Tested Positive 1/9/22. Isolation ends 1/20/22. - CXR: No acute cardiopulmonary abnormality grossly seen. - Stable on room air. no respiratory complaints - No indication for steroids or remdesivir" On 1/16/2021 MD progress note: "Myocardial injury - Troponin gotten this morning as part of routine COVID-19 labs and found to be 2.67 and now downtrending. Patient is asymtomatic likely NSTEMI type 2 possibly stress induced cardiomyopathy. Continue Coreg, ASA, Statin. ECHO ordered. Cardiology Hyperkalemia in setting of AKI on CKD4 - improved today, similar to admission. Cr improved since admission. Continue to hold Losartan. COVID+ on admission - asymptomatic, never needed oxygen. No indications for therapy at this time." On 1/18/2021 MD note pt with AKI, POA and the following regarding anemia secondary to CKI: "*Anemia - Hgb dropped to 6.1 on 1/17 - transfused 1 U, rechecked 6.5 and received a 2nd unit PRBCs recheck 9.3 - Fe 40, Transferrin 109 - Family interested in full treatment including EGD if indicated - consult GI" On 1/18/2021 pt coded & died at 21:09pm. Death was caused by: myocardial infarction in setting of COVID-19 infection. Pt had received covid vaccine on 7/9/2021 (J&J). Likely pt's death is not related to covid vaccine given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
the patient received two doses of GARDASIL 9, first on 15MAR2011 and second on 31MAY2011/the patient never got the third dose of GARDASIL 9; Information was received from the patient's mother referring to a 35 year old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was unknown.  On 15-MAR-2021 and 31-MAY-2021, the patient was vaccinated with first dose and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiration date were not reported) for prophylaxis.  The patient never got the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and was inquiring dosing/revaccination recommendations (inappropriate schedule of product administration).
Red swollen patch at injection site, it itches and is warm to the touch also a little tender to the touch, it is one inch tall by two inches wide on my upper left arm
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 57 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. Patient did not report any illness at the time of vaccination. Patient had no history of similar event, had no adverse events related to previous vaccinations, no history of allergy to vaccine, drug, or food. Patient did not report any history of pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization and had no family history of any disease. Patient was not pregnant nor breastfeeding at the time of reporting. On 14-JUN-2021, the patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: 203A21A and Expiry: Unknown) 1 total, to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, 1 total, administered to right arm on 20-DEC-2021 for prophylactic vaccination. Vaccine was administered to right arm. The vaccine was stored at 2-8 degrees Celsius. The vaccine was removed thrice from the storage and kept out for 10 minutes. Then returned to refrigerator. The gauze/length of the needle was 25G, 1 inch. No concomitant medications were reported. On 20-DEC-2021, the patient received expired vaccine (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261048, 20220261011, 20220261063, 20220261042, 20220261024, 20220261039, 20220261092, 20220261043 and 20220261022.
Client called and had gone to the doctor the next day.  States the doctor determined it probably was the vaccine as there were not any other different factors identified.  symptoms included: puffy legs and feet, skin red all over like a sunburn, blotchy, itchy type rash. Some nausea and diarrhea. She was put on prednisone for about a week.  Client states it took about two weeks before she completely returned to normal.  She had two prior hepatitis b vaccinations, october and november 2003 without any problems.
On 10/15/10 patient was given ADACEL. See IM (L) arm and MENACTRA .5cc IM (R) arm as part of routine. Physical 10 min later pt developed hives (generalized) no change in vital signs; no respiratory difficulty at all. BENADRYL 36 mg po given -> Hives-> Resolved next 30 minutes.
Patient complained of 101 degree fever with chills approximately 6 hours after flu shot.  Also says that she is weak.
Patient developed fatigue on 11/19/21  (1 week after receiving her first Pfizer COVID vaccine). She had difficulty wakening and was very fatigued and legs were "wobbly." She also noted that her hands were weak. She got out of bed and fell asleep on the stairs on the way to breakfast. She had a low grade temp to 100 x 1 day on 11/20/21.She also had swollen cervical lymph nodes, sore throat,  congestion, and stomach ache starting  11/23/2021. She denied chest pain or difficulty breathing, vomiting,  diarrhea.
The patient had her vaccine at 8:21am. She reported her lips were tingly. At 8:48am , we gave 50mg of benadryl. She reports history of allergy to shellfish. She takes Zyrtec 10mg daily. Her bp was 130/75. HR 71, RR 18, and oxygen 97%. Patient was no worse after benadryl and was ready to return to work. She was cautioned about driving after 50mg of benadryl.
Today I woke up with blood on my pillow and on my pajamas; A spontaneous report was received from a consumer who was an 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, today I woke up with blood on my pillow and on my pajamas.   The patient's medical history was not provided.  Concomitant medications included acetylsalicylic acid.  On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02FL0A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient woke up with blood on her pillow and her pajamas.  She removed the Band-Aid from the injection site, and it was full of blood, but her arm was not bleeding. The event resolved on the same day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, today I woke up with blood on my pillow and on my pajamas, was considered resolved on 06 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case an 82-year-old, female patient who experienced the event of woke up with blood on her pillow and her pajamas (injection site hemorrhage) for mRNA-1273 (Lot number 02FL0A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the event of injection site hemorrhage and vaccine administration cannot be excluded.
Narrative:  Presents approximately 2.5 months after first and second Materna  injection of which patient had severe rash bilateral arms. Provided referral today with evidence of SEVERE reaction. steroids essentially ineffective parenterally, dermatology indicating immediate allergic reaction one day after first vaccine and informed "will have to run it's course and improve". taking once daily antihistamine and topical steroids. remains mildly pruritic.and now evident as scattered rash bilat forearms.
Immediately upon receiving vaccine, patient complained of dizziness and request an ambulance.  Ambulance arrived within a few minutes. patient vitals were obtained and was asked if she'd like to go to the hospital.  Patient decline additional care as she was feeling fine and not dizzy anymore
His leg was sore; Given undiluted dose of vaccine; Given undiluted dose of vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team, Program ID.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 as dose 1, single (Lot number: FT9142) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 08Aug2022, outcome "unknown" and all described as "Given undiluted dose of vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His leg was sore".  Additional Information: The reporter was a pharmacist calling about the COVID-19 vaccine. The reporter reported that, it was administered to a patient without being diluted. Reporter came into the line and verified information received from the transferring agent. Reporter stated that the COVID 19 vaccine she was calling about had a dark red cap. Reporter stated that she was looking for guidance on this situation. Stated that she had not contacted the parents of the patient yet, she wanted to contact Pfizer first. Reporter began to cry and stated that she felt bad that this happened. The reporter was asking about a 3-year-old male patient who received his first dose of dark red cap vaccine, not diluted. She was looking for guidance. The pharmacist reported it was human error. The vaccines are too overwhelming. Every vaccine has different dosage amounts, different age groups, different dilution instructions, different dosages. It was too much and she goes slow when preparing but it was too many variations and calculations and the mistake happened with the overdose. The patient did not receive any prior vaccinations within 4 weeks. Information regarding concomitant drugs and medical history was reported as unknown. The reporter did call the mother after the overdose event and the mother was a physician which was helpful for monitoring the patient. The mother said he was fine but acting like his leg was sore but considered it a normal reaction. No other adverse events reported beyond that one.  Follow-up (10Aug2022): This is a spontaneous follow-up report received from a contactable consumer.  Updated information: reporter information (primary reporters email address and new secondary reporter added) and patient details (age at vaccination captured).  Follow-up (17Aug2022): This is a spontaneous follow-up report received from a contactable pharmacist. Updated Information: suspect drug (vaccine facility information added), reaction data (added new event of his leg was sore) and additional information updated with details of clinical course.
All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.
Patient received first dose on 8/31; patient had no problems that she recalls. Patient has had Zostavax vaccine also.  About 7 years ago patient reports shingles on eye, forehead, head, and eyebrow.   Patient started to get chills so took bath and could not sleep all night long. Both arms were sore and uncomfortable. Patient took ibuprofen and acetaminophen.  Patient had stomach pain and felt nauseated. Patient had 100 fever.  Patient took another acetaminophen this morning when woke up.  Still has same symptoms, loss of appetite, headache, pain in arms if lays on it.   Patient is very uncomfortable.  Patient probably only had 1 hour of sleep last night.   In terms of recovery, symptoms are probably the same at this at this point. Patient has not called doctor or pharmacist yet since handout says they will last 2-3 days.