chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; headache; aches and pain, pain all over; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Caller called to say that she experienced a lot of symptoms and adverse reactions; upset stomach, headache, aches and pain, pain all over after receiving the 1st dose of vaccine on Saturday (10Apr2021). Caller wanted to know if she can take Aspirin or something to help it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got the Moderna on March 1st.  On March 6th I woke up with red puffy eyes.  Took Benadryl and got better. On March 8th woke up with swollen lower lip. Took Benadryl and was better by noon.  On March started breaking out with a rash on right side of body.  Took Benadryl and put Hydrocortisone on it.  Rash kept getting worse  with big spots and itching.  On  March 11th was worse so called the  Medical Center and asked if the Moderna vaccine could have caused this? They said, no! If got worse come in. March 11th at 9:oo P.M.  I could feel my upper lip swelling. Took Benadryl and thought it would be better by morning. It wasn't.  Woke up with red puffy eyes and a swollen upper lip. Looked like I had been in a fight. Time to get medical help.  Got into doctor at 9:30.  They said it wasn't from the shot but I know it was. On Pednisone and cream for shots. Finally getting better!
ACUTE PULMONARY EMBOLISM 3/18/2023 ATHEROSCLEROSIS OF AORTA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2023 ATHEROSCLEROSIS OF AORTA ACUTE PULMONARY EMBOLISM 3/18/2023 CELLULITIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2023 CELLULITIS
received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FK5127, Expiration Date: Aug2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday".  Additional information: Pharmacist stated we received on Friday, Friday not on Thursday we received three Pfizer BioNTech for kids the vaccines and all three boxes are expired as of Aug2021. Pharmacist stated, we did vaccination like 5 kids yesterday. We didn't realize until, when we enter all the information with the LOT# and everything that's when, we found out.  Asked why we get expired medication over here for kids and why do you just send expired vaccines. It's so risky. Stated that there is any damage to those kids because it is not my responsibility right now. You guys sent three expired boxes to vaccinate kids, not you the company and patient wanted to know why first thing, want you to find out for me is one, what is the safety window after the expiration date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101534624 Same product and event, different patient; PFIZER INC-202101534625 Same product and event, different patient; PFIZER INC-202101534626 Same product and event, different patient; PFIZER INC-202101534627 Same product and event, different patient
Systemic: developed arthritis in arm that was injected-Medium, Systemic: Joint Pain-Medium, Additional Details: in addition to arthritis, an enlargement and protrusion of what seems to to be bone in elbow of injected arm has occurred
nerve damage at the elbow and index; elbow pain; redness at the upper arm; numbness in fingers; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVE INJURY (nerve damage at the elbow and index), ARTHRALGIA (elbow pain), VACCINATION SITE ERYTHEMA (redness at the upper arm) and HYPOAESTHESIA (numbness in fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (nerve damage at the elbow and index), ARTHRALGIA (elbow pain), VACCINATION SITE ERYTHEMA (redness at the upper arm) and HYPOAESTHESIA (numbness in fingers). At the time of the report, NERVE INJURY (nerve damage at the elbow and index) and ARTHRALGIA (elbow pain) had not resolved and VACCINATION SITE ERYTHEMA (redness at the upper arm) and HYPOAESTHESIA (numbness in fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided. Treatment medications included bengay cream ,Naprosyn for relief of pain,800mg motrin, gabapentin 300mg 2 caps BID, steroid, nerve blocker. Lab test EMG test has been scheduled for 07 Apr 2021.  Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information requested.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 05-JUN-2017, the patient received an expired dose of VAQTA intramuscularly, for prophylaxis, lot# M022556 with expiration date of 26-MAY-2017 (dose, frequency and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Ongoing Stomach cramps; nausea; bloating; lethargy; foul smelling gas; Effecting my ability to work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:15 (Lot number: EP7534) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP7534, Administration time: 03:15 PM, Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Ongoing Stomach cramps"; NAUSEA (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "nausea"; ABDOMINAL DISTENSION (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "bloating"; LETHARGY (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "lethargy"; FLATULENCE (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "foul smelling gas"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 22Apr2021 15:15, outcome "not recovered", described as "Effecting my ability to work". The events "ongoing stomach cramps", "nausea", "bloating", "lethargy", "foul smelling gas" and "effecting my ability to work" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain upper, nausea, abdominal distension, lethargy, flatulence, loss of personal independence in daily activities.  Additional Information: Facility type vaccine was reported as Workplace clinic. The patient did not receive any vaccine in four weeks. The other medications in two weeks were none. It was reported that the patient had ongoing Stomach cramps, nausea, bloating, lethargy, and foul smelling gas. Effecting her ability to work. The reporter stated that, "three other people I know have all been complaining about the same symptoms". The symptoms were not subsiding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Felt nausea on drive home between 5:30 and 6:00pm. Diarrhea at 6:00pm, vomiting at 6:15pm. Rehydrated with small glass of water, few ounces of gatorade, and a few crackers. Vomited violently 4 more times and diarrhea five more times.   Took 1 dose of Zofran at 9:30pm and slowly rehydrated with water and gatorade. Vomiting and diarrhea stopped after administering of zofran.
Two days after the shot I felt very light headed. Then a fever rapidly started. I felt like I had the flu but did not have the flu. I was very dizzy for days.
About a week after vaccination with dose 3 Pfizer, I woke up in the middle of the night with tachycardia/feeling of beating rapidly. My heart rate woke me up for 3 nights straight. I called the doctor after the 3rd day of elevated heartrate and I went in to see him on 10-15-2021. He ordered an EKG which looked normal. He then put me on a heart monitor for 1 week and it was normal as well. Nothing else was ordered. He put me on a betablocker, name unknown. My blood pressure became extremely elevated so I stopped it. He then tried a second medication Amlodipine 2.5mg. It was eventually increased to 5mg but my blood pressure reacted to it by increasing so I just stopped taking it also. My heart rate and blood pressure are normal today.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
I had a sore throat, cough shortness of breath. I tested as I had been exposed to COVID-19 my first test came back negative but the next one did come back positive. Once I received a positive test I called my doctor, who advised me to take DAYQUIL and NYQUIL and use my nebulizer for breathing. I still have a cough and sore throat and liver damage from having COVID-19.
PAIN; This spontaneous case was reported by a physician and describes the occurrence of PAIN (PAIN) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Latex allergy. Concomitant products included LOVASTATIN, NIFEDIPINE, LEVOTHYROXINE, FUROSEMIDE and VITAMIN B COMPLEX for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 PAIN (PAIN). At the time of the report, PAIN (PAIN) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Anti-itch cream (Sheffield). Patient did not experienced ant immediate side effects after first dose, but itching happened before second dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-072903 ; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072903:1st dose vaccine
Hives and itching started about 15 hours ago. Patient has tried Calamine lotion once about 13 hours ago. Benadryl once about 45 minutes ago. Symptoms have improved with homecares.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications were not reported. Treatment information was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL9265), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 64 years, in right arm for covid-19 immunisation. The patient relevant medical history included: "Inflammatory osteoarthritis" (unspecified if ongoing); "hyperparathyroid" (unspecified if ongoing). The patient concomitant medications were not reported. Past drug history included: Iodine based intravenous test dye, reaction(s): "Allergy: Iodine based intravenous test dye". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jul2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Rebound Covid infection felt unwell. Took home rapid antigen test it was positive. Last tested on 13Jul was negative.  Follow-Up (26Jul2022): Follow-up attempts are completed. No further information is expected.
Achy; chills; fever 101.5/low grade fever; headache; This is a spontaneous report from a contactable physician (patient himself). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number:ER8732 and expiration date: unknown), via intramuscular route of administration in left arm on 16Jul2021 01:00 as dose 1, single (at the age of 50-year-old) for COVID-19 immunization. The patient's medical history was none. Concomitant medications included doxycycline (DOXYCYCLINE) taken for an unspecified indication, start and stop date were not reported. On 17Jul2021 12:00, the patient experienced achy, chills, fever 101.5/low grade fever and headache. The patient was infected seriously in Mar2020 But there were no test to confirm. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 101 degree fahrenheit and body temperature: 37-39 degrees. Therapeutic measures were taken for fever and chills with Tylenol. The outcome for all the events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
stroke; was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; patient seems incoherent; Received Johnson and Johnson vaccine after the Pfizer vaccine; received Johnson and Johnson vaccine after the Pfizer vaccine; his eyes were looking like he was not comprehending what was going on; he cannot even walk; patient weighed 280 before he went to jail now he weighs maybe 190-180lb; This is a spontaneous report from a contactable consumer (patient's fiancee). A 64-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 at the age of 64-yar-old as single dose for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jul2021, at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, oxygen therapy (on Oxygen prior to the vaccines), Covid-19 months prior to the vaccines, use a machine to sleep (not know what the condition was called but he had it bad that he could just fall asleep while driving). There were no concomitant medications. The patient received first dose of the Pfizer Biontech COVID19 vaccine on May2021 but was jailed between his 1st and 2nd dose. After the 1st dose vaccine, he ended up going to jail, when it was time for his second shot and he told the nurse in the jail there that he had the Pfizer and there he was given the Johnson and Johnson, the nurse told the patient it didn't matter that all the shots were the same, she gave him the shot. On Jul2021, he received Janssen as a second dose. The patient told the caller that after about an hour or two (2nd dose vaccination) he started feeling funny, and that evening he hit the floor, was found unconscious and went to the emergency room, he was (now) in a wheel chair, stated he had a stroke and doctor said that he was going to have another stroke. Caller stated the patient seems incoherent. Every time he started talking about it the jail hang up his call, stated now they will not let the patient call her. She went to go see the patient and yesterday they would not let the patient talk to her during her visitation, caller stated he looked so bad, his eyes were looking like he was not comprehending what was going on. Stated he also had to have some type of surgery on his stomach, she was unsure of exact details. Exact dates are unknown. Stated he cannot even walk, he was in a wheelchair. The patient was hospitalized and unknown dates of hospitalizations. Caller stated the patient weighed 280 before he went to jail now he weighs maybe 190-180lb. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Case number PHEH2014US003791 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number 006031A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 14 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff neck for a couple of hours that evening, unable to eat Tuesday, Wednesday, feverish, and shaking. Slowly recovering through week. As of today per pt. "feels perfectly line"
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild
pt recvd vax; inc t w/ v 30mins p/vax;apap given;fussy & crying throughout noc;seen in clinic 24 hrs later w/ t100.5 R;HR 176,R56;phenergan suppos given;rx for advil (ped) & pedialyte ingested during clinic visit w/o emesis 28oct94
Redness around site of injection 5days after injection given, no Tx except to observe.
No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Case  (MOD-2023-720844) found duplicate of case (MOD-2023-720842) hence all source documents are copied from case (deletion case: MOD-2023-720844) and appended into case (retained case:MOD-2023-720842). Case  (retained case: MOD-2023-720842) will retain for further follow up and case ID MOD-2023-720844  needs to be deleted. On 21-Apr-2023: Live follow-up : DOB updated