chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 14 year old male with no pertinent medical history who on 10-SEP-1997 was vaccinated with the first dose of VARIVAX vaccine (Oka/Merck) and on 06-JUN-2007 was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck) (lot# 652556/0246F). Subsequently the patient experienced a mild case of chickenpox (onset date was not reported).  the patient had about 40 pox on his face and back. The patient was taken to a doctor. As of 26-AUG-2008, the patient was recovering from chickenpox. No additional information is available
patient had a headache, weak arm, slept a lot more, experienced pain in arm as well, and a "funny feeling" in her chest. Patient went to the ER and said they found a blood clot.
Within one week of injection, patient got an open sore on his mouth. We thought it was a cold sore since he had had them in the past. The cold sore did not go away after 6 weeks and was seen by his pediatrician. She deemed it Impetigo. The sore got much worse and covered both sides of his mouth, top and bottom lip, onto his cheeks and under his eyes. This went on for 5 months after 5 rounds of antibiotics, two rounds of antivirals, multiple swabs and labs run. No one ever found out what it was or how to help it. We were instructed to stay away from other children for fear that it was contagious. I have been able to get it under control with detox baths, but have to stay on top of it to keep the lesions at bay.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a currently 81 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 16-APR-2019, the patient was administered with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
urticaria, raised rash over face; swelling @ inject site, white blotches all around inject site;
Mother stated child's arm was swollen 2-3 X its normal size, red and hot to touch. She took child to  hospital to ER, was told it was normal reaction to vaccines. Child later developed blisters on the arm so she took her to ER, again was told it looked like a common reaction to vaccines and to bring the child to the clinic. The child's arm was looked at by myself and another RN, arm was slightly swollen, red and warm to touch with 2 broken areas on it that looked to have been scratched open by the child. Instructed mother to put antibiotic ointment on broken areas and cool cloth to help redness and swelling.
This spontaneous report as received from a female dental hygienist (also the patient) of unknown age via field representative. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as assumed to be PNEUMOVAX23 in the arm. Dose, lot and expiry date were not reported. The patient received an unspecified pneumonia shot (pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown, reported as assumed to be PNEUMOVAX23) and an unspecified flu vaccine on the same arm on the same day, and then developed a staph infections. The patient took an unspecified antibiotic as treatment for the infection and then developed an unspecified adverse reaction to the antibiotic. The patient was recovering from the event staph infections at the time of report. The outcome of unspecified adverse reaction to the antibiotic was unknown. The patient had sought medical attention though not specified how. Additional information has been requested.
tested positive after taking the vaccine; tested positive after taking the vaccine; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive after taking the vaccine on an unspecified date in 2021. She wanted to know if she will continue with the second dose which is on 24Feb2021. Lab data included: COVID-19 tested positive in 2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Left wrist swollen, potential reaggravated carpel tunnel; middle finger on the left hand was swollen and unable to bend; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel), MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend) and VACCINATION SITE PAIN (Tenderness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at injection site). On 23-Jan-2021, the patient experienced JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel) and MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend). The patient was treated with HYDROCODONE at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Left wrist swollen, potential reaggravated carpel tunnel), MUSCULOSKELETAL STIFFNESS (middle finger on the left hand was swollen and unable to bend) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information received in TCR FUP- Patient declined further FUP stating everything has been taken care of.
side effects for her neighbor who is pregnant and due in June; arm was sore; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY and PAIN IN EXTREMITY in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY and PAIN IN EXTREMITY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved and PAIN IN EXTREMITY outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was due in June.  No treatment information was provided.
Headache, dry mouth, swollen ankle on left side, thirsty, some heart palpitations.  Soreness where shot was given. .
itching at the injection site; redness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). The patient was treated with CORTISONE ACETATE at an unspecified dose and frequency and ANTIBIOTICS at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
ABOUT 30 Mins post injection 1630, severe  nausea and almost vomited. 2 hours in, at 1800 felt dizzy , light headed and body tingles. Blood pressure creeped down, 110/79 to 95/70 then 90/65 then finally 82/60 and HR reached 110. over a period of 30-40 min. Was not able to move, stand up or talk due to severe weakness and shortness of breath. Had 1 prednisone 20 mg tabs ( old pill left off an old script) and 2 x 10mg cetirizine , just under the tongue for faster absorption.  In addition to gateorade as fluids . Reaction stayed till 6 am in the morning, took 12 hours to subside, as BP recovered at 97/80 and HR at  96.  Still feeling short of breath at 9 am, but dizziness subsided. FYI: Been taking flu shot and never had any reaction to any vaccine prior. New formulation?????
A report was received from a health care professional on 9/15/03 concerning a 86 year old female vaccinee who inadvertently received 2 doses of Fluvirin vaccine, one on 9/4/03 and one on 9/15/03. On 9/4/03 and 9/15/03, the vaccinee inadvertently received 2 doses of Fluvirin (one on 9/4/03 and one on 9/15/03). At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment.
Started out with chest burning, stiff neck, sinus congestion, head pressure and a little spacey feeling.
father phoned 6MAY98 & said that child had a fever of 104 the evening of 5MAY98;the day pt recv IPV pt weak & had pain @ the site;this morning pt temp was 99 & felt better;
1 day old infant with Tonic-Clonic Seizures every couple of hours with no confirmed diagnosis (after months of tests).  Phenobarbital administered but did not prevent seizures.  Currently medicated with daily doses of Topamax, vitamin B6, and Trileptal.  No prior family history of seizures.  07/16/2007 MR received for newborn admission for infant who developed seizure activity on 2nd day of life. PE WNL. 1/11/2010 Seizures/developmental delays in motor and speech.  8/20/2007 MR received for DOS 4/12/2007-5/09/2007.  Infant transfered from hospital of birth on 3rd day of life after having witnessed seizure activity during newborn stay.  Infant averaging 1-2 seizures which last 1-2 min/day. Stridor noted.  Discharge Dx:  Former 38 week female.  Seizures.  Large arytenol and mild posterior laryngomalacia.  Suspected sepsis-unproven. She's on medication which control the seizures at this time.
Fever; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter reported that her husband experienced fever after received Shingrix vaccine. The reporter did not consent to follow up. This case had been linked with US2018GSK077003 by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018GSK077003:same reporter wife case
Following the vaccination patient didn?t feel well. Fever, chills, cold symptoms, incredibly irritable. 5/1 she awake with a terrible headache which continued all day. Around  9:30 pm she laid down and shortly after was unable to move her body. 5/4/21 at 4:19pm her time of death was called. Cause; brain death due to aneurysm and stroke due to passing blood clot in brain.
Fatigue; he had headaches; Achiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 13:30 (Lot number: EW0170) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "he had headaches"; PAIN (non-serious), outcome "unknown", described as "Achiness".  No follow-up attempts are possible. No further information is expected.
Felt fatigue mins. after vaccine. Mild headaches/fever for 6 days beginning the next morning after vaccine; rash and itch all over body and face (esp. on right side of body and face where vaccine was) beginning the day after vaccine for over 10 days; chest pain twice 2 or 3 days after vaccine. Have been using cortisone cream for allergy/rash. Slept in late to get over headaches.
Patient's mother requested to start the covid 10 series for patient. I spoke with and reviewed which vaccine to give with our lead pediatric nurse and covid 19 lead. We ONLY had the dark pink top Moderna 6month-5year vaccine at our center, which is what we gave. Lead and I later learned that we should have given a dark top, which lead was not even aware that that was an option and needed to be ordered. So we did not have the correct supply given to us.
Client presented to clinic and inquired about what booster dose she could recieve. RN reviewed her chart in system and saw she recived a dose of Janssen on 3/18/21 and then a dose of Moderna on 4/21/21. RN determined she could receive a single dose of Pfizer as a booster dose. RN later inquired to state team about this situation and if this was the correct action. RN from the state team determined that the Moderna dose they received would have been considered their booster dose and therefore the Pfizer booster dose given on 2/5/22 was given in error.
She received Arexvy yesterday and today the patient's INR came back elevated at 5.4; This non-serious case was reported by a nurse via call center representative and described the occurrence of international normalized ratio increased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included warfarin.   On 30-AUG-2023, the patient received Arexvy. On 31-AUG-2023, 1 days after receiving Arexvy, the patient experienced international normalized ratio increased (Verbatim: She received Arexvy yesterday and today the patient's INR came back elevated at 5.4).  The outcome of the international normalized ratio increased was unknown.   It was unknown if the reporter considered the international normalized ratio increased to be related to Arexvy.     It was unknown if the company considered the international normalized ratio increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-AUG-2023 The licensed practical nurse (LPN) stated that a patient took Warfarin daily and had been on it for a while.  She received Arexvy yesterday (day before reporting) and today (on the day of vaccination) the patient's INR came back elevated at 5.4. The vaccine administration facility was the same as primary reporter. The health care professional (HCP) declined to provide patient's date of birth and did not had the lot number for the Arexvy. The reporter consented to follow up.
He reported weakness ever since the vaccine.  He now reportedly required a walker to get around.  He became weaker to the point of suffer a fall 9/26, 3 days after vaccine and was hospitalized with trauma and nasal fracture.  Also found to have tested + for rhino/enterovirus.  Subsequently discharged to swing bed and readmitted on October 8 with new onset SEIZURES, now unresponsive and intubated on vent support.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength and route were not provided). Concomitant medications were not reported. The pharmacist reported that, soon after receiving PNEUMOVAX 23, the patient experienced swelling of injection arm up to shoulder, on an unknown date. The patient was admitted to hospital emergency room where it was concluded that "injection must have hit an artery". The patient sought the medical attention by admitting into hospital emergency room. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint was reported. The events were considered serious due to hospitalization. Additional information has been requested.
1st vaccine given on 1/20/21, 2nd dose given on 2/9/21;  tested positive for COVID-19 via PCR on 8/16/2021; admitted to hospital on 8/31/21 with acute respiratory failure secondary to COVID, also had superimposed bacterial pneumonia, severe fever, and died on 9/5/21.
Vaccine administered 12/3/12 - F/U visit 12/13 pt reports - full body muscle pain - in leg so bad could barely walk - (R) arm & side of neck/scapula with persistent spasm - though better still then.
Swelling, soreness, tightness, and redness on my lower left leg, ankle and foot.  Started around end of May and progressively go worse (site/place spread from foot to knee over time).
Patient developed an allergic rxn within 24 hours of receiving vaccination: hives, swollen lips, itching in the vulva area. Symptoms went away after a day or two of BENADRYL use.
Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023; no adverse event; 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) and NO ADVERSE EVENT (no adverse event) in an adult 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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 2nd out of 10 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Headache, Myalgia, Fever, NauseaVomiting, Fatigue Chills.  Narrative:
COVID arm. Swollen and red and vaccination site. Hard raised lump, approx. 1.5 inch diameter.
Chills, low grade fever, muscle and joints pain, tired, abdominal discomfort.
I had real bad leg pain. When I went to the doctor, they thought I had a blood clot. I had EKG, CT scan, and a blood clot test. The blood clot test came back positive, they ordered ultrasound for my leg.
I have no energy, brain fog. I cannot function daily without laying on my couch. I used to run 6 miles a day and do CrossFit 6-7 days a week before getting the vaccine. Whenever I do any running or workout now it's like I can't get enough air in my chest I have to bring an inhaler with me whenever I do. I have never had any depression or suicidal thoughts in my life but ever since I got this vaccine I suffer with depression; I used to be happy go lucky but not anymore. Some days I wake up and feel like I have been beaten with a baseball bat. It's like having COVID without having the respiratory symptoms.
I thought it was early dementia. I had a little of that with the 2nd shot; The foggy headedness had me concerned and was scary; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW6201), via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:00 at the age of 67-year-old as dose 2, single for covid-19 immunisation from pharmacy or drug store.  The patient medical history included biaxin allergy. Concomitant medication included vitamin d taken for an unspecified indication, start and stop date were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 08Feb2021 10:00 at the age of 67-year-old as dose 1, single for covid-19 immunisation. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. In 2021, patient experienced foggy headedness which had concerned and scared her. Patient thought it was early dementia. She had a little of that with the 2nd shot but this was much worse. The patient did not receive any treatment in response to the events. The outcome of the events was recovered.    No follow-up attempts are possible. No further information is expected.