chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient noted dizzy and verbalized having nausea and he threw up; a set of vitals signs obtain BP=96/65 HR=74  T=97.3F. patient observed for 30 min and verbalized feeling better after throwing up ; another set of vitals signs obtained BP=111/65   HR=73 T=97.5  no pain ; patient left the building stable accompanied by mother.
Initial soreness in my arm subsided 4 days after the shot. 2-3 days later I noticed swelling at/surrounding the injection area. It itches and if pressed/rubbed the itchy feeling increases and a cold/tingle sensation travels down to my left wrist.
Donor received shot on 5-14-08. No adverse rxn noted. On 5-16-08 donor states arm was sore after doing a lot of heaving lifting and yard work. On 5-18-08 donor phoned clinic to report to medical staff. Asked donor to come to center. Donor presents at center with 6"x4" red area with 2x2" hard area at injection site.
Employee reported feeling warm and having a headache . Employee was advised to stay home and rest, if symptoms worsened employee was advised to seek medical care for treatment. Donor reported relief of all symptoms on 8/12/22 at 1300
Pt. called in AM of 5-25-16 and stated that she had gotten PNEUMOVAX 23 on 5-24-16, and her arm was hurting and swollen. Advised her to use cold compress and if symptoms persist or get worse to check with her MD. Came in Pharmacy later in day for me to check her arm and it was swollen, red and warm from top of shoulder midway down arm. After talking with her she went to urgent care to get her arm checked. Diagnosis was cellulitis and they prescribed clindamycin 300 mg - 1 capsule four times a day for 10 days. She later when to ER and they prescribed prednisone 10 mg Dospak and BENADRYL 25 mg - 1 capsule every 6 hours as needed, and she picked these up at 10:32 am on 5-26-2016. I tried several times today to contact her, but I not heard anything.
low grade fever; Fatigue; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for covid-19 prophylaxis and COVID-19 VACCINE for covid-19 prophylaxis.   On 8th March 2021, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, the patient received the 2nd dose of COVID-19 VACCINE. In April 2021, the patient received the 1st dose of COVID-19 VACCINE. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced low grade fever, fatigue and muscle pain. On an unknown date, the outcome of the low grade fever, fatigue and muscle pain were recovered/resolved.   It was unknown if the reporter considered the low grade fever, fatigue and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter could not provide the lot or expiration of the vaccine but stated that the doctor's office administered the vaccines and would have that information. The patient received 1st dose of Shingrix in her right arm and experienced low grade fever, muscle pain and fatigue. The patient also received her Covid vaccine in April and May 2021. For the tolerance of second dose refer case US2021AMR213454, reported by same reporter. It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Covid-19 vaccine. She gave consent to contact her doctor.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213454:Same patient
Mother of patient wrote to our office 2 days after administration (12/24/2020) stating patient's Right Arm was red, swollen, and itchy, and broken out in a rash / hives.  Mother of patient stated the redness on patient's right arm started on 12/23/2020.  Mom treated with OTC Tylenol, Cortisone Cream, and antihistamine (per triage note).  Mom also reported that patient had decreased voiding and increased malaise.  Mom reported to office on 12/26/2020 that patient's behavior is back to normal and he is urinating normally. Mom said arm looked much better, redness gone, soft to touch now instead of hard as it was, still just a little bit of swelling there. On 1/7/2021, received online PORTAL message from patient's mother stating  that the swelling had gone down completely, where it was not hard or bright red anymore but it appeared slightly purple and blotchy. Dr. wrote back asking mom to test circulation on arm via testing capillary refill, mom reported back that circulation was good (cap refill < 2 seconds); in addition, mother reports patient is still complaining of itchiness with Right Arm.
vaccine given 6  days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6  days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6  days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6  days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-395985.
NAUSEA; FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, nausea and tiredness was not reported. This report was non-serious.
About 15 minutes after vaccine patient felt dizzy and legs felt "rubbery".  Patient was seated and drank water and felt find about 25 minutes after vaccination.  Patient was called at home 5 hours later and she said she was find.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates between 24-SEP-2016 and 13-OCT-2016, the patients inadvertently received an improperly stored doses of ROTATEQ (lot # M019691, expiration date: 02-NOV-2017) orally, (doses were not provided). The administered doses of vaccine were exposed to a temperature of 35 Fahrenheit (F) degrees for 40 minutes. No previous temperature excursions were reported. Data logger was not used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Second dose given less than 21 days appart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart) had resolved.            Concomitant information was not reported. Treatment information was not reported.
Flu Symptoms: 101' fever, aching joints, headaches. Sore arm at injection site. Lasted one day Note 1: After 1st dose, only sore arm was experienced. Note 2: Spouse had same reaction on first does that I experienced on 2nd. Her reactions to second dose was more signficant - 103' fever, headaches, shaking, aching joints, sore arm. Lasted 2 days.
Right pain at injection site, swelling redness, warm to touch, ecchymosis picture provided.
chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Had reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Had reaction). At the time of the report, ADVERSE REACTION (Had reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Miscarriage. Bleeding beginning on September 17th. Lost the baby on September 24th. Bleeding continues through today October 4th.
Severe pain in left left, pain from hip to ankle sporadically, throbs when sitting down and pains hurt the most at night, when walking he's in pain
non stop vomiting; non stop diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea). At the time of the report, VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.
Problems with his throwing shoulder on the right arm, moderate pain in the right shoulder; His son is having pain on his throwing arm or the right arm; Problems with his throwing shoulder on the right arm; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: was not reported, Expiry Date: was not reported) via an unspecified route of administration in left shoulder on an unspecified date on 11:30 as Dose 2 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date (Batch/Lot Number: was not reported, Expiration Date: was not reported) for covid-19 immunization. Reporter stated after 2 days of vaccination, patient having pain on his throwing arm or the right arm. He did mention that his son plays baseball. He wasn't feeling 100%, but nothing like that. He has pain in the shoulder when trying to throw and it's still bothering him. Reporter stated that he wanted to see if there are any reports; his son who is 16, nearly 17 years old received the Pfizer COVID 19 vaccine in his left shoulder. Reports the next morning, his son is having problems with his throwing shoulder on the right arm and moderate pain in the right shoulder. The outcome of all events was unknown.  Information about lot/batch number has been requested.
patient that got the primary series of the Pfizer Covid-19 vaccine and had covid; patient that got the primary series of the Pfizer Covid-19 vaccine and had covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient that got the primary series of the Pfizer Covid-19 vaccine and had covid". Additional information: The patient wanted to know how long they need to wait after they recover from COVID-19 before getting the new vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and covid 19 and suspect product bnt162b2 cannot be ruled out.
1 1/2 - 2 1/2" red, raised area at injection site, warm to touch, itching. Injection on Friday - had to use inhaler q 4-6 hours until Sun PM - took chlortrimeton q 12 hours all weekend.
Approximately 1 hr. after receiving vaccine developed generalized itching and hives rash to face, neck, and cheeks.
Chills, fever, nausea, fatigue, body aches, headache, dizzyness. Chills came on first at 4 am the next morning, followed by all other symptoms. I rested took fluids, and it passed after 12-15 hours.
Fever and chills for began 9 hours after injection and lasted for 36 hours; Fever and chills for began 9 hours after injection and lasted for 36 hours; Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893; Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 as dose 3 (booster), single (Lot number: fk9893) at the age of 56 years, in right arm and on 12Apr2022 at 09:00 as dose 4 (booster), single (Lot number: fh8028), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese. Concomitant medication(s) included: ZYRTEK; PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; IRON. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Apr2022, outcome "unknown" and all described as "Product: COVID 19, Lot number: fh8028, Administration date: 12Apr2022/ Other vaccine same date lot number: fk9893"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 12Apr2022 at 18:00, outcome "recovered" (Apr2022) and all described as "Fever and chills for began 9 hours after injection and lasted for 36 hours". Therapeutic measures were not taken as a result of pyrexia, chills.  Additional Information:  Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. If other vaccine in four weeks was reported as unknown. If COVID prior vaccination was reported as no. If COVID tested post vaccination was reported as no. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Individual symptomatic with HA, cough, congestion, fever, and SOB tested positive on 10/28/21.  Quarantine until 11/7/21 or until release by DOH.  Individual declined to have  antibody testing.
A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL) started on 25-Jan-2014. The patient was given expired FLUMIST which started on 15-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious as per reporter.
a lot of side effects; still not feeling good; headache; fatigue; vomiting; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02or3Tor5EorC21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-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 VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown.            No concomitant medications were not reported. Patient wants to know if she can take ibuprofen. She also mentioned that she's going to start IVF to get pregnant, and she wants to know if there's awaiting period from the last vaccine to her IVF treatment. The IVF doctor recommended her get the vaccine.
My skin all over my body developed a hyper sensitivity.  Especially my feet and palms. It would become painful to even touch anything. I went to the neurologist. They gave me some meds (dont know the names), but I am still experiencing symptoms.
Patient reports left axillary swelling and pain happening right after the vaccination event, and continuing until his urgent care visit at Facility on 03/28/2022
Plugged ears, bone aches in legs, body aches and pain, sinus, sharp headaches off and on all day. Cold like symptoms
After 8 days since I received 1st vaccine, I started to have a rash on my arm (the spot I received vaccine). No pain or itch but a little hot around the rash and muscle around it is hard.
I have COVID after receiving the Pfizer vaccines in Dec and Jan; I have COVID after receiving the Pfizer vaccines in Dec and Jan; This is a spontaneous report from a contactable consume (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date in Dec2020 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After received the Pfizer vaccines in Dec2020 and Jan2021, patient had COVID on an unknown date in 2021. Patient was concerned that it might happen given the information from (Withheld) and had earlier looked for trials to participate in on waning immunity. It was not my intention to substitute that by traveling to (Withheld) to pick up my granddaughter, however. Patient support WHO position on holding off on booster shots until there was greater vaccination world-wide. If there was any way patient can volunteer to better understand this, patient was willing. The patient underwent lab tests and procedures which included COVID test: had COVID on an unspecified date in 2021. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt. presented 10/20/09 with complaints of L arm pain since injection 10/5/09.  Was informed by private physician a nerve was damaged during injection.  Pain is constant; rated 7-8 on scale of 1-10 and physical therapy has been ordered. Pt. states a topical gel was ordered, but she refuses to use it due to the side effects.  Denies red, raised warm area at injection site; pain surrounds axilla.  Pt. pointed to axillary junction and arm. No x-ray, MRI or further testing ordered.
Itchy, red, swollen spot at the spot of the  injection. It's approximately 2 inches in diameter.
Presented on 9/1 with weakness and syncope. Several days prior had been evaluated at the Medical Center a was diagnosed with sepsis secondary to post COVID pneumonia. Had been discharged with cefdinir, steroids and oxygen concentrator on 8/31.  Admitted to our hospital for sepsis secondary to post covid pneumonia with likely bacterila component and starter on piperacillin-tazobactam and linezolid. Chest xray negative for PE.  Had hypoxemic respiratory failure requiring 4 L O2. By 9/6 reached maximum setting on high glow nasal cannul and ABG showed worsening hypoxemia and was intubated.. Continued on Vaptherm and antibiotics broadened to include vancomycin and doxycyline including methyprednisolone twice a day. Became hypotensive and started on Levophed. Developed acute kidney injury with oliguria. Family declined dialysis and requested extubation with comfort care.
PCV13 outdated on 06/30/2018 and was not removed from fridge.
Parathesia, dysphagia,  fever, nausea,  vomiting,  loss of voice,  loss  bowel movement
Pt developed shingles rash 2 inches under injection site, in a place where she had it before. She was put on antiviral 3 days after vaccine.