chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm was not sore like it was with the first dose; This is a spontaneous report from a contactable pharmacist reporting. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 07Jan2021 (Batch/Lot Number: EL0142) as single dose for covid-19 immunisation. Medical history included intermittent asthma from Mar2020 to an unknown date. There were no concomitant medications. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Patient stated she knew the vaccine was suppose to be administered in the deltoid muscle. Patient stated she thought her vaccine was administered subcutaneously and when nurse administered the vaccine she pinched her skin and she did not feel the injection like she did the first dose and she thought the needle may have slipped out the muscle. Caller stated the following day she felt itchiness and the next day she noticed her arm had a 2x2 inch raised area that was hot and firm which was one inch away from the injection site. Her arm was not sore like it was with the first dose on an unknown date in Jan2021. She believed the nurse gave the dose incorrectly, and the site of injection was not optimally at deltoid and colleague pinched her skin, so it was not where it is at. She said when her colleague injected it, she didn't feel any pain. She said she was thinking that the injection might have been done subcutaneously and not intramuscularly. Caller said she kept the site clean, and she didn't take Benadryl or anything, it was a slight itch, and she didn't want to disrupt anything. Caller said that she felt this was not serious. She said that she was curious if she will have full protection, since she has read studies about how IM meds that are injected subcutaneously stays in the fat for a longer period, and that enzymes can change the efficacy of the vaccine since vaccines that are given IM are meant to be where the blood supply is. She said she did not know if she would need a third dose. The patient underwent lab tests and procedures which included weight: 96-98 lbs. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected..
tinnitus; This is a spontaneous report from a contactable other hcp, the patient. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tinnitus 3 days after getting the vaccine. She stated it was getting worse over time. The clinical outcome of tinnitus was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
joint pain; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain and muscle pain. On an unknown date, the outcome of the joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself.  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient enquired what could be taken to alleviate muscle and joint pain due to shingles vaccine.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced felt sleepy, tired, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sleepy, tired, and mild fever. This report was non-serious.
flu; vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), VOMITING (vomiting) and HEADACHE (Headache) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA (flu), VOMITING (vomiting) and HEADACHE (Headache). At the time of the report, INFLUENZA (flu), VOMITING (vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received 1st vaccine on 01MAR2021. She had a headache, vomitting and flu like symptoms
Information has been received from a healthcare professional, concerning a female patient (age not reported), who on 12-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). On 12-DEC-2007, the patient developed redness and swelling from the injection site to her elbow, and visited the emergency room (details not provided). At the time of this report (14-DEC-2007), the patient was recovering. Additional information has been requested.
tingle of cold sore left upper lip; painful bump on right side of tongue; Canker sore middle of lower lip; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 28Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, diabetes, canker sores oral, cold sores. The patient had environmental allergy and peanut allergy. Concomitant medications included insulin (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), amfetamine aspartate, amfetamine sulfate, dexamfetamine sulfate and dexamfetamine saccharate (ADDERALL), levothyroxine sodium (LEVOXYL), losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) all for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced canker sore oral. It was reported that the patient had painful bump on right side of tongue, likely turning into a canker sore on 31Mar2021, might be tingle of cold sore left upper lip this evening on 31Mar2021. The patient mainly worried because these were not reported side effects, but were possibly symptoms of COVID. The patient would like to be able to see complete list of side effects of vaccine. The patient did not receive any treatment for the adverse events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event canker sore middle of lower lip, painful bump on right side of tongue and tingle of cold sore left upper lip was not recovered.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning an 18 year old female with no medical history and no drug reactions/allergies who on 20-MAR-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL (lot #659439/1267U). Concomitant therapy included TRI-CYCLEN. On 25-MAR-2008 the patient developed redness on her cheeks and forehead with small, red raised bumps. It was noted that the area of redness were itchy. The patient called the office for medical attention. It was reported that the patient is recovering. No product quality complaint was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (after receiving 1st dose on 21st September 2018, see case US2019GSK027100). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient said the fever also happened with the 2nd booster shot in other facility.
Positive test for COVID-19 on 22Jul2022; Positive test for COVID-19 on 22Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN6199), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6199), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovering" and all described as "Positive test for COVID-19 on 22Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient did not take other vaccine in four weeks. Patient was not on other medication in 2 weeks. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Muscles of the arm swollen very painful Could not move arm ,Red rash running down inside of arms inside of legs on stomach neck back
Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she continued with GI upset, fever, and body aches. Toward the afternoon with Tylenol she appeared to be feeling better. At around 6pm she had sudden onset shortness of breath and respiratory distress. Nebulizer was given without improvement, O2 sats were in the 70's and 80's. Tenant was transported to the hospital via ambulance
pt recvd vax & devel a h/a, nausea & vomiting; approx 24 hrs p/vax took analgesic for h/a & no treatment for nausea & vomiting; sx subsided the following day; no other sx since then;
Approximately 4 days post vax, the pt experienced persistent general achiness of her entire body.
Rash on the face and all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the face and all over the body) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced RASH (Rash on the face and all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash on the face and all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
This spontaneous report was received from a pharmacist concerning a 68 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). Co-suspect therapies or concomitant medications were not provided. Subsequently, within a few days of receiving the vaccination (date unspecified), the patient developed a rash on her shoulder. The patient was seen by an unspecified physician on an unspecified date and diagnosed with shingles and treated with VALTREX and ZOSTRIX. The patient was also seen at an unspecified hospital emergency room on an unspecified date, where she was diagnosed with muscle strain. However, it was unspecified if the patient was admitted to the hospital. The outcome of herpes zoster and muscle strain was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Soreness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the right arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the right arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given No treatment information was provided
Narrative:  Per notes, patient was admitted to a local hospital on 5/3/22 with shortness of breath/respiratory failure and was offered intubation; however he did not want any further intervention and was made DNR/DNI. No other records from facility are available. There were 15 days from time of second booster to date of death. No autopsy report available.
Had vaccine 911/2013 at 7am. Three hours after taking vaccine, knees were itchy. At noon, she had itchiness and redness all over skin. At 4p, she took Benadryl. Early Thursday morning she went to ER. She felt dizzy, had hives. She was discharged from ER. But returned on Sat. with chest pain, hives. Was treated and discharged. Returned to ER on Sunday and was hospitalized because of swelling of lips. She was discharged on Monday 9/16/2013.
crying inconsolably all day;fever to 102, inj site painful;seen by MD 25JUL95;
Within an hour or two - very sore arm; General fatigue, aches, chills - for approximately 24-36 hours; noticed slightly raised, red rash patch, several inches in diameter at injection site approx. 1.5-2 days after shot. This was a booster shot - don't recall have the red rash from any of my previous 2 shots
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 16-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
On 28JUL92 had febrile seizure @ home; t104.6 R; no rash taken to ER by ambulance t106 R in ER; 30JUL92 was dx campylobacteriosis;
Woke up this morning with some swelling on my left eye lid. Also very tender to the touch. It seems slightly more tender now at the end of the day and a little more swollen than when I woke up
Large swelling and erythema at injection site 24 to 48 hours after injection. Urticaria at injection site extending on arms and legs BL 5 days after administration.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown gender, in the age between 11-17, who was a participant in a pharmaceutical study. The patient's medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date, estimated as September 2014 (it was reported as "last week"), the patient was vaccinated with one shot of GARDASIL, therapy route was not specified (described as "injection") in the shoulder, lot# and exp. date were not provided, the therapy reason for use was reported as investigational. On the same day, the patient was also vaccinated with MENACTRA (dose, frequency, lot#, exp. date and therapy route were not provided) in the shoulder and ADACEL (dose, frequency, lot#, exp. date and therapy route were not provided) in the shoulder. The patient had an injection site reaction (exact date unspecified, estimated as September 2014) on the shoulder that was injected with GARDASIL and ADACEL, it was reported that MENACTRA was administered on the opposite shoulder. Three days after receiving GARDASIL (estimated date September 2014), the patient experienced cellulitis, redness, swelling and hive-like symptoms of the GARDASIL-injection shoulder. The patient sought medical attention. The patient was given BENADRYL and ibuprofen and symptoms resolved within a day and a half (not specified date in September 2014). The relatedness between vaccination with GARDASIL and the events was not provided. Additional information has been requested.
Pt was irritable/inconsolable starting 1.5 hrs after vaccinations. 3 hrs later, he developed a bulging anterior fontanelle. Irritability waxed and waned, but fontanelle continued and bulge. The next day he was admitted via ER at hospital. Workup was negative. His fontanelle remained bulging until 48 hrs after the shots...resolved and back to his baseline. D/C'd home after 1 day.
I had my vaccine administered on my  left arm 7/16/2021. I?ve recently began having  left breast pain. This is new pain I have not had before. It is a sharp pain on top of breast to my nipple.  To touch it hurts. The left breast also feels slightly swollen and tender. I began to notice the pain Friday 7/30/2021. The pain is slightly worse as the days go on. There is nothing new that I was doing. I do not typically use my left arm for anything, besides I sleep sometimes on my left side. Undergarments are the same I?ve used before vaccine.  I have not had any new supplements, or exercise in the last 14 days.
Initial unsolicited report received from a physician on 11-Jan-2018. This case involves a 4-year-old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (Batch no: C5248AA) via subcutaneous route at right thigh and also with 0.5ml dose of PROQUAD via intramuscular route (Batch number: N020619) at left thigh (expiry date and dose in series were not reported for both the vaccines) on 10-Jan-2018. Patient's medical history and concomitant medications were not reported. Pt did not have any chronic illness, no known drug allergy. It was also reported that this was a well visit for vaccination. On an unknown day following the vaccination, patient's right thigh had local tenderness to the injection site and was limping and dragging the right foot. No other symptoms were reported. It was also a case of actual medication error due to inappropriate route of vaccination as patient received QUADRACEL subcutaneously instead of intramuscularly. Laboratory investigations and corrective treatment were not reported. The outcome of the events limping and vaccination site tenderness were not recovered at time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
I feel really cold (my temp is 96) and have a headache, nausea, muscle pain, and chills.
This is a spontaneous report from a contactable physician (Pediatrician) through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 1st of 3 patients. A 18-year-old female patient of an unspecified race received two doses of TRUMENBA intramuscular at 0.5 ml single, the first on 08Feb2016 and the second dose on 08Aug2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headaches, chills, irritability and fever for both injections, started within a day of both injections and lasted about 2 days after on an unspecified date in 2016 with outcome of unknown. The patient also experienced wound up having strep throat on an unknown date with outcome of unknown. Follow-up (12Sep2016): New information received from a contactable Other HCP includes: New reporter details. Follow-up (13Sep2016): New information received from the contactable physician includes wound up having strep throat added as adverse event. Sender's Comments: Linked Report(s): US-PFIZER INC-2016402459 same reporter, same drug, same AE, different pt. US-PFIZER INC-2016402890 same reporter/drug/event, different patient.
p/vax pt devel severe myalgias w/o fever;could not work for 2-3 days;no evidence of GBS; reporting because of severity of illness; 60 day follow-up received on 09/27/00 provided no additional data. Annual follow-up received on 09/27/00 provided no additional data.
Patient has a newly diagnosed right middle lobe lung mass - underwent Bronchoscopy: Right middle lobe lobectomy: Limited lymph node dissection. The patient was extubated in the operating room, stabilized in the PACU, then transferred to the ICU for post op recovery.  He was stable to be transferred to the floor on POD #2.  The patient's chest tubes were placed on water seal and removed once the drainage was minimal and there was no air leak.  The patient's oxygen was weaned to room air.  The patient progressed well with physical and occupational therapy. The patient was stable to be discharged home on POD #3.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient developed a fever 12-14 hours after the initial vaccines were given. She was given the DTaP and IPV vaccines.  She had a febrile seizure due to a fever that was reported at 103 in the hospital.
Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021