chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Musculoskeletal pain; Inflammation; Bad pain in my right side body; Hand feet chill; Bad headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 01Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included a little high pressure and allergy to shellfish (reported as she'll fish). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ompilp (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously received plantago ovata (LAXAT) for unknown indication on an unknown date and experienced drug allergy. On 02Nov2021 at 13:00, the patient experienced bad pain in the right side of the body, hand and feet chill and bad headache. It had been a week, the patient had bad pain in the body and went to the emergency room on 06Nov2021. The patient was discharged with musculoskeletal pain and inflammation and put on 800 milligram (mg) oral IBU for three times a day for pain and inflammation. The patient was totally healthy and had no pains like the one experienced before the patient received the first dose. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events pain and inflammation which included treatment with ibuprofen (MANUFACTURER UNKNOWN). On an unknown date in Nov2021, the patient underwent blood sugar test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Nov2021, the patient underwent SARS- CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events bad pain in the right-side body, hand feet chill, bad headache, musculoskeletal pain and inflammation were not resolved at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
This spontaneous report from a contactable pharmacist. A 74-year-old female patient received PREVNAR 13 (Lot Number H86680; Expiration Dare Oct2014; NDC Number 00005-1971-02) single dose via intramuscular route of administration into the left arm on 16Oct2014. Relevant medical history was not reported. The patient was taking unspecified concomitant medications. The patient previously received PNEUMOVAX. The patient experienced warm to the touch, quite red, itched really bad, arm is a little swollen, and tender to touch on an unspecified date with outcome of not recovered. The reporter elaborated that the patient had some swelling of her upper arm. It was warm to touch and quite red, it had expanded about 6 inches in diameter in a week since having the shot. Reporter also indicated the patient said that her arm was a little swollen and the reporter said the area was not really large and that the site was a little swollen and tender to the touch and warm to the touch. The reporter indicated that it had probably gone six inches in diameter around the injection site that was quite red, reporter also indicated that the patient said it itched really bad. Per reporter, the patient said it (the reaction) gradually got worse over the week. She told him that it hadn't gotten any better yet, it had just been getting worse throughout the week. But it was kind of gradual. Per reporter, the patient said that after the first couple of days the site did not bother her and the reaction gradually got worse. The patient came into the pharmacy earlier this morning, 22Oct204, and showed the reporter her site. The reporter assessed the events as related to PREVNAR 13. The reporting pharmacist inquired "what are the possibilities of reactions to the vaccine and how long would it last?" The reporter also wanted to know more information on how often something like this happens and if it does happen, how often does it happen and what things should be done with this type of reaction. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Within 2 minutes of Pneumovax, pt felt strong stomach pain, became lightheaded and feeling faint, started to develop hives on face, flushing and itching on arms, started to see spots Immediately treated with epinephrine IM, followed by Zyrtec 20 mg PO, Pepcid 20 mg PO, Depo-medrol 80 mg IM  Pt declined ambulance, was observed for 30 minutes with improvement in symptoms, stable vitals and discharged to care of her husband
This spontaneous report as received from a Registered Nurse refers to 213 female patients of unknown age. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). On an unknown date, the reporter stated that the patients who took GARDASIL suffered permanent disability. At the time of the report outcome of permanent disability was unknown. The reporter considered the events as permanent disability. Additional information has been requested.
On 11/29/17, per report of individual's employer (manager), individual began to complain of numbness and tingling in hands and feet and decreased strength which slowly progress on 11/30/17. On 12/1 individual had difficulty breathing and was unable to walk. Individual is hospitalized in critical care and has been diagnosed with Guillain-Barre syndrome according to report of family.
Experienced extreme itching on my entire body and pain and fever in upper arm during the night following my shot. Had no swelling or rash. Called by pharmacy the next mid-morning and since I did not have swelling or rash he told me to take an allergy pill. I did and itching stopped.
After rec vax, left arm started swelling a lot, was hot to touch, red and painful. Lasted several days. Took ibprophen for pain. Pain left, but swelling and hot to touch continued. Redness in the entire upper arm appeared. Hot painful and swollen were symptoms
injection site/arm soreness/just the area around the needle site/Just tender; This is a spontaneous report received from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (reported for herself) reported that a female patient of an unspecified age (age: 82; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient mentioned "injection site/arm soreness". The patient said it was just the area around the needle site. Just tender. It was not extremely sire, it was tender sore. The patient was asking if how she would know if they will get a hematoma after the vaccine and if she should expect anything and the patient was made aware of signs of potential hematoma with redness, swelling, pain or bruising. The patient was referred to speak with healthcare professional (HCP) if she believes there is a hematoma or concerns about potential hematoma forming. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
having bizarre thoughts and dreams outside of his normal sexual attraction; having bizarre thoughts and dreams outside of his normal sexual attraction; homosexual erotic fantasies exclusively; 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 36 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THINKING ABNORMAL (non-serious), ABNORMAL DREAMS (non-serious) all with onset Oct2021, outcome "unknown" and all described as "having bizarre thoughts and dreams outside of his normal sexual attraction"; ABNORMAL DREAMS (non-serious) with onset Oct2021, outcome "unknown", described as "homosexual erotic fantasies exclusively". Additional information: Caller is a 36-year-old male who reports receiving his first dose of the Pfizer BioNTech Covid 19 vaccine about 3 weeks ago. He then started having bizarre thoughts and dreams outside of his normal sexual attraction. Caller reports having homosexual erotic fantasies exclusively even though he is married to a woman. Caller seeking information on this side effect would like to know why is having this psychological sexual attraction from the vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 2 minutes of receiving hepatitis A and varicella immunizations patient began to complain of severe pruritus. She also had multiple episodes of emesis and very mild wheezing. She was given a dose of epinephrine and transported via ambulance to closest ED.
I had a Covid test  on the 1/4/21 thinking I might have covid. I am negative.  So concerned had a 1/12/21 EKG all was fine. I have had shortness of breath and very rapid heart beat. I had a bruise on my  right arm the size of a desert plate. It is finally gone after 12 days. I never bruise from any kind of an injection,  My blood pressure was up. 135/80 . I am usually 106/68..  1/12/21 Had temp 99. On the 9th day.. Very tired slept the day away. I am a person that requires about 6 hrs a night I am fine. My pulse had been around 88 it is usually 68-70. Oxygen is 98.
Information has been received from a medical assistant concerning two patients who on unspecified dates 'last week" were vaccinated IM with doses of RECOMBIVAX HB (lot# 0438Y, thimerosal free). The medical assistant reported that the patients were unable to receive the complete doses of RECOMBIVAX HB vaccine because the syringe malfunctioned. The products were adult prefilled syringes and the size of the container was 3. The medical assistant reported that in both cases the plunger came out of the syringe following insertion of needle into muscle during aspiration. She stated that the syringes looked intact. The cellophanes were intact and the trays undamaged. She attached the needle onto the syringe and injected the patient. When she pulled the plunger backwards to check for blood, the green portion of the plunger fell out and separated from the gray part. The gray stopper portion stayed inside. She stated that the same thing happened with the second syringe. No adverse effect was reported. A product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information has been received from a medical assistant who confirmed the events, she stated that the patient were never injected with the vaccine. The health care professional contacted during telephone follow-up could not supply the following information: patients name, dates of birth, dates of vaccination/therapy, dose numbers, lot numbers or dates of events. The SR# is 13353358562.
Pharmacist gave my 9yr old daughter the adult dose that was meant for myself by mistake. As of today 11/15/2021 patient has not experienced any visual side effects; however due to issues with being able to communicate she may be experiencing issues internally but is not able to communicate it.
After reciving 2nd dose of Pfizer Covid vaccine, patient waited 15 minutes and was told she was ok to go, she responded ok and apparently when she tried to stand she got dizzy and stated as such.  Pharmacist went out to sit with her/ monitor her - her eyes rolled back and she fell into the pharmacist and her phone fell - she opened her eyes within a few seconds but remained dizzy - she stated she hit her head on the chair but her phone fell when she fell into pharmacist. Pharmacist believes she did not hit chair. She remained sitting the entire time. Ambulance was called in abundance of caution so patient could be checked. She was starting to feel better and refused to be transported to hospital.  She sat for another 35-45 minutes and left with friends.
Rotateq given on 6-18-09 & patient had to undergo surgery for intussusception on 6-22-09.  9/8/09 Hospital records received DOS 6/21/09 to 6/25/09. Assessment: Intussusception status post exploratory laparatomy for reduction and appendectomy. Patient presented with a history of vomiting yesterday morning X3. Gagging, poor oral intake, some discomfort, decreased activity level. Cries out during abdominal examination. Blood in stool, anal fissure. Reduction of intussusception, bowel necrosis, appendectomy performed.  9/4/09 Received hospital ICD9 codes: 5600; 542; 56089; 5601; 78062; 5609.
Blood pressure went down; Booster shot; Booster shot; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 3 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as a DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a DOSE 2, SINGLE for covid-19 immunisation. On Aug2021, the patient experienced booster shot (extra dose administered and off label use) and on Sep2021 blood pressure went down. She said, stating there was nothing wrong with her she was just wondering. Reporter was reporting on the Pfizer Booster shot for Covid 19 and who explained she had it at the 6-month mark, around there. It was explained that with the first 2 shots she noticed she was tired but with the booster shot, after 4 days, her blood pressure went down to 109/69, 116/63, and 109/66. She was wondering if this is a side effect as it was not listed in the literature she was given. Her previous shot was on 13Feb2021, and her booster was on either the 30Aug2021 or 31Aug2021. She does not state which dose she was referring to for 13Feb2021, the first or second. The patient underwent lab tests and procedures which included blood pressure measurement that was 109/69 on an unspecified date in 2021, blood pressure measurement that was 116/63 on an unspecified date in 2021 and blood pressure measurement that was 109/66 on an unspecified date in 2021. Reporter seriousness for the event was unspecified. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
severe headache after the 2nd dose; headache left her on bed all day 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seizures and Heart murmur.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose) outcome was unknown.            The patient reported that they got the second shot of the Moderna COVID-19 vaccine and experienced severe headache, which left the patient in bed all day.   The patient stated they suffered from other medical problems. Reportedly, the patient was taking concomitant/regular medications and had ten regular medications but didn't provide the details.  It was reported that the patient took Advil and wait and stayed in bed.   This case was linked to MOD-2021-421765 (Patient Link).
Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022; Administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 29-Apr-2022, refrigerated on 03-May-2022 and administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 04-May-2022, one patient was administered expired booster dose of Moderna Covid-19 vaccine.  The vial was initially stored in refrigerator on 03-May-2022 at 11am and the vial did not undergo any temperature excursions.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Live follow up received contains Significant information of Updated details about the expired vial received.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches) and PYREXIA (Low fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches) and PYREXIA (Low fever). At the time of the report, MYALGIA (Aches) and PYREXIA (Low fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
received the entire vial contents (0.45 mL), without dilution/overdose; received the entire vial contents (0.45 mL), without dilution/overdose; This case has been considered invalid since the reporters has no first-hand knowledge of the patients and events.  This is a spontaneous report from contactable two Nurse, two Pharmacist and two Physician. These Nurse, Pharmacist and Physician reported similar events for 8 patients. This report is for 7th of 8 patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose (the entire vial contents 0.45 mL) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that eight healthcare workers in a (facility name) received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine.  Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose.  Information on the Lot/batch number has been requested.  Follow-up (22Jan2021): This is a follow-up spontaneous report received from a contactable Pharmacist in response to the mail trail sent regarding the confirmation of below mentioned query. This Pharmacist reported for a patient that:  Query: (name) from Drug Safety Office phoned yesterday & today. She asked that (name) phone or be in touch with her because (name) wrote the article in the newsletter. (name) is interested in whether (name) had first hand knowledge of the patients mentioned in the article. If so, (name) has questions to ask about them & their reactions.  Response: We are a national reporting program. We do not have any patient data. Just what you already saw. We cannot supply additional information. Reporter is confirming there is no first-hand knowledge of events.  Information on the Lot/batch number has already been requested.; Sender's Comments: Linked Report(s) : Same reporter/drug; different patient/event
Within 24 hours pt experienced tenderness, pain, warmth, redness, and slight swelling in the left arm from the deltoid down, was still experience symptoms 48 hours after administration.
Weakness; 100.2 degree fever; body aches; chills; severe headache; sinus and chest congestion; sinus and chest congestion; nausea; dry heaves; loss of appetite/no appetite; loss of taste/not taste; loss of smell/no smell; sore throat; runny nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 24Mar2021 at 18:45 (at the age of 45 years old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunisation. Medical history included no (reported other medical history- No). The patient's concomitant medications were not reported.  The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID-19 prior to vaccination. The patient had been tested for COVID post-vaccination.  On 25Mar2021, the patient experienced sore throat and runny nose. On 26Mar2021, the patient experienced body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, and loss of smell. On 27Mar2021, the patient experienced 100.2 degree fever. On 28Mar2021, the patient experienced weakness. The course of the events was as follows: Day 1: sore throat, runny nose; Day 2: body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, loss of smell; Day 3: 100.2 degree fever, severe headache, sinus and chest congestion, body aches, chills, no appetite, not taste, no smell; Day 4: Weakness, minor headaches, minor sinus and chest congestion, cough, return of some appetite taste and smell. No treatment was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 RT-PCR): negative on 29Mar2021 and SARS-CoV-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
This 1 year old 7 month girl exhibited a red, pain, hot, swollen about the size of a quarter, hard to the touch, lump. No antibiotic regimen was given to her at that time.
gave Moderna to a 13 yr old. no s/s. mother present and aware that Pfizer will be there next dose.