chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient got the flu shot, patient got the flu; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who got flu (influenza), while patient received Influenza vaccine.  Medical history, medical treatments and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received Influenza vaccine [Produce by unknown manufacturer, batch number and expiration date not reported] via an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after receiving the suspect vaccine , patient got flu (influenza).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
walking pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of ATYPICAL PNEUMONIA (walking pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ATYPICAL PNEUMONIA (walking pneumonia) (seriousness criterion medically significant). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ATYPICAL PNEUMONIA (walking pneumonia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, X-ray: abnormal (abnormal) Patient was diagnosed with pneumonia..         No concomitant medication was given. On 28-Dec-2021 when patient visited the doctor it was confirmed that patient still had pneumonia and due to that doctor prescribed more medicine to her. It was reported that doctors keep changing her antibiotics as the medicine were not working. Treatment medication was mentioned as on 28-Dec-2021 patient started with steriods and took them for 5 days.  Company comment: This is a spontaneous case concerning a 73-year-old female patient with no medical history reported, who experienced serious, unexpected event of atypical pneumonia. The event occurred approximately 8 months after the administration of second dose of mRNA-1273 vaccine. It was reported that patient had been coughing for a long time. On 06-Dec-2021 an X-ray was performed and she was diagnosed with pneumonia. on 28-Dec-2021 doctors said the event was not resolved and she started steroids for 5 days. Patient said doctors kept changing her antibiotics because they weren't working. Patient only remembered amoxicillin. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old female patient with no medical history reported, who experienced serious, unexpected event of atypical pneumonia. The event occurred approximately 8 months after the administration of second dose of mRNA-1273 vaccine. It was reported that patient had been coughing for a long time. On 06-Dec-2021 an X-ray was performed and she was diagnosed with pneumonia. on 28-Dec-2021 doctors said the event was not resolved and she started steroids for 5 days. Patient said doctors kept changing her antibiotics because they weren't working. Patient only remembered amoxicillin. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
sinus infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: SINUSITIS (non-serious), outcome "unknown", described as "sinus infection".  Additional information: The patient wanted to know, if any information for the 2nd dose, if patient have a sinus infection, if patient could take the 2nd dose. Any information pertaining to Myocarditis and Pericarditis and the vaccine. What if the second dose cannot be provided at 3 weeks.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD which had Lot number M018637 with an expiration date of 11-OCT-2017 and lot # M038862 with an expiration date of 13-MAR-2018 (strength, dose and route were not reported) for prophylaxis. It was confirmed that all the vaccines were reconstituted with sterile diluent (lot # and expiration date were not reported) which was stored in correct temperature range. No adverse effects were reported. It was reported that the vaccines were exposed to temperature of >-15 centigrade degrees (°C) but <-10°C range, for a time frame of 1 hour. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002377: US-009507513-1705USA001145.
44 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: sensation of throat swelling or throat closure. Pfizer-BioNTech COVID-19 vaccine # 2 in series administered.  o Action(s) taken: Epinephrine administered
On 3/15/18, patient received Tdap in the left arm and hepatitis B vaccine (#1 in series)  in the right arm. She reports that right after the vaccine she had some swelling and induration in the right deltoid which continued throughout the weekend. She did not have any swelling in her face or shortness of breath. She reports that she applied ice to the site, but that it is still swollen, tender, and warm. Her left arm where she had the other vaccine was intact there is a small bruise however at both injection sites but the right deltoid where the hepatitis B vaccine was given shows reaction. Patient reports she's never had any history of hepatitis B in the past.
Since then caller was prescribed  Hydroxychloroquine, leucovorin and methotrexate for rheumatoid arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received the second dose of bnt162b2 (lot number: unknown) in Feb2021 via unknown route of administration at single dose for COVID-19 immunisation. Medical histories included immunocompromised. Concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (lot number: unknown) in Jan2021 via unknown route of administration at single dose for COVID-19 immunisation. The reporter was calling about the covid booster vaccine. The reporter had a compromised immune system and had rheumatoid arthritis. The caller was not on these medications with the initial vaccination of the two doses. Consumer wanted to know if it was ok to take the booster dose Pfizer covid vaccine. She received Pfizer covid vaccine first dose in Jan2021 and second dose in Feb2021. Since then reporter was prescribed, Hydroxychloroquine, leucovorin and methotrexate for rheumatoid arthritis. The patient was currently on methotrexate, hydroxychloroquine, and leucovorin. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Reports approx. 30 minutes after the flu shot was feeling bad and then when got home had difficulty breathing, syncope, vomited, dizziness.  Had the flu shot before with no previous reactions in the past.  Refused to go to hospital.
During vaccination, patient stated she was anxious about getting vaccinated and exclaimed that it "wasn't so bad" after administration was complete. Patient and her parent were informed to stay in the store for 15 minutes to monitor for signs/symptoms of a reaction.  After about 5 minutes passed, patient stated the back of her neck started to ache and her vision was starting to go black.  The mother notified the pharmacy staff that her daughter didn't feel well, and I left the pharmacy to see what was going on.  As soon as I reached the patient, she lost consciousness and unresponsive for about a minute and a half.  At that time I noticed her skin was pale and her body had become rigid.  She regained consciousness and seemed to be functioning in a normal capacity but explained she still felt off (her earing was muffled and she was still experiencing the visual disturbances).  EMS was called to the scene and when they evaluated her, she appeared to have normal vital signs.  The mother decided to have her go with EMS to be evaluated at the hospital to confirm everything was okay.
A non-serious spontaneous report of H1N1 LAIV inadvertently administered to 56-year-old was received from a health professional concerning a patient of unknown gender. The patient's medical history was not provided. On an unknown date in 2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Patient presented to a vaccination clinic on 10/05/2022 @1206 patient was given a Covid Pfizer Monovalent vaccine by accident. The intended vaccination was Covid Pfizer Bivalent vaccine. No adverse reactions were noted, patient educated on the need for revaccination with correct Pfizer Bivalent vaccine.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 21-APR-2017, the patient was vaccinated with an expired dose of VAQTA lot # K008333, expiration date on 10-MAR-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
Face swelling/ Swelling face; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever). At the time of the report, SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High (Fever).     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On an unknown date, patient experienced face swelling and fever and it got resolved.  On an unknown date, body temperature was measured but the exact temperature was not provided but it was reported that patient had fever.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of face swelling and fever with HUMIRA was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Expired vaccine administered to 20 individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 20 individuals) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 20 individuals). On 07-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 20 individuals) had resolved.        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.   Concomitant product use was not provided. Twenty individuals received the dose one day out of expiration (31 days in the refrigerated condition). No symptoms were reported from the patients as of 12-MAY-2021. Treatment information was not provided.
Chicken Pox was diagnoses on 10/29/99.  Pt received Zovarax Rx.  Varivax vaccine administered on 4/27/99.
Menstrual cycle started early, 1 or 2 days after vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 09Sep2022 (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3: 1st Booster), for COVID-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 10Sep2022, outcome "unknown", described as "Menstrual cycle started early, 1 or 2 days after vaccine.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Dose received: More than 3. If other vaccine in four weeks: No. other medications in two weeks: No The patient not had covid prior vaccination and not tested covid post vaccination. Patient had no known allergies.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
double vision when head turns to the left; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision when head turns to the left) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIPLOPIA (double vision when head turns to the left). At the time of the report, DIPLOPIA (double vision when head turns to the left) outcome was unknown.            No concomitant and treatment medications were provided  Reporter said that he was going to eye doctor.
This spontaneous report was received from a physician via a company representative and refers to a 17 year old male patient. The patient did not have any drug reactions or allergies. He was healthy at the time of the vaccination. No information regarding concomitant medications was provided. On 09-JAN-2018, the patient was vaccinated with GARDASIL 9 lot # N022584, expiry date 15-JUN-2020, TRUMENBA lot # S58879, expiry date 30-JUN-2019 both in the left arm, MENACTRA lot # U5766AE, expiry date 02-DEC-2018 and with hepatitis b vaccine (manufacturer unknown) lot # reported as Z2497 and expiry date 19-FEB-2020, both in the right arm (dose and route of administration were not reported for all). The patient was sitting on the exam table when he received the vaccinations. On the same date (reported as "one minute later"), the patient fell off the table, split his head, had 2 seizures, was retching (also reported as wretching) and became sweaty. The patient took 45 minutes to "come around". The patient was sent to the emergency room, where he received stitches and a computed tomography (CT) scan (result was not provided), and was released. Unspecified treatment was given for the events. He went back to school the next day. The patient was seen by the physician, and had no lingering symptoms. The outcome of the events was reported as recovered on an unknown date in January 2018. The causality assessment was not provided. Upon internal review, the event of seizures was considered to be medically significant.
Received Vaccine on 03/21/2021 accoring to niece and had shortness of breath after.  Found dead on 03/24/2021.  No pneumonia, pulmonary thrombus or meningitis at autopsy but posmortem COVID test positive.
Chest pain behind sternum that woke me from sleep-ongoing Upper abdominal pain-ongoing Headache-3 days Fatigue-3 days
Hive left arm-was not measured, larger than .50 piece. Treatment-ice, Claritin
Patient stated that she had an injection site reaction. (Red, swollen, hot, headache, dizziness).
Patient sat in the waiting room after receiving her shot.  After a few minutes, she fainted and fell out of her chair.  I was able to awaken her quickly and have her remain on the floor for a few minutes.  She then sat in the waiting area for about 10 more minutes and left without further incident.
Started throwing up in the night on 9/11.  On 9/12, she started breaking out on her back and it quickly spread to different parts of the body.  By the 13th, it was all over her body including her face and scalp.  Took to a walk in clinic on the 12th and said to give Benadryl and come back if got worse.  As of today, Sept 17th, it is mostly gone and she has returned to school.
Chills, muscle aches, low grade fever 99.7, whole left arm numbness
Cold sore (mouth) within one week of having each of the three Pfizer vaccines.; Dose 3; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the right arm on 06Oct2021 at 10:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN7534) via an unspecified route of administration in the right arm on 18Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 25Feb2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation.  On 10Oct2021, the patient experienced cold sore (mouth) within one week of having each of the three Pfizer vaccines.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore (mouth) within one week of having each of the three Pfizer vaccines was not resolved at the time of this report.
Admitted to hospital 8/11/21 with weakness, body aches, loss of appetite, febrile up to 101. Tested positive for COVID
Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: delayed but quick onset of feeling of warmth-Severe, Additional Details: Patient came to me 5/13/21 to describe that later in the day, after receiving the Janssen vaccine, pt was driving and had a sudden feeling of body warmth and vertigo. Patient further described chest tightness and difficulty breathing, as well as all over body pain. He reported that he was able to safely get to where he was going and the next day had more "expected" grogginess and aches.
Patient found in bed unresponsive Saturday morning, Feb. 10, 2007.  3/1/07 Received autopsy report via email from CME office which reveals COD as SIDS.  Co-sleeping in full size bed w/parents.
Caller states arm sore for a little while; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein), via an unspecified route of administration on 2019 (Batch/Lot number was not reported) as dose number unknown, single for immunisation; influenza vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), as dose number unknown, single for immunization. Medical history included ongoing diabetic and high blood pressure from an unknown date. The patient's concomitant medications were not reported. The patient experienced arm sore for a little while, no concern or anything referring to both the flu vaccine and the Pneumonia vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough COVID first dose 6/30/2021 048A82A, second 7/30/2021 006B21A.   94-year-old female with history coronary artery disease status post stenting, congestive heart failure, difficult to control hypertension, coming in with shortness of breath and a fall.  She is on clonidine on an as-needed basis.  Patient apparently has been coughing for the past few days.  She apparently was walking and tripped and fell against her right chest.  Brought to the emergency room for evaluation.  A rib series was obtained which shows no radiographic evidence of acute fracture or dislocation but diffuse bilateral patchy interstitial and alveolar opacities.  COVID-19 testing was positive.  She had to be placed on BiPAP for increased work of breathing and ICU admission requested and was transferred to hospital.  Also found to have a hypertensive urgency with blood pressure of 229/105 on admission.  She was started on a nitro drip and given Lasix and this was brought down to 180/90 so.  On arrival patient on 4 L of oxygen and in no distress.  She apparently uses oxygen on an as-needed basis at night at home.