chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/26/2022 I started with a headache and stuffiness. I figured it was the animals in the house with allergies. It would not go away. By 12/28/22, I was feeling dazed. I began having chest pains. I had been exposed to COVID. I took a home COVID test and it was positive. Coughing started later that day. I called my physician's office and spoke to the assistant. She had me call the urgent care telehealth. I was prescribed PAXLOVID, and was given a new albuterol inhaler, a FLOVENT inhaler and benzonatate. I began taking PAXLOVID that day. I have been taking those per the instructions. I am still having these symptoms, but they are all better. I can sleep better now. I feel sharper and feel better now. I have not recovered. My main concern has been my chest pain. I am still having the chest pains, but they are better.
ABOUT 30 MINUTES AFTER MY SECOND VACCINE THE LEFT SIDE OF MY BODY STARTED TO FEEL NUMB, TINGLY, AND WARM. SENSATION IS STILL PRESENT THE NEXT DAY WITHOUT IMPROVEMENT
an unleashed dog ran up to him and bit him in the same arm that he received his vaccination in.; This spontaneous case was reported by a consumer and describes the occurrence of ANIMAL BITE (an unleashed dog ran up to him and bit him in the same arm that he received his vaccination in.) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ANIMAL BITE (an unleashed dog ran up to him and bit him in the same arm that he received his vaccination in.). The patient was treated with RABIES VACCINE for Dog bite, at a dose of 3 shots. At the time of the report, ANIMAL BITE (an unleashed dog ran up to him and bit him in the same arm that he received his vaccination in.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment was patient taken to the ER and given a round (3 shots) of rabies vaccine and was due for the next round on 18-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR received and contain non significant information.
Information has been received from a registered nurse and physician concerning a 13 year old Caucasian male with no past medical history and no know drug allergies who was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) on 09/07/1990 and 06/10/1994 respectively.  There was no concomitant medication and no illness at the time of vaccination.  On 10/11/2002, a titer was drawin from the patient that did not show seroconversion for mumps.  On 10/11/2002 the patient's mumps IgG and IgM were <IC EIA units (not detected).  On 10/18/2002 the patient was vaccinated IM with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642440/0233M).  On 11/11/2002 the patient's mumps IgG was 12 EIA units (indeterminate) and mumps IgM was <10 EIA (not detected).  It was also reported that the patients brother was also immunized and developed mumps (WAES # 0212USA02008).  No further information is expected.
allergy/adverse reaction to the vaccine; felt very sick for a day and a half with back ache; felt very sick for a day and a half with back ache; vomiting; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who had allergy/adverse reaction to the vaccine, felt very sick for a day and a half with back ache and vomiting after receiving influenza quadrival A-B vaccine [fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot U8192DA, expiry date: 30-Jun-2024, Dosage strength: 0.5 ml) via unknown route in unknown administration site for immunization.  On an unknown date the patient had allergy/adverse reaction to the vaccine (allergy to vaccine), felt very sick for a day and a half with back ache (illness) (back pain) and vomiting (unknown latency).  Reportedly, administered FLUZONE QUADRIVALENT NP to two of their patients and both of them had an allergy/adverse reaction to the vaccine. The nurse also reported that both patient had an anti-allergy shot before taking the flu shot.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome was Unknown for all the events.  A Product Technical Complaint (PTC) was initiated on 25-Oct-2023 for FLUZONE QIV (quadrivalent influenza vaccine) (lot/batch number: U8192DA, expiry date: 30-Jun-2024) with Global PTC number:  The sample status of the PTC was Requested & Awaited Site Sample Status: Not Received Issue Status: Completed  PTC stated- INVESTIGATION FORWARDED This report has been forwarded to the pharmacovigilance department for registration in the Sanofi global safety database. If the Global Safety Officer decides that a manufacturing investigation is needed, it will be performed by the quality team of the manufacturing site per SWV-QU-WIN-0003203, Manufacturing Investigations in Response to Adverse Events and GMCCQ-QU-WIN-0047713, Global  Manufacturing Lot Review.  Conclusion: The final investigation was completed on 27-Oct-2023 with summarized conclusion as evaluation not possible.  Additional information was received on 27-Oct-2023 from the quality department. PTC details, Batch number, Expiry date, Dosage strength were added. Text amended accordingly.
pt recv influenza vax became febrile with chills and myalgias. 4 wk later devel ear pain, h/a, blurry vision (both eyes). Eye exam acuity of 25/50 OD-20/25 OS visual field defect OD and super nasal defect OS, both optic disc edematous;
Vaccine administration error: mismatched doses  This patient received  a dose of Pfizer covid vaccine on 2/18/2021, and then was scheduled for a second dose of Pfizer vaccine in the afternoon of 3/10/2021, or 20 days later.  However, she checked in to our vaccination clinic in the morning, when Moderna second doses were being given, and she was then mistakenly given a Moderna vaccine instead of the Pfizer that had been planned.  At the request of vaccine clinic staff, I discussed this with patient by phone, and she reported considerable anxiety after being informed of the error, which then resolved after I discussed with her current CDC recommendations for such cases.  She reported no other symptoms.
INJECTION SITE PAIN; LOW GRADE FEVER; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site pain, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and low grade fever was not reported. This report was non-serious.
Per patient she began experiencing shortness of breath and tightness in her  chest a few minutes after vaccine administration. Pt reports using her inhaler and nebulizer treatments with relief in symptoms. Symptoms have persisted for 24 hours.
I had a sore throat, minor achiness and a cough. I also had nasal congestion.
Headache for THREE WEEKS, Lethargy for 4 days, Couldn't get warm for 7 days
On 5/4/21, I thought I had strep throat. I couldn't swallow. I went to an urgent care where they tested for strep which came back negative. They told me it was bronchitis and told me to stay on Mucinex. I took three bottles of Mucinex. I tried Claritin which did not help. I now take Benadryl at night, to help me cough it out. I do not feel as if it is in my lungs, it feels like it is stuck in my throat. I feel fine otherwise. There is no pain in my throat anymore, just the coughing.
Arm started to shake uncontrolably about an hour after taking it. It quit after an hour or so later.
Tenderness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness on the arm of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Macrobid Allergy). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced TENDERNESS (Tenderness on the arm of the injection). On 22-Jan-2021, TENDERNESS (Tenderness on the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include ethylenol .No treatment medications were provided.   This case was linked to MOD-2021-185883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up was received and reporter contact information was updated.
Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter  (pt 3/5) US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter  (pt 5/5) US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter (pt 2/5) US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter  (pt 4/5)
Chills, very cold for 2-3 hrs 14 hrs after shot Tired, feverish, achy 24 - 40 hrs after shot Place of injection very sore, unable to raise arm without pain Ibuprofen provided some relief.
Right facial paralysis started over the weekend and was diagnosed as Bell's Palsy by me in the office on 5/25/21. Prednisone and artificial tears were ordered. Referral made to ophthalmologist and neurologist for further treatment recommendations.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017; dose was unknown). No adverse reactions were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I was fine the same night, my arm was getting sore. But about an hour after I woke up, my left side below the ribs started getting extreme pain. It still hurts after 3 hours, it?s knocked me to my knees a few times. I took tylonel an hour ago and it hasn?t helped at all.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pertinent medical history, current condition and concomitant medications were not reported. On 19-JAN-2017, the patient was vaccinated with ZOSTAVAX (dosage regimen were not reported), subcutaneous and already had received dose of ZOSTAVAX (lot number, expiry unknown by reporter) on an unknown date in May 2016 (extra dose administered). No side effects were reported (no adverse event). No further information available. Additional information has been requested.
A few days after the shot I had a horrible headache behind the ear and right side of forehead that wouldn't go away with tylenol for about 3 days. 1 week after the vaccine I had routine blood drawn, afterwards ate breakfast and had jaw pain and couldn't open my mouth fully. Within a few hours my whole right side of my face was weak. I was able to get into the dr at 2 pm and was prescribed antiviral Valtrex and pregnozone for 1 week. Started taking them immediately and doing facial excersizes. No improvement so far.
3/12/21 Headache and soreness in eyes Extremely tired Soreness in arm
Vaccinated on 8/12. Symptoms of redness, warmth and swelling began to appear the afternoon of 8/15. Physician ruled as adverse reaction to vaccine dose received on 8/12
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) first dose, lot L009209, expiration date: 17-SEP-2016, 0.5 ml, subcutaneous. No concomitant therapies were reported. No adverse effects were reported. This is one of multiple reports from the same reporter. Additional information has been requested.
Fever (102); nausea, lethargic, serious night sweats (for 3 days); soar arm.  All the same ones I had from first shot only worse!
This spontaneous report was received from a physician via a company representative referring to an infant patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, intramuscular injection (lot # and expiry date were not reported) for prophylaxis. Other co-suspect or concomitant medications were not reported. The infant received a dose of GARDASIL, which was not indicated for patients under the age of 9 (drug administered to patient of inappropriate age). The patient did not experience any effects from receiving the GARDASIL vaccine injection (no adverse event). The outcome of drug administered to patient of inappropriate age and no adverse event was unknown. Additional information is not expected; as no consent to obtain follow up was provided.
This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 08:20 (Lot number: EV6203, EN6203) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient took concomitant medications for diabetes, high blood pressure, and cholesterol. Vaccination history included: BNT162B2 (first dose, Lot Number: EZ9265), administration date: 09Feb2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovering", described as "arm was hurting"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "he felt really tired"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "not recovered", described as "weakness"; NAUSEA (non-serious) with onset 03Mar2021 11:00, outcome "not recovered", described as "has been really nauseous". Additional information: He wanted to know how long these side effects would last. Nothing was really bad. He read in the papers that this was normal. The patient asked how long does the events last. Two lot numbers were reported for the second dose of BNT162B2. The events did not require a visit to the emergency room nor the physician office.No follow-up attempts are possible. No further information is expected.
Patient developed a sore arm after the injection, and woke up Thursday to it being sore, warm, and somewhat swollen. Patient began taking Ibuprofen. On Friday 11/17/17 patient's arm had swollen to double its size, it was extremely painful, and she could not move her arm or touch it. It was very warm. Pt took BENADRYL, Ibuprofen, and TYLENOL Thursday and Friday and then slept. Patient came to clinic for assessment on 11/20/17. Arm was still swollen, but arm can be moved. The arm is beginning to itch, and is still very tender to the touch. The injection site is visible, red, and hard. Patient explains the arm has been improving.
subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.
Severe left arm pain, Erythema and edema approx 7cm. Tenderness. Hurts to fully raise arm. Nausea. Ice, Darvocet N for pain.
Felt soreness in her shoulder; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164; Expiry date was not reported) via an unspecified route, administered in Arm Left on 21Apr2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 21Apr2021 after her first shot the patient just felt soreness in her shoulder and so she took Tylenol and that was fine. She only had soreness in her shoulder with the first dose and she treated it with Tylenol a couple of times and it eased off. Outcome of the event was recovered on 22Apr2021.  No follow-up attempts are needed. No further information is expected.
On 12/29/2022 Symptoms of upper respiratory infection started with stuffy nose and continued through 12/31/2022 cough chills and fever up to 99.9 and my COVID-19 test was positive. Started PAXLOVID on 12/31/2022 in the evening and  I missed work 01/03/2023 due to isolating from COVID-19. I have had ongoing fatigue, weakness and brain fog  although beginning to clear now.
Extreme dizziness, lasted for 3 days,  headache, ongoing, so far has lasted 7 days  ibuprofen not helpful, tylenol not helpful  nausea lasting 2-3 days pepto bismol not helpful  severe fatigue lasting around 24-30 hours brain fog, trouble concentrating and thinking clearly, lasting 7 days so far.
Pressure-induced urticaria, primarily localized to the trunk. Hives are itchy; severity is controlled by OTC antihistamines (diphenhydramine and loratadine). Dermatographic urticaria, again localized to the trunk.
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: unknown Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient remained on quarantine until 18 May 2021 and was reported negative at the time of report. The second dose was scheduled on 29 May 2021. No concomitant  and treatment information was not provided. Concomitant product use was not provided. Treatment information was not provided.
Pt is 40 yo male s/p J&J COVID vaccination on 5/21. Pt is an employee of this institution. On 8/2, reports new onset symptoms of fever, chills, cough, SOB/difficulty breathing, fatigue, muscle/body aches, headache, sore throat, and congestion/runny nose. He denies any known exposure to COVID. PCR test results positive on 8/2. Pt is identified as candidate for casirivimab/imdevimab infusion, however, declines treatment.
Patient presented to Emergency Department on 6/15/21 covered in painful, itchy hives from head to toe. Patient receive Moderna 1st dose on 6/11/21 with symptoms beginning within 24 hours of vaccine administration. Patient was not relieved by Benadryl and received prednisone, as well as discharged with prescription for prednisone.
Positive Rapid COVID test on 08/13/2021. Patient fully vaccinated with Moderna at the Health Department
After receiving the vaccine, my throat began to swell and I began to turn red in throat and chest. I was observed by  County EMT for about 30 minutes. I was asked if I needed treatment while being observed but went I went home and took a Benadryl. The throat swelling went down but did take another Benadryl that night.  The next week, my left arm was swollen and I had pain in my hand and wrist.
injected arm that was red; injected arm that was swollen; injected arm that hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox twice, once as a child and again at the age of 51). Previously administered products included Zostavax (had Zostavax at the age of 60).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: injected arm that was red), swelling arm (Verbatim: injected arm that was swollen) and pain in arm (Verbatim: injected arm that hurt). The outcome of the erythema, swelling arm and pain in arm were resolved.   It was unknown if the reporter considered the erythema, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the erythema, swelling arm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023134482   Additional Information: GSK receipt date: 29-Sept-2023 The patient stated that she had a similar local reaction to the first dose of Shingrix (injected arm that was red, swollen and hurt), but was not as severe as the second dose. The reporter gave consent to follow up with health care professional.  However the patient provided limited contact information for the health care professional.  For the tolerance of second dose, refer case US2023134482.; Sender's Comments:  US-GSK-US2023134482:Same patient, second dose
No additional AE or PQC reported.; a 40 year old patient was inadvertently administered PROQUAD.; This spontaneous report was received from a nurse and refers to a 40-year-old patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 20-SEP-2022, the 40 old year patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) administered for prophylaxis lot #W007743  was found as a valid lot, expiration date reported as 04-SEP-2023 (strength  and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event were reported.