chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 44 year old White female. The patient's height, and weight were not reported. The patient's concurrent conditions included: COPD (Chronic obstructive pulmonary disease), and ADHD (Attention deficit hyperactivity disorder), and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 expiry: unknown) dose was not reported, 01 total, administered on left arm on 20-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 43 years old. Concomitant medications included Nyquil (dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol) and Claritin/loratadine for unknown indication. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine included (Moderna) elasomeran (Dose number in series 2) (Form of admin and route of admin were not reported, batch number: 012F21 A and expiry: UNKNOWN) dose was not reported, administered on left arm on 12-DEC-2021 for covid-19 prophylaxis. On an unspecified date, the patient had covid-19 for which patient took non company suspect Paxlovid (form of administration and route of admin were not reported, batch number: GE7067, expiry: unknown) dose was not reported, administered from 12-AUG-2022 for covid-19 treatment (Dose number in series 2). The patient was still in treatment. This symptom usually started right after the patient took the pills and slowly subsided until the next dose. On 13-AUG-2022, the patient experienced metallic taste in mouth, lightheaded (no fog), and hoarse voice (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with Paxlovid was dose maintained. The patient had not recovered from metallic taste in mouth, lightheaded (no fog), and hoarse voice. This report was non-serious.
i get migraines so; This case was reported by a consumer via call center representative and described the occurrence of migraine in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after receiving Shingrix had experienced migraines and patient was trying to detirmin if it is a migraine or reaction. The patient was told majority of people get some or side effects. The patient asked how soon do most see the symptoms reactions.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Tdap Vaccine. Additional Information: GSK Receipt Date: 17-Feb-2023. Reporter's Comment: The patient experienced extreme soreness in his arm before, when he received a Tdap vaccine (unknown manufacturer). The patient stated that the arm soreness from the SHINGRIX vaccine lasted longer in contrast to what he experienced with the Tdap. The patient declined to provide date of birth. The reporter did not consent to follow-up. Additional Supportive Information: This case had been linked with US2023027439, reported by same reporter, for different suspect. Sender's Comments: US-GSK-US2023027439: Same reporter.
Headache, Myalgia, SWEATS AND CHILLS X 1 DAY Narrative:
Fever over 102° for two days, severe body aches, lower back pain, headache, shortness of breath, chills, very fatigued and weak, dizziness, tingling sensation in arms and legs. All of these symptoms occurred the entire next day after receiving the booster shot. Went to sleep in the evening (the day after booster) and woke up the following morning with a fever still, body aches, headache and fatigue. Today is day three following the booster and the only symptoms still lingering are faint body aches but still very fatigued and weak.
A serious report of congenital anomaly and epilepsy has been received from a study investigator concerning a 26-month-old female subject participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for congenital anomaly and epilepsy on 28-Nov-2008. The length of stay was one day. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
Patient was admitted to the hospital on 02/14/2022.  The patient developed pneumonia and  had acute respiratory distress syndrome.  Symptoms present:  fever, chills, muscle aches, cough, shortness of breath, chest pain, vomiting, fatigue.  Patient was treated with dexamethasone and remdesivir.
3 weeks after the 3rd vax I developed hives on my back which lasted for about a month. I went to the doctor and they thought it was an autoimmune reaction to the vaccine.
Tingling sensation in tongue and face. Reports swelling to left side of face with most evident swelling being to lips, cheek and eye lid. Denies any difficulty breathing or swallowing. All symptoms resolved within 24 hours, used OTC Benedryl
numbness from jaw to the tip of my fingers on the left side of my body where i received the injection Heat went across the left side of my chest. My heart was pulsing
Developed a large red mark on my upper arm a couple inches away from the injection site.  And the area is swollen.  I'm using a topical cortisone on it, and the redness is a bit lighter in color.
11 days after shot site itched and discovered red swollen bump with knot under it and fever in it.
shortness of breath; a huge mass under his armpit" which "kept getting larger"; pain, tenderness, soreness on his arm, fever, "really bad" shaking; pain, tenderness, soreness on his arm,; "really bad" shaking; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), MASS (a huge mass under his armpit" which "kept getting larger"), PAIN IN EXTREMITY (pain, tenderness, soreness on his arm, fever, "really bad" shaking), TENDERNESS (pain, tenderness, soreness on his arm,) and TREMOR ("really bad" shaking) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), MASS (a huge mass under his armpit" which "kept getting larger"), PAIN IN EXTREMITY (pain, tenderness, soreness on his arm, fever, "really bad" shaking), TENDERNESS (pain, tenderness, soreness on his arm,), TREMOR ("really bad" shaking) and PYREXIA (fever). In March 2021, MASS (a huge mass under his armpit" which "kept getting larger"), PAIN IN EXTREMITY (pain, tenderness, soreness on his arm, fever, "really bad" shaking), TENDERNESS (pain, tenderness, soreness on his arm,) and PYREXIA (fever) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath) and TREMOR ("really bad" shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes Blood pressure medicine and Heartburn medicine. Treatment medication included Motrin for his symptoms. Patient went to the ER and they did X rays, CT scan, lab work, "and other studies" and in the ER "they didn't know what to say to him". Patient stated that he had again all the symptoms he experienced when he had COVID.
p/vax pt exp faintly erythema area central thigh c/4 papules
In November 2022 you started realizing that I lost my sense of smell and could not tell what I was smelling. I could not smell normal food. I can only smell parts of a aroma and sometimes get a hint of the aromas. I cannot smell my morning coffee aroma that I was used to. I saw my doctor in Dec 2022. I can taste food not my smell is different. I can't remember the date. She told me to take allergies stuff FLONASE for two weeks which did not do anything. I never tested positive COVID-19 at all because, I never felt sick and never took a test. Later in Feb 2023 doxycycline. I had an MRI on my head. In March 2023, I went to an ENT on 7APR23 to see Dr. He gave me prednisone. He could not find anything wrong.
Information has been received from a registered nurse referring to an 11 year old male patient with asthma and allergy to amoxicillin. On 21-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L020015 with expired date 16-AUG-2017, dose and route were unknown) along with MENACTRA and Tdap. Concomitant therapy also included albuterol sulfate inhaler (manufacturer unknown). The patient was observed for 10-15 minutes in the office following administration and he was doing fine with no issues so he was sent home. As the patient was leaving and walking out of the office with his mom, he fainted and hit his head on the ground. The reporter stated that fainting lasted less than a minute and the patient was conscious again. But the patient was very lethargic, was not responding on his own when the reporter asked what his name was and could not get up and walk on his own so the reporter and the patient's mom had to help him get up and they carried him back to exam room. The patient was laid down in the exam room. The patient was given GLUCOLA and some water because the patient did not eat anything this morning prior to receiving vaccines. The reporter checked the patient's blood sugar and pulse oximetry. Both of them were fine. The reporter noticed that the patient's respiration was little shallow and rough. But the patient was slowly coming back. In about 20 minutes, the patient was able to sit up by himself and able to respond to questions. The patient was asked to walk back and forth after he was fully sitting up and he was able to walk on his own without any problem. The patient's vital signs were checked and everything was good. So the patient was sent home. The patient's mother called the office back about 10 minutes after leaving the office to inform the patient was all better and was doing fine. The outcome of the event "head injury" was unknown. Additional information has been requested.
Abdominal cramping; Severe diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN (Abdominal cramping), DIARRHOEA (Severe diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Initial additional
I got my 2nd dose of the Moderna  vaccine Thursday May 27. My symptoms were mild? sore muscles, headache, fatigue. My husband has not had the covid vaccine yet nor did he ever contract covid or had symptoms.  On Saturday May 30, he woke up with a headache and body aches and slept all day. We could not think of where or why he had these symptoms? they seemed very random since he did not get the vaccine. His symptoms were quite similar to mine? mild but very apparent. Seemed interesting and I wanted to report it to contribute to the growing science- could he have had those symptoms because I got the vaccine and we live in very close contact?
Mother reports one day post immunization LA very swollen into shoulder and chest. Child c/o discomfort. Then is redness, area is hot and hcild has trouble moving LA. No fever or SOB. No previous problems with vaccine.
Patient states appt 930/am. By 7P that night temp 101.2, (L) arm swollen & hurt down to fingertips. Sore throat, stiff neck. Tongue, vocal cords slightly swollen, voice hoarse. Strange dreams all night. Swollen tongue/mouth gone by 11PM. Arm slightly sore in AM otherwise symptoms gone.
HIP SURGERY; SHINGLES ON RIGHT SIDE OF FACE; This spontaneous report received from a patient concerned a 72 year old female of unspecified race and ethnicity. The patient's weight and height were not reported. The patient's past medical history included: hip surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On MAR-2021, the patient experienced shingles on right side of face. On 20-JUN-2021, the patient experienced hip surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shingles on right side of face on APR-2021, and the outcome of hip surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211044314-covid-19 vaccine ad26.cov2.s-hip surgery .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Immediate redness and red streaking down the left upper arm when the injection was given. Burning sensation on the arm, face and chest areas immediately following the injection. Face turned red, hot to touch and a rash developed on the face and chest area immediately. Face was swollen. Also, vomited with in 5 minutes of getting the flu shot. Seen by Occupational health doctor at the Clinic. She checked blood pressure and prescribed Benadryl.
11/24 7pm significant Arm soreness began , 11/25 -6am extreme chills continuing throughout the day; fatigue; muscle (neck and shoulder)aches entire day (11/25) ; low grade fever (100.7)  began approx 6pm - 10pm. 11/26 - 7 am only mild arm soreness (injection site) all other symptoms gone
reports that starting the same evening @ 2130 he noticed drainage from his nose.  reports that it was blood.   states that this intermittently happened x4 days.  each episode lasting less than 5 min.  resolved on it's own.  did not need to seek emergency treatment.
11:42 Patient complained of lightheadedness and being hot. BP 97/62, HR 63, O2 sat 98% 11:45 Diphenhydramine given 12.5mg/5ml PO elixir/solution 11:52 BP 103/67, HR 65, O2 sat 97% 12:00 BP 112/74, HR 63, O2 sat 99% 12:10 BP 111/70, HR 64, O2 sat 98%
Approximately 24 hours after MENACTRA (R) hand > (L) hand swelling mild lip swelling, no loss of airway. Seen Urgicare-> currently on prednisone taper and CLARITIN.
Light fatigue 3 days after first shot lasting until the second shot;  Incapacitating fatigue 3 hours after second shot lasting until this date of 08/14/2021 although it did lighten up over time but has not completely stopped.
PATIENT'S 2ND DOSE WAS 11/18/2021 & HE RECEIVED HIS BOOSTER 4/11/2022 WHICH WAS 6 DAYS TOO EARLY
Morning blood sugar reading was 170. This is VERY high; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01580; Expiration Date: Jul2021) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. 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 medications included insulin glargine/lixisenatide (SOLIQUA), metformin (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732; Expiration Date: Jul2021) via an unspecified route of administration in the left arm on 27Mar2021 at 11:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient also received previously pseudoephedrine hydrochloride (SUDAFED) on an unknown date and experienced allergy. On 17Apr2021 at 08:00, day after the shot, the patient's morning blood sugar reading was 170. This was very high for the patient, as she usually run around 100 or under. On 17Apr2021, the patient underwent blood sugar test and the result was 170 (unspecified unit). The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event morning blood sugar reading was 170, this is very high was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient fainted about 2-3 minutes after receiving first Pfizer COVID vaccine. Instantly awoke and remained upright and breathing regularly. Fainted again after another 2-3 minutes of being awake. 911 was called and EMTs arrived. Vitals were normal and patient declined to go to the hospital with EMTs. Patient stayed for another 15 minutes inside the store.
Three (3) days after receiving my second shot, I began to feel nauseous.  Shortly after, diarrhea began and lasted for 24 hours.  Then, I began to have the chills and a migraine-like headache.  The migraine is still continuing past 24 hours.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 49-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0172), intramuscularly, in left arm, on Apr 22, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed influenza (flu symptoms), onset Apr 23, 2021, with outcome of recovered (Apr 24, 2021). Relevant laboratory tests and procedures available in the appropriate section. No therapeutic measures taken as a result of influenza. Additional information: The event did not require the initiation of new medication, other treatment or procedure. No follow-up attempts possible. No further information expected.
Patient said that within a day she had gotten a cold with a bad headache.  She also complained of a rash and swollen/sore arm after the vaccine for a couple of days. She had a hard time lifting her left (vaccinated) arm for 2 days after getting vaccine. She reported this to us 4 days after receiving the vaccine and the arm no longer had a rash or was swollen but she felt sick with a cold/flu.
No additional AE reported.; EDVAX HIB and ROTATEQ were administered to a patient after a temperature excursion.; This spontaneous report was received from a medical assitant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 04-MAY-2023, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, once, lot #W028534 has been verified to be valid, expiration date: 10-MAY-2025 (dose, strength, route of administration and anatomical location of vaccination were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, once, lot #1938977 has been verified to be valid, expiration date: 30-APR-2024 (dose, strength, route of administration and anatomical location of vaccination were not provided), both administered for prophylaxis; that underwent a temperature excursion of 49 Fahrenheit degrees for 1 hour (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Uncontrollable shaking, teeth chattering, fever of 102, barely able to walk due to the shaking, nausea, body aches, and joint pain, occuring approximately 7 hours after vaccination and lasting approximately 14 hours . Severe facial/sinus pain on left side of face March 20 (approximately 48 hrs after vaccine) lasting about 24 hours. And then Mild facial/sinus pain on left side of face lasting another 24 hours. Used ibuprofin, meloxocam 7.5 mg, and extra strength tylenol to help relieve side effects. The first 7 hours after the vaccine none of the anti-inflammatory medications helped to relieve any side effects. The facial pain I experienced a day later was relieved somewhat with the anti-inflammatories.
Complained of feeling nauseated and tired evening of vaccination.  Bruising behind knee-went to MD with diagnosis: down pepliteal pulse/blood clot.  Prescribed 6 Asprin x 2 days and sent home with bedrest.  Liver enzymes up.  All resolved by Monday (2 days later).
Localized reaction of upper arm (vaccination site arm) swelling of upper arm, arm felt feverish. Severe pain in arm, cannot raise arm, sick stomach. Treated with cold compress and ibuprofen.