chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Fever, NauseaVomiting, chills Narrative:
PAIN, SWELLING & REDNESS ALONG UPPER ARM FROM SHOULDER TO ELBOW, ITCHY AROUND SITE.
I firmly believe that what is wrong with me, the vaccine triggered something in my body; I have had this cough since March; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified gender and age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history included cataract surgery. The concomitant medications were not reported. Patient firmly believed that what was wrong, the vaccine triggered something in the body. Patient got the Pfizer vaccine in Mar, the first part in Mar and  can look on card and give the dates. So, took one shot and in the meantime, was having cataract surgery and so, had one eye done and then had to wait for a week or so and then had the other eye done. When had the second eye done and had already taken the second vaccine and got something called episcleritis, it is autoimmune and they say it was not caused from the surgery. So two days after the second vaccine, got a stomach infection, had been tested by ENT, by the allergists and by doctor and they did not know, they said it was not sinus, it was not allergy and have had this cough since March. So was telling us something happened with that vaccine in body, firmly believed it. So when had this coughing, it is really weird, nose ran, usually the left side of nostril, nose, the left side ran and did not cough all the time but it was not going and had been on every medicine. Now was on medicine for acid reflux to see if that is the problem which did not really know if had acid reflux and had been taking this medicine for 3 days (further clarification about acid reflux is unknown, hence acid reflux captured as event) and  was about to switch to something more natural because did not know, tried not to take a whole lot of medicines, so had to stop taking it, it was dangerous. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Patient complained of "normal, typical" soreness in left deltoid area the day after receiving Afluria Influenza vaccine. However, the soreness continued. Patient reported the persistent soreness on 11/3/23. She stated the affected area bothers her when she moves her arm in certain directions. She reports normal range of motion of shoulder. Denies any numbness/tingling to left arm. Denies any swelling to left deltoid area. She describes left deltoid as a muscular soreness equivalent to what one would feel after working out.
Administration Error: Patient had Moderna vaccine  first dose in 3/24/2021 and Pfizer vaccine 8/26/2021 Reason for error:  Patient  came to the Health Center indicating she wants to have the first Covid vaccine. The patient never provided information of having a prior Moderna dose in march 2021.  We came to know about the error when entering the data in the vaccine reporting system of the Health Department.  We are filing the report  as recommended by local Health Department.  There was no side effects of vaccine no adverse reaction of medication. She did not have to look for medical Help after the vaccine.
Patient immediately became pale, nauseated, and diaphoretic. She was momentarily non responsive. Remained nauseated for the remainder of the day.
Feel very bad; Pain; Vvoice is agitated; Eats half of the usual; Tremors; Dizzy; Feels very heavy; As if she had all the AE of covid; Vomits; Headache; Chills; Tired; Nausea; Shivering of cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual) and TREMOR (Tremors) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A or H and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold). At the time of the report, FEELING ABNORMAL (Feel very bad), PAIN (Pain), DYSPHONIA (Vvoice is agitated), DECREASED APPETITE (Eats half of the usual), TREMOR (Tremors), DIZZINESS (Dizzy), LIMB DISCOMFORT (Feels very heavy), VACCINATION COMPLICATION (As if she had all the AE of covid), VOMITING (Vomits), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Tired), NAUSEA (Nausea) and CHILLS (Shivering of cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication list was not provided. Treatment provided include injection for pain and sublingual pill for nausea. The patient reported that she had an X-ray of her lungs.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 21-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient recieved egg free flu shot and while waiting the 15 minute started to have right side arm tingling and right side tingling. Syptoms continued to worsen. Pt became nausiated.  Pt taken to ED for evaluation and treatment. Pt recieved Benadryl, Famotidine, LR, ondansetron, and dexamethasone.  In ED on cardiac monitoring, pulse oximetry, and had IV access. Remained hemodynamically stable. Symptoms resolved and was sent home with a corse of prednison and dose have an epi pen at home.
patient reports having tingling/chills about 90 min after vaccination. No rash/hives/swelling or difficulty breathing.  Some lightheadedness and feeling of blacking out.  Patient did not have this reaction with the first pfizer shot.  Patient was concerned since the onset was so soon after vaccination.  Recommended patient rest as much as possible, drink plenty of water and eat some food.  Patient may take tylenol if needed for fever/pain. Patient did have a granola bar and water for breakfast and had just recently ate lunch.  Recommended no driving or any activity that requires attention/moving due to lightheadedness.  Patient does have someone that will be checking in on him to see how he is doing.  Advised that patient seek medical attention if condition worsens or if any trouble breathing or swelling
muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk; muscle tight; extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like), MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to codene /stantants) and Colitis in 2004. Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN E NOS, CALCIUM, UBIDECARENONE (COQ 10), SALMON OIL, VITAMIN D NOS and MULTI VITAMIN & MINERAL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like). On 26-Feb-2021, the patient experienced MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight). At the time of the report, MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like), MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 94 % (normal) 94 and 97 % (normal) 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021.Added patient details, medical history, concomitant medications and outcome of the event.
Nausea; fatigue; headache; dizzy; lower grade fever; occasional chills; right ear pain; strange sensation in ear; Tingling in face.; strange sensation in glands.; shaking of legs; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient was allergic to penicillin and walnuts and sensitive to most drugs. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received flu shot and experienced swelling of lips on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 17:00 the patient experienced nausea, fatigue, headache, dizzy, lower grade fever, occasional chills, right ear pain and strange sensation in it and glands and tingling in face. On 08Apr2021, first night of vaccination, the patient experienced shaking of legs for 15 minutes while in bed. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event nausea, fatigue, headache, dizzy, lower grade fever, occasional chills, right ear pain and strange sensation in it and glands and tingling in face was unknown. The clinical outcome of the event shaking of legs was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
11/4/2016 Onset of Pain at injection site. 11/8/2016 Seen in Urgent Care c/o dull ache and deep pain in Right Bicep following injection.  11/10/2016 Seen in Urgent Care c/o cough, sinus pain, congestion. 12/27/2016 received report from patient that right arm feels "like concrete" and she has significant less range of motion and strength in that arm since the injection. Reports it has never been "normal" since the injection. At time of this report, patient indicates her symptoms have been permanent since the injection, and worsening.
pt. c/o tingling sensation on left hand. Pt. advised to move left arm to help relieve symptoms.   V/S: 137/83, 87,18,97% RA, PS 0/10  #21 pt stable and went home
tested positive for Covid 19; pneumonia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her 1st dose of Covid 19 Vaccine on 03Apr21 and was tested positive for Covid 19 on 07Apr21. She had been hospitalized and just got release from the hospital (19Apr21), she had pneumonia now and wanted to know if she will still get her 2nd dose and if it was still possible to get it on (24Apr21). The patient was hospitalized for tested positive for covid 19 (covid-19) from 07Apr2021 to 19Apr2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.
day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intestinal tract upset slight nausea and diarrhea. Next day...arm better, lightheadedness better, very tired and slept a lot. Next day: not bad during day. in evening had shooting pains in calves, and sweated a lot at night. Arm much better. Today: arm almost painless, still a bit lightheaded, intestinal tract still "busy". no pains in legs.
On 12/17/19, patient said she had fever and chills, aches, headache, pain and redness at the injection site, and fatigue. On 12/18/19, she said she had severe diarrhea and vomiting. On 12/19 and 12/20, she said her stomach felt distended and she was unable to eat solid food, but she began to have normal bowel movements.
Nausea, body aches, fever, lightheadedness, loss of taste, headache and chills. Chills started about 16 hrs after shot. Rest of the symptoms happened about 24 hrs later from initial injection.
Bitter metallic taste; Tiredness; head pressure; flushing; muscle aches; injection site tenderness; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 23Feb2021 08:30 (Batch/Lot Number: EN5318) (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation. Medical history included allergies in latex and adhesives. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID, 25 ug) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks before vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9265) (at the age of 32-years-old) on 29Jan2021 at 09:00 for COVID-19 immunisation. The patient experienced bitter metallic taste, tiredness, head pressure, flushing, muscle aches and injection site tenderness (for 48 hours) on 25Feb2021 at 12:00, 48 hours post vaccine. The patient received no treatment for the events. The adverse events resulted to none. The outcome of events bitter metallic taste, tiredness, head pressure, flushing, muscle aches was recovering; while outcome of event injection site tenderness was recovered on 27May2021 at 12:00 (48 hours).   No follow-up attempts are possible. No further information is expected.
No adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 6th of 16 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  16 patients were administered pediatric monovalent vaccines instead of bivalent boosters on 21DEC2022.   Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Chest pain; Palpitations; Left arm numbness; Tingling in left arm; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness), PARAESTHESIA (Tingling in left arm) and CHILLS (Severe chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Severe chills). On 08-Jan-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness) and PARAESTHESIA (Tingling in left arm). On 07-Jan-2021, CHILLS (Severe chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness) and PARAESTHESIA (Tingling in left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was provided. Patients wants to confirm that these are common side effects of vaccine and gives her consent to contact her HCP for her side effects.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Booster given 12hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H213) for an unknown indication.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) to be not related.    Patient has not been diagnosed or tested for covid -19. Booster given 12 hrs after puncture of via, specifically 4 days later. No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-416295 (Patient Link).
Drug ineffective; covid test result=Positive; fever; chills; body ache; headache; fatigue; Rash/red splotches on stomach, worsening; red splotches on stomach, worsening; This is a spontaneous report from a contactable other health care professional reported for a 31-Year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EK5730), via intramuscular on 28Jan2021 at 15:15 as single dose in left arm for covid-19 immunization. The patient's medical history included anemia, scoliosis, and anxiety.  Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN) and ethinylestradiol, norgestimate (MONO-LINYAH).  Historical vaccine included BNT162B2 (administration date-07Jan2021, administration time-12:15 PM, administrator route-Intramuscular, vaccine location-Left arm, dose number-1 and Lot number-EL3248). On 28Jan2021, the patient experienced fever, chills, body ache, headache, fatigue, red splotches on stomach and worsening over time. On an unknown date, she experienced rash. The patient experienced events at Doctor or other healthcare professional office/clinic visit. Laboratory details included Nasal Swab (PCR) with results positive on 22Feb2021. It was unknown if patient was received treatment for the events. The outcome of the events was not recovered whereas the event drug ineffective was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Note:  I had a PCR confirmed SARS-CoV-2 infection in March, 2020.  Approximately 12 hours after the second vaccine dose, I experienced intense soreness at the vaccination site (significantly greater than the first dose).  In the middle of the night I awoke with flu-like symptoms.  At 9am I took acetominophen  for fever, rigors, muscle aches.  This brought mild relief from approx. 9:45am to 11:15 am.  My condition continued to worsen through the early afternoon with rigors and significant generalized muscle aches.  I experienced tachycardia (90-105 bpm vs normal of ~70bpm),  SOB,  and starting measuring pulse oximetry which read from 89%-94% (my usual does not go below 97%).  This persisted until approximately 8pm with no improvement.  I took 40 mg prednisone, 600 mg ibuprofen and within 3 hours was starting to have symptom resolution. I am a physician and up to date on all my vaccinations.  I have never had anything approaching this type of response.  I don't know if prior SARS-CoV-2 infection  creates a situation were the very potent mRNA vaccine triggers a large immunologic recall response.  I wanted to get this noted as there may be some reason to alter the vaccine schedule for prior SARS-CoV-2 infections
p/vax pt had red rash @ site;2cm diameter;today 6/21 rash is felt red, not warm, not itchy & 4x3cm;