chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; body aches; headache/ nagging headache; fever; chills; very fatigued; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via intramuscular route of administration, administered in left deltoid on 26Oct2021 10:45 as DOSE 3 (BOOSTER), SINGLE for COVID- 19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included Moderna vaccine (MODERNA COVID-19 VACCINE, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 single both for COVID- 19 immunization. Reporter stated on 27Oct2021 about noon started to feel very fatigued, 17:30 noticed fever and chills, 27Oct2021 19:00 headache began (headache/nagging headache), Fever and chills returned by 22:00, night was uncomfortable, on 26Oct2021 10:45 booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna, booster dose, 28Oct2021 18:00 body aches started, and headache returned, Minor chills and nausea. Continued nagging headache. Body aches improved throughout day. Slept well that night. Event took place after use of product. Therapeutic measures were taken as a result of the events which included fever, chills, headache/ nagging headache included 400 mg Ibuprofen (Took more Ibuprofen at 12:30. 400 mg), 509 mg of Ibuprofen (By 21:40). Outcome of the events was recovered on 29Oct2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt had generalized febrile seizure on 7/13/17, one day after Hep A vaccine. Temp 101.1 degree in ER. Small cut on tongue noted. Tube in (L) TM. Saw neurology on 9/14/17, developing normally.
Confirmed Breakthrough Case   COVID-19 (Moderna) 1  03/17/2021 Health Dept Moderna 044A21A   COVID-19 (Moderna) 2  04/14/2021 Health Dept Moderna 037B21A   COVID-19 (Moderna) 3  10/29/2021 Pharmacy 01745 Moderna 004F21A
Pain from shoulder to elbow in arm first day (the second day swollen spot above elbow from PNEUMOVAX 23 arm only (left arm).
Throat swelling. Constant swallowing as if something was stuck in throat. Mouth swelling and tingling. Sought medical care at 8:30 PM.  Adrenaline shots given at 9:45 PM. No immediate reduction of swelling so was sent to Hospital ER. Swelling was reduced by 12:00 AM and went home.
Sore arm; Received 1mL for 1st and 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 13-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        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.   Patient asked whether she will have any long-term side effects from being given 1ml each of her first and second vaccine doses.   This case was linked to MOD-2021-395750, MOD-2021-395764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Nov-2021: Follow-up received on 27-Nov-2021: contains Non-Significant information.
feeling unwell, tired, considerably achy arm at injection point, lingering headache, slightly warmer temperature, achy, would rather stay in bed and sleep
Symptoms started after 2-3 mins of vaccine. Started having numbness, tingling on face, arms, legs, tachycardia up to 144 bpm, dizziness, palpitations, chest tightness. Lasted up to 1 hour. Observed in clinic and went home after 2.5 hrs. At home continued to have on and off palpitations for 2-3 hrs with heart rate increasing to 110 bpm.
Five minutes after receiving the vaccine patient reported numbness and tingling of her cheekbones (Bilateral) that moved to her lips and then to the tip of her tongue.
he lymph nodes on her lower neck, in line with her shoulder, onthe side of the injection sitebecame swollen; in line with her shoulder, on the side of the injection site, became swollen; Redness around area of injection site; A spontaneous report  was received on 17 Feb 2021,   from a Consumer concerning a 39-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness around area of injection site, swollen lymph nodes next to neck, in line with her shoulder, on the side of the injection site, became swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events redness around area of injection site . On 13 Feb 2021, the patient experienced the events swollen lymph nodes next to neck. in line with her shoulder. On the side of the injection site, became swollen.  Treatment details included Antibiotics  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, redness around area of injection site, On an unknown date the outcome of events, swollen lymph nodes next to neck, On an unknown date the outcome of events, in line with her shoulder, On an unknown date the outcome of events, on the side of the injection site, On an unknown date the outcome of events, became swollen was not reported.
Neuropathy; Shingles; Didn't get it due to COVID-19; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), shingles and social problem. On an unknown date, the outcome of the neuropathy, shingles and social problem were unknown.   It was unknown if the reporter considered the neuropathy and shingles to be related to Shingrix.  Additional information was provided as follows: The patient was due in February to get the second dose and she didn't get it due to COVID-19, which led to social problem. The patient got shingles during a vacation last summer and she experienced neuropathy. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 at 12:00 as DOSE 4 (booster), SINGLE (Lot number: FJ6369 and the expiry date was unknown) at the age of 66 years, in left arm for COVID-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (Batch/Lot number and the expiry date were unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number and the expiry date were unknown) for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "Known allergies: Coconut" (unspecified if ongoing). Concomitant medication(s) included: EZETIMIBE; MONTELUKAST; FLUTICASONE PROPIONATE.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: It was reported that the patient received anti-viral Paxlovid for COVID 19 Treatment, (Lot number=GA7394). It was also reported that the patient received Android Elipta (start date 01Jun2018) other medication within 2 weeks product. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient previously receives a COVID-19 Vaccine. On 01Jul2022 at 06:00 PM the patient experienced very strong metallic taste in mouth and patient did not receive the treatment and the outcome for this event was not recovered.  No follow-up attempts are possible. No further information is expected.
Cervical and facial lymph nodes swelling and pain; Cervical and facial lymph nodes swelling and pain; Cervical and facial lymph nodes swelling and pain; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 12:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included previous mononucleosis infection (mononucleosis infectious) from 2003, chronic shoulder pain, anxiety, irritable bowel syndrome (IBS) and gluten allergy (gluten intolerance). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), cabergoline (MANUFACTURER UNKNOWN) and zolpidem tartrate (AMBIEN) all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received diphenhydramine hydrochloride (BENADRYL) and oxycodone hydrochloride (OXYCONTIN) and experienced drug allergy. On 16Apr2021, the patient experienced cervical and facial lymph nodes swelling and pain for 3 weeks after first shot and vertigo intermittent over 2 weeks. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cervical and facial lymph nodes swelling and pain and vertigo were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007n28) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on his arm). At the time of the report, PAIN IN EXTREMITY (soreness on his arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: MA Data correction; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excludes.
PT SAT FOR 15 MINUTES THEN REPORTED FEELING DIZZY AND NAUSEAOUS AND ASKED FOR WATER. PT SAT AN ADDITIONAL 15 MINUTES AND SAYS SHE FELT THE SAME AND FELT SHAKEY. PT AND PARENTS ASKED WE CALL EMT AT THIS. PT HAS HX OF SEIZURES AND WAS ANXIOUS WHILE GETTING THE SHOT. EMT WAS CALLED AND PT WALKED OUT OF SITE WITH EMT.
Patient was given the Moderna vaccine at age 17, which is not currently approved. No adverse events occurred after this vaccination.
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th January 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of Havrix, which led to expired vaccine used. This case was linked with case US2022005768, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2022005768:same reporter.
Cough, erythematous, macular-papular rash, extensive, non prurtic.
Cellulitis of the left  upper  limb, chills, and fever.  Employee was sent to the ER for further evaluation and possible IV therapy
Patient claimed to be immunocompromised, she had primary series of J&J, her doctor asked her to have another COVID vaccine. She received Moderna 1st dose from other facility on 12/11/2022. She showed up in our facility on 01/20/22 and inadvertently immunized with another full dose of Moderna.
Face heaviness; Hands/feet weak; Hands/feet weak; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 at 10:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. The patient previously received diphenhydramine hydrochloride ( reported as BENADRYL) and pethidine hydrochloride(DEMEROL); both for unspecified indication from unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced face heaviness and hands/feet weak. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prednisone, hydroxyzine and famotidine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of face heaviness and hands/feet weak was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Within 36 hours, 2/27 my knees swelled and I was unable to walk.  On Sunday we went to The ER  near where we were and had x-rays and ultrasound of my knee. Dr. took a fluid sample for culture but said it looked clear. I have no history of arthritis nor any injury. I am an avid bike rider and suddenly cannot stand on my feet due to extreme pain.
headache; nausea; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain). At the time of the report, HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a physician via company representative regarding a 12 month 3 week old female patient. Information on the concurrent condition, pertinent medical history and drug allergies of the patient were not reported. On 16-MAY-2016, the patient was vaccinated with VARIVAX lot #M000760 (expiry date, dose number, route and anatomical location were not reported). Concomitant medication were not reported. On an unknown date, there were bug bites on the baby but some looked like chicken pox and there was a possibility that the marks were chicken pox (unknown by the reporter if it was chicken pox). On 25-JUN-2016, the patient had sought medical attention and treatment was given for the event. There was no Product Quality Concerns (PQC) involved. The outcome of varicella was unknown at the time of reporting. No further information was provided. Relatedness of the event were not reported. Additional information has been requested.
pt states he had chills, fever, body aches, head pressure, achy legs and has developed a red rash from waist up to his neck, on his back, and on both arms.  Pt is not taking any meds for his symptoms.
We had an employee, who reported an incident and concerns after receiving her second Moderna Covid vaccination. Patient reported that the individual who vaccinated her, injected her and shared with her that no dose had been pulled up. Patient asked the vaccinator if she thought another injection with a dose should be given. The vaccinator agreed and proceeded to draw up a dose as witnessed by patient and performed the injection, however, patient reported how she did not feel certain of actually receiving the second dose as she did not witness the disposal of an empty syringe. Patient is concerned to have possibly received 2 doses or no 2nd dose.    The report was discussed with the vaccinator and the vaccinator confirmed that 2 physical injections were given, with the first not having any vaccine drawn into the syringe. She explained that she knew she had not pulled up any vaccine with the first injection as the plunger did not advance.  So the vaccinator proceeded to draw the vaccine with a new syringe and confirms having given the 2nd injection with the vaccine drawn.
My symptoms were sore throat, coughing, nausea. I tested positive for COVID-19 on 01/03/2023. I called my provider on 01/04/2023 and provider prescribed medication but did not take medication. I was sick for 10 days and tested negative for COVID-19 on 01/13/2023.
Some effects on her GI; Bowel movement was different; constipation; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE]), OMEPRAZOLE, VORTIOXETINE HYDROBROMIDE (TRINTELLIX), DIAZEPAM (VALIUM), METOPROLOL TARTRATE, OLMESARTAN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PARACETAMOL (TYLENOL), MINERALS NOS, VITAMINS NOS (CENTRUM PLUS), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) and ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation). At the time of the report, ABDOMINAL DISCOMFORT (Some effects on her GI), BOWEL MOVEMENT IRREGULARITY (Bowel movement was different) and CONSTIPATION (constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-047088 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Non significant follow up. Patient demographic details added
Large area of erythema and induration 8.5 cm x 13.5 cm (generalized induration-no definite border). Elevated temp to surface of skin. Received DTaP, IPV to left thigh 36 hour prior to reaction.
Patient received the Moderna Covid-19 vaccine and during the observation the patient was observed to experience a reaction.  Approximately 5 minutes after the vaccine patient experienced warmth, dizziness, weakness, confusion, vision blurred, labored breathing, hypotension, mild nausea.  Blood pressure was dropping after first reading from 96/60 to 86/42 at which point a single dose of epi-pen was administered.  The patient BP stabilized at 105/83 at the time paramedics arrived and took the patient.
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Approximately 5 minutes post vax, the pt complained of hives, itching to both arms. The pt was treated with Benadryl. Approximately 15 minutes later the pt stated the itching has decreased.
I didn't have the vaccine, but my son came from overseas.  I picked him up from the airport on September 15, 2021.  I was with him closely on that evening and on the next three days.  We traveled in my small car for several hours on the 16th, and then we traveled on the 17th. We were in the same house the entire time on the 15th, 16th, 17th, 18th and again on the 19th.  On the 19th at approximately 3PM, I went to the restroom and found the bowl to be filled with bloody and clotted urine.  This happened three times during that afternoon.  I called and got an appt with an ob/gyn because I didn't know where the blood came from. on September 23rd, I saw Dr. he examined me.  He was sure that the blood was from the urinary track.  I was sent for a sonogram to see if they could figure out why I bled on the 19th.  He also sent me to Quest Diagnostic for a CoVid Antibody test.  The test was negative/negative, meaning that I never had CoVid.