chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller is a consumer who received his first Pfizer-Biontech Covid19 vaccine, yesterday, and is reporting a sore throat that "just feels raw"; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine, yesterday (21Jan2021), and is reporting a sore throat that "just feels raw".  He wanted to know if this is normal. He also stated that the weather was poor yesterday and might have contributed to his symptom. The patient got the shot about 24hrs ago; the patient stated, "sore throat - raining and kind of nasty sore - just raw". The outcome of the event was unknown.  Information on the LOT/Batch number has been requested.
Two days post vax, the pt developed severe joint pain, swelling, and pain in hands and feet. She had a mild pink itchy rash on arms and legs and swelling of the lips. The pt was treated with hydroxyzine.
pain in arm, hand; pain in wrist.; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In MAR-2023, 1 week after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain in arm, hand) and wrist pain (Verbatim: pain in wrist.). The outcome of the pain in arm and wrist pain were not resolved.   It was unknown if the reporter considered the pain in arm and wrist pain to be related to Shingrix.     It was unknown if the company considered the pain in arm and wrist pain to be related to Shingrix.   Additional Information: GSK Receipt date: 30-MAR-2023. The reporter was the patient's daughter.  Patient had no pain for the first week. One week after the injection, she experienced pain in her left lower arm, hand and wrist.  The pain resolved but has now returned. Nothing else was reported. The reporter did not consent to follow-up. The case was linked with case US2023048020, reported by same reporter.; Sender's Comments:  US-GSK-US2023048020:same reporter
Booster; Off label use; There was a (Positive Event.) Ive had sore knees for years, after the second dose of Covid -19 vaccine, I no longer had any pain in either knee. This is 5 days as of 3-5-21; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age of 80-years-old) and a third dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included sore knees for years and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 08Feb2021 at 09:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. 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. On 01Mar2021 at 08:00, the patient experienced a positive event. The patient has had sore knees for years, after the second dose of COVID -19 vaccine, he no longer had any pain in either knee. It was 5 days as of 05Mar2021. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event there was a positive event; had sore knees for years, after the second dose of COVID -19 vaccine, no longer had any pain in either knee; it was 5 days as of 05Mar2021 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
right and left hand at the wrist started swelling/fingers were puffy/some both ankle swelling; fingers were puffy; both ankle swelling; painful; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (right and left hand at the wrist started swelling/fingers were puffy/some both ankle swelling), PERIPHERAL SWELLING (fingers were puffy), JOINT SWELLING (both ankle swelling) and ARTHRALGIA (painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ABATACEPT (ORENCIA) from 17-Feb-2021 to an unknown date for Rheumatoid arthritis, VALSARTAN, RABEPRAZOLE SODIUM (ACIPHEX), ATENOLOL (ATEROL [ATENOLOL]), ALPRAZOLAM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (right and left hand at the wrist started swelling/fingers were puffy/some both ankle swelling), PERIPHERAL SWELLING (fingers were puffy), JOINT SWELLING (both ankle swelling) and ARTHRALGIA (painful). At the time of the report, JOINT SWELLING (right and left hand at the wrist started swelling/fingers were puffy/some both ankle swelling), PERIPHERAL SWELLING (fingers were puffy), JOINT SWELLING (both ankle swelling) and ARTHRALGIA (painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were anti-inflammatory OTC medication, and multivitamins Action taken with mRNA-1273 in response to the events were Not Applicable.
Vaccine administered incorrectly via the ID route left inner forearm. Patient developed cellulitis to the area and received IV antibiotics as an outpatient for 5 consecutive days.
Information has been received from a physician via company representative regarding 16-year old female patient. In August 2008 the patient was vaccinated with the first dose GARDASIL (lot number, route and site of administration were not reported) as a prevention of HPV. In September 2011 the patient got her second dose of GARDASIL 0.5 ml (lot number, route and site of administration were not reported) as a prevention of HPV. The doctor told that the patient became pregnant (October 2011) after receiving her second dose of GARDASIL. The patient was as 6 months gestation at time of report and LMP was approximately on 18-OCT-2011, Estimated Delivery Date (EDD) was approximately on 24-JUL-2012. No adverse event was reported. The patient has not yet received her third dose yet. The patient sought medical attention. No treatment was given for the event. The patient sought unspecified medical attention. The outcome of adverse events was not reported. The relatedness between therapy with GARDASIL and adverse events was not reported. Follow-up retrospective pregnancy report was received from a physician refers to a 16 year old female patient. It was reported that the Estimated Delivery Date (EDD) was on 20-JUL-2012. The pregnancy outcome was reported as: normal infant, without congenital anomaly. Additional information is not expected.
Have had a pretty nasty headache since that just won't go away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Have had a pretty nasty headache since that just won't go away) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Have had a pretty nasty headache since that just won't go away). At the time of the report, HEADACHE (Have had a pretty nasty headache since that just won't go away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
no adverse event; patient received an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse, referring a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On an unspecified date in August 2020,  the patient was administered improperly stored Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23)  (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T000702 , which has been verified to be valid, expiration date reported and validated as 01-OCT-2021), as prophylaxis (product storage error). At the reporting time, no adverse events were reported.   The vaccine administered was stored at temperatures that went from above 9 degrees Celsius (C) to 13.4C for a time frame of 51 hours and 36 minutes, as recorded by a data logger. There was no previous temperature excursion.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0196), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had oropharyngeal pain (outcome unknown) and headache (outcome unknown). Additional information: Patient wanted to talk to a nurse. Patient was supposed to have a shot (confirmed later as second shot of Pfizer COVID-19 vaccine on Sep 16, 2021). The patient's throat was kind of sore (a little bit) and having a headache off and on. The patient just wanted to know if it's okay to still take the shot or get tested for COVID-19. No follow-up attempts possible. No further information expected.
A report was received from a health care professional on 10/28/2003 concerning a female vaccinee of approximately 45 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/24/2003. An Ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 03/01/2004: Follow up information received from a health care professional indicated that a 59 year old female vaccinee experienced pain at the injection site running down the are which lasted approximately 20 minutes. No follow up pending. Cross reference with PJP200300925, PJP200300926, PJP200300928, PJP200300929, PJP200300930.
chest palpitations; blood pressure went "way up"; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up") in a 72-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up"). At the time of the report, PALPITATIONS (chest palpitations) and BLOOD PRESSURE INCREASED (blood pressure went "way up") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2022-440090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up document contains non significant information reporters details updated.
Patient experienced sore muscle/arm and chest. Possible tremors late at night that she believes may have been from the shots. All symptoms have subsided. No medical treatment needed.
Sore arm, severe headache, fever, heart palpitations, blood pressure - 87/59, healthcare provider confirmed heart was enlarged. (atrial enlargement)
The patient developed symptoms of congestive heart failure about 1-2 weeks after receiving her COVID booster. She presented to the ED on 11/15/2021 with clinical evidence of congestive heart failure. An echocardiogram revealed severe global left ventricular systolic dysfunction with multiple mobile echodensities noted within the left ventricle suggestive of thrombi. Clinical picture and left ventricular thrombi were suggestive of possible underlying myocarditis.
Both my husband and I received shingles vaccines at pharmacy. The first one led to some arm pain and that was all. After the second shot we both experienced severe headache, nausea, and fever.
Patient reports about 2hrs. after injection had difficulty catching breath, gasping.  Went to drug store and purchased Primetine inhaler.  Took two puffs and felt better, 1 hour later took another puff and went to bed.  During night had night sweats. Heart rate seemed rapid, face flushed.
chills; headache; nauseous; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-093117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26APR2021, Added information about reporter details ( address, email), AE Contact Information Updated
Friend had it got the most extreme migraine. Sharp stabbing.; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's friend) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporters friend experienced had it got the most extreme migraine. sharp stabbing on an unspecified date. The outcome of event was unknown.  Follow-up (02Jul2021):This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (reporters friend) that: No information was provided for Reporters friend.  Information on the lot/batch number has been requested.
little bit of a sore arm; itches; kind of burns; 3 inch by 3 inch red swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), VACCINATION SITE PRURITUS (itches), VACCINATION SITE PAIN (kind of burns) and VACCINATION SITE SWELLING (3 inch by 3 inch red swelling at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itches), VACCINATION SITE PAIN (kind of burns) and VACCINATION SITE SWELLING (3 inch by 3 inch red swelling at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm), VACCINATION SITE PRURITUS (itches), VACCINATION SITE PAIN (kind of burns) and VACCINATION SITE SWELLING (3 inch by 3 inch red swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Bumpy rash on left shoulder blade, aching pain in armpit and stinging pains in left breast. Dr. thought it was beginning of Shingles. Gave me Acyclovir 800 mg 5x a day.
swelling on her armpit; This is the spontaneous report from a contactable consumer (Patient). A female patient of unknown age received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot Number: unspecified), via an unspecified route of administration on 31Mar2021 (Wednesday), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Yesterday, on 01Apr2021, the patient experienced that she had swelling on her armpit and wants to know if this was normal. The outcome of the event was unknown. Follow-up (05Apr2021): This is a follow-up spontaneous report in response to mail trail send to translate the attached report.  No follow-up attempts are possible. Information about lot/ batch number cannot be requested.
Pruritus; Pruritus; Rash; Rash;  Narrative: 68-year-old male reporting that he received flu shot in 12/2022 outside of facility. Per 01/31/2023 Chart Review Note Patient reported itching 24 hours after receiving vaccination and concurrent
Writer had three unopened syringes and went to get them prefilled at lead nursing station. Upon arrival second lead nurse and other nurse that was sitting there had three total prefilled opened syringes. Writer gave the three unopened syringes to other nurse and got her 2 opened what seemed to be prefilled syringes and one open prefilled syringe from second lead nurse. Writer got patient and proceeded to administer one of the syringes from the other nurse but noticed that although plunger was pulled up the were empty syringes and contained none of the vaccine. Writer explained this to the patient and patient understood and agreed to get the correct prefilled syringe with the correct dosage amount of 0.5ml. Explained that all needles were brand newly opened. The vaccine just had bot gotten drawn up into the syringe yet. Advise patient to sit in observation for 30 minut4es. Patient 16:20 checked on patient who  said that she feels normal. At 16:30 checked in again with patient before she departed says that she feels normal she just having soreness in arm which is a normal side effect. Advise she can take Tylenol/ibuprofen and move  arm around. Lead nurse was advised before correct dosage syringe and vaccine was given to patient. We both spoke to patient.
Pt. expired on 10/3/09. Attending MD did not believe immunization was cause of death but reported because of dose temporal proximity. (Pt. expired approx. 24 hrs after receiving the flu vaccine).   10/16/09 Death Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension.
received 2 doses of Shingrix and developed shingles / Suspected vaccination failure; received 2 doses of Shingrix and developed shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received two doses of Shingrix and developed shingles. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.
Headache since getting the vaccine that has not stopped. Shortness of breath, chest pain and palpitations with any activity. HR has significant increase with any activity. Headache gets worse after episode of chest pain, sob etc. Pressure headache that is in the front of the head since getting vaccine. Now on a beta blocker to help with Heart rate and out of work since getting vaccine.
Woke up several hours after adminstration with swelling, redness and heat at the injection site.
Swelling and redness at injection site; taking ibuprofen and antihistamines; also to be noted: I had wisdom teeth extracted the next day.
No AE; While administering VAQTA vaccine, the patient jerked their leg. Small amount left; While administering VAQTA vaccine, the patient jerked their leg. Small amount left; This spontaneous report has been received from a medical assistant and refers to a 12-month-old child patient of unknown gender. Information regarding the patient's current conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications was not provided.  On 19-SEP-2023, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) "25/0.5" intramuscular injection as prophylaxis (dose and route of administration were not provided; lot number 1971534 has been verified to be valid, expiration date reported as 26-OCT-2024, but upon internal validation, it was established as 06-OCT-2024); while administering the vaccine, the patient jerked their leg and a small amount was dripping down the child's leg and a small amount left in syringe (exposure via skin contact and incorrect dose administered). There were no adverse events reported.
Headache, Arthralgia, sweating,nasal congestion, sore throat Narrative:  Had to stay home from work due to symptoms