chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported.  No concomitant medications were reported.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tired; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and MYALGIA (Muscle ache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to analgesics (Anaphylaxis), Hives, Asthma and COPD (Stage 4, getting worse) since 2010. Concomitant products included VITAMIN D NOS, VITAMIN B NOS and MELATONIN for an unknown indication.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (Tired) and MYALGIA (Muscle ache). At the time of the report, FATIGUE (Tired) and MYALGIA (Muscle ache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment includes oxygen with dose as 5L for ever.   This case was linked to MOD-2021-375448, MOD-2021-375483 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 years old patient received the Moderna Covid19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.). On 13-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old patient received the Moderna Covid19 Vaccine.) had resolved.            No concomitant medication were reported.  No treatment information was provided by the reporter.  Company Comment:This is a spontaneous case concerning a 13-year-old, male patient with no relevant medical history, who experienced the non serious event of product administered to patient of inappropriate age. The event product administered to patient of inappropriate age occurred right after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 13-year-old, male patient with no relevant medical history, who experienced the non serious event of product administered to patient of inappropriate age. The event product administered to patient of inappropriate age occurred right after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: Couldn't breath; Severe reaction after getting a covid-19 shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't breath) and VACCINATION COMPLICATION (Severe reaction after getting a covid-19 shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Couldn't breath) and VACCINATION COMPLICATION (Severe reaction after getting a covid-19 shot). At the time of the report, DYSPNOEA (Couldn't breath) and VACCINATION COMPLICATION (Severe reaction after getting a covid-19 shot) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications was reported. Treatment information was not provided.  Company Comment:  This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Dyspnea and Vaccination Complication. The events occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Dyspnea and Vaccination Complication. The events occurred on an unknown date after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  The reporter stated that the vial was frozen this whole time and was thawed out one day before use. Date the vails was initially stored in the refrigerator 23 Oct 2021 and 24 Oct 2021.   This case was linked to MOD-2021-363223 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021 at 2:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021 at 2:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired). On 24-Oct-2021 at 2:53 PM, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID19 Vaccine/ Inadvertently used a lot that looks like it had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported. Seven patients were inadvertantly  administered with booster shots, Moderna,  lot 049E21A. None of the seven patients had reported any adverse reactions till  11/19/2021. Did not have any information on their past corona history.   This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant follow-up received and included patient's details (initials, DOB, age, gender, race), Suspect's details (start date, time, anatomical location, route of administration, dose number, expiration date), vaccine facility information, event onset date and stop date were updated.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: minor soreness in arm; mild headache; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a runner and was naive to medications. Treatment product was not provided by the reporter.  Company Comment The events were downgraded to non serious due to being related to the first dose of the vaccine.   This case was linked to MOD-2021-388577 (Patient Link).; Sender's Comments: The events were downgraded to non serious due to being related to the first dose of the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pharyngeal swelling, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Nerve pain on left side of head/Nerve Pain Left Scalp; tongue and throat swelling; tongue and throat swelling; face numbing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left (also reported as Left Upper Arm) on 17May2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Nerve pain on left side of scalp from 09Sep2020 to 05Jan2021 (also reported stop date nerve pain left in January and came back immediately when the shot was administered I still have it). There were no concomitant medications. The patient had no other vaccine in four weeks and no other medication in two weeks. The patient previously took cypro and experienced allergies (also reported as Known allergies: Cypro). It was reported that the patient experienced Tongue and Throat swelling, Face numbing & Nerve pain on left side of head on 17May2021 at 14:00 (also reported as 02:30 PM). It was added reported that the patient experienced Nerve Pain Left Scalp on 17May2021 at 14:00. The reporter considered the event Nerve Pain Left Scalp as serious (criteria: Important medical event) and resulted in physician office visit. It was further reported that: "Immediately upon receiving my 1st dose of Pfizer vaccine , my tongue swelled, my throat swelled, my face went numb and the nerve pain I had experienced 6 months prior came back. The nerve pain is constant to this day. My pcp and the infectious disease dept recommended, Do not get a 2nd dose of either pfizer or moderna. I am unsure of johnson & johnson too." The patient had no COVID prior vaccination:, however covid tested post vaccination (Nasal swab/ Rapid COVID test) on 09Sep2021 and was negative. The patient also went laboratory tests which includes: Covid-19 test on 19Mar2021 and 26Sep2021 all were negative. No treatment was initiated. The outcome of the events was recovered with sequel (also reported as Recovered with lasting effects); for the event Nerve Pain Left Scalp was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Bone pain, Feeling hot, Immunisation, Influenza like illness
Clinical narrative: Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels hot; Joints and body ache; felt like she was hit by a truck, and every bone in her body hurt; Dose: 3rd, Date: 07Oct2021; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was FF8841, Expiration Date: Unknown) via intramuscular, administered in Arm Left on 07Oct2021 (age at vaccination 65 years) for COVID-19 immunisation. Medical history included headache, body aches, joint pain. Concomitant medication(s) included paracetamol (TYLENOL A); ibuprofen (IBUPROFEN) taken for headache, pain, arthralgia, levothyroxine sodium (LEVOTHYROXINE SODIUM), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at 50 mg for thyroid disorder. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was EN6208, Expiration Date: Jun2021) intramuscular, administered in Arm Left on 03Mar2021 as dose 1, single for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was ER8737, Expiration Date: Jul2021) via intramuscular, administered in Arm Left on 03Apr2021 as dose 2, single for COVID-19 immunisation. No prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date the patient feels like crap, specifically has aches everywhere, does not feel good, feels like the flu, feels hot, joints and body ache everywhere. Patient stated that she felt like she was hit by a truck, and every bone in her body hurt then she was hot and had a glass of water and took some Ibuprofen which seemed to be helping also added she read the information that if you are immunocompromised, you might have issues and patient had always thought that thyroid deficiency was an immune disorder and maybe that was "part of feeling like crap. Patient stated that she is on Thyroid medication, Levothyroxine 50mg because she is immunocompromised and wanted to know if there is an interaction between Levothyroxine and the Pfizer COVID-19 vaccine. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Pain
Clinical narrative: Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels like crap, specifically has aches everywhere, does not feel good, feels like the flu; Feels hot; Joints and body ache; felt like she was hit by a truck, and every bone in her body hurt; Dose: 3rd, Date: 07Oct2021; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was FF8841, Expiration Date: Unknown) via intramuscular, administered in Arm Left on 07Oct2021 (age at vaccination 65 years) for COVID-19 immunisation. Medical history included headache, body aches, joint pain. Concomitant medication(s) included paracetamol (TYLENOL A); ibuprofen (IBUPROFEN) taken for headache, pain, arthralgia, levothyroxine sodium (LEVOTHYROXINE SODIUM), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at 50 mg for thyroid disorder. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was EN6208, Expiration Date: Jun2021) intramuscular, administered in Arm Left on 03Mar2021 as dose 1, single for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was ER8737, Expiration Date: Jul2021) via intramuscular, administered in Arm Left on 03Apr2021 as dose 2, single for COVID-19 immunisation. No prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date the patient feels like crap, specifically has aches everywhere, does not feel good, feels like the flu, feels hot, joints and body ache everywhere. Patient stated that she felt like she was hit by a truck, and every bone in her body hurt then she was hot and had a glass of water and took some Ibuprofen which seemed to be helping also added she read the information that if you are immunocompromised, you might have issues and patient had always thought that thyroid deficiency was an immune disorder and maybe that was "part of feeling like crap. Patient stated that she is on Thyroid medication, Levothyroxine 50mg because she is immunocompromised and wanted to know if there is an interaction between Levothyroxine and the Pfizer COVID-19 vaccine. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Immunisation, Palpitations
Clinical narrative: heart palpitations; Shortness of breath; dizziness; light headed; Booster; This is a spontaneous report from a contactable other hcp.   A 72-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION Batch/Lot Number: 30145BA), dose 3 via an unspecified route of administration, administered in Arm Right on 14Oct2021 13:30 as dose 3 (booster), single for covid-19 immunisation. Medical history included osteoarthritis, rubber sensitivity, Known allergies: Latex, food: Avocados. Patient previously took first and second dose of (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION), dose 1 and 2 via an unspecified route of administration, administered, single for covid-19 immunisation.  The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, The patient experienced booster on 14Oct2021 13:30 with outcome of unknown, Shortness of breath, heart palpitations, dizziness/light headed on with outcome of recovering.   Follow-Up (29Oct2021): Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2021): This is a follow up-spontaneous report from a contactable other HCP. This other HCP reported for the 72-year-old female patient in response to HCP letter [sent to other HCP] via follow-up letter which included  Follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Hypokinesia, Immunisation, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Shoulder and arm somewhat immobile after almost 3 weeks; left arm very sore; Dose number=3; Difficult doing anything requiring reaching; top of shoulder was felt like bursitis; This is a spontaneous report from a contactable consumer (patient). A 86-Year-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FF2589 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 27Sep2021 at 15:00 PM (age at vaccination: 86 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included cholesterol and blood pressure. Concomitant medications were not reported. Past drug included Keflex and had Known allergies: Keflex. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Feb2021 at 15:00 PM (age at vaccination: 85 years), as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VAC-CINE, Solution for injection, lot number: EN6203 and expiry date was not re-ported), via an unspecified route of administration, in Arm Left, on 24Feb2021 at 14:00 PM (age at vaccination: 85 years), as dose 2, single dose for COVID-19 immunization and had no reaction on previous exposure to vaccine for both dose. Concomitant medications included ongoing atenolol for blood pressure, pravastatin sodium (PRAVACOL), ongoing losartan for blood pressure, and on-going atorvastatin for cholesterol. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Sep2021 at 15:00 PM, the patient received dose number=3 (booster). On 27-SEP-2021 18:00, the patient experienced shoulder and arm somewhat immobile after almost 3 weeks. took Ibupropen regularly. No fever. Just continued soreness and limited mobility. After Booster, left arm very sore in 3 hours. (No problems with first two) The injection spot itself was not sore - top of shoulder was felt like bursitis. Could reach around back. Difficult doing anything requiring reaching Comfort with ibuprofen on an unspecified date in 2021. Soreness and lack of mobiling lasted over 3 weeks. Her guess was that needle hit bursa sac. Device Date was 16Oct2021. Outcome of the events shoulder and arm somewhat immobile after almost 3 weeks and left arm very sore was recovered on an unspecified date in 2021 and for all other events, it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Joint stiffness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: right hand: some swelling; joint swelling in left foot; pain and stiffness in knees; possible psoriatic arthritis; Neck stiffness and pain; Neck stiffness and pain; pain and stiffness in knees; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 10Nov2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Apr2021 09:30 (at the age of 46 years) (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Medical history included clinical depression from Oct2017 and ongoing and gold and nickel metals allergy. Concomitant medications included bupropion taken for depression from Oct2017 and ongoing; curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported; and vit D [vitamin D nos] taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 15:30 (at the age of 46 years) (Batch number: EP6955) administered in the right arm for COVID-19 immunization. In Jun2021, the patient began having neck stiffness and pain, joint swelling in left foot, and pain and stiffness in knees. In Sep2021, the patient went to the rheumatologist and was diagnosed with possible psoriatic arthritis although x-rays and blood tests were inconclusive. Events joint swelling, joint pain, and psoriatic arthritis were reported with an onset of 01Jun2021, requiring visit to physician office, and with seriousness criteria: persistent/significant disability. No treatment was received for the events. COVID booster was recommended by the doctor as well as change of diet to anti inflammatory diet. She received the COVID booster on 16Oct2021 and the next day all joints were very swollen and in pain, could not walk, could not close right hand. She made an appointment with the rheumatologist. She said to report it as adverse reaction to vaccine and the patient was started on prednisone, methotrexate and folic acid. The pain and swelling were still out of control 17 days later. The patient underwent tests and procedures which included X-ray on 20Sep2021 with comment: right hand: some swelling and blood test on 21Sep2021 with comment: elevated inflammatory markers. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Psoriatic arthropathy, X-ray
Clinical narrative: right hand: some swelling; joint swelling in left foot; pain and stiffness in knees; possible psoriatic arthritis; Neck stiffness and pain; Neck stiffness and pain; pain and stiffness in knees; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 10Nov2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Apr2021 09:30 (at the age of 46 years) (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Medical history included clinical depression from Oct2017 and ongoing and gold and nickel metals allergy. Concomitant medications included bupropion taken for depression from Oct2017 and ongoing; curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported; and vit D [vitamin D nos] taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 15:30 (at the age of 46 years) (Batch number: EP6955) administered in the right arm for COVID-19 immunization. In Jun2021, the patient began having neck stiffness and pain, joint swelling in left foot, and pain and stiffness in knees. In Sep2021, the patient went to the rheumatologist and was diagnosed with possible psoriatic arthritis although x-rays and blood tests were inconclusive. Events joint swelling, joint pain, and psoriatic arthritis were reported with an onset of 01Jun2021, requiring visit to physician office, and with seriousness criteria: persistent/significant disability. No treatment was received for the events. COVID booster was recommended by the doctor as well as change of diet to anti inflammatory diet. She received the COVID booster on 16Oct2021 and the next day all joints were very swollen and in pain, could not walk, could not close right hand. She made an appointment with the rheumatologist. She said to report it as adverse reaction to vaccine and the patient was started on prednisone, methotrexate and folic acid. The pain and swelling were still out of control 17 days later. The patient underwent tests and procedures which included X-ray on 20Sep2021 with comment: right hand: some swelling and blood test on 21Sep2021 with comment: elevated inflammatory markers. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash flared up, making it worse than before; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection; not sure if she got J&J, but did not say Moderna - it was either Pfizer or J&J COVID Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history included an ongoing rash. Concomitant medications were not reported. The patient was previously on crisaborole (EUCRISA) for an unspecified indication. On an unspecified date, about 10 days after developing a rash, the patient received a COVID vaccine and the rash flared up, making it worse than before. The patient might have applied crisaborole to get it under control, but really flared up when she got the vaccine. She had been on crisaborole before and then ran out of it. The patient has not recovered from the event.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Fatigue, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Had a lump underneath armpit where received injection of booster dose; Then in evening on 23OCT2021, felt really tired; On 23OCT2021 woke up and side of arm was very stiff; On 23OCT2021 woke up and Left leg was very stiff; Had a lot of pain on shoulder where injected with booster dose; Then in evening on 23OCT2021, got a fever; This is a spontaneous report from a contactable consumer or other non hcp.  A 69-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot Number: PFEW0177), via an unspecified route of administration, administered in Arm Left on 20Oct2021 15:30 as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 20Oct2021 (Batch/Lot number was not reported) to 20Oct2021, at UNK, single for immunisation. Medical history included radiation fibrosis - lung from 2009 and ongoing Verbatim: Fibrosis of Lung. Concomitant medication(s) included nintedanib esilate (OFEV) taken for radiation fibrosis - lung from 2009 and ongoing. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, The patient experienced on 23oct2021 woke up and side of arm was very stiff, woke up and left leg was very stiff, had a lot of pain on shoulder where injected with booster dose, with outcome of recovering then in evening on 23oct2021, got a fever on 23Oct2021 with outcome of unknown, had a lump underneath armpit where received injection of booster dose on 24Oct2021 with outcome of recovering , then in evening on 23oct2021, felt really tired (fatigue) (non-serious) on 23Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included pain assessment: 7 or 8 on.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pyrexia
Clinical narrative: Had a lump underneath armpit where received injection of booster dose; Then in evening on 23OCT2021, felt really tired; On 23OCT2021 woke up and side of arm was very stiff; On 23OCT2021 woke up and Left leg was very stiff; Had a lot of pain on shoulder where injected with booster dose; Then in evening on 23OCT2021, got a fever; This is a spontaneous report from a contactable consumer or other non hcp.  A 69-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot Number: PFEW0177), via an unspecified route of administration, administered in Arm Left on 20Oct2021 15:30 as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 20Oct2021 (Batch/Lot number was not reported) to 20Oct2021, at UNK, single for immunisation. Medical history included radiation fibrosis - lung from 2009 and ongoing Verbatim: Fibrosis of Lung. Concomitant medication(s) included nintedanib esilate (OFEV) taken for radiation fibrosis - lung from 2009 and ongoing. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, The patient experienced on 23oct2021 woke up and side of arm was very stiff, woke up and left leg was very stiff, had a lot of pain on shoulder where injected with booster dose, with outcome of recovering then in evening on 23oct2021, got a fever on 23Oct2021 with outcome of unknown, had a lump underneath armpit where received injection of booster dose on 24Oct2021 with outcome of recovering , then in evening on 23oct2021, felt really tired (fatigue) (non-serious) on 23Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included pain assessment: 7 or 8 on.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: Tiredness; headache; muscle pain; chills; joint pain; fever; decreased appetite; received dose 3 on on 25Oct2021; This is a spontaneous report from a contactable consumer (patient) for herself via Regulatory Authority. A 79-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FE 3592), via an unspecified route of administration, administered in left arm on 25Oct2021 08:30(at age of 79-year-old) as dose 3 (BOOSTER), single for covid-19 immunization in hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hyperparathyroid, Polycystic Ovary syndrome. The known allergies were nitrofurantoin (MACROBID) and dextropropoxyphene hydrochloride (DARVON). The other vaccine in four weeks included influenza vaccine(INFLUENZA, Batch/Lot Number: unknown) administered in right arm as dose 1, single for influenza immunization on 20Oct2021. The other concomitant medications in two weeks included Spironolactone 50 mg, Vitamins Multi, D3, glucosamine sulfate(GLUCOSAM). On 27Feb2021 08:15 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN 6203), via an unspecified route of administration, administered in left arm as dose 2, single for covid-19 immunization. On 04Feb2021 08:30 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EM 9809), via an unspecified route of administration, administered in left arm as dose 1, single for covid-19 immunization. The patient experienced Tiredness, headache, muscle pain, chills, joint pain, fever, decreased appetite , all on 25Oct2021 21:00. The event was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature with result fever on 25Oct2021. No treatment was taken for the event. The outcome of event was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Pyrexia
Clinical narrative: Tiredness; headache; muscle pain; chills; joint pain; fever; decreased appetite; received dose 3 on on 25Oct2021; This is a spontaneous report from a contactable consumer (patient) for herself via Regulatory Authority. A 79-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FE 3592), via an unspecified route of administration, administered in left arm on 25Oct2021 08:30(at age of 79-year-old) as dose 3 (BOOSTER), single for covid-19 immunization in hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hyperparathyroid, Polycystic Ovary syndrome. The known allergies were nitrofurantoin (MACROBID) and dextropropoxyphene hydrochloride (DARVON). The other vaccine in four weeks included influenza vaccine(INFLUENZA, Batch/Lot Number: unknown) administered in right arm as dose 1, single for influenza immunization on 20Oct2021. The other concomitant medications in two weeks included Spironolactone 50 mg, Vitamins Multi, D3, glucosamine sulfate(GLUCOSAM). On 27Feb2021 08:15 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN 6203), via an unspecified route of administration, administered in left arm as dose 2, single for covid-19 immunization. On 04Feb2021 08:30 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EM 9809), via an unspecified route of administration, administered in left arm as dose 1, single for covid-19 immunization. The patient experienced Tiredness, headache, muscle pain, chills, joint pain, fever, decreased appetite , all on 25Oct2021 21:00. The event was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature with result fever on 25Oct2021. No treatment was taken for the event. The outcome of event was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph node in armpit on the same arm the vaccine was administered.; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 21-year-old non pregnant female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FF2593),  intramuscular, administered in right arm on 21Oct2021 as dose 1, single for covid-19 immunization in Pharmacy or Drug Store. The patient medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and she was not diagnosed with COVID-19 prior to vaccination. Concomitant medications in two weeks included Steroid Cream. The patient experienced swollen lymph node in armpit on the same arm the vaccine was administered on 27Oct2021. The event was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab for Covid-19: negative on 26Oct2021(post vaccination). No treatment was taken for the event. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Headache, Hyperaesthesia
Clinical narrative: booster doses on 28Oct2021; very very sensitivity to touching of her fingertips and toes; severe headache; severe chills; feverish feeling; bruising; discoloration; swollen toes; She said she is very very tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported, Expiry Date: Unknown, NDC and UPC number: Unknown), via an unspecified route of administration on 28Oct2021 (at the age of 68 years old) as dose 3 (booster), single for COVID-19 immunization. PQC was not present. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 1, Single and dose 2 via an unspecified route of administration on Apr2021 as dose 2, Single for COVID-19 immunisation and no side effects reported. The patient received booster dose on 28oct2021. On 28Oct2021, the patient experienced very very sensitivity to touching of her fingertips and toes, severe headache, severe chills, feverish feeling, bruising, discoloration, swollen toes, she said she was very very tired. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. Lot/batch number was not available despite the follow-up attempts made. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: booster doses on 28Oct2021; very very sensitivity to touching of her fingertips and toes; severe headache; severe chills; feverish feeling; bruising; discoloration; swollen toes; She said she is very very tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported, Expiry Date: Unknown, NDC and UPC number: Unknown), via an unspecified route of administration on 28Oct2021 (at the age of 68 years old) as dose 3 (booster), single for COVID-19 immunization. PQC was not present. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 1, Single and dose 2 via an unspecified route of administration on Apr2021 as dose 2, Single for COVID-19 immunisation and no side effects reported. The patient received booster dose on 28oct2021. On 28Oct2021, the patient experienced very very sensitivity to touching of her fingertips and toes, severe headache, severe chills, feverish feeling, bruising, discoloration, swollen toes, she said she was very very tired. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. Lot/batch number was not available despite the follow-up attempts made. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: First two doses of the shot did not affect her, this one threw her for a loop; Was not aware it would affect her so badly; have no appetite; exhausted; headache; low grade fever; dizziness; inner ear violent dizziness where the room went up and down; she received her booster dose; I was wired; Drenched in sweat; couldn't move the next day; Sick ever since; Did not sleep that night; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Nov2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced sick ever since on 01Nov2021 with outcome of recovering , drenched in sweat on an unspecified date with outcome of not recovered , did not sleep that night on 01Nov2021 with outcome of recovering , couldn't move the next day on 02Nov2021 with outcome of recovering , first two doses of the shot did not affect her, this one threw her for a loop on an unspecified date with outcome of recovering , was not aware it would affect her so badly an unspecified date with outcome of recovering , have no appetite, exhausted, headache, low grade fever, dizziness, inner ear violent dizziness where the room went up and down, she received her booster dose, i was wired on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: unknown results on low grade fever.    Follow up (10Nov2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included the information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Immunisation, Insomnia
Clinical narrative: First two doses of the shot did not affect her, this one threw her for a loop; Was not aware it would affect her so badly; have no appetite; exhausted; headache; low grade fever; dizziness; inner ear violent dizziness where the room went up and down; she received her booster dose; I was wired; Drenched in sweat; couldn't move the next day; Sick ever since; Did not sleep that night; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Nov2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced sick ever since on 01Nov2021 with outcome of recovering , drenched in sweat on an unspecified date with outcome of not recovered , did not sleep that night on 01Nov2021 with outcome of recovering , couldn't move the next day on 02Nov2021 with outcome of recovering , first two doses of the shot did not affect her, this one threw her for a loop on an unspecified date with outcome of recovering , was not aware it would affect her so badly an unspecified date with outcome of recovering , have no appetite, exhausted, headache, low grade fever, dizziness, inner ear violent dizziness where the room went up and down, she received her booster dose, i was wired on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: unknown results on low grade fever.    Follow up (10Nov2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included the information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.