chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hypoaesthesia, Immunisation, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 13:15 (Lot number: 330308D) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 18Nov2021 (ongoing). Vaccination history included: Bnt162b2 (first dose of the Pfizer Covid vaccine was on 14Mar2021 with lot EN6208,), administration date: 14Mar2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (2nd dose was on 04Apr2021 which was three weeks apart and has lot , ER8737), administration date: 04Apr2021, when the patient was 25 years old, for COVID-19 immunization.The following information was reported: HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt numbness in his fingers, specifically his pinky finger"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "started hearing ringing in his ears"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "was getting dizzy like he was almost blacking out"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt nauseous"; FEELING HOT (non-serious) with onset 29Nov2021, outcome "unknown", described as "was just overheated"; IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster".  Additional information: Patient stated that he was calling because his doctor said he should report his symptoms and about 10 minutes after the shot he felt numbness in his fingers, specifically his pinky finger and then started hearing ringing in his ears and was getting dizzy like he was almost blacking out and he felt nauseous too; stated he was just overheated and he had no problem breathing or problems breathing. Numbness was not ongoing and resolved after 30 minutes; the ringing in his ears was not ongoing and has resolved and lasted probably about 20 seconds; symptoms of getting dizzy like he was almost blacking out and feeling nauseous probably lasted 10 minutes and resolved at 20 minutes. Patient did not received any additional Vaccines administered on same Date of the Pfizer Suspect and patient did not received any prior Vaccinations (within 4 weeks). Patient did not visited any physician office or emergency room for the events. Patient did not have family medical history Relevant to AE. No relevant tests was reported. Stated that he had been taking Meloxicam for the last two weeks and it is like a strong NSAID and an anti-inflammatory medication and states he had no lot, expiry date or NDC to provide as it is in an orange pharmacy bottle.   Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 13:15 (Lot number: 330308D) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 18Nov2021 (ongoing). Vaccination history included: Bnt162b2 (first dose of the Pfizer Covid vaccine was on 14Mar2021 with lot EN6208,), administration date: 14Mar2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (2nd dose was on 04Apr2021 which was three weeks apart and has lot , ER8737), administration date: 04Apr2021, when the patient was 25 years old, for COVID-19 immunization.The following information was reported: HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt numbness in his fingers, specifically his pinky finger"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "started hearing ringing in his ears"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "was getting dizzy like he was almost blacking out"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt nauseous"; FEELING HOT (non-serious) with onset 29Nov2021, outcome "unknown", described as "was just overheated"; IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster".  Additional information: Patient stated that he was calling because his doctor said he should report his symptoms and about 10 minutes after the shot he felt numbness in his fingers, specifically his pinky finger and then started hearing ringing in his ears and was getting dizzy like he was almost blacking out and he felt nauseous too; stated he was just overheated and he had no problem breathing or problems breathing. Numbness was not ongoing and resolved after 30 minutes; the ringing in his ears was not ongoing and has resolved and lasted probably about 20 seconds; symptoms of getting dizzy like he was almost blacking out and feeling nauseous probably lasted 10 minutes and resolved at 20 minutes. Patient did not received any additional Vaccines administered on same Date of the Pfizer Suspect and patient did not received any prior Vaccinations (within 4 weeks). Patient did not visited any physician office or emergency room for the events. Patient did not have family medical history Relevant to AE. No relevant tests was reported. Stated that he had been taking Meloxicam for the last two weeks and it is like a strong NSAID and an anti-inflammatory medication and states he had no lot, expiry date or NDC to provide as it is in an orange pharmacy bottle.   Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Immunisation, Influenza like illness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Nov2021 14:15 (Lot number: F63527) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe headache" (unspecified if ongoing); "Covid-19", start date: 06Jan2021, stop date: 26Jan2021, notes: Thought I had flu; "CLL", start date: 2018 (ongoing), notes: Not taking medications. , Green tea only. Concomitant medication(s) included: TYLENOL EXTRA STRENGTH taken for headache, start date: 08Nov2021, stop date: 11Nov2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Date: 29Mar2021, Time: 17:15, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/ Lot number: ER8733), administration date: 29Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Virus symtoms returned", "Diffculty Breathing", "A temperature above 99 F"; Bnt162b2 (DOSE 1, SINGLE, Date: 08Mar2021, Time: 14:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/ Lot number: EN6198), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "Virus symtoms returned", "Mind fog", "Headache", "Body ache", "night sweating", "Inability to concentrate", "Sense of balance", "loss of appetite", "general feeling of exhaustion". The following information was reported: IMMUNISATION (non-serious) with onset 07Nov2021, outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Nov2021 23:00, outcome "recovered" (10Nov2021), described as "virus symptoms returned". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness.  Additional information: Prior Vaccinations (within 4 weeks) was reported as none. It was reported that after each vaccination, virus symptoms returned at no time did the patient have Difficulty breathing or a temperature above 99 F.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Had the Pfizer COVID vaccine booster in Nov2021; Day afterwards his arm was sore; Thinks that he had a fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 19 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacture), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Had the Pfizer COVID vaccine booster in Nov2021"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "Day afterwards his arm was sore"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Thinks that he had a fever".  Additional information: The caller mention that patient had the Pfizer COVID vaccine booster in Nov2021 and the day afterwards his arm was sore and the caller thinks that he had a fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Pain
Clinical narrative: patient seems to have Shingles pain; patient seems to have Shingles pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 16:00 (Lot number: F51620) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2017 (unspecified if ongoing); "Spleen removed", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2 Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM. Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), HERPES ZOSTER (non-serious) all with onset 29Nov2021 08:00, outcome "not recovered" and all described as "patient seems to have Shingles pain"; IMMUNISATION (non-serious) with onset 26Nov2021 16:00, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of pain, herpes zoster.  Additional information: Facility where the most recent COVID-19 vaccine was administered was withheld. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Experienced swollen lymph nodes on the left side where he received the injection; Booster; Swollen left arm (he received the shot on his left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 15:30 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: He has mild Asthma diagnosed as a child., Mild Asthma like seasonal. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot EW0158), administration date: 15Apr2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, LOT EEW0172), administration date: 07May2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021, outcome "not recovered", described as "Experienced swollen lymph nodes on the left side where he received the injection"; VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Swollen left arm (he received the shot on his left arm)".  Additional information: The patient's mother enquired for her son who was away at college  for swelling,which did not happen before with the primary series to him. The patient received the booster 6 months after 2nd shot. This did not happen before. He just had shot on Sunday before going back to school. His primary care provider just retired and has another appointment at Christmas with a new primary care. She did not wish to provide any contact details for the new one. She confirmed all 3 were the Pfizer COVID vaccines. He received, unknown expiration.  Injected in unknown arm. unknown expiration.  Injected in unknown arm. They were the worst state in the country.  They were having to bring in the National Guard because so many people did not get the vaccine.The swollen lymph nodes took about 24 hours and did not happen initially. The patient did not go to Emergency Room or Physician Office, did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Low grade fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Low grade fever"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Headache".  Additional information: Reporter stated, her husband received the Pfizer vaccine yesterday morning and experienced adverse event. She asked what type of pain medicine that she can give him for the headache?. In response for further probing: Reporter stated, What type of Questions? Reporter was informed and provided with the number of Pfizer medical information department. For LOT# , Reporter stated, No, If you can't answer her question. She was not staying on the phone. Reporter was unwilling to complete the report so no further probing was done. Hence limited information was available over the call.  Follow-up (06Dec2021): 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 completed. No further information is expected. .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Weight
Clinical narrative: Booster; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Nov2021 (Lot number: FE3590) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 26Mar2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Diarrhea"; Bnt162b2 (Dose 2), administration date: 19Apr2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Diarrhea". The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (non-serious) with onset 16Nov2021, outcome "not recovered", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness.  additional information: Caller stated that she started a supplement for her eyes a month before the vaccine. Caller states she was not on any prescription medications. States she got all 3 doses in her right arm/shoulder muscle. States she got it around 1:30-2pm.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: covid booster; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "covid booster"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The event lasted for an about 4 days. It was reported that She was calling regarding a possible side effect from the covid booster. Her and her mother also had a flu shot at the same time. The caller is 75 years old and she is a retired RN. This is the report for the caller herself. Reports at the beginning they both had sore arms and that was not a big deal, lasted about 4 days. She is not worried about herself and declined to complete a report. Unable to clarify details provided or gather additional information.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Immunisation, Myalgia, Pain
Clinical narrative: Covid booster; Sore arm; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; skin is tender; she is in a lot of pain; Arthritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 96 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: FF2588) at the age of 96 years as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1 ; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2 ; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Covid booster"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Sore arm"; ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Pain in her shoulders, joints, and muscles"; PAIN OF SKIN (non-serious) with onset Oct2021, outcome "unknown", described as "skin is tender"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "she is in a lot of pain"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Arthritis". The events "sore arm", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "skin is tender", "she is in a lot of pain" and "arthritis" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia, arthralgia, myalgia, pain of skin, pain, arthritis. Additional information: Expiry Date and NDC number of Pfizer covid booster was unknown. Patient was trying prednisone for a month now and it does not help it all. She does not have it handy to provide lot, ndc, or expiration date. There was a Product Complaint.  No follow-up attempts are possible. No further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: Covid booster; Sore arm; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; Pain in her shoulders, joints, and muscles; skin is tender; she is in a lot of pain; Arthritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 96 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: FF2588) at the age of 96 years as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1 ; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2 ; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Covid booster"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Sore arm"; ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Pain in her shoulders, joints, and muscles"; PAIN OF SKIN (non-serious) with onset Oct2021, outcome "unknown", described as "skin is tender"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "she is in a lot of pain"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Arthritis". The events "sore arm", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "pain in her shoulders, joints, and muscles", "skin is tender", "she is in a lot of pain" and "arthritis" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia, arthralgia, myalgia, pain of skin, pain, arthritis. Additional information: Expiry Date and NDC number of Pfizer covid booster was unknown. Patient was trying prednisone for a month now and it does not help it all. She does not have it handy to provide lot, ndc, or expiration date. There was a Product Complaint.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Immunisation, Pain
Clinical narrative: aches; chills; sweats; exhaustion; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FJ1620) , administration date 28Nov2021 15:00 at the age of 58 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort"; BNT162B2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort". The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 15:00, outcome "unknown", described as "booster dose"; PAIN (non-serious) with onset 29Nov2021, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 29Nov2021, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 29Nov2021, outcome "recovering", described as "sweats"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "exhaustion". Therapeutic measures were not taken as a result of pain, chills, hyperhidrosis, fatigue.   Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Immunisation, Pain
Clinical narrative: Aches; Chills; Sweats; Exhaustion; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 15:00 (Lot number: FJ1620) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318), administration date: 20Apr2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318), administration date: 30Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 15:00, outcome "unknown", described as "Booster dose"; PAIN (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Sweats"; FATIGUE (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of pain, chills, hyperhidrosis, fatigue. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Pain at the injection site when arm moves on certain position.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 11:00 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FL 3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, for COVID-19 immunization.  The following information was reported IMMUNISATION (non-serious) with onset 29Nov2021 11:00, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 19:00, outcome unknown. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: It was reported that the event started around After the 8 hours. Around 7pm that same day. The patient had no prior vaccinations within 4 weeks prior to the vaccination and had no other medications the patient received within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Immunisation, Joint stiffness
Clinical narrative: Booster; extreme joint aches and stiffness.; extreme joint aches and stiffness.; Weakness; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 10Oct2021 (Lot number: FF2590) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included High blood pressure (unspecified if ongoing). Concomitant medication(s) included LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 01, lot number: EL0142), administration date: 12Jan2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s) No adverse events with the first two doses; Bnt162b2 (Dose: 02, lot number: EL9264), administration date: 07Jul2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s) No adverse events with the first two doses. The following information was reported IMMUNISATION (non-serious) with onset 10Oct2021, outcome unknown; ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome unknown; ASTHENIA (non-serious) with onset 2021, outcome unknown; FATIGUE (non-serious) with onset 2021, outcome unknown.  It was reported that the caller and his wife had the full series of the Pfizer Covid Vaccine and the booster dose. They had no adverse events with the first two doses but had many side effects with the booster dose. The caller wanted information about the temp tales, he wanted information on the device that monitors the temperature of the shipper the Pfizer Covid Vaccine is shipped in. The joint aches and stiffness started a few days later. They are both very active and walk 5 to 6 miles per day. They have always been very agile. It is really striking to them that they feel weak and tired. She is basically a healthy person. At her age she went to the cardiologist as a precaution. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Exposure to SARS-CoV-2, Immunisation
Clinical narrative: booster; Caller recently got COVID19 from someone at work; there are 3 people with heart problems who have gotten booster dose of the vaccine in the same house; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Pfizer Covid 19 Vaccine, Lot: EW0161, Expiry: Unknown, Right arm for both doses, not feeling good on 25Nov2021), administration date: 30Apr2021, for Covid-19 immunization, reaction(s): "not feeling good", "Tired", "Achy", "Cold"; Bnt162b2 (Dose 1, Pfizer Covid 19 Vaccine, Lot: EW0167, Expiry: Unknown, Right arm for both doses), administration date: 09Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Caller recently got COVID19 from someone at work"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "there are 3 people with heart problems who have gotten booster dose of the vaccine in the same house".  Additional information: Specify Consumer or other non health professional: Mother. He took a test yesterday, and on the bottom line was pink and purple, and the top line was pink so that means he has Covid. States that on 23Nov2021, a 20 year old that her son works with got Covid. He notified the people at work, including her son, and since then several people and their families who have not had the vaccines have gotten Covid. Caller verifies that her son did get both doses of the vaccine but he did not have time to get the booster because he did not meet the age group requirements. Her son started having symptoms of Covid on 26Nov2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Immunisation, Pain
Clinical narrative: Booster dose; High Heart rate; Fatigue; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FG3527) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Caller states that she had all 3 doses on her Left arm., states that it might be R19265 or E19265), administration date: 04Feb2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Booster dose"; HEART RATE INCREASED (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "High Heart rate"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "Fatigue"; PAIN (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that she wanted to report side effects after the Pfizer Vaccine, she confirms it is the Pfizer covid vaccine. After the vaccine she had a high heart rate, she was achy and fatigued. This was after the booster and after the second dose.  After getting the booster she had a high heart rate and was achy and fatigued, it all happened on the same day but later in the day. The high heart rate, achy and fatigue subsided a couple days later. No allergies were reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: Booster; Feeling under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1), for COVID-19 immunization; Bnt162b2 (Dose no:2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; FEELING ABNORMAL (non-serious) with onset 30Nov2021, outcome "unknown", described as "Feeling under the weather".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pain
Clinical narrative: sore arm at shot site; headache; chills; aching; tired; third shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 10:15 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0167), administration date: 04May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm".  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "third shot"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "sore arm at shot site"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "aching"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of vaccination site pain, headache, chills, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at shot site; headache; chills; aching; tired; third shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 10:15 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0167), administration date: 04May2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Sore arm".  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "third shot"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "sore arm at shot site"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 30Nov2021, outcome "recovering", described as "aching"; FATIGUE (non-serious) with onset 30Nov2021, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of vaccination site pain, headache, chills, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Arthropod bite, Dyschromatopsia, Immunisation, Urticaria
Clinical narrative: booster; hives; 2 episodes of mosquito bites; I noticed a marked change in color perception post shots/ Probably around Sept noticed the colors (cars outdoors) were dull again. Post shot, colors bright again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 11:00 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (ongoing), notes: long time; "high blood pressure" (ongoing), notes: progesterone i am taking baby aspirin not normally prone to blood clots just in case.; "nasty cough", start date: 2019 (unspecified if ongoing), notes: i had a really nasty cough Nov/Dec 2019. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; PROGESTERONE (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); BABY ASPIRIN (ongoing); ALVESCO taken for asthma (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Lot/batch no. - EN6198, Administration time=11:00, Anatomical site of Injection = left arm, Route of administration - intramuscular, Route- intramuscular), administration date: 02Mar2021, for COVID-19 immunization; Bnt162b2 (2nd Dose, Lot/batch no. - ER2613, Administration time=11:00, Anatomical site of Injection = left arm, Route of administration - intramuscular), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives"; ARTHROPOD BITE (non-serious) with onset Oct2021, outcome "unknown", described as "2 episodes of mosquito bites"; DYSCHROMATOPSIA (non-serious) with onset Oct2021, outcome "unknown", described as "I noticed a marked change in color perception post shots/ Probably around Sept noticed the colors (cars outdoors) were dull again. Post shot, colors bright again."; IMMUNISATION (non-serious) with onset 27Oct2021 11:00, outcome "unknown", described as "booster". Additional information: Reason for third dose reported as "2 episodes of mosquito bites or hives on left arm, so to see if these happen on rt arm". Prior vaccination and relevant tests were reported as none. Reported "I had a really nasty cough Nov/Dec2019: coughed so hard thought my uterus would fall out - all kidding aside, the non-cold cough was brutal. would like to know if it might have been c-19. I noticed a marked change in color perception post shots. wondered if due to Pfizer shots. I am an artist, so this was/is amazing. I know now that it is due to shot, because I put off getting the booster. beyond the recommended 6 mos. probably around Sept noticed the colors (cars outdoors) were dull again! post shot? colors bright again".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Myalgia, Nasal congestion
Clinical narrative: Headache; Fever; Chills; Nasal Congestion; Muscle Aches; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Nov2021 10:15 (Lot number: 330308D) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 22Nov2021; LEXAPRO; WELLBUTRIN; ATENOLOL; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 10:15, outcome "unknown", described as "dose number: 3"; HEADACHE (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Chills"; NASAL CONGESTION (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Nasal Congestion"; MYALGIA (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Muscle Aches". Therapeutic measures were not taken as a result of headache, pyrexia, chills, nasal congestion, myalgia.  Additional Information: Reported seriousness was non-serious. Patient received unspecified vaccine prior vaccination within 4 weeks. The patient had no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.