chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Inflammation, Mass, Pain, Pain in extremity
Clinical narrative: Inflamation; large, hard lump roughly the size of a 2-4 cm; a sensation in the chest as if the inside of the chest and back had united somehow, resulting in a pain in the left center side of the chest; painful; lingering soreness underneath the arm and throughout the upper chest; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP7534), via an unspecified route of administration, administrated in right arm on 18Mar2021 (age at the time of vaccination 63-years-old) as a single dose for COVID-19 immunization. The patient's medical history included Hypothyroidism, and high cholesterol. The patient's concomitant medications included Levothyroxine 100 MCG, Lisinopril 10 MG, and Atorvastati. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 20Mar2021, the patient experienced Inflammation; large, hard lump roughly the size of a 2-4 cm; a sensation in the chest as if the inside of the chest and back had united somehow, resulting in a pain in the left center side of the chest; painful; and lingering soreness underneath the arm and throughout the upper chest. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received as a result of adverse events. The outcome for all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin papilloma
Clinical narrative: 40+ Warts on multiple parts of my body began to itch and then went away.; 40+ Warts on multiple parts of my body began to itch and then went away.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201) via an unspecified route of administration in Arm Right on 21Feb2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination, was not COVID tested post vaccination. The patient had no known allergies. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Other medications included Diabetes medications (unspecified, in two weeks). On 28Feb2021, the patient experienced 40 plus Warts on multiple parts of my body began to itch and then went away. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts were possible. No further information was expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This is a spontaneous report from a contactable consumer. A 13-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: Not provided, Expiration date: Not provided), on 12Jun2021 around 3.30pm on left Arm as Dose 1 single for covid 19 immunization (age at vaccination: 13-Year-old). The patient had not received any other vaccine and other medication in two weeks. The patient had not affected with covid19 before or after vaccination. Medical history and Concomitant medications were not reported. On 24Jun2021 patient experienced Dizziness and nausea. No known Allergies were reported. No therapeutic treatments were received. The outcome of the events was reported as Not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Entire body was in pain; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jun2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether, the patient had been tested for COVID-19 since the vaccination. It was unknown whether, the patient received any other vaccines within four weeks prior to the vaccination. On 21Jun2021, the patient's entire body was in pain. It was unknown if the patient received any treatment for events.  The clinical outcome of the event entire body was in pain was recovering at the time of reporting.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: Added patient information.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperventilation, Hypoaesthesia, Menstruation delayed
Clinical narrative: About 24 hours after the second Pfizer shot, I started to experience panting; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; My hands and ankles, followed by my lips and chin and neck started to go numb; I was cramping up due to hyperventilation; I was cramping up due to hyperventilation; I've missed 2 periods since the shots; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0177, Expiration date: not reported) via an unspecified route of administration in right arm on 23May2021 11:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included codeine allergy, Had a bleeding ulcer 7 months prior and wondered if the ulcer was from covid-19. Concomitant medications were not reported. On 24May2021 10:00 AM, patient experienced abnormal breathing, chest heaviness, difficulty breathing, numbness localized, cramps, hyperventilation, delayed period. Adverse event resulted in: Emergency room/department or urgent care. Treatment was received for events. Patient also reported about 24 hours after the second vaccination, I started to experience panting. Up to that point, I was doing light household tasks because I felt pretty good. I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air. I decided to use a rescue inhaler(albuterol) to see if I could breathe more freely. I have not used one in about 7 years. I primed the inhaler and followed directions (the inhaler was within expiry). After I used it, I still felt I wasn't getting enough air. My hands and ankles, followed by my lips and chin and neck started to go numb, and I asked my husband to call 911. An ambulance came, and they took my vitals, and talked me through my breathing. The paramedics said I was cramping up due to hyperventilation. After a little while everything was ok. The numbness went away and also, I no longer had the shortness of breath that I had before I used the inhaler. Also I've missed 2 periods since the shots. No other vaccine administered in four weeks. No other medications administered in two weeks. No covid present prior vaccination. No covid tested post vaccination. The outcome of events was recovered on a unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.  Follow-Up (26Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Respiration abnormal
Clinical narrative: About 24 hours after the second Pfizer shot, I started to experience panting; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air; My hands and ankles, followed by my lips and chin and neck started to go numb; I was cramping up due to hyperventilation; I was cramping up due to hyperventilation; I've missed 2 periods since the shots; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0177, Expiration date: not reported) via an unspecified route of administration in right arm on 23May2021 11:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included codeine allergy, Had a bleeding ulcer 7 months prior and wondered if the ulcer was from covid-19. Concomitant medications were not reported. On 24May2021 10:00 AM, patient experienced abnormal breathing, chest heaviness, difficulty breathing, numbness localized, cramps, hyperventilation, delayed period. Adverse event resulted in: Emergency room/department or urgent care. Treatment was received for events. Patient also reported about 24 hours after the second vaccination, I started to experience panting. Up to that point, I was doing light household tasks because I felt pretty good. I lay down in bed and still had a heavy feeling in my chest, like I wasn't getting enough air. I decided to use a rescue inhaler(albuterol) to see if I could breathe more freely. I have not used one in about 7 years. I primed the inhaler and followed directions (the inhaler was within expiry). After I used it, I still felt I wasn't getting enough air. My hands and ankles, followed by my lips and chin and neck started to go numb, and I asked my husband to call 911. An ambulance came, and they took my vitals, and talked me through my breathing. The paramedics said I was cramping up due to hyperventilation. After a little while everything was ok. The numbness went away and also, I no longer had the shortness of breath that I had before I used the inhaler. Also I've missed 2 periods since the shots. No other vaccine administered in four weeks. No other medications administered in two weeks. No covid present prior vaccination. No covid tested post vaccination. The outcome of events was recovered on a unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.  Follow-Up (26Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Vaccination site rash
Clinical narrative: circular 3 cm area of rash that is macular no papules or pustules present/The rash appeared around injection site 2 days after the vaccine; circular 3 cm area of rash that is macular no papules or pustules present/The rash appeared around injection site 2 days after the vaccine; Redness; itching; This is a spontaneous report from a contactable Physician. This Physician reported for a 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0217 and expiry date was not reported), via Intramuscularly, in Arm Left, on 02Jul2021 at 11:30 AM (age at vaccination: 14 years), as a single dose for COVID-19 immunization at Doctor's Office/Urgent Care. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. The family history included that two siblings had this reaction (circular 3 cm area of rash). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via Intramuscularly, in Arm Left, on 10Jun2021 at 03:00 PM, as a single dose for COVID-19 immunization at Doctor's Office/Urgent Care. and Gardasil vaccine via Intramuscularly, in Right arm on OCT-2020 and on 29Jan2021 (at age of 14 years). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 03Jul2021, the patient developed circular 3 cm area of rash that is macular no papules or pustules present. The rash appeared around injection site 2 days after the vaccine, redness, and itching. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Outcome of the events was recovered on 07Jul2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Musculoskeletal stiffness, Pain, Pyrexia, Swelling
Clinical narrative: medical professional recommended to him that the second dose is contraindicated; swelling, pain, and stiffness in right arm and shoulder; fever and chills; swelling, pain, and stiffness in right arm and shoulder; swelling, pain, and stiffness in right arm and shoulder; This is a spontaneous report from a Pfizer-sponsored program. A contactable Health Care Professional reported for a male patient that, A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Jun2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jun2021, the patient experienced medical professional recommended to him that the second dose is contraindicated and swelling, pain, and stiffness in right arm and shoulder, fever and chills. The reporter was reported for a patient who received the first dose of the Covid vaccine, and she said was experiencing delayed reaction from the dose. There was pain and swelling in the right arm, and per agency, it is a side effect from the vaccine. Reporter wanted to know if this is normal and how long side effects will last. Reporter stated the reason she was reporte was because the patient had a medical professional recommend to him that the second dose was contraindicated for him and she just wanted to double check with Pfizer. The first dose was on 04Jun2021 and he had a delayed reaction on 14Jun2021. The patient confirmed at Pfizer Covid-19 Vaccine. The patient had swelling, pain, and stiffness in his right arm and shoulder with fevers and chills that went away after 1 day. It has been steadily improving. He had minimal pain in his right shoulder and arm right now and reporter was trying to explain to him that it was not contraindicated. Reporter had a male patient who received the first dose of Pfizer Covid 19 Vaccine on 04June2021. On 14June2021 the patient experienced swelling, pain & stiffness to the right arm and shoulder. He also experienced fever & chills that lasted for one day. He had minimal pain at this time. The patient was advised by another HCP to refrain from taking the second dose of the Pfizer Covid 19 Vaccine. Reporter was requesting information to inform the patient that the second dose of the vaccine is not contraindicated. Outcome of the medical professional recommended to him that the second dose is contraindicated was unknown whereas, swelling, pain, and stiffness in right arm and shoulder, fever and chills were recovering.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Pain in extremity, Vaccination site discomfort
Clinical narrative: sore arm since she got the 2nd dose; Headache; Fall; injection site is giving her a lot of discomfort; This is a spontaneous report from a contactable consumer (Patient).    A 86-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 16Mar2021 (age at the time of vaccination was 86-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had flu shot before and experienced arm pain. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route on 23Feb2021 (age at the time of vaccination was 86-year-old) as single dose for COVID-19 immunization. In 2021, the patient experienced sore arm since she got the 2nd dose, Headache, Fall and injection site is giving her a lot of discomfort. Patient had both doses of the Pfizer COVID 19 vaccine - 1st dose was Feb2021, 2nd dose 16Mar2021 - She has been experiencing sore arm since she got the 2nd dose - 5 weeks ago she had a bad fall and experience discomfort in the arm - She had the injection in the right arm and the pain extends to the rotator cuff - She had flu shot before and also experienced arm pain - Never sought consultation with primary care physician. Asking if it was normal to have arm pain for 4 months after having the shot and if there is anyone out there who had a similar experience with her. After the second one, the caller got a headache but hadn't eaten or drank water until like 2:00 pm so she thought that's what it was. The caller's arm was really sore and then it started feeling better. The caller had a fall 5 weeks ago and now the injection site is giving her a lot of discomfort. Outcome of all the events was unknown.   Information about batch/Lot number has been requested..
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error, Rash macular
Clinical narrative: tiny red dots on her legs, from her thigh down to her ankles; was injected with 14 vials in the buttocks; was injected with 14 vials in the buttocks; This is a spontaneous report from a contactable other hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Jun2021 (at the age of 45-years-old) as single dose for covid-19 immunization. The patient has no medical history and no known drug allergies and no concomitant medications. The patient has received fillers in the past and previously took Juvederm voluma on 05May2021. On 04Jun2021, the patient was injected with 14 vials in the buttocks and on 06Jun2021, the patient experienced tiny red dots on her legs from her thigh down to her ankles. The patient took a Claritin. Therapeutic measures were taken as a result of tiny red dots on her legs, from her thigh down to her ankles. The outcome of all the events was not recovered.  Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Memory impairment, Vaccination site pain
Clinical narrative: Rapid Heart rate; Shortness of breath; weak memory (inability to recall something); pain at the injection site; dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non pregnant female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 23Jun2021 at 01:00 AM (age at vaccination was 27 years) as dose 1, single for COVID-19 immunisation. Vaccination facility was school or student health clinic. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. No known allergies reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. On 24Jun2021, the patient experienced rapid heart rate, pain at the injection site, dizziness, shortness of breath and weak memory (inability to recall something). The patient did not receive treatment for adverse events. No covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovered/resolved with sequel.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: swollen lymph nodes/inflammation of lymph nodes; now she has pain in the area where they were taken out and then she had swollen lymph nodes another place; inflammation is on the left arm; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Jun2021 as dose 1, single for COVID-19 immunization. Medical history included I had cancer 4 years ago, she had lymph nodes taken (removed from radiation), glucose issue and she was allergic to flu vaccine. Concomitant medications included anastrozole (Estrogen blocker). She did not take any vaccines within 4 weeks prior COVID vaccination. The patient previously took flu vaccine VII (Batch/Lot number and Expiry date: Unknown) for immunisation and experienced allergic to flu vaccine. On an unspecified date in 2021, the patient experienced with swollen lymph nodes/inflammation of lymph nodes, now she has pain in the area where they were taken out and then she had swollen lymph nodes another place and inflammation is on the left arm. On an unspecified date patient stated that there was a diet sugar in the COVID vaccine. She got the COVID vaccine already. She clarified if she had a glucose issue and just wanted to know what type of sugar was in the vaccine. After the first dose of the Pfizer COVID vaccine she had inflammation of lymph nodes. she was allergic to flu vaccine (got bronchitis and cough for 3 months). Patient did not receive any treatment for the events. The outcome of the events was unknown.   Information on Lot/Batch information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eyelid irritation, Eyelids pruritus, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: "got her period 2 weeks early" and reports it was "heavy"; "got her period 2 weeks early" and reports it was "heavy"; Sore arm; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; This is a spontaneous report from a contactable consumer(patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown), via an unspecified route of administration on 05Jul2021 (age at vaccination 35 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was fine, except for a sore arm and on the next day of vaccination, she got her menstrual period 2 weeks early, and it was a heavy flow on 06Jul2021, she also experienced eyelid and face itching and burning. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: "got her period 2 weeks early" and reports it was "heavy"; "got her period 2 weeks early" and reports it was "heavy"; Sore arm; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; This is a spontaneous report from a contactable consumer(patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown), via an unspecified route of administration on 05Jul2021 (age at vaccination 35 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was fine, except for a sore arm and on the next day of vaccination, she got her menstrual period 2 weeks early, and it was a heavy flow on 06Jul2021, she also experienced eyelid and face itching and burning. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Pain in extremity, Vaginal haemorrhage
Clinical narrative: "got her period 2 weeks early" and reports it was "heavy"; "got her period 2 weeks early" and reports it was "heavy"; Sore arm; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; This is a spontaneous report from a contactable consumer(patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown), via an unspecified route of administration on 05Jul2021 (age at vaccination 35 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was fine, except for a sore arm and on the next day of vaccination, she got her menstrual period 2 weeks early, and it was a heavy flow on 06Jul2021, she also experienced eyelid and face itching and burning. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Swelling face, Trismus
Clinical narrative: cheek swelling; Swollen lymph node on right side; lock jaw; Fatigue after vaccination/fatigue increases; This is a spontaneous report from a contactable consumer (patient herself). A 31-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VAC-CINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in arm right on 05Jul2021 16:30 (age at the vaccination 31-year-old) as dose 1, single for COVID-19 immunization (pharmacy or drug store). The patient was not pregnant at time of vaccination. Medical history included pollen-food allergy from an unknown date and unknown if ongoing known allergies. The patient concomitant medications were not reported. On 05Jul2021 20:30, the patient had experienced fatigue after vaccination, fatigue increases, swollen lymph node on right side, swollen cheek and lock jaw. The patient did not receive treatment for the adverse event. AE resulted in doctor or other healthcare professional office/clinic visit. The reporter (health authority) considered the events as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The outcome of the events was not recovered.  Information on Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Muscle spasms, Neck pain
Clinical narrative: Fever over 100F; Chills; Restlessness in legs; Restlessness in Legs/spasms; Back pain; Soreness throughout neck; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) dose 2 via an unspecified route of administration in the left arm on an10Jul2021 at 10:30 (at the age of 28-years-old) as a dose 2 single for COVID-19 immunisation. Patient had no past medical history and no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 28-years-old) as a dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jul2021 at 20:00, the patient experienced fever 100 Fahrenheit for the first night after 2nd dose, fever the next day as well. Chills all night after 2nd dose, restlessness in legs/spasms, back pain and soreness throughout neck was continuing into day 3. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature was over 100 Fahrenheit on 10Jul2021 (Fever over 100F). The patient did not receive any treatment for the events. The clinical outcome of the events of fever 100F, chills, restlessness in legs/spasms, back pain and soreness neck was recovered with sequelae on an unknown date in Jul2021.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness
Clinical narrative: Fever over 100F; Chills; Restlessness in legs; Restlessness in Legs/spasms; Back pain; Soreness throughout neck; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) dose 2 via an unspecified route of administration in the left arm on an10Jul2021 at 10:30 (at the age of 28-years-old) as a dose 2 single for COVID-19 immunisation. Patient had no past medical history and no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 28-years-old) as a dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jul2021 at 20:00, the patient experienced fever 100 Fahrenheit for the first night after 2nd dose, fever the next day as well. Chills all night after 2nd dose, restlessness in legs/spasms, back pain and soreness throughout neck was continuing into day 3. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature was over 100 Fahrenheit on 10Jul2021 (Fever over 100F). The patient did not receive any treatment for the events. The clinical outcome of the events of fever 100F, chills, restlessness in legs/spasms, back pain and soreness neck was recovered with sequelae on an unknown date in Jul2021.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pruritus, Feeling abnormal, Feeling hot, Skin fissures
Clinical narrative: Right ear itching; Ear burning; Skin started to crack; It was the weirdest thing; Ear burning and very hot; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for herself that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID 19 VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included autoimmune disorder from an unknown date and unknown if ongoing Verbatim: auto-immune disorder. The patient's concomitant medications were not reported. The patient experienced right ear itching, ear burning, skin started to crack, it was the weirdest thing, ear burning and very hot on an unspecified date. NDC number of COVID vaccine was not provided. It was unknown that reporter was a Healthcare Professional or the prescribing HCP. No medical questions addressed by this program forwarded/referred to Medical Information. Query was raised to confirm the correct CEP ID and correct CEP id was provided. The outcome for all the events was recovered except for the event ear burning and very hot it was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: maybe more tired than usual; muscle pain in the injection site area/ injection site is very sore; muscle pain in the injection site area/injection site is very sore/ injection site is very sore; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on [26Aug2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via medical information team. This consumer reported for two patients. This is the one of two reports. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via intramuscular route, in left arm, on 25Aug2021 (at the age of 70-years-old), at dose 2, single for covid-19 immunization. Medical history included normally had muscle issues like osteoarthritis throughout her body which is ongoing; she normally has muscle issues, just not in the arm, always in the back, legs, and knees and went to a pain management doctor for epidurals and treatments for the issue, ongoing hypertension, ongoing cholesterol issues and had headaches every day; she is a migraine sufferer but didn't get any headaches at the day of report. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route, in left arm, on an unspecified date in 2021 (at the age of 70-years-old), at dose 1, single for covid-19 immunization. The patient experienced muscle pain in the injection site area/ injection site is very sore on 25Aug2021 and she maybe more tired than usual on 26Aug2021. The outcome of muscle pain in the injection site area was not recovered and outcome of the other event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110251 same reporter/drug/events with different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Palpitations
Clinical narrative: Chest palpitations; difficulty breathing; fatigue; This is a spontaneous report from a contactable consumer or other non hcp.     A 57-years-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8727; Expiration date: 20Jul2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 09:00AM (at the age of 57-year-old) as, 0.3ML single for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, apnoea from an unknown date and unknown if ongoing.   The patient's concomitant medications were not reported.  It was reported that patient did not administered any other vaccine in four weeks. It was reported that other vaccine in two weeks was reported as yes. It was reported that covid prior vaccination was no. Covid tested post vaccination was no. Patient had known allergies. The patient experienced chest palpitations, difficulty breathing, fatigue on 01Jul2021.  Therapeutic measures were taken with inhalers, ekg as a result of chest palpitations, difficulty breathing, fatigue. The outcome of events was not resolved.   Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2 patients inadvertently received DAPTACEL instead of ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (Reference number- 00736452).  This case is linked with the 2021SA282217 (same reporter).  This case involves a 12-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 31-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900A, expiry date-18-Nove-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered (latency same day).  It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL".  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: 6VAX-F, DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Office reports using a mixed schedule of vaxelis and Pentacel - vaxelis at 2 months, Pentacel at 4 months, vaxelis at 6 months, and Pentacel at 15 months with no reported adverse event; Initial information received on 27-Aug-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown demographics patient who administered vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [VAXELIS] [Inappropriate schedule of product administration].  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It is unknown if there were lab data/results available.  This was actual a medication error due to Inappropriate schedule of product administered (latency on same day).  It was reported "Office reports using a mixed schedule of vaxelis and Pentacel - vaxelis at 2 months, Pentacel at 4 months, vaxelis at 6 months, and Pentacel at 15 months."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: realized the syringe only had about 0.1 mL v. 0.7 mL of medication and reported she used a different syringe/ no AE; realized the syringe only had about 0.1 mL v. 0.7 mL of medication and reported she used a different syringe/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional and transmitted to Sanofi on 24-Aug-2021.  This case involves an unknown age and gender patient while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ715AB, expiry date not reported) then reported realized the syringe only had about 0.1 ml instead of 0.7 ml of medication and used a different syringe (underdose and syringe issue) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (latency was on same day).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  At the time of report, no adverse event reported.  It was reported, "Caller reported there was no damage on the box or syringe, but the side was a little flimsy. Caller reported the other syringes look okay."  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to the patient with no reported adverse event; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non healthcare professional via Media information (under reference 00735381).  This case involves a patient (unknown age and gender) who received an expired dose of MENINGOCOCCAL VACCINE (MENACTRA) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENACTRA (lot number and expiration date: not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "What if an expired vaccine was given to a patient."  At time of reporting, the outcome was unknown for the reported event.   There will be no information on batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from an Other health care professional via Agency (Reference number- 00735962) and transmitted to Sanofi on 23-Aug-2021.  This case involves a six-month-old male patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), POLIO VACCINE INACT (IPV), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 20-Aug-2021, the patient received 0.5 mL (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ351AA and expiry date 09-Aug-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was reported, "Office manager reporting an expired dose of ACTHIB was inadvertently administered".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from an Other health care professional via Agency (Reference number- 00736347) and transmitted to Sanofi on 23-Aug-2021.  This case involves an 18-month-old female patient who was given an expired HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 23-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AAA and expiry date 26-Jul-2021] via intramuscular route in left thigh for prophylactic vaccination.  It was reported, "A dose of ACT-HIB was given to a child which was expired. Caller is want to know what to do".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.