chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: soreness started at the injection site; moved into this joints in the elbow and shoulder area; This is an initial spontaneous report from a contactable nurse (patient). An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration, administered in right arm on 03Feb2021 14:15 as single dose for COVID-19 immunization (at hospital). The patient medical history was none. The concomitant medications were not reported. History of all previous immunization reported none. Patient not provided the family medical history. Patient reported that both she and her husband received their first Pfizer COVID-19 vaccine shots 8 days ago (clarified as 03Feb2021). She said her arm was sore for 3 days, and then the arm soreness was gone. She said her husband's arm has been sore for 8 days, clarifying it was 8 days ago that her husband got the COVID-19 vaccine. She said her husband has tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his pain. Reported that she and her husband both received their first COVID-19 Vaccines on the same day and time, and the COVID-19 Vaccines were administered at the same facility. Treatment declined due to the reported stated that she did not need to take anything for her COVID-19 Vaccine injection site pain, saying the vaccine injection site pain went away on its own after 3 days. On 03Feb2021 the patient reported that she experienced soreness started at the injection site, moved into this joints in the elbow and shoulder area. The reaction of duration reaction/event: 03 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The term highlighted by the reporter. The reporter classified the event as Non-serious and assessed the causality between the event and the vaccines as Related. The outcome of the events was recovered on 06Feb2021.  Information about lot and batch number was requested.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from a contactable consumer (patient reported herself). A 76-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history included arthritis (history of arthritis/joint pain to begin). She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021. Concomitant medications were not reported. Call back made on 11Feb2021 at 11:51 AM and reached for discussion. She reported that "she thought she was having side effects from the second Pfizer-BioNTech Covid-19 shot". Patient stated she already reported it to Safety and was transferred to Medical Information. She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021 and second dose was on 04Feb2021. She was 76-year-old with a history of arthritis so she had joint pain to begin with but now she developed muscle pain, specifically after the second dose. She did not have it with the first dose. She currently had a lot of pain and stiffness in muscles, it was difficult to walk and she could not raise arms above shoulders without pain. It started about Sunday (07Feb2021), when this became more noticeable". She planned to discuss this further with her physician. No additional details. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Fatigue
Clinical narrative: muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from a contactable consumer (patient reported herself). A 76-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history included arthritis (history of arthritis/joint pain to begin). She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021. Concomitant medications were not reported. Call back made on 11Feb2021 at 11:51 AM and reached for discussion. She reported that "she thought she was having side effects from the second Pfizer-BioNTech Covid-19 shot". Patient stated she already reported it to Safety and was transferred to Medical Information. She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021 and second dose was on 04Feb2021. She was 76-year-old with a history of arthritis so she had joint pain to begin with but now she developed muscle pain, specifically after the second dose. She did not have it with the first dose. She currently had a lot of pain and stiffness in muscles, it was difficult to walk and she could not raise arms above shoulders without pain. It started about Sunday (07Feb2021), when this became more noticeable". She planned to discuss this further with her physician. No additional details. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nasopharyngitis, Upper-airway cough syndrome
Clinical narrative: Fatigue; moderate cold like symptoms; mild congestion; slight post nasal drip; headache; This is a spontaneous report from a contactable consumer (patient himself). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration, administered in left arm on 10Feb2021 at 01:30 as single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration, administered in left arm on 20Jan2021 at 12:45 as single dose for COVID-19 immunization. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), vitamin c [ascorbic acid] (VITAMIN C), vitamin d and [vitamin d nos] (VITAMIN D). The 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. On 11Feb2021, the patient experienced fatigue and moderate cold like symptoms (mild congestion, slight post nasal drip, headache). The patient did not received treatment for the events. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test
Clinical narrative: Severe lumbar/sacral back pain that began approximately 24 hours after vaccination; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264) via unspecified route of administered in Left arm on 28Jan2021 at 14:00 PM (at the age of 37-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma. Concomitant medication patient received within 2 weeks of vaccination included levonorgestrel (MIRENA) via Intra-uterine route of administration and multivitamins. On 29Jan2021 at 14:00 PM patient experienced severe lumbar/sacral back pain that began approximately 24 hours after vaccination. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse event. The patient received treatment for the adverse event with Diclofenac. Patient had relevant laboratory tests which included 30Jan2021, post vaccination Nasal Swab was done which was negative and COVID test with results negative on an unspecified date in 2021. The patient received diclofenac for the adverse event. The event outcome of recovered with sequelae.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: allergic reaction to something environmental and it resulted in a rash that covered large parts of my body; allergic reaction to something environmental and it resulted in a rash that covered large parts of my body; It started off as small red spots (5-1cm) in no particular pattern on stomach, arms, back, butt that became large red welts/hives across; This is a spontaneous report from a contactable consumer (herself). A 25-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 5EN5318) via an unspecified route of administration, in arm left on 27Jan2021 at 15:30 as single dose for covid-19 immunisation. Medical history included allergy to arthropod bite and concomitant medications were not included. It was reported that on 09Feb2021 19:00 (after vaccination) she had experienced allergic reaction to something environmental and it resulted in a rash that covered large parts of her body, it started off as small red spots (5-1cm) in no particular pattern on stomach, arms, back, butt that became large red welts/hives across. The welts disappeared within 2 hours of taking Benadryl. She took 2 pills the first night and it reappeared around 2pm the next day and another Benadryl pill at 16:00. Timeframe between vaccination and starting of symptoms was 13 days 3 hrs 30 min. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Dry mouth, Dysgeusia
Clinical narrative: Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Facial discomfort, Head discomfort, Muscular weakness, Nausea
Clinical narrative: Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; general body aches; This is a spontaneous report from a contactable consumer reported for an unspecified age of adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included bnt162b2 on 27Jan2021 (product=COVID 19, brand=Pfizer, lot unknown=False, administration date=27Jan2021, dose number=1). Other vaccine in four weeks and Other medications in two weeks was unknown. The patient took vaccine at workplace clinic. On 11Feb2021, the patient left work complaining of fever and general body aches. The patient did not take any treatment for the events. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Investigation
Clinical narrative: red mark in the right arm; This is a spontaneous report from a contactable consumer (self-reported). A 57-years-old female patient received First dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number EL3246) via unspecified route of administration in Arm Right on 22Jan2021 in afternoon as single dose for covid-19 immunisation. Medical history included thyroid cancer from 2011. concomitant medication was not reported. Patient reported 3 days before she got her first COVID-19 Vaccine dose, she got a Shingles vaccine on 19Jan2021. Patient had blood work done recently because she has to go every once in a while to an endocrinologist. Patient reported that, her doctor was against her getting her Shingles shot. She said she had asked her doctor to get the Shingles shot because she had seen a Shingles vaccine commercial that said people over 50 years old should get the Shingles vaccine. She said her doctor told her she didn't need the Shingles vaccine. She said she decided to get the Shingles vaccine on her own because she had worked for a lady who had Shingles. On 22Jan2021, patient noticed that the red mark in the right arm, from the first dose, is still there. She asked if it will ever go away. She stated it has been 3 weeks and if it stays another 20 days she will be concerned. On 11Feb2021, patient got second COVID-19 Vaccine shot on left arm and showed the red mark on her right arm to the staff after the vaccine facility. She said none of the staff could tell her anything about the red mark on her right arm at the first COVID-19 Vaccine. The outcome of the event was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Oropharyngeal discomfort, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Chills; Headache; Arm pain; This is a spontaneous report from the Sponsored Program . A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, headache, and arm pain after the 1st dose on an unknown date in 2021. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Nausea
Clinical narrative: Nausea; fatigue; chills; 99.6 temperature; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EM9809; Expiration Date: unknown) via an unspecified route of administration, in right arm on 09Feb2021 13:45 at single dose for COVID-19 immunisation.  Medical history included complex regional pain syndrome, CRPS (non-active), fibromyalgia, multiple non-life-threatening allergies to medications and environmental. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 11Feb2021 11:00, the patient experienced nausea, fatigue, chills, 99.6 temperature. On 11Feb2021, the patient underwent lab tests and procedures which included body temperature: 99.6 The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: have slightly arm sorenes; This is a spontaneous report from a sponsored program. An unspecified age and gender of contactable male consumer reported for himself that he received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had slightly arm soreness. The 2nd shot scheduled 25 days after the 1st dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Next day Tiredness/ lethargic; This is a spontaneous report from a contactable Other HCP. A 27-year-old male patient receive second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247), via unknown route of administration on Left arm on 11Feb2021 11:15 (the day of vaccination), at single dose for covid-19 immunisation. The patient's medical history includes historical vaccine the first dose of bnt162b2 (BNT162B2, Lot number: EL3247), via unknown route of administration on Left arm on 21Jan2021 11:15 AM (the day of vaccination). Concomitant medications were not reported. It was reported that patient experienced next day Tiredness/ lethargic on 12Feb2021 08:00 AM and did not received any treatment. Patient did not received any medications within 2 weeks of vaccination. The 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 not been tested for COVID-19. The outcome of events was "Recovering".
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site inflammation
Clinical narrative: inflammation with scab; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: cl9261, Expiration date was not provided), via an unspecified route of administration in right arm on 21Jan2021 11:45 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced inflammation with scab in center on 23Jan2021. No pain no itching no oozing. Patient did not receive vaccine in four weeks. Patient did not have covid prior vaccination. Patient was tested covid-19 post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Jan2021. The outcome of the event was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site reaction, Vaccination site warmth
Clinical narrative: injection site became warm, firm, and had redness in a ring around the needle site; injection site became warm, firm, and had redness in a ring around the needle site; injection site became warm, firm, and had redness in a ring around the needle site; soreness/pain; This is a spontaneous report from a contactable consumer. A 68-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 29Jan2021 11:15 as single dose for covid-19 immunisation. Medical history included hypertension, bacterial throat infection 4 weeks prior to vaccination with petechaie treated with azithromicin which resulted in an allergic reaction of itching and mild skin rash. Concomitant medication Losartan 50 mg, fish oil 500 mg, colecalciferol (VITAMIN D3 1000). The patient had allergies to penicillin, sulfa and azithromycin. On an unknown date two weeks after the vaccine the patient experienced injection site became warm, firm, and had redness in a ring around the needle site and soreness/pain. She had redness, soreness, warmth, and pain after the injection for about 2 days. No treatment was given to the patient for events.The patient had no Covid prior vaccination. Patient was not Covid tested post vaccination. Patient did not received other vaccine in four weeks The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nasopharyngitis
Clinical narrative: had a loss of smell, taste; had a loss of smell, taste; had cold; This is a spontaneous report from a contactable male consumer (patient) sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH 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 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had a loss of smell, taste and had cold on an unspecified date. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance
Clinical narrative: About 18 hours after second shot, legs would not hold me so I had a very hard time walking and standing.; About 18 hours after second shot, legs would not hold me so I had a very hard time walking and standing; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 05Feb2021 10:15 as single dose for covid-19 immunisation at Doctor's office. Medical history included multiple sclerosis from 1995 to an unknown date (Multiple Sclerosis diagnosed 1995). Patient historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in Arm Left on 15Jan2021 10:30 AM as single dose for covid-19 immunisation at Doctor's office. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN] and gabapentin. On 06Feb2021 05:00, The patient reported about 18 hours after second shot, legs would not hold me so i had a very hard time walking and standing. Overall weakness in entire body. It took 12 hours to feel stronger and be able to walk correctly. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore left arm, chilled, head was throbbing, temperature was 103 but went down a little bit, and lightheaded; all in Feb2021. Clinical course: The patient stated that she got the first shot of Pfizer vaccine yesterday afternoon. She stated she had a sore left arm, 2-3 hours ago she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She took an Ibuprofen 40 minutes ago. The outcome of event temperature was 103 but went down a little bit was resolving, outcome of event lightheaded was resolved in Feb2021, outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore left arm, chilled, head was throbbing, temperature was 103 but went down a little bit, and lightheaded; all in Feb2021. Clinical course: The patient stated that she got the first shot of Pfizer vaccine yesterday afternoon. She stated she had a sore left arm, 2-3 hours ago she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She took an Ibuprofen 40 minutes ago. The outcome of event temperature was 103 but went down a little bit was resolving, outcome of event lightheaded was resolved in Feb2021, outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach; experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included multiple sclerosis and very sensitive skin. The patient's concomitant medications were not reported. The patient reported 2 days after the administration of the first dose of the Pfizer's COVID-19 vaccine she began experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach on an unspecified date with outcome of unknown. The consumer reported that her physician recommended her to treat the symptoms with paracetamol (TYLENOL), rest and hydration.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I have developed hives on both arms that itch; I have developed hives on both arms that itch; This is a spontaneous report from a contactable consumer (patient reported herself). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: Solution for injection) via an unspecified route of administration on 12Feb2021 02:00 PM at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis (MS) and allergic to COPAXONE (known allergies: Copaxone). Concomitant medications were not reported. Other medications in two weeks was reported none. Facility type vaccine: Workplace clinic. Covid was not tested prior or post vaccination. On 13Feb2021 06:00 PM, the patient developed hives on both arms that itch. The patient did not receive any treatment in response to the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Rash
Clinical narrative: I have developed hives on both arms that itch; I have developed hives on both arms that itch; This is a spontaneous report from a contactable consumer (patient reported herself). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Formulation: Solution for injection) via an unspecified route of administration on 12Feb2021 02:00 PM at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis (MS) and allergic to COPAXONE (known allergies: Copaxone). Concomitant medications were not reported. Other medications in two weeks was reported none. Facility type vaccine: Workplace clinic. Covid was not tested prior or post vaccination. On 13Feb2021 06:00 PM, the patient developed hives on both arms that itch. The patient did not receive any treatment in response to the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; headache; chills; low grade fever; fatigue; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL3247), on 11Feb2021 10:45 AM at Left arm, as single dose for covid-19 immunisation. The patient had received first dose on 0Jan2021. the patients' medical history included hypothyroidism and no known allergies were reported. The concomitant medications included Levoxyl. on 11Feb2021, 05:00 PM, the patient experienced Sore arm, headache, chills, low grade fever, fatigue. the patient was treated with Acetaminophen, ibuprofen (OTC). the outcome of event was Recovering.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pt reports a sore arm; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received first dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history included positive covid infection (she has had to hold Xeljanz in the past due to a positive covid infection). Concomitant medications were not reported. On an unspecified date, patient reports a sore arm currently that patient attributes to recent covid vaccination. Advised to notify MD. Outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Temperature of 105.7; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 12Feb2021 at 02:00 pm to 12Feb2021 at 02:00 pm at single dose (dose number; 1) on left arm for covid-19 immunisation (Facility type vaccine: other). Patient was 62 years old at the time of vaccination. Patient's medical history included diabetes, coronary artery disease, kidney disease and covid-19 (If covid prior vaccination: Yes), known allergies: no true allergies, only unwanted side effects of certain medications (unspecified dates). Patient's concomitant medications were not reported (If other vaccine in four weeks; No, other medications in two weeks; Yes). Patient experienced temperature of 105.7 on 13Feb2021 at 06:00 pm. Treatment received was reported as yes (medication unspecified) for the adverse event. Adverse event did not result in emergency room or physician's office visit. Covid was not tested post vaccination. The outcome of event was recovered on an unknown date in Feb2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Feeling hot, Flushing, Headache
Clinical narrative: severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Palpitations, Throat irritation, Throat tightness
Clinical narrative: severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5  on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Tremor
Clinical narrative: Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5  on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.