chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling at the injection site; Pain at the injection site; burning upon administration; Redness at the injection site; Warmth at the injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1284), via an unspecified route of administration in left arm, on 04Jan2021 at 12:00, at a single dose, COVID-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and fish allergy. The patient's concomitant medications included Curcuma longa (TURMERIC), probiotics, and unspecified multivitamin. 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. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 12:00 PM, the patient experienced swelling, pain, redness, and warmth at the injection site lasting for 3 days. It was burning upon administration. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 07Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Headache, Inappropriate schedule of product administration, Migraine, Nausea
Clinical narrative: BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable Other Health Professional (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ej1685, expiration date was not reported), via an unspecified route of administration in the right arm, on 09Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history included drug known allergies to penicillin (hives). Concomitant medication included bupropion, hydroxyzine, propranolol, levonorgestrel (MIRENA) and OCP (unspecified). Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: Ej1685) via an unspecified route of administration in the right arm, on 19Dec2020 08:30 at a single dose for COVID-19 immunization. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 post vaccination. The patient experienced headache on 09Jan2021 at 09:30 PM with outcome of not recovered. Therapeutic measures were taken as a result of headache with Tylenol.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Erythema, Peripheral swelling, Peripheral vascular disorder
Clinical narrative: Circulation felt impeded; middle finger turned purple; it happened in the right hand middle finger, got red, then swelled; it happened in the right hand middle finger, got red, then swelled; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose and 9 days later her middle finger turned purple. It lasted for 2 days and faded away. Last night, it started up again in one middle section in the middle segment of the middle finger. Circulation felt impeded, it happened in the right hand middle finger, got red, then swelled and then got purple. when she woke up, color came back and everything felt normal. The outcome of the events was recovered on an unspecified date. Information about Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Recieved dose #1 of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site.; This is a spontaneous report from a non-contactable nurse. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK798), intramuscular in the right arm on 18Dec2020 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ergocalciferol (VIT D), ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]). The patient previously took and had allergies with Phenergan. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 post vaccination. The patient received first dose of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site on an unspecified date with outcome of recovering. The event was reported as non-serious. No treatment received for the event.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation.  Medical history included birth control.  Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin.  The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site.  On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation.  Medical history included birth control.  Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin.  The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site.  On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain assessment
Clinical narrative: Headache/headache got worse and worse; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and co-worker). This is the first of two reports. A 61-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EJ1686, expiry date: unknown), intramuscular, on 06Jan2021 13:30 at a single dose on left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was also reported that she received the vaccine at a military facility. There were no additional vaccines administered on same date of bnt162b2. Medical history included high blood pressure diagnosed about a month ago (Dec2020) and ongoing, and glaucoma from an unspecified date (diagnosed when she was 15 years old) and ongoing. Concomitant medications included losartan (Manufacturer: Lupin, 50 mg tablet) for high blood pressure, venlafaxine ER (Manufacturer: Aurobindo, 150 mg Prolonged-release capsule) as anti-depressant, latanoprost (Manufacturer: Sandoz, 0.005 %) for glaucoma, and brimonidine tartrate, timolol maleate (COMBIGAN, Manufacturer: Allergan) for glaucoma; all were from unspecified dates and ongoing. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EH9699), intramuscular, on 19Dec2020 at a single dose on left arm for COVID-19 immunization; there was no adverse event following this vaccination. The patient experienced headache on 06Jan2021 at 11:45 am (As reported, pending clarification). The patient reported that she did not have anything with the first dose. She got the second dose of the Pfizer Covid Vaccine on 06Jan2021 at 13:30. She started getting headache at 11:45 am (as reported) but she didn't think much of it. On 07Jan2021, she had a headache and she took two Tylenol and then went to sleep. She woke up around midnight that night and her headache got a little bit worse, so she took two Tylenol again and fell asleep. In the morning of 08Jan2021, around 2:30 am her headache got worse and worse, and she took three Tylenol. Her headache was still there but it was not enough to go to the emergency room or anything. She panicked on Thursday (07Jan2021) since her headache was still there; her headache was still lingering but it was going away. Her headache pain was at 7 out of 10 on an unspecified date. She stated that she was supposed to work at the time of report, but she called out of work due to her headache. Therapeutic measures were taken as a result of the headache and included treatment with Tylenol 500 mg (lot number: DFE3060A, expiration date: Apr2022). The adverse event did not require a visit to Emergency Room or Physician office. Outcome of the event was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Pruritus, Rash
Clinical narrative: awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs; huge rash on her legs front and back but not on torso only on neck; This is a spontaneous report from a contactable nurse (patient) reported that a 58-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included omeprazole magnesium (PRILOSEC). The patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, EL1284) on 18Dec2020 at 6:00 AM on the right arm. The patient reported that on a cupid days (as reported) after vaccine, she broke out in huge whips and rash from her face to the bottom of torso, it did this twice, so severe had she had to be put on a dose pack. The patient then received her second dose 08Jan2021 and awakes around 3 am with severe itching on my legs and this time huge rash on my legs front and back but not on torso only on neck on 08Jan2021 (as reported). The patient took Benadryl.  The outcome of the events pruritus and rash was recovered while the outcome of the event was unknown. The patient had not been tested for COVID-19 post vaccination.   Information on the lot/ batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: awakes around 3 am with severe itching on my legs; awakes around 3 am with severe itching on my legs; huge rash on her legs front and back but not on torso only on neck; This is a spontaneous report from a contactable nurse (patient) reported that a 58-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included omeprazole magnesium (PRILOSEC). The patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, EL1284) on 18Dec2020 at 6:00 AM on the right arm. The patient reported that on a cupid days (as reported) after vaccine, she broke out in huge whips and rash from her face to the bottom of torso, it did this twice, so severe had she had to be put on a dose pack. The patient then received her second dose 08Jan2021 and awakes around 3 am with severe itching on my legs and this time huge rash on my legs front and back but not on torso only on neck on 08Jan2021 (as reported). The patient took Benadryl.  The outcome of the events pruritus and rash was recovered while the outcome of the event was unknown. The patient had not been tested for COVID-19 post vaccination.   Information on the lot/ batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash pruritic, Urticaria
Clinical narrative: Rash was pruritic and diffuse/one day later became less itchy and more macular papular in nature; Developed urticarial rash; Rash was pruritic and diffuse, spread to extremities, back, trunk and face; This is a spontaneous report from a contactable physician (patient). A 29-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9898; expiration date: unknown), intramuscular left arm on 21Dec2020 16:00 at a single dose for covid-19 vaccination. Medical history included depression and anxiety. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) and escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital on 21Dec2020 04:00 PM. The patient developed urticarial rash about 2 weeks (05Jan2021 07:00 AM) after receiving vaccine. The rash was pruritic and diffuse that spread to extremities, back, trunk and face. About one day later (06Jan2021), it became less itchy and more macular papular in nature. No other symptoms. No airway swelling. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse events. The outcome of the events was recovered in Jan2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable other health care professional. A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJI685), intramuscular on 23Dec2020 04:00 at single dose at arm right for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included sertraline hydrochloride (ZOLOFT), and desvenlafaxine succinate (PRISTIQ). On 24Dec2020 08:00, the patient experienced sore arm. The patient did not receive treatment for the event. The outcome of the event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Mild fatigue; Sore arm; Body aches; Had a tickle in her throat; Had a mild come and go headache; He had a Fever of 100.5, but hers was only 99.9; Exposure to COVID; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced mild fatigue, sore arm, body aches, had a tickle in her throat, had a mild come and go headache, "he had a fever of 100.5, but hers was only 99.9", and exposure to covid on an unspecified date. Event details: The patient received the first COVID vaccine on 19Dec2020, through work. She did really well with it. She had mild fatigue, but she also worked for 12 hours so it was hard to tell if it was from that or working. She did have a sore arm like from getting a tetanus shot. At the beginning of this week, her boyfriend got COVID symptoms on Monday, and tested positive. On Monday, she had mild COVID symptoms as well. He had a Fever of 100.5, but hers was only 99.9. She had body aches, and her arms were sore like she did bicep exercises. She had a tickle in her throat. She has had a mild come and go headache. Her boyfriend has had all the symptoms. She has tested negative for COVID twice. She worked with two different ERs. One was saying she was presumed positive, and must be out of work / on quarantine a month. The other one said it could be because of the vaccine. The one who was telling her to have an extensive quarantine was supposed to give her the second vaccine on 07Jan2021, yesterday. The other says she shouldn't get the second dose of the vaccine any way if she was sick. She felt like she was fine. She didn't think this was the vaccine. She thought it was COVID exposure, and she just had mild symptoms and a negative test because she had the vaccine.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: Mild fatigue; Sore arm; Body aches; Had a tickle in her throat; Had a mild come and go headache; He had a Fever of 100.5, but hers was only 99.9; Exposure to COVID; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced mild fatigue, sore arm, body aches, had a tickle in her throat, had a mild come and go headache, "he had a fever of 100.5, but hers was only 99.9", and exposure to covid on an unspecified date. Event details: The patient received the first COVID vaccine on 19Dec2020, through work. She did really well with it. She had mild fatigue, but she also worked for 12 hours so it was hard to tell if it was from that or working. She did have a sore arm like from getting a tetanus shot. At the beginning of this week, her boyfriend got COVID symptoms on Monday, and tested positive. On Monday, she had mild COVID symptoms as well. He had a Fever of 100.5, but hers was only 99.9. She had body aches, and her arms were sore like she did bicep exercises. She had a tickle in her throat. She has had a mild come and go headache. Her boyfriend has had all the symptoms. She has tested negative for COVID twice. She worked with two different ERs. One was saying she was presumed positive, and must be out of work / on quarantine a month. The other one said it could be because of the vaccine. The one who was telling her to have an extensive quarantine was supposed to give her the second vaccine on 07Jan2021, yesterday. The other says she shouldn't get the second dose of the vaccine any way if she was sick. She felt like she was fine. She didn't think this was the vaccine. She thought it was COVID exposure, and she just had mild symptoms and a negative test because she had the vaccine.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 3 days of very bad headache; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not reported), via an unspecified route of administration in left arm, on 09Jan2021 19:00, at single dose, for COVID-19 immunization. Medical history included food allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced 3 days of very bad headache on 10Jan2021 at 08:00. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Soreness at injection site Supraclavicular lymphadenopathy on side of injection; Soreness at injection site Supraclavicular lymphadenopathy on side of injection; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (arm left) second dose on 08Jan2021 17:15 at single dose for COVID-19 immunisation. The patient's medical history was not reported.  The patient's concomitant medications included venlafaxine and levothyroxine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 for covid-19 immunisation (first dose, left arm, lot number EH9899). On 10Jan2021, the patient experienced Soreness at injection site, Supraclavicular lymphadenopathy on side of injection. No treatment was given. The outcome of the events was unknown. Facility where the most recent COVID-19 vaccine was administered was in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety
Clinical narrative: anaphylactic reaction/anaphylaxis; This is a spontaneous report from a Pfizer Sponsored Program from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EK4176), via an unspecified route of administration on 09Jan2021 at 0.3 mL, single (standard like 0.3ml by injection once to deltoid, side unknown) to prevent from getting COVID. The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction/anaphylaxis on 09Jan2021. Clinical course: The patient got the vaccine while waiting to go into the watch room, to be watched for a few minutes, and she experienced anaphylactic reaction/anaphylaxis, she went down, they gave her an Epinephrine, she didn't respond to the first dose, a second dose was given in the arm where the vaccine was given, then she was picked up by an ambulance. Agent stated the caller has been on hold for almost an hour. Caller clarifies dose was given in the arm, it occurred on Saturday with the same lot. Saturday and it went away on Saturday, the patient was worried about it coming back, thus why she asked about Epinephrine pen, the patient was taken to the hospital, and given Epinephrine a couple more times, and it resolved eventually, the patient was not admitted, she went to the Emergency Department. It could have required hospitalization but would most likely say life threatening had she not been treated. Reporter seriousness for anaphylaxis is life threatening. The outcome of event was recovered on 09Jan2021.  Relatedness of bnt162b2 to reaction anaphylaxis is related for primary source.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylactic reaction/anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D).  The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. 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 been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D).  The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. 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 been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: the muscle was very tight and stiff; the muscle was very tight and stiff; fatigued; a fever of 100.5 developed; my arm was very sore; This is a spontaneous report from a non-contactable nurse (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in the right arm on 02Jan2021 11:15 at single dose for COVID-19 immunization. There was no medical history. The patient has no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient got the vaccine Saturday, by 1500 her arm was very sore. Sunday morning her arm was so sore she could hardly move it the muscle was very tight and stiff. She was also very fatigued all day Sunday (03Jan2021) and slept most of the day, a fever of 100.5 developed. When she woke up Monday morning the fever was gone, fatigue was gone and the soreness in her arm felt like normal soreness after a vaccine such as the flu vaccine. Come Wednesday her arm was finally not sore anymore. The patient did not received treatment for the events. The outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Balance disorder, Blood pressure measurement, Dizziness, Heart rate
Clinical narrative: She has one big toe that is arthritic and it does not seem to want to bend; More like her balance does not feel right/Still feels a little off kilter; Dizziness; Hard time focusing her sight; Neck and toe stiffness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 around 13:00-14:00 at single dose for covid-19 immunization.  There were no medical history or concomitant medications. The patient got the vaccine this week on 06Jan2021 right after lunch/early afternoon. She had no issues. In the afternoon of 07Jan2021, she started getting a little dizzy and had a hard time focusing her sight. The patient also had neck and toe stiffness on 07Jan2021. She did not think about the vaccine until last evening of 07Jan2021. The hospital called to see how she was doing, and then it dawned on her. After, she took her blood pressure which was 126/68 with 81 pulse. She slept well last night of 07Jan2021. This morning on 08Jan2021 she had breakfast but still felt a little off kilter. It is like dizziness, not really dizzy, but more like her balance does not feel right. She was focusing better on 08Jan2021, but not like normal. The dizziness hit her on 07Jan2021 about 15:00. It had improved. She felt more at the time of the report, not really dizzy, but more like her balance did not feel right. It was earlier on 07Jan2021 around 14:00 she was on the ladder taking down her Christmas bows. She had no dizziness whatsoever. For neck and toes stiffness, she had one big toe that was arthritic and it did not seem to want to bend. She had been doing neck exercises which had helped. The outcome of dizziness, hard time focusing her sight, neck and toe stiffness were resolving, outcome of rest events were unknown.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vision blurred
Clinical narrative: She has one big toe that is arthritic and it does not seem to want to bend; More like her balance does not feel right/Still feels a little off kilter; Dizziness; Hard time focusing her sight; Neck and toe stiffness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 around 13:00-14:00 at single dose for covid-19 immunization.  There were no medical history or concomitant medications. The patient got the vaccine this week on 06Jan2021 right after lunch/early afternoon. She had no issues. In the afternoon of 07Jan2021, she started getting a little dizzy and had a hard time focusing her sight. The patient also had neck and toe stiffness on 07Jan2021. She did not think about the vaccine until last evening of 07Jan2021. The hospital called to see how she was doing, and then it dawned on her. After, she took her blood pressure which was 126/68 with 81 pulse. She slept well last night of 07Jan2021. This morning on 08Jan2021 she had breakfast but still felt a little off kilter. It is like dizziness, not really dizzy, but more like her balance does not feel right. She was focusing better on 08Jan2021, but not like normal. The dizziness hit her on 07Jan2021 about 15:00. It had improved. She felt more at the time of the report, not really dizzy, but more like her balance did not feel right. It was earlier on 07Jan2021 around 14:00 she was on the ladder taking down her Christmas bows. She had no dizziness whatsoever. For neck and toes stiffness, she had one big toe that was arthritic and it did not seem to want to bend. She had been doing neck exercises which had helped. The outcome of dizziness, hard time focusing her sight, neck and toe stiffness were resolving, outcome of rest events were unknown.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Chills, Cough, Headache
Clinical narrative: severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Sinus pain
Clinical narrative: severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms started at 12 hours post injection of 2nd dose.; severe body aches; shivering; significant fatigue; This is a spontaneous report from a non-contactable physician (patient). A 37-year-old male patient started to received the second dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EK9231, intramuscular in left arm on 06Jan2021 at single dose for COVID-19 immunization in a hospital. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, lot no: EH9899, on 18Dec2020 intramuscularly in left arm for immunization. No other vaccines were administered in four weeks. The patient had no COVID-19 prior to vaccination was not tested for COVID-19 post vaccination.  The patient experienced flu-like symptoms started at 12 hours post injection of 2nd dose. Started with severe body aches, then shivering and significant fatigue. The patient improved only a little with paracetamol (TYLENOL). After 24 hours symptoms onset, symptoms mostly resolved. The adverse events were reported as non-serious. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose.   The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left  arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt bad after their 2nd Covid 19 Pfizer vaccine; This is a spontaneous report from a non-contactable nurse via Pfizer sales representative. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt bad after their second Pfizer vaccine. It was not unexpected. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot and batch number could not be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Disease recurrence, Dyspnoea, Ear discomfort
Clinical narrative: Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; Stuffy nose and ears; Stuffy nose and ears; Short of breath; Loss of appetite; Headache; Headache; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 08Jan2021 07:15 at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 28Dec2020 at right arm, at single dose for covid-19 immunization, and experienced mild headache and mild arm soreness. The patient received the second dose, and experienced extreme fatigue, uncontrollable chills for 3 hours, flu-like symptoms (headache, generalized muscle soreness, stuffy nose and ears), short of breath, loss of appetite, all at 08Jan2021 13:00. The outcome of the events was recovering. No treatment was received for all events. Prior to 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.