chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Intermittent internal vibration/Buzzingsensation in right lower leg (outer calfarea mainly, sometimes radiating upto knee); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer- BioNTech Covid-19 Vaccine, Solution for injection, Lot number: EL0140, exp date not reported), intramuscular (vaccine location: left arm) on 22Dec2020 20:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included rheumatoid arthritis and cancer wherein patient received radiation and chemo (patient was a cancer survivor 10 years post radiation and chemo). The patient was not pregnant. The patient had no known allergies. Concomitant medication (other medications in two weeks) included etanercept (ENBREL) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intermittent internal vibration/buzzing sensation in right lower leg (outer calf area mainly, sometimes radiating up to knee) beginning 31Dec2020 16:00 (4:00 pm), 01Jan2021, 02Jan2021, and 03Jan2021. Patient was also started feeling this sensation in left foot on 02Jan2021. Further stated that if feels like a massager was on her leg/foot.  No treatment was provided for the events. The reporter considered the events as non-serious. The patient did not have Covid prior vaccination. The patient was not Covid tested post vaccination. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Electrocardiogram, Vaccination site pain, X-ray
Clinical narrative: sharp pains on left side of chest/ when taking a deep breath there is a little soreness right below the ribcage; received shot and felt soreness/like with a tetanus shot; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at site of left arm at 09:00 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included colitis (in remission right now). There were no concomitant medications. The patient received shot and felt soreness on 29Dec2020, had sharp pains on left side of chest on 30Dec2020, and when taking a deep breath there is a little soreness right below the ribcage. Clinical course: patient got the vaccine on 29Dec2020 and felt soreness, like with a tetanus shot. On the 30th2020 he was kind of sore and then by midday all of a sudden felt the sharp pain in his chest, and once in a while when taking a deep breath there is a little soreness right below the ribcage. He went to the emergency room on 01Jan2021 and they first did the EKG, then the X-ray and they both were normal. To rule out pulmonary embolism they did CT scan and that was all fine. He also just wanted to rule out heart or lung problems since he is pretty healthy. He did not receive any other vaccines the same day and none 4 weeks prior. Vaccination facility type in hospital. The outcome of events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient).  A 62-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 30Dec2020 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma, psoriasis, arthritis, overactive bladder, and obesity. The patient also had allergies with penicillin and many non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included etodolac (LODINE), zinc (ZINC), mirabegron (MYRBETRIQ), colecalciferol (VIT D3), ascorbic acid (VIT C), and famotidine (PEPCID). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 30Dec2020 18:00, the patient experienced diarrhea. The patient received bismuth subsalicylate (PEPTO-BISMOL) and loperamide as treatment. The patient was recovering from the event.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence
Clinical narrative: Excessive abdominal gas with pain; This is a spontaneous report from a non-contactable nurse (patient).  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration on Arm Left from 04Jan2021 14:45 to 04Jan2021 14:45 as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 04Jan2021 18:00, the patient experienced excessive abdominal gas with pain with outcome of recovering. No treatment was received for the event. Since the vaccination, has the patient has not been tested for COVID-19.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful Lymphadenopathy on day 6 post vaccination, not present prior to day 5, localized to axilla on the same side as vaccination; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140; expiry date: unknown) via an unspecified route of administration (left arm), on 30Dec2020 at 07:15 a.m., at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified birth control. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 04Jan2021, at 07:00 a.m., the patient experienced painful lymphadenopathy on day 6 post vaccination, not present prior to day 5, localized to axilla on the same side as vaccination. The patient did not receive treatment for the event. Outcome of the event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: Extreme pain in vaccine area for 72 hours post shot/ dull ache; Could not perform daily activities; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899;expiry date: unknown) via an unspecified route of administration (arm left), on 29Dec2020 at 15:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included an unspecified birth control. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 29Dec2020, at 18:00, the patient experienced extreme pain in vaccine area for 72 hours post shot. The patient could not perform daily activities. Post 72 hours extreme pain subsided and became a dull ache for 2 days. The patient received pain medication as treatment for extreme pain. Outcome of the events "extreme pain in vaccine area for 72 hours post shot/ dull ache" was recovering, while for the other event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Diarrhoea, Dizziness, Dyspnoea exertional
Clinical narrative: dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself.  A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip injury, Paraesthesia oral, Pruritus
Clinical narrative: dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself.  A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: Salt water taste in mouth, lasted strongly 5 min immediately after injection. Got less strong as time went on for approx 45 min after injection; Dry mouth with lasted an addition 30 min; This is a spontaneous report from a contactable consumer (patient himself).  This 19-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 05Jan2011 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was arm left. Relevant medical history included asthma. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 19-year-old. No known allergies. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed. The patient had salt water taste in mouth, lasted strongly 5 minutes immediately after injection. Got less strong as time went on for approx 45 minutes after injection. This was followed with dry mouth with lasted an addition 30 minutes. The onset date of the events 05Jan2021 at 13:45 (as reported). The patient was not treated for the events. The patient recovered from the events on 05Jan2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: A rapid heartbeat that lasted more than 20 mins.; This is a spontaneous report from a non-contactable other healthcare professional. A 33-year-old female patient started to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. On 04Jan2021, the patient experienced a rapid heartbeat that lasted more than 20 minutes (mins). The patient did not receive treatment for the event. The patient recovered from the event on the same day. The patient has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: headache/ his head was really pounding; nausea; chills; he had no appetite; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration in the right arm on 31Dec2020 at 14:00 at single dose for COVID-19 immunization as front line health care worker. There were no medical history and no concomitant medications.  The patient received the Pfizer COVID 19 vaccine first dose 31Dec2020 at 14:00 in the right arm and then experienced a headache, nausea, and chills on 02Jan2021. He took two days off from work and now felt better, had no more symptoms. He noticed the symptoms on Saturday 02Jan2021, then Sunday he was able to go to work then he took off on Monday because the symptoms got worse. He had no appetite on 02Jan2021. Today he felt great. He was supposed to get the second dose 21Jan2021. He did take Ibuprofen with strength 600 mg oral once on 02Jan2021, because his head was really pounding and then he went to sleep and it was better the next day. He had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations -within 4 weeks. There was no family medical history. He had the COVID 19 test 3 months ago in 2020 and it was negative. The outcome of the events was recovered on 04Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test
Clinical narrative: experiencing in upper body chills; This is a spontaneous report from a contactable Pharmacist reporting for a patient. A 6-decade-old (early 50s) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The Pharmacist reported two patients with delayed onset symptoms, he was not entirely sure if they were related to the vaccine. The Pharmacist wanted to know if there is any data on delayed onset side effects. 10 days after vaccine, the patient in early 50s and was experiencing in upper body chills on an unspecified date and negative for COVID on unknown date. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: itchiness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient asked if she should use Benadryl for the itchiness and stiffness that the administration of the Pfizer's COVID-19 vaccine left her in the administration site in Jan2021. She was administered with the first dose of the vaccine yesterday 04Jan2021 and she was experiencing these symptoms after that. She was going to contact her Physician for that information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Sinusitis, Vaccination site pain
Clinical narrative: muscle aches and pain; sinus infection; fatigue; pain at the injection site; This is a spontaneous report from a Pfizer-sponsored program. From a contactable nurse (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received 1st dose of vaccine yesterday (04Jan2021). She needed to see her PCP for a sinus infection. She usually received a "Z-pack, a steroid injection and a Rocephin injection." She also stated some fatigue, muscle aches and pain at the injection site, but the fatigue and aches could be her sinus infection. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pain in extremity, Urinary tract infection
Clinical narrative: Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm.  She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol.  She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of  the other events was resolved on 20Dec2020.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm.  She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol.  She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of  the other events was resolved on 20Dec2020.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Movement disorder
Clinical narrative: lethargic; unable to get out of bed; This is a spontaneous report from a contactable nurse. A patient in late 50's or 60's of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. It was reported one of the report's doctors in late 50's or 60's was lethargic and was unable to get out of bed for 2 days on an unspecified date after getting the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gout, Limb discomfort, Pain in extremity
Clinical narrative: He has acute gout attack; some pains in the toes; left foot full blown gout attack happened; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported potential side effect of the vaccine. He had acute gout attack. On the 1st week he had experienced some pains in the toes - left foot full blown gout attack happened. He wanted to know what to do if he will continue on getting the 2nd dose since he did not want to experience another episodes of flare ups. He asked if it had aluminum adjuvant on the vaccine. The events were reported as non-serious. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was apprx 54 year old activities coordinator at a long term care facility. She had first dose of vaccine and had tingling. She was wondering how long the tingling will last and will it ever go away? She was also asking what did the expiration date mean. The event outcome was not resolved.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: she had some mild redness; swelling in the whole arm; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She already received the first dose and she had some mild redness and swelling in the whole arm. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate increased, Vaccination site pain, Vaccination site pruritus
Clinical narrative: noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Facial numbness/tingling; Facial numbness/tingling; This is a spontaneous report from a contactable other hcp (Patient).  A adult female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization.  Medical history included asthma, Known allergies: Sulphur drugs and adhesive sensitivity.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced facial numbness/tingling on 16Dec2020 with outcome of recovered on unknown date. The patient did not receive any treatment. Information on Lot/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Rash macular
Clinical narrative: Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Rash
Clinical narrative: Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin.  The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dysphonia, Dyspnoea, Mouth swelling
Clinical narrative: Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient.  A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization.  Medical history included severe dust mite allergy (based on skin test).  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening.  The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath,  throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient.  A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization.  Medical history included severe dust mite allergy (based on skin test).  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening.  The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath,  throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Salivary hypersecretion
Clinical narrative: numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.