chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: swelling on his right arm; swelling on his right arm next to his chest; where his breast is on the right hand side and it is about the size of a baseball, doctor said lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right in Mar2021 (Batch/Lot number was not reported) at vaccination age of 75 years old as single dose for covid-19 immunisation.  There was no medical history. There was no family medical history relevant to events. There were no concomitant medications. No events following prior vaccinations. No additional vaccines administered on same date of the Pfizer.The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), in Mar2021 as single dose for covid-19 immunisation. The patient took the Pfizer vaccine about a month ago and after a week or two, he got swelling on his right arm next to his chest where he took the shot at. His arm was still swollen and he went to doctor. The doctor said it looked like a swollen lymph node. It was where his breast was on the right hand side and it was about the size of a baseball. He was supposed to go back to doctor on 14Apr2021.  Clarified this happened about two weeks after his second dose, and it was on a Thursday. They were supposed to do more tests on Wednesday of this week (14Apr2021). They were talking about giving him an ultrasound, but he was not sure. Time of event onset reported as 10 AM. Events did not require emergency room, required physician office. The outcome of events was unknown.  No follow up attempts are needed; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever; fatigue; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) 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. The patient experienced sore arm, fatigue and fever after use of product. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity
Clinical narrative: sore arm; tiny little cough; This is a spontaneous report received from a contactable consumer (patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (reported "on Friday") (at the age of 90-year-old), at single dose, for COVID-19 immunization. Medical history included she was just getting over COVID-19. Concomitant medications were not reported. The patient experienced sore arm. It was reported the second dose scheduled four weeks after first dose. Patient was 90 and she could not even remember the phone number a while ago. She just got over COVID 1 or 2 months ago. She was still kind of getting over it, didn't get over it right away. She had the first one and it was fine, she had a little sore arm and the usual. Patient asked if she would need to get the 2 shots since she had COVID. Her appointment was for 07May2021. She didn't know if anyone every really gets over COVID. It hangs on for awhile. She wanted to get what she needs, but if she didn't need it she won't get it. The smell, tiny little cough, different things. 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: Pain in extremity, Product administered at inappropriate site, Underdose, Vaccination site erythema, Vaccination site extravasation
Clinical narrative: some of the vaccine "leaked out" when the provider pulled the needle out; some of the vaccine "leaked out" when the provider pulled the needle out; vaccine gave it to her almost exactly between her shoulder and her elbow; She reports that her arm was a little sore after this dose as well and it is also red in the area that she received the injection.; She reports that her arm was a little sore after this dose as well and it is also red in the area that she received the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of BNT162B2 for covid-19 immunization and had soreness in her arm after her first dose. The patient is concerned because she stated the person who administered her vaccine gave it to her almost exactly between her shoulder and her elbow instead of "3 fingers down from her shoulder" like her first dose was given. She also stated that some of the vaccine "leaked out" when the provider pulled the needle out. The patient was concerned that if the second dose was not given in the appropriate place that she will not be protected against Covid or that the vaccine will not be as effective. She reported that her arm was a little sore after this dose as well and it was also red in the area that she received the injection on an unknown date in Apr2021. She denied any other type of side effects at this time. The outcome of the events was unknown. Patient wanted to known if the vaccine was as effective if it is administered somewhere other than 3 fingers down from the shoulder, what she should do if the second dose of the Pfizer COVID-19 vaccine was in fact administered incorrectly and if she should get tested for antibodies to evaluate for efficacy of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Poor quality sleep
Clinical narrative: Restless sleep; Fever; Chills; Body aches; Tired; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, tired, restless sleep on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Restless sleep; Fever; Chills; Body aches; Tired; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, tired, restless sleep on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound thyroid
Clinical narrative: gland swelling under chin, upper neck; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (BNT162B2, Pfizer Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 30Jan2021 12:30 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included ongoing diabetes type 2. There were no concomitant medications. The patient received dose 1 (lot: EL3246) on 09Jan2021 for Covid-19 immunisation. The patient experienced gland swelling under chin, upper neck in Apr2021.  The patient underwent lab tests and procedures which included ultrasound thyroid with unknown result on 08Apr2021. The outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sweating pretty; felt a little too ill to get up and walk away; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 13Apr2021 15:00 (Lot number was not reported) (at age 46 years old) as single dose for covid-19 immunisation in a pharmacy.  Medical history included covid-19 from an unknown date and unknown if ongoing. Patient was not covid tested post vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 13Apr2021 15:00, within one minute of receiving the vaccine, his ears were ringing, he felt faint, and began sweating pretty significantly. He took a seat immediately, and these symptoms seemed to pass after about 8-10 minutes. He stayed seated for 40 minutes after in the pharmacy as he felt a little too ill to get up and walk away. Next day, on 14Apr2021, symptoms are mild fatigue, mild fever, mild cough, and moderate muscle aches. Treatment not given for the events. The patient was recovering from the events.  Information on the batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sweating pretty; felt a little too ill to get up and walk away; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 13Apr2021 15:00 (Lot number was not reported) (at age 46 years old) as single dose for covid-19 immunisation in a pharmacy.  Medical history included covid-19 from an unknown date and unknown if ongoing. Patient was not covid tested post vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 13Apr2021 15:00, within one minute of receiving the vaccine, his ears were ringing, he felt faint, and began sweating pretty significantly. He took a seat immediately, and these symptoms seemed to pass after about 8-10 minutes. He stayed seated for 40 minutes after in the pharmacy as he felt a little too ill to get up and walk away. Next day, on 14Apr2021, symptoms are mild fatigue, mild fever, mild cough, and moderate muscle aches. Treatment not given for the events. The patient was recovering from the events.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis
Clinical narrative: Having symptoms of sinus and cold, but no fever; Having symptoms of sinus and cold, but no fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 16Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had the first vaccine on 16Mar2021. She was supposed to go get second dose tomorrow (on 13Apr2021). She was having symptoms of sinus and cold, but no fever. She asked if she can go ahead and get the second dose. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Contraceptive diaphragm, Eye pain
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; my eyes hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; my hips hurt/my joint hurts; I have a gland swelled right underneath my chin under my jaw; My hands hurt; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; This is spontaneous report received from a contactable consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) for covid-19 immunisation. The patient experienced she had both the shots in her left arm her shoulder and second shot hurt and it was bleeding. She didn't know blood came out from the vaccine for what but it hurt. She got a very stiff neck on her left side and she could not look over her shoulder on her left side, her tongue was swollen and she end up biting and that is hurting. It hurts to hold her head up, her teeth even hurt, her eyes hurt, she had a headache in my temple area, her skin hurts when touched, she had weakness all over and it hurts to talk. Her back hurts, her hips hurt, her joint hurts and she had a gland swelled right underneath her chin under her jaw. Her hands hurt, and she had nauseated also. This was awful, it seems like she had a disease or something. Her diaphragm also hurts, it felt like she did 100 pushups or something. The event onset date was Mar2021. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412713 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Lymphadenopathy, Musculoskeletal stiffness, Nausea
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; my eyes hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; my hips hurt/my joint hurts; I have a gland swelled right underneath my chin under my jaw; My hands hurt; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; This is spontaneous report received from a contactable consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) for covid-19 immunisation. The patient experienced she had both the shots in her left arm her shoulder and second shot hurt and it was bleeding. She didn't know blood came out from the vaccine for what but it hurt. She got a very stiff neck on her left side and she could not look over her shoulder on her left side, her tongue was swollen and she end up biting and that is hurting. It hurts to hold her head up, her teeth even hurt, her eyes hurt, she had a headache in my temple area, her skin hurts when touched, she had weakness all over and it hurts to talk. Her back hurts, her hips hurt, her joint hurts and she had a gland swelled right underneath her chin under her jaw. Her hands hurt, and she had nauseated also. This was awful, it seems like she had a disease or something. Her diaphragm also hurts, it felt like she did 100 pushups or something. The event onset date was Mar2021. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412713 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Swollen tongue, Tongue biting, Toothache
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; my eyes hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; my hips hurt/my joint hurts; I have a gland swelled right underneath my chin under my jaw; My hands hurt; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; This is spontaneous report received from a contactable consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) for covid-19 immunisation. The patient experienced she had both the shots in her left arm her shoulder and second shot hurt and it was bleeding. She didn't know blood came out from the vaccine for what but it hurt. She got a very stiff neck on her left side and she could not look over her shoulder on her left side, her tongue was swollen and she end up biting and that is hurting. It hurts to hold her head up, her teeth even hurt, her eyes hurt, she had a headache in my temple area, her skin hurts when touched, she had weakness all over and it hurts to talk. Her back hurts, her hips hurt, her joint hurts and she had a gland swelled right underneath her chin under her jaw. Her hands hurt, and she had nauseated also. This was awful, it seems like she had a disease or something. Her diaphragm also hurts, it felt like she did 100 pushups or something. The event onset date was Mar2021. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412713 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; my eyes hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; my hips hurt/my joint hurts; I have a gland swelled right underneath my chin under my jaw; My hands hurt; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; This is spontaneous report received from a contactable consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) for covid-19 immunisation. The patient experienced she had both the shots in her left arm her shoulder and second shot hurt and it was bleeding. She didn't know blood came out from the vaccine for what but it hurt. She got a very stiff neck on her left side and she could not look over her shoulder on her left side, her tongue was swollen and she end up biting and that is hurting. It hurts to hold her head up, her teeth even hurt, her eyes hurt, she had a headache in my temple area, her skin hurts when touched, she had weakness all over and it hurts to talk. Her back hurts, her hips hurt, her joint hurts and she had a gland swelled right underneath her chin under her jaw. Her hands hurt, and she had nauseated also. This was awful, it seems like she had a disease or something. Her diaphragm also hurts, it felt like she did 100 pushups or something. The event onset date was Mar2021. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412713 same reporter/drug, different patient/event
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Vaccination site pain
Clinical narrative: Troubled sleep (tossing & turning, frequent waking); slight fever; injection site pain; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 11Apr2021 (Lot number was not reported) as single dose for covid-19 immunization. Patient received dose 1 for covid-19 immunization on unknown date. The patient's concomitant medications were not reported. The patient experienced troubled sleep (tossing & turning, frequent waking), slight fever, injection site pain on 11Apr2021. The outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Diarrhoea, Eye pain, Oropharyngeal pain
Clinical narrative: Eye pain; sore throat; diarrhea; bone pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine in 4 weeks and unknown whether the patient had COVID prior to vaccination. On 06Apr2021, the patient experienced eye pain, sore throat, diarrhea and bone pain. The patient did not tested for COVID since vaccination. The patient did not receive treatment for the events. The outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's father and mother). This is second of two reports. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his parents received the first dose of the Pfizer COVID vaccine in Jan2021 and then was diagnosed with COVID-19 and could not receive the second dose of the vaccine. He had been told conflicting things regarding if and when they should receive the second dose. He was originally told they had to wait 90 days to receive the second dose and then he was told they had to restart the series and not just receive the second dose. He would like to know what the correct guidance for his parents is. He would like to know if the first and second dose is the same composition and quantity. He stated the vaccination facility where his parents received the first dose of the vaccine ran out Pfizer COVID vaccines so he was wondering if he could go to another location that had Pfizer COVID vaccines. He would like to know if the vaccine will be still as effective if given greater than 90 days apart from the first dose. He was trying to get answers regarding the Covid-19 vaccine. His parents received the first dose of the vaccine in Jan2021. Between the first and second dose they had Covid and was unable to get the second dose. They were told they had to wait 90 days and start over. After 90 days was told only the second dose was needed. He tried to schedule the vaccine and was told they had to start over. He kept getting the back and forth. Case was reported as non-serious. Outcome of the events was unknown.  Information on lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411801 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was none. The reporter stated that, both he and his wife had the Pfizer COVID vaccine and the next day he had a fever. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414763 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Feeling achy in her back; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced feeling achy in her back on an unspecified date. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021414762 same reporter/drug, different patient/AE
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lethargy, Pyrexia, Vaccination site erythema
Clinical narrative: Redness at injection site; shortness of breath; Feverish; lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 13:15 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation in hospital.  Medical history included, drug hypersensitivity (Penicillin allergy) from an unknown date and unknown if ongoing known allergies. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid-19 immunisation.  The patient was feverish and had lethargy on 13Apr2021, a day after receiving COVID-19 vaccine. The patient developed redness at injection site and shortness of breath on day 2. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Heart rate increased, Nausea, Pyrexia
Clinical narrative: fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush
Clinical narrative: hot flashes; body was hot all over; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient got vaccine and got hot flashes and body was hot all over that night and was fine the next day. The event outcome for events was recovered.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: she felt chills; feeling of tiredness; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller wants to check if she can have other vaccines for the 2nd dose instead of Pfizer since she got Pfizer for the first dose. She wants to know also why people are getting blood clots with other vaccines. She said she felt chills and a feeling of tiredness. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia and fever lasting several days; Myalgia and fever lasting several days; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myalgia and fever lasting several days. The outcome of the event was recovered.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: I was on my 4th week pregnancy. The next day I took my second dose I had spotting and the third day I'm having a miscarriage. ( this is my third pregnancy); I was on my 4th week pregnancy. The next day I took my second dose; I was on my 4th week pregnancy. The next day I took my second dose; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534), second dose via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (at 43 years old, pregnant), single dose for covid-19 immunisation. The patient's medical history included that this was her third pregnancy. The patient's  concomitant medications were not reported.  The patient had his first dose of bnt162b2 on 23Mar2021  14:45 for covid-19 immunisation, left arm, lot number EP7534. Patient was on her 4th week pregnancy. The next day, she took her second dose, she had Spotting and the third day (also reported as 14Apr2021 15:00) she was having a miscarriage. Treatment was Received. The outcome of the event Miscarriage of pregnancy was recovering. No covid prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products.; Sender's Comments: Based on the information currently available and known safety profile of the drug, a possible contributory role of suspect product Bnt162b2 to the reported events can not be ruled out. But product is not indicated in this population group.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: She has not had the second dose. (1st dose 01Mar2021/PRD 15Apr2021); She has not had the second dose. (1st dose 01Mar2021/PRD 15Apr2021); received the first dose of the Pfizer COVID 19 vaccine on 01Mar. She tested positive for COVID on 18Mar; received the first dose of the Pfizer COVID 19 vaccine on March 1st. She tested positive for COVID on March 18; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 01Mar2021 (at the age of 60-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received 1st Pfizer dose on 01Mar2021 and tested positive for Covid on 18Mar2021. On 22Mar2021 she received the antibody infusion and was wondering if she should receive the 2nd Pfizer shot. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching all over her body; This is a spontaneous report from a contactable consumer.   A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Mar2021 16:00 (Batch/Lot Number: EP7534) as SINGLE DOSE (at the age of 51 years) for covid-19 immunisation.  Medical history included mycotic allergy from an unknown date, seasonal allergy from an unknown date ( Grass/ Weeds allergies), allergy to animal from an unknown (various animals), asthma from an unknown date, sinusitis from 2021 to an unknown date, fruit allergy from an unknown date (she has had reactions to strawberries, apples, basically every fruit  except bananas). Concomitant medications included loratadine (LORATADINE) taken for outside allergies; triamcinolone acetonide (NASACORT) taken for sinus infection and budesonide, formoterol fumarate (SYMBICORT) taken for asthma.  Patient states that she started immunotherapy around Oct2020 and gives herself unspecified "allergy shots" every other day. Dr. did not know how they would interact with Covid vaccine and sent her a letter advising her to stop allergy shots 48 hours before and 48 hours after receiving Pfizer COVID-19 vaccine, which she did. She started taking her allergy shots in 16Feb2021 and had no problems, no hives, no reactions, no itching until she got the Pfizer COVID-19 vaccine.  The patient experienced hives on 18Mar2021 with outcome of recovering and itching all over her body on 18Mar2021 with outcome of not recovered.  She had hives on her feet, neck, and legs. Therapeutic measures were taken as a result of hives and itching all over her body.  She has taken Calamine lotion, oatmeal baths, and Benadryl (not brand name) to treat her symptoms. She has seen a doctor who prescribed steroids to take. She was prescribed Prednisone 20mg tablets twice a day on 13Apr2021. She states her doctor advised her to take a break on the allergy shots since on prednisone. She does have an Epi pen but didn't feel any kind of respiratory distress, she did not feel she needed to use it. No additional vaccines administered on same date of the Pfizer product.  No other vaccines were given within 4 weeks of the Pfizer product. She states on 07Apr2021 she was supposed to get her second Pfizer COVID-19 vaccine, but she was advised not to take the second dose by her MD. She never had a reaction to any vaccination, and she has had unspecified pneumonia and flu vaccinations.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain
Clinical narrative: body aches; fatigue; sore ''armpit''; This is spontaneous report from a contactable consumer (Patient) reported for himself. A male patient of unspecified age received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, fatigue, sore ''armpit'', all on an unspecified date with outcome of unknown. Event took place after use of product.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal
Clinical narrative: Foggy head; lots of anxiety; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced foggy head, lots of anxiety on an unspecified date. The outcome was unknown.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eyelid pain, Fatigue, Headache
Clinical narrative: Sore arm at injection; back ache; body aches; chills; swollen tongue; burning eyelids(inner); nausea; headache; fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in left deltoid on 18Mar2021 09:55 (Batch/Lot Number: Er2613) as single dose for covid-19 immunisation. Medical history low back pain, ACP (advance care planning), chronic constipation, allergic rhinitis caused by unspecified, postmenopausal asymptomatic status sp hysterectomy with BSO, osteoarthritis hands, other and unspecified hyperlipidemia, overweight (BMI 25.0-29.9), osteopenia, ex-cigarette smoker, fatigue. Concomitant medication(s) included atorvastatin calcium (LIPITOR) taken for hyperlipidaemia; biotin; colecalciferol (VITAMIN D3 1000); loratadine (CLARITIN ONCE-A-DAY) taken for allergy symptoms; melatonin taken for sleep; plantago afra (PSYLLIUM SEEDS) taken for constipation; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (OCUVITE LUTEIN & ZEAXANTHIN); vitamin b complex (B-COMPLEX). Patient previously took BNT162B2 first dose on 25Feb2021 21:00 (lot number: EN60205) experienced back ache, tired and fatigue, treatment received and went to chiropractor for back ache. The patient experienced back ache, body aches, chills, swollen tongue, burning eyelids(inner), nausea, headache, fatigue, all on 18Mar2021; sore arm at injection on unspecified date. The event outcome for sore arm at injection was recovered on unspecified date, for other events was recovered on 21Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Swollen tongue, Vaccination site pain
Clinical narrative: Sore arm at injection; back ache; body aches; chills; swollen tongue; burning eyelids(inner); nausea; headache; fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in left deltoid on 18Mar2021 09:55 (Batch/Lot Number: Er2613) as single dose for covid-19 immunisation. Medical history low back pain, ACP (advance care planning), chronic constipation, allergic rhinitis caused by unspecified, postmenopausal asymptomatic status sp hysterectomy with BSO, osteoarthritis hands, other and unspecified hyperlipidemia, overweight (BMI 25.0-29.9), osteopenia, ex-cigarette smoker, fatigue. Concomitant medication(s) included atorvastatin calcium (LIPITOR) taken for hyperlipidaemia; biotin; colecalciferol (VITAMIN D3 1000); loratadine (CLARITIN ONCE-A-DAY) taken for allergy symptoms; melatonin taken for sleep; plantago afra (PSYLLIUM SEEDS) taken for constipation; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (OCUVITE LUTEIN & ZEAXANTHIN); vitamin b complex (B-COMPLEX). Patient previously took BNT162B2 first dose on 25Feb2021 21:00 (lot number: EN60205) experienced back ache, tired and fatigue, treatment received and went to chiropractor for back ache. The patient experienced back ache, body aches, chills, swollen tongue, burning eyelids(inner), nausea, headache, fatigue, all on 18Mar2021; sore arm at injection on unspecified date. The event outcome for sore arm at injection was recovered on unspecified date, for other events was recovered on 21Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), Lot number: Expiry date: Unknown, dose 1 via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified sate the patient experienced fever and chills. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: caller got positive result of COVID 19 after first shot/tested positive; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown), via an unspecified route of administration on 03Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that at first he had no side effects. Then, last Saturday on 10Apr2021, he started getting a headache and a cough. Sunday on 11Apr2021, it got worse. Monday on 12Apr2021 he had a fever. On 13Apr2021, Tuesday he was getting ready to go to work but he tested positive. He was still going through it but he's wondering if he can get the second dose. He also mentioned that they told to him to isolate for 10 days from the time he showed symptoms, then he can go get tested. He has to get 2 negative tests before going back to work. Patient got positive result of COVID 19 after first shot. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.