chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Inflammation, Interchange of vaccine products, Off label use
Clinical narrative: took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; 18 lb weight loss; voice changed to soft and horse; inflammation flare up in lower back; extreme fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 78-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included heart disease, Kidney disease, and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Mar2021, as dose 1, single  and second dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Apr2021, as dose 2, single for covid-19 immunisation. The patient took 2 doses of moderna shot in Mar and Apr and Pfizer booster shot in Sep2021. On an unspecified date, on 2021, the patient experienced 18 lb weight loss, voice changed to soft and horse, inflammation flare up in lower back and extreme fatigue. On an unspecified date, the patient underwent lab tests and procedures which included weight which was 18 lbs (weight loss). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; 18 lb weight loss; voice changed to soft and horse; inflammation flare up in lower back; extreme fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 78-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included heart disease, Kidney disease, and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Mar2021, as dose 1, single  and second dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Apr2021, as dose 2, single for covid-19 immunisation. The patient took 2 doses of moderna shot in Mar and Apr and Pfizer booster shot in Sep2021. On an unspecified date, on 2021, the patient experienced 18 lb weight loss, voice changed to soft and horse, inflammation flare up in lower back and extreme fatigue. On an unspecified date, the patient underwent lab tests and procedures which included weight which was 18 lbs (weight loss). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received bnt162b2 (BNT162B2) at the age of 38-years-old, dose 1 via an unspecified route of administration, administered in arm left on 05Aug2021 15:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks, no other medications in two weeks. There were no concomitant medications. No Covid prior vaccination. The patient previously took cephalex [cefalexin] and experienced drug allergy. The patient experienced acute appendicitis on 06Aug2021 01:00. Adverse event: Acute Appendicitis was observed within 24 hours and intensified to go to the emergency room where it was officially diagnosed resulting in an Appendectomy. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for acute appendicitis for 1 days. Covid tested post vaccination included Nasal swab: negative on 07Aug2021 Nasal Swab. The event outcome was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Insomnia, Myalgia
Clinical narrative: limbs paralyzed (arms and legs); leg swelling; extreme tiredness; extreme joint pain in elbows and knees; could hardly walk; muscle pain; she couldn't sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on Sep2021 as single dose for COVID-19 immunization. The patient's medical history included hypertension (She does not have illness except high blood pressure) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient got the tetanus shot on an unspecified date in 2001 and had no reaction to it. On an unspecified date, after first dose patient experienced limbs paralyzed, leg swelling, extreme tiredness, extreme joint pain in elbows and knees, could hardly walk, muscle pain and she couldn't sleep. she still has symptoms and with the aspirin they are not as bad, her friend told her to take some, she hadn't thought to. Patient had it for 2 weeks and she is hoping it goes away. Patient states she was a little afraid and she doesn't take aspirin and her friend told her to take some so last night she took some and it helped a little but the joint pain and muscle pain was still there. Caller relays that the swelling of her leg went down but it still feels uncomfortable. States the swelling is scary they felt like phone poles, big and heavy. Patient felt like she should go to the hospital and it's not supposed to kill you, it was bad severe pain in her muscles and joints and she felt like her limbs were kind of paralyzed. Patient didn't have arm pain or swelling at the injection site or other symptoms like nausea, vomiting or diarrhea but the paralysis, tiredness, muscle and joint pain was overwhelming. Patient states when she went to get a tetanus and something else and her whole life she hasn't needed any and doesn't get sick a lot. Patient asking should she get the 2nd shot. Patients doctor moved out of state and the new doctor she was supposed to meet was out on administrative leave and she got a new physician and sees them 02Nov2021. Therapeutic measures were taken as a result of extreme tiredness, extreme joint pain in elbows and knees and muscle pain. The outcome of the events sleep difficult, could hardly walk, limbs paralyzed (arms and legs) was unknown; muscle pain, extreme joint pain in elbows and knees, leg swelling was not recovered; extreme tiredness was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Peripheral swelling
Clinical narrative: limbs paralyzed (arms and legs); leg swelling; extreme tiredness; extreme joint pain in elbows and knees; could hardly walk; muscle pain; she couldn't sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on Sep2021 as single dose for COVID-19 immunization. The patient's medical history included hypertension (She does not have illness except high blood pressure) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient got the tetanus shot on an unspecified date in 2001 and had no reaction to it. On an unspecified date, after first dose patient experienced limbs paralyzed, leg swelling, extreme tiredness, extreme joint pain in elbows and knees, could hardly walk, muscle pain and she couldn't sleep. she still has symptoms and with the aspirin they are not as bad, her friend told her to take some, she hadn't thought to. Patient had it for 2 weeks and she is hoping it goes away. Patient states she was a little afraid and she doesn't take aspirin and her friend told her to take some so last night she took some and it helped a little but the joint pain and muscle pain was still there. Caller relays that the swelling of her leg went down but it still feels uncomfortable. States the swelling is scary they felt like phone poles, big and heavy. Patient felt like she should go to the hospital and it's not supposed to kill you, it was bad severe pain in her muscles and joints and she felt like her limbs were kind of paralyzed. Patient didn't have arm pain or swelling at the injection site or other symptoms like nausea, vomiting or diarrhea but the paralysis, tiredness, muscle and joint pain was overwhelming. Patient states when she went to get a tetanus and something else and her whole life she hasn't needed any and doesn't get sick a lot. Patient asking should she get the 2nd shot. Patients doctor moved out of state and the new doctor she was supposed to meet was out on administrative leave and she got a new physician and sees them 02Nov2021. Therapeutic measures were taken as a result of extreme tiredness, extreme joint pain in elbows and knees and muscle pain. The outcome of the events sleep difficult, could hardly walk, limbs paralyzed (arms and legs) was unknown; muscle pain, extreme joint pain in elbows and knees, leg swelling was not recovered; extreme tiredness was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: Epilepsy; This is a spontaneous report from a Pfizer sponsored Program from a non-contactable consumer reported for patient (consumer's husband). A 71-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first and second dose of Pfizer Covid-19 vaccine last April 2021 and wanted to get an appointment to get the booster dose. He had epilepsy as mentioned. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: COVID test result Positive; Within minutes, joint pain inflamed my wrist/hand of the arm I received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain; Within minutes, joint pain inflamed my wrist/hand of the arm I received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183), via an unspecified route of administration in left arm on 27Aug2021 at 16:30 (at the age of 27 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications the patient received within 2 weeks of vaccination included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 27Aug2021, 16:45 within minutes, joint pain inflamed wrist/hand of the arm she received the shot. It quickly spread to the rest of the joints in her arm, then to her shoulders/neck and down the other arm, including the wrist/hand. And within the hour, it had spread to the rest of her body back, knees, ankles/feet every joint inflamed with pain. It has not gone away, despite using ibuprofen to get the inflammation down. She have also experimented with anti-inflammatory diets and supplements and on her 2nd doctor trying to find treatment that will work. She was dealing with chronic joint pain constantly that was not there before. The patient underwent lab tests and procedures which included sars-cov-2 test (Diagnostic PCR): positive on 29Sep2021, Post vaccination: Nasal Swab. Therapeutic measures were taken as a result of within minutes, joint pain inflamed my wrist/hand of the arm i received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain with Ibuprofen, anti-inflammatory supplements. The events arthralgia and arthritis resulted in doctor or other healthcare professional office/clinic visit. No hospitalization required. Reporter considered events as non-serious. The outcome of the covid-19 was unknown, while with other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Doctor had confirmed patient had shingles; This is a spontaneous report from a contactable consumer (patient).  A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 (Age at vaccination 35 years-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type Vaccine was workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had not known allergies. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0186) via an unspecified route of administration, administered in arm left on 18Aug2021 12:00 (age at vaccination 34-years-old) as DOSE 1, SINGLE for covid-19 immunization. There was no COVID prior vaccination. There was no COVID tested post vaccination. On 05Oct2021 after second dose of vaccination, the patient experienced doctor had confirmed patient had shingles. This event was considered as medically significant. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment of valacyclovir for adverse event. The outcome of event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Death Cause-Loss of Oxygen; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 08Oct2021 (at the age of 74 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose and second dose of BNT162B2 (lot numbers were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks and it was unknown if the patient had other medications was received in 2 weeks. The patient experienced loss of oxygen as death cause on 11Oct2021. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Event resulted in life threatening illness (immediate risk of death from the event). The patient died on 11Oct2021. An autopsy was not performed.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death Cause-Loss of Oxygen
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Hyperthyroidism, Thyroid disorder, Vertigo
Clinical narrative: blood pressure went up, with maximum BP of 173/110; hyperthyroid symptoms; had a bad thyroid reaction; Thinks it may be related to vestibular neuritis; he got bad vertigo, especially on bridges, which he now avoids; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration on an unspecified date for covid-19immunisation. On 30Jan2021 the patient experienced blood pressure went up, bad thyroid reaction, hyperthyroid symptoms, vestibular neuritis, bad vertigo. The reporter reported that he had a bad thyroid reaction after that second dose.  Patient reported that the reaction did not occur until about 3 weeks after the second dose and that he had issues in the past to get the right dose for his thyroid medication. The patient went on to say that sometimes in the spring, it (thyroid) produces more, patient had hyperthyroid symptoms.  The patient had to go to the ER for his reaction and blood pressure went up, with maximum BP of 173/110. The patient said he had never had an issue with blood pressure before. That all took place on 30Jan2021. reporter reported that the thyroid was almost cured, and that the patient no longer takes medication for that. The patient went to the VAERS website and found reports of thyroid issues, blood pressure increase, as well as vertigo. E-transmitted to DSU for possible duplicate or additional AE information. No Information section of the attached VR and referred to HCP for guidance on whether or not to get the booster dose.The patient received beta blocker and Lisinopril as treatment for the events. The patient underwent lab tests and procedures on 30Jan2021 blood pressure was 173/110. The outcome of the event of hypertension is not recovered while for thyroid disorder, hyperthyroidism was recovering. The outcome of the event of vestibular neuritis and vertigo was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: blood pressure went up, with maximum BP of 173/110; hyperthyroid symptoms; had a bad thyroid reaction; Thinks it may be related to vestibular neuritis; he got bad vertigo, especially on bridges, which he now avoids; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration on an unspecified date for covid-19immunisation. On 30Jan2021 the patient experienced blood pressure went up, bad thyroid reaction, hyperthyroid symptoms, vestibular neuritis, bad vertigo. The reporter reported that he had a bad thyroid reaction after that second dose.  Patient reported that the reaction did not occur until about 3 weeks after the second dose and that he had issues in the past to get the right dose for his thyroid medication. The patient went on to say that sometimes in the spring, it (thyroid) produces more, patient had hyperthyroid symptoms.  The patient had to go to the ER for his reaction and blood pressure went up, with maximum BP of 173/110. The patient said he had never had an issue with blood pressure before. That all took place on 30Jan2021. reporter reported that the thyroid was almost cured, and that the patient no longer takes medication for that. The patient went to the VAERS website and found reports of thyroid issues, blood pressure increase, as well as vertigo. E-transmitted to DSU for possible duplicate or additional AE information. No Information section of the attached VR and referred to HCP for guidance on whether or not to get the booster dose.The patient received beta blocker and Lisinopril as treatment for the events. The patient underwent lab tests and procedures on 30Jan2021 blood pressure was 173/110. The outcome of the event of hypertension is not recovered while for thyroid disorder, hyperthyroidism was recovering. The outcome of the event of vestibular neuritis and vertigo was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID-19 infection; Contracted COVID-19 infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 23Aug2021 (at the age of 64 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient was contracted COVID-19 infection and received Regeneron. She was told that could not get any vaccination for 90 days. Caller has not received her second dose of the Pfizer COVID-19 vaccine yet. Caller would like to know if she receives the second dose of the Pfizer COVID-19 vaccine 90 days or more after the first dose, does she have to start over the vaccination series.Therapeutic measures were taken as a result of contracted covid-19 infection (suspected covid-19). The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Breakthrough Covid Infection; Breakthrough Covid Infection; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EP6955), intramuscular, in left arm on 24Mar2021 as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EL3248), intramuscular, in left arm on 03Mar2021 as dose 1, single, both at the age of 55-years-old, for COVID-19 immunization. The patient had no medical history or no known, allergies. Concomitant medications included citalopram, omeprazole and levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccine was given in four weeks. The patient experienced breakthrough covid infection on 05Oct2021. The patient underwent lab tests and procedures which included nasal swab test: positive on 05Oct2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received Regeneron Antibody Infusion as treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spams...about 80 to 100 times per day; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), intramuscular on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first injection of the Pfizer COVID-19 vaccine 4 to 6 weeks ago (2021) and he experienced muscle spams in the muscle where he was administered the shot, for about 80 to 100 times per day for 3 weeks after he received his first shot. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Headache
Clinical narrative: body aches; extreme fatigue; upset stomach; diarrhea; extreme headaches; muscles aches/every muscle in her body hurts; knee pain/ joint pain/ can''t even touch her elbow where she got the shot because of the pain; muscle pain at the site; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 10Oct2021 at 15:30 (Batch/Lot number was not reported) at the age of 53 years old as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. The patient stated that this vaccine, there's no words for it. The patient was reporting to complain but she feels like she is wasting her energy, nobody is going to care, Pfizer doesn't care. The patient stated she is not yelling, agent is on speaker phone because she can't hold it up to her. The patient stated that it was her first dose, the first and last, she will never get it again. On 10Oct2021, the patient stated she was having body aches, extreme fatigue, upset stomach, diarrhea, extreme headaches, she is just fatigued to the point she can't even go to work, muscle aches, body ache, knee pain, joint pain, the elbow she had it put in she can't even touch that elbow because of the pain. The patient was missing work now for 48 hours. The patient stated the symptoms began 10 minutes after the vaccine and that it happened almost instaneously and confirmed all symptoms began 10Oct2021, are ongoing, have worsened, they are not getting any better, its actually scaring her. The patient got sent home from work because she's going to the bathroom and she's tired, having headaches. She states every muscle everything in her body hurts, she can hardly move, headache, fatigue, diarrhea, muscle pain at the site, muscle pain at every joint in her body. The patient stated that when she got the Pfizer vaccine, she was so sick, Pfizer should be sued, Pfizer is horrible, its like somebody injected her with poison. She has every side effect known to man, it's literally poison. She can't go to work, she's really upset. She states she would be happy to tell. This should not be on the market, the Pfizer Vaccine. The patient had not recovered from the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: body aches; extreme fatigue; upset stomach; diarrhea; extreme headaches; muscles aches/every muscle in her body hurts; knee pain/ joint pain/ can''t even touch her elbow where she got the shot because of the pain; muscle pain at the site; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 10Oct2021 at 15:30 (Batch/Lot number was not reported) at the age of 53 years old as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. The patient stated that this vaccine, there's no words for it. The patient was reporting to complain but she feels like she is wasting her energy, nobody is going to care, Pfizer doesn't care. The patient stated she is not yelling, agent is on speaker phone because she can't hold it up to her. The patient stated that it was her first dose, the first and last, she will never get it again. On 10Oct2021, the patient stated she was having body aches, extreme fatigue, upset stomach, diarrhea, extreme headaches, she is just fatigued to the point she can't even go to work, muscle aches, body ache, knee pain, joint pain, the elbow she had it put in she can't even touch that elbow because of the pain. The patient was missing work now for 48 hours. The patient stated the symptoms began 10 minutes after the vaccine and that it happened almost instaneously and confirmed all symptoms began 10Oct2021, are ongoing, have worsened, they are not getting any better, its actually scaring her. The patient got sent home from work because she's going to the bathroom and she's tired, having headaches. She states every muscle everything in her body hurts, she can hardly move, headache, fatigue, diarrhea, muscle pain at the site, muscle pain at every joint in her body. The patient stated that when she got the Pfizer vaccine, she was so sick, Pfizer should be sued, Pfizer is horrible, its like somebody injected her with poison. She has every side effect known to man, it's literally poison. She can't go to work, she's really upset. She states she would be happy to tell. This should not be on the market, the Pfizer Vaccine. The patient had not recovered from the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Chills, Confusional state, Fatigue, Nausea
Clinical narrative: began to experience adrenal stress; fatigue; teeth chattering; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: 30155BA), dose 2 via an unspecified route of administration, administered in arm left on 29Sep2021 13:30 (at the age of 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included Congenital Adrenal Hyperplasia and known allergies. Concomitant medication included dexamethasone 0.5 mg. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: FD0809) administered in arm left on 01Sep2021 13:45 as single dose for COVID-19 immunization.  No Covid prior vaccination nor Covid tested post vaccination. The patient has a congenital Adrenal Hyperplasia and 4 hours after injection on 29Sep2021 at 17:30 began to experience adrenal stress including fatigue, teeth chattering, confusion, nausea. Initiated stress protocol of increased dexamethasone (1.0 mg) in addition to normal dose. Symptoms abated within the hour. The adverse events resulted in Life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included dexamethasone 1.0 mg. The patient recovered from the events 29Sep2021.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (Husband).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot no and expiry date were not reported), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient developed shingles two (2) weeks after receiving her second dose of the COVID-19 vaccine. Please send him a summary of how many other patients had developed shingles after taking the vaccine. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: right side coronary artery blockage; Heart attack; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in left arm on 10Aug2021 (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history included Diabetes. The patient has not had COVID prior to vaccination. Concomitant medications included metformin, lisinopril, insulin glargine (LANTUS), colecalciferol (VIT D), and simvastatin. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: FA7485) via an unspecified route of administration, administered in the left arm on 17Jul2021 15:00 (at the age of 56 years old) for Covid-19 immunization. No other vaccines were given in four weeks. On 02Oct2021 09:00, the patient suffered a right side coronary artery blockage (heart attack) requiring stent placement. The events resulted in Emergency room/department or urgent care, Hospitalization for 2 days on an unspecified date, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Therapeutic measures were taken as a result of the events which included coronary artery stent placement. The patient underwent nasal swab post vaccination with test result unknown on 02Oct2021. The outcome of the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Atelectasis, Dyspnoea, Pneumothorax, SARS-CoV-2 test
Clinical narrative: Partially collapsed lung; pain in my abdomine; shortness of breath; Atelectasis; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy or Drug Store, administered via an unspecified route, in left arm on 03Oct2021 13:30, at 26 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (AIHA) from an unknown date; splenectomy, appendicectomy, tumor removal of the colon, tubal removal, gallbladder removal and intracranial brain anyerisum surgery on unknown dates and allergy to morphine and penicillin from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the 4 weeks prior BNT162B2 vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 04Oct2021 the patient started to have pain in her abdomen and shortness of breath, therefore she went to the ER and got a chest X-ray and was told it was atelectasis or a partially collapsed lung. She received treatment with pain managment and oxygen. The event "partially collapsed lung" was assessed as medically significant. On 06Oct2021 the patient underwent SARS-CoV2 test via nasal swab, which resulted negative. At the time of the report the events were resolving.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Partially collapsed lung; pain in my abdomine; shortness of breath; Atelectasis; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy or Drug Store, administered via an unspecified route, in left arm on 03Oct2021 13:30, at 26 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (AIHA) from an unknown date; splenectomy, appendicectomy, tumor removal of the colon, tubal removal, gallbladder removal and intracranial brain anyerisum surgery on unknown dates and allergy to morphine and penicillin from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the 4 weeks prior BNT162B2 vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 04Oct2021 the patient started to have pain in her abdomen and shortness of breath, therefore she went to the ER and got a chest X-ray and was told it was atelectasis or a partially collapsed lung. She received treatment with pain managment and oxygen. The event "partially collapsed lung" was assessed as medically significant. On 06Oct2021 the patient underwent SARS-CoV2 test via nasal swab, which resulted negative. At the time of the report the events were resolving.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Illness, Myocardial infarction, Ocular vascular disorder, Spinal fracture
Clinical narrative: 6 fractures in his back that broke; sick; Heart attack; stroke in the back of his eye; could not see out of his right eye/ blind; This is a spontaneous report from a contactable consumer (patient's wife). A 69-year-old male patient received BNT162B2 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021; NDC number: 59267-1000-1), via an unspecified route of administration, administered in arm on 03Mar2021 (time the vaccination was given: between 1330-1400) at the age of 69 years old, as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) - had it for years. No family medical history relevant to events. There were no concomitant medications. In Mar2021, they had the first Pfizer shot and within a week, the patient had a heart attack. It was almost like he was dead and does not expect him to live much longer; he crashed a week after the vaccine. The patient has been in the hospital and had a heart attack (Mar2021) and has 6 fractures in his back that broke (unknown date). He has been in and out of hospital since March and was in the hospital 'now'. It caused him to have a heart attack. When querying the details of heart attack, stated that he drove himself and was going to the store. He was honking his car for ambulance, he laid on the horn since he could not breathe and was weak. Also reported that the patient must have had a stroke since he woke up one day and could not see out of his right eye, went to eye doctor and said it was a stroke in the back of his eye and he cannot see out of that eye, he is blind. This occurred about 2.5 to 3 months ago (in 2021). He has seen so many doctors. Doctor said his sight in his right eye will never come back. Saw two specialists and they tried everything they could to save his eyesight but could not. The patient always gets the flu shot but he was sick in the hospital and they do not want to give it to him. The patient was hospitalized from Mar2021 to an unknown date. The reporter talked to all of the patient's doctors and asked if the shot did this to him and they say they don't know. He was fine before the shot. The patient did not get a second dose and neither did the reporter. Outcome of events stroke in the back of his eye and could not see out of his right eye/ blind were not recovered, while other events were unknown.  Follow-Up (18Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer and a physician. This consumer reported similar events for 5 patients. This report is the fifth of 5 reports.  A patient of unspecified age and gender started to receive 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's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.  Follow-up (21Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (27Apr2021): New information reported from a contactable consumer includes: patient details, relevant medical history, concomitant medications, suspect vaccine details, and reaction data (onset, seriousness, outcome of COVID; new event shortness of breath).  Follow-up (13Jul2021): The is a follow-up spontaneous report received from product quality complaints group. New information received included: investigation results were received from Product Quality Complaint group.   Follow up attempts are completed. No further information is expected.  Follow-up (22Jul2021): Further information was received from a Product Quality Complaint Group. This report included that: Investigation findings- Summary of Investigation for Lot number EN6200 were added in the narrative.  Follow-up (07Oct2021): New information received from a contactable consumer: reporter details updated. This is also a follow-up report being submitted to amend previously reported information: the reported information from date 27Apr2021 to 22Jul2021 were not belong to this patient, the information will be reported in another report.  Follow-up (18Oct2021): This is a follow-up report to notify that the case 2021317618 and case 202101389497 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number case 202101389497.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Pain in extremity
Clinical narrative: hips were hurting; having hard time getting up and down; Her arm is a little sore now; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Feb2021 11:00 (at the age of 78-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included heart condition, AFib (atrial fibrillation) had in last Jan2020 (on a blood thinner for that now), breast cancer, blood pressure, and sensitivity to medication (some medications do not agree with her). The other conditions were started about 8-9 years ago. In the left breast no investigation assessment was performed. Concomitant medications included apixaban (ELIQUIS) taken for AFib (atrial fibrillation) and ongoing, diltiazem hcl (DILTIAZEM HCL) taken to regulate her heart and ongoing, lisinopril (LISINOPRIL) taken for blood pressure and ongoing and hydralazine (HYDRALAZINE) taken for blood pressure and ongoing. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration on 01Feb2021 (at the age of 78-year-old) as dose 1, single for COVID-19 immunization and she said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. It was reported that, the patient had the second shot yesterday around 11:00 on 22Feb2021 and stated that around 14:00- 15:00 (3) her hips started hurting (hips were hurting) and got progressively worse. Then they hurt all night and have hurt ever since. She was "having hard time getting up and down". She said that she kept a hot water bottle on it. She said that it was hard to get up and down, especially off of the toilet. She took a Tylenol at 09:00 on 23Feb2021. She said that she has had no problem with her hip prior to this. The patient said that she last saw her physician last Thursday. She said that she felt her age today, but she usually did not. The pain in her hips had improved since she took a Tylenol. "She said that she does have a sensitivity to medication. She said that some medications do not agree with her". The patient said, on an unspecified date in 2021 "her arm is a little sore now", but it was her hip that was bothering her now. She said that she did not have any artificial hips or anything. "She said that she has all of her body parts". The outcome of event hips were hurting was reported as resolving. The outcome of the event "having hard time getting up and down" was reported as not recovered. The outcome of event "her arm is a little sore now" was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225296 Same patient, different AE, different dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache; Mild nausea; Muscle ache; This is a spontaneous report from a contactable consumer. A 45-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 22Feb2021 (age at vaccination 45 years) as dose 2, single for COVID-19 immunization. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 23Feb2021 the patient experienced headache, nausea, muscle ache. It was unknown that patient was received any treatment for events. The events accessed as a non serious. The outcome of all events was reported as not recovered.  Information about lot/batch number cannot be obtained. No further information expected.