chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Laboratory test, Palpitations, Tremor
Clinical narrative: The tremors are still with her and sometimes are better than other times.; voice changes; heart palpitations; This is a spontaneous report from a contactable consumer (reported for herself). A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 10Mar2021 (at the age of 73-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Heart surgery/triple bypass surgery, Additional Information for Other Conditions: Had triple bypass surgery at age 70, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 17Feb2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced tremors; thought it was sugar dropping and had been tested, voice changes, heart palpitations. The patient previously received Flu shot, mentioned she got a Flu shot that last fall, unable to provide NDC, Lot, or expiry for Flu shot and pneumonia shot Had a month before the Covid vaccine, a pneumonia shot, but unable to provide NDC, Lot, or expiry for the pneumonia shot. On an unspecified date in 2021, the patient experienced the tremors are still with her and sometimes are better than other times, hearing aids are not working, voice changes, heart palpitations. It was reported that hearing aids are not working. Patient saw heart specialist. Heart surgeon/specialist did do some tests. The patient underwent lab tests and procedures which included laboratory test: he didn't see anything on an unspecified date. The clinical outcome of events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: a patient who received the vaccine and got ill; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that a patient who received the vaccine and got ill on an unspecified date in 2021. It was reported that caller was the consumer, wanted to know the exact percentage of each ingredient of the Pfizer COVID 19 vaccine. She believed that the vaccine caused cardiac arrest, DVT and other cardio related diseases. Caller was very upset with Pfizer since she believed that there was more ingredients in the vaccine that was not publicized. She also mentioned that the fact sheet provided for the recipients does not include the percentage of each ingredients. Even the pharmacists and doctors cannot provide her information. She wanted to have the full list of the mRNA vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Insisted to speak with higher position, she believed that someone would have an answer for her. She wanted to speak with the next level since she believed that there were still more information available with the specialist II. Outcome of the event was reported as Unknown.   Information on the Batch/lot number has been requested
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Poor quality product administered, Product preparation error
Clinical narrative: The second dose was prepped by adding normal saline into the vial in front of her before being administered.; The second dose was prepped by adding normal saline into the vial in front of her before being administered; Caller reported hair loss post vaccination/Second dose: she has a hair brush and it's full of her hair; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 (age at vaccination:63 Years) as dose 2, single for covid-19 immunisation. Patient did not received other vaccines within 4weeks prior to vaccination. Medical history included left mastectomy from an unknown date and unknown if ongoing, chemotherapy from 2001 to an unknown date she had chemotherapy about 20 years ago. The patient concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as dose 1, single for covid-19 immunisation. The caller reported hair loss post vaccination/second dose: she has a hairbrush and it was full of her hair on 2021. The second dose was prepped by adding normal saline into the vial in front of her before being administered on 21Apr2021. She reported she cannot have anything done to her left arm as she had a left mastectomy. She started to notice her hair loss about a week after receiving the first Covid 19 vaccine. She knew she was losing her hair because the hair loss was the same as when she had chemotherapy about 20 years ago. When probing for information on her medical history and concomitant medications she reports she had been taking all her medications normally. She also tried to rule out the hair loss being related to any of her medications, but nothing has changed. She added that with the second Covid 19 vaccine she reported the nurse drew up sterile saline, added the sterile saline to the Covid 19 vaccine vial, then withdrew from that Covid 19 vaccine vial a dose and administered the Covid 19 vaccine. This did not make any sense to her. The nurse told her it was, so the vaccine lasted longer. The outcome of the event alopecia was not recovered and the outcome of the events product preparation error and poor quality product administered was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little bit of soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   An 83-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received his first dose of the vaccine on Friday and that he was "doing well" with a "little bit of soreness" and knows "that was normal". He also said his wife received both vaccines and is doing well. He commented that they are both trying their best to protect themselves and that he was thankful for the opportunity to have the vaccine. Caller asked what the dosage of the vaccine was, if the dose was the same for someone who was 12 years old as for himself, and what the dose for the second shot was the same as the first. The clinical outcome of the events was reported as unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Arm is really swollen; It was on fire; After the second one, it is very swollen and red, the whole arm, the whole upper arm, there's a fever in there; After the second one, it is very swollen and red, the whole arm, the whole upper arm, there's a fever in there; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization and did not experience any adverse reaction. Caller stated she had her second Pfizer shot on 05Jul2021 and on an unknown date in Jul2021, her arm was really swollen and it was on fire. Caller stated the fire was kind of gone out now (on an unknown date in Jul2021). Caller stated she was really concerned, and reported they gave her the shot at home. Caller stated the first one was fine, but after the second one, it was very swollen and red, the whole arm, the whole upper arm, there was a fever in there and also stated what she really needs to know was if those people that gave her the shot could come back and check her arm. The outcome of the event It was on fire was recovered on an unknown date in Jul2021, whereas for rest of the events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 10:15 as (At the age of 41-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have patient history and investigation assessment. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162) on 17Apr2021 at 10:28AM into left arm for COVID-19 immunization. The patient experienced she is experiencing mild pain on the upper arm where she got the vaccine. it is not even that painful, it comes and goes on 11Jul2021. It was reported that Caller is a consumer who received her Pfizer-Biontech Covid19 vaccine series approximately 2 months ago. She is now reporting she is experiencing mild pain on the upper arm where she got the vaccine. She states it's not even that painful, just a sensation that she was noticing, and that the sensation comes and goes. Reporter was asking Has this been reported before. Response: Spoke from Fact Sheet Sect 6.1: Solicited Local and Systemic Adverse Reactions Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Later patient was reported that She now has a very mild pain on her upper arm where she received the covid vaccine. It is not even that painful, it comes and goes: It just began yesterday. She cannot even call it a pain because it is very mild. She is just concerned because she is not sure what it is. It is bothering her, but it is very mild. It happens maybe one or two times an hour. It is so mild that she did not take Ibuprofen. Reporter seriousness for events: Unspecified. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Tinnitus
Clinical narrative: the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number and Expiry Date was not reported), via an unspecified route of administration on 19Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Other products was reported as Not provided. The patient received the first dose of the Pfizer Covid-19 vaccine on 19Jun2021 and On 23Jun2021(wednesday), the patient experienced developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day. She is unable to receive the second dose of the Pfizer Covid-19 vaccine and was asked "Should I get the second dose?" Response included: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The patient reported that She received the 1st dose on 19Jun2021 and a week later, in the middle of that next week, she got, and it is still there, a humming in her right ear. She doesn't know if it is in her ear or in her head. It is real light and she is wondering if this could be a side effect and she just wants to know if anyone else has had this side effect. The outcome of the events was not recovered.  Information on Lot/Batch information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menopausal symptoms
Clinical narrative: Post menopausal hot flashes every day; Post menopausal hot flashes every day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731, Expiration date not reported), via intramuscular in right arm on 13Apr2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization at hospital. The patient medical history included: high blood pressure and thyroid from an unknown date and unknown if ongoing. The patient was allergic to stone fruit. The patient concomitant medication included thyroid (ARMOUR THYROID), metoprolol tartrate (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL [IBUPROFEN]). The patient previously received codeine and experienced allergy on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown whether the patient had COVID prior vaccination. The patient was not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number ER8727, Expiration date not reported), via unspecified route of administration in right arm on 23Mar2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization. On 20Apr2021 16:30, the patient experienced Post-menopausal hot flashes every day. The patient did not receive any treatment for the event. The outcome of event was not resolved. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache, Neck pain, Pyrexia, Vomiting
Clinical narrative: potential not to get the second shot; headache; neck ache; fever; throwing up; This is a spontaneous report from a contactable consumer (grandparent). This consumer reported for a 12-year-old male patient (grandson).   A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 11:30 (At the age of 12 year old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller called on behalf of his grandson (12-year-old) who received the first dose of the Pfizer Biontech COVID-19 vaccine and on the same day he got the shot, he experienced headache, neck ache, fever, and throwing up on 07Jul2021. Stated that the headache gets better and comes better. Stated that it was tolerable and comes back. Stated that the fever comes and goes. Started throwing up 2-3 days ago. She wanted to know if those side effects were related to the COVID19 vaccine and if she needed to go to the doctor and if he could get the second dose. Caller also stated that the side effects outweigh the COVID shot, I do not want my grandchild to suffer like that. Vaccines were supposed to make you feel better, not sick. Caller asked if the vaccine was tested on children and if they had side effects. Wanted to know if she needed to go the doctor because he cannot live throwing up all the time. Stated that he had never been sick before. Stated that he was only 12 years old. Does not think that vaccine was adequate for children. Therapeutic measures included Ibuprofen for his headache and fever. Stated that he had cold compresses for the neckache. Stated that he had ginger ale and Pepto Bismol for throwing up. Outcome of the event headache and throwing up was reported as not recovered at this time of the time. Outcome of the event neck ache was reported as recovered on 11Jul2021. Outcome of the event fever was reported as recovering and outcome of the event potential not to get the second shot was reported as Unknown.   Information about the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cognitive disorder, Computerised tomogram head, Computerised tomogram neck, Fatigue
Clinical narrative: Severe vertigo; Cognitive impairment; Chronic fatigue; Speech issues; Vision difficulties; Numbness in face; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 11May2021 (Age at vaccination: 33 Years) as dose 2, single for covid-19 immunisation. Medical history included as blood cholesterol increased, gastroesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. She received historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 2021. She has no allergies. She was no Pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 07Jul2021, The patient experienced severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties, numbness in face. The patient was hospitalized for severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties from 2021 to 2021. Presented to ER 2 weeks after 2nd shot. Admitted to hospital overnight. There was 2 days of hospitalization. She has taken Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient underwent lab tests and procedures which included blood test: inconclusive on 2021 All tests inconclusive,computerised tomogram head: inconclusive on 2021 All tests inconclusive , computerised tomogram neck: inconclusive on 2021 All tests inconclusive , magnetic resonance imaging head: inconclusive on 2021 All tests inconclusive. She has taken treatment as Meclizine for vertigo. It was not working. Therapeutic measures were taken as a result of severe vertigo. The outcome of the event (vertigo, cognitive disorder, fatigue, visual impairment, hypaesthesia) was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head, Speech disorder, Vertigo, Visual impairment
Clinical narrative: Severe vertigo; Cognitive impairment; Chronic fatigue; Speech issues; Vision difficulties; Numbness in face; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 11May2021 (Age at vaccination: 33 Years) as dose 2, single for covid-19 immunisation. Medical history included as blood cholesterol increased, gastroesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. She received historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 2021. She has no allergies. She was no Pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 07Jul2021, The patient experienced severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties, numbness in face. The patient was hospitalized for severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties from 2021 to 2021. Presented to ER 2 weeks after 2nd shot. Admitted to hospital overnight. There was 2 days of hospitalization. She has taken Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient underwent lab tests and procedures which included blood test: inconclusive on 2021 All tests inconclusive,computerised tomogram head: inconclusive on 2021 All tests inconclusive , computerised tomogram neck: inconclusive on 2021 All tests inconclusive , magnetic resonance imaging head: inconclusive on 2021 All tests inconclusive. She has taken treatment as Meclizine for vertigo. It was not working. Therapeutic measures were taken as a result of severe vertigo. The outcome of the event (vertigo, cognitive disorder, fatigue, visual impairment, hypaesthesia) was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hepatic pain, Hypokinesia, Musculoskeletal discomfort
Clinical narrative: he was literally hit with the sensation that his back got thrown out/ His back and liver area is hurting.; I didn't lift anything, I didn't do any new activity./ it almost dropped me to my knees; His back and liver area is hurting.; back pain; This is a spontaneous report from a contactable consumer (patient himself). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot number and expiry date were not reported) via an unspecified route of administration on 09Jul2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. On 10Jul2021 he was literally hit with the sensation that his back got thrown out. On an unspecified date in Jul2021, his back and liver area was hurting. It came out of nowhere, I didn't lift anything, I didn't do any new activity. Then Saturday he was hit with literally the sensation that his back got thrown out. He was a healthy person. He does not even take Tylenol. He unfortunately was forced to take the covid vaccine. He was asking has anyone else reported this. His back and liver area was hurting. He thought that it would pass. It gets better, and here today it came back. Patient's concern was it returned again today, he was helping his 03-year-old son put on his seat belt when it hit him like it did on Saturday, it almost dropped him to my knees and guess his concern was that resurfaced fairly quickly and it never dissipated completely but it hit him like it did Saturday at work. The outcome of the event movements reduced was unknown and for all other events was not resolved.  Information on batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; Big bump on her arm that was hot and swollen; Lump on my arm which was very hot and sore; Bump on my arm; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route on 17Apr2021 (at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. The patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET6955), via an unspecified route on 27Mar2021(at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. Medical history included stress from an unknown date and unknown if ongoing (stress a lot). The patient's concomitant medications were not reported. She received her second dose of the vaccine on 17Apr2021 and had no side effects other than a bump on her arm that was hot, red, and really sore on an unspecified date in 2021. She received both doses, the only thing she had received as an adverse event was a big bump on her arm that was hot and swollen; just like a lump on her arm which was very hot and sore for a few days but that was all that happened. The patient underwent lab tests and procedures which included antibody test: negative on a negative antibody test after being fully vaccinated on an unspecified date in 2021. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; Big bump on her arm that was hot and swollen; Lump on my arm which was very hot and sore; Bump on my arm; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route on 17Apr2021 (at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. The patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET6955), via an unspecified route on 27Mar2021(at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. Medical history included stress from an unknown date and unknown if ongoing (stress a lot). The patient's concomitant medications were not reported. She received her second dose of the vaccine on 17Apr2021 and had no side effects other than a bump on her arm that was hot, red, and really sore on an unspecified date in 2021. She received both doses, the only thing she had received as an adverse event was a big bump on her arm that was hot and swollen; just like a lump on her arm which was very hot and sore for a few days but that was all that happened. The patient underwent lab tests and procedures which included antibody test: negative on a negative antibody test after being fully vaccinated on an unspecified date in 2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Discharge
Clinical narrative: the patient said she had yellow fluid coming out of her hand; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, with the first dose of the vaccine, on an unspecified date, the patient had yellow fluid coming out of her hand. The outcome of the event was unknown at the time of report.  Information about lot/batch number is requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain, Scar
Clinical narrative: I developed a limited range of motion with my left arm; I found that there is a problem called SCAR; When reaching up for reaching back there is pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Left arm on 30Mar2021 at 16:00 (at the age of 74-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, cervical disc 5 and 6 replace with a plate and screws in 1995 and panic attack from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Left arm on an unspecified date for covid-19 immunisation and sulphur, cortisone, ultram [tramadol hydrochloride], codeine, penicillin and experienced drug allergy. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 12Jul2021. It was reported that after the second covid-19 Pfizer vaccine, On 30Mar2021 at 21:00, the patient developed a limited range of motion with her left arm. When reaching up for reaching back there was pain. This was not present before the vaccine. When questioning this event, she found that there was a problem called SCAR. Treatment for adverse events was unknown. Adverse events resulted in Disability or permanent damage. The reporter assessed events as Serious with seriousness criteria of resulting in Disabling/Incapacitating and no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Congenital anomaly or birth defect. As of 12July2021, she was still having this problem. The outcome of events was Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for COVID-19 immunization. The historical vaccine include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 09Jun2021 as dose 1, single for COVID-19 immunization. The report  was not related to a study or programme. The patient's medical history and concomitant medications were not reported. The patient experienced her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting on 02Jul2021. Caller wanted to enquire if there were any reports of any muscle problems and she was wondering if she had not taken the vaccine just like everyone else and said that she might just go to the hospital. Patient got the 2nd dose of the Pfizer vaccine last 30Jun2021 and mentioned that it's been 10 days now and she was still experiencing muscle pain in her back and a pain in her shoulder blade and arms. She wanted to know if she needs to go to the hospital and needs some assistance. She got her first dose on 09Jun2021. The outcome of the event was non recovered.  Information on the lot/batch has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: On day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm,; my upper torso well all enlarged and swollen; fever of 101 and was completely exhausted; completely exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Left Arm on 15Apr2021 09:15 AM (at the age of 50 years old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store.  Medical history included malignant melanoma (recovered). The patient has known allergies to Iodine, codeine, Cephdiner. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 12Jul2021.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide (MULTIVITAMINS AND MINERALS PLUS LUTEIN) and Birth control. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: unknown), as first dose in arm Left on 17Mar2021 as dose 1, single for COVID-19 immunization. On 18Apr2021, day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm, my upper torso well all enlarged and swollen. I had a fever of 101 and was completely exhausted. This lasted for 10 days before she started feeling better. The fever would come and go. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included pyrexia: 101 Fahrenheit on 18Apr2021. The outcome of the events was recovered on an unspecified date in 2021.    Was requested for additional information  Information about lot/batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Immunosuppression
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single dose and via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a suppressed immune system. It was reported that patient had a suppressed immune system and had received the first two vaccination shots for COVID-19 but was interested in participating in a trial for a booster if one is available. Outcome of the event was unknown. Information about Lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: Er8737) via an unspecified route of administration (age at vaccination 59-year) in Left Arm on 03Apr2021 as dose 1, single for COVID-19 immunization. Medical history included Peripheral neuropathy, High cholestrol and Arthritis from an unknown date and unknown if ongoing. Concomitant medications included gabapentin; celecoxib (CELEBREX); rosuvastatin calcium (CRESTOLIP) taken for an unspecified indication, start and stop date were not reported. No known drug allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 the patient experienced severe exacerbation of my peripheral neuropathy with severe burning, tingling, numbness, pain. AE resulted in Doctor or other Healthcare professional office/clinic visit. No treatment was received for the adverse events. The clinical outcome of the events was recovered with sequel (recovered with lasting effects) on an unspecified date.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Pain
Clinical narrative: A  lot of pain/horrible body aches; can barely move; This is a spontaneous report from a contactable consumer and patient (non-contactable). This patient of an unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and no adverse event reported for it. Reportedly, the patient wondered that has anyone experienced horrible body aches with their second covid vaccine (Pfizer), and if so, how long did it last. The patient got his on Tuesday and the patient was still dealing with a lot of pain (unspecified date) and can barely move today (unspecified date). But the patient was glad that the patient had vaccine. Event took place after use of product. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Drug ineffective, Illness, Pyrexia
Clinical narrative: On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); This is a spontaneous report from a Pfizer sponsored program COVAX US support.   A 28-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 02Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine in Jan2021 and was fully vaccinated 02Feb2021. The patient was so excited and so grateful for the vaccine and protection. On 04Jul2021, the patient believe he/she contracted covid 19. The patient has been quite sick (high fever, chills, cough, respiratory symptoms). The patient was also 28 and in good health. Hopefully the patient's story could push for a booster to the vaccine for others and myself. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory symptom, Suspected COVID-19
Clinical narrative: On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); This is a spontaneous report from a Pfizer sponsored program COVAX US support.   A 28-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 02Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine in Jan2021 and was fully vaccinated 02Feb2021. The patient was so excited and so grateful for the vaccine and protection. On 04Jul2021, the patient believe he/she contracted covid 19. The patient has been quite sick (high fever, chills, cough, respiratory symptoms). The patient was also 28 and in good health. Hopefully the patient's story could push for a booster to the vaccine for others and myself. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Fatigue, Malaise, Oxygen saturation
Clinical narrative: she was exhausted for an entire week/She generally felt fatigued; She felt very weak/ She had no energy; She was not feeling great for about 7-10 days; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EU6199, Expiry date: not reported), via an unspecified route of administration on 06Mar2021 (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included seasonal allergy from an unknown date and unknown if ongoing , sinus disorder from an unknown date and unknown if ongoing , hay fever, pet dander and pollen allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not administer any other vaccines on same date of Pfizer vaccine and did not receive any other vaccinations within 4 weeks of Pfizer vaccination. On an unknown date in Mar2021, after the first vaccination the patient was exhausted for an entire week. The patient felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. The patient recuperated from her first COVID-19 Vaccine dose. The patient received a corrective therapy for all the events. The patient visited emergency room/ physician office visit due to the events. The patient underwent lab tests and procedures which included chest x-ray and result was normal on an unknown date Jan2020, oxygen saturation: always in the 90s on an unknown date in 2021. The outcome of all events was recovered on an unknown date in 2021.