chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity, Testicular swelling
Clinical narrative: enlarged testicles; The patient just got the booster shot of the Pfizer covid vaccine 2 days ago and now he has enlarged testicles; The patient just got the booster shot of the Pfizer covid vaccine 2 days ago and now he has enlarged testicles; Soreness in his arm; This is a spontaneous report from a contactable consumer (Caller is a consumer calling on behalf of his father) or other non hcp.  An 87-year-old male patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 20Sep2021 08:45, (Age at vaccination: 87 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included lost his ability to swallow and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine 50-75 mcg, it varies by day taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. On 20Sep2021 Monday, the patient just got the booster shot of the pfizer covid vaccine 2 days ago and now he has enlarged testicles (extra dose administered (booster), off label use). On Tuesday, 21Sep2021, the patient experienced swollen enlarged testicles, soreness in his arm on an unspecified date in Sep2021. The outcome of the events enlarged testicles and soreness in his arms was unknown.  Follow-up (24Sep2021): 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 completed. No further information is expected.  Follow-up (24Sep2021): New information received from a same contactable consumer reported for a patient (father) included: Vaccination date updated, onset date for event updated.  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 completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Two sore arms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received an unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, Batch/lot number, NDC number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. On an unknown date the patient received the Pfizer shot, unspecified, and had two sore arms. The patient's investigation assessment was not provided. The 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Gait disturbance, Immunisation, Off label use, Pain in extremity
Clinical narrative: this was my third dose; this was my third dose; I can''t walk; something happens at top of my right foot there''s a big fluid sac on top of my right foot and it''s very painful; I can't walk; something happens at top of my right foot there's a big fluid sac on top of my right foot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received third dose of bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EW0191, Expiry date were not reported) via an unspecified route of administration, administered in left arm on 13Sep2021 (at the age of 65-year-old) as dose 3 (booster), single for COVID-19 immunization (Clinic). The patient medical history included Crohn's disease, high blood pressure, low potassium, and high cholesterol. The patient concomitant medications included ustekinumab (STELARA) taken for Crohn's disease, Potassium taken for low Potassium, Atenolol for high blood pressure, losartan potassium (COZAAR) taken for heart and atorvastatin calcium (LIPITOR) for high cholesterol. The patient previously received first dose and second dose of bnt162b2 (BIONTECH 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 (at the age of 65-year-old) for COVID-19 immunization. On an unspecified date in Sep2021, the patient experienced I can't walk, something happens at top of my right foot there's a big fluid sac on top of my right foot and it's very painful. Patient had reported that no treatment was taken for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Off label use, Pain
Clinical narrative: Fever; Headache; Body ache; Chills; The third I got the booster, 2 days ago.; The third I got the booster, 2 days ago.; This is a spontaneous report from a contactable other HCP. A 72-years-old female patient received bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183), dose 3 via an unspecified route of administration, administered in Arm Left on 23Sep2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization (At the age of 72 years old). Medical history included hypertension from an unknown date and unknown if ongoing high blood pressure, diabetes mellitus from an unknown date and unknown if ongoing, renal disorder from an unknown date and unknown if ongoing kidney disease, adverse event from an unknown date and unknown if ongoing, I can't take NSAIDS. The patient's concomitant medications were not reported.  The patient previously took bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183) for covid-19 immunization and experienced no adverse event, bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982) for covid-19 immunization and experienced no adverse event, motrin (ibuprofen) and experienced adverse event. On 23Sep2021 patient got the third dose (booster), 2 days ago, Nurse stated, "The first two Pfizer shot, I had no problem with. The third I got the booster, 2 days ago. I was fine for 2 days, now I have a fever, headache, body ache, chills I just want to report it. Nurse stated, No, I cannot take NSAIDS (Unspecified Medication) because of my kidney so I canot, they consider and it helps but I cannot or a Motrin but I cannot. On 25Sep2021 patient experiences fever, headache, body ache, chills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Body ache; Chills; The third I got the booster, 2 days ago.; The third I got the booster, 2 days ago.; This is a spontaneous report from a contactable other HCP. A 72-years-old female patient received bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183), dose 3 via an unspecified route of administration, administered in Arm Left on 23Sep2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization (At the age of 72 years old). Medical history included hypertension from an unknown date and unknown if ongoing high blood pressure, diabetes mellitus from an unknown date and unknown if ongoing, renal disorder from an unknown date and unknown if ongoing kidney disease, adverse event from an unknown date and unknown if ongoing, I can't take NSAIDS. The patient's concomitant medications were not reported.  The patient previously took bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: FC3183) for covid-19 immunization and experienced no adverse event, bnt162b2 (Pfizer- Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982) for covid-19 immunization and experienced no adverse event, motrin (ibuprofen) and experienced adverse event. On 23Sep2021 patient got the third dose (booster), 2 days ago, Nurse stated, "The first two Pfizer shot, I had no problem with. The third I got the booster, 2 days ago. I was fine for 2 days, now I have a fever, headache, body ache, chills I just want to report it. Nurse stated, No, I cannot take NSAIDS (Unspecified Medication) because of my kidney so I canot, they consider and it helps but I cannot or a Motrin but I cannot. On 25Sep2021 patient experiences fever, headache, body ache, chills. The outcome of the events was unknown on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: aches; slight fever; booster; booster; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number : 3013s8a ) dose 3 via an unspecified route of administration, administered in Arm Right on 24Sep2021 19:15 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included asthma, aspirin-exacerbated respiratory disease and drug hypersensitivity from an unknown date and unknown if ongoing. The patient Known allergies: sulfa .The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, avelox and experienced drug hypersensitivity, influenza vaccine, flu vaccine on 21Sep2021 in the left arm and bnt162b2 for covid-19 immunization. The patient previously received the first and the second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration as DOSE 1 and DOSE 2, SINGLE for COVID-19 immunization. On 24Sep2021, at 19:15 the patient experienced booster (off label use) and Immunization. On 25Sep2021 at 17:00, the patient had aches (pain) and slight fever (pyrexia). The patient became aware of the event on the evening of 25Sep. The patient did not receive any treatment for the adverse events. The outcome of events slight fever (pyrexia) and aches (pain) was recovered in 2021. The outcome for the other events was unknown.  Follow-Up (06 OCT2021): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: I had a mild fever; I had no energy whatsoever; and I hurt like crazy/  I was in a lot of pain; I would have gone to the hospital because it felt so bad; its felt like the flu only much, much worse it only lasted about 36 hours altogether; Its very uncomfortable; Headache; just the pain, muscle pain; I felt so wretched; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Sep2021 (age at vaccination: 75 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient's medical history included Grave's disease and anxiety. Concomitant medications included thyroid (ARMOUR THYROID), acetylsalicylic acid (ASPIRINE), and antacid. The patient reported that she had ache, her body aches, she had a mild fever. She had no energy whatsoever and she hurt like crazy; it's felt like the flu only much, much worse it only lasted about 36 hours altogether on 26Sep2021. It's very uncomfortable. She was in a lot of pain. She would have gone to the hospital because it felt so bad. She just took some Tylenol finally she didn't like Tylenol it didn't work very well but she did take some; she fell asleep afterwards and so she really didn't know if it helped or not. The patient had head-ache. She finally took some Tylenol (captured as suspect) that was the only treatment that she, you know, she tried to do something about the aches and pains and the muscle pain and well mostly muscle pain and with headache. She felt asleep she have spent yesterday she was trying very, very hard to sleep through it because it was very uncomfortable. It wasn't life threatening but it was very uncomfortable, and she was worried that it would a last long time but it sure did not. The patient felt so wretched on 26Sep2021. Outcome of the events was recovered on an unspecified date in Sep2021.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: I had a mild fever; I had no energy whatsoever; and I hurt like crazy/  I was in a lot of pain; I would have gone to the hospital because it felt so bad; its felt like the flu only much, much worse it only lasted about 36 hours altogether; Its very uncomfortable; Headache; just the pain, muscle pain; I felt so wretched; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Sep2021 (age at vaccination: 75 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient's medical history included Grave's disease and anxiety. Concomitant medications included thyroid (ARMOUR THYROID), acetylsalicylic acid (ASPIRINE), and antacid. The patient reported that she had ache, her body aches, she had a mild fever. She had no energy whatsoever and she hurt like crazy; it's felt like the flu only much, much worse it only lasted about 36 hours altogether on 26Sep2021. It's very uncomfortable. She was in a lot of pain. She would have gone to the hospital because it felt so bad. She just took some Tylenol finally she didn't like Tylenol it didn't work very well but she did take some; she fell asleep afterwards and so she really didn't know if it helped or not. The patient had head-ache. She finally took some Tylenol (captured as suspect) that was the only treatment that she, you know, she tried to do something about the aches and pains and the muscle pain and well mostly muscle pain and with headache. She felt asleep she have spent yesterday she was trying very, very hard to sleep through it because it was very uncomfortable. It wasn't life threatening but it was very uncomfortable, and she was worried that it would a last long time but it sure did not. The patient felt so wretched on 26Sep2021. Outcome of the events was recovered on an unspecified date in Sep2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Heart beating really fast, and it lasted a few minutes before it went away. She said when she got home, it happened again and it lasted longer; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 58-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date in Sep2021 as dose 1, single for covid-19 immunization. Medical history included allergies to certain medications, bee stings, and "all kinds of stuff". The patient's concomitant medications were not reported. On an unspecified in Sep2021, she had the vaccine about 2 and a half weeks ago, the 1st dose, and right after she had it and was sitting there she felt her heart breathing really fast, and it lasted a few minutes before it went away. Patient also reported that they made her stay for 30 minutes and it lasted a few minutes. She said when she got home, it happened again and it lasted longer. 2 hours later, it happened again and it lasted for 10-15 minutes. Consumer said she was scared it would happen again with the 2nd dose. She wanted to know if she should go ahead and proceed with getting her 2nd dose. Outcome of the event was recovered on an unspecified date in Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes were swelling on his left arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 44-year-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH 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 26Sep2021 11:30 as dose 2, single for covid-19 immunisation. Patient Age at Time of Vaccination: 44 Years old. Medical history included. There were no concomitant medications. No Prior Vaccinations within 4 weeks none aside from first dose of covid vaccine.Patient previously took first dose of vaccine BNT162B2 on unknown date of sep 2021, unknown route of administration on left arm Batch lot number was unknown for covid 19 immunization. It was reported that, her husband got his second dose of the Pfizer covid vaccine Sunday morning at a local pharmacy and he has swelling under the lymph node that is growing to about half a baseball size. The patient experienced lymph nodes were swelling on his left arm on 28Sep2021 with outcome of not recovered.Therapeutic measures were ibubrofen taken as a result of lymph nodes were swelling on his left arm (lymphadenopathy).  Follow-up(29Sep2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a 44-Year-old male patient reported information included:  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: she had regular periods more than a year and she had not missed any and she is 7 to 10 days late and it's only happened since she got her vaccine/ delayed on her periods; This is a spontaneous report from a contactable nurse via medical information team. A 13-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her second dose of the Pfizer-BioNTech covid-19 vaccine. Since then, she had not had her period and was 7-10 days late. It was reported she had regular periods more than a year and she had not missed any and she was 7 to 10 days late and it's only happened since she got her vaccine. Reporter also reported that she has friend whose daughter had received the vaccine already but then after her daughter had received the vaccine and she did not gap a period since she got the vaccine. But there was a delayed on her periods. Causality noted and reporter stated, might be a possibility her mom said she had period. So, reporter meant a possibility, reporter meant non other are reasons why it could be late so, she was concerned about it, reporter was trying to ease her little bit. HCP said she has read that some people did report of the same reaction, and it was resolved in about 2-3 months. She wanted to know if this was something that people have reported with the vaccine. Nurse was informed about the Pfizer medical information department. 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.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: it is not sore to touch but sore on the inside and on the muscle; arm is still sore that when she lifts, she can feel it on her muscle; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number was not reported, Expiry date: Not Provided), via an unspecified route of administration on 15Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, patient mentioned that her arm was still sore that when she lifted, she could feel it on her muscle, she also added that it was not sore to touch but sore on the inside and on the muscle. She wanted to know if this was normal since it had been 5 weeks already and it was not getting better. She hopes she doesn't have an infection. She was very disappointed and didn't want to get the second vaccine. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Immunisation, Lymphadenopathy, Malaise
Clinical narrative: lymphnode enlargement; 100 fever; general malais; Redness; swelling; received her 3rd dose; This is a spontaneous report from a contactable nurse (patient). This female nurse reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date and patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 for covid-19 immunisation. On an unspecified date on 2021, the patient experienced lymph node enlargement, 100 fever, general malaise, redness, swelling. Redness and swelling with lymph node enlargement, 100 fever and general malaise. Symptoms presented 24 hours after dose was administered The patient underwent lab tests and procedures which included body temperature: 100 on 2021. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: lymphnode enlargement; 100 fever; general malais; Redness; swelling; received her 3rd dose; This is a spontaneous report from a contactable nurse (patient). This female nurse reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date and patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 for covid-19 immunisation. On an unspecified date on 2021, the patient experienced lymph node enlargement, 100 fever, general malaise, redness, swelling. Redness and swelling with lymph node enlargement, 100 fever and general malaise. Symptoms presented 24 hours after dose was administered The patient underwent lab tests and procedures which included body temperature: 100 on 2021. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, SARS-CoV-2 test, Sinusitis
Clinical narrative: felt very sick; She had a bad sinus infection; She had a bad sinus infection; This is a spontaneous report from a Pfizer- sponsored program COVAX US Support. A contactable consumer reported for herself that, a 73-year-old female received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration, administered in Arm Left on 12Aug2021 (Batch/Lot Number: FC3100) as dose 1, single for (at age of 72-years old) covid-19 immunization. Medical history included Borderline Diabetic from an unknown date and unknown if ongoing, Acid Reflux from an unknown date and unknown if ongoing which had it a couple of years, arthralgia from an unknown date and unknown if ongoing and not thinking about a knee replacement. She can endure the pain. She does water aerobics, asthma from an unknown date and unknown if ongoing, sinusitis from an unknown date and unknown if ongoing. She had a sinus earlier that year in March, a really bad sinus infection, bronchitis from an unknown date and unknown if ongoing. She had surgery on the right one in 2010 and then she wore the left one out. She had COVID test and was negative for COVID but had infected sinuses. She was not putting that on the COVID shot because it could be something in her house making her sneeze and her eyes waters. She has allergies. She always gets a cold after the flu shot. She hasn't had the flu shot this year. She was waiting to take the vaccination before the flu shot. If not, she will get the flu shot. No Vaccines Administered on Same Date of the Pfizer Suspect. Concomitant medication included metformin taken for borderline diabetic from 2010 and ongoing. She did not take insulin but takes the pills. The pills were Metformin. The patient experienced felt very sick, had a sinus infection, and Condition aggravated on unknown date in 2021. It was reported that, she received first dose of Pfizer Covid19 Vaccine on 12Aug2021. She got very sick afterwards. She was not able to get second dose because she was 47 days over the recommended time. Reporter added that she was not able to get her 2nd dose on time because of adverse events experienced. She got sick. She had a bad sinus infection. She was not sure if that came from the shot or what. She was not sure if the shot did it. She has a sinus infection regularly. About a week or so later was when she got very sick. She has recovered. She feels great. She went to Urgent Care. No emergency visits. She didn't have x-ray to check for pneumonia. The patient underwent lab tests and procedures which included SARS-CoV-2 RT-PCR test: negative on unknown date. The patient recovered from the events on unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, SARS-CoV-2 test
Clinical narrative: Brain Fog; so dang sick / really sick for three days; This is a spontaneous report from a contactable Health Care Professional. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 from Feb2021 to an unknown date; he had had COVID in Feb 2021 prior to receiving the one dose. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient had COVID prior vaccination and post vaccination, Unknown if patient had tested with covid 19. The patient's concomitant medications were not reported. On an unspecified date of 2021 the patient experienced brain fog and so dang sick and really sick for three days. The patient reports having "Brain Fog" which he experiences at times such as in the shower. He does not experience it while walking his dog or other physical activities. He relates this to having had the vaccine and COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid on an unspecified date of Feb2021. Known allergies reported for the patient as Unknown. Treatment was given for the reported events was Unknown. The outcome of event brain fog was not recovered while outcome of event so dang sick / really sick for three days was recovered on an unspecified date.  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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: His arm was sore, and that was it.; The Booster was given on 27Sep2021 at 2 pm.; This is a spontaneous report from a contactable consumer(patient) reported for himself that: A 80-years-old male patient received third dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8839) via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:30 (Age at Vaccination 80-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.Medical history included , tonsillitis from 1952 to an unknown date Pertinent details : Surgical Removal , appendix disorder from 1955 to an unknown date Pertinent details : Surgical Removal , vasectomy from 1974 to an unknown date Pertinent details : Surgical , colon cancer from 19Dec1997 to an unknown date Pertinent details : Surgical Removal portion of colon , hernia repair from 20May2005 to an unknown date Pertinent details : Surgical Repair , prostate cancer from 16Nov2011 to an unknown date Pertinent details : Surgical Removing of prostate , hernia repair from 12Nov2011 to an unknown date Pertinent details : Surgical Repair. There were no concomitant medications. Previously patient was received First dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9263) via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:30 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:10 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. On 27Sep2021 17:00 the patient experienced his arm was sore, and that was it, the booster was given on 27sep2021 at 2 pm. (immunisation) on 27Sep2021 14:00. The outcome of the event His arm was sore, and that was it was recovered on 29Sep2021.The outcome of the event The Booster was given on 27Sep2021 at 2 pm was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Immunisation, Pain in extremity, Wrong technique in product usage process
Clinical narrative: chills and couldn''t warm up; Burning sensation; He had the booster on the 28th; booster dose did not do it the same way, squeezed the fat on his arm; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration, administered in Arm on 28Sep2021, as dose 3 (BOOSTER), single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. And received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. On 28Sep2021, the patient had the booster, experienced sore arm and burning sensation. On 29Sep2021, the patient had chills and couldn't warm up. The patient got all three of his at the first two he hardly felt anything but they didn't do what she did on the 28th. What she did caused a burning sensation. He asked her and she didn't know. She pinched and squeezed the fat on his arm before giving the shot. He read that might not be the right way because the needle might not reach the muscle the patient inquired was that right. Everything else was fine. However, last night he had chills, could not warm up. Wanted to know if that was normal to occur a couple days late. He has his first two. The lady that gave him the booster dose did not do it the same way, squeezed the fat on his arm. Burning sensation. Caller: Read an article, the correct arm you should not pinch the fat if the needle is not long enough it won't reach the muscle. The chills the day after. On the day of reporting morning, it seems to be alright the patient was freezing. That one burned. The first two did not experience. On 29Sep2021, the event sore arm was recovered. The outcome of the other events was unknown.  Follow-up attempts completed. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Left arm was very sore worse than prior two shots; lymph nodes are swollen and very painful; Lymph nodes are swollen and very painful; Left arm was very sore worse than prior two shots; This is my 3rd shot (Booster); This is a spontaneous report received from a contactable Other HCP (patient) reported for herself that: A 51-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF839) via an unspecified route of administration, administered in Arm Left on 28Sep2021 18:15 (Age at Vaccination 51-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Hashimoto from an unknown date and unknown if ongoing. patient had no known allergies.Concomitant medication(s) included rosuvastatin calcium (ADVASTAT) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; hydrochloride fenfluramine (HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, on unspecified date as SINGLE dose for COVID-19 immunisation. After first and second dose patient resulting in to Left arm was very sore worse than prior two shots Pain in arm. On 28Sep2021 20:00 the patient experienced left arm was very sore worse than prior two shots, lymph nodes are swollen and very painful, lymph nodes are swollen and very painful, left arm was very sore worse than prior two shots. this is my 3rd shot (booster) (immunisation) on 28Sep2021 18:15. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Sep2021 Nasal Swab. The outcome of the event Left arm was very sore worse than prior two shots and was unknown, while other events was not recovered.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Left arm was very sore worse than prior two shots; lymph nodes are swollen and very painful; Lymph nodes are swollen and very painful; Left arm was very sore worse than prior two shots; This is my 3rd shot (Booster); This is a spontaneous report received from a contactable Other HCP (patient) reported for herself that: A 51-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF839) via an unspecified route of administration, administered in Arm Left on 28Sep2021 18:15 (Age at Vaccination 51-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Hashimoto from an unknown date and unknown if ongoing. patient had no known allergies.Concomitant medication(s) included rosuvastatin calcium (ADVASTAT) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; hydrochloride fenfluramine (HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, on unspecified date as SINGLE dose for COVID-19 immunisation. After first and second dose patient resulting in to Left arm was very sore worse than prior two shots Pain in arm. On 28Sep2021 20:00 the patient experienced left arm was very sore worse than prior two shots, lymph nodes are swollen and very painful, lymph nodes are swollen and very painful, left arm was very sore worse than prior two shots. this is my 3rd shot (booster) (immunisation) on 28Sep2021 18:15. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 22Sep2021 Nasal Swab. The outcome of the event Left arm was very sore worse than prior two shots and was unknown, while other events was not recovered.  Follow-Up (06Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Immunisation, Pyrexia
Clinical narrative: I felt a strong chest pain. I feel it in the heart.; Fever; headache; This was the 3rd dose.; This was the 3rd dose.; This was the 3rd dose; This is a spontaneous report from a contactable other HCP. A 35-year male patient received BNT162B2(COMIRNATY, Solution for injection), in right arm on an 29Sep2021 (Batch/Lot number EL9268), as dose 3 (BOOSTER), SINGLE for covid-19 immunization. Age at vaccination was 35 years. The patient medical history was none reported. The patient did not have any known allergies. The patient did not have any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. List of any other medications the patient received within 2 weeks of vaccination was no. Historical vaccine includes BNT162B2 (COMIRNATY, Solution for injection), in right arm on 14JAN2021 at 16:00 (Batch/Lot number EL3247), dose 1 for covid-19 immunization and BNT162B2(COMIRNATY, Solution for injection), in right arm on an 29Sep2021 at 10:00 (Batch/Lot number FF2588) as dose 2 for covid-19 immunization (at the age of 35 years old). On 29Sep2021 patient experienced off label use, overdose, booster and patient experienced Fever and headache, patient experienced strong chest pain, feel in the heart on 30Sep2021 at 11:00. The patient did not receive any treatment for the events. The outcome for events was Recovering.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Chills, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FF8841; Expiration Date: Unknown), via an unspecified route of administration in Arm Left on 29Sep2021 17:00 as dose 3 (booster), single for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6201; Expiration Date: Unknown), via an unspecified route of administration on 22Feb2021 as dose 1, single also received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6203; Expiration Date: Unknown), via an unspecified route of administration on 15Mar2021 as dose 2, single for COVID-19 Immunization with no adverse events. The patient previously received Flu shot (Formulation: unknown dosage shot to her left arm, Lot Number: unknown; Expiration Date: unknown), on 19Aug2021, the patient was taking flu shot to stay safe. The patient medical history was not reported. Concomitant medications included OXYGEN taken for an unspecified indication, start and stop date were not reported. It was reported that the patient has been on oxygen for 15 years further it was mentioned that the patient was on it before Covid shot. It was reported that the patient stated that she is weak, chills, can't eat, had a hard time getting her to drink, has been in bed, left arm hurting/sore, and got booster yesterday on 29Sep2021. The patient underwent lab tests and procedures which included body temperature which is unknown on an unspecified date in Sep2021. The patient did not receive the treatment for all the events. The outcome of all the events was not recovered.   No follow-up attempts are possible, no further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FF8841; Expiration Date: Unknown), via an unspecified route of administration in Arm Left on 29Sep2021 17:00 as dose 3 (booster), single for COVID-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6201; Expiration Date: Unknown), via an unspecified route of administration on 22Feb2021 as dose 1, single also received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6203; Expiration Date: Unknown), via an unspecified route of administration on 15Mar2021 as dose 2, single for COVID-19 Immunization with no adverse events. The patient previously received Flu shot (Formulation: unknown dosage shot to her left arm, Lot Number: unknown; Expiration Date: unknown), on 19Aug2021, the patient was taking flu shot to stay safe. The patient medical history was not reported. Concomitant medications included OXYGEN taken for an unspecified indication, start and stop date were not reported. It was reported that the patient has been on oxygen for 15 years further it was mentioned that the patient was on it before Covid shot. It was reported that the patient stated that she is weak, chills, can't eat, had a hard time getting her to drink, has been in bed, left arm hurting/sore, and got booster yesterday on 29Sep2021. The patient underwent lab tests and procedures which included body temperature which is unknown on an unspecified date in Sep2021. The patient did not receive the treatment for all the events. The outcome of all the events was not recovered.   No follow-up attempts are possible, no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation
Clinical narrative: chills; Had chills after receiving third (booster) shot.; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown; Expiration Date: Unknown), via an unspecified route of administration on 2021, as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 as dose 1 and dose 2 respectively, for COVID-19 immunisation. . On an unspecified date in 2021, the patient experienced chills after receiving third (booster) shot. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation
Clinical narrative: I was informed that I did receive the booster on May 27/2021; I was informed that I did receive the booster on May 27/2021; sick; This is a spontaneous report from a contactable Nurse (patient) reported for herself that: A 68-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27May2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06Aug2020 as DOSE 1 SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Aug2021 as DOSE 2 SINGLE for COVID-19 immunisation. The patient experienced I was informed that I did receive the booster on May 27/2021 (off label use), I was informed that I did receive the booster on May 27/2021 (immunisation) (non-serious) on 27May2021. Patient was sick in 2021. I was sick after dose 2 and the booster dose. So sick I called the hotline for clinical trials adverse events. He took the information down and called the clinical trial people and the doctor called and told me to take more Tylenol. The patient underwent lab tests and procedures which included body temperature: 102.9 on huge fever of 102.9. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.