chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Caller took Tylenol for his head before and after the 1st dose; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Pfizer First Connect. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took Tylenol for his head before and after the 1st dose. The outcome for the event was Unknown.  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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test
Clinical narrative: other vaccine same date; other vaccine same date; Chills; upper arm soreness; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered on an unspecified date (at the age of 29-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took unknown vaccine of dose number 1 on same date as of COVID-19 vaccine administered on upper arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. On an unknown date, the patient experienced chills, upper arm soreness and other vaccine administered on same date as of COVID-19 vaccine. The patient did not receive any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test found to be negative post vaccination via nasal swab. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: P220895-0068L), via an unspecified route of administration, in left arm on 02Feb2021 at 15:45 (at the age of 34-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications that patient received within 2 weeks of vaccination included naproxen (NAPROXEN) and levonorgestrel (KYLEENA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not prior to vaccination and was not diagnosed with COVID-19. On 03Feb2021 at 07:00, the patient experienced sore arm. The patient did not receive treatment for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The report was non-serious. Outcome of the event was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITING; weak; tired, fatigue; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from a company (manufacturer control number: EC-2020-085712), for BNT162B2.   A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Co-suspect drug included oral Lenvima 8mg daily from 21Jan2021 for liver cell carcinoma. The patient's medical history and concomitant medications were not reported. On an unspecified date, 2 weeks after COVID-19 vaccination, the patient experienced nausea, vomiting and fatigue. On 21Jan2021, she was feeling weak and tired and did not want to get up from bed. Patient missed 2 doses of Lenvima due to side effects and planned to see primary care physician. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Headache, Malaise, Pain assessment
Clinical narrative: soreness at inj site 5/10; joint pain, mild; low appetite; mild headache; malaise; This is a spontaneous report from a contactable consumer (patient, self-reported). A 30-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Jan2021, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Jan2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unknown date, about 17 hours post injection, the patient had soreness at inj site 5/10, joint pain, mild, low appetite, mild headache, and malaise. The patient was not reported about nausea, vomiting, rash, fever, diarrhea or any other s/s. Duration of events was 24/30 hours. The patient took treatment as 400mg Advil 2x, most above s/s resolved, Inc fluid intake, and rest. Outcome of the events was resolved on an unknown date.  Information on the lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at inj site 5/10; joint pain, mild; low appetite; mild headache; malaise; This is a spontaneous report from a contactable consumer (patient, self-reported). A 30-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Jan2021, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Jan2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unknown date, about 17 hours post injection, the patient had soreness at inj site 5/10, joint pain, mild, low appetite, mild headache, and malaise. The patient was not reported about nausea, vomiting, rash, fever, diarrhea or any other s/s. Duration of events was 24/30 hours. The patient took treatment as 400mg Advil 2x, most above s/s resolved, Inc fluid intake, and rest. Outcome of the events was resolved on an unknown date.  Information on the lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Poor quality product administered, Product quality issue, Vaccination site pain
Clinical narrative: Caller stated he may have gotten the "water " not good or not have gotten the full dose.; he may have gotten a bad dose; He said he got the second dose on the 29Jan "felt the heat like alcohol burning"/Second dose burned a little; he may have gotten a bad dose; This is a spontaneous report from a contactable consumer (patient).   An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3249), via an unspecified route of administration on 29Jan2021 as 2nd dose, single for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunisation and experienced sore arm, felt the fire chills and heat, arm pain for a couple days, felt the burning of it going in, little heat and a little chill but the next day he was on the way to being good. The patient medical history included really sick with the flu before getting the vaccine, it was just sick not really an event and was like he got the flu but in 2 hours. The concomitant medications were Advil and Tylenol. One Benadryl will knock him out. He said he gets sick with flu vaccine. On an unspecified date, the patient experienced felt the heat like alcohol burning when injecting but no sore arm nothing else, did feel the burn and it go into his arm but after an hour he left and has had no pain, none in his arm or hurting, nothing. His mind is going to go there and is thinking did he get a bad dose. He may have gotten the water not good or not have gotten the full dose. He wanted to know the proof that he has gotten the vaccine, are there any blood test or any test he could have to see if he got the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, SARS-CoV-2 test, Sluggishness
Clinical narrative: Brain fog; feeling of sluggishness; annoyingly mild headache; Mildly sore left arm where injection was; Body felt warmer than usual when went to bed; This is a spontaneous report from a non-contactable consumer (patient herself). A 35-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1686), via an unspecified route of administration in left arm on 14Jan2021 at 17:45 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. No allergies to medications, food, or other products/known allergies. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D); Patient received both drugs within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration in left arm on 24Dec2020 at 09:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization and experienced sorest left arm where the injection was and very mild swelling of the area. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 14Jan2021 2nd dose. Later that night had a mildly sore left arm where injection was. Body felt warmer than usual when went to bed. Next morning, 15Jan2021, woke up with a brain fog, feeling of sluggishness. Mid-day, 15Jan2021 around noon, started having an annoyingly mild headache. Same night my body felt warmer than usual again. Next morning 16Jan2021 woke up feeling great and all symptoms resolved. Did not take any medications except for nature made Vitamin C and D. No treatment medications were received for the adverse events. On 22Jan2021, the patient underwent lab tests and procedures which included nasal swab: Negative, RT-PCR COVID-19 test: Negative. The events were considered as non-serious by the consumer. The outcome of the events was recovered on 16Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Brain fog; feeling of sluggishness; annoyingly mild headache; Mildly sore left arm where injection was; Body felt warmer than usual when went to bed; This is a spontaneous report from a non-contactable consumer (patient herself). A 35-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1686), via an unspecified route of administration in left arm on 14Jan2021 at 17:45 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. No allergies to medications, food, or other products/known allergies. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D); Patient received both drugs within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration in left arm on 24Dec2020 at 09:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization and experienced sorest left arm where the injection was and very mild swelling of the area. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 14Jan2021 2nd dose. Later that night had a mildly sore left arm where injection was. Body felt warmer than usual when went to bed. Next morning, 15Jan2021, woke up with a brain fog, feeling of sluggishness. Mid-day, 15Jan2021 around noon, started having an annoyingly mild headache. Same night my body felt warmer than usual again. Next morning 16Jan2021 woke up feeling great and all symptoms resolved. Did not take any medications except for nature made Vitamin C and D. No treatment medications were received for the adverse events. On 22Jan2021, the patient underwent lab tests and procedures which included nasal swab: Negative, RT-PCR COVID-19 test: Negative. The events were considered as non-serious by the consumer. The outcome of the events was recovered on 16Jan2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Growing pains, Lymphadenopathy
Clinical narrative: body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore; I was very cold; swollen lymph node in the armpit of the arm where vaccine was given.; Chills lasted until about 24 hours after vaccine was given; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 9264), via unspecified route of administration in the left arm on 05Feb2021 at 06:30 PM, as single for COVID-19 immunization at Public Health Clinic. The patient's medical history included hypothyroidism, high cholesterol, acid reflux, gallbladder stone, overweight and seasonal allergies that last all year. The patient was not allergic to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, montelukast sodium (SINGULAIR), levocetirizine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E13247), via an unspecified route of administration in the left arm on 14Jan2021 at 06:30 PM, as single dose for COVID-19 immunisation. On 06Feb2021 at 07:30 AM, 12-13 hours after the vaccine: body aches (like growing pains in the joints), she was fatigued, was very cold. Arm where vaccine was given was sore and swollen lymph node in the armpit of the arm where vaccine was given. Chills lasted until about 24 hours after vaccine was given. Body aches went away about 30 hours after vaccine was given. Swollen lymph node still swollen 2.5 days after vaccine. Took Tylenol about 19 hours after vaccine and it seemed to take the edge off the aches. Took 1 more dose of Tylenol 6 hours later and that's all she needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events body aches (went away about 30 hours) and chills (was lasted until about 24 hours) was recovered on 07Feb2021; swollen lymph node was not recovered; for rest of events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore; I was very cold; swollen lymph node in the armpit of the arm where vaccine was given.; Chills lasted until about 24 hours after vaccine was given; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 9264), via unspecified route of administration in the left arm on 05Feb2021 at 06:30 PM, as single for COVID-19 immunization at Public Health Clinic. The patient's medical history included hypothyroidism, high cholesterol, acid reflux, gallbladder stone, overweight and seasonal allergies that last all year. The patient was not allergic to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, montelukast sodium (SINGULAIR), levocetirizine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E13247), via an unspecified route of administration in the left arm on 14Jan2021 at 06:30 PM, as single dose for COVID-19 immunisation. On 06Feb2021 at 07:30 AM, 12-13 hours after the vaccine: body aches (like growing pains in the joints), she was fatigued, was very cold. Arm where vaccine was given was sore and swollen lymph node in the armpit of the arm where vaccine was given. Chills lasted until about 24 hours after vaccine was given. Body aches went away about 30 hours after vaccine was given. Swollen lymph node still swollen 2.5 days after vaccine. Took Tylenol about 19 hours after vaccine and it seemed to take the edge off the aches. Took 1 more dose of Tylenol 6 hours later and that's all she needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events body aches (went away about 30 hours) and chills (was lasted until about 24 hours) was recovered on 07Feb2021; swollen lymph node was not recovered; for rest of events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Aches; Fever; Chills; Redness injection site swelling under arm; Redness injection site swelling under arm; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EL1284, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 12Jan2021 (at the age of 57-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation administered in Hospital. The medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), started 10yrs; tamoxifen, started 4 yrs; vitamin c [ascorbic acid]; zinc all from an unspecified date to ongoing.  Historical vaccine included BNT162B2 for covid-19 immunization. On 12Jan2021 23:00 after 2nd dose the patient experienced, fever, chills, aches and Redness injection site swelling under arm. Admission to hospital is not involved. Therapeutic measures were taken for the events with Anti-inflammatory + Benadryl and Naproxen Sodium for taking is Redness injection site swelling under arm, Chills, Fever, Aches, 25 mg twice daily from 31Dec2020 to an unspecified date. The outcome for the events was resolved.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little aching in the injection site(arm); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that: a female patient of an unspecified age received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and expiration date were not reported) dose 2 via an unspecified route of administration, administered in Arm on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got the 2nd dose of Covid 19 Vaccine yesterday, she's feeling good and no side effects at all, a little aching in the injection site (arm) on an unknown date in Feb2021 but she said that it's fine. Want to know if she can take the prescription Cyclobenzaprine, just wondering if this drug will interfere with the vaccine. The outcome of the event resolved on unknown date in Feb2021.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: body aches, fatigue for 24 hrs; body aches, fatigue for 24 hrs; This is a spontaneous report from a contactable Other HCP. A 26-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL/284), via an unspecified route of administration on Right Deltoid on 11Jan2021 (Age at Time of Vaccination: 26 years) at single dose for COVID-19 immunization at hospital. The patient Medical history included ongoing allergies to Augmentin, strawberries, bananas from 2002. It was reported that patient was not deceased.Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as not applicable and there was no events following prior vaccinations. Family Medical History Relevant to adverse events was reported as not applicable.The concomitant medications included Cryselle from Mar2014 (daily dose and regimen including Formulation, Route, Frequency: Daily Tablet) for menses regulation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EJ/685), via an unspecified route of administration on Right Deltoid on 21Dec2020 at single dose for COVID-19 immunization. On an unspecified date after second dose, the patient experienced body aches, fatigue for 24 hrs. It was reported that reaction recurred on re-administration of product. The events resulted in Emergency Room or Physician Office. The relevant lab tests was reported as none. The patient was not required any treatment for the events. The outcome of the events was resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Fatigue, Illness, Pyrexia
Clinical narrative: Got really sick after getting vaccine; had diarrhea all day long; exhausted; Fever; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program Pfizer First Connect. A 71-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: Unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included ongoing 2 arteries that are blocked, has post-traumatic stress syndrome, had stroke, only seemed to affect her emotions and nothing physical, was supposed to get blood work done and had infection. Was placed on anti-biotic. Same time as starting antibiotic she received 1st dose of covid vaccine. The doctor gave her an antibiotic that is the generic, Telocin, 300mg three times. Spelling of generic antibiotic documented as provided by caller. She takes it with food and a lot of water. Caller clarified that she is taking the antibiotic now, but she also got something to help the infection when she was seen at the doctor, ongoing nightmare. The patient's concomitant medications were not reported. On 28Jan2021 caller clarified that when she got home, she had diarrhea all day long, she was exhausted, and she had fever. She is scheduled to go back for her second shot on 18Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleep for two days; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 77-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm right on 03Feb2021 13:45 as unknown, single dose for COVID-19 immunization. Medical history included subclavian artery stenosis from an unknown date and unknown if ongoing, arteriosclerosis from an unknown date and unknown if ongoing and allergy to penicillin. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for covid post vaccination. The patient concomitant medications were not reported. On 05Feb2021, 36 hours after the injection and the patient experienced all the side effects except fever and nausea and needed bed rest and sleep for two days and was worried about what will happen with the second dose of the vaccine. Will she get all the unpleasant effects again and could it be worse enquired. The treatment was not received. The outcome of the event was recovered.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinus disorder
Clinical narrative: scratchy nose/sinus and sore throat; scratchy nose/sinus and sore throat; This is a spontaneous report from a Pfizer-. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration on an unknown date in Jan2021 (reported as first dose was 3 weeks ago), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she was scheduled to take the second dose of the COVID-19 vaccine today on 03Feb2021 and experiencing scratchy nose/sinus and sore throat on an unknown date in 2021 and she has been taking sinus medication for it. She wanted to know if she will take the second dose today. The outcome of the events was unknown.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Mobility decreased, Pain, Pain in extremity
Clinical narrative: arm was so sore; arm was swollen; Event: Pain was reported as worsened; she cannot move 1 arm, being the left arm; Swollen lymph nodes; Pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiration date was not reported) via an unspecified route of administration in left arm on 27Jan2021 (at age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history included migraine pain. Concomitant medication included acetylsalicylic acid; caffeine; paracetamol (EXCEDRIN) for migraine pain, took it after the vaccine and takes birth control pills regularly. Patient had previously received first dose of vaccine (Lot EL3249) in left arm on 06Jan2021 and only had mild pain all over the body. It was reported that this time with the second dose she was having swollen lymph nodes and she cant move 1 arm, being the left arm. The Second Dose was on 27Jan2021 and the next day she had the pain from the shot, then last night her arm was so sore that she got up and saw that arm was swollen. This occurred on 28Jan2021 for swelling of the lymph nodes and the pain. She wants to know what she should do next and if this was a normal Side effect. Caller was frustrated asking how long she will have to wait for the other department, She waited 1 hour just to give all this information and now she was going to be transferred again. The outcome for events swollen lymph nodes and pain was not resolved and for other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm was so sore; arm was swollen; Event: Pain was reported as worsened; she cannot move 1 arm, being the left arm; Swollen lymph nodes; Pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiration date was not reported) via an unspecified route of administration in left arm on 27Jan2021 (at age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history included migraine pain. Concomitant medication included acetylsalicylic acid; caffeine; paracetamol (EXCEDRIN) for migraine pain, took it after the vaccine and takes birth control pills regularly. Patient had previously received first dose of vaccine (Lot EL3249) in left arm on 06Jan2021 and only had mild pain all over the body. It was reported that this time with the second dose she was having swollen lymph nodes and she cant move 1 arm, being the left arm. The Second Dose was on 27Jan2021 and the next day she had the pain from the shot, then last night her arm was so sore that she got up and saw that arm was swollen. This occurred on 28Jan2021 for swelling of the lymph nodes and the pain. She wants to know what she should do next and if this was a normal Side effect. Caller was frustrated asking how long she will have to wait for the other department, She waited 1 hour just to give all this information and now she was going to be transferred again. The outcome for events swollen lymph nodes and pain was not resolved and for other events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself) reported that a female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in Arm Left on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. Medical history included ongoing arthralgia. The patient's concomitant medications were not reported. Caller states a week ago today she had the COVID 19 vaccine shot, and is calling to ask, she is having, not related to the shot, she has had this before, pain in her right shoulder, can she take Aleve? Clarifies she got the vaccine a week ago today, this just came because of the way she slept, she had it before, pain in her right shoulder, she got the vaccine in her left arm, she usually takes Aleve, and just wishes to know if she can take Aleve? States the pain is bad this morning. The outcome of the event was unknown.  Information about batch/lot number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Drainage, Low density lipoprotein, Pain in extremity, SARS-CoV-2 test
Clinical narrative: increased drainage since getting the vaccine; increased drainage since getting the vaccine; sore arm for one day; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL3302) as a Single dose for covid-19 immunization. The patient past medical history included Sinus node dysfunction, neurological condition were the heart rate goes low, She has a pace maker (pacemaker insertion), flu vaccine, Tetanus vaccine, menopause and drainage. The patient's concomitant medications were not reported. on an unspecified date the patient reported increased drainage since getting the vaccine and sore arm for one day. They were vaccinated on 15Jan2021 with first dose. The Wednesday after which was about 5 days after the vaccine her husband got chills, sneezing, and fatigue. He did not call the doctor and did not get tested. About a week later her son had nasal congestion and cough. This was the third day for that. Called her son's doctor since this was the second person in the house to have symptoms. The patient son had COVID test and it came back positive. The patient enquired was the COVID vaccine enough to give a positive test. She had symptoms too, but she normally get sinusitis this time of year. No one in her family had a fever. She was at a quandary. She has to quarantine in case it was. The patient enquired could the vaccination cause a positive COVID test result. She thought the symptoms should show up in 1 to 3 days. A week in between her husband and son and it was hard to believe. It should have been her to get it worse since she sleeps with her husband. Praise the Lord she has not. She and her husband have not been tested for COVID. Only her son was COVID tested.Her drainage started in Oct2020. It could be dust in the house. She had increased drainage since vaccination. She didn't think much of it. She had sore arm for one day. It was worse than after the flu vaccine because she was over 60 and they give her the enhanced version. With this last flu vaccine her arm was more sore than with the Tetanus vaccine.She wants everyone to wear a mask in the house. If she had been thinking straight she would have had them wearing mask sooner.  The patient underwent lab tests low density lipoprotein (LDL): result:34 and Sars-Cov-2 Test: Negative on an unspecified date. The event outcome is Unknown for increased drainage since getting the vaccine and recovered for sore arm for one day on an unspecified date.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Sinusitis
Clinical narrative: Sinusitis; headache; ear ache; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot number, expiration date: unknown) as unknown dose number, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient experienced sinusitis, headache, ear ache, dizziness on an unspecified date. She took Tylenol and wants to know if she can take other medications. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: More sore with second vaccine, within a handswidth of injection site; Intermittent runny nose/sneezing; Intermittent runny nose/sneezing; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Feb2021 16:30 as SINGLE DOSE for covid-19 immunization. Medical history included osteoporosis, stroke at 35 yrs old, lactose intolerance, significant lactose intolerance and gastrointestinal (GI) issues and allergic to caine family of drugs from an unknown date and unknown if ongoing. Concomitant medications included evolocumab (REPATHA SURECLICK) and lorazepam; both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 12:00 PM as SINGLE DOSE for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 at 12:00 AM, the patient developed more sore with second vaccine, within a handswidth of injection site. Intermittent runny nose/sneezing. It was unclear if related to vaccine. I was asked by Pfizer to report, since I am on a bi-monthly dose of injectable Repatha. The patient did not received any treatment. The outcome of the events was recovered in Feb2021.  Follow-up attempts have been completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema
Clinical narrative: Both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn; Both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot Number: EN9581), via an unspecified route of administration on 03Feb2021 17:15 as 1st dose, single dose for I don't want get covid. The patient's medical history and concomitant medication were not reported. On 03Feb2021, the patient experienced both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash; look like a sunburn. Consumer stated, I had my first dose of Pfizer vaccine yesterday and 5:15 PM ,  okay at 5:15 PM 03Feb2021 (yesterday). Felt fine, looked fine, got home and of course everyone worldwide is wearing a mask now so when I got home and took the mask off, my both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, it looked like a rash and I thought well maybe because I had the mask on, you know all day long and so got that, well it really look like a sunburn, so you know when you are out in the sun too long and your skin gets burned instead getting brown, so I monitored it all night it never improved, again this morning after lying down seems like it improved, but within minute after being upright again it gets bad again so this morning again I have what looks like a red rash or sunburn on my left cheek and on right cheek and my forehand, left cheek worse, it's very modeled looking and needless to say I am little bit concerned, so what you can tell me about this kind of reaction, has it been reported before, or is this the first time you are hearing about it. Still experiencing the event: consumer stated, yes this morning, still. Outcome of event: consumer stated, it persisting and it's little bit better, than it was last night when I went to bed, but the longer I am awake the more it is looking like it did yesterday. Treatment: consumer stated, no, I did not take anything because I was not sure if I should or what I should, so that's another question can I take advil or something or does that think can help, advil is over the counter I am sure you know, so what you recommending it terms of over the counter, okay I need to talk to the medical people. The patient did not receive any treatment for the events. The clinical outcome of the both cheeks both side left and right but left more very red, as was my forehead, which was also slightly red, looked like a rash, look like a sunburn were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Blood pressure measurement, Disturbance in attention, Ear discomfort, Head discomfort
Clinical narrative: Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did not feel well; Vision was blur; Hard to open eyes; it is like a pressure; Still I had at back of my head like a pressure little bit; concentration, everything was gone within like so fast; This is a spontaneous report from a Contactable consumer (patient).   A 48-Years-old female consumer received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 as an 1ST DOSE, SINGLE for COVID-19 immunization (age a vaccination 48-Years-old). Medical history and concomitant medications of the patient were none. On 28Jan2021 around one hour after vaccination, the patient had slight pressure like ears and eyes, slight headache but it had become so bad that she never had, hard to open eyes; it was like a pressure, did not feel well, vision was blur, concentration, everything was gone within like so fast, Still I had at back of my head like a pressure little bit. Clinical course was provided as follows: She had her first dose and started having some symptoms right like within an hour or so. It was a slight pressure like ears and eyes and little like slight headache but then it had become like at the end of the day, it was so bad that she never had, (intensity was more than before). It was sudden, and she could not keep her eyes open. It was to that point like hard to open her eyes and it was like a pressure. She went back to the site and checked blood pressure, she recorded it was fine, '100.2 and over' (not further clarified), pulse and everything was fine, but she did not feel well. Even she felt like her vision was blur her concentration, everything was gone within like so fast." She did not receive any medication, but she had sat down and was laid on until she felt normal.    Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise, Vision blurred
Clinical narrative: Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did not feel well; Vision was blur; Hard to open eyes; it is like a pressure; Still I had at back of my head like a pressure little bit; concentration, everything was gone within like so fast; This is a spontaneous report from a Contactable consumer (patient).   A 48-Years-old female consumer received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 as an 1ST DOSE, SINGLE for COVID-19 immunization (age a vaccination 48-Years-old). Medical history and concomitant medications of the patient were none. On 28Jan2021 around one hour after vaccination, the patient had slight pressure like ears and eyes, slight headache but it had become so bad that she never had, hard to open eyes; it was like a pressure, did not feel well, vision was blur, concentration, everything was gone within like so fast, Still I had at back of my head like a pressure little bit. Clinical course was provided as follows: She had her first dose and started having some symptoms right like within an hour or so. It was a slight pressure like ears and eyes and little like slight headache but then it had become like at the end of the day, it was so bad that she never had, (intensity was more than before). It was sudden, and she could not keep her eyes open. It was to that point like hard to open her eyes and it was like a pressure. She went back to the site and checked blood pressure, she recorded it was fine, '100.2 and over' (not further clarified), pulse and everything was fine, but she did not feel well. Even she felt like her vision was blur her concentration, everything was gone within like so fast." She did not receive any medication, but she had sat down and was laid on until she felt normal.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental restoration failure
Clinical narrative: lost a filling and will need dental work done; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took vaccine on the 30th. On an unspecified date, she just lost a filling and will need dental work done and was wondering if she can take antibiotics. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Implant site swelling to face; This is a spontaneous report based on the information received by Pfizer from a contactable other healthcare professional.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received hyaluronic acid (RESTYLANE) for an unspecified indication on an unspecified date.  On an unspecified date the patient experienced Implant site swelling to face post Restylane Lyft injection. Patient received Pfizer COVID 19 Vaccine 1 week prior to injection. Outcome of the event Implant site swelling to face is unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.