chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash
Clinical narrative: Headache; Muscle ache; Fever; Chills; Painful redness in her left arm where she received the vaccine; painful redness in my left arm where she received the vaccine; Malaise; Rash and redness; rash and redness; she might be allergic to that product; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was none. There were no concomitant medications. The patient was next in line to get the COVID vaccine but has a little concern about the COVID vaccine. When she got the PREVNAR 13 shot she had all the side effects, she got it 2 years ago (unspecified date). She reported fever, chills, malaise, pretty much almost all the side effects listed. She had a headache, muscle ache in her right thigh, fever, chills and painful redness in her left arm where she received the vaccine. Her doctor said she might be allergic to that product. She asked her doctor about the ingredients for the COVID but the doctor didn't know any of the ingredients so she wanted to call us to find out if the same ones in the PREVNAR 13 are found in the COVID vaccine. The reporter explained the side effects of fever, chills, and malaise lasted a day or two and resolved. She also had a rash and redness which lasted longer. They did all go away eventually but she doesn't remember how long it took or what she did to treat. She knew she did not get a prescription. She thought Tylenol was taken but doesn't remember what else, she mentioned maybe Benadryl. She did go back to the doctor's office, nothing was done, just told to take some over the counter products but she doesn't remember what. The first day she was kind of worried. The outcome of the events headache and muscle ache was unknown. The outcome of the events was recovered on an unspecified date.  No follow up attempts are needed; information about lot batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Pain
Clinical narrative: Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Fatigue, Headache, Illness
Clinical narrative: Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Urticaria
Clinical narrative: Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: herpes Simplex 1 outbreak; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscularly on 17Dec2020 16:15 at left arm, at single dose, and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), intramuscularly on 07Jan2021 07:15 at right arm, at single dose, all for covid-19 immunization. Medical history included covid-19 from an unknown date, the patient had covid prior vaccination, known allergies was none. There were no concomitant medications. The patient experienced herpes simplex 1 outbreak on 29Dec2020 08:00 and experienced herpes simplex 1 on 10Jan2021 13:00. Therapeutic measures were taken as a result of herpes simplex 1 outbreak (herpes simplex) and included treatment with Valtrex. The outcome of the event was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Both vaccines have caused severe pain in elbows all around the elbow. Where it hurts to lift them at all.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at Right arm on 23Dec2020 10:30 at single dose, then received the second dose of BNT162B2 (lot number: EL1284), via an unspecified route of administration at Right arm on 13Jan2021 at single dose, both for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included Epilepsy, Heart disease, quad bypass. The patient's concomitant therapy reported as Yes (patient received other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced both vaccines have caused severe pain in elbows all around the elbow, where it hurts to lift them at all on 14Dec2020 16:00. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: unknown results on 13Jan2021. The outcome of the event was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood test, Diarrhoea, Ultrasound scan
Clinical narrative: Bad stomach pain; I had extreme abdominal pain for hours and diarrhea; I had extreme abdominal pain for hours and diarrhea; This is a spontaneous report from a non-contactable other Health Professional (patient).  A 19-years-old female patient (not pregnant) started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (lot number: EL1284) at left arm on 22Dec2020. The patient had extreme abdominal pain for hours and diarrhea. She ended up in the emergency room and nothing was found wrong with her ultrasound, bloodwork, or urine sample. She never had stomach issues so the doctor thinks this was a result of the second dose of the vaccine. She have had experienced such bad stomach pain. The adverse event (AE) start date was 13Jan2021. AE resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included intravenous fluid and pain relievers and zofran. The patient recovered from events in Jan2021. Since the vaccination the patient hadn't been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Bad stomach pain; I had extreme abdominal pain for hours and diarrhea; I had extreme abdominal pain for hours and diarrhea; This is a spontaneous report from a non-contactable other Health Professional (patient).  A 19-years-old female patient (not pregnant) started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (lot number: EL1284) at left arm on 22Dec2020. The patient had extreme abdominal pain for hours and diarrhea. She ended up in the emergency room and nothing was found wrong with her ultrasound, bloodwork, or urine sample. She never had stomach issues so the doctor thinks this was a result of the second dose of the vaccine. She have had experienced such bad stomach pain. The adverse event (AE) start date was 13Jan2021. AE resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included intravenous fluid and pain relievers and zofran. The patient recovered from events in Jan2021. Since the vaccination the patient hadn't been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hot flush, Hypoaesthesia, Hypoaesthesia oral, Lymph node pain
Clinical narrative: the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: shaking chills; temp of 101.4 at 2:00 pm; sudden onset extreme fatigue; This is a spontaneous report from a contactable Nurse reported for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), Intramuscular at Left arm on 13Jan2021 10:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at clinic. Medical history included chronic cerebrospinal fluid leakage (CSF) Leak, intraductal papillary mucinous neoplasm (IPMN) pancreatic lesion, chronic thyroiditis with large nodule, mitral valve prolapse, osteoporosis, multiple breast fibroadenomas, timalleolar fracture, ankle, and prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lansoprazole, tramadol, potassium citrate, ASA and "Vi".  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden onset extreme fatigue at 1:00 pm on 14Jan2021 followed by shaking chills and temperature of 101.4 at 2:00 pm. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Exposure during pregnancy, Syncope
Clinical narrative: one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pregnant female patient received the vaccine; pregnant female patient received the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional only reported information for the mother (herself). This is the maternal case. A 31-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm, on 11Jan2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient's last menstrual period was 05Dec2020 and the patient was pregnant at the time of vaccination (5 gestation weeks) with a due date of 11Sep2021. Concomitant medications, taken within two weeks of vaccination, included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685) on 21Dec2020 at 09:00 (at the age of 31-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shaking chills, light headed, and one syncopal episode on 12Jan2021 at 01:00. The pregnant female patient received the vaccine on 11Jan2021 at 08:15. The patient did not receive any treatment for the events. The clinical outcome of shaking chills, light headed, and one syncopal episode was recovered in Jan2021 and of pregnant female patient received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the close temporal relationship, the association between the event syncopal episode with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: temperature 101; vaccine was administered to 7-year-old son; This is a spontaneous report from a Pfizer sponsored program, received from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports.  A 7-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 12Jan2021 at a single dose for Covid-19 immunization. Medical history included respiratory distress (at birth had persistent respiratory distress requiring oxygen for 10-12 days), Febrile seizure in Jan2017, and pneumonia in Jan2017. The patient's concomitant medications were not reported. A mother went to get vaccinated for Covid-19. She took her kids ages 7 and 15. The kids were also vaccinated. The vaccine was administered to the 7-year-old son on 12Jan2021. Her son (patient) had a temperature of 101 on 13Jan2021. The mother was concerned because the vaccine was not recommended for his age. She was wondering if he should be in the ER. The reporter does not know if the child still has a fever. She said that the vaccination providers went ahead and gave the vaccine to the children as well even if they were not scheduled to get them. Outcome of the event was unknown.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041926 Same reporter, product, and event, different patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Pyrexia
Clinical narrative: syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient).   A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation.  Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility.  No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tachycardia
Clinical narrative: syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient).   A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation.  Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility.  No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Lymphadenopathy
Clinical narrative: Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: right side under her eye was swollen; right side of face was swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient reported she had the first shot on yesterday (12Jan2021); it was given by a nurse at the hospital where she works. Last night, she noticed on the same side that she got shot, her right side under her eye was swollen and the right side of her face was swollen too. She wanted to know what to do and wanted to know if they were side effects. No therapeutics measures were done in response to the events. At the time of last observation, events' outcome was not recovered.  Information about Lot/Batch number is requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report from a contactable nurse (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 13Jan2021 10:30 AM at a single dose for COVID vaccine. Medical history was not reported. The patient had no known allergies. Concomitant medication included lisinopril (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID vaccine. The patient experienced chills and fever on unspecified dates. Treatment for the events included Tylenol. The patient did not have COVID prior vaccination. He did not have COVID tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Pain
Clinical narrative: Pain; Dizziness; cannot walk safely; This is a spontaneous report from a contactable consumer report self. This 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunization. Medical history included ongoing diabetic diagnosed about 5 years ago or longer, had COVID back in Nov2020, he was in the hospital for 3 days with pneumonia and was sent home and he could not keep his oxygen levels up, then he was put on oxygen and he just got off oxygen 2 weeks ago. Concomitant medication included ongoing Metformin for diabetes for years. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. The patient received the first dose of Pfizer covid vaccine on 12Jan2021 and had a reaction. His pain started around 12:30 to 1am last night (13Jan2021). He took Aleve this morning for the pain. The pain is now getting close to where he would have to take another Aleve. The pain was probably getting worse. He started experiencing dizziness on 13Jan2021 afternoon and he cannot walk safely, the doctor is aware. He will try to get to the bedroom to get in bed. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Rash macular
Clinical narrative: red splotches; lymph nodes could swell under the arm on the side the shot was given; the area are sore/Currently there is still soreness with the lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization administered in a hospital. The patient has no medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EKS or 5730) on 18Dec2020 for COVID-19 immunization and no events were experienced. The patient experienced lymph nodes swelled on the arm and the area are sore/currently there is still soreness with the lymph nodes on 10Jan2021, red splotches on 12Jan2021. It was explained that patient got the second dose on 09Jan2021. She read that the lymph nodes could swell under the arm on the side, the shot was given and it did plus the area were sore, this was on 10Jan2021. On 12Jan2021, in the morning, is when she noticed that in the lymph area and going to the outer breast there are red splotches. It was not tender or warm to the touch and she can tell it will fade on its own but she thought it was weird. It might have been there the day before; she didn't really look. Currently there was still soreness with the lymph nodes but she would have to press to feel it, she would say that was over. She has a picture if needed of the red splotches. Patient stated that she is healthy for her age. She has no medical conditions or takes no medications. The events did not require a visit to Emergency Room or Physician Office. The outcome of the lymph node pain was not recovered while for the other events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node swelled to about pea size after 1st dose; This is a spontaneous report from a contactable Other-HCP. This 48-year-old female Other-HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at Left arm at single dose for COVID-19 immunization in Dec2020 06:00 AM.  Relevant history included Known- allergies: Augmentin. Other medications in two weeks included sertraline 50mg, vitamin D3 5000 IU. The patient was not pregnant. The patient experienced  supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose.  The outcome of event was Recovered with lasting effects. No treatment was received. The patient was not diagnosed with covid-prior-vaccination. The patient did not have covid-tested-post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030973 Same patient same product, similar event, different event time gap
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Joint stiffness, Nausea
Clinical narrative: Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea
Clinical narrative: weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contactable nurse. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), intramuscular on 09Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included had known allergies to sulfa and patient had the COVID virus back in Oct2020 to an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEBREX). The patient had the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Patient wanted to report a side effect and was reading a little about it. She had her second dose of the Pfizer Covid-19 vaccine last Saturday, 09Jan2021 and has like a weird taste in her mouth on 11Jan2021. It's like a burnt oatmeal taste. Patient wanted to know if anyone has ever reported that. Patient reported nausea with weird taste in my mouth, not a loss of taste but taste of burnt oatmeal. Patient had the COVID virus back in Oct2020 and she didn't have taste or smell at all then and now she has a taste so it's not like she has COVID again. No treatments received in related to the events reported. Since the vaccination, the patient has not been tested for COVID19.  The outcome of the events "weird taste in mouth; like a burnt oatmeal taste" and nausea was not recovered.  Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025273 Pfizer
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site is swollen; redness at injection site; redness at the injection site and it hurts to touch; injection site was also warm to the touch; was warm to the touch and it is hard; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular in left arm on 06Jan2021 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. The patient previously had Flu vaccine around the beginning of October. The patient got the vaccine last Wednesday 06Jan2021, the patient noticed recently that the injection site is swollen, there is redness at the injection site and it hurts to touch. It was also warm to touch. She thinks it started yesterday and she did not realize it she just knew there was something involved there. Today she noticed it was warm to touch and it was hard. The patient said that it did not hurt when she got the vaccine. She is basically healthy and takes a world of supplements. The events were experienced in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the residence community. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: shortness of breath; headache; body aches; dizziness; fatigue; heart palpitations; This is a spontaneous report from a contactable other Health Professional (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), paracetamol (TYLENOL). The patient did not receive other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via intramuscular on 23Dec2020 08:00 at single dose om left arm for COVID-19 immunization and experienced headache, body aches, dizziness, fatigue. It was reported that with 2nd dose, the patient experienced heart palpitations, shortness of breath. With both doses, experienced headache, body aches, dizziness, fatigue on an unspecified date. No treatment was received for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: shortness of breath; headache; body aches; dizziness; fatigue; heart palpitations; This is a spontaneous report from a contactable other Health Professional (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), paracetamol (TYLENOL). The patient did not receive other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via intramuscular on 23Dec2020 08:00 at single dose om left arm for COVID-19 immunization and experienced headache, body aches, dizziness, fatigue. It was reported that with 2nd dose, the patient experienced heart palpitations, shortness of breath. With both doses, experienced headache, body aches, dizziness, fatigue on an unspecified date. No treatment was received for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: soreness injection site; feel tired; Headache; Chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Dec2021), via an unspecified route of administration on 12Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included diabetes from 1980 and high blood pressure from 1990. Concomitant medications were not reported. The patient's concomitant medications were not reported. On 12Jan2021, the patient experienced soreness injection site, feel tired, headache, chills, and was feeling unwell. The patient recovered from chills on 12Jan2021; recovering from soreness injection site and feeling unwell while the other events were not recovered.