chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Tingling throat; This is a spontaneous report from a contactable physician. This physician reported same event for two patients. This is second of two reports. A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; unknown lot number, NDC number and expiration date), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that it was unknown if other products were received or if an investigation assessment was performed. On 16Dec2020, the patient experienced tingling throat (non-serious). The physician called regarding COVID 19 vaccine since they had two events that happened yesterday (16Dec2020), however, the physician stated that she needs to ask a question before speaking with DSU and reporting the events. the physician mentioned that two patients complained of tingling in their throat during the observation period after the vaccine was administered. The physician thought "they just panicked and overreacted " and she did not think they had a reaction. The patients did go the ER (emergency room) and were discharged the same day. The physician wanted to be able to give the second dose. The physician wants to ask about the side effects of the vaccine. The outcome of the event was unknown.  The following information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502608 same reporter/event, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Fever; Chill; whole muscle ache; Headache; Runny nose; This is a spontaneous report from a contactable Other HCP reported for herself. This 32-year-old female (no pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscular at left arm on 20Dec2020 11:00 at single dose for COVID-19 immunization. None medical history reported. The patient's concomitant medications were not reported. No Covid prior vaccination, No Covid tested post vaccination. No other vaccine in four weeks. On 20Dec2020 02:00 PM, the patient experienced fever, chill, whole muscle ache, headache, runny nose. No treatment received for the events. The outcome of events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchiness and small rash on forehead; Itchiness and small rash on forehead; This is a spontaneous report from a contactable nurse (Patient). A 35-year-old female patient received bnt162b2 (lot number: EJ1685), intramuscularly at left arm, 1st dose on 20Dec2020 08:00 AM, at single dose, for COVID-19 immunization. No COVID prior vaccination, COVID tested post vaccination, known allergies, or other medical history. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination and after vaccination. Not pregnant at the time of vaccination. There were no concomitant medications. The patient experienced itchiness and small rash on forehead on 21Dec2020 01:00. The event was reported as non-serious. Therapeutic measures were taken as a result of itchiness and small rash on forehead, treatment included: allergy medicine PO (Oral). The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Joint pain; Muscle pain; Headache; Fever (100.7 F); Fatigue; This is a spontaneous report from a non-contactable Other Healthcare professional (HCP).  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK5730), intramuscular, on 18Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 61-years-old. Medical history included the patient diagnosed with COVID 19 before vaccination.  On 19Dec2020 at 06:00 PM, the patient experienced joint pain, muscle pain, headache, fever (100.7 F) and fatigue. No treatment was administered for the events. The patient recovered from the events on an unknown date in Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Bitter taste with food and drink for 2 hours post injection; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # ej1685), intramuscular, on 19Dec2020 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 49-years-old. No other vaccines were administered within 4 weeks prior to the COVID vaccine. Medical history included allergies to iodine, migraine, and gastrooesophageal reflux disease (GERD). Concomitant medications included duloxetine, erenumab aooe (AIMOVIG), and ubrogepant (UBRELVY) The patient experienced bitter taste with food and drink for 2 hours post injection on 19Dec2020 at 05:30 PM, reported as non-serious. No treatment was received for the event. The patient recovered from the event on an unknown date in Dec2020.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: feeling tingling in my lips & face.& tongue; feeling tingling in my lips & face.& tongue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0140) via an unspecified route of administration at the right arm on 19Dec2020 08:30 at a single dose for covid-19 immunisation. Medical history included allergies to medications: sulfa drugs. Concomitant medication included zinc, magnesium, calcium phosphate, colecalciferol (CALCIUM+D), ascorbic acid (VITAMIN C) and clarithromycin (CLARITIN). On 20Dec2020 21:00, the patient felt tingling in her lips, face and tongue. The patient reported that she took diphenhydramine (BENADRYL) orally, 25mg when she got home as treatment. Outcome of events recovered on an unspecified date in Dec2020.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: headache on left side of head which was similar to migraine; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1685, expiry date unknown) intramuscular on left arm on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included penicillin allergies, allergies to sulfa drugs and allergies to cephalosporins. Concomitant medication included vitamin D3 and amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS); both from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020 13:00, the patient experienced headache on left side of head which was similar to migraine and went away on Dec2020 by taking 2 Aleve. The event was considered non-serious and did not results in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, not a congenital anomaly/birth defect.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; A large raised whelp (welt) at the injection site painful itchy hard and still there 5 days post injection; This is a spontaneous report from a contactable other healthcare professional, patient. A 56-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Dec2020 16:00 in the right arm at single dose for COVID-19 immunization. Patient medical history included hypertension (htn), obesity, chronic pain, arthritis, and season allergies chronic. Concomitant medications were not reported. The patient previously took tramadol, tizanidine and duloxetine hcl (CYMBALTA) and experienced drug allergies. On 09Dec2020 17:00, the patient developed a large raised whelp (welt) at the injection site, painful, itchy, hard and still there 5 days post injection. The events were assessed as non-serious. Outcome of the events was not recovered.  Information on batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vision blurred
Clinical narrative: Chilled; headache; blurred vision; This is a spontaneous report from a contactable Other Health Professional (patient). A 64-year-old female patient receivef bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose on 18Dec2020 10:15 at a single dose for immunisation. Medical history included cervical dystonia wherein she takes botox treatments quarterly for this. Concomitant medications included estradiol, rosuvastatin calcium (CRESTOR), gabapentin and montelukast sodium (SINGULAIR). The patient was not pregnant. The patient was not diagnosed with covid 19 prior to vaccination nor been tested since vaccination. The patient experienced chilled, headache, and blurred vision on 18Dec2020 at 12:00 PM with outcome of recovered on an unknown date in Dec2020. The patient did not receive any treatment for the events. The events are considered non-serious by the reporter.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Somnolence
Clinical narrative: Injection site pain level 7 to 8 about 6 hours after injection; Very tired and sleepy 4 hours after injection; Very tired and sleepy 4 hours after injection; This is a spontaneous report from a  contactable healthcare professional.  A 54-year-old male patient received first dose of BNT162B2 (lot number: Ek5730), intramuscularly at the right arm, on 19Dec2020 09:00 at a single dose for COVID-19 immunization at a public health clinic/veterans administration facility. Medical history included continuous positive airway pressure (CPAP), high cholesterol, and high blood pressure (BP). Patient has no known allergy. The patient was no previously diagnosed with COVID-19 not was tested for it. Also the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included atorvastatin calcium (LIPITOR). The patient was very tired and sleepy 4 hours after injection on 19Dec2020 13:00 and experienced injection site pain level 7 to 8 about 6 hours after injection on the same day of 19Dec2020, 15:00. Therapeutic measures were taken as a result of injection site pain which included acetaminophen (TYLENOL). The patient recovered from the event injection site pain by the next day of 20Dec2020 and from the event tired and sleepy after a nap on the same day of 19Dec2020.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; Fatigue; General malaise; Low grade temp; Headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: not provided) solution for injection at a hospital, via an unspecified route of administration (on left arm) on 17Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included allergy to Sulfa, and FS (flushing and sweating). Concomitant medication included estrogens esterified, methyltestosterone (ESTRATEST) daily. The patient received the vaccine on left arm, dose number 1. The patient experienced arm soreness, fatigue, general malaise, low grade temp, and headache on 17Dec2020. No treatment was given. The events were reported as non-serious. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine; patient has not been tested or diagnosed of Covid-19. Outcome of the events was recovering.    No follow-up attempts needed. No further information was expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Muscle spasms
Clinical narrative: chills; flulike symptoms; cramping in left leg; fatigue; This is a spontaneous report from a contactable other healthcare professional which is also the patient.  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced having cramping in left leg that has resolved and fatigue, chills that began last night from the time of report, and flulike symptoms since getting the vaccine. The reporter asked if he should be worried and get a COVID test. He was given paperwork and knows these are possible symptoms of the vaccine.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysphonia, Fatigue, Hypoaesthesia, Impaired work ability
Clinical narrative: chills; flulike symptoms; cramping in left leg; fatigue; This is a spontaneous report from a contactable other healthcare professional which is also the patient.  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced having cramping in left leg that has resolved and fatigue, chills that began last night from the time of report, and flulike symptoms since getting the vaccine. The reporter asked if he should be worried and get a COVID test. He was given paperwork and knows these are possible symptoms of the vaccine.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: chills; flulike symptoms; cramping in left leg; fatigue; This is a spontaneous report from a contactable other healthcare professional which is also the patient.  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced having cramping in left leg that has resolved and fatigue, chills that began last night from the time of report, and flulike symptoms since getting the vaccine. The reporter asked if he should be worried and get a COVID test. He was given paperwork and knows these are possible symptoms of the vaccine.  Information on lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Muscle spasms
Clinical narrative: Chills; I felt like I am getting a fever; like flu like symptoms; nausea and that is why my voice is like this; nausea and that is why my voice is like this; felt like fatigued and tired; Numbness; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration, on 18Dec2020, at single dose, for COVID-19 immunization. Medical history included hypertension (also reported as borderline hypertension, which was before, and the patient got better). The patient reported exercising, he was heavier, but he is losing weight now. There were no concomitant medications. The patient reported, "I got my COVID vaccine last Friday, that would be on the 18Dec2020. So I feel like I see the side effect of having it, (voice incomprehensible). The day that I got it, when I got back, on 18Dec2020, I felt like fatigued and tired. And then on Saturday (19Dec2020), which I was off, I felt a little better. But then, you know, I had a little numbness (Dec2020) but it disappeared. And then on Sunday, I went to work and last night (20Dec2020), I just woke up and I had chills and I felt like I am getting a fever, like flu like symptoms like nausea and that is why my voice is like this. Is it normal to feel after 3 days this side effect? I mean actually I was reading the paper that I got it because I need to, because I have work today, I need to inform my manager that I cannot go to work because I am feeling this side effect and I don't want him to think that you know." The patient did not have lab work done and did not receive treatment for the events. The outcome of fatigue was recovering, numbness was recovered on an unspecified date in Dec2020, and the outcome of the remaining events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysphonia, Fatigue, Hypoaesthesia, Impaired work ability
Clinical narrative: Chills; I felt like I am getting a fever; like flu like symptoms; nausea and that is why my voice is like this; nausea and that is why my voice is like this; felt like fatigued and tired; Numbness; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration, on 18Dec2020, at single dose, for COVID-19 immunization. Medical history included hypertension (also reported as borderline hypertension, which was before, and the patient got better). The patient reported exercising, he was heavier, but he is losing weight now. There were no concomitant medications. The patient reported, "I got my COVID vaccine last Friday, that would be on the 18Dec2020. So I feel like I see the side effect of having it, (voice incomprehensible). The day that I got it, when I got back, on 18Dec2020, I felt like fatigued and tired. And then on Saturday (19Dec2020), which I was off, I felt a little better. But then, you know, I had a little numbness (Dec2020) but it disappeared. And then on Sunday, I went to work and last night (20Dec2020), I just woke up and I had chills and I felt like I am getting a fever, like flu like symptoms like nausea and that is why my voice is like this. Is it normal to feel after 3 days this side effect? I mean actually I was reading the paper that I got it because I need to, because I have work today, I need to inform my manager that I cannot go to work because I am feeling this side effect and I don't want him to think that you know." The patient did not have lab work done and did not receive treatment for the events. The outcome of fatigue was recovering, numbness was recovered on an unspecified date in Dec2020, and the outcome of the remaining events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Chills; I felt like I am getting a fever; like flu like symptoms; nausea and that is why my voice is like this; nausea and that is why my voice is like this; felt like fatigued and tired; Numbness; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration, on 18Dec2020, at single dose, for COVID-19 immunization. Medical history included hypertension (also reported as borderline hypertension, which was before, and the patient got better). The patient reported exercising, he was heavier, but he is losing weight now. There were no concomitant medications. The patient reported, "I got my COVID vaccine last Friday, that would be on the 18Dec2020. So I feel like I see the side effect of having it, (voice incomprehensible). The day that I got it, when I got back, on 18Dec2020, I felt like fatigued and tired. And then on Saturday (19Dec2020), which I was off, I felt a little better. But then, you know, I had a little numbness (Dec2020) but it disappeared. And then on Sunday, I went to work and last night (20Dec2020), I just woke up and I had chills and I felt like I am getting a fever, like flu like symptoms like nausea and that is why my voice is like this. Is it normal to feel after 3 days this side effect? I mean actually I was reading the paper that I got it because I need to, because I have work today, I need to inform my manager that I cannot go to work because I am feeling this side effect and I don't want him to think that you know." The patient did not have lab work done and did not receive treatment for the events. The outcome of fatigue was recovering, numbness was recovered on an unspecified date in Dec2020, and the outcome of the remaining events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: nausea; headache; fatigue; muscle pain; feeling unwell; This is a spontaneous report from a contactable nurse who reported for herself. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Left arm on 17Dec2020 at 11:30 am at single dose for COVID-19 immunization. Patient was not pregnant. No known allergies. Concomitant medication included unspecified drug: patient received other unspecified medication in two weeks. No other vaccine in four weeks administered. On 17Dec2020 at 11:45 am, the patient experienced nausea, headache, fatigue ,muscle pain and feeling unwell, all non serious. No treatment given. Outcome of the events was reported as recovered in Dec2020. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of bnt162b2 (BNT162B2; lot number: EK5730), via an unspecified route of administration on 20Dec2020 14:00 on right arm , SINGLE DOSE for COVID-19 immunization.  Medical history included Known allergies: Contrast dye, sulfur drugs. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced Known allergies: Erythromycin. No COVID prior vaccination. The patient has not been tested for COVID-19 since the vaccination. On 20Dec2020 18:30, the patient experienced Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning. Felt like hives, but skin did not break out into hives. The events was assessed as non-serious. The outcome of the events was recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; injection site swelling; nausea; swollen lymph nodes; feeling unwell; onset of menstrual cycle; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), intramuscular on the left arm on 17Dec2020 17:00 at SINGLE DOSE as COVID-19 immunization at the workplace clinic.  Medical history included Hashimoto's Thyroiditis & Environmental Allergies. The patient also had allergies to ibuprofen, penicillin, & sulfa. Concomitant medications included levothyroxine (LEVOTHYROXINE), montelukast (MONTELUKAST), ethinylestradiol, norgestimate (TRINESSA) and multivitamins. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On 18Dec2020 12:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, injection site swelling, nausea, swollen lymph nodes, feeling unwell, and onset of menstrual cycle (as reported). The patient did not receive any treatments for the events. The patient recovered from the events in Dec2020.   Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Nausea
Clinical narrative: Injection site pain; tiredness; headache; muscle pain; chills; injection site swelling; nausea; swollen lymph nodes; feeling unwell; onset of menstrual cycle; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), intramuscular on the left arm on 17Dec2020 17:00 at SINGLE DOSE as COVID-19 immunization at the workplace clinic.  Medical history included Hashimoto's Thyroiditis & Environmental Allergies. The patient also had allergies to ibuprofen, penicillin, & sulfa. Concomitant medications included levothyroxine (LEVOTHYROXINE), montelukast (MONTELUKAST), ethinylestradiol, norgestimate (TRINESSA) and multivitamins. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. On 18Dec2020 12:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, injection site swelling, nausea, swollen lymph nodes, feeling unwell, and onset of menstrual cycle (as reported). The patient did not receive any treatments for the events. The patient recovered from the events in Dec2020.   Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives, urticaria mostly over torso, face; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 15Dec2020 19:30 at a single dose for covid-19 immunization. The patient's medical history included persistent depressive disorder and known allergic reaction to wood varnish. The patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN). 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 and had not been tested for COVID-19 since the vaccination. The patient experienced hives, urticaria mostly over torso, face on 17Dec2020 18:00. Therapeutic measures were taken as a result of hives, urticaria mostly over torso, face and included treatment with dexamethasone. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe, watery diarrhea; This is a spontaneous report from a non-contactable other healthcare professional. A 30-year-old female patient received bnt162b2 (BNT162B2, lot no and expiry date was unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is not pregnant. The patient experienced severe, watery diarrhea on 18Dec2020. No treatment received for the event. The outcome of the event was not recovered.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain, Pruritus
Clinical narrative: Really bad body aches the next day.; Itching at site and then itching went to rest of body. No hives.; Itching at site and then itching went to rest of body. No hives.; This is a spontaneous report from a contactable nurse (reported for herself).  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot/batch number and expiry date not reported), intramuscular on 18Dec2020 16:45 at single dose (dose number 1) in the right arm for immunisation. Medical history was none. Patient was allergic to medication sulfa, food, or other products.  She had no other vaccine in four weeks, no covid prior vaccination. The patient's concomitant medications included unspecified multivitamins. The patient experienced itching at site and then itching went to rest of body (no hives) on 18Dec2020 16:45. She had really bad body aches the next day (19Dec2020). No treatment was given. No hospitalization reported. The outcome of events was recovered on unknown date in Dec2020.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure via breast milk, Lethargy, Vomiting
Clinical narrative: mother received BNT162B2/while the mother was breast feeding this 5-month-old patient; vomiting (throwing up); not eating. Not nursing, Not breastfeeding and not taking her bottle; her 5month old baby is lethargic; all of a sudden took ill; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and baby. This is baby report.   This is a case for a 5-month-old patient of an unspecified gender whose mother of unspecified age received first dose of BNT162B2 (PFIZER/BNT162 Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 13:15 at a single dose for COVID-19 immunization, while the mother was breast feeding this 5-month-old patient. The patient's medical history and concomitant medications were not reported. On 19Dec2020, all of a sudden took ill. The patient was lethargic, vomiting (throwing up) and not eating. Not nursing, Not breastfeeding and not taking her bottle. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503099 mother/baby case
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Received the vaccine last Friday. Having fever. Temperature high as 101.4F .; I have a body ache; This is a spontaneous report from a contactable nurse.  A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: 30Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation.  Medical history included blood pressure, cholesterol, covid-19 (Had Covid-19 in March).  Concomitant medication included amlodipine for Blood pressure, rosuvastatin calcium (CRESTOR) for Cholesterol.  Nurse calling on behalf of herself. 60 years old almost 61. Received the vaccine last Friday. Having fever. Temperature high as 101.4F. Still having it lingering between 99F and 100F. How long will it last? Had Covid-19 in March. Compared with her colleagues and they had no side effects except pain at injection site. Lab test: Nurse stated, "I did a Covid swab on the 14th its negative." Treatment: Nurse stated, "When I had a fever I had something, Yes, I did, I took Tylenol." Causality: Nurse stated, "Yes, because I was fine before COVID Vaccine." Nurse further stated, "Besides the fever I have like my body is aching, my whole body is aching. I have a body ache." The outcome of the events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: doesn't feel good; migraine level headaches; body aches; injection site pain; Tiredness; headache; muscle pain; Chills; Nausea; arm is still a little sore; bottom of the arm hurt; she couldn't move it; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EH9899, intramuscular in the deltoid on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  She works in Urgent Care and has to swab people with COVID all day long. The caller had the injection on 17Dec2020 and still doesn't feel good. The patient is a medical assistant calling because of herself. She did not want to go back to work, she does not feel good, she has a headache that is horrible, migraine level headache and a few body aches. This happened two hours after the injection- she had injection site pain, tiredness, headache, muscle pain, chills, nausea. She also stated that her arm is still a little sore, she got it in the deltoid, and the bottom of the arm hurt, she couldn't move it, but the next day, her arm was fine. The outcome of body aches, tiredness, muscle pain, chills, nausea was recovering; migraine level headaches and headaches was not recovered; doesn't feel good and injection site pain was unknown; arm is still a little sore; bottom of the arm hurt and she couldn't move it recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Migraine, Mobility decreased, Myalgia, Nausea
Clinical narrative: doesn't feel good; migraine level headaches; body aches; injection site pain; Tiredness; headache; muscle pain; Chills; Nausea; arm is still a little sore; bottom of the arm hurt; she couldn't move it; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EH9899, intramuscular in the deltoid on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  She works in Urgent Care and has to swab people with COVID all day long. The caller had the injection on 17Dec2020 and still doesn't feel good. The patient is a medical assistant calling because of herself. She did not want to go back to work, she does not feel good, she has a headache that is horrible, migraine level headache and a few body aches. This happened two hours after the injection- she had injection site pain, tiredness, headache, muscle pain, chills, nausea. She also stated that her arm is still a little sore, she got it in the deltoid, and the bottom of the arm hurt, she couldn't move it, but the next day, her arm was fine. The outcome of body aches, tiredness, muscle pain, chills, nausea was recovering; migraine level headaches and headaches was not recovered; doesn't feel good and injection site pain was unknown; arm is still a little sore; bottom of the arm hurt and she couldn't move it recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: doesn't feel good; migraine level headaches; body aches; injection site pain; Tiredness; headache; muscle pain; Chills; Nausea; arm is still a little sore; bottom of the arm hurt; she couldn't move it; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EH9899, intramuscular in the deltoid on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  She works in Urgent Care and has to swab people with COVID all day long. The caller had the injection on 17Dec2020 and still doesn't feel good. The patient is a medical assistant calling because of herself. She did not want to go back to work, she does not feel good, she has a headache that is horrible, migraine level headache and a few body aches. This happened two hours after the injection- she had injection site pain, tiredness, headache, muscle pain, chills, nausea. She also stated that her arm is still a little sore, she got it in the deltoid, and the bottom of the arm hurt, she couldn't move it, but the next day, her arm was fine. The outcome of body aches, tiredness, muscle pain, chills, nausea was recovering; migraine level headaches and headaches was not recovered; doesn't feel good and injection site pain was unknown; arm is still a little sore; bottom of the arm hurt and she couldn't move it recovered on an unspecified date.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Tenderness and slight swelling in my left neck and left armpit; Tenderness and slight swelling in my left neck and left armpit; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, first dose via an unspecified route of administration in left arm on 17Dec2020 20:30 at single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination and penicillin allergy from an unknown date and unknown if ongoing. On 19Dec2020, the patient stated, "tenderness and slight swelling in my left neck and left armpit on day 2 after vaccine. The patient had no other vaccine in four weeks. The patient had taken other unspecified medications in two weeks. No treatment was given to patient for the events. The patient had COVID prior vaccination to vaccination and not had COVID test post vaccination. The events were reported as non serious as it did not result in death, not life threatening, did not cause prolonged hospitalization, not disabling or incapacitating and no congenital anomaly or birth defect. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain; This is a spontaneous report from a contactable pharmacist. An adult (reported as 39, unit unknown) female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot number and expiry date were unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient received COVID-19 vaccine in a hospital facility. The patient's medical history and concomitant medications were not reported. The patient previously experienced vaccination site pain from flu 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 patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had 1st dose of COVID-19 vaccine and experience injection site pain. She described it as "more painful than any flu vaccine received". The patient did not receive treatment for the adverse event. The outcome of the event was recovered in Dec2020.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade temp; headache; achy; diarrhea; tiredness; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EJ1685, via an unspecified route of administration on the left arm on 19Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient has no allergies to medications, food, or other products. On 20Dec2020 11:00, the patient experienced low grade temp, headache, achy, diarrhea and tiredness. The patient did not receive any treatment for the events and were reported as non-serious. The vaccine was administered in a hospital. The patient has not received 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 events  low grade temp, headache, achy, diarrhea and tiredness was recovered on an unspecified date in Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: lymphadenopathy; joint pain; muscle pain; chills; fatigued; sore, pain at site normal for vaccine admin; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685) intramuscularly on 17Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Dec2020 21:00, the patient was fatigued and had sore pain at the site of vaccine administration. On 18Dec2020, the patient experienced joint pain, muscle pain and chills. On 19Dec2020, the patient developed lymphadenopathy. The events were reported as non-serious. Outcome of events recovered on an unspecified date on Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: lymphadenopathy; joint pain; muscle pain; chills; fatigued; sore, pain at site normal for vaccine admin; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685) intramuscularly on 17Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Dec2020 21:00, the patient was fatigued and had sore pain at the site of vaccine administration. On 18Dec2020, the patient experienced joint pain, muscle pain and chills. On 19Dec2020, the patient developed lymphadenopathy. The events were reported as non-serious. Outcome of events recovered on an unspecified date on Dec2020.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary nail refill test abnormal, Chills, Erythema, Skin discolouration
Clinical narrative: purple discoloration to her right arm and right fingers; chills; redness across her chest and stomach; cap refill was sluggish; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EJ1685), via intramuscular on 18Dec2020 11:00 in right arm at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Employee reported purple discoloration to her right arm and right fingers. She reported her cap refill was sluggish. She stated she had chills and redness across her chest and stomach on 18Dec2020 at 16:00. The events result in Emergency room/department or urgent care. The patient received the treatment for the events. Outcome of events were unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: My arm pit is swollen and a little painful; My arm pit is swollen and a little painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient noticed that his arm pit was swollen and a little painful on 20Dec2020. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Oedema peripheral
Clinical narrative: My arm pit is swollen and a little painful; My arm pit is swollen and a little painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient noticed that his arm pit was swollen and a little painful on 20Dec2020. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Armpit is swollen; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient (also reported as female, pending clarification) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as "It is hard to read this handwriting EIP5730. This one it might be A or K, EK5730" (clarification pending), expiry date not reported), via an unspecified route of administration in gluteus, on 18Dec2020, at single dose, for COVID-19 immunization. Medical history included sexually transmitted disease (STD). There were no concomitant medications. The patient reported, "I took vaccine shot (COVIDvaccine) on 18th and I noticed my, yesterday (20Dec2020), my armpit is swollen is like big hill, it is like swollen." The patient stated, "Armpits, under my arm is swollen." The patient underwent lab tests and procedures which included blood work (unspecified date) with unknown results, the patient reported that this was for his STD. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Oedema peripheral
Clinical narrative: Armpit is swollen; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient (also reported as female, pending clarification) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as "It is hard to read this handwriting EIP5730. This one it might be A or K, EK5730" (clarification pending), expiry date not reported), via an unspecified route of administration in gluteus, on 18Dec2020, at single dose, for COVID-19 immunization. Medical history included sexually transmitted disease (STD). There were no concomitant medications. The patient reported, "I took vaccine shot (COVIDvaccine) on 18th and I noticed my, yesterday (20Dec2020), my armpit is swollen is like big hill, it is like swollen." The patient stated, "Armpits, under my arm is swollen." The patient underwent lab tests and procedures which included blood work (unspecified date) with unknown results, the patient reported that this was for his STD. The outcome of the event was unknown.  Information about lot/batch number has been requested.