chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, SARS-CoV-2 test
Clinical narrative: heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home/Senior Living Facility. The patient had no medical history. The patient had not received other vaccine in four weeks. Concomitant medication included erythromycin eye ointment. On the 17Jan2021 4PM, 3 days after being vaccinated the patient got heart palpitations and shortness of breath. This continued until the 23Jan2021 when he stopped having the heart palpitations. However, the shortness of breath has continued. It started out as light shortness of breath and has evolved into moderate. He was not gasping for air but it was uncomfortable enough where he has had to take time off of work. He was seen by a doctor on 27Jan2021. The patient did not receive any treatment for the event. The patient had Nasal swab/ SARs CoV-2 RNA Real time RT PCR on 25Jan2021, and the result was negative. The outcome of the event heart palpitations was recovered on 23Jan2021 and shortness of breath was not recovered.  Information on lot number/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This is a spontaneous report from a contactable Physician (reporting for himself). A 71-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK9231), via an unspecified route of administration on the left arm, at age 71 years first dose on 04Jan2021, at single dose for COVID-19 vaccination. Medical history included allergic to is seasonal from an unknown date and unknown if ongoing. There were no concomitant medications.  On 04Jan2021, the patient had no reaction whatsoever, except a slightly sore arm. The outcome of the event was recovered on an unspecified date in Jan2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Myalgia, Palpitations
Clinical narrative: Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain and a calcium deposit on her shoulder; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization.  Medical history included calcium deposit on her shoulder.  The patient's concomitant medications were not reported.  It was reported that she was scheduled to receive her second dose next week. She stated that she has pain and a calcium deposit on her shoulder, in which is on the opposite arm of injection site. She clarified that calcium deposit was there prior to receiving the vaccine and was not related to the vaccine. She stated that she was supposed to go to physical therapy and take steroids but was wondering if she should wait to take the steroids before the second injection. Patient asked if she can use antipyretics before or after vaccination and if there is a delay to receive the second dose, should it be minimum of 3 weeks. She stated she was told 17-22 days the second dose could be given. Outcome of the event was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contactable nurse (patient). A 44-year-old male 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 22Dec2020, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medication included ibuprofen. The patient received the vaccine on 22Dec2020 at the hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Dec2020 18:00 sudden onset of bilateral lower extremity numbness, tingling, and foot pain. These continued to present day. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received gabapentin as treatment for these adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient has not been COVID-tested post-vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Feeling of body temperature change, Malaise
Clinical narrative: Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Back pain, Cough, Dyspnoea, Fatigue
Clinical narrative: tired so quickly; Headache; back pain or the area of the lungs; like my asthma is worse; back pain or the area of the lungs; more like sore on the throat; Short of breath; coughing a few times; Throat pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date unknown) via unspecified route of administration on left arm, on 16Jan2021, at a single dose for COVID-19 immunisation. The patient medical history included asthma. The concomitant medication were not reported. It was reported that on 19Jan2021, she had back pain, or the area of the lungs, headaches, throat pain, like more like sore on the throat, and she wasn't having too much coughing. She reported that initially she felt fine but 3 days later (19Jan2021), she began having shortness of breath "like my asthma is worse". She was coughing a few times, sporadically, not like one day coughing like crazy on 19Jan2021. On 26Jan2021, the patient tired so quickly even in her own place doing normal stuff, like cleaning and cooking. The patient used inhaler for short of breath which she usually did not use, like for year, and she saw it had already expired, and she got nervous that she saw it was expired, so she called her doctor to see if she could go, he said he was not receiving patients, all this stuff became so horrible. She tried to go to Urgent Care and they didn't see her, they said she had to go to the hospital, and she wanted to check her blood to see if she needs to receive the second shot or not, no one gave an answer, she doesn't know what to do, her second shot of vaccination was planned on 06Feb2021. Inhaler that was expired was Albuterol: expiry was Dec2020, lot DAEO68. During a call patient stated that the only symptom that worsened was short of breath. The patient wanted to know whether she could receive her second dose of vaccine. It was also reported that patient was not accepted in urgent care locations because she "may have covid" and was instructed to go to the ER (as reported). The patient assessed the events as non-serious. The patient was recovering from the events back pain or the area of the lungs, more like sore on the throat, coughing a few times, throat pain and headache and not recovered from other events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pulmonary pain
Clinical narrative: tired so quickly; Headache; back pain or the area of the lungs; like my asthma is worse; back pain or the area of the lungs; more like sore on the throat; Short of breath; coughing a few times; Throat pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date unknown) via unspecified route of administration on left arm, on 16Jan2021, at a single dose for COVID-19 immunisation. The patient medical history included asthma. The concomitant medication were not reported. It was reported that on 19Jan2021, she had back pain, or the area of the lungs, headaches, throat pain, like more like sore on the throat, and she wasn't having too much coughing. She reported that initially she felt fine but 3 days later (19Jan2021), she began having shortness of breath "like my asthma is worse". She was coughing a few times, sporadically, not like one day coughing like crazy on 19Jan2021. On 26Jan2021, the patient tired so quickly even in her own place doing normal stuff, like cleaning and cooking. The patient used inhaler for short of breath which she usually did not use, like for year, and she saw it had already expired, and she got nervous that she saw it was expired, so she called her doctor to see if she could go, he said he was not receiving patients, all this stuff became so horrible. She tried to go to Urgent Care and they didn't see her, they said she had to go to the hospital, and she wanted to check her blood to see if she needs to receive the second shot or not, no one gave an answer, she doesn't know what to do, her second shot of vaccination was planned on 06Feb2021. Inhaler that was expired was Albuterol: expiry was Dec2020, lot DAEO68. During a call patient stated that the only symptom that worsened was short of breath. The patient wanted to know whether she could receive her second dose of vaccine. It was also reported that patient was not accepted in urgent care locations because she "may have covid" and was instructed to go to the ER (as reported). The patient assessed the events as non-serious. The patient was recovering from the events back pain or the area of the lungs, more like sore on the throat, coughing a few times, throat pain and headache and not recovered from other events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: and expiry date were not reported), via an unspecified route of administration in the right arm on 27Jan2021 10:30 at a single dose "to not get the disease." Medical history included ongoing mood disorder and ongoing hypertension. Concomitant medication included alprazolam (XANAX) from Apr2020 for hypertension, valproate semisodium (DIVALPROEX) from Dec2020 as mood stabilizer, risperidone from Dec2020 as mood stabilizer and for hypertension, and amlodipine besilate from May2020 for blood pressure. The patient previously took alprazolam (XANAX) for hypertension and had been trying to wean herself because she was getting addicted to it. Alprazolam (XANAX) also made her dizzy and depressed. She also previously took escitalopram (LEXAPRO), fluoxetine (PROZAC), and Zoloft  as antidepressants and stated that "they drove her crazier." The patient had no additional vaccines administered on same date of the Pfizer Suspect. The patient received that vaccine at housing complex where she resides and was looking at the list that she was given that had reactions. She was feeling dizzy on 27Jan2021 and wanted to know if she should be concerned. The patient reported that she will be speaking with her psychiatrist at 1:30pm during an online appointment asked if she should mention this to her. The event did not require visit to the emergency room or physician office. No relevant tests were conducted. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Pain in extremity
Clinical narrative: go for a walk and had onset of shortness of breath; little soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot/NDC number and expiration date were not provided), via an unspecified route of administration on 26Jan2021 at about 10:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID-19 vaccine on 26Jan2021 about 10:30 AM at the hospital and he had no effects then. He had a little soreness in arm that night (26Jan2021), but woke up in the morning of the report date, on 27Jan2021 with no soreness in arm, and felt pretty good. Also, at the time of the report on 27Jan2021, he went out to go for a walk and had onset of shortness of breath. He waited a few minutes then continued to walk and still getting the shortness of breath. He called to ask if that was a normal side effect of the vaccine. The patient further indicated having "no problems," went for a walk and experienced shortness of breath. The patient recovered from the event "little soreness in arm" on 27Jan2021, while the outcome of the event "go for a walk and had onset of shortness of breath" was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dyspnoea exertional, Fatigue, Feeling abnormal
Clinical narrative: Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Chills; shortness of breath with exertion; Palpitations; Paresthesias to bilateral hands and right foot/leg; Weakness to bilateral hands; This is a spontaneous report received from a contactable nurse (who is also the patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELB9B2, expiry date: unknown), intramuscular on the left arm, on 16Jan2021 12:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included myelitis transverse from 2015, and depression. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were unspecified concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: unknown), intramuscular on the left arm, on 26Dec2020 11:30, for COVID-19 immunization and the patient experienced paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. The patient did not receive other vaccines in four weeks. On 17Jan2021 at 07:00 (also reported as "12-18 hours after injection"), the patient experienced paresthesias to bilateral hands and right foot/leg; weakness to bilateral hands; brain fog and fatigue, increased from first; chills and shortness of breath with exertion; and palpitations. The events palpitations and shortness of breath with exertion were noticed on day 6 resulting to emergency room visit. It was also reported that the events resulted to emergency room and physician office visits. No treatment was given for the events. The patient was tested for COVID-19 post vaccination via nasal swab with negative result on 22Jan2021. The outcome of the events was recovering (improved gradually).
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Palpitations, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Chills; shortness of breath with exertion; Palpitations; Paresthesias to bilateral hands and right foot/leg; Weakness to bilateral hands; This is a spontaneous report received from a contactable nurse (who is also the patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELB9B2, expiry date: unknown), intramuscular on the left arm, on 16Jan2021 12:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included myelitis transverse from 2015, and depression. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were unspecified concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: unknown), intramuscular on the left arm, on 26Dec2020 11:30, for COVID-19 immunization and the patient experienced paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. The patient did not receive other vaccines in four weeks. On 17Jan2021 at 07:00 (also reported as "12-18 hours after injection"), the patient experienced paresthesias to bilateral hands and right foot/leg; weakness to bilateral hands; brain fog and fatigue, increased from first; chills and shortness of breath with exertion; and palpitations. The events palpitations and shortness of breath with exertion were noticed on day 6 resulting to emergency room visit. It was also reported that the events resulted to emergency room and physician office visits. No treatment was given for the events. The patient was tested for COVID-19 post vaccination via nasal swab with negative result on 22Jan2021. The outcome of the events was recovering (improved gradually).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: had a little muscle soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his vaccine on the 24th, four days ago. He only had a little muscle soreness and took Tylenol. He has another vaccine coming up next week. His next dose isn't until valentine's day. He asked if it was ok to get another vaccine between his doses. The outcome of the event was unknown.  No follow-up attempts are possible; information on batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Confusional state, Disturbance in attention
Clinical narrative: stated that he developed confusion; experienced awful dreams; concentration to do normal things/it was too difficult to concentrate on the road and talk to her at the same time.; This is a spontaneous report from a contactable consumer (the patient).  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249, expiry 31May2021), intramuscular in the left arm, on 27Jan2021 at 09:30 AM (at the age of 78 years) as a single dose for COVID-19 immunization.  Medical history was none. Concomitant medication included ergocalciferol (VITAMIN D). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Jan2021 he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night. The slight degree of confusion causing him to have to concentrate more than usual for ordinary tasks. The clinical outcome of the events he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Vaccination site pain
Clinical narrative: Itching skin - Began on arms and legs but has extended to chest, face, scalp, back, etc.; No hives but itching and skin became red; hot in areas; Muscle soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL 3247), via an unspecified route of administration at the left arm on 27Jan2021 10:00 at SINGLE DOSE for covid-19 immunization. The vaccine was administered in a Workplace Clinic. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. 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 has not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amoxicillin. The patient experienced Itching skin - began on arms and legs but has extended to chest, face, scalp, back, etc. No hives but itching and skin became red and hot in areas. Itching started around 12 hours post-dose. Muscle soreness at injection site - started approximately 12 hours post-dose. It was reported that event started on 27Jan2021 22:00. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint range of motion decreased, Nausea, Pain in extremity
Clinical narrative: Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation.  Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10).  The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation.  Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10).  The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#:not provided), via an unspecified route of administration from on 27Jan2021 (at the age of 74-year-old) at SINGLE DOSE for COVID-19 immunization at the hospital and paracetamol (TYLENOL), via an unspecified route of administration and dates at 2 DF, daily (every morning) for aches and pains. Medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot#: not provided) on an unknown date at SINGLE DOSE for COVID-19 immunization and says that she had no reaction to the first shot. The patient received the second dose and had a sore arm (in Jan2021) that was better today. She stated that in the morning she always took two paracetamol for aches and pains; and after she got the first and second shot she read three articles to do not take paracetamol  before you get the vaccines as it might affect antibodies. However, no one published about this or said this at the hospital when she went to get the shot, they just asked what she was allergic to it. She would like to know if now she was not so protected because she took paracetamol and if this was a problem. The action taken in response with the adverse event for paracetamol was unknown. Outcome of the event was recovering  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Heart rate increased, Lethargy, Pain in extremity
Clinical narrative: Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to  penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and  thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and  thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient has not been tested for COVID-19 since the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to  penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and  thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and  thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient has not been tested for COVID-19 since the vaccination.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Night sweats, Pain
Clinical narrative: headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29Dec2020; This is a spontaneous report from a contactable nurse reporting for herself.   A 31-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 29Dec2020 at 13:00 (at the age of 31 years old) as a single dose in the left arm for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date, acid reflux disease from an unknown date, headaches from an unknown date, and irritable bowel syndrome from an unknown date.  Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), prenatal vitamins, cetirizine hydrochloride (ZYRTEC), and unspecified allergy shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache on an unspecified date, night sweats on an unspecified date, achy on an unspecified date, chills on an unspecified date, and last menstrual date 19Dec2020 and first administration date of 29Dec2020. The mother was due to deliver on 25Sep2021. The patient did not receive treatment for the events. The outcome of the events headache, night sweats, achy and chills, and exposure during pregnancy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: petechiae; This is a spontaneous report from a contactable pharmacist (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the arm on 27Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced 6 spots of petechiae on the inside of the arm that she received her vaccine. She stated that she got shot on outside of arm. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Sore and stiff arm at injection site only; Sore and stiff arm at injection site only; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EN 5318, expiration date unknown), via an unspecified route of administration on left arm on 27Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included asthma, moderate to marked outdoor allergies. Allergies to medications, food, or other products was none. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), triamcinolone acetonide (NASACORT) and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced Sore and stiff arm at injection site only on 26Jan2021 at 17:00. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.