chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Erythema, Feeling hot, Lymphadenopathy, Migraine
Clinical narrative: Severe Stomach Cramping; Headache/Migraine; Very Nauseous; Neck On the "(Left Side)" Was Very Swollen Like I Had A "(2-Inch-Sized-Bouncy Ball)" Inside My Neck Around Area Of my Left Lymph Nodes/Right Side Of My Neck Was Slightly Swollen; My Neck, Head, Face, Ears & Chest Became Very Red; Felt Like I Had A Fever; Skin Felt Unbelievably Hot Like I Was On Fire; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration, administered in Arm Right on 24Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 49 yaers). Medical history included cancer at 22 Years old, rheumatoid arthritis, fibromyalgia, chronic obstructive pulmonary disease, glaucoma, cataract, intervertebral disc degeneration, Degenerative Discs, spinal stenosis, lymphadenectomy on an unknown (Right Lymph Nodes Inside My Neck Were Removed VIA Surgery 25+Years Ago), Sinus. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient had 22 to 26 active prescriptions. The patient previously took codeine and experienced known_allergies CODEINE. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced headache/migraine on 24Feb2021 15:15, very nauseous, neck on the left side was very swollen like I had a 2-inch-sized-bouncy ball inside my neck around area of my left lymph nodes/right side of my neck was slightly swollen on 24Feb2021, my neck, head, face, ears & chest became very red, felt like I had a fever, skin felt unbelievably hot like I was on fire on 24Feb2021 and severe stomach cramping on 25Feb2021 at 13.00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021, 03Feb2021, 11Feb2021, 15Feb2021 and 24Feb2021. No treatment was received for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe Stomach Cramping; Headache/Migraine; Very Nauseous; Neck On the "(Left Side)" Was Very Swollen Like I Had A "(2-Inch-Sized-Bouncy Ball)" Inside My Neck Around Area Of my Left Lymph Nodes/Right Side Of My Neck Was Slightly Swollen; My Neck, Head, Face, Ears & Chest Became Very Red; Felt Like I Had A Fever; Skin Felt Unbelievably Hot Like I Was On Fire; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration, administered in Arm Right on 24Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 49 yaers). Medical history included cancer at 22 Years old, rheumatoid arthritis, fibromyalgia, chronic obstructive pulmonary disease, glaucoma, cataract, intervertebral disc degeneration, Degenerative Discs, spinal stenosis, lymphadenectomy on an unknown (Right Lymph Nodes Inside My Neck Were Removed VIA Surgery 25+Years Ago), Sinus. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient had 22 to 26 active prescriptions. The patient previously took codeine and experienced known_allergies CODEINE. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced headache/migraine on 24Feb2021 15:15, very nauseous, neck on the left side was very swollen like I had a 2-inch-sized-bouncy ball inside my neck around area of my left lymph nodes/right side of my neck was slightly swollen on 24Feb2021, my neck, head, face, ears & chest became very red, felt like I had a fever, skin felt unbelievably hot like I was on fire on 24Feb2021 and severe stomach cramping on 25Feb2021 at 13.00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021, 03Feb2021, 11Feb2021, 15Feb2021 and 24Feb2021. No treatment was received for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lips is swelling; This is a spontaneous report from a Pfizer sponsored program Support. A contactable female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, after the first dose the patient experienced inside her lips was swelling. The event outcome was unknown.  Information about Lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts were completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Limb discomfort, Product administration error
Clinical narrative: I still have a big bruise after 2 weeks; I think a little bit of it came out the injection site and ran down my arm; that side of my arm has a little bumpier like solution has ran down from; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender received first dose of bnt162b2 (COVID 19 Vaccine Pfizer, Solution for injection, Batch/lot number: EL9269, Expiration date: Unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, when patient received covid shot, patient think a little bit of it came out the injection site where the needle was, think that some of it came down the arm because he put the cotton of about 4 inches below the injection site and ran it up and then held it. Patient understand how this is normal but can feel afterwards that, that side of the arm has a little bumpier like solution has ran down the arm. Was that going to be a problem in the effectiveness? Patient want to know that because some it ran out, if it was still effective because patient still have a big bruise after 2 weeks and also, can see where the needle went in still. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Nervousness, Peripheral swelling, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 16Feb2021 (at the age of 69-years-old) as a single dose for covid-19 immunization. Medical history included diabetes mellitus- Diabetic- don't have medication, it's controlled by diet; hypertension. Concomitant medication(s) included hydrochlorothiazide; atenolol; potassium. On an unspecified date, the patient stated, "I don't know if I am having an allergic reaction to Pfizer first shot, COVID-19 vaccine I got (later confirmed). My arm is still swollen and I am just really extremely nervous. So, my arm has like a little square on it and it's puffy and swollen at the area where I got the shot." When paraphrased the concern, the patient stated, "No, I don't have pain but my arm is swollen. It has like a little square on it and it's really puffy and red like a (incomplete sentence). And I am extremely nervous because I don't know what is going on." As the treatment, patient put heat on it and last night, took some Benadryl to see if that works. Due date for second dose was 09Mar2021. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise at injection site; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EM9810), via an unspecified route of administration on 06Feb2021(at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included sinus pain from an unknown date and unknown if ongoing Verbatim: sinus problems , allergy to plants from an unknown date and unknown if ongoing , allergy to plants from an unknown date and unknown if ongoing. Concomitant medication(s) included cefdinir taken for sinusitis from 02Feb2021 to 16Feb2021; montelukast sodium taken for an unspecified indication from 02Feb2021 to an unspecified stop date; mupirocin taken for sinusitis from 02Feb2021 to an unspecified stop date. On 06Feb2021, the patient experienced Bruises at injection site. The first dose of the Covid-19 vaccine on 06 Feb 2021. She still has bruising at the injection site. She read that it could last for 3-4 days. This has been way over that time. It is not as pronounced as what it was. She was also on an antibiotic to rule out a staph infection. She is allergic to pine trees. When providing product details, caller states she was prescribed an ointment to use for 7 days. She used it for 10-12 days. rovides Lot: 19201551, Expiry Mar2022.When she was smaller, she had a bad reaction to a diphtheria injection. She was in the 5th grade. She does not have the exact name, NDC, Lot or Expiry. She had to get a second shot to counteract it. Her body is very sensitive to certain drugs like pain medications. She is unable to provide names, NDC, Lot or Expiry. She is also allergic to raspberries. She asked if the vaccine had raspberries. She saw on the news that the second dose of the Pfizer vaccine may not be needed because the first dose is 90% effective. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rash on her lower front of her legs /it is bright red, about 5-6 inches long and 3-4 inches wide; Rash on her lower front of her legs /it is bright red, about 5-6 inches long and 3-4 inches wide; Soreness left upper arm at injection site; Swelling left upper arm at injection site; This is a spontaneous report from a contactable nurse (patient). A 85-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 11Feb2021 16:00 (Batch/Lot Number: EL9269) (at the age of 85-years-old) as SINGLE for covid-19 immunization. The patient denied for any Medical history and concomitant medications. On 11Feb2021, she just had a little soreness and swelling at injection site in upper left arm. Also, stated on Sunday morning, 14Feb2021 at 7 AM when she woke up she had a rash on her lower front of her legs, states it is bright red, about 5-6 inches long and 3-4 inches wide, for no reason. The patient did not treat rash, went to dermatologist, just her 6 month regular visit, doctor went through the list of everything she could have had been allergic to, the only thing they have done differently is the Pfizer vaccine, dermatologist gave her some cream to start, will start treating the rash today, medication was triamcinolone cream. The outcome of events little soreness and swelling at injection site in upper left arm was recovered on 11Feb2021 whereas, other events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Limb discomfort
Clinical narrative: low grade fever 100.2; mild fatigue/extreme fatigue; headache; not hungry; body felt heavy like someone was pushing down on them; sore arm; This is a spontaneous report from a contactable consumer. A 44-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL9269, Expiration date: Unknown), on 12Feb2021 around 8.15Am on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 44-Year-old). Medical history included Blood pressure and heart burn. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL9261) around 3.30pm on left Arm as Dose 1 single for covid 19 immunization on 22Jan2021 and same day experienced mild fatigue and sore left arm at the injection site. Other medications in two weeks included blood pressure and heart burn medications. The patient had not affected with covid19 before or after vaccination. On 13Feb2021 patient experienced mild fatigue and sore arm (same day of the injection), the following day, low grade fever (100.2), extreme fatigue, headache, not hungry, body felt heavy like someone was pushing down on them and she woke up the next day and felt good. None of the Allergies were reported. No therapeutic treatments were received. The patient laboratorial test included fever 100.2 (low grade fever) on 13Feb2021. On an unspecified date in Feb2021 the outcome of the events was reported as recovered/resolved.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: low grade fever 100.2; mild fatigue/extreme fatigue; headache; not hungry; body felt heavy like someone was pushing down on them; sore arm; This is a spontaneous report from a contactable consumer. A 44-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL9269, Expiration date: Unknown), on 12Feb2021 around 8.15Am on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 44-Year-old). Medical history included Blood pressure and heart burn. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL9261) around 3.30pm on left Arm as Dose 1 single for covid 19 immunization on 22Jan2021 and same day experienced mild fatigue and sore left arm at the injection site. Other medications in two weeks included blood pressure and heart burn medications. The patient had not affected with covid19 before or after vaccination. On 13Feb2021 patient experienced mild fatigue and sore arm (same day of the injection), the following day, low grade fever (100.2), extreme fatigue, headache, not hungry, body felt heavy like someone was pushing down on them and she woke up the next day and felt good. None of the Allergies were reported. No therapeutic treatments were received. The patient laboratorial test included fever 100.2 (low grade fever) on 13Feb2021. On an unspecified date in Feb2021 the outcome of the events was reported as recovered/resolved.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint range of motion decreased, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Headache; Fingers on right hand feel tight, like they're getting swollen; I could not move my right arm because of the pain; I could not move my right arm because of the pain; had pain and swelling around my right elbow; had pain and swelling around my right elbow; This is a spontaneous report from a contactable consumer or non-health care professional (Patient).  A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Batch no: unknown) via unspecified route of administration, administered in right arm, on 18Feb2021 (at the age of 65-year-old) as dose 2 single for COVID-19 immunization. Medical history included osteoarthritis, fibromyalgia. Known allergies reported as patient had some food sensitivities and meds. The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Batch no: unknown) via unspecified route of administration, administered in Left arm, on 27Jan2021 10:00AM as dose 1 single for COVID-19 immunization. No other vaccines received with in four weeks and no other medications received within in two weeks of vaccination. Patient had no covid prior vaccination and not tested for covid post vaccination. On 18Feb2021 17:00, Thursday afternoon through Saturday patient had pain and swelling around her right elbow. She could not move her right arm because of the pain. Fingers on right hand feel tight, like they were getting swollen. on 20Feb2021, Saturday afternoon headache came on really strong. AE was not resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for resulted AE. Clinical outcome of all events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Fingers on right hand feel tight, like they're getting swollen; I could not move my right arm because of the pain; I could not move my right arm because of the pain; had pain and swelling around my right elbow; had pain and swelling around my right elbow; This is a spontaneous report from a contactable consumer or non-health care professional (Patient).  A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Batch no: unknown) via unspecified route of administration, administered in right arm, on 18Feb2021 (at the age of 65-year-old) as dose 2 single for COVID-19 immunization. Medical history included osteoarthritis, fibromyalgia. Known allergies reported as patient had some food sensitivities and meds. The patient's concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Batch no: unknown) via unspecified route of administration, administered in Left arm, on 27Jan2021 10:00AM as dose 1 single for COVID-19 immunization. No other vaccines received with in four weeks and no other medications received within in two weeks of vaccination. Patient had no covid prior vaccination and not tested for covid post vaccination. On 18Feb2021 17:00, Thursday afternoon through Saturday patient had pain and swelling around her right elbow. She could not move her right arm because of the pain. Fingers on right hand feel tight, like they were getting swollen. on 20Feb2021, Saturday afternoon headache came on really strong. AE was not resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for resulted AE. Clinical outcome of all events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Hot flush, Pain, Pain in extremity
Clinical narrative: right arm pain; full body aches; chills; slight temp; hot flashes; swollen right armpit tender to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN5318), via intramuscular, administered in right arm on 18Feb2021 at 02:00 pm (42-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history included  allergies to Sulfa, penicillin, milk intolerance and egg intolerance. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) for unknown indication from unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EL9261), via intramuscular, administered in right arm on 28Jan2021 at 01:00 pm (42-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and experienced hand tingling and medicine head feel for 30 mins with nausea occurring 2 days later. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 19Feb 2021, at 20:00 (reported as 10PM), the patient experienced right arm pain, full body aches, chills, slight temp, and hot flashes, swollen right armpit tender to the touch. The patient stated that she woke on Saturday morning with a swollen right armpit tender to the touch and if pushed in would have increased soreness, while still with arm pain. The outcome of the events were recovering.   Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: right arm pain; full body aches; chills; slight temp; hot flashes; swollen right armpit tender to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN5318), via intramuscular, administered in right arm on 18Feb2021 at 02:00 pm (42-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history included  allergies to Sulfa, penicillin, milk intolerance and egg intolerance. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) for unknown indication from unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EL9261), via intramuscular, administered in right arm on 28Jan2021 at 01:00 pm (42-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and experienced hand tingling and medicine head feel for 30 mins with nausea occurring 2 days later. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 19Feb 2021, at 20:00 (reported as 10PM), the patient experienced right arm pain, full body aches, chills, slight temp, and hot flashes, swollen right armpit tender to the touch. The patient stated that she woke on Saturday morning with a swollen right armpit tender to the touch and if pushed in would have increased soreness, while still with arm pain. The outcome of the events were recovering.   Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity, Pyrexia, Rash
Clinical narrative: chills the next day; knot in the arm at injection site soreness of the whole arm; knot in the arm at injection site soreness of the whole arm; Light headed; Rash lower arm and wrist; Fever for a few hours after injection, chills the next day; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2, ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:00 as dose 2, single for covid-19 immunization. The patient did not have any known allergies. The patient Medical history included diabetes mellitus The patient previously received a dose of BNT162B2, ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 at 02:00PM as dose 1, single for covid-19 immunization. The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination.The patient did not have COVID post vaccination. Concomitant medications included METFORMIN HCL taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 18Feb2021, at 14:30, the patient experienced knot in the arm at injection site soreness of the whole arm (pain in extremity), light headed (dizziness), rash lower arm and wrist and fever for a few hours after injection. On 19Feb2021, the next day the patient was having chills. The patient did not receive any treatment for the events. The clinical outcome of the events recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.  .
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: chills the next day; knot in the arm at injection site soreness of the whole arm; knot in the arm at injection site soreness of the whole arm; Light headed; Rash lower arm and wrist; Fever for a few hours after injection, chills the next day; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2, ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:00 as dose 2, single for covid-19 immunization. The patient did not have any known allergies. The patient Medical history included diabetes mellitus The patient previously received a dose of BNT162B2, ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 at 02:00PM as dose 1, single for covid-19 immunization. The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination.The patient did not have COVID post vaccination. Concomitant medications included METFORMIN HCL taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 18Feb2021, at 14:30, the patient experienced knot in the arm at injection site soreness of the whole arm (pain in extremity), light headed (dizziness), rash lower arm and wrist and fever for a few hours after injection. On 19Feb2021, the next day the patient was having chills. The patient did not receive any treatment for the events. The clinical outcome of the events recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.  .
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going; Little tired; develop a little pain in my arm where the injection was given; Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This patient (age: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiration date: not reported), via an unspecified route of administration as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, this patient started experiencing little tired, develop a little pain in my arm where the injection was given, Extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going and nothing seems to be alleviating this pain. Consumer stated, "I had the Pfizer second shot (clarified as Covid-19 Vaccine) on Monday and then on Monday I was just little tired, on Tuesday morning I was little tired and then I develop a little pain in my arm where the injection was given, I realized it was a normal sort of kind of pain however this is Friday and I have had extreme pain from my shoulder through my elbow wrist down to my fingers ever since coming and going and I have been taking Tylenol, I put some on heat, I sprayed with pain reliever and nothing seems to be alleviating this pain and I don't know quite what to do about it." The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red bumpy rash on neck and chest; This is a spontaneous report from a contactable other HCP (patient, self-reported). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ENS318 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Jan2021 at 01:45 PM (age at vaccination: 51 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included egg intolerance. Concomitant medications were not reported. Past drug included morphine (known allergies: sensitive to morphine). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that 0n 29Jan2021, following first COVID vaccine injection, she developed red bumpy rash on neck and chest. Onset roughly 24 hrs after injection. Duration of approx. 5 days. The patient did not receive any treatment for the event. Outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: targeted head pain (not a generalized headache); Fever; chills; muscle and joint pain; muscle and joint pain and soreness; nausea; thirst; tiredness; injection site soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Feb2021 at 15:15 pm (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma, migraines, sinus infections, carpal tunnel and allergy (OTC allergy meds). Concomitant medications the patient received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), montelukast sodium (SINGULAIR) calcium, magnesium, OTC allergy meds and daily multivitamin all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Jan2021 at 15:30 pm (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021 at 04:30 am, the patient experienced fever, chills, muscle and joint pain and soreness, targeted head pain (not a generalized headache), nausea, thirst, tiredness, injection site soreness. No treatment was received for the adverse events. The outcome of the events was not resolved.   Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Thirst, Vaccination site pain
Clinical narrative: targeted head pain (not a generalized headache); Fever; chills; muscle and joint pain; muscle and joint pain and soreness; nausea; thirst; tiredness; injection site soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Feb2021 at 15:15 pm (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma, migraines, sinus infections, carpal tunnel and allergy (OTC allergy meds). Concomitant medications the patient received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), montelukast sodium (SINGULAIR) calcium, magnesium, OTC allergy meds and daily multivitamin all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Jan2021 at 15:30 pm (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021 at 04:30 am, the patient experienced fever, chills, muscle and joint pain and soreness, targeted head pain (not a generalized headache), nausea, thirst, tiredness, injection site soreness. No treatment was received for the adverse events. The outcome of the events was not resolved.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling
Clinical narrative: under eyes swollen and puffy; under eyes swollen and puffy; This is a spontaneous report from a contactable consumer (Patient).  A 68-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EM9890), via an unspecified route of administration, on 12Feb2021 (at the age of 68 years old) as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient medical history was not reported. The concomitant medication of the patient included Simvastatin (SIMVASTATIN) from unspecified start and stop date. No further details provided about Simvastatin, details documented as provided. It was reported that it was not a new medication but her dose was upped for her Simvastatin, it was 10 and now it is 20, but they doesn't think that has anything to do with it. The patient reported that they were calling about the Pfizer COVID-19 vaccine, they received the vaccine on 12Feb2021 and it was weird, the next day (13Feb2021) her eyes were swollen, under her eyes they were puffy when patient woke up. Patient told her husband that the puffy made her look like a little pig and in two days that was gone. Patient took Benadryl, she was little tired and went cross county skiing that day and it was cold outside, she could have stuck her face in the snow it might have helped, her eyes didn't itch or anything, it was just puffy and weird like her sinus under and over her eyes and across her nose. She says that the puffiness was better now. Patient wanted to know if anyone else has reported this or if she should get the second dose of the vaccine. She says she was supposed to get her second dose on March 5th. Patient reported that they have not had any other recent vaccinations or started any new medications. Outcome of event was recovered on unspecified date in 2021. Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: Joints pain; I looked up to the general symptoms at the injection site and it is joints pain and muscular body aches and in my left hip; I looked up to the general symptoms at the injection site and it is joints pain and muscular body aches and in my left hip; my left leg sometimes I had aches in it; This is a spontaneous report from a contactable consumer. This 80-years-old consumer reported that: A 80-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included Historical Vaccine BNT162B2 for Covid 19 immunization Dose 1 on an unspecified date. The patient's concomitant medications were not reported. The patient experienced Joints pain, the patient looked up to the general symptoms at the injection site and it was joints pain and muscular body aches and in my left hip, the patients left leg sometimes had aches in it on 16Feb2021. There it was bothering the patient ever since Tuesday it was coming and going and my left leg sometimes the patient had aches in it. Patients wanted to know was this a symptom because of the vaccine that was all the patient wanted to know. Consumer was informed about role of Pfizer Drug Safety department. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Sore throat; Runny nose; This is a spontaneous report from a contactable consumer (Patient).   A 39-year-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an 17Feb2021 (age at the time of vaccination was 39-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced sneezing, Sore throat and Runny nose. Caller states he got his first dose of the Pfizer Covid vaccine a couple of days ago on Wednesday, 17Feb2021. Caller states starting yesterday 18Feb2021, he has sore throat, runny nose and sneezing. States today it was more of a throbbing throat pain, it comes and goes, very random, like when you feel like you are about to get sick. Wants to know if these symptoms are normal. Caller states he was currently at work and was just trying to get answers about his symptoms. Outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia
Clinical narrative: flush, something kind of went over her whole body; hands started tingling; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in left arm on 02Feb2021 at 08:00 (at the age of 71-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported previously received pneumonia vaccine for immunisation (4 weeks before the covid vaccine). On 02Feb2021, 15 minutes after taking the covid-19 vaccine, the patient had a flush, something kind of went over her whole body and then her hands started tingling, it lasted a few seconds. The patient reported it started at the top, you could feel something inside of you go from the top and then just down and that was it and then the tingling started. The patient reported it was localized to hands and clarifies it was both hands. Patient did not any AE(s) require a visit to emergency room and physician office. The patient had not received any treatment for event. The outcome of the event was recovered on 02Feb2021.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I was having difficulty in breathing and short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EL9267) via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that "the patient had the first Pfizer shot (clarified as Covid 19 vaccine) on 09Feb2021 and the next day on 10Feb2021 was having difficulty breathing and short of breath and went to urgent care and they gave patient a shot of he/she think (statement incomplete) and they put patient on a breathing machine and patient was wondering if he/she should go get the second shot on 02Mar2021". The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the front of her legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced rash on the front of her legs. The patient was using Benadryl, for 3 days. Therapeutic measures were taken as a result of rash on the front of her legs. The outcome of the event was unknown.   Information about lot/ batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Her face was swollen; This is a spontaneous report from a contactable consumer or other non hcp (parent) via pfizer-sponsored program. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unknown date, the patient's face was swollen. Going to doctor office as we speak. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer or other non HCP (Patient) reported that a male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation; Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reports worsening arthritis after first dose on 17Feb2021. The outcome of event reported as unknown. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Dizziness
Clinical narrative: vertigo; dizziness; fatigue; chills; headache; elevated temperature (around 100F); light nausea; achiness; muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 13:00 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. He was not diagnosed with COVID-19 prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), in left arm on 27Jan2021 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 1, single for COVID-19 immunization and experienced mild pain at the side of vaccination (left arm). On 17Feb2021 21:00, about 8h after the vaccination, the patient experienced chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue. The patient was informed about the possibility of these common side effect by the person who administered the vaccine. The symptoms ceased about 48h after. In addition, the patient started experiencing nausea and vertigo/ dizziness on 22Feb2021, 4th day after the vaccination. The patient did not think that they were related to the vaccine but still wanted to report them. He reported that he cleaned his ear with a q-tip on 21Feb2021 which might have caused the symptoms. The patient did not receive treatment for the events. Outcome of chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue was recovered on 19Feb2021 21:00; of remaining events was unknown. Patient was not tested for COVID-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events vertigo, dizziness and the suspect drug BNT162B2.