chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 27-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration on an unknown date in Jul2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced swollen lymph node. The clinical outcome of the event swollen lymph node was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm.; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose, Second dose via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing Caller stated that she is immunocompromised and is concerned about getting sick , illness from an unknown date and unknown if ongoing verbatim: Caller stated that she is immunocompromised and is concerned about getting sick. The patient's concomitant medications were not reported. The patient experienced she did not react to both doses of the pfizer covid-19 vaccine, except having sore arm. Clinical course reported as has received both doses of the Pfizer BioNTech COVID-19 vaccine. She received her first dose in Jan2021 and her second dose 3 weeks later in early Feb2021. Caller is concerned about getting the booster dose and she would like to know when to get and if she is eligible. Caller stated that she is immunocompromised and is concerned about getting sick. She heard that an Infectious disease doctor at the national health department said that the efficacy of the Pfizer COVID-19 vaccine decreases to 84% after 6 months. Caller stated that she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass, Ultrasound scan
Clinical narrative: Soft lumps appeared on the top/sides of scalp (both sides); Enlarged lymph node in left neck; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pain medications. 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. Concomitant medications included escitalopram oxalate (LEXAPRO), imipramine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and ibuprofen (ADVIL); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7553) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient previously received hydrocodone bitartrate/paracetamol (VICODIN), paracetamol/oxycodone hydrochloride (PERCOCET) and hydromorphone hydrochloride (DILAUDID); all on unknown dates for unknown indications and experienced drug allergy. On 26Apr2021, within a week of the final vaccine, soft lumps appeared on the top/sides of the scalp (both sides) and the patient also had an enlarged lymph node in the left neck area that was currently being checked through an ultrasound. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events soft lumps appeared on the top/sides of scalp (both sides) and enlarged lymph node in left neck were not recovered at the time of this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Inflammation, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: unable to curl the finger down; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0271; Expiration Date: Sep2021) intramuscular, administered in Arm Left on 10Aug2021 11:50 (at age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not any history or other products. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, her husband (patient) got COVID shot yesterday. On his left hand, index finger, it was red, swollen, inflamed and painful on 10Aug2021. On an unspecified date he was unable to curl the finger down because of the inflammation. He got the shot before lunch at 11:50 AM yesterday. The index finger being red, swollen, inflamed, and painful started a couple of hours after the shot. He mentioned it started to bother him in the afternoon. When he woke up this morning it was much worse on an unspecified date. They were not sure where it would progress from here. He never had an issue with his hand before. Adverse event did not require to visit emergency room or physician office; but caller told him to that she recommended that he follow up with his doctor. She was calling because she was required to report it within 24 hours. The outcome of events unable to curl the finger down and it is red and swollen and inflamed and painful (Condition aggravated) was unknown while it was not recovered for all other events.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: unable to curl the finger down; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0271; Expiration Date: Sep2021) intramuscular, administered in Arm Left on 10Aug2021 11:50 (at age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not any history or other products. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, her husband (patient) got COVID shot yesterday. On his left hand, index finger, it was red, swollen, inflamed and painful on 10Aug2021. On an unspecified date he was unable to curl the finger down because of the inflammation. He got the shot before lunch at 11:50 AM yesterday. The index finger being red, swollen, inflamed, and painful started a couple of hours after the shot. He mentioned it started to bother him in the afternoon. When he woke up this morning it was much worse on an unspecified date. They were not sure where it would progress from here. He never had an issue with his hand before. Adverse event did not require to visit emergency room or physician office; but caller told him to that she recommended that he follow up with his doctor. She was calling because she was required to report it within 24 hours. The outcome of events unable to curl the finger down and it is red and swollen and inflamed and painful (Condition aggravated) was unknown while it was not recovered for all other events.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old patient, of unspecified gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EM9809), at the age of 70, intramuscularly, left arm, on Feb 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history included polymyalgia (Oct 2020); she was treated for a few months with prednisone 5mg; and rheumatic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date in Feb 2021, patient experienced a sore arm. Patient received treatment for event. The patient underwent lab tests and procedures, which included SARS-CoV-2 RNA test: negative on May 13, 2020. The event assessed non-serious, with outcome of unknown. Follow-Up (Aug 18, 2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: pins and needles; skin feels wormed; sore arm; felt numbness in his fingertips; This isThis is a spontaneous report from a contactable consumer or other non-healthcare professional. A 32-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 10Aug2021 (Batch/Lot number and Expiry date was not reported) (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pins and needles, skin feels wormed, sore arm and felt numbness in his fingertips. The reporter stated that he did not want to report a side effect as it did not do him any good to just report it. He declined to complete report. He was calling in regard to the Pfizer COVID vaccine and wanted some information about a side effect. The reporter stated that his side effect was not the same day and it was the day after. He further stated that he received the vaccine on Tuesday 10Aug2021 and starting yesterday and today he felt pins and needles throughout his body as if he took pre-workout. His skin feels wormed like pins and needles or as if he took beta alanine or been in the sun too long, it varies in intensity. The reporter would like to know if this side effect has been reported and is it something that goes away. It was reported that on 10Aug2021 the day he received the vaccine he did not have many side effects and he did not really have a sore arm until the next day and he felt numbness in his fingertips on the same side he got the shot but that went away. Also stated that three hours prior to the receiving the shot he took a medication called meloxicam and he told the pharmacist initially and they did not think it would be an issue. After delivering response to question caller stated that was true and he knew that they have to cover themselves and this was a waste of time. Caller then disconnected call. Unable to offer survey as the call was disconnected. Unable to attempt to transfer again as the reporter disconnected call. He is 32-years-old male. Unable to ask for consent to contact as caller disconnected call. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced "memory issues" and can't remember if she ever had a vaccine card on an unspecified date. Patient stated, she went to get a 2nd dose of Pfizer COVID-19 vaccine and was turned away because she did not have a vaccination card. She wanted to know what can she do about the card. Received the 1st Pfizer COVID-19 vaccine 4 months ago. She went to the hospital shortly after the 1st dose for "side effects from the vaccine." After discharge from the hospital, she never received a 2nd vaccine dose. Has it been too long now to get the second dose? Wanted to know if she needed both doses again. The outcome of event: unknown. The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: awful cough/Horrendous cough; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:15 (at the age of 53-years-old) (Batch/Lot Number: EN1201) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes, hypothyroidism (from 2000) and blood pressure. Concomitant medication included metoprolol tartrate taken for blood pressure from 2003 and ongoing. Patient previously took first dose of bnt162b2 (Batch/Lot Number: (F or E) L3248, No Expiry or NDC) administered in left arm on 29Jan2021 at 02:30pm (at the age of 53-years-old) for covid-19 immunisation. The patient experienced awful cough/horrendous cough and shortness of breath on unspecified date in 1st week in Mar2021. It was reported that She received her second dose in the middle of Feb2021 and 2 weeks after experienced an awful cough and shortness of breath. The shortness of breath has resolved, but she still has a cough. She is a diabetic for the past 50 years. Her doctor follows her closely and she had an insulin pump, the Dexcom System. Callers husband and she thinks it was coincidental that a few weeks after the second dose, she developed a cough. She contacted her doctor and her primary care provider advised her to stay home. She went to a Cardiologist and had a chemical stress test done on 18-19May2021, and he found that she had 3 blockages between 30-40%. But the doctor felt that was not the cause of the shortness of breath. States that no one has been able to tell her why she had shortness of breath. Previous to finding the blockages she didn't had any problems. She knows with having the diabetes for so long that it was just a matter of time, but it was a little to coincidental in her opinion. She doesn't remember exactly when, but the shortness of breath resolved in either Apr2021 or May2021. The patient underwent lab tests and procedures which included cardiac stress test showed 3 blockages between 30-40% on unspecified date in May2021, sars-cov-2 test was negative on an unknown date and on unspecified date in Dec2020. Outcome of the event shortness of breath was recovered on unspecified date in 2021 and outcome of event cough was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient just took the vaccine that day (yesterday) and the patient was wondering what the different side effects were and do they have a 'black box label' (Clarification unknown) and what should the patient do if something was like 'talking about the' nausea it did or something because the patient experienced felt dizzy earlier on an unspecified date in 2021. The patient concern was about the different 'black box label'. The patient had already asked the questions, and this was concerning self then and the patient took the vaccine, questioned whether she would get the COVID or not. The patient was unclear about that question. The patient just did not want to die on that medicine. The patient questioned the side effect of catching COVID while taking it. The patient questioned if the vaccine caused hearing loss. Outcome of the event dizzy was reported as Unknown at this time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Hangover, Malaise, Photophobia
Clinical narrative: Felt ill for 24 hours after second dose; light sensitivity; similar to hangove; loss of appetite; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date in Apr2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date in Apr2021, as a single for COVID-19 immunisation. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient felt ill for 24 hours after second dose, light sensitivity, similar to hangover, loss of appetite. No treatment was received for the events. The outcome of the event was reported as resolved on an unspecified date.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pain, Pruritus, Skin disorder
Clinical narrative: get these purple bumps all over your body; itching; pain; she was dealing with it through tears; This is a spontaneous report received from a contactable consumer. This consumer reported for a Female patient (Daughter in Law). This is the second case out of 3 split cases.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, My daughter in law has an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she has met the worst case ever as I complaint this which was that where you get these purple bumps all over your body. So, I just wanted to report that, she was dealing with it through tears and pain and itching. But I really would recommend that something needs to be said prior to getting that shot. If you have an auto-immune condition that really needs to be truly discussed with their doctor because anyone with the auto-immune condition is sounds like to me they are having some trouble. It is just breaking in my heart (general sentence) So, I just wanted to report that, it is horrible. Reporter further stated, What strange was, I have met two other people that have developed the same condition So, anyway I really think a warning or just say you know kind of deal. You know, something that the person administrating the vaccine could share. But anyway, you know just like they should not take the Flu Vaccine So, it is the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, I just wanted to report that. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050810 same report/drug/AE, different patients;US-PFIZER INC-202101050518 same report/drug/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Patient had 100.3 temp 16 hours after vaccine administration; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old patient of an unspecified gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On2021, The patient experienced patient had 100.3 temp 16 hours after vaccine administration. The patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: my face is like swelled up; hives on my face; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), first dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Report not related to a study or programme. On an unspecified date, the patient experienced face was like swelled up, hives on face. It was reported that, yesterday "I got my first dose with Pfizer vaccine and I don't know if I am having allergic reactions to it because my face is like swelled up". When asked to specify the reaction, consumer stated, Like hives on my face. Further probing could not be done as consumer was unwilling to further answer the questions. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 68-year-old female consumer (patient) reported that: A 68-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, single dose for covid-19 immunisation. Medical history included, animal bite, panic attack, agoraphobia from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took penicillin b and experienced drug hypersensitivity, tetanus vaccines. On an unspecified date, she experiences a severe allergic reaction with the Pfizer BioNTech covid-19 vaccine. Patient has Agoraphobia and panic disorder for 30 years and is taking MAO Inhibitor which is Phenelzine and wanted to know if this and other medications she is on has an interaction or contraindication with the Pfizer BioNTech COVID-19 vaccine. She wanted to know if Penicillin is in the Pfizer BioNTech COVID-19 vaccine because she mentioned that when she was 6 years old, she had a shot of Penicillin and died on the kitchen table and her father got a doctor who gave her a shot, took her to the hospital and she lived. Patient mentioned that she had a lethal allergic reaction to Penicillin. She mentioned that she had severe reactions with other medications before. She mentioned that when she got bitten by her cat, they had to give her medicines in half doses, the medication was Tetnus perhaps. She wanted to know if there is an interaction with Tetnus and the Pfizer BioNTech COVID-19 vaccine. She mentioned that Phenelzine is a tricky medicine, but it works and that she tried different medicines that didn't work. She mentioned that she had horrible panic attacks and couldn't leave the house and with the medicine, she got better, she got her master's in fine arts and she became a full professor. She mentioned that she is on MAO Inhibitor Phenelzine and is not sure if she can be given an Epi pen or Epinephrine since she can't have any decongestants in case, she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine. She decided to call Pfizer because Pfizer makes the MAO Inhibitor. AE. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Little rash on my ankle; Have a rash on both ankles and on my legs and on my back; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number: FC318O, expiration date not provided) via an unknown route of administration, administered on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not provided. On 13Aug2021, the patient experienced a little rash on ankle and then had a rash on both ankles, legs and on back. The patient wanted to know what could take to reduce it. The patient did not receive any treatment for the events. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: dizzy and really light headed; Tired; dizzy and really light headed; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 13-year-old female patient 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 17Aug2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced dizzy and really lightheaded, tired. Reporter stated, my 13-year-old got her first shot today (Confirmed Pfizer COVID 19 vaccine) and she is like really dizzy and really lightheaded, Is that normal. Reporter stated, tired she said. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: sick; 101F temperature/temperature of 101.5; aching; she's really flu-like; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Caller is a consumer reporting adverse event symptom for his wife after receiving her second dose of the Pfizer-Biontech Covid19 vaccine yesterday (17Aug2021). He reports my wife has a 101F temperature, she got her second shot yesterday. She's aching, she's really flu-like, she's very very sick. Caller reports that he has been trying to get in touch with someone at Pfizer since midnight last night and that he's so concerned about his wife, I want to take her to the hospital, but they don't want us to bring her, that's how sick she is. Reporter stated, It was too ridiculous. Pfizer should be ashamed of itself when someone is sick and they must fill out all of that stuff, that is baloney. How dare them. So, my wife is very sick right now. She said she feels beyond the flu. Last night when this developed at about 12 o'clock, she was at a 10 and now she is at a 9. We just took the temperature, and she is a 101.5. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on an unspecified date, body temperature: 101.5 fahrenheit on an unspecified date. The outcome of the events was unknown.  The action taken in response to the events for bnt162b2 was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid diagnosis; Covid diagnosis; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received an unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were not reported. Patient previously received Psyllins on an unspecified date and experienced allergy. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. Patient was not tested for COVID prior vaccination. On 16Aug2021, patient was diagnosed with COVID-19. Patient was tested for COVID-19 post vaccination on an unspecified date [test type: unknown] and had diagnosis of COVID-19. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment in response to the event. Outcome of the event was resolving.  That information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Palpitations
Clinical narrative: extreme dizziness; weakness; heart was racing; had trouble walking; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Aug2021 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Aug2021, she experienced extreme dizziness and weakness, my heart was racing immediately after receiving the shot. It was pretty bad for one hour, had trouble walking and with 2-3 hours it was completely gone and queried that she had a side effect after first dose and if she should get the 2nd Pfizer covid vaccine dose. The clinical outcome of the events was resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Skin disorder
Clinical narrative: swollen lymph nodes in the groin area; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 14Aug2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. On 16Aug2021, two days after receiving the dose, the patient experienced swollen lymph nodes in the groin area, she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm. The bumps are on the side of the body where she received the vaccine, the left side. The patient reports feeling the same today, according to the caller. Outcome of the event was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Since having the vaccine though, the patient is reporting that she sleeps all through the day, wakes up and then goes back to sleep; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of ad-ministration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. Patient medical history included insomnia from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Caller reported after having the Pfizer COVID-19 Vaccine she was having a harder time with her sleep schedule. She stated she previously, after the first dose had insomnia on an unspecified date in 2021 and took sleeping medications. The outcome of the events was not recovered.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Extra dose administered, Off label use, Pain
Clinical narrative: received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; achiness; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. It was reported that a 48 year male "received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021" and since then had "achiness, which has gone away", but "still has a metallic taste in his mouth". The patient had not seen this listed as a common side effect. He was wondering if this had been reported. "Because it is not getting any better". The outcome of the event achiness was reported as resolved on an unspecified date in 2021. The outcome of the event "metallic taste in his mouth" was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Fatigue, Nausea, Off label use, Pain
Clinical narrative: received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; achiness; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. It was reported that a 48 year male "received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021" and since then had "achiness, which has gone away", but "still has a metallic taste in his mouth". The patient had not seen this listed as a common side effect. He was wondering if this had been reported. "Because it is not getting any better". The outcome of the event achiness was reported as resolved on an unspecified date in 2021. The outcome of the event "metallic taste in his mouth" was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; achiness; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. It was reported that a 48 year male "received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021" and since then had "achiness, which has gone away", but "still has a metallic taste in his mouth". The patient had not seen this listed as a common side effect. He was wondering if this had been reported. "Because it is not getting any better". The outcome of the event achiness was reported as resolved on an unspecified date in 2021. The outcome of the event "metallic taste in his mouth" was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: she could "barely walk after the 2nd dose/had to help her walk around for a couple days; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's wife) that:  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and was fine after first dose. On an unspecified date after receiving second dose of vaccination, patient could barely walk. Patient couldn't walk, her husband (reporter) had to help her walk around for a couple days. Reported also mentioned that patient had loss of both his mother and grandmother, although they did not pass due to COVID related illnesses. When probing for information regarding the caller's wife he reports she was ok now, he was concerned for her when it happened.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: headaches; she felt weak; having a little bit of a temperature; had to ice arm because it felt swollen and painful; had to ice arm because it felt swollen and painful; sweating; felt hot; This is a spontaneous report from a contactable consumer reported for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Aug2021 (at the age 42-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. On 16Aug2021 (Monday), having headaches after injection of Pfizer covid-19 vaccine. On Monday, when patient got it, patient felt weak. Patient read the paper they gave her that said it was normal and little bit of a temperature, but that was fine. Yesterday, patient felt really weak, had headaches, and had to ice arm because it felt swollen and painful. The headaches come and go. This morning, patient could not even get out of bed; felt really weak. Describes headache as the top portion of it (her head) was pulsating, hurting. States this was too much. Patient was tearful. States that patient knows it was part of the side effects, but thought it was more with the second dose. Patient works in front of computer, but can't with this. Patient was trying to clean up a little bit, but was sweating like crazy. Patient told her son it felt hot, he said its not hot. Patient was supposed to go back to work yesterday and today, but could not. Asked what patient should do, keep taking Tylenol. The outcome of the event pyrexia was unknown while other events were not recovered.   The lot number was not provided. Information on lot number has been requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: headaches; she felt weak; having a little bit of a temperature; had to ice arm because it felt swollen and painful; had to ice arm because it felt swollen and painful; sweating; felt hot; This is a spontaneous report from a contactable consumer reported for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Aug2021 (at the age 42-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. On 16Aug2021 (Monday), having headaches after injection of Pfizer covid-19 vaccine. On Monday, when patient got it, patient felt weak. Patient read the paper they gave her that said it was normal and little bit of a temperature, but that was fine. Yesterday, patient felt really weak, had headaches, and had to ice arm because it felt swollen and painful. The headaches come and go. This morning, patient could not even get out of bed; felt really weak. Describes headache as the top portion of it (her head) was pulsating, hurting. States this was too much. Patient was tearful. States that patient knows it was part of the side effects, but thought it was more with the second dose. Patient works in front of computer, but can't with this. Patient was trying to clean up a little bit, but was sweating like crazy. Patient told her son it felt hot, he said its not hot. Patient was supposed to go back to work yesterday and today, but could not. Asked what patient should do, keep taking Tylenol. The outcome of the event pyrexia was unknown while other events were not recovered.   The lot number was not provided. Information on lot number has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath/ she is gasping for air.; This is a spontaneous report from contactable Physician. A 69-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 16Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Aug2021, the patient experienced shortness of breath. Reporter stated that patient had been having shortness of breath when talking. She had been fine when going up and down stairs and when walking. But when talking it's like she is gasping for air. The event was assessed as non-serious. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck; Swollen lymph nodes; This is a spontaneous report received from a contactable pharmacist. A 15-years-old male patient received unknow dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter called about a patient who received the Pfizer Covid-19 vaccine on 16Aug2021 and developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck and has developed swollen lymph nodes as well. Health care professional was asking how long will it be before the above rash will disappear and if there are treatment recommendations for the rash. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.