chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: 24 hours of fatigue; slight fever first night; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on Apr2021 as dose one, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecific date of Apr2021, the patient experienced 24 hours of fatigue, and slight fever first night. The outcome of the events was unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pruritus, Rash
Clinical narrative: After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant 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, administered in left arm on 11Mar2021 at 10:45 AM (at the age of 40-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included occipital neuralgia from an unknown date and unknown if ongoing. Concomitant medications included trazodone (TRAZODONE) and gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Patient had no known allergies. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as no. Vaccine Facility, ethnicity and race information reported as available. After 1st dose, within 48 hours on 13Mar2021 at 20:00, patients middle finger started to hurt towards the tip, mostly at night and 5 days later right middle finger did the same during this time patient felt right big toe feeling numb and the past 2 weeks right hand itches and patient had a raised rash. Patient never had these symptoms before the vaccine. The pain was definitely bearable, but patient thought it was worth reporting. Seriousness criteria Results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all were reported as no. Adverse event resulted in: Doctor or other health care professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination the patient did not tested for COVID. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Frustration tolerance decreased, Headache, Insomnia, Nausea
Clinical narrative: This is a spontaneous report from a noncontactable male consumer (patient). A male patient, of unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On unspecified date, patient experienced nausea, chills, headache, fever with chills, he felt like he couldn't sleep and was frustrated continuously. The outcome of the events: unknown. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a noncontactable male consumer (patient). A male patient, of unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On unspecified date, patient experienced nausea, chills, headache, fever with chills, he felt like he couldn't sleep and was frustrated continuously. The outcome of the events: unknown. No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea since two days after first shot until present day; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, administered in Arm Left on 20Feb2021 15:15 as DOSE 1, SINGLE and second dose via an unspecified route of administration, administered in Arm Right on 13Mar2021 14:15 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included insomnia. Concomitant medications included eszopiclone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Feb2021, the patient experienced diarrhea since two days after first shot until present day. Therapeutic measures were taken as a result of diarrhea since two days after first shot until present day (diarrhoea). The outcome of the event was resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: Respiratory Problems; This is a spontaneous report from a contactable consumer or other non hcp. This is report 2 of 2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 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. On an unspecified date, the patient experienced respiratory problems. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Breast swelling, Diarrhoea, Facial pain, Panic attack
Clinical narrative: Breast swelled up to 3 times its size; Vomiting; Diarrhea; Face was swollen; Lips tingled; Right side of face tingled/Pain in face; Panic attack; Breast swelled up to 3 times its size; This is a spontaneous report from a contactable consumer (parent) or other non-healthcare professional. A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown, Expiry Date: unknown), via an unspecified route of administration, administered in Arm Right on an unspecified date in 2021 as dose 2, single (at age of 46-years old) for covid-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing (did not know how long had taken it, about 5 years). The patient previously taken first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in right arm at 14:30-15:00 (at the age of 46 years old) as single dose for covid-19 immunization. It was reported that Investigation Assessment was No. Prior Vaccinations (within 4 weeks) was no. Family medical history relevant to adverse event was none. History of all previous immunization with the Pfizer vaccine considered as suspect was second dose. Additional vaccines administered on same date of the Pfizer suspect was none. The reporter stated that her daughter had a reaction to the Covid vaccine breast swelled up to 3 times its size, vomiting, diarrhea, face was swollen, lips tingled, right side of face tingled/ Pain in face, panic attack on 2021 and took some medicine and it finally went away. Reporter stated did not know what day her symptoms started. It happened three days after getting the vaccine and did not remember what day got the shot. Therapeutic measures were taken as a result of, panic attack. Adverse events did not require a visit to Emergency Room or Physician Office visit. Relevant tests were none. The outcome of events was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face, Vomiting
Clinical narrative: Breast swelled up to 3 times its size; Vomiting; Diarrhea; Face was swollen; Lips tingled; Right side of face tingled/Pain in face; Panic attack; Breast swelled up to 3 times its size; This is a spontaneous report from a contactable consumer (parent) or other non-healthcare professional. A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown, Expiry Date: unknown), via an unspecified route of administration, administered in Arm Right on an unspecified date in 2021 as dose 2, single (at age of 46-years old) for covid-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing (did not know how long had taken it, about 5 years). The patient previously taken first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in right arm at 14:30-15:00 (at the age of 46 years old) as single dose for covid-19 immunization. It was reported that Investigation Assessment was No. Prior Vaccinations (within 4 weeks) was no. Family medical history relevant to adverse event was none. History of all previous immunization with the Pfizer vaccine considered as suspect was second dose. Additional vaccines administered on same date of the Pfizer suspect was none. The reporter stated that her daughter had a reaction to the Covid vaccine breast swelled up to 3 times its size, vomiting, diarrhea, face was swollen, lips tingled, right side of face tingled/ Pain in face, panic attack on 2021 and took some medicine and it finally went away. Reporter stated did not know what day her symptoms started. It happened three days after getting the vaccine and did not remember what day got the shot. Therapeutic measures were taken as a result of, panic attack. Adverse events did not require a visit to Emergency Room or Physician Office visit. Relevant tests were none. The outcome of events was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's son). A male patient of an unspecified age received first 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 an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The investigation assessment was not provided. The reporter reported that, his son had the COVID vaccine and had joint pain on an unspecified date. The caller stated his son was healthy and fine. Caller declined to complete report. Full details not obtained. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402260 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19, UNK
Symptoms: Lip swelling
Clinical narrative: less than 24h the upper lip swelled; This is a spontaneous report received from a non-contactable other healthcare professional reporting for a patient.. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and also injected with hyaluronic acid, lidocaine (JUVEDERM ULTRA SMILE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) as 0.55ml for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced immediately after the vaccine, less than 24h had upper lip swelled. HCP believes it is an allergic reaction to the vaccine rather than a reaction to the Juvederm filler. The patient recovered in 24h without treatment. Outcome of the event was recovered.  Complaint - Dermal No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: experience swelling; pain at the injection sites; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included lidocaine hcl (LIDOCAINE HCL), hyaluronic acid (JUVEDERM VOLUMA), hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLBELLA WITH LIDOCAINE), hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLIFT WITH LIDOCAINE), all taken for an unspecified indication, start and stop date were not reported. Reported as, the patient was injected approximately 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLITE. Treated with Telfast and betacorten steroidal ointment. Symptoms resolved. This record captures events relating to the injection with Juvederm VOLITE. The patient experienced experience swelling, pain at the injection sites on an unspecified date. Reported as, patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the Covid 19 Pfizer vaccine. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling
Clinical narrative: lips get swollen, raw and lips get really bad; lips get swollen, raw and lips get really bad; This is a Spontaneous report from a contactable female consumer.This consumer (patient) reported that.  A female patient of an unspecified age 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 06Apr2021 as dose 1, single for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing verbatim: some type of allergy to some type of food product. The patient's concomitant medications were not reported. The patient experienced lips get swollen, raw and lips get really bad (lip swelling and lip disorder) on an unspecified date. Caller states that she got her shot-on Tuesday this week, 06Apr2021, beside that maybe twice a year she has some type of allergy to some type of food product, but she doesn't know what it is. She has an appointment with allergist on Thursday next week. Her lips get swollen, raw and lips get really bad. Patient was asking Is it ok to get a steroid shot or not. Caller states this was happening last week before she got the shot, clarifying this is just her life and has nothing to do with the Pfizer COVID-19 vaccine. Caller declined to proceed with safety report. Caller provided her name, phone number and date of her Pfizer COVID-19 vaccine. No further details provided. PSCC Communication: Caller states that she has been on hold for about 30 minutes, and she doesn't have time, she has to go to see her mom in a nursing home. Caller states that she didn't realize it would be such a process. Caller provided with USMI phone number and hours of operation. Caller declined website information. Caller declined to be warm transferred to USMI and hung up.  No follow-up information needed. Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Lethargy, Pain, Pyrexia
Clinical narrative: she did not feel good; she felt achy; FEVERISH; LETHARGY; flu-ish; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-087504), for BNT162B2.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included allergies (Vicodin, Sulfamethoxazole, Percocet). Concomitant medications included Losartan potassium (MANUFACTURER UNKNOWN) 50 mg tablet, Calcium 500 (1250) (MANUFACTURER UNKNOWN) tablet, Magnesium (MANUFACTURER UNKNOWN) 100 mg tablet, Zinc (MANUFACTURER UNKNOWN) 50 Mg Tablet, Vitamin D3 (MANUFACTURER UNKNOWN) 10 mcg chewable tablet,  Alendronate sodium (FOSAMAX, 70 Mg Tablet), Pembrolizumab (KEYTRUDA, 100mg/4 ml vial), Vitamin B12 (MANUFACTURER UNKNOWN) and Fish oil (OMEGA 3 FISH OILS). Patient also took Lenvima (LENVATINIB MESILATE 4 mg (5 day PK-COMM, Frequency: 1-14 mg/1-10 mg daily, oral, Lot number: 1265566, Expiration date: 30Jun2023) from 11Jan2021. It was reported that, she got her second COVID shot and missed the next day (Lenvima dose). On 06Apr2021, the patient did not feel good, and she felt achy, feverish, lethargy and flu-ish. Physician was aware. The outcome of the events was unknown.  No follow-up attempts needed. No further follow-up information expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling, Swelling face
Clinical narrative: Patient's systems are swelling; mouth swelling; swelling around Patient's upper cheeks; swelling eye area; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Physician reported 3 weeks post vaccine and 4 months post treatment (Mouth, cheeks, and eye area). Patient's systems were swelling and hardening of filler present. It was at its worst in the morning. It was improving around Patient's mouth but not around Patient's upper cheeks and eye area. Patient was currently taking Antihistamines. Related to [Unspecified] Juvederm, Voluma. Symptoms were still ongoing. The outcome of the event mouth swelling was recovering. The outcome of the other events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid oedema, Oedema
Clinical narrative: This is a spontaneous report from a noncontactable other healthcare professional. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history not reported. The patient's concomitant medication(s) included Juvederm Volbella with Lidocaine (hyaluronic acid, lidocaine hydrochloride) taken as dermal filler injection. The patient was injected with 1mL in temples; 3mL in cheeks; 1mL Volift midface; 1 mL Volbella tear trough and 3mL Volux in chin. 2 months later patient also received 0.5mL non-Allergan dermal filler in lips and a small correction of 0.1mL in the left tear trough. Following month, patient received the COVID-19 vaccine. Next morning (unspecified date), patient woke up in the morning with edema on chin and lower eyelids. This record related to Juvederm Volbella with Lidocaine. The outcome of the events recovered on an unknown date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Inflammation
Clinical narrative: inflammatory reaction in the areas of prior JUVEDERM VOLUMA XC injections three days after second Pfizer vaccination; This is a spontaneous report received from a contactable other healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation; and hyaluronic acid, lidocaine (JUVEDERM VOLUMA XC, formulation: injection, route of administration, start and stop date, batch/lot number and dose were not reported) for an unspecified indication. The patient medical history and concomitant medications were not reported. Reportedly, the reporter was consulting on a case of a patient who had an inflammatory reaction in the areas of prior JUVEDERM VOLUMA XC injections on an unspecified date (three days after second Pfizer vaccination). Patient was given 5mg of lisinopril (as therapeutic measures for inflammatory reaction), an ACE inhibitor, with 80 % resolution overnight and complete resolution the day after second dose. The action taken in response to the event(s) for hyaluronic acid was unknown. Outcome of event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling; This is a spontaneous report received from regulatory authority. A non contactable health care professional reported for the patient. A patient of unspecified age and gender received second 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 unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications included hyaluronic acid (JUVEDERM) taken for an unspecified indication, start and stop date were not reported. The Health professional reported injecting a patient with JUVÉDERM® Ultra. A year later, the patient was injected with Juvéderm® VOLIFT with Lidocaine. Two and half years later, the patient was injected with Belotero Soft. The patient experienced lip swelling 4.5 hours after the second dose of the Pfizer vaccine on an unspecified date. The patient was treated with antihistamine and Dexamethasone. The event resolved 48 hours later. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report from a contactable 60-year-old female consumer reported for herself. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiry date: unknown), via an unspecified route in lower forearm left on 17Mar2021 (age at vaccination: 60-year-old), as a single dose for covid-19 immunization. Medical history included shellfish reaction/allergies and arthritis in hip. Concomitant medications included loratadine 24-hour tablet, sold over the counter and acetylsalicylic acid (ASPIRIN) for arthritis in her hip. On an unknown date, patient was having some allergies last week and didn't think much about it/patient had allergies the week prior to the second dose, so she is unsure if her symptoms are from her allergies or the vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Flushing, Headache, Pain in extremity
Clinical narrative: I completely flushed red, my face and my chest; rash; problem in breathing or anything; sore arm and headache; sore arm and terrible headache; stomach upset; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported), via an unspecified route , administered in right arm on 09Apr2021 as a single dose for (at the age of 67 year) COVID-19 immunization. The Patient medical history were not reported. Patient received an unspecified concomitant medication therapy. On 10Apr2021, 24 hours after the vaccine, she had completely flushed red, her face and chest. It could be a rash but it was all red. On an unknown date in Apr2021, she had the usual side effects which was sore arm and headache. The headache was really awful with the flushing. On an unknown date in Apr2021, there was problem in breathing or anything, stomach upset and she was in a loss. Treatment received for the flushing include Benadryl One tablet, every six hours, standard dose. Outcome of the event problem in breathing it was unknown, and the other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I completely flushed red, my face and my chest; rash; problem in breathing or anything; sore arm and headache; sore arm and terrible headache; stomach upset; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported), via an unspecified route , administered in right arm on 09Apr2021 as a single dose for (at the age of 67 year) COVID-19 immunization. The Patient medical history were not reported. Patient received an unspecified concomitant medication therapy. On 10Apr2021, 24 hours after the vaccine, she had completely flushed red, her face and chest. It could be a rash but it was all red. On an unknown date in Apr2021, she had the usual side effects which was sore arm and headache. The headache was really awful with the flushing. On an unknown date in Apr2021, there was problem in breathing or anything, stomach upset and she was in a loss. Treatment received for the flushing include Benadryl One tablet, every six hours, standard dose. Outcome of the event problem in breathing it was unknown, and the other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Cough, Nasopharyngitis
Clinical narrative: very bad dry cough; her back and chest hurts and also is experiencing some cold coming up; her back and chest hurts and also is experiencing some cold coming up; experiencing some cold coming up; This is a spontaneous report from via Regulatory Authority Support. A contactable female consumer (patient) of an unspecified age reported for herself that she patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Consumer took her second shot of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021 and had experienced a very bad dry cough for the first 7 days after getting the shot. She also mentioned that her back and chest hurts and also experienced some cold coming up. The cough was still there up to the date of report. Talked with her physician and was prescribed, Codeine at night and Mucinex in the morning to manage that. Caller wanted to know if they had any data on the clinical trials about that. The outcome of event very bad dry cough was not recovered while the outcome of other events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cough, Fatigue
Clinical narrative: very bad dry cough; her back and chest hurts and also is experiencing some cold coming up; her back and chest hurts and also is experiencing some cold coming up; experiencing some cold coming up; This is a spontaneous report from via Regulatory Authority Support. A contactable female consumer (patient) of an unspecified age reported for herself that she patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Consumer took her second shot of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021 and had experienced a very bad dry cough for the first 7 days after getting the shot. She also mentioned that her back and chest hurts and also experienced some cold coming up. The cough was still there up to the date of report. Talked with her physician and was prescribed, Codeine at night and Mucinex in the morning to manage that. Caller wanted to know if they had any data on the clinical trials about that. The outcome of event very bad dry cough was not recovered while the outcome of other events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Cough, Nasopharyngitis
Clinical narrative: Really bad cough; Makes her so tired; Makes her chest hurt; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously 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 unspecified date as dose 1, single for COVID-19 immunization. The patient has never had a Covid test. On 26Mar2021, 2 days later, the patient experienced really bad cough. On an unspecified date in Mar2021, the patient experienced makes her so tired and makes her chest hurt. The patient has been coughing ever since and was still coughing. The patient went to the doctor 7 days after the cough started and she started taking a cough medicine at night. The patient was still taking the cough medicine at night. The patient does not know what it was. It makes the patient so tired and makes her chest hurt. The patient called to check if this was a symptom of the vaccine. Therapeutic measures were taken as a result of really bad cough using Mucinex. The outcome of the event really bad cough was not resolved while other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cough, Fatigue
Clinical narrative: Really bad cough; Makes her so tired; Makes her chest hurt; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously 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 unspecified date as dose 1, single for COVID-19 immunization. The patient has never had a Covid test. On 26Mar2021, 2 days later, the patient experienced really bad cough. On an unspecified date in Mar2021, the patient experienced makes her so tired and makes her chest hurt. The patient has been coughing ever since and was still coughing. The patient went to the doctor 7 days after the cough started and she started taking a cough medicine at night. The patient was still taking the cough medicine at night. The patient does not know what it was. It makes the patient so tired and makes her chest hurt. The patient called to check if this was a symptom of the vaccine. Therapeutic measures were taken as a result of really bad cough using Mucinex. The outcome of the event really bad cough was not resolved while other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Headache
Clinical narrative: I had joint pain in my knees, lower back, hands, shoulders; I had joint pain in my knees, lower back, hands, shoulders; muscle pain; pain in my stomach; numbness in my arms, legs and face; weaknesses in her body; neck pains; mild headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history included OA (osteoarthritis), RA (rheumatoid arthritis), both from unknown date and unknown if ongoing. Concomitant medications were not reported. Patient was petrified to get the 2nd dose and had a reaction after receiving the 1st dose on 15Mar2021. On an unspecified date patient had joint pain in my knees, lower back, hands, shoulders, had muscle pain, pain in my stomach, and had numbness in my arms, legs, and face. Patient not having so many effects anymore. It was reported that my doctor recommended I call Pfizer, I also will see a rheumatologist. I heard the second shot can be worse. 30 years ago, I had a vaccine that affected my joints as well. I am m trying to decide if I should risk getting the 2nd dose. Consumer had first COVAX on 15Mar2021 side effects of woke in the morning had effects like attacking her joints, she does have RA and OA, weaknesses in her body, mild headache, arms, and legs went numb and lower back and neck pains that came and went. Scheduled out for second one for 40 days out and she is afraid to have it. It was asked that what is the maximum of time between the 1st and 2nd dose and what happens if I dont get the 2nd dose, what if down the road in 1 year I decide to take it will I have had to start from scratch and does the vaccine contain any of the ingredients found in Besphosphanate drugs (like Actonel, Fosomax) which can cause Osteonecrosis. Revised, 06Apr2021 regarding osteonecrosis. Will there be any booster shots for other variants and response received was no information found on booster shots for variants. Studies still on going. Had anyone else reposted osteonecrosis with the product. No information found regarding osteonecrosis, no statistical data available to know if this has been reported. Did not find that there is fosomax, actonel, bisphosphonate in the product + disclaimer from attached VR provided. I explained that Bisphosphonates are a family of drugs used to treat osteoporosis referred to HCP to give more information on ingredients in those types of products and which would be the cause of the Osteonecrosis. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Neck pain
Clinical narrative: I had joint pain in my knees, lower back, hands, shoulders; I had joint pain in my knees, lower back, hands, shoulders; muscle pain; pain in my stomach; numbness in my arms, legs and face; weaknesses in her body; neck pains; mild headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history included OA (osteoarthritis), RA (rheumatoid arthritis), both from unknown date and unknown if ongoing. Concomitant medications were not reported. Patient was petrified to get the 2nd dose and had a reaction after receiving the 1st dose on 15Mar2021. On an unspecified date patient had joint pain in my knees, lower back, hands, shoulders, had muscle pain, pain in my stomach, and had numbness in my arms, legs, and face. Patient not having so many effects anymore. It was reported that my doctor recommended I call Pfizer, I also will see a rheumatologist. I heard the second shot can be worse. 30 years ago, I had a vaccine that affected my joints as well. I am m trying to decide if I should risk getting the 2nd dose. Consumer had first COVAX on 15Mar2021 side effects of woke in the morning had effects like attacking her joints, she does have RA and OA, weaknesses in her body, mild headache, arms, and legs went numb and lower back and neck pains that came and went. Scheduled out for second one for 40 days out and she is afraid to have it. It was asked that what is the maximum of time between the 1st and 2nd dose and what happens if I dont get the 2nd dose, what if down the road in 1 year I decide to take it will I have had to start from scratch and does the vaccine contain any of the ingredients found in Besphosphanate drugs (like Actonel, Fosomax) which can cause Osteonecrosis. Revised, 06Apr2021 regarding osteonecrosis. Will there be any booster shots for other variants and response received was no information found on booster shots for variants. Studies still on going. Had anyone else reposted osteonecrosis with the product. No information found regarding osteonecrosis, no statistical data available to know if this has been reported. Did not find that there is fosomax, actonel, bisphosphonate in the product + disclaimer from attached VR provided. I explained that Bisphosphonates are a family of drugs used to treat osteoporosis referred to HCP to give more information on ingredients in those types of products and which would be the cause of the Osteonecrosis. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site urticaria
Clinical narrative: had welts on the site where he got the shot; rash; Today he has whelps on the other arm and arm pit.; This is a spontaneous report from a contactable consumer or other non hcp (Patient's wife). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 12Apr2021 11:00 (at the age of 62-year-old) at dose number un-known, single for covid-19 immunisation. Medical history included diabetes from 2011 and ongoing (Verbatim: Diabetes). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On 12Apr2021 the patient experienced had welts on the site where he got the shot, rash and on an unspecified date in Apr2021 Today he has whelps on the other arm and arm pit. Reporter mentioned that she and her husband received Pfizer COVID Shot yesterday at 11:00am. At about 3pm, her husband had welts on the site where he got the shot and a sort of rash. They noticed that it had spread underneath his arm as well. She mentioned that upon looking at the paper, it mentioned that once a rash develops on the whole body, only then should they see a doctor. She called this line because it was on the paper to call if there were any problems. She is asking for what to do because the rash is not in his entire body yet. Event: rash was reported as worsened. Event: whelps was reported as worsened. Additional Context: Reporter and her husband received the Covid-19 vaccine yesterday. She is speaking on behalf of her husband Vince. He had the vaccine at 11:00am. A couple hours later he started getting a rash and whelps on the left arm. It is a little like he was bitten by a mosquito. Today he has whelps on the other arm and arm pit. She read the pamphlet and it says if you rash all over to contact the doctor. Does he not do anything for it since it is a little bit and not all over or what he should do. Should he see the doctor. Adverse Event: rash, whelps. Time of Onset (24 hour clock): a couple hours later. Adverse events did not require a visit to emergency room, physician office. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal operation, Contusion, Swelling
Clinical narrative: she had abdominal surgery; bruising; swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A 57-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced she had abdominal surgery on 01Apr2021, bruising and swelling on an unspecified date in 2021. The patient stated that, she was scheduled to have the second vaccine today and she underwent surgery on 01Apr2021. She just wanted to make sure the vaccine would not interfere with her healing. She had swelling and bruising. She stated the surgery was scheduled after the first dose. It was abdominal surgery. She did not wish to provide any further details about the surgery. No further details provided. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: got rashes on her right arm to her elbow down and also scattered to different parts of her body; This is a spontaneous report from a contactable consumer or other non health care professional (Patient herself). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as dose 2, single for covid-19 immunization. Patient previously received dose 1, COVID-19 on an unspecified date. The patients medical history and concomitant medications were not reported. Patient stated that she has gotten both dose of the Pfizer COVID-19 vaccine and got rashes on her right arm to her elbow down and also scattered to different parts of her body on an unspecified date. Patient was asking  if this is normal, duration of this side effect and how she should treat it. Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pain, Ocular hyperaemia
Clinical narrative: Pain and redness on her left eye; Pain and redness on her left eye; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received her first dose of the Covid-19 vaccine yesterday afternoon and on an unspecified date, she has experienced pain and redness on her left eye and shortness of breath. She would like to know if it was normal and what she needs to do. The patient also wanted to know what side effects of Covid were. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.