chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itching/head, back, arms and feet itching; Hives or rash present; This is a spontaneous report from a non-contactable other HCP (Nurse). A 74-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0150), via an unspecified route of administration on an unspecified date at 17:14 as dose 2, single (Age at vaccination: Unknown) for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization. Medical history included asthma, tachycardia, hypertension, diabetes mellitus. Concomitant medications includes Vitamins. Patient Allergies (food/drugs/etc.) includes Penicillin, Acrylic allergy. Patient denies Illness at time of vaccination or up to 1-month prior. On an unspecified date the patient experienced itching/head, back, arms and feet itching and hives or rash present. The patient underwent lab tests and procedures which included BP (blood pressure measurement): 131/74, HR (heart rate): 67, O2 SAT (oxygen saturation): transmit too long, RESP (respiratory rate): 18. Therapeutic measures were taken as a result of itching/head, back, arms and feet itching, hives or rash present which includes Diphenhydramine (Dose: 25mg; Route: PO). Stated relief of itching at 17:50 (10 mins after taking PO Diphenhydramine). No CPR indicated. The outcome of event itching/head, back, arms and feet itching was recovering while outcome of event hives or rash present was unknown. No follow-up attempts are possible; no further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: low grade fever; body aches; This is a spontaneous report from a contactable consumer (patients friend).   A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included unspecified autoimmune disorder. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 1 for COVID-19 immunisation on unspecified date. Patient was not on Keytruda. Patient reported that she heard more reaction occur with the second dose of the Covid vaccine. The patient experienced low grade fever and body aches on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Hypersensitivity, Red ear syndrome
Clinical narrative: shake/shaking, but very mild; I had a wave of chill; I had fatigue after first and second shot; ears were red; mild allergic response; my cheeks were beat red; This is a spontaneous report from a contactable Physician. This female Physician reported for herself that: A female patient of an unspecified age 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 immunization. The patient medical history was not reported. Concomitant medication(s) included Diphenhydramine Hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included the patient previously received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; Solution for Injection, Batch/Lot number was not provided) via unspecified route of administration on an unspecified date as Dose 1 Single for COVID-19 immunisation and experienced Fatigue. On an unspecified date,the patient experienced Shake/Shaking, But Very Mild and I had a wave of chill, I had fatigue after first and second shot, Ears Were Red, Mild Allergic Response and My cheeks were beat red on an unspecified date. The events were assessed as non serious. The outcome of events for Shake/Shaking, But Very Mild and I had a wave of chill was recovered on an unspecified date while the outcome of the rest of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shake/shaking, but very mild; I had a wave of chill; I had fatigue after first and second shot; ears were red; mild allergic response; my cheeks were beat red; This is a spontaneous report from a contactable Physician. This female Physician reported for herself that: A female patient of an unspecified age 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 immunization. The patient medical history was not reported. Concomitant medication(s) included Diphenhydramine Hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included the patient previously received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; Solution for Injection, Batch/Lot number was not provided) via unspecified route of administration on an unspecified date as Dose 1 Single for COVID-19 immunisation and experienced Fatigue. On an unspecified date,the patient experienced Shake/Shaking, But Very Mild and I had a wave of chill, I had fatigue after first and second shot, Ears Were Red, Mild Allergic Response and My cheeks were beat red on an unspecified date. The events were assessed as non serious. The outcome of events for Shake/Shaking, But Very Mild and I had a wave of chill was recovered on an unspecified date while the outcome of the rest of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Interchange of vaccine products, Off label use
Clinical narrative: previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; blood in my urine; This is a spontaneous report from a contactable consumer (patient reported for self). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 11:00 (Age at Vaccination is 59 years) (Batch/Lot Number: EN 6206 and Expiry date was not provided) as dose 2 (initial Pfizer dose), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included Rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. The patient previously received Vaxzevria, Formulation; Solution for Injection, Batch/Lot number; EP7534b, and Expiry date was not provided) via unspecified route of administration as DOSE 1 on Left arm on 13Mar2021, 11:00 AM for COVID-19 immunisation and reported stating 3 days after the first dose patient developed a blood clot in right calf, never had one before, no trauma, patient was very active on 16Mar2021, 07:00 AM. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood in my urine on Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysphagia, Feeling abnormal, Pain in extremity, Swelling
Clinical narrative: Swelling in the whole body; Especially the throat area, making it discomfort to swallow.; Stomach sick; pain in arm; brain fog.; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son) that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date at 10:00 AM as dose 1, single for COVID-19 Immunization. Medical history included Wolff-Parkinson-White syndrome and essential tremor from an unknown date and unknown if ongoing and autism. Concomitant medication(s) included Ibuprofen (IBUPROFEN) 400 mg (each 200mgs x2 pills) taken for an unspecified indication, start and stop date were not reported. The patient previously received Morphine Batch/Lot number, and Expiry date was not provided) and experienced hives, Cefdinir Batch/Lot number, and Expiry date was not provided and experienced Pharyngeal swelling and Dysphagia. There was no other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient did not Covid tested post vaccination. The patient experienced Swelling in the whole body, Especially the throat area, making it discomfort to swallow, Stomach sick, Pain in arm and Brain fog on 07Mar2021 12:00. No treatment was received for the events. The events were assessed as Non serious. The outcome of events recovered on an unspecified date in 2021.   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: not have any effects to the vaccine, other than a sore arm.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced not have any effects to the vaccine, other than a sore arm. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Dose 2 -14 hours after shot: Severe Vertigo; dizziness; fever; headache; body aches; nausea; vomiting; diarrhea; loss of balance; dehydration; debilitating; This is a spontaneous report from a contactable consumer(patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation:Solution for Injection, Batch/Lot Number: EN6205 and Expiry date was not provided),via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at the age of 69-year-old) as Dose 2, Single for Covid-19 immunization. Medical history included Hypothyroidism, Hypertension, Sleep Apnoea syndrome, Malignant melanoma and Endometrial cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine Sodium (SYNTHROID) 125 ug; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg and Ergocalciferol (VIT D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: EN6201 and Expiry date was not provided) via unspecified route of administration as Dose 1 Single on Left arm on 06Feb2021, (at 13:15) for COVID-19 immunization and experienced diarrhoea. The patient did not receive no other vaccine in four weeks and not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced Dose 2 -14 hours after shot: Severe vertigo, Dizziness, Fever, Headache, Body Aches, Nausea, Vomiting, Diarrhea, Loss of balance, Dehydration and Debilitating on 28Feb2021 03:15. No treatment was received for the events. The events were assessed as Non serious. The outcome of all the events was recovering.    No follow up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vertigo
Clinical narrative: Dose 2 -14 hours after shot: Severe Vertigo; dizziness; fever; headache; body aches; nausea; vomiting; diarrhea; loss of balance; dehydration; debilitating; This is a spontaneous report from a contactable consumer(patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation:Solution for Injection, Batch/Lot Number: EN6205 and Expiry date was not provided),via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at the age of 69-year-old) as Dose 2, Single for Covid-19 immunization. Medical history included Hypothyroidism, Hypertension, Sleep Apnoea syndrome, Malignant melanoma and Endometrial cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine Sodium (SYNTHROID) 125 ug; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg and Ergocalciferol (VIT D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: EN6201 and Expiry date was not provided) via unspecified route of administration as Dose 1 Single on Left arm on 06Feb2021, (at 13:15) for COVID-19 immunization and experienced diarrhoea. The patient did not receive no other vaccine in four weeks and not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced Dose 2 -14 hours after shot: Severe vertigo, Dizziness, Fever, Headache, Body Aches, Nausea, Vomiting, Diarrhea, Loss of balance, Dehydration and Debilitating on 28Feb2021 03:15. No treatment was received for the events. The events were assessed as Non serious. The outcome of all the events was recovering.    No follow up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dose 2 -14 hours after shot: Severe Vertigo; dizziness; fever; headache; body aches; nausea; vomiting; diarrhea; loss of balance; dehydration; debilitating; This is a spontaneous report from a contactable consumer(patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation:Solution for Injection, Batch/Lot Number: EN6205 and Expiry date was not provided),via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at the age of 69-year-old) as Dose 2, Single for Covid-19 immunization. Medical history included Hypothyroidism, Hypertension, Sleep Apnoea syndrome, Malignant melanoma and Endometrial cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine Sodium (SYNTHROID) 125 ug; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg and Ergocalciferol (VIT D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number: EN6201 and Expiry date was not provided) via unspecified route of administration as Dose 1 Single on Left arm on 06Feb2021, (at 13:15) for COVID-19 immunization and experienced diarrhoea. The patient did not receive no other vaccine in four weeks and not have Covid prior vaccination. The patient was not tested Covid post vaccination. The patient experienced Dose 2 -14 hours after shot: Severe vertigo, Dizziness, Fever, Headache, Body Aches, Nausea, Vomiting, Diarrhea, Loss of balance, Dehydration and Debilitating on 28Feb2021 03:15. No treatment was received for the events. The events were assessed as Non serious. The outcome of all the events was recovering.    No follow up attempts are possible. No further information is expected
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypersomnia
Clinical narrative: sleep a lot; Blister; This is a spontaneous Other company report from a contactable physician (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL12184 and expiration date was not reported), via intramuscular on 02Mar2021 as dose number unknown, single for covid-19 immunization (at the age of 91-years-old ), hydrocodone bitartrate, paracetamol (VICODIN), via oral route from an unspecified date (Lot number was not reported) and ongoing, at 325 mg, 2x/day for an unspecified indication. Medical history included psychotic disorder. Concomitant medications included atorvastatin calcium (10 mg, 1x/day ), solifenacin (10 mg, 1x/day), colecalciferol (1 tablet twice a week), docusate sodium (3 in 1 week) taken for diarrhoea. On 04Mar2021 the patient experienced blister on left knee after sitting in the sun. On an unspecified date patient experienced sleep a lot. Relevant tests were none. The patient was recovered from blister in March2021 and outcome of sleep a lot was unknown.  The reporter's causality for the event of makes sleep a lot and Blisters on. Left knee after sitting in the sun was provided.  No follow-up information needed. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Slight fever; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiration Date was not reported), an unspecified route of administration in left arm on 24Feb2021 at 10:15 (at the age of 74-years-old), as dose 1, single for COVID-19 immunisation. Medical history included dry eye, migraines, scoliosis, thyroid, osteoporosis and arthritis. The patient had allergies to food, medications, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine (MANUFACTURER UNKNOWN), vitamin D2 (ergocalciferol) (MANUFACTURER UNKNOWN) and Ciclosporin (RESTASIS) all taken for unspecified indication with stop and start dates not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, next day of vaccination, the patient experienced injection site pain, slight fever, and muscle pain. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain, slight fever, and muscle pain was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Swelling face
Clinical narrative: exhausted; rash on upper chest, thighs and the edges of the face; face felt tight in a pre-swelling phase; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6204), via an unspecified route of administration, administered in arm left on 26Mar2021 at 17:45 (at the age of 27-year-old), as dose 2, single for COVID-19 immunization. The patient medical history included mood disorder, asthma, migraine, arthritis and ADD, allergic to mosquitos, fire ants, sun. The patient concomitant medications included lithium; verapamil; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), topiramate and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), all drugs taken for an unknown indication from unknown date to unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: gn6206), via an unspecified route of administration, administered in arm left on 04Mar2021 at 17:30 as dose 1 single for COVID-19 immunization and experienced bruising at the injection site for a week and a half with minor soreness. The patient past drug event included lamictal, imitrex, neosporin and experienced allergy. Prior to the 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 four weeks prior to the vaccination. On 26Mar2021 at 21:45, about 4 hours after the second dose, the patient experienced rash on upper chest, thighs and the edges of the face. The right side of face felt tight in a pre-swelling phase. The patient had prior allergic reactions to meds and insects, and this had the same early precursors because of the time elapsed, what read in the patient guide and no breathing issues. The next day, the patient's left arm felt like a bat hit it and the patient was more exhausted than normal for about 24 hours on 27Mar2021. The patient received treatment for the events rash, swelling face which included benadryl and tylenol regiment for reactions which worked within one to two hours. Outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: After the first dose I had bruising at the injection site for a week; a half with minor soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for self). A 27-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation; Solution for Injection, Batch/Lot Number: gn6206 and Expiry date was not provided), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 17:30 as dose 1, single for COVID-19 immunisation. Medical history included mood disorder, Asthma, Migraines, Arthritis, Attention deficit hyperactivity disorder (ADD), Known allergies to mosquitos, fire ants, sun from an unknown date and unknown if ongoing. Patient was not pregnant at time of vaccination. Concomitant medications included Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); Fluticasone Furoate, Vilanterol trifenatate (BREO ELLIPTA); Lithium; Topiramate and Verapamil taken for an unspecified indication, start and stop date were not reported. The patient experienced drug hypersensitivity with Lamictal, Neosporine, Imitrex on unspecified date(s). The patient did not have covid prior vaccination, Patient did not test covid post vaccination. There were no other vaccine in four weeks. The patient experienced after the first dose patient had bruising at the injection site for a week and a half with minor soreness on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest tightness and pressure since the day of vaccination. Going on 6 full days of constant dull pressure and tightness in the chest/Almost as if someone is sitting on my chest.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:15 (at the age of 30-year-old) as dose 1, single for covid-19 immunization. Medical history included anxiety. The patient had no allergies to medications, food, or other products. The patient was not received other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. It was Unknown that Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had chest tightness and pressure since the day of vaccination 02Apr2021 at 16:30. Going on 6 full days of constant dull pressure and tightness in the chest. Does not hurt to take a deep breath, but feels like she can't make it all the way to the top. Almost as if someone is sitting on her chest. The adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown that the treatment received for the adverse event. The case was considered as non-Serious. The outcome of the event of not recovered  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program Support.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported) single dose via an unspecified route of administration on 31Mar2021 for COVID-19 immunization and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), 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. After first dose patient experienced headache, on an unspecified date in 2021. She wanted to know the medication Excedrin migraine is allowed. The outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis, X-ray
Clinical narrative: Coughing up a little blood; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunization. Medical history included emphysema from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced that she was coughing up a little blood since the beginning of Apr2021. The patient underwent lab tests and procedures which included xray: unknown result on an unspecified date. The outcome of the event was unknown. It was reported that the patient was scheduled supposedly on 30Mar2021 for the second dose, but it was cancelled because she underwent X-ray procedure prior to 2nd dose schedule. The patient was querying if she could get the second dose despite of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Malaise
Clinical narrative: Feeling asthmatic; not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a Female Patient that:   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection, Batch/Lot Number and Expiry date was not provided), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization. The patient's medical history and patient's concomitant medications were not reported. It was unknown that Reporter was a Healthcare Professional or prescribing HCP. The unaddressed medical questions were referred or forwarded to Medical Information. The patient experienced Feeling Asthmatic and Not feeling well on an unspecified date. Caller's mom got her 1st dose at their local hospital and she's supposed to get her 2nd dose but she's not feeling well and is feeling asthmatic. The events were assessed as Non serious. The outcome of events was unknown.    No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Having persistent allergic reactions; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced persistent allergic reactions. It was reported that the patient received first dose 01Apr and having persistent allergic reactions. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Ocular hyperaemia
Clinical narrative: The right eye swelled up 45 mins after the shot and feels sore to the touch; The right eye swelled up 45 mins after the shot and feels sore to the touch; eyeball is bloodshot; This is a spontaneous report received from a contactable consumer.   This 44-year-old male consumer (patient) reported that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the right arm on 06Apr2021 at 09:15 AM (at the age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included reflux/reflux gastritis from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin (B12-VITAMIIN) and atenolol (ATENOLOL) taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the left arm on 16Mar2021 at 02:30 PM (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. On 06Apr2021 at around 10:00 AM, the patient experienced the right eye swelled up 45 minutes after the shot and feels sore to the touch and eyeball was bloodshot. It was unknown if treatment was received for the adverse event. Outcome was unknown for all the events.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Feeling abnormal, Illness, Lymph node pain, Nausea
Clinical narrative: Right arm and my under armpit are swollen; I am not feeling myself; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; Lymph node and everything was sore; I am feeling sick; I want to throw up. Also, I am not feeling like talking; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 03Apr2021), via an unspecified route of administration, administered in Arm on an unspecified date (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included Blood pressure from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included fist dose of BNT162B2 on 10Mar2021 for Covid-19 immunization and experienced Arm was sore, arm just went down with swelling, Lymph node and everything was sore. It was reported that got her second dose of Pfizer Covid vaccine on Saturday and right now, her right arm and her under armpit are swollen and she was feeling sick like she want to throw up. Also, she not feeling like talking. she just want to know like what is this like she was not feeling herself. read side effects and everything. When she got her first dose, she was fine and just like she got the second dose and by the second day, she started feeling very sick. But from the first dose her arm just went down with swelling and everything and she had to go to see my doctor because her arm and the lymph node and everything was sore and now it is happening in her right arm again and its really painful and its actual going down under like into her breast area and I cannot even wear her bra properly. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Right arm and my under armpit are swollen; I am not feeling myself; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; Lymph node and everything was sore; I am feeling sick; I want to throw up. Also, I am not feeling like talking; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 03Apr2021), via an unspecified route of administration, administered in Arm on an unspecified date (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included Blood pressure from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included fist dose of BNT162B2 on 10Mar2021 for Covid-19 immunization and experienced Arm was sore, arm just went down with swelling, Lymph node and everything was sore. It was reported that got her second dose of Pfizer Covid vaccine on Saturday and right now, her right arm and her under armpit are swollen and she was feeling sick like she want to throw up. Also, she not feeling like talking. she just want to know like what is this like she was not feeling herself. read side effects and everything. When she got her first dose, she was fine and just like she got the second dose and by the second day, she started feeling very sick. But from the first dose her arm just went down with swelling and everything and she had to go to see my doctor because her arm and the lymph node and everything was sore and now it is happening in her right arm again and its really painful and its actual going down under like into her breast area and I cannot even wear her bra properly. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Sore arm following injection; Patient received Moderna 1st dose vaccine and Pfizer 2nd dose vaccine; This is a spontaneous report from a contactable nurse and other HCP. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EN6204) dose 1 via intramuscular route of administration in the left arm on 11Mar2021 at 10:15 (at the age of 64-years-old) as dose 1, single and also received first dose of MODERNA (COVID-19 vaccine mRNA (mRNA 1273); solution for injection; Lot number: 039K20A) dose 1 via an unspecified route of administration in the right deltoid on 11Feb2021 (at the age of 64-years-old) as dose 1, single for an unknown indication and also received for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included stroke as reported by the patient. The patient had no known allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021, the patient experienced sore arm following injection. The patient denied any other symptoms/adverse events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event sore arm following injection. The clinical outcome of the event sore arm following injection was recovered on an unknown date in 2021 and wrong product administered was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Constipation, Fatigue, Onychoclasis
Clinical narrative: constipation; fatigue/sleepy; fatigue/sleepy; weight gain; nails cracking; elevated blood pressure; change in thyroid lab with Levothyroxine dose adjusted; sore arm after vaccine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Mar2021 (at the age of 63-year-old) (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) oral from 05Dec2020 and ongoing at 8 mg (frequency unspecified) for endometrial cancer. Medical history included endometrial cancer. Concomitant medication included pembrolizumab (KEYTRUDA) taken for endometrial cancer, start and stop date were not reported. The patient experienced constipation on an unspecified date with outcome of not recovered, fatigue/sleepy on an unspecified date with outcome of not recovered, weight gain on an unspecified date with outcome of not recovered, nails cracking on an unspecified date with outcome of not recovered, elevated blood pressure on an unspecified date with outcome of recovering, change in thyroid lab with levothyroxine dose adjusted on an unspecified date with outcome of recovering, sore arm after vaccine on 17Mar2021 with outcome of recovered on 18Mar2021. All the events were considered as non-serious. The patient reported constipation, fatigue/sleepy, weight gain, nails cracking, elevated blood pressure (lisinopril dose increased again - now at 30mg/QD), change in thyroid lab with levothyroxine dose adjusted, sore arm on 17Mar2021 after 1st Covid vaccine resolved after 1 day, scan last month (e.g. Feb2021) showed decrease in tumor size. The patient will discuss all symptoms with MD at appointment the following week. The action taken with Lenvatinib mesilate in response to the events was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Scan, Somnolence, Thyroid function test, Thyroid function test abnormal
Clinical narrative: constipation; fatigue/sleepy; fatigue/sleepy; weight gain; nails cracking; elevated blood pressure; change in thyroid lab with Levothyroxine dose adjusted; sore arm after vaccine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Mar2021 (at the age of 63-year-old) (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) oral from 05Dec2020 and ongoing at 8 mg (frequency unspecified) for endometrial cancer. Medical history included endometrial cancer. Concomitant medication included pembrolizumab (KEYTRUDA) taken for endometrial cancer, start and stop date were not reported. The patient experienced constipation on an unspecified date with outcome of not recovered, fatigue/sleepy on an unspecified date with outcome of not recovered, weight gain on an unspecified date with outcome of not recovered, nails cracking on an unspecified date with outcome of not recovered, elevated blood pressure on an unspecified date with outcome of recovering, change in thyroid lab with levothyroxine dose adjusted on an unspecified date with outcome of recovering, sore arm after vaccine on 17Mar2021 with outcome of recovered on 18Mar2021. All the events were considered as non-serious. The patient reported constipation, fatigue/sleepy, weight gain, nails cracking, elevated blood pressure (lisinopril dose increased again - now at 30mg/QD), change in thyroid lab with levothyroxine dose adjusted, sore arm on 17Mar2021 after 1st Covid vaccine resolved after 1 day, scan last month (e.g. Feb2021) showed decrease in tumor size. The patient will discuss all symptoms with MD at appointment the following week. The action taken with Lenvatinib mesilate in response to the events was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: constipation; fatigue/sleepy; fatigue/sleepy; weight gain; nails cracking; elevated blood pressure; change in thyroid lab with Levothyroxine dose adjusted; sore arm after vaccine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Mar2021 (at the age of 63-year-old) (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) oral from 05Dec2020 and ongoing at 8 mg (frequency unspecified) for endometrial cancer. Medical history included endometrial cancer. Concomitant medication included pembrolizumab (KEYTRUDA) taken for endometrial cancer, start and stop date were not reported. The patient experienced constipation on an unspecified date with outcome of not recovered, fatigue/sleepy on an unspecified date with outcome of not recovered, weight gain on an unspecified date with outcome of not recovered, nails cracking on an unspecified date with outcome of not recovered, elevated blood pressure on an unspecified date with outcome of recovering, change in thyroid lab with levothyroxine dose adjusted on an unspecified date with outcome of recovering, sore arm after vaccine on 17Mar2021 with outcome of recovered on 18Mar2021. All the events were considered as non-serious. The patient reported constipation, fatigue/sleepy, weight gain, nails cracking, elevated blood pressure (lisinopril dose increased again - now at 30mg/QD), change in thyroid lab with levothyroxine dose adjusted, sore arm on 17Mar2021 after 1st Covid vaccine resolved after 1 day, scan last month (e.g. Feb2021) showed decrease in tumor size. The patient will discuss all symptoms with MD at appointment the following week. The action taken with Lenvatinib mesilate in response to the events was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Got real severe rash from it; It is all over my neck, it is going on my back and all over; This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date (Thursday) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient got real severe rash from it; it is all over my neck, it is going on my back and all over. It wasn't too bad at first and thought it was no big deal but right now it was real bad. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Heart rate, Myalgia
Clinical narrative: little bit of headache in the forehead; Chills; Muscle pain; Joint pain; This is a spontaneous report from a non-contactable consumer. The consumer reported for a patient that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: 06Apr2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The medical history and concomitant medications were not reported.  The patient experienced little bit of headache in the forehead, chills, muscle pain, joint pain on an unspecified date. The patient underwent lab tests and investigations which included oxygen 93 and pulse was 96. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: little bit of headache in the forehead; Chills; Muscle pain; Joint pain; This is a spontaneous report from a non-contactable consumer. The consumer reported for a patient that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: 06Apr2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The medical history and concomitant medications were not reported.  The patient experienced little bit of headache in the forehead, chills, muscle pain, joint pain on an unspecified date. The patient underwent lab tests and investigations which included oxygen 93 and pulse was 96. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.