chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Poor quality sleep
Clinical narrative: joint pain on her wrist and ankles; headache; was tired; anxiety; slept okay a little bit/ couldn't sleep real well; felt very lethargic; Patient needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 at 11:30 (lot number: unknown) as first dose, single for covid-19 immunisation. Medical history included temperature and aches (got temperature and aches from shingles vaccine). The patient previously took baby aspirin and blood thinner. Also the patient previously had hepatitis vaccines. On unspecified date in Mar2021, the patient felt joint pain on her wrist and ankles and stated she can handle pain, it was okay. She had a headache, was tired, slept okay a little bit, had anxiety and couldn't sleep real well. She had a whole glass of water and it helped that was what she usually did when she got a headache. When she got backed from the grocery store, she felt very lethargic like when coming out of surgery then she slept for a bit which did helped. Patient reported that she actually tried to went walking because she had medical condition where she needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day. She was home and right night now, her ankles, joint pain and all over headache, for me it was hard to knew because she did had a medical condition. She stated it felt different though. Patient previously took shingles, hepatitis vaccines when she travelled and she got temperature and aches from shingles vaccine and stated this one seems to hit me harder. Patient asked that can she take Tylenol. She reported that she took baby aspirin all the time and also another blood thinner but skipped on vaccination day and medicine to increase platelets. Patient reported that her friends who took the Moderna, they told her they had to take something as well and always waited it out. Patient stated that her pain tolerance was high. Seriousness of the event was reported as non-serious. The outcome of the event headache and felt very lethargic was recovering; outcome of all other event was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Having an allergic reaction on my forearms, and upper thighs.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 03:30 (Batch/Lot Number: En6206) as SINGLE DOSE for covid-19 immunisation.The Patient's Medical history were not reported.The patient's concomitant medications were not reported. The patient experienced having an allergic reaction on my forearms, and upper thighs. (drug hypersensitivity) on 05Mar2021 15:45 with outcome of not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Illness
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. Medical history included immune system "compromised." The patient's concomitant medications were not reported. On an unspecified date, had a very bad reaction to that and was sick for almost 2 weeks." The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very slight muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198 and Expiration Date not reported) via an unspecified route of administration, in Arm Left on 05Mar2021 07:00 PM (Age at vaccination: 73 years) as single dose COVID-19 immunization. The patient's medical history included coronary artery disease. The patient concomitant medications included metoprolol, chlorthalidone, simvastatin and clopidogr; all taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 06Mar2021 06:30 AM, the patient experienced very slight muscle soreness. The patient did not receive any treatment for event. On the same day, the event was resolved.  Follow-up activities closed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; 102 degrees F Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266 and expiry date: unknown), via an unspecified route of administration, in arm left on 04Mar2021 at 11:30 AM as second dose, single for COVID-19 immunisation. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265 and expiry date: unknown), via an unspecified route of administration on 10Feb20211 2:30 PM on left arm as single dose for COVID-19 immunisation. The patient medical history and allergies was not reported. Concomitant medication included 100 mcg levothyroxine (LEVOTHYROXINE), medication in two weeks. The patient experienced chills and 102 degrees f fever on 04Mar2021 21:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit. Facility type vaccine. The patient did not receive other vaccine in four weeks. The patient did not receive any treatment for the adverse event. No covid prior vaccination and did not tested covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: rash all over her face; turned very red in the face; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The first dose of BNT162B2 was received on unspecified date for covid-19 immunisation. On an unspecified date, patient had a reaction to second dose of vaccine, patient experienced rash all over her face and turned very red in the face. Patient reported that she heard if she had an adverse reaction to vaccine that means she was not protected. Patient would like to know if this information was true. Patient reported that she has already spoken to company about her symptoms yesterday. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection
Clinical narrative: Injection site infection; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 (at the age of 66-year-old) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was not pregnant at the time of vaccination. On an unspecified date in 2021, patient experienced injection site infection. Patient received antibiotic as treatment for event. Due to event patient visited doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of injection site infection. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Small amount of bleeding from vaccination site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) 1st dose, via an unspecified route of administration in Arm Right on 06Mar2021 single dose for covid-19 immunisation. The patient's medical history was not reported. Allergies known was none. Concomitant medication included lisinopril (LISINOPRIL), and omeprazole (OMEPRAZOLE) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. No other vaccines prior vaccination. The patient was not tested for covid prior to vaccination. The patient experienced small amount of bleeding from vaccination site on 06Mar2021 at 08:45. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Sensitive skin
Clinical narrative: My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules  (raised lumps) were rotating between fire and ice; My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules  (raised lumps) were rotating between fire and ice; Under my arm from elbow to half way up that under-arm was so extremely sensitive.; This is a spontaneous report from a contactable other Health Care Professional. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 09:30 as 2ND DOSE, SINGLE for covid-19 immunization. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EN6198 and Expiry date: Unknown) dose 1 via an unspecified route of administration, on 06-FEB-2021 for COVID-19 immunization. Medical history included allergy to arthropod sting from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not received any treatment and was not diagnosed with COVID-19 since the vaccination, the patient had not been tested for COVID-19 as well. Concomitant medication included trazodone taken for an unspecified indication, start and stop date were not reported. On 01Mar2021 16:30 the patient experienced  "shot arm" felt like a string of sore defined nodules were rotating between fire and ice, under arm from elbow to halfway up that under-arm was so extremely sensitive. It was reported that, first shot on Saturday, 06Feb2021 at 1:45 pm, she had no adverse effects. Second shot on Saturday, 27Feb2021 at 9:30am, she had one adverse event on Monday, March 1 (52 hours after second shot) from 4:30pm until patient went to bed/sleep at 10:30pm. My "shot arm" (left, above elbow, underneath my arm on soft skin) felt like a string of sore defined nodules (raised lumps) were rotating between fire and ice, like someone had beat me up there only, like  must surely be black and blue there but was not. Under my arm from elbow to half way up that under-arm was so extremely sensitive. Patient did not take any RX for it or put on an ice pack, so she was really grateful to be able to sleep. Symptoms did not cause her to awaken and were mostly gone when she woke up in the morning, she could feel the nodules but there was not much sensitivity or pain at all. The outcome of event nodule was not recovered and other events were recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Decreased immune responsiveness, Fungal infection, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient, reported for self). A 68-years-old (non pregnant) female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EN 6202), via an unspecified route of administration, administered in Left arm on 24Feb2021 at 20:00 (At 68-years-old) as single dose for COVID-19 immunization.  Medical history included Vaginal yeast infection on and unspecified date. Patient had no known allergies. Other medical history : Not much. Concomitant medications (other medications in two weeks) included fluoxetine hydrochloride (PROZAC); quetiapine fumarate (SEROQUEL); levothyroxine (LEVOTHYROXINE), Vitamins taken for an unspecified indication at unspecified dose, start and stop date were not reported. Patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 01Mar2021 (Monday) at 07:00, starting on four days after receiving the first vaccine patient started getting a yeast infection. Patient reported that she was not sexually active and not on hormones. Patient was retired. Patient reported that she was told this could be from the vaccine due to it lowering her immune system as it begins to work. Patient reported that she has had only had one vaginal yeast infection in her whole life, and mentions she does not know why she got this, and wondered if it could be related to the vaccine at all. Also, within a few minutes after receiving the first vaccine, patient experienced heart racing and it felt like when one goes to the dentist and receive novocaine and heart speeds up. The paramedics came over and checked her heart rate (high) and blood pressure (high) and waited for about30 minutes and talked with the patient, then rechecked the patient and it was okay. Patient received treatment for the reported adverse events. Patient reported to have purchased over-the-counter medicine that was taking care of it. Patient mentioned that her second vaccine was set for the 18Mar. No COVID tested post vaccination. Seriousness of the events yeast infection, lowering my immune system, heartracing, heart rate (high) and blood pressure (high) were non-serious. Outcome of the events were reported as recovering. No Follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient, reported for self). A 68-years-old (non pregnant) female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EN 6202), via an unspecified route of administration, administered in Left arm on 24Feb2021 at 20:00 (At 68-years-old) as single dose for COVID-19 immunization.  Medical history included Vaginal yeast infection on and unspecified date. Patient had no known allergies. Other medical history : Not much. Concomitant medications (other medications in two weeks) included fluoxetine hydrochloride (PROZAC); quetiapine fumarate (SEROQUEL); levothyroxine (LEVOTHYROXINE), Vitamins taken for an unspecified indication at unspecified dose, start and stop date were not reported. Patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 01Mar2021 (Monday) at 07:00, starting on four days after receiving the first vaccine patient started getting a yeast infection. Patient reported that she was not sexually active and not on hormones. Patient was retired. Patient reported that she was told this could be from the vaccine due to it lowering her immune system as it begins to work. Patient reported that she has had only had one vaginal yeast infection in her whole life, and mentions she does not know why she got this, and wondered if it could be related to the vaccine at all. Also, within a few minutes after receiving the first vaccine, patient experienced heart racing and it felt like when one goes to the dentist and receive novocaine and heart speeds up. The paramedics came over and checked her heart rate (high) and blood pressure (high) and waited for about30 minutes and talked with the patient, then rechecked the patient and it was okay. Patient received treatment for the reported adverse events. Patient reported to have purchased over-the-counter medicine that was taking care of it. Patient mentioned that her second vaccine was set for the 18Mar. No COVID tested post vaccination. Seriousness of the events yeast infection, lowering my immune system, heartracing, heart rate (high) and blood pressure (high) were non-serious. Outcome of the events were reported as recovering. No Follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Oropharyngeal pain, Pyrexia, Respiratory tract irritation, Rhinorrhoea
Clinical narrative: Sore throat; lungs burning; runny nose; fever over 100; This is a spontaneous report received from a contactable other health care professional (Patient, self-reporting). A 36-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration in left arm on 05Mar2021 at 01:15 PM as first dose, single for COVID-19 immunization. Medical history included bowel obstruction from 2019 to an unknown date, gastric bypass from 2018 to an unknown date and allergies to morphine, penicillin, ulcer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for ulcer and one a day multivitamin. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Mar2021 at 06:00 PM, patient experienced sore throat, lungs burning, runny nose, fever over 100. The patient underwent lab tests and procedures which included body temperature: fever over 100 on 05Mar2021. The patient did not receive any treatments for the events. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Flatulence, Hyperaesthesia teeth, Musculoskeletal chest pain
Clinical narrative: sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration, Toothache
Clinical narrative: sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Head cold like symptoms including severe head congestion; headache; runny nose; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN9581) 1st dose, via an unspecified route of administration, administered in right arm on 03Mar2021 10:00 (age at vaccination: 55 years) as single dose for covid-19 immunization at Health Clinic/Administration facility. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITIN) for unknown indication and from unspecified date. There were no known allergies. On 04Mar2021 10:30, the patient experienced head cold like symptoms including severe head congestion, headache and runny nose. The patient did not receive any treatment for adverse events. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior to vaccination nor was tested for covid post vaccination. outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Paraesthesia oral, Rash
Clinical narrative: Tingling lips and tongue; tingling body sensation in skin; hives; rash; shortness of breath; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 11:00 (at age of 34-year-old) as single in Arm Left for covid-19 immunization. The patient's medical history included allergies to coconut sunflower, and cats and dogs. No covid prior vaccination and has not tested covid post vaccination. The patients concomitant medications included quetiapine (SEROQUEL) and diphenhydramine hydrochloride (CETIRIZINE). On 06Mar2021 16:00, the patient experienced tingling lips and tongue, tingling body sensation in skin, hives, rash, shortness of breath, and dizziness. The outcome of all events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Tingling lips and tongue; tingling body sensation in skin; hives; rash; shortness of breath; dizziness; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 11:00 (at age of 34-year-old) as single in Arm Left for covid-19 immunization. The patient's medical history included allergies to coconut sunflower, and cats and dogs. No covid prior vaccination and has not tested covid post vaccination. The patients concomitant medications included quetiapine (SEROQUEL) and diphenhydramine hydrochloride (CETIRIZINE). On 06Mar2021 16:00, the patient experienced tingling lips and tongue, tingling body sensation in skin, hives, rash, shortness of breath, and dizziness. The outcome of all events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red around injection site tenderness, itches; Red around injection site tenderness, itches; Red around injection site tenderness, itches; This is a spontaneous report from a contactable consumer (the patient). A 82-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration in left arm on 03Mar2021 12:45 as second dose, single for COVID-19 immunization in hospital. Medical history included high blood pressure, atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient previously took sulfa, keflexIlosone, penicillin and tetanus experienced events drug allergy. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unknown date as first dose, single dose for COVID-19 immunization. The patient receive other regular medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the 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 03Mar2021 at 00:45, the patient experienced red around injection site tenderness, itches. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat like the onset of a cold; sore throat like the onset of a cold; Some minor chills; minor fatigue/Moderate fatigue; Day of injection sore arm/Day 2 very sore arm/ Minor arm soreness; This is a spontaneous report received from a contactable consumer (patient, self-reporting). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6199 and expiration date was not reported), (patient was 71-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 03Mar2021 at 12:45 as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809 and expiration date was not reported), via an unspecified route of administration in left arm on 08Feb2021 at 12:30 PM for COVID-19 immunisation. On 05Mar2021 at 12: 00 pm, the patient experienced day of injection sore arm/day 2 very sore arm/ minor arm soreness, on 06Mar2021, the patient experienced minor fatigue/moderate fatigue and on 07Mar2021, the patient experienced sore throat like the onset of a cold, some minor chills. Reported that patient had not received other vaccine in four weeks. Reported that Day of injection sore arm. Day 2 very sore arm, minor fatigue and Day 3 Very sore throat like the onset of a cold, some minor chills, no fever, moderate fatigue, minor arm soreness. Day 4 Back to normal. The sore throat was surprising more so because of the day. Adverse event on 05Mar2021 at 12:00 PM, no treatment received for AE. Patient had no COVID prior vaccination and not tested COVID post vaccination. The outcome of events was recovered on 08Mar2021.  No follow-up attempts are possible; no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on cheese and upper arms 7 hours after receiving vaccine.; This is a spontaneous report from a contactable consumer (patient).A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on 06Mar2021 at 02:15 (at the age of 51-years-old) as 1st dose,single dose for COVID-19 immunization. Patient's medical history included hypothyroidism, penicillin allergy and depression. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Patient received concomitant medications within two weeks included Synthroid.75, Wellbutrin 300, vitamin D and biocell. The patient had not been tested for COVID19 nor before neither since the vaccination.On 06Mar2021 at 20:45,The patient experienced rash on cheese and upper arms 7 hours after receiving vaccine . The event was not treated. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: I started itching on my elbows, legs, rear./break out in hives; driving me crazy; This is a spontaneous report from a contactable consumer or other non hcp.   A 50-years-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3249 expiry date was not reported), first dose , single via an unspecified route in the right arm on an 21Jan2021 at 06:30 AM as a single dose and dose 2 via an unspecified route of administration, at Arm Right on 12Feb2021 06:00 (Lot Number: EL9269, expiry date was not reported) as a SINGLE DOSE for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had Known allergies Sulfa. The patient did not have covid prior vaccination. The patient did not covid tested post vaccination. On 20Feb2021 08:15 the patient experienced itching on patient elbows, legs, rear, break out in hives, (driving me crazy (feeling abnormal) the outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Speech disorder, Throat tightness
Clinical narrative: I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers.; I could not speak without coughing; I could not speak without coughing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in arm left on 04Mar2021 17:15 (at the age of 45-year-old), at a 1st dose, single dose for covid-19 immunisation. Medical history included patient was allergic to Sulfa, penicillin, tramadol, compazine, Levaquin. No other medical history was reported. Concomitant medications included desvenlafaxine succinate (PRISTIQ); buspirone hydrochloride (BUSPAR); bupropion hydrochloride (WELLBUTRIN); gabapentin (GABAPENTIN); topiramate (TOPAMAX). Patient did not had other vaccine in four weeks, patient did not had covid prior vaccination and patient has not covid tested post vaccination. On 04Mar2021 17:45 the patient experienced I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Adverse events resulted in emergency room visit. Therapeutic measures were taken as a result of I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Patient was treated with Steroid, benedryl, and Pepcid injections. Outcome of the events was resolved with sequel on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: stood up quickly and felt a couple of waves of lightheadedness and swaying; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female (Non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, expiry date: unknown), via an unspecified route of administration, administered in arm Left on 07Mar2021 at 14:00 as a 1st dose Single Dose for covid-19 immunization. The patient past Medical history included Sulfa allergy. Patient Concomitant medication included Ascorbic Acid (VIT C) and cholecalciferol (VIT D3). No prior vaccination was received and tested for positive before vaccination. No other vaccination was received within 4weeks.  It was reported that she felt great immediately after but approx. 95 minutes after she was putting groceries on the bottom of her freezer. she stood up quickly and felt a couple of waves of lightheadedness and Swaying on 07Mar2021 at 03:30 PM. Held the counter until it passed then went a sat down for a few minutes. No treatment was received. The outcome for the event was Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen left supraclavicular and left axillary lymph nodes; Swollen left supraclavicular and left axillary lymph nodes; fever; chills; fatigue; headache; body aches; sore muscles/joints; sore muscles/joints; This is a spontaneous report from a contactable other-healthcare professional (patient) reporting herself.  A 27-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6199), via intramuscular route of administration in arm left on 05Mar2021 at 15:00 as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none and the patient had known allergies to sulfa and latex. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via intramuscular in arm left on 12Feb2021 at 13:00 as a 1st dose, single dose for COVID-19 immunisation. Age at vaccination was 27 years and the patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. Other medications in two weeks included daily multivitamin and oral birth control. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 06Mar2021 at 05:00 AM, the patient experienced swollen left supraclavicular and left axillary lymph nodes, fever, chills, fatigue, headache, body aches and sore muscles/joints. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Swollen left supraclavicular and left axillary lymph nodes; Swollen left supraclavicular and left axillary lymph nodes; fever; chills; fatigue; headache; body aches; sore muscles/joints; sore muscles/joints; This is a spontaneous report from a contactable other-healthcare professional (patient) reporting herself.  A 27-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6199), via intramuscular route of administration in arm left on 05Mar2021 at 15:00 as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none and the patient had known allergies to sulfa and latex. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via intramuscular in arm left on 12Feb2021 at 13:00 as a 1st dose, single dose for COVID-19 immunisation. Age at vaccination was 27 years and the patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. Other medications in two weeks included daily multivitamin and oral birth control. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 06Mar2021 at 05:00 AM, the patient experienced swollen left supraclavicular and left axillary lymph nodes, fever, chills, fatigue, headache, body aches and sore muscles/joints. Treatment was not received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Malaise, Myalgia
Clinical narrative: Red rash wrists and hands 4-6 hours after shot w/ itchiness; Red rash wrists and hands 4-6 hours after shot w/ itchiness/Severe red rash all over body; Red rash wrists and hands 4-6 hours after shot w/ itchiness; cough; tiredness; muscle and wrist joint pain; muscle and wrist joint pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient himself).  A 66-year-old male patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN6206, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 14:45 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (Severe COPD with Chronic Bronchities), drug hypersensitivity (known allergies: Penicillin), bronchitis chronic (Severe COPD with Chronic Bronchities). Concomitant medications included umeclidinium bromide (INCRUSE ELLIPTA, 62.5 mg); salbutamol sulfate (VENTOLIN HFA, 90 ug).  other medications in two weeks Incruse included Ellipta 62.5 mcg, Ventolin HFA 90 mcg. No other vaccine taken in four weeks. On 06Mar2021 07:45 PM the patient experienced, Red rash wrists and hands 4-6 hours after shot w/ itchiness. Severe red rash all over body 12-24 hours after. shot with cough, tiredness, muscle and wrist joint pain, feeling unwell. No treatment taken for ae. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was not resolved.  No follow attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash wrists and hands 4-6 hours after shot w/ itchiness; Red rash wrists and hands 4-6 hours after shot w/ itchiness/Severe red rash all over body; Red rash wrists and hands 4-6 hours after shot w/ itchiness; cough; tiredness; muscle and wrist joint pain; muscle and wrist joint pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient himself).  A 66-year-old male patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN6206, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 14:45 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (Severe COPD with Chronic Bronchities), drug hypersensitivity (known allergies: Penicillin), bronchitis chronic (Severe COPD with Chronic Bronchities). Concomitant medications included umeclidinium bromide (INCRUSE ELLIPTA, 62.5 mg); salbutamol sulfate (VENTOLIN HFA, 90 ug).  other medications in two weeks Incruse included Ellipta 62.5 mcg, Ventolin HFA 90 mcg. No other vaccine taken in four weeks. On 06Mar2021 07:45 PM the patient experienced, Red rash wrists and hands 4-6 hours after shot w/ itchiness. Severe red rash all over body 12-24 hours after. shot with cough, tiredness, muscle and wrist joint pain, feeling unwell. No treatment taken for ae. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was not resolved.  No follow attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: mild tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in right arm on 05Mar2021 13:00 as 1st dose, single dose for COVID-19 immunization. The patient was 62-years-old and was not pregnant at the time of vaccination. Patient did not had COVID prior to vaccination. Patient was not tested for COVID post vaccination. Vaccine facility type was reported as workplace clinic. Patient did not receive any other vaccine in four weeks. Patient medical history included osteoporosis, acid reflux and had no known allergies. The concomitant medications included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), alendronate sodium (FOSAMAX). On 05Mar2021 at 13:30, patient experienced mild tiredness. Patient did not receive any treatment for the adverse events. On an unspecified date in Mar2021, the outcome of the event was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; chills; headache; This is a spontaneous report from a contactable consumer (patient reported himself). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: Ep6955q), via an unspecified route of administration, administered in left arm on 06Mar2021 at 09:30 AM (at the age of 29-years-old), as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced covid prior to the vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for covid post vaccination. On 07Mar2021 at 12:00 PM, one day after administration of first vaccine, the patient experienced fever, chills, and headache. No treatment was received by the patient to treat the events. All the events were reported as non-serious. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tinnitus, Vaccination site pain
Clinical narrative: Surge in Tinnitus; Burning in muscle at injection site; Sore arthritic like pain in fingers; Sore arthritic like pain in fingers; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), silodosin (SILODOSIN DSEP) at 8 mg amlodipine 2.5 mg. 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. On 06Mar2021 at 08:00 AM, patient experienced burning in muscle at injection site, sore arthritic like pain in fingers. On 09Mar021 at 07:00 AM, patient experienced surge in tinnitus. Since the vaccination, the patient had not been tested for COVID-19. The treatment received for the adverse event surge in tinnitus included hearing aid. No treatment was received for the other adverse events. The outcome of the events was not recovered.  Follow up attempts are completed. No further information is expected.