chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Carotid pulse, Computerised tomogram, Hyperhidrosis
Clinical narrative: Loss of consciousness; cardiologist assumes cardiac arrhythmias; Vertigo; Sweating; Nausea; pain in the shoulder; A spontaneous report was received from a physician  concerning a 72 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain (arthralgia), loss of consciousness, vertigo, nausea, sweating (hyperhidrosis) and cardiologist assumes cardiac arrhythmias(arrhythmias).  The patient's medical history included myocardial infarction and stent. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 29 Jan 2021 intramuscularly in his left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced shoulder pain. On 08 Feb 2021, the patient experienced loss of consciousness, vertigo, nausea, sweating and cardiac arrhythmias. Treatment information was not provided.  Laboratory data includes MRI, CT scan, X-RAYs and blood flow of carotids.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, shoulder pain was resolved on 31 Jan 2021 and loss of consciousness, vertigo, nausea, sweating, cardiac arrhythmias were considered unknown.; Reporter's Comments: This case concerns an 72 year old, male patient, with medical history of MI and stent placement, who experienced a serious unexpected event of Asthenia, confusional state, and impaired self-care, 11 days after receiving 1st dose of mRNA- 1273 (Lot# 004M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Nausea, Vertigo, X-ray
Clinical narrative: Loss of consciousness; cardiologist assumes cardiac arrhythmias; Vertigo; Sweating; Nausea; pain in the shoulder; A spontaneous report was received from a physician  concerning a 72 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain (arthralgia), loss of consciousness, vertigo, nausea, sweating (hyperhidrosis) and cardiologist assumes cardiac arrhythmias(arrhythmias).  The patient's medical history included myocardial infarction and stent. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 29 Jan 2021 intramuscularly in his left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced shoulder pain. On 08 Feb 2021, the patient experienced loss of consciousness, vertigo, nausea, sweating and cardiac arrhythmias. Treatment information was not provided.  Laboratory data includes MRI, CT scan, X-RAYs and blood flow of carotids.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, shoulder pain was resolved on 31 Jan 2021 and loss of consciousness, vertigo, nausea, sweating, cardiac arrhythmias were considered unknown.; Reporter's Comments: This case concerns an 72 year old, male patient, with medical history of MI and stent placement, who experienced a serious unexpected event of Asthenia, confusional state, and impaired self-care, 11 days after receiving 1st dose of mRNA- 1273 (Lot# 004M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a Consumer concerning an 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection on 11 Jan 2021.  On 08 Feb 2021, approximately 11 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient was diagnosed with Bell's palsy. Treatment details, as reported by the reporter, included prednisone.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, Bell's Palsy was unknown on 23 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of Bell's palsy, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19.    The patient's medical history was not provided.  Concomitant medication was not provided by the reporter.     On 08 Jan 2021, approximately thirteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    The patient was diagnosed with COVID-19 on 20 Jan 2021. On an unknown date the patient was hospitalized and on 30 Jan 2021 the patient was released from the hospital.   Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was not reported.; Reporter's Comments: This case concerns a male of unknown who was hospitalized with a serious unexpected event of COVID-19.  The event occurred 13 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Round red mark on the injection site; A spontaneous report was received from a consumer, concerning a 97-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed round red mark on the injection site/vaccination site erythema.   The patient's medical history was not provided. No concomitant product use was provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: not provided) on an unspecified date.   On 01 Feb 2021, approximately 5 days, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Feb 2021, post vaccination the patient developed a round red mark on the injection site.   The seriousness criteria for the event round red mark on the injection site.   Treatment information was not provided.   The outcome of the event, round red mark on the injection site/ vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 97-year-old female who had a medically significant and serious expected event of Vaccination site erythema.  The events occurred 5 days after the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site swelling
Clinical narrative: Injection site swelling; Numbness on the left side of the face; Left facial tingling; A spontaneous report was received from a Health Care Professional concerning a 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling on the left side of the face, numbness on the left side of the face and swelling on left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (0Batch Number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced tingling and numbness on the left side of the face and subsided after 3hrs. On 07-JAN-2021, the patient experienced swelling on left arm that got worse for over 2 weeks before it goes away.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events tingling and numbness on the left side of the face was considered resolved(subsided after 3hrs) on 06 Jan 2021. The outcome of event swelling on left arm that got worse for over 2 weeks before it goes away was considered resolved.; Reporter's Comments: This case concerns a 59-year-old female who experienced serious unexpected events of Hypoaesthesia along with a NS unexpected event of Paraesthesia and NS expected event of Vaccination site swelling.  The events occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Could not get out of bed as he lost function of his legs and they would not work; A spontaneous report was received from a consumer, concerning her husband, a 87-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not get out of bed as he lost function of his legs and they would not work.  The patients' medical history and concomitant medication details were not reported.  On 07-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection.   On 07-Jan-2021, after the first dose of vaccine, the patient could not get out of his bed as he lost function of his legs and his legs would not work. Hence, he was taken to hospital on 07-Jan-2021 and was discharged on 10-Jan-2021.  The patient's wife reported that the treating physician did not determine the cause of the patient's symptoms.  On 04-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection.  On 04-Feb-2021 following the second dose of the vaccine, he could not get out of bed, legs would not work.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the events Could not get out of bed as he lost function of his legs and they would not work was considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030097:Same patient, 2nd dose
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Pleurisy, Troponin normal
Clinical narrative: Pleurisy/Pleuritis; A spontaneous report was received from a Consumer concerning a 51 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pleurisy.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 08 JAN 2021, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection.  He received the vaccine on 08 JAN 2021 and the pain developed 3 days after the vaccination. He received this first dose in his left deltoid. The chest cavity pain was on his left side. The pain lasted for 6-7 days.  On 11 JAN 2021, the patient diagnosed with Pleurisy which is a medically important event and intervention was required. Laboratory details were provided as Chest X-ray, Echocardiogram, Electrocardiogram, Troponin normal and the results were reported as normal. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   On 11 JAN 2021, the outcome of the event Pleurisy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: she was underage; arm was sore; A spontaneous report was received from a 17-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore/vaccination site pain, and she was underage/inappropriate age at vaccine administration.  The patient's medical history was not provided. No concomitant product use was reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 16-Jan-2021, the patient reported that her arm was sore for 2 days.  On an unspecified date, the patient reported that she did not receive her second vaccination as she was underage.  Action taken with mRNA-1273 was unknown.  The outcome of the event, arm was sore/vaccination site pain was resolved on 18 Jan 2021.  The outcome of the event, she was underage/inappropriate age at vaccine administration was resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration and vaccination site pain for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start of vaccination site pain, a causal relationship cannot be excluded.  The causality for inappropriate age at vaccine administration is assessed to be not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: tiny sore in her arm; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318, expiry date unknown), via an unspecified route of administration on 23Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included back surgery on an unknow date and back pain from an unknown date.  Concomitant medication included paracetamol (TYLENOL) for back pain from back surgery. The patient reported that her doctor prescribed Tylenol to ease the back pain after a back surgery that she had before. She is prescribed to take the Tylenol 4 times a day at 6 hour intervals. She stated that she read something about after taking the COVID vaccine to not take Tylenol. At the time of the report she is feeling good with no side effects but based on the report she read that after, she is not supposed to take anything, she wanted to ask will it affect the effectivity as she read in a literature that Tylenol will decrease the efficacy of the COVID vaccine. She was wondering if it is ok for her to continue to take Tylenol. The patient also reported that she only had a tiny sore in her arm on an unspecified date in 2021. She was scheduled for the second dose on 13Feb2021. The outcome of the event was unknown. The events were reported as non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness; injection site soreness/injection site tenderness; Injection site itching; swelled up a little bit; This is a spontaneous report from a contactable consumer (patient). This 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL9263), via an unspecified route of administration on 27Jan2021 10:35 at single dose in the left arm for COVID-19 immunization. The patient's medical history included diabetes, thin blood, heart, kidneys, allergic to shellfish. Family history included heart and kidney problems. The patient's concomitant medications included metformin (GLUCOPHAGE) for diabetes for 25 years, metoprolol succinate for heart for 3 years, furosemide for 3 years, acetylsalicylic acid (ASPIRIN) for thin blood for five years, fenofibrate for heart for 3 years, colecalciferol (VITAMIN D) for kidneys for 3 years, and multivitamin to keep her healthy for a long time, all ongoing. Vaccination Facility Type was drive through. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional vaccines administered on same date of the Pfizer suspect: none. The patient experienced injection site itching on 27Jan2021, injection site redness on 28Jan2021 and injection site tenderness on 28Jan2021. Clinical course reported as follow: patient had the first dose of the Pfizer BioNTech COVID-19 vaccine on 27Jan2021. On the night (27Jan2021) she got the first dose, she experienced injection site itching. Yesterday (28Jan2021), she experienced injection site redness. Last night (28Jan2021) at 20:00, she took a diphenhydramine hydrochloride (BENADRYL) and the itching stopped but she was still experiencing injection site redness and soreness. Clarified she received the first dose in the left arm. Added it was tender to touch. Patient was scheduled for the second dose on 17Feb2021 at 10:10. Patient stated when she got first shot she had some reaction to it, it wasn't that bad, it was itchy and it swelled up a little bit (Jan2021) and got real red. The adverse events did not require a visit to physician or ER. No prior vaccinations within 4 weeks. No relevant test. Outcome of injection site itching was recovered on 28Jan2021, outcome of injection site redness was not recovered, outcome of injection site soreness/injection site tenderness was recovering, outcome of other event was unknown. The report was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain in extremity
Clinical narrative: Chills; Headache; Pain in her arm/arm is sore; joint pain; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team and also from a Pfizer Sponsored Program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration on 26Jan2021 at 30 ug, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of the COVID vaccine on 26Jan2021. Her next appointment was scheduled 23Feb2021 (10 days in addition to 21 days). The patient had headache, chill and pain in her arm/arm is sore and joint pain after the first dose of COVID vaccine in Jan2021. Caller stated her chills have went away but was still getting a little bit of a headache and she had some pain in her arm in Jan2021, but it was much better now. The patient got the shot on the 26th and was given her second shot on 23Feb2021. The outcome of the event headache was not recovered, pain in her arm was recovering, chills was recovered on an unspecified date in 2021 and joint pain was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A male patient (father) of unknown age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Jan2021 at single dose for COVID-19 Immunization. Medical history and Concomitant medications were not reported. The patient received the first dose of the Covid vaccine on 22Jan2021. On the 3rd day (25Jan2021) developed a headache that has now lasted 5 days. further stated that it was getting better, but still not going away. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Strong rash in different parts of my body. Arms, chest, lower back, buttocks, thighs/very painful; This is a spontaneous report from a contactable consumer (patient). This 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the right arm on 26Jan2021 at 16:45 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included heart valve disease, with a new aortic valve and two bypasses from Jun2018 and unknown if ongoing; and allergy to sugar, dairy and wheat from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) from an unknown date for an unknown indication, and warfarin sodium 7.5 mg from an unknown date for an unknown indication. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that two days after receiving the first dose he had broken out in a strong rash in different parts of his body; arms, chest, lower back, buttocks, and thighs. He reported they were starting to settle down a bit now (as of 01Feb2021) but were very painful. The event was reported as non-serious, and did not require hospitalization. No treatment was provided for the event. The clinical outcome of strong rash in different parts of my body; arms, chest, lower back, buttocks, thighs, very painful was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pruritus
Clinical narrative: started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; .  It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering  Information on the lot/batch number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate increased, Poor quality sleep
Clinical narrative: chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious.  The patient underwent lab tests and procedures which included heart rate: increased on  26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day  she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, SARS-CoV-2 test
Clinical narrative: headache; Fatigue; Flu like symptoms; This is a spontaneous report from a non-contactable consumer.  A non-pregnant female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Jan2021 at a single dose for COVID-19 immunization; administered in a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history included allergy from an unknown date and unknown if ongoing (allergies to medications, food, or other products: yes). Concomitant medications were not reported. On 28Jan2021, the patient experienced headache (non-serious), fatigue (non-serious), and flu like symptoms (non-serious). There was no treatment received for the adverse events. The clinical course was reported as follows: The patient had a headache for the last four days (at the time of the report); which started about three hours after receiving the vaccine. The patient was also very fatigued and experienced flu like symptoms since receiving the vaccine. The patient underwent lab tests and procedures which included COVID test post vaccination: pending results on 02Feb2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: slight stiffness & tenderness in jab site; slight stiffness & tenderness in jab site; This is a spontaneous report from a contactable consumer.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced slight stiffness & tenderness in jab site on an unspecified date, which were non-serious. Prior to vaccination, no diagnoses of COVID-19 was noted and since the vaccination, it was unknown if the patient was tested for COVID-19.  The outcome of slight stiffness & tenderness in jab site was unknown; it was unknown if treatment was given for the events.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received first dose of bnt162b2 (BNT162B2 lot number and expiry date not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148908 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Pain in extremity, Pruritus, Rash pruritic
Clinical narrative: rash that itches; arm hurts; trouble hearing; itchiness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash and itchiness on an unspecified date in 2021. The patient reported she had the Covid shot on 21Jan2021 and has a rash now and it itches. On 2021, her arm hurts, but otherwise she was fine. The patient was due for the other one on 11Feb2021 and she wanted to know if she can take it in the same arm. She mentioned trouble with hearing and also puts husband on line. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Fatigue, SARS-CoV-2 test
Clinical narrative: knocked out due to fatigue; legs were just worked up/area where he had arthritis (knees and wrist) were affected the most/knee joints were so bad/knee joints were so bad that he could barely walk/wrist joints were also bad; This is a spontaneous report from a contactable consumer (patient) reported that an 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization.  Medical history included ongoing arthritis which the patient had for 10 years or so and blood pressure. The patient has a positive COVID test on Sep2020. Concomitant medication included methotrexate (manufacturer unknown) for arthritis, losartan (manufacturer unknown) for blood pressure, hydroxychloroquine sulfate (PLAQUENIL) for arthritis and acetylsalicylic acid (CARTIA, reported as 'kartia') for blood pressure all ongoing and levothyroxine sodium (SYNTHROID) from an unspecified date to an unspecified date. The patient stated that he was okay the first day. Then the next day, it knocked the legs right from underneath him. His legs were just worked up and he knocked out due to fatigue. Mainly the area where he had arthritis (knees and wrist) were affected the most. He was in bed for a couple of days. At one point, his knee joints were so bad that he could barely walk. His wrist joints were also bad as he has arthritis in both knees and wrists. It lasted from the 28Jan2021 to the 30Jan2021. He has recovered from it. His knees are good, and his wrists are back to their normal aches and pains.  During the time of the report he was feeling pretty good. He was concerned about the second shot and would like more information. He wanted to know if the second shot will cause more severe side effects. The outcome of the events was recovered on 30Jan2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness swelling; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm, on 22Jan2021 at 17:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atorvastatin calcium (LIPITOR). The patient experienced pain in right arm redness swelling on 23Jan2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of pain in right arm redness swelling was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Malaise, Pain, Sleep disorder due to a general medical condition
Clinical narrative: Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that could only sleep; This is a spontaneous report from a contactable consumer.  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), via an unspecified route of administration in the left arm on 29Jan2021, at 14:15 as single dose for covid-19 immunization.  Medical history included allergy to mangos from an unknown date.  The patient felt unwell on 01Feb2021 with outcome of not recovered; extreme tiredness/so tired that could only sleep on 01Feb2021 with outcome of not recovered; heavy headed on 02Feb2021 with outcome of not recovered; sore on 02Feb2021 with outcome of not recovered.  The events were reported as non-serious as no treatment was given for them. Prior to vaccination, no diagnosis of COVID-19 was noted, and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; tired; This is a spontaneous report from a contactable consumer.  A non-pregnant 72-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EL9261), via an unspecified route of administration in the left arm on 01Feb2021 at 14:00 at 72-years-old at a single dose for covid-19 immunization; administered in a hospital. . The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history was reported as none. Concomitant medications included elderberry [sambucus nigra] (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 02Feb2021 (also reported as 01Feb2021 at 16:00), the patient experienced headache (non-serious) and tired (non-serious). There was no treatment received for the adverse events. The clinical outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a non-contactable consumer (patient wife). An elderly male patient of unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient medical history included covid prior vaccination. The patient concomitant medication was not reported. The patient experienced arm soreness on an unknown date in Jan2021. The outcome of the event arm soreness was unknown  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Pain in extremity, Paraesthesia oral
Clinical narrative: Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Thermal burn
Clinical narrative: Four small raspberry type "burn" left arm; Small taste in mouth; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient (non-pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization at Hospital. Medical history included embolism in 2012 and pacemaker in 2019. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took lidocaine and ciproflaxin and experienced allergies to both. After patient had First shot on unspecified date also had four small raspberry type "burn" left arm and small taste in mouth they advised to take Tylenol. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was unknown.  Information about batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021091714 Same reporter/patient/drug, different events
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; Chills, aches, minor headache, minor nausea, and fatigue; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 63-years-old patient of an unspecified gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL8982, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took warfarin for cerebrovascular accident, anastrazol vegal for neoplasm malignant. On an unspecified date the patient experienced chills, aches, minor headache, minor nausea, and fatigue. At the time of the report the event outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: they have sore arms; This is spontaneous report from Pfizer Sponsored program. A non-contactable female consumer of an unspecified age reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 01Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sore arms on an unspecified date. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: chronic pain in right side of her body/sharp pain; she was experiencing a sharp pain or sensation of  burning; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for similar events. This is the first of the two reports.  A female patient of an unspecified age received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of vaccine on 22Dec2020 and she was fine with just a little sore arm. On 29Jan2021, she was in the ER for chronic pain in right side of her body and also was experiencing a sharp pain or sensation of burning. The outcome of events was unknown.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149308 same reporter/drug/event, different patient
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: ache on her left arm; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included breast cancer from 01Dec2020 to an unknown date.  Concomitant medication included simvastatin and lisinopril. It was reported that she got her first dose on 23Jan2021 and she got an ache on her left arm and then she was originally scheduled for second dose on 13Feb2021, however though, she was rescheduled to have the second dose on 9Feb2021, that is 17 days earlier and she is worried about it and matter of fact is she will have an surgery of breast lumpectomy on 11Feb2021. So, her concern is if she can second dose early and or if it's okay to have the surgery prior the vaccination. The patient underwent lab tests and procedures which included weight: about 200 pounds (overweight) on an unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm is a little sore; Initial information was received on 24-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (demographics unknown) whose arm was little sore (pain in extremity), when received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor,  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a little soreness in his arm (pain in extremity) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available  It was not reported if the patient received a corrective treatment.  At the time of this report, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient administered expired dose of Pentacel vaccine/ NO AE; Initial information received on 22-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-years-old patient who received vaccine 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ, expiry date: 14-Feb-2021 via an unknown route at an unknown administration site) (expired product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Medical assistant asks for information regarding expiration of Pentacel and reports pontential adverse event and still not using product.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.