chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Skin discolouration, Tenderness, Vaccination site pain
Clinical narrative: Discolored, raised lump on left breast with tenderness; Discolored, raised lump on left breast with tenderness; Discolored, raised lump on left breast with tenderness; Fever; chills; whole body muscle aches; headache; nausea; fatigue; sore injection site; This is a spontaneous report from a non-contactable consumer or other non health care professional (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot Number: EL3247, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in arm right on 24Feb2021 14:45 (29-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a known allergy to eggs, peanuts and tree nut. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19), dose 1 via an unspecified route of administration, administered in right arm on 04Feb2021 14:45 PM (Lot Number: EL3247, Expiry date was not reported) (29-year-old at the time of vaccination) as dose 1, single for covid-19 immunization. On 25Feb2021,12:45 the patient experienced Fever, chills, whole body muscle aches, headache, nausea, fatigue, sore injection site. On 27Feb2021, the patient experienced discolored, raised lump on left breast with tenderness and she visited doctor office and emergency room for this event. The clinical outcome of the event discolored, raised lump on left breast with tenderness was not recovered and other events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diplopia, Fatigue
Clinical narrative: Double-vision; loss of appetite; woke up with all over body aches; fever/low grade fever all day after vaccine (99.5 with taking Tylenol); chills; nausea; Pain; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 27Feb2021 at 13:45 (at the age of 26-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included Hypothyroidism, asthma, eczema, vitamin d deficient. Known allergies included Pediazole, Suprax, Sulfa drugs, Penicillin and reaction to Toradol. Concomitant medications included spironolactone, levothyroxine sodium (SYNTHROID) and birth control; all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of Vaccination. Patient not had Covid prior vaccination. Patient was not tested Covid post vaccination. Patient not administered other vaccine in four weeks. The patient experienced double-vision on 28Feb2021 at 16:30 for about 30 minutes, extreme fatigue on 27Feb2021 at 19:00, woke up with all over body aches on 28Feb2021 at 04:00, fever/low grade fever all day after vaccine (99.5 with taking Tylenol), chills, nausea, on 28Feb2021 at 04:00, loss of appetite on 28Feb2021 at 16:30, pain on 28Feb2021. The patient underwent lab tests and procedures which included body temperature: 99.5 on 28Feb2021 low grade fever all day after vaccine. Therapeutic measures were taken as a result of fever/low grade fever all day after vaccine (99.5 with taking tylenol) and no treatment was received for other events. The outcome of the events pain and double vision was resolved on an unspecified date in 2021 and outcome of other events was resolving.  No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Double-vision; loss of appetite; woke up with all over body aches; fever/low grade fever all day after vaccine (99.5 with taking Tylenol); chills; nausea; Pain; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 27Feb2021 at 13:45 (at the age of 26-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included Hypothyroidism, asthma, eczema, vitamin d deficient. Known allergies included Pediazole, Suprax, Sulfa drugs, Penicillin and reaction to Toradol. Concomitant medications included spironolactone, levothyroxine sodium (SYNTHROID) and birth control; all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at time of Vaccination. Patient not had Covid prior vaccination. Patient was not tested Covid post vaccination. Patient not administered other vaccine in four weeks. The patient experienced double-vision on 28Feb2021 at 16:30 for about 30 minutes, extreme fatigue on 27Feb2021 at 19:00, woke up with all over body aches on 28Feb2021 at 04:00, fever/low grade fever all day after vaccine (99.5 with taking Tylenol), chills, nausea, on 28Feb2021 at 04:00, loss of appetite on 28Feb2021 at 16:30, pain on 28Feb2021. The patient underwent lab tests and procedures which included body temperature: 99.5 on 28Feb2021 low grade fever all day after vaccine. Therapeutic measures were taken as a result of fever/low grade fever all day after vaccine (99.5 with taking tylenol) and no treatment was received for other events. The outcome of the events pain and double vision was resolved on an unspecified date in 2021 and outcome of other events was resolving.  No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Allergic respiratory symptom, Asthma, Eye pruritus, Hypersensitivity, Pruritus
Clinical narrative: itchy eyes; asthma; severe itchy skin; random hives; blotchy sunburn type rash on ifferent parts of the body including face; blotchy sunburn type rash on ifferent parts of the body including face; severe aggravation of allergy type symptoms congestion; severe aggravation of allergy type symptoms congestion; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: not provided, expiry date not provided) via an unknown route of administration, administered in Arm Left on 12Feb2021 16:00 as DOSE 2, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included asthma, Autoimmune neutropenia, idiopathic thrombocytopenic purpura (ITP), allergy to animal dander, Allergies to dust, food allergy, kiwi, known allergies: sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of bnt162b2(BNT162B2) administered on 22Jan2021 as DOSE 1, SINGLE (at the age of 42-year-old) for covid-19 immunisation and experienced slight aggravation of allergy sneezing, congestion and Itchy eyes 2 days after vaccine was given. The patient previously took Rocephine, Ciproflaxin and experienced allergy. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received unknown concomitant medications in two weeks. On an unknown date after second dose of vaccination, the patient experienced severe aggravation of allergy type symptoms: congestion, severe itchy eyes, blotchy sunburn type rash on different parts of the body including face, severe itchy skin, random hives, asthma felt as though rolled in fiberglass and snuggled a kitten simultaneously in 2021. The patient received allergy eye drops for itchy eyes and inhaler for asthma for treatment. Outcome of events itchy eyes and asthma was recovering, and other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: itchy eyes; asthma; severe itchy skin; random hives; blotchy sunburn type rash on ifferent parts of the body including face; blotchy sunburn type rash on ifferent parts of the body including face; severe aggravation of allergy type symptoms congestion; severe aggravation of allergy type symptoms congestion; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: not provided, expiry date not provided) via an unknown route of administration, administered in Arm Left on 12Feb2021 16:00 as DOSE 2, SINGLE (at the age of 42-year-old) for covid-19 immunisation. Medical history included asthma, Autoimmune neutropenia, idiopathic thrombocytopenic purpura (ITP), allergy to animal dander, Allergies to dust, food allergy, kiwi, known allergies: sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of bnt162b2(BNT162B2) administered on 22Jan2021 as DOSE 1, SINGLE (at the age of 42-year-old) for covid-19 immunisation and experienced slight aggravation of allergy sneezing, congestion and Itchy eyes 2 days after vaccine was given. The patient previously took Rocephine, Ciproflaxin and experienced allergy. Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received unknown concomitant medications in two weeks. On an unknown date after second dose of vaccination, the patient experienced severe aggravation of allergy type symptoms: congestion, severe itchy eyes, blotchy sunburn type rash on different parts of the body including face, severe itchy skin, random hives, asthma felt as though rolled in fiberglass and snuggled a kitten simultaneously in 2021. The patient received allergy eye drops for itchy eyes and inhaler for asthma for treatment. Outcome of events itchy eyes and asthma was recovering, and other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Lymphadenopathy, Pruritus, Rash
Clinical narrative: itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; swelling of lymph nodes in her neck; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 2 via an unspecified route of administration in right arm on 20Jan2021 (at the age of 44-year-old) as dose 2 single for covid-19 immunization at Workplace clinic. Medical history included Type 1 diabetes, hypothyroid. No known allergies. No Covid prior vaccination. Not tested for covid post vaccination. Concomitant medications included insulin, levothyroxine, amitriptyline hydrochloride (AMITRIPTYLIN), escitalopram, all received in two weeks. No other vaccine received in four weeks. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration in left arm on 30Dec2020 at 04:00 PM (at the age of 44-year-old) as dose 1 single for covid-19 immunization. After first injection she experienced brain fog and confusion, which resolved after 4 weeks. On 11Feb2021 07:00 AM, three weeks after the 2nd injection, she developed itching on the skin of ears. A week later this spread to her scalp and face. She had swelling of lymph nodes in her neck, and 10 days after the itching started, her face swelled, especially around her eyes. That same day, the itching spread to her arms and legs, along with a rash. These symptoms have persisted. Events resulted in visit to Emergency room/department or urgent care. Received treatment with Cetirizine, hydroxyzine. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19, TTOX
Symptoms: Body temperature, Dyspnoea, Fatigue, Irritable bowel syndrome, Pyrexia
Clinical narrative: 2nd vaccine- slight tenderness; shortness of breath; fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs; triggered my IBS; walking dog up a hill and felt like pass out; fatigue/ extreme fatigue; This is a spontaneous report from a contactable consumer, the patient via Pfizer Sponsored Program. A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EN5318 and expiration date not reported), via an unspecified route of administration, administered in left arm on 13Feb2021 13:30 (at the age of 67 years) as dose 2, single for covid-19 immunization; and tetanus vaccine, via an unspecified route of administration in left arm on 22Jan2021 (lot number and expiration date not reported), for an unspecified indication. Medical history included ongoing irritable bowel syndrome and osteoporosis. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EL3246 and expiration date not reported) via an unspecified route of administration, administered in right arm on 20Jan2021 10:15 (at the age of 67 years) as dose 1, single for covid-19 immunization. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since the vaccination. Concomitant medications were not reported. On 14Feb2021, patient experienced slight tenderness, fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs, shortness of breath, and got triggered irritable bowel syndrome. On an unknown date patient had fatigue/ extreme fatigue and while walking dog up a hill patient felt like she was going to pass out. All symptoms resolved the 15Feb2021. One week later, on 20Feb2021, the patient again experienced fatique and severe shortness of breath with slight exertion recured and persisting as of 22Feb2021. Patient did not take any treatment for the events. The outcome of event slight tenderness, and fever was recovered on 15Feb2021, shortness of breath and fatigue/ extreme fatigue was recovered with sequel and for triggered irritable bowel syndrome and walking dog up a hill and felt like pass out was unknown.  No follow up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, TTOX
Symptoms: Vaccination site pain
Clinical narrative: 2nd vaccine- slight tenderness; shortness of breath; fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs; triggered my IBS; walking dog up a hill and felt like pass out; fatigue/ extreme fatigue; This is a spontaneous report from a contactable consumer, the patient via Pfizer Sponsored Program. A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EN5318 and expiration date not reported), via an unspecified route of administration, administered in left arm on 13Feb2021 13:30 (at the age of 67 years) as dose 2, single for covid-19 immunization; and tetanus vaccine, via an unspecified route of administration in left arm on 22Jan2021 (lot number and expiration date not reported), for an unspecified indication. Medical history included ongoing irritable bowel syndrome and osteoporosis. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot mumber: EL3246 and expiration date not reported) via an unspecified route of administration, administered in right arm on 20Jan2021 10:15 (at the age of 67 years) as dose 1, single for covid-19 immunization. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, since the vaccination. Concomitant medications were not reported. On 14Feb2021, patient experienced slight tenderness, fever for 24 hours started 12 hours after shot/ 101 fever for about 24 hrs, shortness of breath, and got triggered irritable bowel syndrome. On an unknown date patient had fatigue/ extreme fatigue and while walking dog up a hill patient felt like she was going to pass out. All symptoms resolved the 15Feb2021. One week later, on 20Feb2021, the patient again experienced fatique and severe shortness of breath with slight exertion recured and persisting as of 22Feb2021. Patient did not take any treatment for the events. The outcome of event slight tenderness, and fever was recovered on 15Feb2021, shortness of breath and fatigue/ extreme fatigue was recovered with sequel and for triggered irritable bowel syndrome and walking dog up a hill and felt like pass out was unknown.  No follow up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry throat, Dyspnoea, Fatigue, Hypersomnia
Clinical narrative: I got the shot Wednesday and I have been sick ever since then; Shortness of breath; Joints hurt; My throat is very raspy and it seems, it want to stay dry; I started feeling like I had the flu; I went to bed and then I was sound asleep like in a state of coma for 12 hours; I was so tired, I couldn't get my eyes open; This is a spontaneous report from a contactable consumer or other non hcp.     A 63-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, (Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration on 24Feb2021 as dose 1 single for covid-19 immunisation. Medical history included thyroid disorder. It was Reported that, The patient experienced got the shot Wednesday and had sick ever since then, shortness of breath, joints hurt, my throat is very raspy and it seems, it want to stay dry, started feeling like had the flu on an unspecified date with outcome of unknown, went to bed and then was sound asleep like in a state of coma for 12 hours on an unspecified date with outcome of unknown , was so tired, i couldn't get my eyes open on an unspecified date with outcome of unknown.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: I got the shot Wednesday and I have been sick ever since then; Shortness of breath; Joints hurt; My throat is very raspy and it seems, it want to stay dry; I started feeling like I had the flu; I went to bed and then I was sound asleep like in a state of coma for 12 hours; I was so tired, I couldn't get my eyes open; This is a spontaneous report from a contactable consumer or other non hcp.     A 63-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, (Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration on 24Feb2021 as dose 1 single for covid-19 immunisation. Medical history included thyroid disorder. It was Reported that, The patient experienced got the shot Wednesday and had sick ever since then, shortness of breath, joints hurt, my throat is very raspy and it seems, it want to stay dry, started feeling like had the flu on an unspecified date with outcome of unknown, went to bed and then was sound asleep like in a state of coma for 12 hours on an unspecified date with outcome of unknown , was so tired, i couldn't get my eyes open on an unspecified date with outcome of unknown.  No follow up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Rhinorrhoea
Clinical narrative: L axillary, clavicular Lymphadenopathy lasting into 10th day; more intense fatigue; worse/stronger arthralgia; nose running; This is a spontaneous report from a contactable Nurse (patient). A 53-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administrated in Left deltoid on 18Feb2021 (age at the time of vaccination 53-years-old), as a single dose for COVID-19 immunization at Hospital. The patient's medical history included Ewings sarcoma as a teen. The patient's concomitant medications included Omeprazole 20mg, and Amlodipine 2.5mg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administrated in Left arm on 26Jan2021 12:30 (age at the time of vaccination 53-years-old), as a single dose for COVID-19 immunization and experienced runny nose, Light Arthralgia, upper back/shoulders, progressing to arms, wrists, hands, Fatigue, and in bed by 7pm and sleeping 10h. No other vaccine in four weeks. covid prior vaccination was unknown. No covid tested post vaccination. Patient had no known allergies. On an unspecified date Feb2021, the patient experienced L axillary, clavicular Lymphadenopathy lasting into 10th day, more intense fatigue, worse/stronger arthralgia, and nose running. Patient received treatment as a result of adverse events which included Ibuprofen but no relief. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever (102.5); Headache; Aches/body aches; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6203), via an unspecified route of administration, administered in Arm Left on 26Feb2021 18:00 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208), via unknown route of administration, administered in Arm Left on 17Mar2021 13:45 (both doses at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus, obesity, shrimp allergy, covid-19 from (If covid prior vaccination: Yes), HBP from an unknown date and unknown if ongoing. Concomitant medications included sitagliptin (JANUVIA [SITAGLIPTIN]), metoprolol (METOPROLOL), losartan potassium (COZARTAN), losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced drug hypersensitivity. Since the vaccination, did not patient been tested for COVID-19. The patient experienced chills, fever (102.5), headache, aches/body aches. The patient underwent lab tests and procedures which included body temperature: 102.5 on 18Mar2021. The outcome of the events was reported as recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia, Mobility decreased
Clinical narrative: shortness of breath; left side of her body - leg, arm and face - started to get numb; Dizziness; sharp pain in neck; fever; nauseating headache; nauseating headache; body ache; reduced mobility of left arm; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 27Feb2021 at 20:00 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included food allergy (Known allergy: cucumber). Patient was not pregnant. Patient not administered other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), fluoxetine, collagen; all taken for an unspecified indication, start and stop date were not reported. The patient experienced shortness of breath, left side of her body, leg, arm and face started to get numb, dizziness, sharp pain in neck, fever, nauseating headache, body ache and reduced mobility of left arm on 27Feb2021 at 20:15. Patient not had COVID prior vaccination. Patient was tested COVID post vaccination. Patient not administered other vaccine in four weeks. Patient did not receive any treatment as a result of event. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: shortness of breath; left side of her body - leg, arm and face - started to get numb; Dizziness; sharp pain in neck; fever; nauseating headache; nauseating headache; body ache; reduced mobility of left arm; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 27Feb2021 at 20:00 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included food allergy (Known allergy: cucumber). Patient was not pregnant. Patient not administered other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), fluoxetine, collagen; all taken for an unspecified indication, start and stop date were not reported. The patient experienced shortness of breath, left side of her body, leg, arm and face started to get numb, dizziness, sharp pain in neck, fever, nauseating headache, body ache and reduced mobility of left arm on 27Feb2021 at 20:15. Patient not had COVID prior vaccination. Patient was tested COVID post vaccination. Patient not administered other vaccine in four weeks. Patient did not receive any treatment as a result of event. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: feeling miserable; Chills; Extreme tiredness; fever 101-102; severe aches; Exhaustion; This is a spontaneous report from a contactable nurse. A 59-years-old non-pregnant female nurse (Patient) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 09:30 (at the age of 59 years) as dose number unknown, single for covid-19 immunisation. Medical history included allergies to several antibiotics and covid-19 (prior to vaccination). It was reported that patient had not tested Covid Post Vaccination. Patient was not received any other vaccine in four weeks nor any medications in two weeks. There were no concomitant medications. On 09Feb2021, the patient experienced Exhaustion and Chills in the evening and severe aches keeping me awake most of the night, Extreme tiredness, fever 101-102, and feeling miserable most of Thursday. Patient ate soup at 5 and fine thereafter. Patient was not received any treatment for the events. On an unknown date, patient had recovered from all the events.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Headache, Rash
Clinical narrative: vivid dreams; fatigue; headache; rash on my neck; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date Had COVID in Dec and recovered, autoimmune disorder from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced vivid dreams, fatigue, headache, rash on my neck. Patient wanted to know whether she can receive the second dose of vaccination. The outcome of the events abnormal dreams, fatigue, headache, rash was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Lip swelling, Rash erythematous, Sinus pain
Clinical narrative: can't breathe; her back and chest had the red rash; glands in her neck were tender for about 4 or 5 days; upper lip swelled; had a hard time swallowing; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date, number was not reported), via an unspecified route of administration, administered in Arm Right on 10Feb2021 00:45 (Age at vaccination 70-years-old) as dose 1, single for covid-19 immunisation. Medical history included cancer, allergic to penicillin and sulfars, and caller had 3 eye surgeries in 8 months and she was given a couple eye drops that she had horrible reactions tofrom from an unknown date and unknown if ongoing. The patient's concomitant medications, she takes a high blood pressure medicine, that is a beta blocker, and some cholesterol drugs, and eye drops, but caller did not take anything the same day as her COVID vaccine that was unusual. No further details, or product names, were provided by the caller. Caller explained she had a reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine and is scheduled to receive the second dose of the vaccine this Wednesday. She asked Can I take Benadryl before of after this second injection. Caller states that she is going for her second shot Wednesday at the hospital, and she is kind of nervous to take the second dose. Caller states that she is allergic to penicillins, she swells up and can't breathe and gets hives. Caller states that she had the same thing happen with this vaccine, about 24 hours after getting the injection, her upper lip swelled, she had a hard time swallowing on 11Feb2021, and her back and chest had the red rash. Caller states that it lasted about an hour, but now she is kind of nervous to take the second shot and she is wondering if it is okay to take Benadryl before or after getting the shot. Caller had her shot on 10Feb2021, and it was about 24 hours later that her symptoms occurred. Caller reports that most of her symptoms resolved within an hour, but her glands in her neck were tender for about 4 or 5 days following her side effects. Patient had no other vaccines on the same day as the suspect product. Patient considered going to the ER, but her symptoms resolved within an hour. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. The outcome of events her back and chest had the red rash and hard time swallowing was recovered on 11Feb2021, hard time swallowing was recovered on unspecified date and rest of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: extreme chills; body ache; slight fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included covid-19 and spent two weeks in the hospital battling the virus , lung carcinoma cell type unspecified stage iv I also have stage 4 lung cancer which I take Alectinib from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took alectinib. On an unspecified date, the patient experienced extreme chills, body ache, slight fever. It was further reported that does anyone else have similar reporting of these side effects as it might make my decision as to take the second dose of Pfizer vaccine or not easier. The clinical outcome for all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: Severe chills; headache; Dizziness; short of breath; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL9265) via an unspecified route of administration in left arm on 23Feb2021 07:00 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history was not reported. The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications included lisinopril, atorvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3249) via an unspecified route of administration in left arm on 02Feb2021 07:00 as dose 1, single for COVID-19 immunization. The patient experienced severe chills, headache, dizziness, short of breath on 23Feb2021 20:00. The patient did not receive any treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Sars-cov-2 test (reported as Rapid test Covid test) (Nasal Swab) with result as negative on 26Feb2021. The outcome of the event was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Product administered at inappropriate site, Swollen tongue
Clinical narrative: receiving her vaccine in her thigh; her tongue and lips felt fuzzy; her face was red; tongue felt like it was fuzzy and swelling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6201, NDC number: unknown) dose 1 via an unspecified route of administration, administered in thigh on 28Feb2021 (at the age of 61-years) as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from Dec2005 to an unknown date, lymphoedema from 2009 to an unknown date, had surgery to remove lymph nodes in both arms on an unspecified date. There were no concomitant medications. No PQC was present. Investigation assessment was not provided. On 28Feb2021, the patient received her vaccine in her thigh, her tongue and lips felt fuzzy, her face was red, tongue felt like it was fuzzy and swelling. Patient stated that the symptoms left about 10 or 11 minutes, so they were not there the full 15 minutes and after they drove away, she said she was not making this up and she took off her mask and her face was red. The symptoms disappeared within an hour. Her husband was not concerned at all about the second dose and her brother was a physician as well and he isn't alarmed, but she wanted to double check with Pfizer to see if they have any information on experiences like this. She kind of wanted to know if there were other reports from people like this as well. The clinical outcome of the events her tongue and lips felt fuzzy, her face was red, tongue felt like it was fuzzy, and swelling was reported as recovered on an unspecified date of 2021 and clinical outcome of the event receiving her vaccine in her thigh was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Swelling face
Clinical narrative: rash from head to toe; chills; face swelled up; This is a spontaneous report from a contactable consumer (Patient) reported for self. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration on 24Feb2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included thyroid disorder (Thyroid) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported. Investigation assessment reported as no. Patient wanted to report symptoms after the Pfizer vaccine. On 24Feb2021 Patient had rash all over body and swelled up a little hands, face everything and got the chills. Patient was in the last stages hopefully of rash disappearing. Rash all over my body from head to toe. Second dose schedule on 17Mar2021. Patient was asking, will experience the same side effects on the second dose with what experienced in the first dose. If it would be safe to get only one dose of the vaccine? Patient took Benadryl. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; today patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose.; This is a spontaneous report from a contactable Pharmacist.   A 23-years-old female patient received bnt162b2 (Pfizer Covid-19 vaccine, Formulation: Solution for injection) dose 1 via intramuscular route of administration on an unspecified date (Lot unknown-not reported) as dose 1, single for COVID-19 immunisation. The patient medical history included PEG (unknown product, unknown reaction). The patient previously received Typhoid vaccine (unknown reaction) and patient experienced allergy. The patients pregnant condition was unknown. Patient stated that she did have a previous reaction of hives, rash, and itching for 2 weeks status post 1st vaccine dose. Patient observation continued and it was found that after calling patients mother that the patient did have a reaction to the Typhoid Vaccine in the past with a noted PEG Allergy. The outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash erythematous, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: swelling, redness, itching at injection site. "size of nickel. little red bumps around it; red spots; Swelling arm; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 22Feb2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took ace inhibitors and experienced drug allergy. The patient had no concomitant medications. Caller got dose on 22Feb2021 approximately 12 noon, the following symptoms began Tuesday night was swelling, redness, itching at injection site. Size of nickel. Little red bumps around it. Caller asked, should I be taking any action on this. Caller voices concerns about going to be evaluated by a health care professional since this was a new vaccine with limited information. Caller believes health care professional will not know how to evaluate and treat her symptoms. She was called about the vaccine for COVID. She has concerns, she took it last Monday, and experienced mild side effects. She had swelling on the arm. As the week progressed, she began to itch and have red spots, it still persists. She was just wondering was this an issue that will dissipate or should she be concerned. The Swelling started the same day as receiving the vaccine on 22Feb2021 it now gone but there was a little hard skin around the area, harder than the other skin. She has recovered with lasting effects. The Itch and red spots started approximately on 24Feb2021, it was still ongoing vacillates, it was more intense at time yet less at times, it was fluctuating up and down. Regarding COVID vaccine card, she just stated her name and birthday. Her second dose schedule, which she was recalled from her memory, was on 15Mar2021 at about 10 she thinks. She was just taking her normal stuff, she takes lotions and vitamins, she was nothing new. The outcome of red spots, swelling arm was recovered with sequelae and rest all the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling, redness, itching at injection site. "size of nickel. little red bumps around it; red spots; Swelling arm; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; swelling, redness, itching at injection site. "size of nickel. little red bumps around it; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 22Feb2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took ace inhibitors and experienced drug allergy. The patient had no concomitant medications. Caller got dose on 22Feb2021 approximately 12 noon, the following symptoms began Tuesday night was swelling, redness, itching at injection site. Size of nickel. Little red bumps around it. Caller asked, should I be taking any action on this. Caller voices concerns about going to be evaluated by a health care professional since this was a new vaccine with limited information. Caller believes health care professional will not know how to evaluate and treat her symptoms. She was called about the vaccine for COVID. She has concerns, she took it last Monday, and experienced mild side effects. She had swelling on the arm. As the week progressed, she began to itch and have red spots, it still persists. She was just wondering was this an issue that will dissipate or should she be concerned. The Swelling started the same day as receiving the vaccine on 22Feb2021 it now gone but there was a little hard skin around the area, harder than the other skin. She has recovered with lasting effects. The Itch and red spots started approximately on 24Feb2021, it was still ongoing vacillates, it was more intense at time yet less at times, it was fluctuating up and down. Regarding COVID vaccine card, she just stated her name and birthday. Her second dose schedule, which she was recalled from her memory, was on 15Mar2021 at about 10 she thinks. She was just taking her normal stuff, she takes lotions and vitamins, she was nothing new. The outcome of red spots, swelling arm was recovered with sequelae and rest all the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; her arm was a little sore; hoarseness/raspiness of the voice; pressure in the chest; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age(Age: 71; Unit: Unknown)  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 27Feb2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Feb2021 the patient experienced sore throat, her arm was a little sore, hoarseness and raspiness of the voice and pressure in the chest. The outcome of event her arm was a little sore was unknown while outcome of rest all events was recovered on 27Feb2021  No follow up attempts are possible; information on Lot/batch number cannot be obtained.