chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit; Left arm sore; Left arm was just a little swollen; A little swollen in her left underarm and armpit; Started getting hot and cold and hot and cold; Achy; Nauseous/Feeling like she was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration in the left arm, first dose on 19Dec2020 07:30 at a single dose for vaccination. Medical history included ongoing colitis ulcerative when she was 23 years old (1993), POTS (Postural Orthostatic Tachycardia Syndrome) from 2017 and ongoing, had thyroid problem, with heart medication.  Concomitant medication included prednisone, levothyroxine sodium (SYNTHROID), irbesartan, bisoprolol fumarate, fluticasone and potassium. The patient stopped prednisone about 4-5 days before COVID-19 Vaccine administered. She talked to her doctor about prednisone use and getting COVID-19 Vaccine, doctor told her to go ahead and get COVID-19 Vaccine. The patient is a Certified Nursing Assistant who received the Pfizer COVID-19 Vaccine at her place of employment on 19Dec2020. This was her first dose of 2 dose series of the vaccine. She reported after she received the vaccine injection, she had onset of 'achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, she started getting hot and cold and hot and cold, feeling like she was going to throw up and was running a temperature. She added that at the night of 19Dec2020 she felt achy and a little nauseous but it was not bad so she took some TYLENOL and she was feeling fine. She stayed at work Saturday. Starting morning of 20Dec2020 she woke up and her left arm felt like she had gotten a tetanus shot, left arm was sore and just a little swollen and she was a little swollen in her left underarm and armpit; she felt achy all over again; so she took some more TYLENOL and went to work and was feeling fine until about lunch time on 20Dec2020. Around lunch time on 20Dec2020, she started getting hot and cold and hot and cold, feeling like she was going to throw up; by about 4:30pm on 20Dec2020 she was running a temperature of 100.3 degrees Fahrenheit. The highest her temperature got up to last night was 101.9 degrees Fahrenheit. She took a Tylenol PM to knock her out to sleep because she was achy. The outcome of the events achy, nauseous, left arm sore, left arm was just a little swollen, a little swollen in her left underarm and armpit, started getting hot and cold and hot and cold, feeling like she was going to throw up, and she was running a temperature of 100.3 degrees Fahrenheit/highest her temperature got up to last night was 101.9 degrees Fahrenheit was recovering.  Information about Batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Full blood count, Laboratory test, Swelling
Clinical narrative: Pt developed "intense dizziness" following vaccine and also noted she had not yet eaten.  She was given crackers and juice and monitored for about 45 minutes.  She felt better and was cleared to go home.  Some hours later, around 2pm of the same day, she felt like her face was swelling and was feeling short of breath and faint.  She called 911 and administered her own EPI pen, took 30 mg of prednisone, and 50 mg of Benadryl.  This improved symptoms.  EMS transported her to the ED for further evaluation.  ED found no signs of anaphylaxis and ordered chest x-rays and basic labs.  Pt given an additional 30 mg of prednisone.  She was released with instructions to continue the prednisone for 3 days.  She then presented back to the ED a few hours later because she felt her neck was swelling.  She was given IV fluids and Pepcid and admitted for observation.  She felt better overnight but experienced exertional dyspnea.  She was treated with albuterol and symptoms improved.  She was discharged 12/27 on a prednisone taper due to her dyspnea and hx of reactive airways.  She returned a third time to the ED (12/28 at 7:22pm) complaining of a swollen throat, light-headedness, and some nausea but no vomiting.  She is currently in observation status and has been treated with Benadryl, Pepcid, and Albuterol, with oxygen as needed (she is currently at 98% on room air).  Infectious Disease has been consulted.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Dyspnoea exertional, Nausea, Pharyngeal swelling
Clinical narrative: Pt developed "intense dizziness" following vaccine and also noted she had not yet eaten.  She was given crackers and juice and monitored for about 45 minutes.  She felt better and was cleared to go home.  Some hours later, around 2pm of the same day, she felt like her face was swelling and was feeling short of breath and faint.  She called 911 and administered her own EPI pen, took 30 mg of prednisone, and 50 mg of Benadryl.  This improved symptoms.  EMS transported her to the ED for further evaluation.  ED found no signs of anaphylaxis and ordered chest x-rays and basic labs.  Pt given an additional 30 mg of prednisone.  She was released with instructions to continue the prednisone for 3 days.  She then presented back to the ED a few hours later because she felt her neck was swelling.  She was given IV fluids and Pepcid and admitted for observation.  She felt better overnight but experienced exertional dyspnea.  She was treated with albuterol and symptoms improved.  She was discharged 12/27 on a prednisone taper due to her dyspnea and hx of reactive airways.  She returned a third time to the ED (12/28 at 7:22pm) complaining of a swollen throat, light-headedness, and some nausea but no vomiting.  She is currently in observation status and has been treated with Benadryl, Pepcid, and Albuterol, with oxygen as needed (she is currently at 98% on room air).  Infectious Disease has been consulted.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Pt developed "intense dizziness" following vaccine and also noted she had not yet eaten.  She was given crackers and juice and monitored for about 45 minutes.  She felt better and was cleared to go home.  Some hours later, around 2pm of the same day, she felt like her face was swelling and was feeling short of breath and faint.  She called 911 and administered her own EPI pen, took 30 mg of prednisone, and 50 mg of Benadryl.  This improved symptoms.  EMS transported her to the ED for further evaluation.  ED found no signs of anaphylaxis and ordered chest x-rays and basic labs.  Pt given an additional 30 mg of prednisone.  She was released with instructions to continue the prednisone for 3 days.  She then presented back to the ED a few hours later because she felt her neck was swelling.  She was given IV fluids and Pepcid and admitted for observation.  She felt better overnight but experienced exertional dyspnea.  She was treated with albuterol and symptoms improved.  She was discharged 12/27 on a prednisone taper due to her dyspnea and hx of reactive airways.  She returned a third time to the ED (12/28 at 7:22pm) complaining of a swollen throat, light-headedness, and some nausea but no vomiting.  She is currently in observation status and has been treated with Benadryl, Pepcid, and Albuterol, with oxygen as needed (she is currently at 98% on room air).  Infectious Disease has been consulted.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood calcium, Blood creatine phosphokinase, Blood creatinine, Blood electrolytes, Blood glucose
Clinical narrative: Patient presented five days after first COVID vaccine with complaints of tingling running down her arm (peripheral paresthesias per MD report) and also swelling and redness at injection site.  She does also complain of feeling a little achy the day following her vaccination. She was given prednisone and diphenyhdramine while in the ED.  She was prescribed prednisone (20 mg x 3 days) upon discharge.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Blood urea, Computerised tomogram, Computerised tomogram head, Full blood count
Clinical narrative: Patient presented five days after first COVID vaccine with complaints of tingling running down her arm (peripheral paresthesias per MD report) and also swelling and redness at injection site.  She does also complain of feeling a little achy the day following her vaccination. She was given prednisone and diphenyhdramine while in the ED.  She was prescribed prednisone (20 mg x 3 days) upon discharge.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Livedo reticularis, Paraesthesia
Clinical narrative: Patient presented five days after first COVID vaccine with complaints of tingling running down her arm (peripheral paresthesias per MD report) and also swelling and redness at injection site.  She does also complain of feeling a little achy the day following her vaccination. She was given prednisone and diphenyhdramine while in the ED.  She was prescribed prednisone (20 mg x 3 days) upon discharge.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Computerised tomogram head normal, Computerised tomogram normal, Full blood count normal, Injection site erythema
Clinical narrative: Patient presented five days after first COVID vaccine with complaints of tingling running down her arm (peripheral paresthesias per MD report) and also swelling and redness at injection site.  She does also complain of feeling a little achy the day following her vaccination. She was given prednisone and diphenyhdramine while in the ED.  She was prescribed prednisone (20 mg x 3 days) upon discharge.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Pain, Paraesthesia
Clinical narrative: Patient presented five days after first COVID vaccine with complaints of tingling running down her arm (peripheral paresthesias per MD report) and also swelling and redness at injection site.  She does also complain of feeling a little achy the day following her vaccination. She was given prednisone and diphenyhdramine while in the ED.  She was prescribed prednisone (20 mg x 3 days) upon discharge.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Electroencephalogram, Pruritus, Psychogenic seizure, Swollen tongue
Clinical narrative: Patient was experiencing itching of trunk, patient was placed in chair, and continued to experience worsening itching, she received epinephrine and then seemed to experience seizure like reactions, was stuttering her speech.  911 2as called and when she was being transported to the hospital had difficulty speaking.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus, Urticaria
Clinical narrative: Patient was experiencing itching of trunk, patient was placed in chair, and continued to experience worsening itching, she received epinephrine and then seemed to experience seizure like reactions, was stuttering her speech.  911 2as called and when she was being transported to the hospital had difficulty speaking.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphemia, Pruritus, Seizure like phenomena, Speech disorder
Clinical narrative: Patient was experiencing itching of trunk, patient was placed in chair, and continued to experience worsening itching, she received epinephrine and then seemed to experience seizure like reactions, was stuttering her speech.  911 2as called and when she was being transported to the hospital had difficulty speaking.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Hypoaesthesia, Urticaria
Clinical narrative: The vaccine was administered on the following date: 12/28/20 and at approximately the following time: 12:20pm   The symptoms began 5 min after administration of the vaccine.  The symptoms were:  5 min after vaccine had hives, felt itchy and warm. Symptoms were on chest, face and scalp.  Tingling in her arm and left jaw tingling. She did not have swelling, wheezing, SOB, dysphagia, GI symptoms. She went to the ER- given IV benadryl, pepcid, solumedrol.  30 min it felt much better By the time she left 2 h later, she felt much better.  She had some blotchiness and itcihng on her skin this AM (24h later) so she took allegra. She was prescribed prednisone but has not yet picked it up.  The treatment of the reaction was:   o Antihistamines: benadryl 25mg, famotidine 20mg o Steroids: methylprednisolone 125mg in the ER o Epinephrine: none   Other medications taken on day of reaction:  zoloft and MVI- taken for years. Other possible exposures (e.g. foods): none Was this the first dose of the vaccine?: yes Location of injection site: Left upper arm Other pertinent past medical history: none  History of COVID infection: no  History of systemic allergic reactions to drugs, foods, vaccine: none Other pertinent medications: none
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Pruritus, Rash macular, Skin warm, Urticaria
Clinical narrative: The vaccine was administered on the following date: 12/28/20 and at approximately the following time: 12:20pm   The symptoms began 5 min after administration of the vaccine.  The symptoms were:  5 min after vaccine had hives, felt itchy and warm. Symptoms were on chest, face and scalp.  Tingling in her arm and left jaw tingling. She did not have swelling, wheezing, SOB, dysphagia, GI symptoms. She went to the ER- given IV benadryl, pepcid, solumedrol.  30 min it felt much better By the time she left 2 h later, she felt much better.  She had some blotchiness and itcihng on her skin this AM (24h later) so she took allegra. She was prescribed prednisone but has not yet picked it up.  The treatment of the reaction was:   o Antihistamines: benadryl 25mg, famotidine 20mg o Steroids: methylprednisolone 125mg in the ER o Epinephrine: none   Other medications taken on day of reaction:  zoloft and MVI- taken for years. Other possible exposures (e.g. foods): none Was this the first dose of the vaccine?: yes Location of injection site: Left upper arm Other pertinent past medical history: none  History of COVID infection: no  History of systemic allergic reactions to drugs, foods, vaccine: none Other pertinent medications: none
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: The vaccine was administered on the following date: 12/28/20 and at approximately the following time: 12:20pm   The symptoms began 5 min after administration of the vaccine.  The symptoms were:  5 min after vaccine had hives, felt itchy and warm. Symptoms were on chest, face and scalp.  Tingling in her arm and left jaw tingling. She did not have swelling, wheezing, SOB, dysphagia, GI symptoms. She went to the ER- given IV benadryl, pepcid, solumedrol.  30 min it felt much better By the time she left 2 h later, she felt much better.  She had some blotchiness and itcihng on her skin this AM (24h later) so she took allegra. She was prescribed prednisone but has not yet picked it up.  The treatment of the reaction was:   o Antihistamines: benadryl 25mg, famotidine 20mg o Steroids: methylprednisolone 125mg in the ER o Epinephrine: none   Other medications taken on day of reaction:  zoloft and MVI- taken for years. Other possible exposures (e.g. foods): none Was this the first dose of the vaccine?: yes Location of injection site: Left upper arm Other pertinent past medical history: none  History of COVID infection: no  History of systemic allergic reactions to drugs, foods, vaccine: none Other pertinent medications: none
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Hypoaesthesia, Pain in extremity, Pulmonary pain
Clinical narrative: hurts to breathe or move; severe pleuritic pain at the right ribcage; abdominal pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She experienced abdominal pain 14 hours after receiving the vaccine (went away after 6 hours). At 26 hours after she experienced severe pleuritic pain at the right ribcage (vaccine was injected on her left arm), saturation is at mid 90s, and it hurts to breathe or move. The outcome of the event abdominal pain was recovered, while unknown for the other events.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: hurts to breathe or move; severe pleuritic pain at the right ribcage; abdominal pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She experienced abdominal pain 14 hours after receiving the vaccine (went away after 6 hours). At 26 hours after she experienced severe pleuritic pain at the right ribcage (vaccine was injected on her left arm), saturation is at mid 90s, and it hurts to breathe or move. The outcome of the event abdominal pain was recovered, while unknown for the other events.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Pain, Painful respiration, Pleuritic pain
Clinical narrative: hurts to breathe or move; severe pleuritic pain at the right ribcage; abdominal pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She experienced abdominal pain 14 hours after receiving the vaccine (went away after 6 hours). At 26 hours after she experienced severe pleuritic pain at the right ribcage (vaccine was injected on her left arm), saturation is at mid 90s, and it hurts to breathe or move. The outcome of the event abdominal pain was recovered, while unknown for the other events.   Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling jittery, Impaired work ability, Rash, Swelling face
Clinical narrative: thin red line on back of neck/redness at her right eyebrow and in the midline of her forehead/reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand; Rash; dot markings on her left hand and redness which is where she received vaccine in her left arm; dot markings on her left hand and redness which is where she received vaccine in her left arm; reddened area above eyebrow along with puffiness, redness on nose, cheeks; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via intramuscular in left deltoid on 19Dec2020 10:30 at single dose for COVID-19 immunization. Medical history included hypertension diagnosed when she was 47, hypothyroidism diagnosed 20 years ago and allergic to penicillin and sulfur; all ongoing. Concomitant medication included ongoing metoprolol succinate for hypertension. The patient received her first dose of vaccine on Friday 19Dec2020 at her job. Stated that she woke up Saturday with redness at her right eyebrow and in the midline of her forehead between her eyebrows and nose. Stated that she had dot markings on her left hand and redness which is where she received vaccine in her left arm. Stated that she had went to ER and was put on Prednisone 60mg for 5 days and Benadryl 50mg prn. Stated that a few people said few different things. Stated that she is allergic to penicillin and sulfur. No further details provided. The patient wanted to know if sulfur is in the vaccine to know if in three weeks should she take the second vaccine. On 19Dec2020, states she had a rash when she woke up. The patient had reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand. The patient went to the emergency department and an HCP saw a thin red line on back of neck. The patient was prescribed prednisone and benadryl and now symptoms have resolved. The patient was asking about more information regarding this type of reaction. The outcome of the event rash was recovered on unspecified date and the remaining events was recovered on 20Dec2020. The events were reported as non serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: thin red line on back of neck/redness at her right eyebrow and in the midline of her forehead/reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand; Rash; dot markings on her left hand and redness which is where she received vaccine in her left arm; dot markings on her left hand and redness which is where she received vaccine in her left arm; reddened area above eyebrow along with puffiness, redness on nose, cheeks; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via intramuscular in left deltoid on 19Dec2020 10:30 at single dose for COVID-19 immunization. Medical history included hypertension diagnosed when she was 47, hypothyroidism diagnosed 20 years ago and allergic to penicillin and sulfur; all ongoing. Concomitant medication included ongoing metoprolol succinate for hypertension. The patient received her first dose of vaccine on Friday 19Dec2020 at her job. Stated that she woke up Saturday with redness at her right eyebrow and in the midline of her forehead between her eyebrows and nose. Stated that she had dot markings on her left hand and redness which is where she received vaccine in her left arm. Stated that she had went to ER and was put on Prednisone 60mg for 5 days and Benadryl 50mg prn. Stated that a few people said few different things. Stated that she is allergic to penicillin and sulfur. No further details provided. The patient wanted to know if sulfur is in the vaccine to know if in three weeks should she take the second vaccine. On 19Dec2020, states she had a rash when she woke up. The patient had reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand. The patient went to the emergency department and an HCP saw a thin red line on back of neck. The patient was prescribed prednisone and benadryl and now symptoms have resolved. The patient was asking about more information regarding this type of reaction. The outcome of the event rash was recovered on unspecified date and the remaining events was recovered on 20Dec2020. The events were reported as non serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: thin red line on back of neck/redness at her right eyebrow and in the midline of her forehead/reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand; Rash; dot markings on her left hand and redness which is where she received vaccine in her left arm; dot markings on her left hand and redness which is where she received vaccine in her left arm; reddened area above eyebrow along with puffiness, redness on nose, cheeks; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via intramuscular in left deltoid on 19Dec2020 10:30 at single dose for COVID-19 immunization. Medical history included hypertension diagnosed when she was 47, hypothyroidism diagnosed 20 years ago and allergic to penicillin and sulfur; all ongoing. Concomitant medication included ongoing metoprolol succinate for hypertension. The patient received her first dose of vaccine on Friday 19Dec2020 at her job. Stated that she woke up Saturday with redness at her right eyebrow and in the midline of her forehead between her eyebrows and nose. Stated that she had dot markings on her left hand and redness which is where she received vaccine in her left arm. Stated that she had went to ER and was put on Prednisone 60mg for 5 days and Benadryl 50mg prn. Stated that a few people said few different things. Stated that she is allergic to penicillin and sulfur. No further details provided. The patient wanted to know if sulfur is in the vaccine to know if in three weeks should she take the second vaccine. On 19Dec2020, states she had a rash when she woke up. The patient had reddened area above eyebrow along with puffiness, redness on nose, cheeks and left hand. The patient went to the emergency department and an HCP saw a thin red line on back of neck. The patient was prescribed prednisone and benadryl and now symptoms have resolved. The patient was asking about more information regarding this type of reaction. The outcome of the event rash was recovered on unspecified date and the remaining events was recovered on 20Dec2020. The events were reported as non serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling jittery, Impaired work ability, Rash, Swelling face
Clinical narrative: redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line; right eyebrow was swollen and neck had a thin red line; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization.  Medical history included hypertension (diagnosed at 47 years old ), hypothyroidism, Hashimoto's disease from 2000 to an unknown date (diagnosed 20 years ago), anxious person and weight loss.  Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN), taken for blood pressure from 2000 to an unspecified date, levothyroxine sodium (SYNTHROID), taken for hypothyroidism and Hashimoto's disease from 2015 to an unspecified date, rosuvastatin calcium (CRESTOR), taken prophylactically from 2010 to an unspecified date and semaglutide (OZEMPIC) taken for weight loss from May2020 to an unspecified date.  Family history included; the patients mother had an allergy to Sulfa and allergy to penicillin and the patients father had unspecified allergies and hay fever.  There were no prior vaccinations within 4 weeks. On 19Dec2020, the patient experienced redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line and right eyebrow was swollen.  The reporter considered the events to be non-serious. The patient was worried about anaphylaxis, so they went to the emergency room (ER) for the reported events but was not admitted.  The patient was treated in the ER for the events with diphenhydramine hydrochloride (BENADRYL), prednisone (MANUFACTURER UNKNOWN) and famotidine (PEPCID).  Relevant tests were none.  The outcome of the events was recovering.  The reporter stated that there was a reasonable possibility that the events were related to the suspect product.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line; right eyebrow was swollen and neck had a thin red line; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization.  Medical history included hypertension (diagnosed at 47 years old ), hypothyroidism, Hashimoto's disease from 2000 to an unknown date (diagnosed 20 years ago), anxious person and weight loss.  Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN), taken for blood pressure from 2000 to an unspecified date, levothyroxine sodium (SYNTHROID), taken for hypothyroidism and Hashimoto's disease from 2015 to an unspecified date, rosuvastatin calcium (CRESTOR), taken prophylactically from 2010 to an unspecified date and semaglutide (OZEMPIC) taken for weight loss from May2020 to an unspecified date.  Family history included; the patients mother had an allergy to Sulfa and allergy to penicillin and the patients father had unspecified allergies and hay fever.  There were no prior vaccinations within 4 weeks. On 19Dec2020, the patient experienced redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line and right eyebrow was swollen.  The reporter considered the events to be non-serious. The patient was worried about anaphylaxis, so they went to the emergency room (ER) for the reported events but was not admitted.  The patient was treated in the ER for the events with diphenhydramine hydrochloride (BENADRYL), prednisone (MANUFACTURER UNKNOWN) and famotidine (PEPCID).  Relevant tests were none.  The outcome of the events was recovering.  The reporter stated that there was a reasonable possibility that the events were related to the suspect product.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line; right eyebrow was swollen and neck had a thin red line; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization.  Medical history included hypertension (diagnosed at 47 years old ), hypothyroidism, Hashimoto's disease from 2000 to an unknown date (diagnosed 20 years ago), anxious person and weight loss.  Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN), taken for blood pressure from 2000 to an unspecified date, levothyroxine sodium (SYNTHROID), taken for hypothyroidism and Hashimoto's disease from 2015 to an unspecified date, rosuvastatin calcium (CRESTOR), taken prophylactically from 2010 to an unspecified date and semaglutide (OZEMPIC) taken for weight loss from May2020 to an unspecified date.  Family history included; the patients mother had an allergy to Sulfa and allergy to penicillin and the patients father had unspecified allergies and hay fever.  There were no prior vaccinations within 4 weeks. On 19Dec2020, the patient experienced redness above eyebrow, nose and cheek and left hand had few reddened marks on skin, neck had a thin red line and right eyebrow was swollen.  The reporter considered the events to be non-serious. The patient was worried about anaphylaxis, so they went to the emergency room (ER) for the reported events but was not admitted.  The patient was treated in the ER for the events with diphenhydramine hydrochloride (BENADRYL), prednisone (MANUFACTURER UNKNOWN) and famotidine (PEPCID).  Relevant tests were none.  The outcome of the events was recovering.  The reporter stated that there was a reasonable possibility that the events were related to the suspect product.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: C/o itching and redness to arms and face approx. 20 minutes post vaccine administration.  Admin Benadryl 25mg po x1 per S.O.  1400-Pt reports itching is nearly resolved; redness improving.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pain, Pruritus, Pyrexia
Clinical narrative: Fever Chills Rash and hive Fatigue
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash, Urticaria
Clinical narrative: Fever Chills Rash and hive Fatigue
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: within 15 minute waiting period after vaccine, employee felt like she was going to black out, no LOC.  Increased BP 180/130 and tachycardia, HR 120's.  After sitting/resting, VS returned to normal and employee felt weak but better.  On 12/29 called employee and she had called in ill to work today for h/a, vomiting and is now reporting severe dizziness that she cannot stand up, chills with the h/a and vomiting.  She is taking Tylenol/ibuprofen.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Dysstasia
Clinical narrative: within 15 minute waiting period after vaccine, employee felt like she was going to black out, no LOC.  Increased BP 180/130 and tachycardia, HR 120's.  After sitting/resting, VS returned to normal and employee felt weak but better.  On 12/29 called employee and she had called in ill to work today for h/a, vomiting and is now reporting severe dizziness that she cannot stand up, chills with the h/a and vomiting.  She is taking Tylenol/ibuprofen.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Tachycardia, Vomiting
Clinical narrative: within 15 minute waiting period after vaccine, employee felt like she was going to black out, no LOC.  Increased BP 180/130 and tachycardia, HR 120's.  After sitting/resting, VS returned to normal and employee felt weak but better.  On 12/29 called employee and she had called in ill to work today for h/a, vomiting and is now reporting severe dizziness that she cannot stand up, chills with the h/a and vomiting.  She is taking Tylenol/ibuprofen.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Feeling abnormal
Clinical narrative: Feeling lightheaded and faint 40 minutes after vaccine, heart racing, tightness in chest, trouble breathing, shortness of breath, tongue felt heavy, lips puffy. Transferred to ER. Needed oxygen and was being monitored due to spiked blood pressure. Was given 40 mg of Prednisone. Sent home but still didn't feel right. Went back to the ER later in the evening due to chest tightness and heart racing. EKG showed spikes in heart rate. Sent home after vitals stabilized.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Feeling lightheaded and faint 40 minutes after vaccine, heart racing, tightness in chest, trouble breathing, shortness of breath, tongue felt heavy, lips puffy. Transferred to ER. Needed oxygen and was being monitored due to spiked blood pressure. Was given 40 mg of Prednisone. Sent home but still didn't feel right. Went back to the ER later in the evening due to chest tightness and heart racing. EKG showed spikes in heart rate. Sent home after vitals stabilized.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Feeling abnormal, Heart rate increased, Lip swelling, Oxygen therapy
Clinical narrative: Feeling lightheaded and faint 40 minutes after vaccine, heart racing, tightness in chest, trouble breathing, shortness of breath, tongue felt heavy, lips puffy. Transferred to ER. Needed oxygen and was being monitored due to spiked blood pressure. Was given 40 mg of Prednisone. Sent home but still didn't feel right. Went back to the ER later in the evening due to chest tightness and heart racing. EKG showed spikes in heart rate. Sent home after vitals stabilized.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tongue discomfort
Clinical narrative: Feeling lightheaded and faint 40 minutes after vaccine, heart racing, tightness in chest, trouble breathing, shortness of breath, tongue felt heavy, lips puffy. Transferred to ER. Needed oxygen and was being monitored due to spiked blood pressure. Was given 40 mg of Prednisone. Sent home but still didn't feel right. Went back to the ER later in the evening due to chest tightness and heart racing. EKG showed spikes in heart rate. Sent home after vitals stabilized.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Received expired dose of ZOSTAVAX; This spontaneous report was received from a physician and refers to a 69-year-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 20-DEC-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) lot # N035033, expiration date: 07-MAR-2019 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Caller is a nurse calling to report a temperature excursion involving PROQUAD and VARlCELLA.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 09-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided, lot number T021302 which has been verified to be valid, expiration date reported as 29-DEC-2021, but upon internal review it was established as 19-DEC-2021), on an unknown date, the patient received varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). Both vaccines experienced a temperature excursion on 2 separate dates of -5 degrees Celsius (C) for 20 hours, by a time frame of 20 hours, as recorded by a data logger. There was no previous temperature excursion reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; post-expiry stability data of an expired dose of PNEUMOVAX23; This spontaneous report was received from a registered nurse referring to a 67-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 23-DEC-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S005856, expiration date 03-DEC-2020, 0.5 milliliter; route was not reported) for prophylaxis (expired product administered). No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); ; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Glaucoma drainage device placement, Guillain-Barre syndrome, Immediate post-injection reaction, Intraocular pressure increased, Ophthalmic herpes zoster
Clinical narrative: high ocular pressure was caused by the Herpes virus /  dormant in his system / This exacerbated it; My...... is......Guillain-Barre disease; high ocular pressure (over 40) / ended up with shunts in both eyes; This case was reported by a consumer via other manufacturer and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and increased intraocular pressure. On an unknown date, the outcome of the ophthalmic herpes zoster, guillain barre syndrome and increased intraocular pressure were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, guillain barre syndrome and increased intraocular pressure to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced Guillain-Barre disease.  The patient had a few side effects from it. The patient was not allowed to have the influenza vaccine and this had been highly publicized over the years on TV and also written instructions when one receive it.  So the patient had not taken the Flu vaccine now for many years. The patient took a while though for this information to be publicized not to get it.  Two years before, the patient received the Shingles vaccine. Shortly after he develop extremely high ocular pressure (over 40) and saw several eye specialists.  Finally one infection Ophthalmologist researched and found the cause of high ocular pressure was caused by the herpes virus which they think was dormant in his system until he received the Shingles vaccine. This exacerbated it. He ended up with shunts in both eyes as a result and had been on several eye drops daily. The concern was with new vaccine. The patient was afraid of what could happen if the fact he had Guillain-Barre disease and took this vaccine could cause any further problems.  That was they were asking if someone at Pfizer to reassure one way or other whether he should take this Covid 19 vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Warmth inside the right side of her throat / Warmth in her right arm and leg; Tingling and Warmth inside the right side of her throat / Tingling and Warmth in her right arm and leg; This case was reported by a consumer via call center representative and described the occurrence of localized feeling of warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, immediately after receiving Shingrix, the patient experienced localized feeling of warmth and localized tingling. In August 2020, the outcome of the localized feeling of warmth and localized tingling were recovered/resolved.   It was unknown if the reporter considered the localized feeling of warmth and localized tingling to be related to Shingrix.  Additional information was provided as follows: The patient experienced tingling and warmth inside the right side of her throat immediately after the injection.  The patient stated that within a few moments after the initial events, she had tingling and warmth in her right arm and leg. She stated that these sensations dissipated within five minutes. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Hyperhidrosis, Hysteroscopy, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Feeling of swelling of the upper lip and throat; Feeling of swelling of the upper lip and throat; Brief tongue tingling; her palms felt sweaty; her throat felt dry; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EH9899 and expiry date unknown) via an unspecified route of administration at the left arm on 19Dec2020 08:45AM at a single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included rare, mild exercise induced asthma with cold a few times in the past; history of pre-eclampsia; and known allergies: wheezing with iodine injected for a hysterogram in 2014. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 and has not received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 19Dec2020, 09:15 the patient experienced a feeling of swelling of the upper lip and throat. There was a brief tongue tingling about a half hour after the injection. Immediately after the injection, her palms felt sweaty and her throat felt dry. Therapeutic measures were taken in response to the events. The patient took Claritin about 9:15 and Benadryl 50 mg twice so far; the first was taken about 9:30AM. At 1:30 pm, the feeling of lip and throat swelling came back and she took 50 mg of Benadryl again. At the time of the last observation, the outcome of the events was not recovered. The events were reported as Non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Feeling of swelling of the upper lip and throat; Feeling of swelling of the upper lip and throat; Brief tongue tingling; her palms felt sweaty; her throat felt dry; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EH9899 and expiry date unknown) via an unspecified route of administration at the left arm on 19Dec2020 08:45AM at a single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included rare, mild exercise induced asthma with cold a few times in the past; history of pre-eclampsia; and known allergies: wheezing with iodine injected for a hysterogram in 2014. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 and has not received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 19Dec2020, 09:15 the patient experienced a feeling of swelling of the upper lip and throat. There was a brief tongue tingling about a half hour after the injection. Immediately after the injection, her palms felt sweaty and her throat felt dry. Therapeutic measures were taken in response to the events. The patient took Claritin about 9:15 and Benadryl 50 mg twice so far; the first was taken about 9:30AM. At 1:30 pm, the feeling of lip and throat swelling came back and she took 50 mg of Benadryl again. At the time of the last observation, the outcome of the events was not recovered. The events were reported as Non-serious.