chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: she was blacked out for a good 30-40 seconds; drenched and very sweaty; extremely hot; nauseated; A spontaneous  report was received from a consumer concerning a 25-year-old, female patient who received Moderna's COVID-19 vaccine and experienced blacking out, nausea, feeling extremely hot and sweaty.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included desogestrel-ethinylestradiol for birth control.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 16 Jan 2021, one day after the vaccination, the patient was found in the bathroom unconscious. The patient reported feeling very nauseated, extremely hot and drenched with sweat prior to blacking out. The duration of the blackout was approximately 30 to 40 seconds. Patient states she was washing hands, about to plug something in and next thing she knows she is being rolled over by her husband.  Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, blacking out, nausea, feeling extremely hot and sweaty, was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Hypoaesthesia, Neuralgia
Clinical narrative: Right arm numbness and tingling, joint pain right  wrist and hand  x 12 hours. Bilateral hip and knee pain-ongoing. Burning nerve pain in shoulder, neck and right side of face .x12 hours.  Ongoing low grade fever 99.5-100 and fatigue.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Right arm numbness and tingling, joint pain right  wrist and hand  x 12 hours. Bilateral hip and knee pain-ongoing. Burning nerve pain in shoulder, neck and right side of face .x12 hours.  Ongoing low grade fever 99.5-100 and fatigue.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Pruritus
Clinical narrative: Anaphylactic reaction; Had severe itching in the whole body; chills; A spontaneous report was received from a physician concerning a 80-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic reaction, severe itching in the whole body and chills.  The patient's medical history was not provided. Concomitant medications reported included tamsulosin, omperazole, simvastatin, amlodipine and finasteride all for unknown indications.  On an unknown date, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 01120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe itching and chills for about a day following vaccination. 2 days following vaccination, the subject experienced an anaphylactic reaction. He sought medical attention from his dermatologist who gave him the diagnosis. Treatment for the event included sertac at night, claritin in the morning, and betamethasone 0.05% cream.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events anaphylactic reaction, severe itching in the whole body and chills were unknown.; Reporter's Comments: This case concerns a 80-year old, male patient, who experienced a serious unexpected event of anaphylactic reaction and pruritus (had severe itching in the whole body), and a non-serious expected event of chills. The event of anaphylactic reaction occurred 2 days after first dose of mRNA-1273, lot # 011L20A. The event of, pruritus and chills occurred on an unspecified date after first dose of mRNA-1273, lot # 011L20A. Treatment included Sertac-one pill at night, Claritin- one pill in the morning and Betamethasone dipropionate 0.05% cream.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Developed cellulitis at the injection site; Injection site red; Injection site inflamed; Slight reaction; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a slight reaction, developed cellulitis at the injection site, injection site red and injection site inflamed.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient received the vaccine and had a slight reaction for one or two days. About five days later, the patient developed cellulitis at the injection site that was red and inflamed. Treatment for the event included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The event, slight reaction, was considered resolved on 13 Jan 2021. The outcome of the events, developed cellulitis at the injection site, injection site red and injection site inflamed were unknown.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of cellulitis at the injection site and non-serious events of injection site red and injection site inflamed. The events occurred approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The events are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. The non-serious events of injection site redness injection site inflamed, and injection site reaction are consistent with the known safety profile of the vaccine.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Injection site pain, Pyrexia
Clinical narrative: Mild fever, severe pain at site of vaccine injection Also bruising on forearm area same arm as vaccine injection
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock.    The patient's medical history was not provided.  Concomitant product use was not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced a severe reaction to the vaccine that resulted in being transported to the emergency room and treated for anaphylactic shock. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, anaphylactic shock, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of anaphylactic shock. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine. Treatment information was reported; however, patient was transported to emergency room.  Outcome of reported anaphylactic shock is unknown. The event was assessed as possibly related, however additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Injection site pain, Oropharyngeal discomfort, Throat irritation
Clinical narrative: Anaphylactic reaction; Scratchy throat; Pain-near injection site; A spontaneous report was received from a consumer concerning a 48-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, scratchy throat and pain near the injection site.  The patient's medical history included COVID-19. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) on 06 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, almost immediately after receiving the vaccine the patient reported having a scratchy throat and pain near the injection site. She stated she spoke with her health care provider who advised her she was having an anaphylactic reaction.  Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events anaphylactic reaction, scratchy throat and pain near the injection site were unknown.; Reporter's Comments: This case concerns a 48-year-old female patient. The patient experienced an unexpected event of Anaphylactic Reaction that was considered medically significant, and an unexpected non-serious event of Scratchy throat along with an expected non-serious event of pain near the injection site. The events occurred almost immediately after receiving first dose of first of two planned doses of mRNA-1273 (Lot number 039K20-2A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. Treatment included Benadryl. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform minor of hands and feet; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed erythema multiform minor of hands and feet.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient developed erythema multiform minor of hands and feet mostly. On 19 Jan 2021, the patient had a telehealth visit with an allergist, who confirmed the diagnosis. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, erythema multiform minor of hands and feet was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication is not provided. The patient experienced an unexpected and medically significant event of Erythema multiforme. The event occurred approximately seven days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Treatment details were not provided. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eyelid function disorder, Facial paralysis, Influenza like illness, Lacrimation increased
Clinical narrative: Bell's Palsy/ Facial paralysis/ Dropiness on the rightside; Light sensitivity; Tearing; Felt like flu; Sore; A spontaneous report was received from a 50 year-old, male patient who received Moderna's COVID-19 vaccine and experienced sore, felt like had the flu, light sensitivity, tearing of his right eye, Bell's palsy (right eye won't blink on its own, lip and speech issues).  The patient's medical history was not provided. Concomitant medications were not reported.  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A), intramuscularly in left arm, for prophylaxis of COVID-19 infection.  On 10 Jan 2021, he was sore, felt like had the flu. On 13 Jan 2021, he experienced light sensitivity, and tearing of his right eye. On 19 Jan 2021, he went to the emergency room and found with facial paralysis, droopiness on the right side. He was diagnosed with Bell's palsy (right eye won't blink on its own, lip and speech issues).  Treatment included Valtrex.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, sore, felt like had the flu was considered resolved on 11 Jan 2021. The outcome of the event, Bell's palsy (right eye won't blink on its own, lip and speech issues) was not recovered. The outcome of the events, light sensitivity, and tearing of right eye was unknown.; Reporter's Comments: This case concerns a 50-year-old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis and unexpected non-serious events of Influenza, Pain, Photophobia and Lacrimation increased. The events of Influenza and Pain occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 025J20A). Photophobia and Lacrimation increased occurred approximately four days after the first dose of mRNA-1273 (Lot number: 025J20A). Event of Facial Paralysis was diagnosed approximately ten days after the first dose of mRNA-1273 (Lot number: 025J20A). Treatment included Valtrex. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lip disorder, Pain, Photophobia, Sensitive skin, Speech disorder
Clinical narrative: Bell's Palsy/ Facial paralysis/ Dropiness on the rightside; Light sensitivity; Tearing; Felt like flu; Sore; A spontaneous report was received from a 50 year-old, male patient who received Moderna's COVID-19 vaccine and experienced sore, felt like had the flu, light sensitivity, tearing of his right eye, Bell's palsy (right eye won't blink on its own, lip and speech issues).  The patient's medical history was not provided. Concomitant medications were not reported.  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A), intramuscularly in left arm, for prophylaxis of COVID-19 infection.  On 10 Jan 2021, he was sore, felt like had the flu. On 13 Jan 2021, he experienced light sensitivity, and tearing of his right eye. On 19 Jan 2021, he went to the emergency room and found with facial paralysis, droopiness on the right side. He was diagnosed with Bell's palsy (right eye won't blink on its own, lip and speech issues).  Treatment included Valtrex.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, sore, felt like had the flu was considered resolved on 11 Jan 2021. The outcome of the event, Bell's palsy (right eye won't blink on its own, lip and speech issues) was not recovered. The outcome of the events, light sensitivity, and tearing of right eye was unknown.; Reporter's Comments: This case concerns a 50-year-old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis and unexpected non-serious events of Influenza, Pain, Photophobia and Lacrimation increased. The events of Influenza and Pain occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 025J20A). Photophobia and Lacrimation increased occurred approximately four days after the first dose of mRNA-1273 (Lot number: 025J20A). Event of Facial Paralysis was diagnosed approximately ten days after the first dose of mRNA-1273 (Lot number: 025J20A). Treatment included Valtrex. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Paraesthesia
Clinical narrative: I have had a swollen painful lymph node above my left collarbone..causing tingling and sometimes numbess aroind that area..notified where I was given the vaccine amd PCP..I was told to continue monitoring..the pain is still present for all that time
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swollen Tongue; A spontaneous report was received from a consumer concerning a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced swollen tongue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 31 Dec 2020, approximately 3 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, patient experienced swollen tongue. Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, swollen tongue was not reported.; Reporter's Comments: This case concerns a 63-years old female patient with unknown medical history subject, who experienced a serious unexpected event of swollen tongue. The event occurred three days after  first dose of mRNA-1273 vaccine. Treatment for the event included Benadryl.; however, outcome wasn't reported. The event was assessed as possibly related due to temporal association, however additional information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematochezia, Pain, Splenomegaly
Clinical narrative: Symptoms of an enlarged spleen; Blood in stool that lasted 3 days; General tiredness; A spontaneous report was received from a dentist, a 63 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced general tiredness, blood in stool that lasted 3 days, and symptoms of an enlarged spleen.  The patient's medical history, as provided by the reporter, included high blood pressure. No relevant concomitant medications were reported.   On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 026L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   On 04 Jan 2021, the patient had general tiredness.  On 16 Jan 2021, the patient experienced blood in his stool.   On 17 Jan 2021, the patient had symptoms of an enlarged spleen. He stated that he had intense pain on the side of the spleen. Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, blood in stool that lasted 3 days, was considered resolved on 19 Jan 2021. The outcome of the event, symptoms of an enlarged spleen, was considered resolved on 19 Jan 2021. The outcome of the event, general tiredness, was considered unknown.; Reporter's Comments: This case concerns a 63-years-old male patient, who experienced a medically significant unexpected event of blood in his stool, and non-serious unexpected event of Symptoms of an enlarged spleen along with expected non-serious event of General tiredness. General tiredness occurred on the same date after the first dose of mRNA-1273, lot # 026L20A. The event of blood in his stool occurred approximately 12 days after first dose of mRNA-1273, lot # 026L20A. The event of Symptoms of an enlarged spleen occurred approximately 13 days after first dose of mRNA-1273, lot # 026L20A. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema
Clinical narrative: Angioedema in the face; Redness in the face; A spontaneous report was received from a 37 year-old, female, nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema in the face and redness in the face.   The patient had a medical history of allergy to a lot of chemical compounds. No relevant concomitant medications were reported.   On 05 Jan 2021, 48 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026AL20A) intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, 48 hours after receiving the vaccine, the patient started with angioedema and some redness on the skin in her face. She stated it lasted for a complete week.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events angioedema in the face and redness in the face were resolved on 15 Jan 2021.; Reporter's Comments: This case concerns a 37-year-old female patient with relevant medical history of allergy to chemicals who experienced an unexpected medically significant event of Angioedema and an unexpected non-serious event of Erythema. The events occurred approximately 48 hours after receiving first dose of mRNA-1273 (Lot number: 026AL20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Patient's prior history of allergy to chemicals may have been contributory.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: First it was itchy, and then started scratched it a little.  Lifted up shirt sleeve and noticed big red blotches going  from mid arm down to close to the  elbow.  Arm is sore where the red blotches are.  No pain or blotches at the injection site, but lower on the arm
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Losing consciousness; Dizziness; Vomiting; Nausea; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced nausea, vomiting, dizziness, and losing consciousness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 18 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 18 Jan 2021, the patient reported having nausea and vomiting all night. Additionally, she also experienced dizziness and losing consciousness. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events nausea, vomiting, dizziness, and losing consciousness was unknown.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of losing consciousness and non-serious events of nausea and vomiting. The events occurred on the same day after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown).  No treatment was reported, and outcome is unknown.  Based on the information provided, which includes a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Nausea and vomiting are consistent with the known safety profile of mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Nausea, Pyrexia, Vomiting
Clinical narrative: erectile dysfunction; nausea; vomiting; fever; This is a spontaneous report from a contactable Nurse reporting for himself  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 19Jan2021  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient started experiencing side effects of nausea and vomiting. On an unspecified date (yesterday) he experienced a fever and last night (as reported) had erectile dysfunction. At the time of the reporting event outcome was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Erectile dysfunction more likely represents a coincidental medical condition unrelated to the vaccine use because of the absence of a biological plausibility.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was Nursing Home/Senior Living Facility. The patient medical history was not reported. No Covid prior vaccination. Concomitant medications included unspecified other medications received in two weeks. The patient experienced stroke on 13Jan2021. AE resulted in ''Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization''. The patient was hospitalized from Jan2021 to Jan2021 for 2 days for stroke. Patient not received other vaccine in four weeks. Patient was not pregnant. Therapeutic measures were taken as a result of stroke. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Dark pink area roughly the size of her hand to her left arm from the shoulder extending down below the vaccination site. Patient reports area smooth, not raised, no itching, no pain with slight warmth to the area.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Headache, Hypoacusis, Injection site pain
Clinical narrative: Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021).  He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect.  No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Sluggishness
Clinical narrative: Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021).  He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect.  No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Injection site pain, Sleep disorder
Clinical narrative: pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she "was going to pass out"; kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event "was going to pass out" was recovered in Jan2021. The outcome of event "pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Rash, Vomiting
Clinical narrative: Rash on chest and around injection site. Pounding headache lasted 2 days. Emesis all Friday night and Saturday and finally afebrile yesterday afternoon. lasting 3 days.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Vertigo
Clinical narrative: room seemed to be spinning; elevations in blood pressure; felt extremely dizzy; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a resident of a long-term care facility. The patient, within a few minutes of receiving first dose of vaccine (unspecified date), experienced elevations in blood pressure and felt extremely dizzy and described that the room seemed to be spinning. The outcome of the events elevations in blood pressure, felt extremely dizzy and room seemed to be spinning was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable nurse, the patient.  A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 20Jan2021 at 06:00 (at the age of 41-years-old)  as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.   The patient previously received the first dose of BNT162B2 (at the age of 41-years-old; Lot Number: EJ1685) on 30Dec2020 at 06:00 in the left arm for COVID-19 immunization.   The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 20Jan2021 at 19:00, the patient experienced fever, body aches, headache, fatigue, and arm soreness. The patient was not treated for the events. The clinical outcomes of fever, body aches, headache, fatigue, and arm soreness, were not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: The patient did okay on the day of the vaccine.  She began to develop worsening immune response symptoms over the afternoon of the day after through the next 3-4 days.  She woke up the morning listed with Bell's Palsy.  I evaluated her one week after her vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Poor quality sleep
Clinical narrative: tired; restless night of sleeping/poor sleep; This is a spontaneous report from a non-contactable consumer. An 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247 and expiry date unknown) via unspecified route of administration on 22Jan2021 at single dose for Covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced having a restless night of sleeping the night of having gotten the COVID-19 vaccine (22Jan2021). The patient was tired the next day (23Jan2021) but was unsure if it was related to poor sleep itself or as a side effect of the vaccine, otherwise she felt good and did not seek any medical attention. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the events. The outcome of the events restless night of sleeping, tired was recovered. The reporter considered the event non-serious; did not results in death; not life threatening; did not caused/prolonged hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Symptoms manifested approximately 12 hours after injection and lasted 30-36 hours.  Started with rather severe chills, fever of 102 for next 24 hours, extreme fatigue, body aches, head ache, loss of appetite.  NOTE that I was tested Covid positive on November 2, 2020. I was tested for Covid antibodies in December 2020.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Symptoms manifested approximately 12 hours after injection and lasted 30-36 hours.  Started with rather severe chills, fever of 102 for next 24 hours, extreme fatigue, body aches, head ache, loss of appetite.  NOTE that I was tested Covid positive on November 2, 2020. I was tested for Covid antibodies in December 2020.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: I took both doses of the pfizer vaccine and noticed that my thumb joints and my right wrist started to hurt. It hasn't resolved and it seems to not be getting any better
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site within 5 hours; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 22Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 42 years. The vaccine was administered at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included doxycycline.  On 22Jan2021 at 05:00 PM, the patient experienced soreness at injection site within 5 hours, reported as non serious. Soreness was reducing within 24 hours. No treatment was received for the adverse event. The event had resolved on an unspecified date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: The week after I received the Moderna COVID-19 shot 1st dose I had a big whelped circle at the injection site with warm to the touch feel and a lot of itching. Circle was about 4" in diameter. The date of the injection was 01/25/2021 and right at a week when this happened was 02/01/2021. To this day (02/04/2021) I still have a little itching and a circle still appears on my arm, it's not warm to the touch. Dr. at work place advised me to put CORTIZONE for the itch and keep it hydrated with eucrin cream.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Hit her pretty hard. Did not feel good; This is a spontaneous report from a contactable consumer received via a sales representative.   A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on an unknown date for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that the vaccine hit her pretty hard and she did not feel good on an unspecified date. The outcome was unknown.    Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Received 1st Pfizer dose on 12/18/20, received 2nd dose of Pfizer on 1/6/21. Tested positive for COVID 2/3/21, asymptomatic following high risk exposure on 1/29/21.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling of left index finger; This is a spontaneous report from a contactable (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 23Jan2021 16:00 at single dose for Covid-19 immunization in a facility. Medical history included recent finger injury. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 16:45, the patient experienced swelling of left index finger in area of recent injury. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the event. The outcome of the event was unknown. The patient informed that this may not be related to the vaccine but thought it should be reported. The reporter considered the event non-serious; did not results in death; not life threatening; did not caused/prolonged hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.