chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pyrexia, SARS-CoV-2 test
Clinical narrative: Flushed; Developed a fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US077894.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Aug2021 (unspecified if ongoing); "Illness" (unspecified if ongoing), notes: she became ill. The patient's concomitant medications were not reported. The following information was reported: FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "Flushed"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Developed a fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Event: Member notes early August was diagnosed with COVID-19 after she became ill. Reports recovered from COVID-19 and received COVID-19 vaccine 15Aug, notes post COVID-19 vaccine became flushed and developed a fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "flu like symptoms".  Additional Information: Consumer stated, "I am calling about the Pfizer vaccination that I received." When probed if it is COVID vaccine or any other vaccine, consumer stated, "No, I am not." When probed if calling for COVID vaccine, consumer stated, "Yes, I am." Concern: Consumer stated, "I am having flu like symptoms and I want to take some medicines (further clarification unknown) because I do not want to get sick but I do not know if it is okay to take medicine with this shot. I want to take some emergency, I do not know if you are familiar with it or not but I want to take some emergency and also I have asthma (further clarification unknown hence not captured in tab) and I do not know whether or not I can use my inhaler (Unspecified product). Now I hope all I have not to repeat this again. Do you understand what I am concerned about?" Consumer further stated, "Would you just stop and answer whether I can take anything or not and do not do this. It shouldn't be this difficult just tell me whether or not I can take this emergency medicine and whether or not I can use my inhaler please. Do not apologize anymore and just answer it if you can. I also have somebody else on the phone. I hate to be rude to you but this is irritating."  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus, Skin discolouration, Skin exfoliation, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 47-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Oct2021 13:00 (Lot number: 301458A) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cerebral spinal fluid leak" (ongoing), notes: Additional Information for Other Conditions: Stated that she needed to get the surgery.; "immunocompromised condition" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date Sep2021. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6198), for Covid-19 Immunization; Bnt162b2 (Dose number: 2, Lot number: ER8727), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 01Oct2021 13:00, outcome "unknown", described as "indication: cerebral spinal fluid leak"; SKIN DISCOLOURATION (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "neck turned pink"; SKIN EXFOLIATION (non-serious) with onset 04Oct2021 06:00, outcome "not recovered", described as "neck is peeling"; SWELLING (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck swollen"; PRURITUS (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck itchy"; SWELLING FACE (non-serious) with onset 02Oct2021, outcome "recovering", described as "face swollen". Therapeutic measures were not taken as a result of skin discoloration, skin exfoliation, swelling, pruritus, swelling face.  Additional Information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine was Flu vaccine. it was reported that she wanted to her adverse reaction to Comirnaty. Stated that her neck turned pink, swollen, itchy and peeling now. Stated that her face was swollen. Stated that this was after her booster dose because of her immunocompromised condition. Stated that she had it before Comirnaty.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 47-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Oct2021 13:00 (Lot number: 301458A) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cerebral spinal fluid leak" (ongoing), notes: Additional Information for Other Conditions: Stated that she needed to get the surgery.; "immunocompromised condition" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date Sep2021. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6198), for Covid-19 Immunization; Bnt162b2 (Dose number: 2, Lot number: ER8727), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 01Oct2021 13:00, outcome "unknown", described as "indication: cerebral spinal fluid leak"; SKIN DISCOLOURATION (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "neck turned pink"; SKIN EXFOLIATION (non-serious) with onset 04Oct2021 06:00, outcome "not recovered", described as "neck is peeling"; SWELLING (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck swollen"; PRURITUS (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck itchy"; SWELLING FACE (non-serious) with onset 02Oct2021, outcome "recovering", described as "face swollen". Therapeutic measures were not taken as a result of skin discoloration, skin exfoliation, swelling, pruritus, swelling face.  Additional Information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine was Flu vaccine. it was reported that she wanted to her adverse reaction to Comirnaty. Stated that her neck turned pink, swollen, itchy and peeling now. Stated that her face was swollen. Stated that this was after her booster dose because of her immunocompromised condition. Stated that she had it before Comirnaty.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: severe pain and soreness in her shoulder going down to her hips; hard time lifting her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "severe pain and soreness in her shoulder going down to her hips"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "hard time lifting her hand".  Additional Information: Patient received the third dose of Pfizer Covid-19 Vaccine 11Oct2021. Patient was concerned because she had severe pain and soreness in her shoulder going down to her hips. Patient was also having a hard time lifting her hand. Patient just called to ask if those symptoms were normal after the third dose of Pfizer Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, SARS-CoV-2 test, Swelling face
Clinical narrative: have a numbness/tingling feeling in my left cheek; have a numbness/tingling feeling in my left cheek; swell in my cheek area under my eye; then my lips, chin and nose started to feel numb and tingle; then my lips, chin and nose started to feel numb and tingle; then my lips, chin and nose started to feel numb and tingle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 16:45 (Lot number: 30130BA) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Bees" (unspecified if ongoing), notes: Known allergies: Bees; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Adrenaline for Allergy. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose lot number=EW0187,, prev dose administration date=26Aug2021,, prev dose administration time=04:15 PM, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 26Aug2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 16Sep2021 16:45, outcome "recovered" (Sep2021) and all described as "have a numbness/tingling feeling in my left cheek"; SWELLING FACE (non-serious) with onset 16Sep2021 16:45, outcome "recovered" (Sep2021), described as "swell in my cheek area under my eye"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 16Sep2021 16:45, outcome "recovered" (Sep2021) and all described as "then my lips, chin and nose started to feel numb and tingle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, swelling face, hypoaesthesia oral, hypoaesthesia, paraesthesia.  Additional information: Facility type Vaccine was Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. All the event were stayed for about 24hr. Therapeutic measures were taken as a result of events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: My arm, my shoulder was sore but I think about gone by now; My arm, my shoulder was sore but I think about gone by now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization; Bnt162b2 (second dose), administration date: Mar2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "recovered" (Oct2021) and all described as "My arm, my shoulder was sore but I think about gone by now". Additional information: The patient stated that he got his third shot, booster yesterday and now he was not having a reaction, his arm, his shoulder was sore and stated that he thought about gone by now but that was no reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: started spotting and started having her period again; started spotting and started having her period again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "started spotting and started having her period again".  Additional Information: States that she did not know if what she experienced was a side effect of the vaccine but she was told to call and report any possible side effects. States that both of her girls are 15 years old, and when they got their Pfizer Covid 19 vaccines they both got swelling and pain at the injection site, but one of them has started to feel a stabbing pain. Clarified that one of her girls had an episode yesterday where she felt a stabbing pain around her heart area. Verified that both girls are 15. Declined to provide mailing address or email address.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm the night of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 16:15 (Lot number: EW0153) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "Sore arm the night of the vaccine". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Sore arm the night of the vaccine, lasting approximately 48 hours on both shots. Minimal side effects from 1st shot. Facility type vaccine: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: With previous two COVID-19 Vaccines, injection site was sore 2-3 days/first two doses her arm was sore for about a week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101426931 (Pfizer).  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6208) at the age of 71 years as dose 1, single and administered in arm left, administration date 02Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (Flu shot, 3-4 weeks ago. , /LOT/EXP: Unknown, Injected into left arm), for immunization, reaction(s): "no adverse effect". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "With previous two COVID-19 Vaccines, injection site was sore 2-3 days/first two doses her arm was sore for about a week".  Additional information: With previous two COVID-19 Vaccines, injection site was sore 2-3 days. She didn't look at her arm to see if it was red, just figured it was sore. With the first two doses her arm was sore for about a week but that she never really noticed any swelling or redness but that it could have just been due to not looking at it. AE(s) did not require a visit to Emergency Room or Physician Office.  Follow-up attempts completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Influenza like illness, Malaise
Clinical narrative: shortness of breath; Fatigue; felt achy the next day; flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); feeling weak; sore arm, specifically on her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 20Oct2021 (Lot number: EW0186) at the age of 74 years as dose 3 (booster) 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Heart issue" (ongoing), notes: it started a couple of years ago.; "Heart surgery", start date: Mar2021 (unspecified if ongoing), notes: she had heart surgery in March before the vaccine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), PYREXIA (non-serious) all with onset 20Oct2021, outcome "recovered with sequelae" (21Oct2021) and all described as "flu-like symptoms (unwell, and had fever)"; PAIN (non-serious) with onset 21Oct2021, outcome "recovering", described as "felt achy the next day"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm, specifically on her right arm"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "recovering", described as "feeling weak"; FATIGUE (non-serious) with onset 21Oct2021, outcome "recovering", described as "Fatigue"; DYSPNOEA (non-serious) with onset 22Oct2021, outcome "recovered" (22Oct2021), described as "shortness of breath". Therapeutic measures were taken as a result of pain, pain in extremity.  Additional information: Patient received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine on Wednesday, 20Oct2021. Then that night, she developed flu-like symptoms (unwell, and had fever), and felt achy the next day. She said she had sore arm, specifically on her right arm. She said she was feeling weak as if she had the flu today. She also mentioned that she was already feeling better. She took Tylenol twice for being achy.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: shortness of breath; Fatigue; felt achy the next day; flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); feeling weak; sore arm, specifically on her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 20Oct2021 (Lot number: EW0186) at the age of 74 years as dose 3 (booster) 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Heart issue" (ongoing), notes: it started a couple of years ago.; "Heart surgery", start date: Mar2021 (unspecified if ongoing), notes: she had heart surgery in March before the vaccine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), PYREXIA (non-serious) all with onset 20Oct2021, outcome "recovered with sequelae" (21Oct2021) and all described as "flu-like symptoms (unwell, and had fever)"; PAIN (non-serious) with onset 21Oct2021, outcome "recovering", described as "felt achy the next day"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm, specifically on her right arm"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "recovering", described as "feeling weak"; FATIGUE (non-serious) with onset 21Oct2021, outcome "recovering", described as "Fatigue"; DYSPNOEA (non-serious) with onset 22Oct2021, outcome "recovered" (22Oct2021), described as "shortness of breath". Therapeutic measures were taken as a result of pain, pain in extremity.  Additional information: Patient received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine on Wednesday, 20Oct2021. Then that night, she developed flu-like symptoms (unwell, and had fever), and felt achy the next day. She said she had sore arm, specifically on her right arm. She said she was feeling weak as if she had the flu today. She also mentioned that she was already feeling better. She took Tylenol twice for being achy.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash papular, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Redness within 2-inch in the area of the injection site; redness within 2-inch in the area of the injection site; rashes that grew in size and raised; rashes that grew in size and raised; Feverish but went away quickly.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 10:00 (Lot number: 30155BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperthyroidism" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "soy" (unspecified if ongoing), notes: Verbatim; known allergy: soy; "Berries" (unspecified if ongoing), notes: Verbatim; known allergy: Berries. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL0140, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Jan2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 21Dec2020, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Redness within 2-inch in the area of the injection site"; VACCINATION SITE REACTION (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "redness within 2-inch in the area of the injection site"; RASH (non-serious), RASH PAPULAR (non-serious) all with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021) and all described as "rashes that grew in size and raised"; PYREXIA (non-serious) with onset 08Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Feverish but went away quickly.". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site reaction, rash, rash papular, pyrexia.  Additional information: It was reported that the most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Fever; Nausea; Body Aches; Headache; Not able to remember things; sweating; chills; dizzy; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101440905 (Pfizer).  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 10:00 (Lot number: FC3180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "scoliosis in her back and metal pins in her back." (unspecified if ongoing), notes: That was placed when she was 18.; "She still has back issues." (ongoing). There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Nausea"; PAIN (non-serious) with onset 07Aug2021, outcome "unknown", described as "Body Aches"; HEADACHE (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Headache"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Not able to remember things"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "sweating"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizzy".  Additional information: Events diarrhoea, fever, nausea, headache, unable to remember things, dizziness, sweating, were reported as worsened. The patient's symptoms were coming and going. She had diarrhoea. The frequency was more. The Fever was worsened and she had headache all the time. Body aches were off and on. She may get pain in her shoulder. She had headache from being lightheaded. The night sweats have been going on for a couple of weeks. They happened mostly at night. No emergency room and physician office visit. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event prior vaccinations, she was really healthy.     No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Nausea; Body Aches; Headache; Not able to remember things; sweating; chills; dizzy; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101440905 (Pfizer).  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 10:00 (Lot number: FC3180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "scoliosis in her back and metal pins in her back." (unspecified if ongoing), notes: That was placed when she was 18.; "She still has back issues." (ongoing). There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Nausea"; PAIN (non-serious) with onset 07Aug2021, outcome "unknown", described as "Body Aches"; HEADACHE (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Headache"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Not able to remember things"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "sweating"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizzy".  Additional information: Events diarrhoea, fever, nausea, headache, unable to remember things, dizziness, sweating, were reported as worsened. The patient's symptoms were coming and going. She had diarrhoea. The frequency was more. The Fever was worsened and she had headache all the time. Body aches were off and on. She may get pain in her shoulder. She had headache from being lightheaded. The night sweats have been going on for a couple of weeks. They happened mostly at night. No emergency room and physician office visit. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event prior vaccinations, she was really healthy.     No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Generalized urticarial; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Generalized erythema; Hives were located on my chest and neck/Hives on anterior chest, neck and jaw line; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 13Jan2021 (Lot number: EL3248) at the age of 38 years as dose 1, single and administered in arm, administration date 03Feb2021 (Lot number: EL1283) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "allergy: Medication" (unspecified if ongoing), notes: Does the patient have a history of any previous allergies to specific products or any condition indicative of an allergy: Medication. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 16Jan2021, outcome "recovering", described as "Hives were located on my chest and neck/Hives on anterior chest, neck and jaw line"; URTICARIA (non-serious), outcome "recovering", described as "Generalized urticarial"; PRURITUS (non-serious), RASH (non-serious), outcome "unknown" and all described as "Generalized pruritus with skin rash"; ERYTHEMA (non-serious), outcome "unknown", described as "Generalized erythema". Therapeutic measures were taken as a result of urticaria, urticaria.  Additional information: Both shots I had hives for 2-3 weeks after. Hives were located on my chest and neck. Hives would come and disappear, then come back again. Prior to vaccination, 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Dizziness; nausea; full body itch/itchy red arm; itchy red arm; Swollen/painful lymph node; Swollen/painful lymph node; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:00 (Lot number: EW0158) at the age of 55 years as dose 2, single and administered in arm left, administration date 22Oct2021 16:00 (Lot number: FF9941) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing), notes: known allergies: Yes, many. Concomitant medication(s) included: SINGULAIR; ZYRTEC; CLARITIN; BENADRYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovering", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "nausea"; PRURITUS (non-serious) with onset 2021, outcome "recovering", described as "full body itch/itchy red arm"; ERYTHEMA (non-serious) with onset 2021, outcome "recovering", described as "itchy red arm"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "Swollen/painful lymph node"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of dizziness, nausea, pruritus, erythema, lymphadenopathy, lymph node pain, pyrexia.  Additional Information: The patient did not taken other vaccine in four weeks and taken Other medications in two weeks was singulair, Zyrtec, Claritin, Benadryl, Prevacid. After 2nd and 3rd shots (not the first) she experienced Dizziness, nausea, full body itch, itchy red arm,  Swollen/painful lymph node and  Fever especially after 2nd shot. The patient did not have covid prior vaccination and not tested covid post vaccination. She had many know allergies.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Dizziness; nausea; full body itch/itchy red arm; itchy red arm; Swollen/painful lymph node; Swollen/painful lymph node; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:00 (Lot number: EW0158) at the age of 55 years as dose 2, single and administered in arm left, administration date 22Oct2021 16:00 (Lot number: FF9941) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing), notes: known allergies: Yes, many. Concomitant medication(s) included: SINGULAIR; ZYRTEC; CLARITIN; BENADRYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "recovering", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "nausea"; PRURITUS (non-serious) with onset 2021, outcome "recovering", described as "full body itch/itchy red arm"; ERYTHEMA (non-serious) with onset 2021, outcome "recovering", described as "itchy red arm"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "Swollen/painful lymph node"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of dizziness, nausea, pruritus, erythema, lymphadenopathy, lymph node pain, pyrexia.  Additional Information: The patient did not taken other vaccine in four weeks and taken Other medications in two weeks was singulair, Zyrtec, Claritin, Benadryl, Prevacid. After 2nd and 3rd shots (not the first) she experienced Dizziness, nausea, full body itch, itchy red arm,  Swollen/painful lymph node and  Fever especially after 2nd shot. The patient did not have covid prior vaccination and not tested covid post vaccination. She had many know allergies.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Nausea, Pruritus
Clinical narrative: Dizziness; nausea; itchy red arm/full body itch; itchy red arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 09:00 (Lot number: EP6955) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes, many " (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITINE; BENADRYL; PREVACID. The following information was reported: DIZZINESS (non-serious) with onset 22Mar2021, outcome "recovering", described as "Dizziness"; NAUSEA (non-serious) with onset 22Mar2021, outcome "recovering", described as "nausea"; PRURITUS (non-serious) with onset 22Mar2021, outcome "recovering", described as "full body itch"; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 22Mar2021, outcome "recovering" and all described as "itchy red arm". Therapeutic measures were not taken as a result of dizziness, nausea, pruritus, pruritus, erythema.  Additional information: It was reported that prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion, Erythema, Ocular hyperaemia, Oral pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Apr2021 (Lot number: EL9264, Expiration Date: 21May2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Spleen removed", start date: 2007, stop date: 2007. Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; TRIAMCINOLONE. Past drug history included: Methotrexate for arthritis, notes: diagnosed prior to receiving the Pfizer COVID Vaccine; Methotrexate for Lupus, notes: Stopped four weeks before the 1st dose of Pfizer COVID vaccine and stayed off Methotrexate for four weeks afterward; began Methotrexate 10 years ago. Vaccination history included: Bnt162b2 (Dose 1, single; Lot no: EL9263, Anatomical Site of injection: Arms), administration date: 01Apr2021, when the patient was 66 years old, for COVID-19 immunization; Shingles, for immunization. The following information was reported: CONTUSION (non-serious) with onset 2021, outcome "not recovered", described as "broke out completely all over her face and fingers / is still breaking out in the corners of her mouth and the side of her nose"; BLISTER (non-serious) with onset 2021, outcome "not recovered", described as "blisters"; ORAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "soreness of mouth"; ERYTHEMA (non-serious) with onset 2021, outcome "not recovered", described as "redness"; OCULAR HYPERAEMIA (non-serious) with onset 2021, outcome "not recovered", described as "eye turned real red". The event "broke out completely all over her face and fingers / is still breaking out in the corners of her mouth and the side of her nose" was evaluated at the physician office visit. Additional information: Patient stated her husband died on 29Apr2021 and it upset her, and she thinks she did start a sleeping medication about 5-6 days after his death. But has no name of that sleeping medication or lot, expiry date or NDC to provide as it has been discarded; stated she took one pill of the sleeping medication and her eye turned really red and she never took it again and threw them all away. Patient stated the breakout began about 2-3 weeks and she was not certain about the dates, but the breakout began about 2-3 weeks after the 2nd dose of the Pfizer COVID Vaccine. Patient stated she was still breaking out in the corners of her mouth and the side of her nose, but it was a lot better than what it was. In morning vaccination was given. Not any additional vaccines administered on same date of the Pfizer suspect. Not any family medical history relevant to AE(s). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Lymphadenopathy, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Can barely swallow; her glands are huge; Cough; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme's disease" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPHAGIA (non-serious) with onset 14Oct2021, outcome "not recovered", described as "Can barely swallow"; LYMPHADENOPATHY (non-serious) with onset 14Oct2021, outcome "not recovered", described as "her glands are huge"; COUGH (non-serious) with onset 14Oct2021, outcome "not recovered", described as "Cough"; NASAL CONGESTION (non-serious) with onset 14Oct2021, outcome "not recovered", described as "congestion". The events "can barely swallow", "her glands are huge", "cough" and "congestion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dysphagia, lymphadenopathy, cough, nasal congestion.  Additional information: the patient did not have Covid prior to vaccination. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Polymenorrhoea, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Patient was getting period every 2 weeks since receiving the vaccine; Patient was getting period every 2 weeks since receiving the vaccine; Patient finished last period a week ago and now patient was spotting; Patient began bleeding every 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 (Lot number: Ewol68) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ewol68, Location of injection: Arm Left), administration date: 28Jun2021, when the patient was 21 years old, for Covid-19 Immunization. The following information was reported: POLYMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 17Aug2021, outcome "not recovered" and all described as "Patient was getting period every 2 weeks since receiving the vaccine"; INTERMENSTRUAL BLEEDING (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Patient finished last period a week ago and now patient was spotting"; VAGINAL HAEMORRHAGE (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Patient began bleeding every 2 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of polymenorrhoea, menstrual disorder, intermenstrual bleeding, vaginal haemorrhage.  Additional information: No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. Patient was getting period every 2 weeks since receiving the vaccine. Patient has always had a regular 28day cycle and then starting the period after second dose, Patient began bleeding every 2 weeks. Patient finished last period a week ago and now patient was spotting, which patient also have never done before. Patient's periods have been lasting 5 days and were starting almost exactly 2 weeks after the last one ends.  Follow-up attempts are completed. No further information is expected.