chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Oral mucosal eruption, Pain, Rash, Skin irritation
Clinical narrative: razor burn; has a rash that started 2 days ago on her face; she is in pain; Developing a rash around her mouth and nose; developing a rash around her mouth and nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Jan2022 17:40 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bee sting", start date: Jul2021 (unspecified if ongoing), notes: she had a prior bee sting this summer in Jul2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Location: Arm right, time: 17:40), administration date: 20Dec2021, for COVID-19 Immunization, reaction(s): "Break out in a rash on her forearm". The following information was reported: ORAL MUCOSAL ERUPTION (non-serious) with onset Jan2022, outcome "unknown", described as "Developing a rash around her mouth and nose"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "developing a rash around her mouth and nose"; SKIN IRRITATION (non-serious), outcome "unknown", described as "razor burn"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "has a rash that started 2 days ago on her face"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "she is in pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Feb2022): 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Insomnia, Investigation, Tinnitus
Clinical narrative: like the ringing is causing pain.; tinnitus; she could not sleep; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Jan2021 (Lot number: EL3249) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing), notes: Additional Information for Other Conditions: diagnosed about 10 years ago. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for autoimmune thyroiditis (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EK9231, Expiration: unknown), administration date: 07Jan2021, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 28Jan2021, outcome "not recovered", described as "tinnitus"; INSOMNIA (non-serious) with onset 28Jan2021, outcome "unknown", described as "she could not sleep"; EAR PAIN (non-serious), outcome "unknown", described as "like the ringing is causing pain.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus, insomnia, ear pain.  Follow-up (17Jan2022): This is a spontaneous follow-up report received from a contactable nurse. This 54-year-old female nurse (patient) reported that: Updated Information included: Slider#02 in reporter section, Concomitant drug. Suspect vaccine information, new event Batch/lot number, intramuscular injection in left arm  Additional Context: She just got the Pfizer covid booster on Thursday. When she got the second vaccine in Feb2021,she developed tinnitus. Clarified she got the second vaccine on 28Jan2021, not in Feb2021. The tinnitus is ten times worse within a day of getting the booster. She can still hear the ringing even if she has the TV on. With the second dose she could only hear the ringing in her ear if the room was silent.  States she she does not get sick and she is not on any medication. Asking what should she do. It is to the point that she has to go to the doctor but they will not know what to do.   Follow-up (26Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: First dose: after first dose, both thumbs went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8730) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Dec2020 (ongoing), notes: Verbatim: Anxiety; "Panic attack", start date: Dec2020 (ongoing), notes: Verbatim: panic attacks. Concomitant medication(s) included: CITALOPRAM taken for anxiety, panic attack (ongoing). The following information was reported: HYPOAESTHESIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "First dose: after first dose, both thumbs went numb".  Additional Information: The patient received Dose 2 and Dose 3(Booster) of Pfizer Covid 19 vaccine. No side effects after administration of Dose 2 noted. Patient received Booster dose(Dose 3) of Pfizer Covid 19 Vaccine (Right arm) on 15Jan2022 with a Lot no. FJ1614. Patient experienced a very large whelp around injection site, severe pain in right shoulder and clavicle.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tinnitus
Clinical narrative: Numbness in left-side of face 5 minutes after injection, lasted several days. 2-3 weeks after vaccine, tinnitus started in both ears. Tinnitus still continues.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Fear, Hypoaesthesia, Hypokinesia
Clinical narrative: I received the vaccine shot on May 21st, 2021. Immediately after I received the vaccine, I felt a severe pain on my right shoulder where the vaccine was given and there were some blood that came out. I was told by the pharmacy agent to sit for a while to allow the pain to go away. I did a little few minutes after and I went home. I could still feel a pain in my arm for the following days like a soreness. Around June 4th or 6th, the pain became excruciating, especially at night even if was not moving my arm. The pain would come with numbness of the fingers of my right hand on and off, the numbness was felt especially early in the morning. There was bad days were i the pain was really severe around 10/10 and other days I was better. Overall it and on the day when the pain was really bad, i was very difficult for to do my activities of daily live such as dressing up, cooking, cleaning, carry object, taking a shower, in general I could not use lift or move my right hand/shoulder up or around. Around the summer of 2021 as the pain was still coming on and off, I saw a doctor who gave several injection of a pain medication called "Lipatolam". Later in summer 2021, early fall 2021, I started feeling pain in my right wrist accompany with rigidity and I could not move my right wrist around. I also, started feeling pain in left forearm and also especially a night even when my left forearm was at rest. I couldn't receive any other vaccine because i was scared of the symptoms. In december 2021 I got covid-19 for the second time and all my symptoms became worst. Today the pain is continue and consistant on both of my arm and and on my right wrist and do not go away. I'm taking Neurontin 300 mg 2 tabs a day and cyclobenzaprine 10 mg 1 day daily for the pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Incomplete course of vaccination, Injected limb mobility decreased, Loss of personal independence in daily activities, Muscle rigidity
Clinical narrative: I received the vaccine shot on May 21st, 2021. Immediately after I received the vaccine, I felt a severe pain on my right shoulder where the vaccine was given and there were some blood that came out. I was told by the pharmacy agent to sit for a while to allow the pain to go away. I did a little few minutes after and I went home. I could still feel a pain in my arm for the following days like a soreness. Around June 4th or 6th, the pain became excruciating, especially at night even if was not moving my arm. The pain would come with numbness of the fingers of my right hand on and off, the numbness was felt especially early in the morning. There was bad days were i the pain was really severe around 10/10 and other days I was better. Overall it and on the day when the pain was really bad, i was very difficult for to do my activities of daily live such as dressing up, cooking, cleaning, carry object, taking a shower, in general I could not use lift or move my right hand/shoulder up or around. Around the summer of 2021 as the pain was still coming on and off, I saw a doctor who gave several injection of a pain medication called "Lipatolam". Later in summer 2021, early fall 2021, I started feeling pain in my right wrist accompany with rigidity and I could not move my right wrist around. I also, started feeling pain in left forearm and also especially a night even when my left forearm was at rest. I couldn't receive any other vaccine because i was scared of the symptoms. In december 2021 I got covid-19 for the second time and all my symptoms became worst. Today the pain is continue and consistant on both of my arm and and on my right wrist and do not go away. I'm taking Neurontin 300 mg 2 tabs a day and cyclobenzaprine 10 mg 1 day daily for the pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: I received the vaccine shot on May 21st, 2021. Immediately after I received the vaccine, I felt a severe pain on my right shoulder where the vaccine was given and there were some blood that came out. I was told by the pharmacy agent to sit for a while to allow the pain to go away. I did a little few minutes after and I went home. I could still feel a pain in my arm for the following days like a soreness. Around June 4th or 6th, the pain became excruciating, especially at night even if was not moving my arm. The pain would come with numbness of the fingers of my right hand on and off, the numbness was felt especially early in the morning. There was bad days were i the pain was really severe around 10/10 and other days I was better. Overall it and on the day when the pain was really bad, i was very difficult for to do my activities of daily live such as dressing up, cooking, cleaning, carry object, taking a shower, in general I could not use lift or move my right hand/shoulder up or around. Around the summer of 2021 as the pain was still coming on and off, I saw a doctor who gave several injection of a pain medication called "Lipatolam". Later in summer 2021, early fall 2021, I started feeling pain in my right wrist accompany with rigidity and I could not move my right wrist around. I also, started feeling pain in left forearm and also especially a night even when my left forearm was at rest. I couldn't receive any other vaccine because i was scared of the symptoms. In december 2021 I got covid-19 for the second time and all my symptoms became worst. Today the pain is continue and consistant on both of my arm and and on my right wrist and do not go away. I'm taking Neurontin 300 mg 2 tabs a day and cyclobenzaprine 10 mg 1 day daily for the pain.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Thumb felt funny and kind of numb a few hours after first dose; Thumb felt funny and kind of numb a few hours after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (Pfizer Covid 19 Vaccine -Solution for injection), administration date 15Jan2022 (Lot number: FJ1614) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), HYPOAESTHESIA (non-serious) all with onset 15Jan2022, outcome "recovered" and all described as "Thumb felt funny and kind of numb a few hours after first dose". Additional information: The caller was a consumer who reports the callers daughter received the first dose Pfizer Covid 19 Vaccine on Saturday, 15Jan2022 with lot: FJ1614. The daughter did not have a whelp. The daughter noticed thumb felt funny and kind of numb a few hours after receiving first dose Pfizer Covid 19 Vaccine on 15Jan2022. The caller does not wish to complete a report for the callers daughter since the issues are fully resolved, the caller thinks its fine.  No follow-up attempts are possible. No further information is expected.  Follow-Up (19Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: headache; fatigue/tiredness; muscle pain; pain at the injection site; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/tiredness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  Additional information: Reporter states that 2-3 hours after he received the 1st and 2nd doses of the vaccine, he experienced the expected side effects of headache, tiredness, fatigue, and pain at the injection site. He just got the 3rd booster dose yesterday, and is just now noticing those same expected side effects the day after the vaccine. Have people been reporting that? States that he did not report his side effects after the 1st and 2nd dose because he knew that was going to occur; he knew he was going to get the side effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101326581 same suspect drug, similar events, different patient
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had three plantar's warts on my right foot that I had been going through months of treatments for and nothing worked. Within a month of the second vaccine, they all disappeared without a trace.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0172) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing); "plantars warts" (unspecified if ongoing), notes: I had three plantar's warts on my right foot.; "hypothyroidsim" (unspecified if ongoing); "known allergies: almost all antibiotics" (unspecified if ongoing), notes: known allergies: almost all antibiotics. Concomitant medication(s) included: ELTROXIN; IBUPROFEN; SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 18May2021, outcome "unknown", described as "I had three plantar's warts on my right foot that I had been going through months of treatments for and nothing worked. Within a month of the second vaccine, they all disappeared without a trace.". The event "i had three plantar's warts on my right foot that i had been going through months of treatments for and nothing worked. within a month of the second vaccine, they all disappeared without a trace." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: This was not adverse but the patient still wanted to report it. The patient had three plantar's warts on her right foot that she had been going through months of treatments for and nothing worked. Within a month of the second vaccine, they all disappeared without a trace. The patient believed she was not the only one to experience this, but she was not sure how often it was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   Follow-up: Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Gait inability, Loss of personal independence in daily activities, Nausea
Clinical narrative: couldn't walk /having trouble with stairs and stuff; having trouble with stairs and stuff; weak; nauseous; couldn't eat; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4527027 (Genentech).  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 49 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Patient's concurrent condition included: Multiple sclerosis. Concomitant medication(s) included: OCREVUS. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "couldn't walk /having trouble with stairs and stuff"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "having trouble with stairs and stuff"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FEEDING DISORDER (non-serious), outcome "unknown", described as "couldn't eat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Peripheral swelling, Skin lesion, Skin weeping
Clinical narrative: She had a bite on her right arm a week later, possibly in Jul2021, that totally blew up and it looked like Popeye; on her deck and got mosquito bites; her legs swelled and her legs were oozing; her legs swelled and her legs were oozing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Lot number: EW0151, Expiration Date: Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot: EP6955, Expiration: Jun2021), administration date: 20Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: ARTHROPOD BITE (non-serious) with onset Jun2021, outcome "unknown", described as "on her deck and got mosquito bites"; PERIPHERAL SWELLING (non-serious), SKIN WEEPING (non-serious) all with onset Jun2021, outcome "unknown" and all described as "her legs swelled and her legs were oozing"; SKIN LESION (non-serious) with onset Jul2021, outcome "unknown", described as "She had a bite on her right arm a week later, possibly in Jul2021, that totally blew up and it looked like Popeye". The events "on her deck and got mosquito bites", "her legs swelled and her legs were oozing" and "her legs swelled and her legs were oozing" were evaluated at the emergency room visit.  Additional info: Patient had a bite on her right arm a week later, possibly in Jul2021, that totally blew up and it looked like Popeye, it was bizarre and looked like cellulitis. ER confirmed it was not cellulitis.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER2613) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Connective tissue disease" (unspecified if ongoing); "Aneurysm" (unspecified if ongoing), notes: I have an aneurysm on my heart; "AFib" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "lung cancer" (unspecified if ongoing), notes: I am a lung cancer survivor and also a have a decreased oxygen supply at night time. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; LORATADINE; LIPITOR; XARELTO; LEXAPRO taken for anxiety; LEVOTHYROXINE; TOPROL taken for atrial fibrillation. Vaccination history included: Bnt162b2 (Dose 01, Lot number; EN6205, Anatomical location; left arm), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "didn't have any symptoms at all". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Body ache". Additional information; Treatment: The patient stated "Tylenol." LOT for the Tylenol:, "The patient don't have that, the patient at work right now and my bottle of Tylenol at home. I can't take anything because I am on a blood thinner, so that's the only thing I can take is Tylenol. But the Tylenol did help but when the Tylenol start 'wearing' off I can really feel it because the chills start coming back really hard again. I was sick for 5 days, for last 2 days I had fever for 3 days and then the last 2 days after my fever broke I had profuse sweating, I mean bad like I couldn't sleep dry 'clothed', just like profuse sweating." The patient further stated, "I have had, when I got my first vaccine I didn't have any symptoms at all,  the second vaccine, I had chills and body ache for 24 hours and but then the booster put me in bed for 5 days." When probed if the patient had not any other vaccination 4 weeks prior to COVID 19 Vaccine, the patient stated, the first two were like in a hospital and the last one was done at withheld.  No follow-up attempts are possible. No further information is expected.   Follow-Up (20Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report received from a noncontactable reporter consumer or other non-HCP (patient). A 74-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EY4825), in left arm left, on May 5, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had injection site pain (pain at the injection site: left arm), with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: ER8736) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. There were no concomitant medications. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. Vaccination history included: Bnt162b2 (dose number=1, dose lot number=FW0151, dose vaccine location=Right arm), administration date: 13Apr2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 22Aug2021, outcome "not recovered", described as "I have been experiencing extreme hair loss since my second dose of the Pfizer Vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: No Other medications in two weeks; No Other vaccine in four weeks, No covid prior vaccination ;covid tested post vaccination: Yes   No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: elevated glucose recently on 17Jan2022. States it was 154; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: 30130BA, Expiration Date: 28Feb2022) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Unknown (it seems the last time he had any was in Oct2020), administration date: Oct2020. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 17Jan2022, outcome "unknown", described as "elevated glucose recently on 17Jan2022. States it was 154". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Influenza like illness
Clinical narrative: Got sick; getting chills; tired; she felt like she had the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4528946.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Worsening menstrual cramps" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "Allergies" (ongoing); "Forgetfulness" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick"; CHILLS (non-serious), outcome "unknown", described as "getting chills"; FATIGUE (non-serious), outcome "unknown", described as "tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she felt like she had the flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness and pain of the arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "stomach" (unspecified if ongoing), notes: Pantoprazole for stomach. Concomitant medication(s) included: ABILIFY; ZOLOFT; KLONOPIN; FENOFIBRATE; CLARITIN [CLARITHROMYCIN]; PANTOPRAZOLE taken for abdominal discomfort. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness and pain of the arm".  Additional Information: The medications he is asking if it's ok to take with the Pfizer Covid19 Booster shot are Abilify, Zoloft, Klonopin, Fenofibrate, prescription Claritin, and Pantoprazole. He stated he received the first and second Covid19 shot and is getting booster. He was on the products Abilify, Zoloft, Klonopin, Fenofibrate, prescription Claritin, and Pantoprazole when he received the first and second dose. After first dose of Pfizer Covid19 shot, the next day the only problem was in the arm where he got it. He couldn't tell it was bothering him, only when he moved it. The second dose was given in Jul2021. He started having symptoms after, but he can't remember. They were one after another.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleep for years; tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "stomach" (unspecified if ongoing), notes: he has now is Pantoprazole. It is for the stomach. Concomitant medication(s) included: ABILIFY; ZOLOFT; FENOFIBRATE; CLARITIN [LORATADINE]; PANTOPRAZOLE taken for abdominal discomfort; KLONOPIN. Vaccination history included: Bnt162b2 (DOSE- 1, After the first dose of the vaccine his side effects were noted to be Soreness and pain of the arm when ever he moved his muscle), for Covid-19 immunization, reaction(s): "Soreness and pain of the arm", "problem was in the arm where he got it".  The following information was reported: SOMNOLENCE (non-serious), outcome "recovered", described as "sleep for years"; FATIGUE (non-serious), outcome "recovered", described as "tired".  Additional Information: The medications he is asking if it's ok to take with the Pfizer Covid19 Booster shot are Abilify, Zoloft, Klonopin, Fenofibrate, prescription Claritin, and Pantoprazole. He stated he received the first and second Covid19 shot and is getting booster. He was on the products Abilify, Zoloft, Klonopin, Fenofibrate, prescription Claritin, and Pantoprazole when he received the first and second dose. After first dose of Pfizer Covid19 shot, the next day the only problem was in the arm where he got it. He couldn't tell it was bothering him, only when he moved it. The second dose was given in Jul2021. He started having symptoms after, but he can't remember. They were one after another.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Lip pain
Clinical narrative: they have like sores on their lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FL0007) at the age of 7 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIP PAIN (non-serious) with onset 10Jan2022, outcome "recovered" (2022), described as "they have like sores on their lips".  Additional information: No Lab test within 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200112958 Same product and event, different patient
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Lip pain
Clinical narrative: they have like sores on their lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 (Lot number: FL0007) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient relevant medical history was reported as None. There were no concomitant medications.The following information was reported: LIP PAIN (non-serious) with onset 10Jan2022, outcome "recovered" (2022), described as "they have like sores on their lips". Additional information: This was the first case out of 2 cases. Kids recently got the Pfizer vaccine and then by the Monday they have like sores on their lips. The age at the time of, they were 9 and 7, they are both born in (month). The older one was born on the (withheld) and the younger one was born on the (withheld), he was 9. Lot number FL0007 was same for both kids. The one that was 7, COVID vaccine was administered on his left arm. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200112924 Same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: Irregular heartbeat; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2022 02:45 (Lot number: 33036BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 21Mar2021, for COVID-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 13Jan2022 08:00, outcome "recovered", described as "Irregular heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination include hydrothiachlorizide. The patient didn't have covid prior vaccination, no known allergies and not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: felt bad for 36 hours after second dose; First two doses made her arm kind of sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EP7533) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heartburn" (unspecified if ongoing); "Headaches" (unspecified if ongoing); "Body aches" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for headache, pain; NEXIUM [ESOMEPRAZOLE SODIUM] taken for dyspepsia. Vaccination history included: Bnt162b2 (Dose:01, Lot: EN6199, First two doses made her arm kind of sore.), administration date: 10Mar2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "arm kind of sore". The following information was reported: FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "felt bad for 36 hours after second dose"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "First two doses made her arm kind of sore".  Additional information: Concomitant Products Nexium: 20mg or 25mg, usually takes capsule but patient has taken both tablet and capsule formulation, has been known to take two a day at times depending on how bad her heartburn.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: her daughter, 13 started her first period ever 3 days after her first shot and did not have another period for 6 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm (Batch/Lot number: unknown) at the age of 13 years as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "her daughter, 13 started her first period ever 3 days after her first shot and did not have another period for 6 months". Additional information: Mensuration started within 48 hours of her first two vaccine doses even though her cycle was due 10-15 days later. That was unusual for her. Additionally, her daughter, 13 started her first period ever 3 days after her first shot and did not have another period for 6 months. She reported mensural cramps again after her third 1 day after her booster shot but had not started menstruating at the time of our discussion. No covid prior vaccination. covid was tested post vaccination. Patient got Pfizer/BioNTech vaccine and started first period days after the injection. Mom doesn't remember if it was first or second shot. Didn't have another period for 6 months. Mom and sister started period 2 years later in age than patient. No other adverse events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: hitting head; stomach going crazy or hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "hitting head"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach going crazy or hurting".  Additional information: on Morning Radio Show started to tell story on 1/20 in AM regarding either her stomach going crazy or hurting the evening of 1/19 while she was watching TV. I switched channel before got all details. Do not know vaccination status - but she is likely vaccinated to some degree. Submitted another AE previously for hitting head. Believe she is in late 30s or in 40s.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): MDCA22-00239 (Moderna).  An adult female patient received bnt162b2 (BNT162B2), administration date 16Jul2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jul2021, outcome "unknown", described as "sore arm".  Additional Information: Patient had the Moderna Booster Dose (Lot No.063H21A) on 16Jan2022. Patient was fine on 17Jan2022, but on 19Jan2022 she woke up feeling like she was thrown down a set of stairs. The patient didn't know the timeline of the side effects of the Moderna booster. She wanted to know how long it's supposed to last for. She was feeling like crap. Head was pounding, body feels like Hiten by a truck, elbows and joints were so sore. She had trouble lifting stuff; it was painful on the crease inside her elbows (the muscles and joints). She was struggling to bend over. She was feeling chilly. She felt stiff in morning on 19Jan2022, but it worsened throughout the course of the day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2201715US (RA).  A female patient received bnt162b2 (BNT162B2) (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: MIGRAINE (non-serious), outcome "not recovered", described as "Migraines". Therapeutic measures were taken as a result of migraine.  Additional information: Patient do not know where they got this information, it was incorrect. Patient had no adverse reaction to Ketorolac, Patient had a serious adverse reaction from the Pfizer vaccine lasting 4 months and it was still an ongoing issue. Patient was prescribed Ketorolac for the migraines being one of the adverse side effects from the vaccine. Please get there facts right.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain that comes and goes; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200120237 (Pfizer).  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "pain that comes and goes". Therapeutic measures were taken as a result of pain.  Additional information: Reporter states, patient had a booster shot on 07Jan2022, and on today the 21st he still has pain almost every day, which he has been taking tylenol and still the pain comes and goes. Patient has been worrying about maybe they gave him the wrong dose or something. Patient when he will get to speak to someone regarding his issue, which is pain, ongoing pain, which he wants to know if this part of a regular dose or if something might have happened mistakenly like being given 3mL instead of 0.3mL. He says he also wants to know if there would be adverse effects if given that way mistakenly. He says he would like to know if it is normal and to expect pain that comes and goes for more than two weeks now.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 12:00 (Lot number: EN6206) at the age of 30 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid reported prior vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose 1 (Manufacturer unknown), ), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "skin rashes". The event "skin rashes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Facility where the most recent COVID-19 vaccine was administered was unknown. List of any other medications the patient received within 2 weeks of vaccination was not applicable. Prior to vaccination, the patient was diagnosed with COVID-19Patient experiences skin rashes two days after vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit and patient received Benadryl as treatment for the adverse event. Since the vaccination, the patient been tested for COVID-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: forgot to reconstitute the vaccine with a purple cap; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "forgot to reconstitute the vaccine with a purple cap".  Additional information: The patient would like to report it, and apart from that, she would like to get advice on what else has to be monitored for in this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.