chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Edema on the lower extremities; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 01Jun2021 (Lot number: EW0178, Expiration Date: 31Aug2021) at the age of 68 years 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: OEDEMA PERIPHERAL (non-serious) with onset Jun2021, outcome "unknown", described as "Edema on the lower extremities".  Additional information: Clinical course: It was reported that a patient was given a dose of the PFIZER-BIONTECH COVID-19 VACCINE on 01Jun2021 and had developed edema on the lower extremities. Reporter was not positive that this AE was brought by the vaccine but still wanted to check and wants to know if this has been reported as a side effect of the vaccine. The reporter intern would like to know if anyone else is experiencing this. If any more people are reporting this. If it's common. He doesn't think it's related to the vaccine. He would like to verify to make sure it's not something due to the Pfizer vaccine. Reporter stated today is the first time he has contacted Pfizer. He believes some of the pharmacy staff have contacted Pfizer before.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Haematocrit increased, Haemoglobin, Hypertension
Clinical narrative: Hematocrit was high; Blood pressure is higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EP7534, Expiration Date: 30Jun2021) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, single dose, Lot: EN6203), administration date: 25Feb2021, for COVID-19 Immunization. The following information was reported: HAEMATOCRIT INCREASED (non-serious), outcome "unknown", described as "Hematocrit was high"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure is higher". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site extravasation
Clinical narrative: Vaccine leaked out of the injection site./the patient had the vaccine administered and some of it leaked out of the site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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: VACCINATION SITE EXTRAVASATION (non-serious), outcome "unknown", described as "Vaccine leaked out of the injection site./the patient had the vaccine administered and some of it leaked out of the site".  Follow-up (12Jul2021): 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Panic attack
Clinical narrative: dreaming of every dead person that I know.  It's very, very strange; Panic attacks; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23May2021 11:30 (Lot number: EW0178) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing), notes: Caller reported that she developed depression because of school and stress. Concomitant medication(s) included: ZOLOFT taken for depression (ongoing). The following information was reported: ABNORMAL DREAMS (non-serious) with onset 24May2021, outcome "not recovered", described as "dreaming of every dead person that I know.  It's very, very strange"; PANIC ATTACK (non-serious) with onset 24May2021, outcome "not recovered", described as "Panic attacks".  Follow-up (09Jun2021): This is a spontaneous report from a contactable other HCP. A 55-year-old female consumer (patient) reported for herself that: Updated information: New events, Dosage details, Concomitant medications,   Additional Information: Vaccine was not Administered at Military Facility. AE(s) require a visit to Emergency Room, Physician Office. There were no Prior Vaccinations (within 4 weeks).  Communication: Report 1 of 2.  Caller declined transfer.  Caller provided with reportum reference number, and notified of survey prior to disconnect.   Follow-up actions are needed. Further information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: She cant get the second dose because she is allergic to it.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "She cant get the second dose because she is allergic to it.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I have an IUD and have infrequent or no periods over the last year, and after receiving the vaccine, I have started a regular monthly period.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:00 (Lot number: ER8733) at the age of 27 years as dose 1, single and administered in arm left, administration date 29Mar2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Monistat, reaction(s): "Known allergies: Monistat"; Levofloxacin, reaction(s): "Known allergies: levofloxacin". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 31Mar2021, outcome "unknown", described as "I have an IUD and have infrequent or no periods over the last year, and after receiving the vaccine, I have started a regular monthly period.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Facility type vaccine was other. No other vaccine in four weeks. Other vaccine received in two weeks. Patient had an IUD and had infrequent or no periods over the last year, and after receiving the vaccine, patient had started a regular monthly period. Is there any information on the long term effects on her hormones or other female-specific side effect? No treatment received for event. No covid present prior vaccination. No covid tested post vaccination. Known allergy was monistat, levofloxacin. Other medical history was ADHD.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: She is constantly tired and extremely beyond tired and her body still aches and this all started from the vaccines; She is constantly tired and extremely beyond tired and her body still aches and this all started from the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ER8731) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar" (unspecified if ongoing); "Acute anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM taken for anxiety; OLANZAPINE; LITHIUM. Vaccination history included: Bnt162b2 (Dose no: 1, Time: 15:00, Anatomical location: Left arm, Lot number: ERG733), administration date: 24Mar2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "She is having chronic fatigue", "loss of appetite", "body aches", "no energy", "sporadic headaches", "wants to sleep all the time", "Unsteadiness on her feet". The following information was reported: FATIGUE (non-serious), PAIN (non-serious) all with onset Apr2021, outcome "unknown" and all described as "She is constantly tired and extremely beyond tired and her body still aches and this all started from the vaccines".  Additional information: Olanzapine, Alprazolam, Lithium Taking for 24 years. It was reported she gets the second dose 14Apr2021 and it all started all over. Now she is in Jun2021 and she is constantly tired and extremely beyond tired and her body still aches and this all started from the vaccines. She was wondering if the vaccine is triggering and increasing her lithium levels, something is going on and all started since the vaccine. At this point she is wanting to report it and if another person is on these medication so they can start connecting dots. She wanted to know if vaccine increased lithium levels. She is picking lithium since it interacts with everything. She wanted to know if anything or anybody else calling up or is this interaction to Lithium. Could the vaccine be increasing her lithium levels. She has been on Lithium since 1996, for 24 years she has been on 900mg of the product. No additional vaccines on same date. Events not resulted in Emergency Room or Physician Office visit. No Prior Vaccinations within 4 weeks. patient was vaccinated when she was a baby.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: I had intensely puckered/tingling around my mouth and cheeks as well as tingling down both of my arms to both hands; I had intensely puckered/tingling around my mouth and cheeks as well as tingling down both of my arms to both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28May2021 14:30 (Lot number: EW0178) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "known allergies: Pineapple" (unspecified if ongoing), notes: known allergies: Pineapple. Concomitant medication(s) included: BENAZEPRIL HCL. The following information was reported: PARAESTHESIA (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 29May2021 09:00, outcome "recovered" (29May2021) and all described as "I had intensely puckered/tingling around my mouth and cheeks as well as tingling down both of my arms to both hands". Therapeutic measures were not taken as a result of paraesthesia, paraesthesia oral.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: left arm was swollen and pain, but it went away in 24 hours; left arm was swollen and pain, but it went away in 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 (Batch/Lot number: unknown) at the age of 34 years 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: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 15May2021, outcome "recovered" (16May2021 23:00) and all described as "left arm was swollen and pain, but it went away in 24 hours". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  Additional information: Vaccine facility type was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in None of the above. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Expiry date: unknown), via an unspecified route of administration, administered on an unspecified date as dose 2, single for covid-19 immunisation and experienced low fever at around 100F. Lot numbers were reported as EW0164 and EW0173. Vaccination time reported as 12:30 pm and Adverse event start time reported as 11:00 pm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Movement disorder, Myalgia, Pain
Clinical narrative: Slight headache; Muscles hurt; Not feeling well; Body aches; My arm where they shot me, I cannot move it, it hurts so bad; My arm where they shot me, I cannot move it, it hurts so bad; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 (Lot number: EW0180) at the age of 50 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 (first dose), administration date: 18May2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Jun2021, outcome "unknown", described as "Slight headache"; MYALGIA (non-serious) with onset 08Jun2021, outcome "unknown", described as "Muscles hurt"; MALAISE (non-serious) with onset 08Jun2021, outcome "unknown", described as "Not feeling well"; PAIN (non-serious) with onset 08Jun2021, outcome "unknown", described as "Body aches"; MOVEMENT DISORDER (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Jun2021, outcome "unknown" and all described as "My arm where they shot me, I cannot move it, it hurts so bad". Therapeutic measures were taken as a result of headache, myalgia, malaise, pain, movement disorder, pain in extremity.  Additional information: Treatment received was Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight headache; Muscles hurt; Not feeling well; Body aches; My arm where they shot me, I cannot move it, it hurts so bad; My arm where they shot me, I cannot move it, it hurts so bad; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 (Lot number: EW0180) at the age of 50 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 (first dose), administration date: 18May2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Jun2021, outcome "unknown", described as "Slight headache"; MYALGIA (non-serious) with onset 08Jun2021, outcome "unknown", described as "Muscles hurt"; MALAISE (non-serious) with onset 08Jun2021, outcome "unknown", described as "Not feeling well"; PAIN (non-serious) with onset 08Jun2021, outcome "unknown", described as "Body aches"; MOVEMENT DISORDER (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Jun2021, outcome "unknown" and all described as "My arm where they shot me, I cannot move it, it hurts so bad". Therapeutic measures were taken as a result of headache, myalgia, malaise, pain, movement disorder, pain in extremity.  Additional information: Treatment received was Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Head discomfort
Clinical narrative: Felt a little bit heaviness; Little bit bone ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2021 (Lot number: EL3248) at the age of 68 years as dose 2, single and administered in arm left, administration date 21Dec2020 09:00 (Lot number: EJ168) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Insomnia" (unspecified if ongoing), notes: Verbatim: Insomnia. The patient's concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Felt a little bit heaviness"; BONE PAIN (non-serious), outcome "unknown", described as "Little bit bone ache". Therapeutic measures were not taken as a result of head discomfort, bone pain.  Additional information: it was reported got my vaccine was doing just fine, lately she feel like a little bit heaviness, a little bit bone ache, a little bit, not just 'drive' by herself and about 2 weeks ago she received a case for one of her friend saying that the people that have Pfizer they did their body get magnet and feeling that they can attract magnet. she ignored that she said no this is not true and did not pay attention to that. Today one of doctor claim that his body has like metal 'attracting' electricity magnet and she thought let me trying on herself and see if its having the pain or may be something has wrong and she put some screw on her chest and arm and none of them is dropping down and his magnet attaching to her skin. Vaccination facility: Hospital. No other vaccine within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Lymphadenopathy
Clinical narrative: Her lymph node under her right armpit became the size of the boiled egg; could not let my arm down; Nurse injected the vaccine on the backside of the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 09:00 (Lot number: EW0173) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 08May2021, outcome "unknown", described as "Nurse injected the vaccine on the backside of the arm"; LYMPHADENOPATHY (non-serious) with onset 09May2021, outcome "unknown", described as "Her lymph node under her right armpit became the size of the boiled egg; could not let my arm down". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT no.: EW0173, Expiry date: unknown), administered intramuscular in right arm on 08Jun2021 at 09:00 as dose 2, single for covid-19 immunisation and experienced some type of discomfort between the shoulder blades she mentioned that it was all like the foot was pushing in between them and it got worse and later on the discomfort eased but still present. And, to add to that she mentioned that last night she felt chills. Felt achy my body aches and earlier had pressure and her lower back, rib, back and chest area it felt like pressure feel like somebody was hitting in her back and it was gone a while now but yesterday it was terrible it was so painful. Her other sisters do not take the Pfizer they took the Moderna.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Panic reaction, Sluggishness
Clinical narrative: I usually suffer anxiety and panic attack;  It induced the panic attack; I felt a bit sluggish; get tired; I felt a bit sluggish; get tired; my arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 15:00 (Lot number: EW0182) at the age of 29 years as dose 2, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Batch/lot number  : EW0173    , Anatomical Site : Left arm), administration date: 06May2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "unknown", described as "my arm was sore"; SLUGGISHNESS (non-serious), FATIGUE (non-serious) all with onset 09Jun2021, outcome "unknown" and all described as "I felt a bit sluggish; get tired"; PANIC REACTION (non-serious), outcome "unknown", described as "I usually suffer anxiety and panic attack;  It induced the panic attack". Therapeutic measures were not taken as a result of pain in extremity, sluggishness, fatigue, panic reaction.  Additional information: Consumer stated, Okay so yesterday he got it on 3 obviously his arm was sore that's given he was okay, this morning its in for today at work he felt a bit sluggish and that's all you know the doc said you get tired you know really sluggish but he usually suffer anxiety and panic attack. It induced the panic attack which you know he haven't heard of anybody having panic attack. So he don't know if its because he usually have panic attack but so it kind slowly brought the panic attack all at work and then sent him up. Patient not taken any other vaccines 4 weeks Prior Vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache
Clinical narrative: Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jun2021 13:10 (Lot number: EWD171, Expiration Date: 08Jun2021) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for headache; HEPA [HEPATITIS A VACCINE] taken for immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: It was reported that her daughter got the first dose yesterday and she was experiencing headache so she would like to know if she could take Ibuprofen so she was reporting an adverse event. Dosage (Metformin): Reporter stated, she always get headache, the headache was not from the shot she just get headache all time, wanted to know and want to make sure (unclear). No, she had not taken anything treatment yet. Urgent Care Pediatric, vaccine facility type. Patient did receive HepA122908 and 8910 vaccine within 4 weeks prior to the COVID vaccine on 04May2021 and MCV 71615 on 05Apr2021 (Further clarification was unknown and not confirmed). This was just towards a health certificate of immunization.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, Overdose
Clinical narrative: My left lymph node is swollen and painful; My left lymph node is swollen and painful; Dose 1 and Dose 2 taken on same date; Dose 1 and Dose 2 taken on same date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0164) at the age of 40 years as dose 2, single and administered in arm left, administration date 18May2021 14:30 (Lot number: ER8730) 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: OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 18May2021, outcome "unknown" and all described as "Dose 1 and Dose 2 taken on same date"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Jun2021 16:00, outcome "not recovered" and all described as "My left lymph node is swollen and painful". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: Facility type where vaccine was administered was Other. No other vaccine were received in four weeks. No covid prior vaccination and not tested for covid post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: vomiting; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 (Lot number: EW0179, Expiration Date: 31Aug2021) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prediabetic", start date: 2021 (ongoing); "Cervical Cancer", start date: 2020 (ongoing); "Pre COPD", start date: 2021 (ongoing), notes: Pre COPD. Concomitant medication(s) included: LEVONORGESTREL, start date: 26May2020 (ongoing); SPIRIVA HANDIHALER, start date: 16Apr2021 (ongoing); ALBUTEROL SULFATE, start date: 06Apr2021 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 18May2021, outcome "recovered" (21May2021), described as "tiredness"; VOMITING (non-serious) with onset 19May2021, outcome "recovered" (20May2021), described as "vomiting". Therapeutic measures were not taken as a result of fatigue. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0173, Expiration Date: Aug2021) at the age of 58 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site".  Additional information: Caller reported that the injection site swelling, and redness started the same day that she received the second dose of the Covid-19 vaccine, 02Jun2021, an hour or two after she received the vaccine. Caller is a consumer calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was given the second dose of the Covid-19 vaccine on 02Jun2021 at 8:30 AM, about 36 hours ago. Caller reported that last night, 03Jun2021, before going to bed, the lymph node under her armpit on the same arm as the injection was given was swollen. Caller reported the lymph node is swollen and it hurts. Caller inquired how long is this supposed to go on for and what can she do to alleviate the pain. Caller reported that she thought that if there's more Covids coming with different numbers on the end, like Covid-28, she wanted to just go ahead and be prepared for Covid-25 or whatever is coming next. Caller reported that she just wants to be protected. Prior Vaccinations the patient was not diagnosed within 4 weeks of covid-19.  Information on Lot/Batch number was available. Additional information has been requested  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastational Diabetes" (unspecified if ongoing); "Para Thyroid Precancerous" (unspecified if ongoing); "Optic neuritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Diabetes type II" (unspecified if ongoing); "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Acid-GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Low Vitamin D" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Low White Blood Count" (unspecified if ongoing); "Peanut allergy worsened" (unspecified if ongoing); "Weight gain" (unspecified if ongoing); "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; LEVOTHYROXINE; LISINOPRIL; SERTRALINE; CHLORDIAZEPOXIDE; NEXIUM 1-2-3; VITAMIN D 3; TRULICITY; CRANBERRY; ATORVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: Patient's concomitant medication included: Blood Booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Renal disorder
Clinical narrative: something going on with his kidneys; high blood pressure; 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 62 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) at the age of 62 years as dose  1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "something going on with his kidneys"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". Therapeutic measures were taken as a result of hypertension. Additional information- it was reported that patient received the first dose of the vaccine on 24May2021. Caller stated he was in the hospital for something going on with his kidneys. Been in the hospital off and on since April. Reports he has high blood pressure and they can't figure out why his medications aren't working. 62 year old male. Declined to be warm transferred to safety. Stated the reason he was in the hospital had nothing to do with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Dizziness, Fatigue, Menstrual disorder
Clinical narrative: Abnormal bleeding from uterus. My period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period; anemia-like dizziness and fatigue; anemia-like dizziness and fatigue; bloating; less appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 13:45 (Lot number: EW0153) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: hay fever" (unspecified if ongoing), notes: hay fever. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "Abnormal bleeding from uterus. My period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period"; DIZZINESS (non-serious), FATIGUE (non-serious) all with onset 15May2021 07:00, outcome "recovering" and all described as "anemia-like dizziness and fatigue"; ABDOMINAL DISTENSION (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "bloating"; DECREASED APPETITE (non-serious) with onset 15May2021 07:00, outcome "recovering", described as "less appetite". The events "abnormal bleeding from uterus. my period the bleeding continued with a small amount of most of the time,  with occasional heavy bleeding like the day 2 of a period", "anemia-like dizziness and fatigue", "anemia-like dizziness and fatigue", "bloating" and "less appetite" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder, dizziness, fatigue, abdominal distension, decreased appetite.  Additional information: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Patient took 2nd vaccine shot on 27May and had headaches and cold-like symptoms for 1 day but not so bad. The bleeding has increased from the next day but ended in a week. Patient took a blood test but results were all in normal region. This week patient feel dizzy sometimes.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: First shot gave me a sore arm and fatigue; First shot gave me a sore arm and fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0153) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Penicillin-Allergy" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LEXAPRO; FENOFIBRATE. Past drug history included: Augmentin for Product used for unknown indication, reaction(s): "Drug allergy", notes: Augmentin. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset May2021, outcome "unknown" and all described as "First shot gave me a sore arm and fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Incorrect route of product administration
Clinical narrative: Felt Very Bad /Truck passed through me; Inappropriate route of vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Physician) for a Pfizer sponsored program (164402). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), subcutaneous, administration date Dec2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, No events reported), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Dec2020, outcome "recovered" (Dec2020), described as "Felt Very Bad /Truck passed through me"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Dec2020, outcome "unknown", described as "Inappropriate route of vaccination".  Additional information: It was reported the physician stated that she received the Pfizer/Biontech Covid 19 vaccine and 'felt so bad' after the 2nd dose. She described is a feeling like a 'truck passed through me', but that it only lasted 24 hours and then she felt fine. She went on to say that means that your immune system is working.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone scan, Malaise, Somnolence
Clinical narrative: felt unwell; she has not had any energy; all she wants to do is sleep/she was drowsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:00 (Lot number: EN6205) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cataracts" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B12 [VITAMIN B12 NOS] taken for bone deformity, start date: Mar2021; VITAMIN D NOS, start date: Mar2021; ZINC taken for cataract. Vaccination history included: Bnt162b2 (DOSE 1, Lot number : EN6205, Time at vaccination : 11:00, Anatomical Location: Upper left arm), administration date: 26Apr2021, when the patient was 79 years old, for COVID-19 Immunization, reaction(s): "dizzy", "dizzy like all the energy went out of her foot"; Penicillin vaccine (she came home and she got hives on her chest and neck and up on her face), for allergic to Penicillin. The following information was reported: MALAISE (non-serious) with onset 18May2021, outcome "not recovered", described as "felt unwell"; ASTHENIA (non-serious) with onset 18May2021, outcome "not recovered", described as "she has not had any energy"; SOMNOLENCE (non-serious) with onset 18May2021, outcome "not recovered", described as "all she wants to do is sleep/she was drowsy". The patient underwent the following laboratory tests and procedures: bone scan: it showed her bones were deteriorating, notes: from get older. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient got the second dose from a hospital. No family medical history relevant to AE. She was taking Vitamin B12 that way before the shot, had a bone scan and it showed her bones were deteriorating from get older so that was why she started taking it. Vitamin D (the bottle says 125 mg [5000 mcg]) started when she had her wellness check. she had enough trouble with her eyes (cataracts and macular degeneration). So, she takes it for her eyes. She confirmed she had those prior to using the Zine. She was going to have cataract surgery on 04Aug2021. No further information provided. Patient confirmed that both doses were given in her upper left arm. She got the second dose on 18May2021 and she began feeling unwell the same day, in the late afternoon, early night. It was like she just duh, like drugged out and did not have any energy. She said that was ongoing, all she wanted to do was sleep. She said she began feeling like all she wanted to do was sleep the same day as well, about late afternoon, she was drowsy and went to bed. The events did not result in emergency room or physician office visit. Patient did not undergo any investigation assessment.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: mild pain in left elbow same arm as inflection) when arm is bent; Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent; arm had significant pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Erythromycin for Allergy. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "arm had significant pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "mild pain in left elbow same arm as inflection) when arm is bent"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, musculoskeletal stiffness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. It was reported that patient had Stiffness and mild pain in left elbow (same arm as inflection) when arm is bent. Her arm had significant pain within the first 24 hours after her first vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Second shot gave me severe body aches; fatigue; headache; sore arm; swollen lymph node in left armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 14:00 (Lot number: EW0182) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LEXAPRO; FENOFIBRATE. Past drug history included: Augmentin. Vaccination history included: Bnt162b2 (1st dose, lot number=EW0153, vaccine location=Left arm), administration date: 18May2021, when the patient was 26 years old, for COVID-19 immunization, reaction(s): "Sore arm", "Fatigue". The following information was reported: PAIN (non-serious) with onset 08Jun2021, outcome "recovering", described as "Second shot gave me severe body aches"; FATIGUE (non-serious) with onset 08Jun2021, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 08Jun2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "recovering", described as "sore arm"; LYMPHADENOPATHY (non-serious) with onset 08Jun2021, outcome "recovering", described as "swollen lymph node in left armpit". Therapeutic measures were not taken as a result of pain, fatigue, headache, pain in extremity, lymphadenopathy.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: After the first shot he felt sick with flu symptoms for several days.; After the first shot he felt sick with flu symptoms for several days.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male 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: INFLUENZA (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "After the first shot he felt sick with flu symptoms for several days.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.