chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pharyngeal disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 51-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed nasal congestion/stuffy nose/nose stuffed-up and has to be blown all the time, pharyngeal disorder/throat changed a little bit and nasopharyngitis/described as "I got a sinus cold," with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021334756 same reporter and drug; similar events, different patient.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 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 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EN6202) at the age of 17 years 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: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph nodes under his left arm chest area / lymph node swelling under his arm". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The event started about a week after the first dose of the vaccine which occurred every so often and maybe very briefly for around 5 minutes a day if he was consciously looking at it or touches it. The lymph node swelling was not under his neck, it was under his left chest side. Reporter was wondering if the swollen lymph node was still there after the 3 week period and was querying if it would that lower the effectiveness of the vaccine itself; concerned that the patient still has slightly swollen lymph node glands at the time of the second vaccine administration; asked if there was a possibility at all that the second dose may not be as effective for his son as his son still has side effects from the first dose; queried if there was any reason why somebody should not receive the second dose of the vaccine if that person still has symptoms from the first; clarified that his question is after the second dose and added that the rule was 3 weeks or 21 days to receive the second dose; queried if the patient should have waited longer than the three weeks to have received the second dose. The reporter has not seen anything to be concerned with in regard to being affected if somebody has side effects still from the first dose when that person received the second dose and if the person should still get the second dose. The patient received the second dose of BNT162B2 (Lot: EP7534) on 19Mar2021, 23 days after the first on. The patient received both vaccinations at around 4 or 4:30 pm for both doses. The patient had no additional vaccinations administered on the same day, no prior vaccinations within 4 weeks, no adverse effects following prior vaccinations, no family medical history relevant to adverse events and no relevant tests. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021331532 Same reporter and suspect drug; similar event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Muscle tightness, Neck pain
Clinical narrative: neck tightness; neck / pain; elevated 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 66 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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 (dose 1, single), for COVID-19 immunisation. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 11Mar2021, outcome "unknown", described as "neck tightness"; NECK PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "neck / pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 11Mar2021, outcome "not recovered", described as "elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Events was experienced two weeks after the vaccine. It was reported that elevated blood pressure goes sometimes, and was still experienced yesterday and today (day of the report).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 19, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  myalgia/little muscle soreness, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little soreness on the injection site; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little soreness on the injection site".  Additional Information: The patient wanted to know if it's ok for the second shot to be scheduled for the 05Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy
Clinical narrative: discomfort; swollen lymph node (lump) in left armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 19:00 (Lot number: EN6205) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VITAMINS NOS. The following information was reported: DISCOMFORT (non-serious) with onset 23Mar2021, outcome "not recovered", described as "discomfort"; LYMPHADENOPATHY (non-serious) with onset 23Mar2021, outcome "not recovered", described as "swollen lymph node (lump) in left armpit". Therapeutic measures were not taken as a result of discomfort, lymphadenopathy.  Additional information: The patient's concomitant medication included unspecified insulin. The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Intense freezing feeling in the lower half of my body up into my lower back / felt more like an internal coldness; This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 10:30 (Lot number: EN8207) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Concerta Allergy" (unspecified if ongoing). Concomitant medications included: TOPAMAX; ZOVIA; IMITREX; DITROPAN; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose 1, single (Lot number: EL9265) via intramuscular route of administration in the left arm at 13:00), administration date: 04Feb2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: FEELING COLD (non-serious) with onset 18Mar2021 20:00, outcome "unknown", described as "Intense freezing feeling in the lower half of my body up into my lower back / felt more like an internal coldness". Therapeutic measures were not taken as a result of feeling cold.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 08:00 PM, the patient experienced an intense freezing feeling in the lower half of her body up into her lower back. The patient reported that this had not felt like chills when one gets sick. This felt more like an internal coldness and not like the pins and needles feeling associated with topiramate (TOPAMAX). The patient reported that she had not felt this until after she received the second dose of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Product administered at inappropriate site
Clinical narrative: it was administered way too high and it felt like she hit the bone; it felt like she hit the bone and it hurts; 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 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: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as " it was administered way too high and it felt like she hit the bone"; BONE PAIN (non-serious), outcome "unknown", described as "it felt like she hit the bone and it hurts".  Additional information: Patient was asking if this was still effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: transit blurred vision; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: VISION BLURRED (non-serious), outcome "unknown", described as "transit blurred vision".  Additional information:  The patient asked the doctor if it is transit or permanent in nature.   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: little sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Headache, Vaccination site pain
Clinical narrative: headache; headache coming from his eyes; his arm started bothering him/ his arm was sore in the muscle/ it was pretty sore; little sore, shoulder; 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), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: on medication that his psychiatrist and doctor prescribed him; "hurt his ankle" (unspecified if ongoing), notes: prior to first dose of the vaccine , has therapy tomorrow. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for arthralgia. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "his arm started bothering him/ his arm was sore in the muscle/ it was pretty sore"; ARTHRALGIA (non-serious) with onset 24Mar2021, outcome "unknown", described as "little sore, shoulder"; HEADACHE (non-serious), outcome "unknown", described as "headache"; EYE PAIN (non-serious), outcome "unknown", described as "headache coming from his eyes". Therapeutic measures were taken as a result of vaccination site pain, arthralgia. Additional information: Patient's age was reported as 60 (unit was unknown). Clinical course: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday in his right arm. He didn't feel the injection, last night his arm started bothering him while he was sleeping; today his arm was sore in the muscle (first he said it was pretty sore and then he said a little sore, shoulder), he has been reading and knew this could happen. He has been using ice on his arm to minor the soreness, he read online that this could be the best treatment. It was reported that the patient got new glasses (last 7 days) and he has been reading a lot. The patient also experienced headache and he knew this has been reported with the vaccine however he believed that his headache was related to the glasses, due to this headache coming from his eyes. It was reported that his teeth and cheek were bothering him. Patient has no fever and he hurt his ankle prior to first dose of the vaccine so he took a small dose of aspirin every morning for his ankle, he also has therapy tomorrow. Patient was also on medication for a disability that his psychiatrist and doctor prescribed him. Patient would like to know if taken Aspirin for his ankle before receiving the first dose could affect the vaccine, how long the pain in his arm will last, if he can continue using ice and how long 30 minutes-1 hour and if he can take Aspirin. Patient was also querying if the second dose of the vaccine needs to be given in the same arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue
Clinical narrative: she hadn't eaten anything since the night before; felt dizzy; a little more fatigued than usual; 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 52 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to sulfa" (unspecified if ongoing), notes: allergic to sulfa; "she has arthritis on her knee" (unspecified if ongoing), notes: takes a steroid injection. The patient's concomitant medications were not reported. Past drug history included: Steroid injection for arthritis on knee. The following information was reported: DECREASED APPETITE (non-serious) with onset Mar2021, outcome "unknown", described as "she hadn't eaten anything since the night before"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "felt dizzy"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "a little more fatigued than usual". Therapeutic measures were taken as a result of dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; 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 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "slight headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient took TYLENOL as treatment for slight headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: tooth pain; 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), administration date 22Mar2021 (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: TOOTHACHE (non-serious), outcome "unknown", described as "tooth pain".  Additional information: Patient was asking if he can take ibuprofen (ADVIL and MOTRIN) for tooth pain and if there will be any interaction between these drugs and the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in jaw
Clinical narrative: Sore jaw; my face is semi numb; This is a spontaneous report from a contactable consumer (patient herself) from medical information team.   A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (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: PAIN IN JAW (non-serious) with onset 23Mar2021, outcome "unknown", described as "sore jaw"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "my face is semi numb". Clinical course: on 23Mar2021, she woke up with sore jaw and now it has progressed to both sides and her face is semi numb.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 17:30 (Lot number: EN6205) at the age of 60 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medications included: METFORMIN; LIPITOR; PREDNISONE. The following information was reported: DIARRHOEA (non-serious) with onset 03Mar2021 11:00, outcome "recovered" (06Mar2021 11:00), described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: It was reported that the event lasted for 3 days, but the outcome was also reported as recovering. Additional concomitant medication included Q-NOL. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in 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 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 2011 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "soreness in arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: Clinical course: The patient wanted to know when can he safely resume his aspirin maintenance therapy after receipt of the Pfizer-BioNTech COVID-19 Vaccine. The patient has been on aspirin 81 mg for many years (at least 10 years) as maintenance therapy. He has many health issues (unspecified). The patient stopped aspirin on his own, on either Friday or Saturday (19Mar2021 or 20Mar2021) in preparation for receipt of the Pfizer-BioNTech COVID-19 Vaccine. He got his first dose of the Pfizer-BioNTech COVID-19 Vaccine on Monday, 22Mar2021 and took a couple of paracetamol (TYLENOL) that same night because of soreness in his arm. The next day he was okay. The patient has not resumed his aspirin yet and planned to speak further with provider.  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, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Aches; Inflammation on my left shoulder where I got the vaccine; Burning where I got the vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN (Lot Number: Not provided)), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Aches"; VACCINATION SITE INFLAMMATION (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Inflammation on my left shoulder where I got the vaccine"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Burning where I got the vaccine". The events "aches", "inflammation on my left shoulder where I got the vaccine" and "burning where I got the vaccine" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, vaccination site inflammation, vaccination site pain.  Additional Information: The patient had his second dose on 27Feb2021 and since then it was affecting his body and he had aches. He had inflammation on his left shoulder and burning where he got the vaccine. He did see his doctor and was prescribed with three medications but it did not help. He would have therapy next week (date unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious) with onset 13Mar2021, outcome "unknown", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovered" (14Mar2021), described as "sore arm".  Additional information: Since the vaccination, the patient had developed dizziness. It has gone to the point where she could not use computer because of her dizziness. The patient could only work if she had sunglasses in front of her computer monitor. The patient thought it was vertigo since she had experienced it before, but her HCPs had tested her for it and told her she had no vertigo. The patient also mentioned that she had a sore arm on the day of her vaccination until the next day. The patient wanted to know if her adverse events were common and should she be concerned about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Faeces pale
Clinical narrative: green stool/Sometimes it would be tan, other times green; Sometimes it would be tan, other times green; 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 female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (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: FAECES DISCOLOURED (non-serious) with onset 16Mar2021, outcome "not recovered", described as "green stool/Sometimes it would be tan, other times green"; FAECES PALE (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Sometimes it would be tan, other times green".  Additional information: Patient (Age: 67, Unit: Unknown) received the 1st shot on 15Mar2021, the day after, she started having green stool daily since then. Sometimes it would be tan, other times green. Not diarrhea. She has scheduled an appointment with her doctor on 19Apr2021. Patient would like to know whether she should get the 2nd dose of the COVID vaccine after the side effects she experienced.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Oropharyngeal pain
Clinical narrative: sick all week with diarrhea and has a slight sore throat; sick all week with diarrhea and has a slight sore throat; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: DIARRHOEA (non-serious), OROPHARYNGEAL PAIN (non-serious), outcome "unknown" and all described as "sick all week with diarrhea and has a slight sore throat". Additional information: The patient wanted to reschedule her appoint for the second dose on 26Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: got gout one day after first dose; got gout in left big toe one day after second dose; 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 (reported as patient's age: 67; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: GOUT (non-serious), outcome "unknown", described as "got gout one day after first dose; got gout in left big toe one day after second dose".  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-2021332273 duplicate case
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vulval ulceration, Vulvovaginal pruritus
Clinical narrative: Vaginal itching; Appearance of vulvar ulcers; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 08:45 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Genital ulcers" (unspecified if ongoing), notes: Epstein-Barr virus (EBV) resulting in genital ulcers at 9 years old; "COVID-19" (unspecified if ongoing); "Trimethoprim allergy" (unspecified if ongoing). Concomitant medication included: ZOLOFT. Vaccination history included: Bnt162b2 (Dose 1, single (Lot number: Not provided) in the left arm at 08:45 AM), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: VULVOVAGINAL PRURITUS (non-serious) with onset 17Mar2021 15:45, outcome "recovering", described as "Vaginal itching"; VULVAL ULCERATION (non-serious) with onset 17Mar2021 15:45, outcome "recovering", described as "Appearance of vulvar ulcers". The events "vaginal itching" and "appearance of vulvar ulcers" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vulvovaginal pruritus, vulval ulceration..  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received sertraline (ZOLOFT) within 2 weeks of vaccination. The patient received acyclovir as treatment for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and the result was pending.   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: little a soreness in the arm like when he gets the Flu shot; 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 70 year-old male patient received bnt162b2 (BNT162B2) (Lot number: ER8732) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, reaction(s): "little a soreness in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little a soreness in the arm like when he gets the Flu shot".  Additional information: Patient stated that he had no reaction for the vaccine except for the event. He asked if there was a website where he can have searched for the expiration and manufacturing date of the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymphadenopathy - pain and swelling under left armpit; Lymphadenopathy - pain and swelling under left armpit; 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 (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 14:30 (Lot number: EL3247) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELATONIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162B2 (Lot number: EL3247; Administration time: 09:45 AM; Vaccine location: Left leg; Dose number: 1), administration date: 02Mar2021, when the patient was 44 years old, for COVID-19 immunisation, reaction(s): "Vaccine location: Left leg". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021 05:00, outcome "recovering" and all described as "Lymphadenopathy - pain and swelling under left armpit". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient's concomitant medications also included Birth control and magne. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was given in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Much less arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 10Feb2021 11:30 (Lot number: EL9267) at the age of 42 years as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Much less arm pain".  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach cramps; diarhea; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 24Mar2021 (Lot number: ER8727) at the age of 60 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergies to medications, food, or other products: penicillin" (unspecified if ongoing). Concomitant medication included: NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: EN6202), administration date: 03Mar2021 16:00, when the patient was 60 years old, for COVID-19 immunisation, reactions: "severe stomach cramps", "bad lower back pain". The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "recovering", described as "stomach cramps"; DIARRHOEA (non-serious) with onset Mar2021, outcome "recovering", described as "diarhea". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt like broken shins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt like broken shins".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: mild headache within 24 hours; muscle aches within 18 hours; sore arm within 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 24Mar2021 09:30 (Lot number: ER8727) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "sarcoidosis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LIPITOR [ATORVASTATIN]; PREDNISONE; QNOL. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN6205) at 05:30 PM in left arm), administration date: 02Mar2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "diarrhea". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 21:30, outcome "recovering", described as "sore arm within 12 hours"; MYALGIA (non-serious) with onset 25Mar2021 03:30, outcome "recovering", described as "muscle aches within 18 hours"; HEADACHE (non-serious) with onset 25Mar2021 09:30, outcome "recovering", described as "mild headache within 24 hours". Therapeutic measures were not taken as a result of pain in extremity, myalgia, headache. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Additional information: Patient was a healthy woman of 66 years old. She had arm pain after the first injection of Pfizer COVID 19 vaccination, but felt nothing after the second injection. Patient wondered if the second vaccine was effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in the second ear (right); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Bicuspid aortic valve" (unspecified if ongoing). Concomitant medications included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose 1, single (Lot Number: Not provided) in the right arm), administration date: 25Jan2021, when the patient was 31 years old, for COVID-19 immunisation, reaction: "Tinnitus in the first ear (left)". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus in the second ear (right)". The event "tinnitus in the second ear (right)" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional Information: The patient did not receive other vaccine in four weeks and his other medications in two weeks were losartan and amlodipine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior vaccination, was not tested for COVID post vaccination and had no known allergies.  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-2021330066 Same reporter, patient, and drug; Different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having some left arm pain really hard; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "having some left arm pain really hard".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured, Gastric disorder
Clinical narrative: stool was black; diarrhea/liquid poop; problems in her stomach; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 19Mar2021 (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: Covid-19 vaccine (Dose 1, Single, MANUFACTURER UNKNOWN (Lot # not provided)), for COVID-19 Immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 24Mar2021, outcome "unknown", described as "diarrhea/liquid poop"; GASTRIC DISORDER (non-serious) with onset 24Mar2021, outcome "unknown", described as "problems in her stomach"; FAECES DISCOLOURED (non-serious), outcome "unknown", described as "stool was black". Additional Information: The patient received the second dose of the Covid 19 vaccine on March 19th. After a few days, on 24Mar2021, she started with diarrhea, it started in the morning. She had liquid poop and problems in her stomach. Yesterday her stool was watery and black. She forced herself to eat something yesterday, it may have hardened already. The patient asked if she should get tested to see if she has Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle tightness, Tension headache
Clinical narrative: feeling muscle tension in the back of her neck that spread up to her eyebrows; it was like a tension headache; discomfort; 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 female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (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: MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "feeling muscle tension in the back of her neck that spread up to her eyebrows"; TENSION HEADACHE (non-serious), outcome "unknown", described as "it was like a tension headache"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort". Therapeutic measures were taken as a result of muscle tightness, tension headache, discomfort. Additional information: The patient experienced 7-10 days ago, began to feel muscle tension in the back of her neck that spread up to her eyebrows. She stated that it was like a tension headache. The patient has been taking Motrin to treat the events, the headache goes away but then returns. Patient reported that she had a friend who went the same day as her to get the vaccine and she reported the same discomfort. The patient was scheduled to get her second dose of the Pfizer Covid vaccine on 28Mar20201 and wanted to know how long to expect this side effect to last.  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-2021337114 Same reporter, suspect drug and events; different patient.