chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness at site of 2nd injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jun2021 10:30 (Lot number: EW0196) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid adenoma", start date: Jan2017, stop date: Mar2017, notes: Thyroid Removal; "Hypothyroidism", start date: Jan2017, stop date: Mar2017; "DCIS", start date: May2015, stop date: Jun2015, notes: Unilateral Mastectomy right breast w/5 Lymph nodes; "High Cholesterol" (unspecified if ongoing); "Hot Flushes" (unspecified if ongoing); "Supplement" (unspecified if ongoing), notes: Supplement; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: May2017 (ongoing); SIMVASTATIN taken for blood cholesterol increased, start date: Sep2019 (ongoing); AMBEREN taken for hot flush, start date: Feb2021 (ongoing); VITAMIN D NOS taken for supplementation therapy, start date: Mar2021, stop date: Aug2021. Vaccination history included: Bnt162b2 (1st Dose time : 10:15, Anatomical site: Left arm shoulder, Route: Intramuscular , Lot: EW0179), administration date: 04Jun2021, for COVID-19 Immunization, reaction(s): "Quarter size swelling of lymph node at Collar Bone". The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset 25Jun2021 21:00, outcome "recovered" (2021), described as "redness at site of 2nd injection". Therapeutic measures were not taken as a result of injection site erythema.  Additional information: Vaccination facility type was pharmacy/drug store. Vaccine was not administered at military facility. No any prior vaccinations. No any relevant test.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Lymphadenopathy, Musculoskeletal chest pain, Nausea
Clinical narrative: arm feels worse than any injection she's ever had; enlarged lymph nodes; feels horrible; really bad nausea; pain up through her rib cage; stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 15:00 (Lot number: FC3181) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing); "Enlarged lymph nodes" (ongoing); "CLL" (unspecified if ongoing); "Enlarged spleen" (unspecified if ongoing); "enlarged brain" (unspecified if ongoing); "Stomach pain" (unspecified if ongoing); "States her brain does not work as it is." (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 08Sep2021 18:00, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 09Sep2021 02:30, outcome "unknown", described as "really bad nausea"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 09Sep2021, outcome "unknown", described as "pain up through her rib cage"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm feels worse than any injection she's ever had"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels horrible". Therapeutic measures were taken as a result of abdominal pain upper, nausea, musculoskeletal chest pain, pain in extremity.  Additional information: Consumer was on chemo and has an enlarged brain and enlarged lymph nodes. She was 70 years old with COPD. She was diagnosed with enlarged lymph nodes about a year ago, states they are getting really big under her arm. She clarified about a week and a half ago she had severe stomach pains and went to the ER and had a cat scan and was told she had an enlarged spleen, not an enlarged brain. This occurred prior to the vaccine. After received the first dose, she started developing severe stomach pain last night on 08Sep2021 at 18:00 and woke up with really bad nausea this morning at 02:30, which included pain up through her rib cage. Stated that her arm feels worse than any injection she's ever had. She called her primary this morning for a prescription for pain meds and nausea medication. She reports that she already had enlarged lymph nodes, and she expected her side effects to be worse. She was wondering if these symptoms are going to go away soon. She feels horrible. She wanted to make sure it was temporary. She was asking if there was information on how long these side effects are expected to last.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm feels worse than any injection she's ever had; enlarged lymph nodes; feels horrible; really bad nausea; pain up through her rib cage; stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 15:00 (Lot number: FC3181) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing); "Enlarged lymph nodes" (ongoing); "CLL" (unspecified if ongoing); "Enlarged spleen" (unspecified if ongoing); "enlarged brain" (unspecified if ongoing); "Stomach pain" (unspecified if ongoing); "States her brain does not work as it is." (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 08Sep2021 18:00, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 09Sep2021 02:30, outcome "unknown", described as "really bad nausea"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 09Sep2021, outcome "unknown", described as "pain up through her rib cage"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm feels worse than any injection she's ever had"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels horrible". Therapeutic measures were taken as a result of abdominal pain upper, nausea, musculoskeletal chest pain, pain in extremity.  Additional information: Consumer was on chemo and has an enlarged brain and enlarged lymph nodes. She was 70 years old with COPD. She was diagnosed with enlarged lymph nodes about a year ago, states they are getting really big under her arm. She clarified about a week and a half ago she had severe stomach pains and went to the ER and had a cat scan and was told she had an enlarged spleen, not an enlarged brain. This occurred prior to the vaccine. After received the first dose, she started developing severe stomach pain last night on 08Sep2021 at 18:00 and woke up with really bad nausea this morning at 02:30, which included pain up through her rib cage. Stated that her arm feels worse than any injection she's ever had. She called her primary this morning for a prescription for pain meds and nausea medication. She reports that she already had enlarged lymph nodes, and she expected her side effects to be worse. She was wondering if these symptoms are going to go away soon. She feels horrible. She wanted to make sure it was temporary. She was asking if there was information on how long these side effects are expected to last.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: One friend had a bad time with the second one, being a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) 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. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "One friend had a bad time with the second one, being a sore 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: Menstrual disorder, Taste disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 11:30 (Lot number: FC3182) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS. The following information was reported: TASTE DISORDER (non-serious) with onset 03Sep2021 06:00, outcome "not recovered", described as "Within 30 minutes of shot I experienced a distinct taste in my mouth/throat (minor)"; MENSTRUAL DISORDER (non-serious) with onset 03Sep2021 06:00, outcome "not recovered", described as "Then within 24 hours I started a menstrual cycle. Currently on day 7 of bleeding". Therapeutic measures were not taken as a result of taste disorder, menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient currently has the Mirena IUD. The IUD prevents her from having a menstrual cycle. Within 30 minutes of shot I experienced a distinct taste in her mouth/throat (minor). Then within 24 hours I started a menstrual cycle. Currently on day 7 of bleeding. A bit alarming to why my body is reacting in this way. And enquired about Causing a hormonal spike. No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Suppressed lactation
Clinical narrative: I am breastfeeding and it caused my supply to drop drastically; I am breastfeeding; I am breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 08:00 (Batch/Lot number: unknown) at the age of 24 years as dose 1, single and administered in arm right, administration date 07Sep2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL [FOLIC ACID;IRON]; BIOTIN. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Aug2021 08:00, outcome "not recovered" and all described as "I am breastfeeding"; SUPPRESSED LACTATION (non-serious) with onset 21Aug2021 08:00, outcome "not recovered", described as "I am breastfeeding and it caused my supply to drop drastically". Therapeutic measures were not taken as a result of suppressed lactation.  Additional Information: Patient received other medications in two weeks prenatals and biotin. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not receive other vaccine in four weeks of vaccination. The patient 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-202101182557 mother/baby
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient was bedridden (on the fourth day it hit him, he was in bed for a couple of days), with outcome of unknown. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: Metallic taste; Headache; metal is sticking to my arm and serval lot of side effects; metal is sticking to my arm and serval lot of side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 05Sep2021 (Lot number: FC3182) at the age of 41 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Systemic lupus" (unspecified if ongoing), notes: Verbatim: Systemic lupus. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "Metallic taste"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), ADVERSE DRUG REACTION (non-serious) all with onset 2021, outcome "unknown" and all described as "metal is sticking to my arm and serval lot of side effects". Therapeutic measures were not taken as a result of dysgeusia, headache, feeling abnormal, adverse drug reaction.  Additional information: Patient reported, she went out for vaccine two days ago on Sunday 05Sep2021 and the first shot and a metal was sticking to her arm, she had metallic taste and then an imbibing' headache and serval lot of side effects and went to the pharmacy and they wanted her to call you and she had already contacted her doctor.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: consistent drowsiness that persists to this day and it has been weeks.; upper arm sore; 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 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 11:30 (Lot number: FC3180) at the age of 40 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) with onset 2021, outcome "recovered" (2021), described as "upper arm sore"; SOMNOLENCE (non-serious) with onset 11Aug2021, outcome "not recovered", described as "consistent drowsiness that persists to this day and it has been weeks.".  Additional information: Upper arm  sore  was went away in 48 hours.The patient stated that she can't drive and stay in her house and do certain things. She was asking if this was a normal reaction after receiving the Pfizer Covid Vaccine. She did not experience the drowsiness until receiving the Pfizer Covid Vaccine. None of additional Vaccines Administered on Same Date of the Pfizer Suspect. Any adverse event does not required to visit to Emergency Room or Physician Office. The patient did not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).Patient does not had any Medical History (including any illness at time of vaccination).   Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Worn out; severe chill attack; teeth were chattering; 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 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 10:30 (Batch/Lot number: unknown) at the age of 78 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: CHILLS (non-serious) with onset 25Aug2021, outcome "recovered" (26Aug2021), described as "severe chill attack"; CHILLS (non-serious) with onset 25Aug2021, outcome "unknown", described as "teeth were chattering"; FATIGUE (non-serious) with onset 26Aug2021, outcome "unknown", described as "Worn out".  Additional information: The severe chills happened that same night at around 12 am. He put on 2-3 blankets, but that didn't work. He then tried a heating pad and blanket, and that helped. It lasted an hour or so. He was worn out the next day. He feels better not, but he isn't where he normally was. He still feels a little worn out, but that could be because he was 78 years old. His wife has his card in her pocketbook so he doesn't have it right now. He has never had anything like this happen before. He did not have to go to the emergency room or doctor's office. After the heating pad he was fine, and went back to sleep. The patient was due for his second shot of the COVID 19 vaccine this Wednesday. The patient enquired whether it was safe to even get the second dose. The patient did not receive any other vaccines within 4 weeks.   Follow-up (13Oct2021): 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Sep2021 (Batch/Lot number: unknown, Expiration Date: Sep2024) at the age of 87 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Sep2021, outcome "unknown", described as "legs started hurting"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "back hurts so bad I can just sit down and cry". Therapeutic measures were not taken as a result of pain in extremity, back pain. Additional Information: Patient stated, she got the vaccine last Friday. Her first shot last Friday and yesterday her legs started hurting and her back hurt so bad she could just sit down and cry. She just wanted to know can she take Tylenol. She really wanted to take some what she was supposed to. Patient stated on 03Sep2021. Well, that was the date written on here (Later 03Sep2021 Confirmed as date of vaccination of first dose). There was another date on the back side. On the back side there was another date. It says 24Sep (Further Clarification Unknown). She guessed that was when she got it. Last Friday, whatever Last Friday it was. Patient asked to see it on her card. That would be on her little card they gave her, (further not clarified, hence not captured in tab). Weight: Patient stated, "Probably 162."(not clarified further, hence not captured in tab). Scheduled Date of second dose: Consumer stated, "They had not that here, they said they will contact her." Anatomical site of administration: Patient stated that "In her right arm, upper arm." Other Medical Conditions: Patient stated, "No, it said on here if you have pain or something like this. No, her leg started hurting yesterday and then her back started hurting and I thought in case it was from the vaccine. I did not know whether to take something or not."(medical history was not appropriately clarified). Time of vaccination: Patient stated, "It was probably around 2 o clock at evening. Facility Type: Patient stated, "It was a premise of School. Patient stated that no prior vaccination (within 4 weeks of Pfizer vaccine). Patient stated that no Family Medical History relevant to AE. No lab tests were performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a little headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 19:00 (Lot number: EK9231) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: Known allergies: yes; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "a little headache".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. First dose of the Pfizer Covid-19 vaccine is 06Jan2021 and the lot number is EK9231. Reporter stated that after administration of the first dose she only experienced a little headache which lasted a few days. Reporter stated that she did not have the start and stop dates of event a little headache.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pelvic pain
Clinical narrative: muscle twitching; pelvic pain; 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 (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Sep2021 (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 TWITCHING (non-serious) with onset Sep2021, outcome "unknown", described as "muscle twitching"; PELVIC PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "pelvic pain".  Additional information: She would like to know what is going on in her body and would like someone to explain to her the mechanism of how the vaccine is causing this to her body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea
Clinical narrative: sick; is not feeling well; nauseated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Aug2021 13:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid problem" (unspecified if ongoing), notes: she takes medication; "Diabetic" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Sep2021, outcome "not recovered", described as "nauseated"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "is not feeling well".  Additional information: Caller was a consumer who received the first dose of the Pfizer BioNtech COVID-19 vaccine on 04Aug2021. Anatomical Location of Administration of Pfizer vaccine: right upper arm. Caller said she felt nauseated and that she can express how sick she is, which started on Sunday. Caller wants to know if it is a side effect with the vaccine. Caller was not able to receive second dose since she is not feeling well. NDC number of Covid vaccine: Unknown. Reason for no lot number: of Covid vaccine: Other: caller does not have her card with her. Expiry Date of Covid vaccine: Unknown. Other Products: No. Additional Information for Other Conditions: states she takes medication. Medical History: Caller states she has mental health medication she is on also. Vaccination Facility Type: Pharmacy. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to Emergency Room/Physician Office: No. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Investigation: States she called for something for nausea and the nurse is supposed to get back to her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Nasopharyngitis, Pain
Clinical narrative: Migraine headache; cold chills; body aches; cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 15:00 (Lot number: FC3184, Expiration Date: 30Jan2022) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "had a stoke 3 years ago" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number FA7484;exp:30Sep2021, administration time 05:00 PM, vaccine location Left arm), administration date: 16Aug2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: MIGRAINE (non-serious) with onset 08Sep2021 18:00, outcome "not recovered", described as "Migraine headache"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 08Sep2021 18:00, outcome "not recovered" and all described as "cold chills"; PAIN (non-serious) with onset 08Sep2021 18:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of migraine, chills, pain, nasopharyngitis.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified prescription medicine within 2 weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Having consistent drowsiness; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 11:30 (Lot number: FC3180) at the age of 40 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 (First dose: 10Aug2021, Lot: FC3180, NDC: Unknown , Expiration: Unknown , Route of administration: Right shoulder, Time the Vaccination Was Given: First dose: 11:30), administration date: 10Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Having consistent drowsiness".  Additional information: The caller states she received her first dose Pfizer Covid Vaccine on 10Aug2021 and the first day of drowsiness was on 11Aug2021. The caller states the drowsiness is persistent and continued after receiving the second dose Pfizer Covid Vaccine on 31Aug2021. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal inflammation
Clinical narrative: Inflammation in the gut; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 15:45 (Batch/Lot number: unknown) at the age of 42 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 (lot unknown: True, lot unknown reason: Not available/provided to reporter at the time of report completion, dose number: 1), for COVID-19 Immunization. The following information was reported: GASTROINTESTINAL INFLAMMATION (non-serious) with onset 23Jun2021, outcome "not recovered", described as "Inflammation in the gut". The event "inflammation in the gut" was evaluated at the physician office visit. Therapeutic measures were taken as a result of gastrointestinal inflammation.  Additional Information: Facility type vaccine of administered was pharmacy or drug Store. No other vaccine in four weeks. No covid prior vaccination and patient not tested covid post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Headache that lasted about 4 days; nausea for about two days in the days following the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 (Lot number: FD8448) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thrombocytopenia" (unspecified if ongoing). Concomitant medication(s) included: CYANOCOBALAMIN. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0179, Dose 1, single, vaccine location=Left arm), administration date: 02Aug2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 24Aug2021, outcome "recovered with sequelae" (28Aug2021), described as "Headache that lasted about 4 days"; NAUSEA (non-serious) with onset 24Aug2021, outcome "recovered with sequelae" (26Aug2021), described as "nausea for about two days in the days following the second dose.". The events "headache that lasted about 4 days" and "nausea for about two days in the days following the second dose." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient been tested for COVID-19 was negative. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had fatigue (very tired after both doses of Pfizer COVID-19 vaccine), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Overdose, Pain
Clinical narrative: This is a spontaneous report received from 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 right, administration date 08Sep2021 04:30 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and administered in leg left, administration date 08Sep2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: other medical history: Ms. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Administration date: 08Sep2021, Dose number: 2, Administration date: 08Sep2021, Dose number:1"; PAIN (non-serious) with onset 08Sep2021 18:45, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 08Sep2021 18:45, outcome "recovering", described as "shivers/chills". Therapeutic measures were not taken as a result of pain, chills. Additional information: Patient had not received other vaccine in four weeks. Patient not had Covid prior vaccination and was not tested to Covid post vaccination. Patient had no known allergies. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Peripheral swelling, Rhinorrhoea, Throat clearing
Clinical narrative: swelling of the arm; tired; gland swelling under her arm; runny nose; having to clear her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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), for COVID-19 Immunization. T  he following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the arm"; FATIGUE (non-serious), outcome "unknown", described as "tired"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "gland swelling under her arm"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; THROAT CLEARING (non-serious), outcome "unknown", described as "having to clear her throat".  Additional information: The patient and her mother took the second dose of Covid vaccine last Thursday. They both experienced swelling of the arm but her mother's was hotter, redder and hard. She had gland swelling under her arm and they are both tired. Now developing a runny nose and is having to clear her throat. She wondering if this is side effect from Covid vaccine as her mother in in her 90's and wants to make sure mother is ok.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (143231). A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 58, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had increased hair loss and peripheral swelling (swollen feet), with outcome of unknown. Additional information: Ibrance on hold while pending PET scan in next two weeks. Last dose Aug 26, 2021 end of cycle. Had 1st COVID-19 vaccine a couple weeks ago. Side effects (after vaccination): increased hair loss and feet swelling. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is with pain for this month; I can't hold up very painful; I am with pain in my two arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Aug2021 (Lot number: FA6780) 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 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arm is with pain for this month; I can't hold up very painful; I am with pain in my two arms".  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lasting deep muscle tenderness in region of injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 36-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 14May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included samters triad- asthma, non-steroidal anti-inflammatory drug (NSAID) allergy, nasal polyps and allergy to NSAIDs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included fluticasone propionate/salmeterol xinafoate (ADVAIR), beclometasone dipropionate (QNASL), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication and unknown if ongoing. On an unknown date in 2021, the patient experienced lasting deep muscle tenderness in region of injection site. It seemed to be getting more prevalent over time. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lasting deep muscle tenderness in region of injection site was not resolved at the time of the report.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: For suspect vaccine, Dose 1 was re-ranked as Primary Regimen. Vaccine Facility Information captured.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Copper taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on an unknown date in 2021 as dose 2, single for COVID-19 immunisation. Medical history included postpartum within 2 months and known allergy to penicillin (Pcn) and NSAIDs (non-steroidal anti-inflammatory drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and unspecified multivitamins; both for an unknown indication from an unknown date and an unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced copper taste in mouth within 5 minutes of vaccination, lasting up to 2 hours post vaccination. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event copper taste in mouth was resolved on an unknown date of 2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment Of vaccination information and narrative.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Peripheral swelling
Clinical narrative: Foot Became Swollen; Feet are Swollen; Can't Walk/Almost Cannot Walk; pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female 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 (DOSE 1, SINGLE), for COVID-19 immunization.The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Foot Became Swollen; Feet are Swollen"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can't Walk/Almost Cannot Walk"; PAIN (non-serious), outcome "unknown", described as "pain". The events "foot became swollen; feet are swollen", "can't walk/almost cannot walk" and "pain" were evaluated at the physician office visit.  Additional information: Caller reports that she received both Pfizer Covid vaccine doses and after her second vaccine dose her foot became swollen and she almost can't walk. Caller reports that they went to 2 different doctors who can't figure out what is wrong and advised them to call Pfizer. Caller reports "My sister is in trouble, she's crying she was vaccinated twice by Pfizer and her foot became swollen almost instantly, 2 days after her shot. Now she cannot walk, she is in pain, the doctors don't understand and can't find anything wrong". Caller now asking, what can she do to make it better, caller asking for medical advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  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-202101190403 different patient, different event and same drug.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (soreness in the arm), with outcome of unknown. Additional information: Reporter wanted to find out where she can take her grandkids (12 years old, 13 years old and 25 years old) to get the Pfizer vaccine. Reporter said her neighbor did not have a major problem regarding the vaccine, only soreness in the arm. Follow-up attempts completed. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101190402 different patient, different event and same drug.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Throat irritation
Clinical narrative: pain in my arms; pain in my body; itchy throat and nasal mucus; itchy throat and nasal mucus; 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 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my arms"; PAIN (non-serious), outcome "unknown", described as "pain in my body"; THROAT IRRITATION (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "itchy throat and nasal mucus".  Additional Information: Caller asked: "I got the first dose of the Pfizer COVID vaccine in (State). The problem is since Tuesday I'm experiencing symptoms. should I be tested for COVID? My question is should I get a COVID test if I feel all these symptoms; first I started having pain in my arms, pain in my body. Now I'm feeling an itchy throat and nasal mucus."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.