chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The first 2 shots were simple, she had a sore arm for a couple days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EN6208) at the age of 61 years as dose 2, single and administered in arm right, administration date 10Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: Verbatim: super clavicular tachycardia; "Breast cancer" (unspecified if ongoing), notes: Verbatim: Breast cancer, Left Breast. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The first 2 shots were simple, she had a sore arm for a couple days".  Additional information: The first 2 shots were simple, she had a sore arm in 6 to 12 hours for a couple days.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Protein urine present, Urine analysis
Clinical narrative: the last 2 vaccines that I had from you I had a lot of protein in my urine from the vaccine."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Transplant" (unspecified if ongoing), notes: I am transplant patient. The patient's concomitant medications were not reported. The following information was reported: PROTEIN URINE PRESENT (non-serious) with onset 2021, outcome "recovered" (2021), described as "the last 2 vaccines that I had from you I had a lot of protein in my urine from the vaccine."". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reason for no lot number of COVID-19 Vaccine: Other: LOT number: Consumer stated that they did not knew what the number was would it be on their card. As they did not had their card with them right now, they would had to call Pfizer later and then tell him for options 3? Consumer stated that they knew about having the Pfizer Vaccine and were thinking about taking a booster. Consumer was transplant patient (Further clarification was unknown). The last 2 vaccines that patient had from you they had a lot of protein in their urine from the vaccine. Consumer asked whether that was okay. When informed about the role of Pfizer Drug Safety and Pfizer medical information department, consumer stated that they cannot really understand you, you are gonna, they mean they could ask another one in your department if that was alright? Consumer was again informed about medical information department and was provided with the number, was provided with the number and told to press number 3. Consumer stated that was what they called now. Consumer stated: You are the pharmacist. Okay, after few days it disappeared, patient did not had protein. Consumer confirmed the vaccine as Pfizer COVID-19 Vaccine. Consumer stated that they would call that number again? When asked to file a safety report. Consumer was provided with the timings of Medical information department 8 am to 8pm EST and stated they will call. When asked for further probing: Consumer stated that they just cannot understand what you are saying and asked to call that number later. Further probing could not be done as the consumer was not willing to provide further information. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP. A patient (no qualifiers provided) 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 experienced vaccination site reaction (one of their vaccine recipients had a reaction with the vaccine), 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: Drug hypersensitivity, Vaccination site vesicles
Clinical narrative: This is a spontaneous report received from a contactable physician. A 47-year-old female 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 experienced drug hypersensitivity (allergic reaction to the Pfizer COVID-19 vaccine), and  vaccination site vesicles (developed 4-6 cm blister at injection site), with outcome of unknown. Additional information: Patient experienced an allergic reaction to the Pfizer COVID-19 vaccine. Developed 4-6 cm blister at injection site. No anaphylaxis. No guidance on recommendations for a second vaccination. Non-severe but immediate; needed specific information on reactions to the PEG/distearoyl ingredients. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Strong heart beat; heart palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jul2021 16:00 (Lot number: ER8734) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number ER8734,, administration time 03:00 PM, vaccine location Left arm), administration date: 11Jun2021, when the patient was 16 years old, for COVID-19 immunization.  The following information was reported: HEART RATE INCREASED (non-serious) with onset 06Jul2021 13:00, outcome "recovering", described as "Strong heart beat"; PALPITATIONS (non-serious) with onset 06Jul2021 13:00, outcome "recovering", described as "heart palpitations". The events "strong heart beat" and "heart palpitations" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of heart rate increased, palpitations.  Additional information: The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive no other medications within 2 weeks of vaccination. It was stated that Strong heart beat/heart palpitations stated 4 days after 2nd vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain
Clinical narrative: achy; muscle pain / could hardly move without it hurting; fatigue; Back ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 (Lot number: FC3182) at the age of 84 years as booster, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL9261, LEFT ARM), administration date: 24Jan2021; Bnt162b2 (Dose 2, Lot: EN6200, LEFT ARM), administration date: 22Feb2021. The following information was reported: PAIN (non-serious) with onset 23Sep2021, outcome "recovering", described as "achy"; MYALGIA (non-serious) with onset 23Sep2021, outcome "recovering", described as "muscle pain / could hardly move without it hurting"; FATIGUE (non-serious) with onset 23Sep2021, outcome "recovering", described as "fatigue"; BACK PAIN (non-serious) with onset 23Sep2021, outcome "recovering", described as "Back ache". Additional information: Time the Vaccination Was Given: AROUND NOON. The Vaccination Facility Type was Pharmacy. The patient did not receive 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Magnetic resonance imaging head, Muscle twitching, Paraesthesia
Clinical narrative: paresthesia; eye and lip twitching has gone away; leg problems have gone away; It was awful awful for months and months; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) reported for herself that: A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 14:30 (Lot number: EN6206) at the age of 58 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: PARAESTHESIA (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "paresthesia"; MUSCLE TWITCHING (non-serious) with onset 12Mar2021 20:30, outcome "not recovered", described as "eye and lip twitching has gone away"; LIMB DISCOMFORT (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "leg problems have gone away"; FEELING ABNORMAL (non-serious) with onset 12Mar2021 20:30, outcome "recovered" (2021), described as "It was awful awful for months and months". The events "paresthesia", "eye and lip twitching has gone away", "leg problems have gone away" and "it was awful awful for months and months" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had one dose of Pfizer on 12Mar2021. Could she get a second dose still. She had paresthesia starting 6 hours after first shot for 3 months. She was Leary of getting 2nd shot but now her job requires fully vaccinated and she would like to get the 2nd dose. It had been slightly over six months since the first." She wanted to know if she could still get the second dose. Her MRI was negative. She was hoping she didn't have to start he series over again." She saw a General Practitioner and a Neurologist.  No prior neuro symptoms before getting the vaccine. She still had minor symptoms. The majority of the symptoms went away in a month. The eye twitching and lip twitching lasted an additional month. By three months 90 % of the issues had resolved. She didn't have any heat or cold sensitivity anymore. She just had minor leg twitching/ tingling. It was all on her right side. Her right eye and corner of her right lip both twitched on and off daily for two months. She has never had any tingling or numbness in limbs.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in her leg; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 73 year-old 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in her leg".  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: Back pain, Overdose, Product preparation error, Vaccination site pain
Clinical narrative: soreness at injection site; Back ache; administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient; administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 10:00 (Lot number: FC3184) as dose 3 (booster), 0.3 ml 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; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 28Sep2021 10:00, outcome "unknown" and all described as "administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient"; VACCINATION SITE PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "soreness at injection site"; BACK PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "Back ache". Therapeutic measures were taken as a result of vaccination site pain, back pain.  Additional information: She was calling because one of their pharmacist administered an undiluted 0.3 ml Pfizer-BioNTech COVID-19 Vaccine to a 66 year old female patient. She was asking if there would be any side effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: nightmares; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FF2589) for 1 day 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: NIGHTMARE (non-serious), outcome "recovering", described as "nightmares". Therapeutic measures were not taken as a result of nightmare.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not tested for COVID-19 after the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: I have pain to the left arm, it is not really pain, its more like an inability to lift my left arm; Then it began to progressively get worse,; 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), administration date 2021 (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) with onset 2021, outcome "unknown", described as "I have pain to the left arm, it is not really pain, its more like an inability to lift my left arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Then it began to progressively get worse,".  Additional information: He had pain to the left arm, it was not really pain, its more like an inability to lift his left arm. He took the shot with his mother who he cares for, and has not had any side effects. When he go the injection he did not feel anything at all, and had no soreness for a couple of days, then it began to progressively get worse, and now he was not able to lift it about my shoulders, while his right arm he can lift it over his head, and if he use his right hand to lift his left arm over his head, it does not hurt, its just that he cannot control lifting it without help. He had no body aches, no flu like symptoms, he had nothing except this. He went to see a pharmacist and asked him about this and he was no help other than to tell him to got the VAERS site. He was due to receive the second dose of the Pfizer Covid vaccine, but he still had this symptom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 17:30 (Lot number: FF2588) at the age of 69 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 27Sep2021 21:00, outcome "recovering", described as "sore throat"; MYALGIA (non-serious) with onset 27Sep2021 21:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of oropharyngeal pain, myalgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstruation irregular
Clinical narrative: I got my period on Sep 23 on schedule, but it only lasted 1 day and was very light; I got my period on Sep 23 on schedule, but it only lasted 1 day and was very light; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FD8448) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CLINDAMYCIN PHOSPHATE; TRETINOIN. The following information was reported: MENSTRUATION IRREGULAR (non-serious), HYPOMENORRHOEA (non-serious) all with onset 23Sep2021, outcome "unknown" and all described as "I got my period on Sep 23 on schedule, but it only lasted 1 day and was very light". Therapeutic measures were not taken as a result of menstruation irregular, hypomenorrhoea.  No follow-up attempts are possible. No further information is expected.  Additional information: Patient got her period on Sep 23 on schedule, but it only lasted 1 day and was very light. Patient period was like clockwork and was never off - usually 5 days, the first two were heavy and the other 3 light. Patient was not on birth control. The patient did not receive any other vac-cines within 4 weeks prior to the COVID vaccine. The patient received Clindamycin phosphate pimple cream, tretinoin cream within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Headache
Clinical narrative: Bad Headache; lead on cough; pressure in chest; 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 23Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "2 stents", start date: 15Jan2019 (ongoing); "Gall stones", start date: 2016 (unspecified if ongoing); "Cholecystectomy", start date: 2016 (unspecified if ongoing). Family history included: "Coronary artery disease", start date: 27Nov2012 (ongoing); "quintuple bypass", start date: 27Nov2012 (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiovascular disorder, start date: 2012 (ongoing); METOPROLOL TARTRATE taken for cardiovascular disorder, start date: 2012 (ongoing); ISOSORBIDE MONONITRATE taken for cardiovascular disorder, start date: 2014 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT: FA7484, EXPIRATION DATE: 01Sep2021). The following information was reported: HEADACHE (non-serious) with onset 24Aug2021, outcome "unknown", described as "Bad Headache"; COUGH (non-serious) with onset 24Aug2021, outcome "unknown", described as "lead on cough"; CHEST DISCOMFORT (non-serious) with onset 24Aug2021, outcome "unknown", described as "pressure in chest".  Follow-up attempts completed. No further information is expected. lot/batch number is not available despite the follow-up attempts made.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: a little bit fatigue; sore arm; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 immunization, reaction(s): "shingles"; Bnt162b2 (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "sore arms". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "a little bit fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: Caller wanted to get the booster dose as she was 74 years old, but she was informed that only immunocompromised individuals and those who have had a solid organ transplantation are eligible to receive the booster dose. Caller wanted to confirm this and mentioned that her son informed her other people have gotten the booster dose so wanted to know why the guidelines have changed. Caller wanted to also know who else gives out vaccinations. Caller stated that had previously called Pfizer due to having shingles after getting the 1st dose of the Comirnaty vaccine. She wanted to know if there are reports of people who have had this same side effect and she also wanted to know if this was normal. Caller also mentioned that she experienced sore arms after the 2nd dose. She also stated that she got the booster shot, three days ago and was feeling good, a little bit fatigue and sore arm, but she was good now. She further stated that arm was a little sore, but that was it. A contactable female consumer communicated to a Pfizer colleague via phone call that: Phone-Out 12:24 PM: 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Consumer did not want to provide mailing address but agree to provide e-mail address instead. She also stated: She got the booster shot, three days ago, feeling good, a little bit fatigue and sore arm, but she was good now. Arm a little sore, but that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state
Clinical narrative: I am confused; a bit of weakness and felt weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Apr2021 (Lot number: ER8737) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (ongoing), notes: diagnosed when she was a little girl in the 1950's; "COPD" (ongoing), notes: diagnosed just in the past 15 years. The patient's concomitant medications were not reported. Past drug history included: Prednisone, notes: she has been on Prednisone for about a year. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "I am confused"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "a bit of weakness and felt weak".  Additional information: I am confused. On 05Apr2021 I received my first Pfizer, COVID-19 vaccine. On 27Apr2021 I received my second Pfizer, COVID-19 vaccine. I received a third Pfizer COVID-19 vaccine on 20Aug2021. I was told it was the Pfizer Booster. Now I am hearing on the news that the Pfizer Booster was just approved and released this week. I do have health issues and I am 73 years old. my question is, did I or did I not received the Booster since the news is saying it was just released. After the 1st dose she experienced a bit of weakness and felt weak. The events did not require a visit to emergency room or physician office.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis allergic
Clinical narrative: Allergic conjunctivitis of both eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 (Lot number: EW0171) as dose 1, single and administered in arm left, administration date 14Jun2021 (Lot number: EW0217) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Yes" (unspecified if ongoing), notes: Other medical history: Yes; "known allergies - Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CONJUNCTIVITIS ALLERGIC (non-serious) with onset 04Jun2021, outcome "not recovered", described as "Allergic conjunctivitis of both eyes". The event "allergic conjunctivitis of both eyes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of conjunctivitis allergic. Additional Information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Patient age at vaccination was 63 years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 29Sep2021  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Racing heart; Breathing difficulty; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (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: PALPITATIONS (non-serious) with onset 27Sep2021, outcome "unknown", described as "Racing heart"; DYSPNOEA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Breathing difficulty".  Additional Information: Patient was a minor, the child of a friend. He experienced symptoms while at school and followed up with his physician. Vaccine was administered Thursday last week and symptoms occurred Monday, so there may be no correlation. Event took place after use of product.  Follow-up attempts completed. No further information is expected
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in my left leg especially at hip, from hip to knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 14:30 (Lot number: FC3183) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: MYALGIA (non-serious) with onset 25Sep2021, outcome "not recovered", described as "muscle pain in my left leg especially at hip, from hip to knee". Therapeutic measures were not taken as a result of myalgia. Additional Information-Patient had not received other vaccines in four weeks. Patient did not had covid prior vaccination. Patient did not tested covid post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: feels stiff in the mornings; numbness and tingling in the hands; numbness and tingling in the hands; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program .  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "feels stiff in the mornings"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling in the hands".  Additional information: As per clinical notes, she stopped taking all medications (records not available) and was doing well until a year ago until she restarted having symptoms. She developed pain and swelling in the knees bilaterally ankles, hands with swelling. The symptoms have been getting progressively worse. She feels stiff in the mornings for approximately 1 hour. Has numbness and tingling in the hands She bilaterally at night. Also states, I recommend that she gets a third dose of Pfizer COVID- 19 vaccine. She will hold Xeljanz for a week after getting the injection. Patient is prescribed Xeljanz 11 mg. All quotations in this verbatim entered as they appear in the reporters documentation. No additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: EW0162) at the age of 62 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: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021, outcome "not recovered", described as "left arm pain at the injection site". Therapeutic measures were taken as a result of vaccination site pain.  additional information:she takes Tylenol and Motrin for the pain, states she does moves her arm, does water aerobics, so its not like she is keeping it still. If she does not take a tylenol or Motrin, she cannot raise arm up.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Sinusitis
Clinical narrative: did not feel well; had sinus infection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "did not feel well"; SINUSITIS (non-serious), outcome "unknown", described as "had sinus infection.".  Additional information: Patient stated she received the COVID-19 vaccine, did not feel well and had sinus infection.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysmenorrhoea, Malaise, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jun2021 15:30 (Lot number: EW0181) at the age of 13 years 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: DYSMENORRHOEA (non-serious) with onset 25Jun2021, outcome "recovered with sequelae" (2021), described as "Started to have very painful cramps when I menstruate"; NAUSEA (non-serious), MALAISE (non-serious) all with onset 25Jun2021, outcome "recovered with sequelae" (2021) and all described as "I get very nauseous and sick"; DECREASED APPETITE (non-serious) with onset 25Jun2021, outcome "recovered with sequelae" (2021), described as "No appetite". Therapeutic measures were taken as a result of dysmenorrhoea, nausea, malaise, decreased appetite. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported her mother gave several Aleve for the pain. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast scan abnormal, Mammogram, Pain
Clinical narrative: spot was so painful and sore; left Brest tissue got change it looks like I had surgery or biopsy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: Ev16200) at the age of 48 years as dose 2, single and administered in arm left, administration date 05Mar2021 02:45 (Lot number: EN9581) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have fibrocystic Brest" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 20Mar2021 12:00, outcome "unknown", described as "spot was so painful and sore"; BREAST SCAN ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "left Brest tissue got change it looks like I had surgery or biopsy.". The events "spot was so painful and sore" and "left brest tissue got change it looks like i had surgery or biopsy." 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 pain, breast scan abnormal. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: abdominal pain comes and goes; 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 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 26Sep2021 (Batch/Lot number: unknown) at the age of 33 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: ABDOMINAL PAIN (non-serious) with onset Sep2021, outcome "not recovered", described as "abdominal pain comes and goes".  Additional information: Caller received first dose of product 26Sep2021. Caller was reported intermittent abdominal pain comes and goes. He was asking if he should go to the emergency room or if it's a reported adverse event. States him and his son had cases of it and saw it was was reported with the J & J. Asked if it was standard.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Limb discomfort, Pain in extremity
Clinical narrative: paraesthesia, tingling and pins and needles, feeling in both feet that has continued since; Heaviness in her legs; Fatigue; Headache; Dry mouth; Soreness in right arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 23Sep2021 12:45 (Lot number: EW0172, Expiration Date: 30Nov2021) at the age of 39 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: PARAESTHESIA (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since"; LIMB DISCOMFORT (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "Heaviness in her legs"; FATIGUE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Headache"; DRY MOUTH (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Dry mouth"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Soreness in right arm". The events "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since", "heaviness in her legs", "fatigue", "headache", "dry mouth" and "soreness in right arm" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of paraesthesia, limb discomfort, fatigue, headache, dry mouth, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called on 28Sep2021, started that experienced an unusual adverse reaction from the Pfizer BioNTech Covid-19 Vaccine. Received Vaccine on 23Sep2021. On 24Sep2021, the patient experienced fatigue, headache, dry mouth, and soreness in right arm. She had those during the day and then she had the others later at night. Later in day on 24Sep2021, the patient was most concerned about paraesthesia, tingling and pins and needles, feeling in both feet that has continued since, plus a heavy feeling in both legs. She was going to see primary care physician on 29Sep2021. The patient called back in Nov to say she  had recovered but the patient did not know what treatment her PCP provided and how long it took to recover.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paraesthesia, tingling and pins and needles, feeling in both feet that has continued since; Heaviness in her legs; Fatigue; Headache; Dry mouth; Soreness in right arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 23Sep2021 12:45 (Lot number: EW0172, Expiration Date: 30Nov2021) at the age of 39 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: PARAESTHESIA (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since"; LIMB DISCOMFORT (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "Heaviness in her legs"; FATIGUE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Headache"; DRY MOUTH (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Dry mouth"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Soreness in right arm". The events "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since", "heaviness in her legs", "fatigue", "headache", "dry mouth" and "soreness in right arm" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of paraesthesia, limb discomfort, fatigue, headache, dry mouth, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called on 28Sep2021, started that experienced an unusual adverse reaction from the Pfizer BioNTech Covid-19 Vaccine. Received Vaccine on 23Sep2021. On 24Sep2021, the patient experienced fatigue, headache, dry mouth, and soreness in right arm. She had those during the day and then she had the others later at night. Later in day on 24Sep2021, the patient was most concerned about paraesthesia, tingling and pins and needles, feeling in both feet that has continued since, plus a heavy feeling in both legs. She was going to see primary care physician on 29Sep2021. The patient called back in Nov to say she  had recovered but the patient did not know what treatment her PCP provided and how long it took to recover.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Period was 2 weeks late in June and 2 weeks late in September; Menstrual Cycle affected; 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), intramuscular, administered in arm left, administration date 13Apr2021 09:30 (Lot number: EW0162) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, notes: No. Vaccination history included: Bnt162b2 (Dose:01, Anatomical Location : Arm Left   , Batch/lot number : EN6208   , Administration of time: 09:30 AM), administration date: 18Mar2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 18Jun2021, outcome "unknown", described as "Menstrual Cycle affected"; MENSTRUATION DELAYED (non-serious) with onset 29Sep2021, outcome "unknown", described as "Period was 2 weeks late in June and 2 weeks late in September". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstruation delayed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Epistaxis, Lip swelling, Lymphadenopathy
Clinical narrative: bloody nose on Thursday morning upon waking; body aches; chills; fever throughout the day; chest pains; had left underarm lymph node swelling; swelling on the right side of her top lip; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Restylane kysse, start date: Sep2020, notes: Her lips were previously injected; Restylane dyfyne, start date: Mar2021, notes: Her lips were previously injected. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for Covid-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "bloody nose on Thursday morning upon waking"; PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "fever throughout the day"; CHEST PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "chest pains"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "had left underarm lymph node swelling"; LIP SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "swelling on the right side of her top lip".  Additional information: Patient received 2nd Pfizer Covid-19 Vaccine on Wednesday, 15Sep in the left arm. Patient experienced  a bloody nose on Thursday morning upon waking and body aches, chills, and fever throughout the day. She had chest pains that evening and a bloody nose upon waking Friday morning. Patient had left underarm lymph node swelling and swelling on the right side of her top lip.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.