chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal
Clinical narrative: Pulse drop down; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: ER8737, Expiration Date: Jul2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension, When I was in my early 20s. Concomitant medication(s) included: CLONIDINE; ALISKIREN. Vaccination history included: Bnt162b2 (Dose number: 1, LOT number: EN6198, Expiration date: Jun2021), administration date: 12Mar2021, for Covid-19 Immunization. The following information was reported: PULSE ABNORMAL (non-serious), outcome "not recovered", described as "Pulse drop down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated, "After both the Pfizer shot the second dose was 2 weeks ago today and she think the first week was okay and the second week her Pulse drop down to 68 but It meant to like 52, 50, 42, 45, and she was wandering was this connected, did she need to worry about or will it give away, her pulse has never been that." She took the clonidine, she didn't take Aliskiren last night because she was afraid to go to the sleep with pulse of 42.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: body pain; feeling like she had the flu; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8727) at the age of 68 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 (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "body pain"; FEELING ABNORMAL (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "feeling like she had the flu"; HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (28Mar2021), described as "headache".  Additional information: Patient was not visited to emergency room or physician's office. Patient did not received any prior vaccination within 4 weeks prior to Covid-19 vaccination.The side effects from her first dose she believes only lasted two days. She had a headache, body pain and she was feeling like she had the flu but that only lasted two days. Confirmed she recovered completely.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: normal arm soreness; 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 48 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 48 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), outcome "unknown", described as "normal arm soreness".  Additional Information: The patient reported that with the first time after the shot it was just like the patient had the shot normal feeling, so that night the middle of the night other than the normal. The patient received the second dose on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: transient pain at injection site (arm); weariness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing), notes: (outgrew~10 years ago). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered", described as "transient pain at injection site (arm)"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "weariness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: involuntary movement of her head and tongue. No previous hx of Tourette's syndrome; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 16 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Apr2021 08:30 (Lot number: ER8729) at the age of 16 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "Stone fruits allergy" (unspecified if ongoing). Concomitant medications included: LEXAPRO; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DYSKINESIA (non-serious) with onset 17Apr2021 17:30, outcome "not recovered", described as "involuntary movement of her head and tongue. No previous hx of Tourette's syndrome". Therapeutic measures were not taken as a result of dyskinesia. Additional information: It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polymenorrhoea
Clinical narrative: arm pain for 48 hours; early menstrual cycle (came 4 days early); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Mar2021 14:30 (Lot number: ER8730) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies to Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm pain for 48 hours"; POLYMENORRHOEA (non-serious) with onset 2021, outcome "recovering", described as "early menstrual cycle (came 4 days early)". Therapeutic measures were not taken as a result of pain in extremity, polymenorrhoea.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: suffered from pain in the vaccine area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent reported for her son (Patient) that: 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "suffered from pain in the vaccine area".  Additional Information: The reporter reported that her son got the COVID vaccine and he suffered from pain in the vaccine area. He lives in the same house as she and he got pain in the arm, just a little in the area.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: both experienced pain but just in the vaccine area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "both experienced pain but just in the vaccine area".  Additional information: The reporter stated that the coworker had experienced pain but just in the vaccine area not in the opposite side like the caller has experienced.  Relevant Family History related to AE(S): No, her son and her daughter they as well got the COVID vaccine and they suffered from pain in the vaccine area. Her issue and her preoccupation is her arm but it is not where she got her COVID vaccine. Yesterday when she was taking a shower and grabbed her soap she realized that she couldn't move it and it hurt all night and all morning. This morning she called her daughter who works at a pharmacy and she asked her about the pain and the daughter and her coworker have both experienced pain but just in the vaccine area not in the opposite side like the caller has experienced. Obtained clarity from caller and she says that her son and his wife live in the same house as the caller and they all got the Pfizer COVID vaccine and they all got pain in the arm, just a little in the area. Her daughter and the coworker had the COVID vaccine and they had pain in the same area. Caller declined to complete a report on her son, her son's wife, her daughter and her daughter's coworker at this time. Unable to obtain further details  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Formication, Headache, Malaise, Pain in extremity
Clinical narrative: Crawling skin and scalp; headache; fatigue; sore arm; general malaise; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:45 (Lot number: EP7534) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing), notes: Chronic migraines; "post-herpetic neuralgia" (unspecified if ongoing), notes: post-herpetic neuralgia; "allergies" (unspecified if ongoing), notes: allergies; "iga deficiency" (unspecified if ongoing), notes: iga deficiency; "ADHD" (unspecified if ongoing), notes: ADHD; "food allergy" (unspecified if ongoing), notes: Pineapple. Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [MOMETASONE FUROATE]; ALBUTEROL [SALBUTAMOL]; CONCERTA. The following information was reported: FORMICATION (non-serious), outcome "unknown", described as "Crawling skin and scalp"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Therapeutic measures were not taken as a result of formication, headache, fatigue, pain in extremity, malaise. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. It is unknown if the patient has been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446526 same patient, different drug dose/event
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Formication, Menstruation irregular, Pain in extremity
Clinical narrative: a little skin crawling; sore arm; fatigue; menstrual cycle changes- 8 days late and only 3 days of flow (cycle is typically very regular at 24 days and 5 days of flow; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 09:45 (Lot number: Ew0153) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing); "post-herpetic neuralgia" (unspecified if ongoing); "allergies" (unspecified if ongoing); "iga deficiency" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "known allergies: Pineapple" (unspecified if ongoing), notes: known allergies: Pineapple. Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [FLUTICASONE PROPIONATE]; ALBUTEROL [SALBUTAMOL]; CONCERTA. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EP7534, Administration time: 09:45 AM, Vaccine Location: Left arm), administration date: 20Mar2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "Crawling skin and scalp", "headache", "fatigue", "sore arm", "general malaise". The following information was reported: FORMICATION (non-serious), outcome "unknown", described as "a little skin crawling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual cycle changes- 8 days late and only 3 days of flow (cycle is typically very regular at 24 days and 5 days of flow". Therapeutic measures were not taken as a result of formication, pain in extremity, fatigue, menstruation irregular. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. It is unknown if the patient has been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446464 same patient, different drug dose/event
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 13:30 (Batch/Lot number: unknown) at the age of 56 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: PARAESTHESIA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "tingling in body/burning tingling she is experiencing is Paresthesia". Therapeutic measures were taken as a result of paraesthesia. Additional Information: Description: Tingling in body: Caller stated this started in her chest, arms, and head and then she took a Benadryl which seemed to help. Caller stated she is still kind of getting tingling in her back and foot which comes and goes and is still there. Caller stated she is scared to get the second shot and worried about possibly having nerve damage. Caller stated she thinks the technical name for the burning tingling she is experiencing is Paresthesia. Caller stated the outcome is not worse except it has spread to foot and leg and she is not sure it is somewhere between the same and better. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 01907850.  A patient (no qualifiers provided) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Caller who was calling on patient's behalf. Merck field employee reported other company adverse event on patient's behalf. Patient was never on the line. Patient who previously was administered the PFIZER COVID 10 Vaccine on unknown, previous date had experienced a sore arm on unknown, previous date after receiving the 1st and 2nd PFIZER COVID 19 Vaccine doses. At same reporting time, Patient mentioned a separate, unknown patient who was administered the PFIZER COVID 19 Vaccine on unknown, previous date and had experienced a sore arm on unknown previous date after receiving the 1st and 2nd PFIZER COVID 19 Vaccine doses. Also at same reporting time, Patient mentioned a separate, unknown patient who was administered MODERNA COVID 19 vaccine and had become ill after receiving the 1st and 2nd MODERNA COVID 19 Vaccine doses. Employee had extremely limited information at call time. No additional adverse event. No PQC. No further information available. Please note that this information has not been reported to the FDA. If you have any questions, Please contact.  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-2021446495 Same reporter/ drug/ event for different patients
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache on day 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:15 (Lot number: EW 0158) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ZOLPIDEM; LISINOPRIL. Vaccination history included: Bnt162b2 (dose1, lot number: EP6955, administration time: 15:15, vaccine location: left arm), administration date: 24Mar2021, when the patient was 54 years old, for Covid-19 immunisation, reaction(s): "extremely tired", "hoarse in my speech ", "lip sore". The following information was reported: HEADACHE (non-serious) with onset 17Apr2021 07:00, outcome "recovering", described as "Slight headache on day 3". Therapeutic measures were not taken as a result of headache.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hot flush, Pain
Clinical narrative: It was so like burning; Had a lot of pain; Hot flashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 14:00 (Lot number: ER8730) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VIT C; VIT D. The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovering", described as "Had a lot of pain"; HOT FLUSH (non-serious) with onset 25Mar2021, outcome "recovering", described as "Hot flashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "It was so like burning".  Additional information: On 25Mar2021, The patient experienced had a lot of pain, hot flashes. On an unspecified date, it was so like burning. The patient stated that she had her 1st vaccine on 5Apr2021 and had a lot of pain and hot flashes like crazy pain in her body and hot flashes like crazy and she handled that, it was a lot of pain and a lot of hot flashes, it was crazy, not usual for her. Stated it was so like burning, she did not have a fever, nothing else and she doesn't know what is going on at all and she was disappointed and angry and at work worrying about her health because she got the vaccine. The reporter also said from the minute she put it on for the 1st dose, about an hour or so she started to have a lot of pain and a lot of hot flashes. Stated they got better but didn't go away and provides that the card says 1st dose 25Mar2021 at Soka University, and she got it at 2pm in her left arm. The outcome of pain, hot flush was resolving and burning sensation was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Insomnia, Pain
Clinical narrative: Could not sleep; Sore; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (ongoing), notes: Verbatim: High cholesterol. The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 13Feb2021, outcome "recovered" (14Feb2021), described as "Could not sleep"; PAIN (non-serious) with onset 13Feb2021, outcome "unknown", described as "Sore".  Additional information: Caller mentioned her husband also could not sleep. It was like they did a whole bunch of cocaine, a lot of tossing and turning. It was after the first shot they could not sleep. Caller stated her and her husband got their doses on the same dates one after the other. After the first dose he was very sore. It was later that same day. He was more sore than she was. The soreness lasted a day or two. States he's having physical therapy on his right arm. Caller says he has gone like 3 different times. He goes to therapy every Thursday for his right arm. However, she has never put the two and two together regarding physical therapy until now. No prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: "minor soreness".Reporter was made aware of the adverse event at 6:18 on 19 April 2021.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 46 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 (DOSE 1, SINGLE, Lot number:Not Reported), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Apr2021 06:18, outcome "recovered" (Apr2021), described as ""minor soreness".Reporter was made aware of the adverse event at 6:18 on 19 April 2021.". Therapeutic measures were not taken as a result of pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown that patient receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got pain in the arm, just a little in the area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Got pain in the arm, just a little in the area".  Additional information: While the caller was reporting AE/ MI with the COVID vaccine and PCs on two other products. During this report she mentioned: Her son's wife lives in the same house as the caller and she got the Pfizer COVID vaccine and she got pain in the arm, just a little in the area. Caller declined to complete a report on her son's wife. Unable to obtain further details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 25 year-old male 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: ILLNESS (non-serious), outcome "unknown", described as "got really ill".  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-2021447082 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got really ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult 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: ILLNESS (non-serious), outcome "unknown", described as "Got really ill".  Additional information: It was stated by the reporter that, 2 guys aged 25-30 got really ill after taking Pfizer Covid vaccine. This case refers to second patient from 2 guys.   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-2021447081 same drug/AE, different patient
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: he got the Pfizer vaccine and had a very liquid bowel movement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6198) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number EN6198, Dosage text Unknown dose shot in left arm), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "he got the Pfizer vaccine and had a very liquid bowel movement".  Additional Information: Reporter reported that the seriousness for Xeljanz is not as effective as it used to for loose bowel movements over the past couple of months: (From: 2020, Ongoing) Complainant does not have the product with them at the time of call. Patient had no History and No Investigation Assessment, reoprter calling about Xeljanz not being as effective as it used to be. Wanted to know there is anything he can do to make more effective. Wanted to know they only allow one pill. He Stated that he got the Pfizer vaccine and had a very liquid bowel movement. He Stated that he had the second one on 27Feb. Stated that he did not have loose bowel movements before the vaccine. Is for the Pfizer Covid vaccine. Clarified medication as Xeljanz slow release. Stated that he has not changed his diet or medication. Reporter details: Email address captured as provided. Physician details: Does not provide an address, phone number or email address. Event details: Stated that it started not being as effective three months ago. He Stated that it is not being as effective as it used to Wanted to know there is anything he can do to make more effective. Product strength and count size dispensed: 11 mg, Reporter not provided Is a sample of the product available to be returned, not provided Packaging sealed and intact.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: there was one man who just layed on a couch and said he did not feel good but he was ok he got up rather quickly if he needed something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1.), for Covid-19 Immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "there was one man who just layed on a couch and said he did not feel good but he was ok he got up rather quickly if he needed something".  Additional information: He didn't feel good but he was ok he got up rather quickly if he needed something. After two days he was good as normal his 75-year-old father showed no signs in comparison so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Muscular weakness, Nausea
Clinical narrative: temp of 100.7; cough; Muscle weakness (horrible!); fatigue; nausea; dizziness; total-body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 11:45 (Lot number: EW0167) at the age of 79 years as dose 1, single and administered in arm left, administration date 11May2021 10:15 (Lot number: EW0167) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior vaccination: yes. The patient's concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "Muscle weakness (horrible!)"; FATIGUE (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "fatigue"; NAUSEA (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "nausea"; DIZZINESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "dizziness"; PAIN (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "total-body ache"; PYREXIA (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "temp of 100.7"; COUGH (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "cough". Therapeutic measures were not taken as a result of muscular weakness, fatigue, nausea, dizziness, pain, pyrexia, cough.  Additional information: Other vaccine in four weeks reported as none. other medications in two weeks reported as Several. Patient did have COVID prior vaccination and did not test COVID positive post vaccination.Known allergies: No  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: temp of 100.7; cough; Muscle weakness (horrible!); fatigue; nausea; dizziness; total-body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 11:45 (Lot number: EW0167) at the age of 79 years as dose 1, single and administered in arm left, administration date 11May2021 10:15 (Lot number: EW0167) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior vaccination: yes. The patient's concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "Muscle weakness (horrible!)"; FATIGUE (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "fatigue"; NAUSEA (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "nausea"; DIZZINESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "dizziness"; PAIN (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "total-body ache"; PYREXIA (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "temp of 100.7"; COUGH (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "cough". Therapeutic measures were not taken as a result of muscular weakness, fatigue, nausea, dizziness, pain, pyrexia, cough.  Additional information: Other vaccine in four weeks reported as none. other medications in two weeks reported as Several. Patient did have COVID prior vaccination and did not test COVID positive post vaccination.Known allergies: No  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; left arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 11:45 (Lot number: ep6455) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "A Fib", stop date: 2018, notes: Ablation in 2018, None since then however, irregulation heart beat; "irregulation heart beat" (ongoing); "restless legs" (ongoing); "tachycardia" (ongoing). Concomitant medication(s) included: METOPROLOL taken for tachycardia, start date: 2017 (ongoing); GABAPENTIN taken for restless legs syndrome, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single. Anatomical site- Left arm, Route of administration- Intramuscular, I received my first COVID vaccination on 26Feb2021 at about 11:30. I had two very short waves of dizziness wash over me and be gone within the first hour of the vaccination. I had to use the restroom immediately after receiving the shot and noticed that my upper things were flushed.), administration date: 26Feb1021, for Covid-19 immunisation, reaction(s): "Dizziness", "my upper things were flushed". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left arm hurt".  Additional information: It was reported that patient received first COVID vaccination on 26Feb2021 at about 11:30. I had two very short waves of dizziness wash over me and be gone within the first hour of the vaccination. I had to use the restroom immediately after receiving the shot and noticed that my upper things were flushed. I don't know how long the flush lasted. I had a to do list that was quite long, which I completed immediately after receiving the vaccination. That took about 2hours. I went home and did normal housework. The next day, I was mildly dizzy most of the day. I did report this to my doctor. The nurse told me to report it to you and to take it easy for the rest of the day. The next day, I was tired, but ok. When I went in for the second shot, I reported all this to the pharmacist, who told me "we are hearing that a lot!" I got the shot and went home and rested in my recliner the rest of the day. I was tired the next day, but ok. No big deal. What was interesting is that I got the first shot in the left arm. No soreness until I got the second shot in the right arm, then the left arm hurt! (It did have a small bruise). The right arm never hurt. I'm so glad I was able to get vaccinations-and I'm glad it was Pfizer. That just 'feels' right.. Patient did not received any prior vaccine within 4 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discolouration
Clinical narrative: reaction at the injection site "very light pink color"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "reaction at the injection site "very light pink color"". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a side effect from first dose, she had a reaction at the injection site "very light pink color, imagined it was the first time, it will go away".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st vaccine only had a sore arm for a few hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 16:45 (Lot number: EP6955) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes; "factor V leiden" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes; "pre-diabetes" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes. Concomitant medication(s) included: SPIRONOLACTONE; TRIAMCINOLONE; BIOTIN; TYLENOL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "1st vaccine only had a sore arm for a few hours.". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Motor dysfunction, Movement disorder
Clinical narrative: I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions.; I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions.; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "CRPS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION. The following information was reported: MOVEMENT DISORDER (non-serious), MOTOR DYSFUNCTION (non-serious) all with onset 17Apr2021, outcome "unknown" and all described as "I was barely able to get to the bathroom from the bedroom---a trip no more than 10 feet. It felt like I had no control over my motor functions."  Additional information: Patient recently had second shot of vaccine for the COVID-19 pandemic. I had been told that the second shot would/could be a real issue with side-effects. Well, I am here to tell you that people who already suffer from a condition called Complex regional pain syndrome (CRPS) and any related ailment, they should really be warry of these side-effects. Patient had taken the shot on Friday. On Saturday patient was barely able to get to the bathroom from the bedroom--a trip no more than 10 feet. It felt like had no control over motor functions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Asthenia, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: a weird sensation ran through my body, from my head to feet; I got lightheaded and weak; I had trouble texting like my fingers didn't have the strength.; warm; agitated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 14:15 (Lot number: ER8732) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Past drug history included: Vicodin, reaction(s): "Allergies: vicodin", notes: Known allergies Vicoden. The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "a weird sensation ran through my body, from my head to feet"; DIZZINESS (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "I got lightheaded and weak"; ASTHENIA (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "I had trouble texting like my fingers didn't have the strength."; FEELING HOT (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "warm"; AGITATION (non-serious) with onset 25Mar2021 02:30, outcome "not recovered", described as "agitated". The events "a weird sensation ran through my body, from my head to feet", "i got lightheaded and weak", "i had trouble texting like my fingers didn't have the strength.", "warm" and "agitated" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness, asthenia, feeling hot, agitation.  Additional Information: Patient went to a nurse who checked her pulse etc. Her heart rate was normal, but patient got pretty warm and agitated. It passed after about 50 minutes, though patient had to call someone to come drive her home. It was reported that a couple of days before she felt normal. Patient did not took any other vaccination within four weeks. Patient was not tested positive for Covid-19 prior as well as post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: a weird sensation ran through my body, from my head to feet; I got lightheaded and weak; I had trouble texting like my fingers didn't have the strength.; warm; agitated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 14:15 (Lot number: ER8732) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Past drug history included: Vicodin, reaction(s): "Allergies: vicodin", notes: Known allergies Vicoden. The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "a weird sensation ran through my body, from my head to feet"; DIZZINESS (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "I got lightheaded and weak"; ASTHENIA (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "I had trouble texting like my fingers didn't have the strength."; FEELING HOT (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "warm"; AGITATION (non-serious) with onset 25Mar2021 02:30, outcome "not recovered", described as "agitated". The events "a weird sensation ran through my body, from my head to feet", "i got lightheaded and weak", "i had trouble texting like my fingers didn't have the strength.", "warm" and "agitated" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness, asthenia, feeling hot, agitation.  Additional Information: Patient went to a nurse who checked her pulse etc. Her heart rate was normal, but patient got pretty warm and agitated. It passed after about 50 minutes, though patient had to call someone to come drive her home. It was reported that a couple of days before she felt normal. Patient did not took any other vaccination within four weeks. Patient was not tested positive for Covid-19 prior as well as post vaccination.  No follow-up attempts are possible. No further information is expected.