chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, Blood pressure measurement, Condition aggravated, Oxygen saturation, Vital signs measurement
Clinical narrative: She has had to use her inhaler a lot more the past week; Acute anxiety disorder; 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 47 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "She hacks a lot and brings up mucous" (ongoing), notes: Verbatim:She hacks a lot and brings up mucous and she has been doing this for the past three years. The patient's concomitant medications were not reported. Past drug history included: Singulair, notes: Verbatim:She takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time; Flonase, notes: Verbatim:She takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "unknown", described as "She has had to use her inhaler a lot more the past week"; ANXIETY DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Acute anxiety disorder". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, states she received the Pfizer COVID vaccine first dose on 01Apr2021 and the second dose on 22Apr2021. Patient like to know if she was protected? Patient states she hacks a lot and brings up mucous and she has been doing this for the past three years. she takes Singulair, Flonase and a nasal rinse for these symptoms and she has been taking them for a long time. She has had to use her inhaler a lot more the past week and she was waiting for her doctor to prescribe her something stronger. She also has acute anxiety disorder and she has been very worried. She doesn't go anywhere and she stays in her room and all the people in her house have been vaccinated. She has the ability to check her vital signs and they have all been perfect her blood pressure and oxygen. She just wanted to make sure she was protected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Hyperhidrosis
Clinical narrative: Anxiety week after first, confusion, sweats.; Anxiety week after first, confusion, sweats.; Anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ER8732) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hep B inactive" (unspecified if ongoing), notes: Hep B inactive, Hep c cured, Genital Herpes, Gastroparesis, IBS, arthritis; "Hep c cured" (unspecified if ongoing); "Genital Herpes" (unspecified if ongoing); "gastroparisis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; XANAX; OMEPRAZOLE; PEG3350. Past drug history included: Steriods for Known allergies, reaction(s): "Allergy", notes: steriods, Codeine, ciprofloxacin drugs; Codeine for Known allergies, reaction(s): "Allergy"; Ciprofloxacin for Known allergies, reaction(s): "Allergy". The following information was reported: CONFUSIONAL STATE (non-serious), HYPERHIDROSIS (non-serious) all with onset 13Apr2021 07:00, outcome "not recovered" and all described as "Anxiety week after first, confusion, sweats."; ANXIETY (non-serious) with onset 13Apr2021 07:00, outcome "not recovered", described as "Anxiety". It was unknown if therapeutic measures were taken as a result of confusional state, hyperhidrosis, anxiety.  Additional information: The recent COVID-19 vaccine was administered in School or Student Health Clinic. 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, has the patient does not test for COVID-19. The patient did not take other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea with the headaches; excruciating headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 10:30 (Lot number: ER8733) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for hypertension, start date: 2020 (ongoing); LISINOPRIL taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Route: Injection, Anatomical Location: Left arm), administration date: 05Mar2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "not recovered", described as "excruciating headache"; NAUSEA (non-serious), outcome "recovering", described as "Nausea with the headaches". Therapeutic measures were taken as a result of headache.  Additional information: Concomitant Products Atorvastatin patient gets them through the mail. Reporter stated that she had to go get the bottles to confirm the dosages for her medications. Prior Vaccinations (within 4 weeks) was Pfizer COVID Vaccine, 1st dose. No Family Medical History Relevant to adverse events. Relevant Tests were None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. It was reported that about 3 hours after administration patient experienced an excruciating headache. Reporter queried that how long the headache may last. They had been constant every day since then got the shot. She thought the headaches would go away on their own, but she said that they seem like they are getting worse sometimes. She had a headache so bad the other day she felt nauseous, like she was going to throw up. Reporter stated that the nausea comes and goes, it just depends on how bad her head was hurting. Reporter seriousness for the events were Unspecified. Patient was taking Pfizer covid vaccine because "didnt want to get the virus". Treatment: None, she thought they were going to go away by themselves, but they were not. She took Acetaminophen (Possible Lot number: OKV1626; Expiration: AUG2022) when her headaches get really bad, but it did not help. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Reporter reports none but call handler she did have the 1st dose of the Pfizer COVID Vaccine on 05Mar2021 in the left arm via injection. Adverse event did not require a visit to Emergency Room or Physician Office.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Strange headache; Right arm muscle pain at injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 14:15 (Lot number: EW0171) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOCETIRIZINE DIHYDROCHLORIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot Number: EP7533Administration site: Right armAdministration time: 14:45), administration date: 03Apr2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "Vaccination site pain".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01May2021 16:00, outcome "recovered" (May2021), described as "Right arm muscle pain at injection site."; HEADACHE (non-serious) with onset 02May2021 09:00, outcome "recovered" (03May2021), described as "Strange headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02 May2021 at 9:00 the patient experienced a strange headache and took Acetaminophen (TYLENOL), but it continued to get worse by noon. It was not a regular headache. The patient took Diclofenac and felt better until about 9 PM then again needed to take one more Diclofenac. She woke up in the morning and was feeling fine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Upper gastric pain; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program (159558).  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: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "Upper gastric pain"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Vaccination site pain
Clinical narrative: Right arm muscle pain at injection site. More painful than from 1st dose and also earlier onset, by about 4 PM vs 8 PM from the 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 14:45 (Lot number: EP7533) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOCETIRIZINE DIHYDROCHLORIDE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Right arm muscle pain at injection site. More painful than from 1st dose and also earlier onset, by about 4 PM vs 8 PM from the 1st dose.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not receive any other vaccine in four weeks. Other medications in two weeks include Levocetirizine Dihydrochloride 5mg. Patient experienced Right arm muscle pain at injection site. More painful than from 1st dose and also earlier onset, by about 4 PM vs 8 PM from the 1st dose. The next morning had a strange headache and took Tylenol, but it continued to get worse by noon. It was not a regular headache. Patien took diclofenac and felt better until about 9 PM then patient needed to take one more diclofenac. Patient woke up in the morning feeling fine. Patient did not experience covid prior to vaccination. Patient was tested negative for covid post vaccination. There are no known allergies and other medical history.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498495 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Paraesthesia
Clinical narrative: Pins and needles and tingling in her face and both her hands; Bad headache; Tired; Dizzy; 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 35 year-old female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: EW0171) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Pins and needles and tingling in her face and both her hands"; HEADACHE (non-serious), outcome "recovered", described as "Bad headache"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Therapeutic measures were taken as a result of paraesthesia, headache, fatigue, dizziness.  Additional information: The reporter stated that after couple about 2 or 3 hours after she had her shot she had pins and needles and tingling in her face and both her hands. She said she called she called her PCP and local helpline from the hospital she got it from and it in a way after two hours. She said she had an appointment to talk to her doctor tomorrow and to discuss whether not she should get the second shot. She wanted to know if this was something that was common or that has happened and was concerned about getting a second shot. She said she's been fine since. She did said she has been having other symptoms for about a week. She said normal stuff, really bad headache, she was dizzy, tired and she stated that dizziness started almost after she took Advil and Tylenol for first 3 days for her headache and after the headache went away that's when she noticed the dizziness. She said her dizziness would just come and go. She says that is something made her feel more dizzy than others and she also wanted to mentioned that she actually had the Covid virus back in November 2020.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Ache and pain have settled to hips and buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6200) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu shot", start date: Sep2020 (unspecified if ongoing), notes: Anatomical location: Left arm, Number: 1, Age at immunization if date not available: 70+; "Prostate" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE taken for prostate examination (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot no: EL9266, Anatomical location: Left arm, Expiry date: 31May2021), administration date: 16Feb2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "Joint pain", "Muscle pain". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Ache and pain have settled to hips and buttocks". Therapeutic measures were not taken as a result of pain.  Additional information: Now, a month after 2 shot, ache and pain have settled to hips and buttocks. Patient stated, it was painful to move. Patient had to give up his daily walking exercise due to pain in thighs and buttocks, but he was resorting to calisthenics in the meantime. Appreciate an earliest help response The AE did not require to visit emergency room and physician office. The family medical history relevant to AE taking Finasteride and Rosuvastatin Rx daily for Prostate and cholesterol. There was not any other product that were taken together with those indicated above.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes; arm pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Pfizer sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Next day coming & going fatigue; Soreness at injection sites lasting a week; 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), intramuscular, administered in arm right, administration date 23Mar2021 10:00 (Lot number: EN6204) as dose 2, single and intramuscular, administered in arm left, administration date 02Mar2021 10:15 (Lot number: EN6148) as dose 1, single for covid-19 immunisation. Family history included: "Obese" (unspecified if ongoing); "Heart disease" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Peripheral artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Soreness at injection sites lasting a week"; FATIGUE (non-serious), outcome "not recovered", described as "Next day coming & going fatigue".  Additional information: Patient has not received any other vaccines prior to COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; 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 74 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Patient called to cancel her appointment because she had a cold. Patient stated that she had her first dose of  PFIZER-BIONTECH COVID-19 VACCINE few weeks ago ( patient did not remember the date) was scheduled to get second dose tomorrow but needed to cancel it because she had a cold.  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: her arms are a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arms are a little sore". Additional information: Patient said that she just had the first dose today and her arms are a little sore. She would like to know if it is okay to take alcohol after the first dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Spinal pain, Vaccination site pain
Clinical narrative: severe pain in her right arm, where she had the injection; she is having pain in her arm which has moved to her spine; her back area is really hurting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 12:30 (Lot number: EW0173) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Tb shot (Manufacturer: unknown, Lot Number: unknown, injection on left arm, AE(s) following prior vaccinations was None), administration date: 13Apr2021, reaction(s): "no adverse effect".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "severe pain in her right arm, where she had the injection"; SPINAL PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "she is having pain in her arm which has moved to her spine"; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "her back area is really hurting".  Additional information: The reporter was reporting on behalf of her daughter. The patient complain of severe pain in her right arm, where she had the injection, and now the pain has moved to the back of her spine. She had the vaccine 3 weeks ago and experienced back pain as well, not as severe, and it comes and goes. The patient was first tuberculin test was from a blood draw by her doctor for college. The severe pain in right arm moving into spine was reported as worsened. The patient did not visit Emergency Room or Physician Office. did not receive any vaccinations prior COVID vaccination within 4 weeks. Patient did not had Medical History (including any illness at time of vaccination) and Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: experienced tenderness on the left side of her face/the left side of her face is tender around the jaw and underneath her eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: diagnosed at least 10 years. Concomitant medication(s) included: TOPAMAX taken for migraine (been taking at least 10 years). Vaccination history included: Bnt162b2 (Lot number:EN6207, Anatomical location: Right arm), when the patient was 49 years old, for COVID-19 Immunisation. The following information was reported: FACIAL PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "experienced tenderness on the left side of her face/the left side of her face is tender around the jaw and underneath her eye". Therapeutic measures were taken as a result of facial pain.  Additional information: Got vaccine on 16Apr2021, stated for about a week now, the left side of her face was tender around the jaw and underneath her eye, stated she has not hit face or had any incidents. Does not know the exact date of the start of the event. Treated the tenderness with Motrin and ice and it got a little better. Reporter informed that tenderness of the face is not listed, but this list does not include all possible side effects, just commonly reported ones. Referred caller to HCP for further guidance  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Fatigue, Feeling hot, Nausea
Clinical narrative: no energy; fatigue; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; nauseous; Immediately I felt heat; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0164) at the age of 63 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: FEELING HOT (non-serious) with onset 15Apr2021, outcome "recovered" (15Apr2021), described as "Immediately I felt heat"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", BURNING SENSATION (non-serious) with onset 15Apr2021, outcome "not recovered" and all described as "this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,"; NAUSEA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "nauseous".  Additional information: Caller had her first dose of the Pfizer Covid 19 vaccine on 15Apr2021, "Immediately she felt heat. She has had the flu and pneumonia vaccines and never felt this before. As soon as it was injected, she could feel heat in the arm. When she brought the needle out, it's like the heat went down her arm and then just stopped within 5 minutes. she sat there until it dissipated. She has been struggling ever since. every day she has absolutely no energy, she suffered from fatigue but have never felt anything like this. She was completely depleted from this. She suffered with chronic pain anyway. She has diseases in her spine, this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down her spine, it just hits her. She was also very nauseous, been nauseous ever since she took the thing, to the point where she can't eat.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: no energy; fatigue; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; nauseous; Immediately I felt heat; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0164) at the age of 63 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: FEELING HOT (non-serious) with onset 15Apr2021, outcome "recovered" (15Apr2021), described as "Immediately I felt heat"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", BURNING SENSATION (non-serious) with onset 15Apr2021, outcome "not recovered" and all described as "this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,"; NAUSEA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "nauseous".  Additional information: Caller had her first dose of the Pfizer Covid 19 vaccine on 15Apr2021, "Immediately she felt heat. She has had the flu and pneumonia vaccines and never felt this before. As soon as it was injected, she could feel heat in the arm. When she brought the needle out, it's like the heat went down her arm and then just stopped within 5 minutes. she sat there until it dissipated. She has been struggling ever since. every day she has absolutely no energy, she suffered from fatigue but have never felt anything like this. She was completely depleted from this. She suffered with chronic pain anyway. She has diseases in her spine, this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down her spine, it just hits her. She was also very nauseous, been nauseous ever since she took the thing, to the point where she can't eat.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Redness; sweats; Inflamed sorearm; headache; Extreme fatigue; Inflamed sorearm; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 08:30 (Lot number: EL9267) at the age of 71 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 (At 11:30, Dose 1 (Lot/Batch number: EL9262).), administration date: 25Jan2021, for covid-19 immunisation, reaction(s): "Swelling", "Redness", "soreness down to the elbow". The following information was reported: HEADACHE (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "headache"; FATIGUE (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "Extreme fatigue"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021) and all described as "Inflamed sorearm"; CHILLS (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 19Feb2021 15:00, outcome "recovered" (20Feb2021), described as "sweats"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness". Therapeutic measures were not taken as a result of headache, fatigue, peripheral swelling, chills, hyperhidrosis, pain in extremity.  Additional information: after 1st shot swelling was noted within 9 hours. Redness and soreness, increased insignificantly from top of arm to elbow 7 days afterwards peaking at about 9days and disappearance at about 11days.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Redness; sweats; Inflamed sorearm; headache; Extreme fatigue; Inflamed sorearm; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 08:30 (Lot number: EL9267) at the age of 71 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 (At 11:30, Dose 1 (Lot/Batch number: EL9262).), administration date: 25Jan2021, for covid-19 immunisation, reaction(s): "Swelling", "Redness", "soreness down to the elbow". The following information was reported: HEADACHE (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "headache"; FATIGUE (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "Extreme fatigue"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021) and all described as "Inflamed sorearm"; CHILLS (non-serious) with onset 18Feb2021 17:00, outcome "recovered" (20Feb2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 19Feb2021 15:00, outcome "recovered" (20Feb2021), described as "sweats"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness". Therapeutic measures were not taken as a result of headache, fatigue, peripheral swelling, chills, hyperhidrosis, pain in extremity.  Additional information: after 1st shot swelling was noted within 9 hours. Redness and soreness, increased insignificantly from top of arm to elbow 7 days afterwards peaking at about 9days and disappearance at about 11days.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm remains sore to touch; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Rabies vaccine, administration date: 01Apr2021. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm remains sore to touch".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had the same reaction but with cotton wood trees pollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570).  A patient (no qualifiers provided) 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had the same reaction but with cotton wood trees pollen".  Additional information: I recently received your vaccination shots. I have found an interesting reaction that occurs. When a vaccinated person encounters an allergen, in my case mold, the vaccine appears to attack the allergen. I encountered mold days after my 2nd shot. My reaction started as hay fever, which is normal, but within 2 days I developed a fever. It's as if the vaccine was trying to rid me of the allergen by attacking it. I have a friend who has had the same reaction but with cotton wood trees pollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose decreased, Discomfort, Dizziness
Clinical narrative: Felt his sugar was going low; felt tired; had no strength; heart was sometimes beating too fast, sometimes beating slower; Felt dizzy; Uncomfortable; 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 50 year-old male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Lot number: 0175, Expiration Date: Aug2021) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Has been diabetic for about 10 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 26Apr2021, outcome "unknown", described as "Felt his sugar was going low"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "felt tired"; ASTHENIA (non-serious) with onset 26Apr2021, outcome "unknown", described as "had no strength"; HEART RATE ABNORMAL (non-serious) with onset 24Apr2021, outcome "recovered" (Apr2021), described as "heart was sometimes beating too fast, sometimes beating slower"; DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (24Apr2021), described as "Felt dizzy"; DISCOMFORT (non-serious) with onset 24Apr2021, outcome "unknown", described as "Uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical Information: It was reported that the patient scheduled for the second dose on 15May2021. Patient doesn't know if he should get the second dose of the Covid Vaccine. The patient was diabetic. He doesn't know if he should take his diabetes pills, he doesn't know what to do. Sometimes his sugar goes up. He was taking metformin and another medicine he doesn't remember. Patient does not take this medication on a regular basis. Patient also asked If he has a headache can he take medication for that or can he take any other medication. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to events. There was no history of previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were reported. The caller mentioned that the only other vaccine he had gotten was the flu vaccine many years ago.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate abnormal
Clinical narrative: Felt his sugar was going low; felt tired; had no strength; heart was sometimes beating too fast, sometimes beating slower; Felt dizzy; Uncomfortable; 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 50 year-old male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Lot number: 0175, Expiration Date: Aug2021) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: Has been diabetic for about 10 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset 26Apr2021, outcome "unknown", described as "Felt his sugar was going low"; FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "felt tired"; ASTHENIA (non-serious) with onset 26Apr2021, outcome "unknown", described as "had no strength"; HEART RATE ABNORMAL (non-serious) with onset 24Apr2021, outcome "recovered" (Apr2021), described as "heart was sometimes beating too fast, sometimes beating slower"; DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (24Apr2021), described as "Felt dizzy"; DISCOMFORT (non-serious) with onset 24Apr2021, outcome "unknown", described as "Uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical Information: It was reported that the patient scheduled for the second dose on 15May2021. Patient doesn't know if he should get the second dose of the Covid Vaccine. The patient was diabetic. He doesn't know if he should take his diabetes pills, he doesn't know what to do. Sometimes his sugar goes up. He was taking metformin and another medicine he doesn't remember. Patient does not take this medication on a regular basis. Patient also asked If he has a headache can he take medication for that or can he take any other medication. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to events. There was no history of previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were reported. The caller mentioned that the only other vaccine he had gotten was the flu vaccine many years ago.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had pain on the interior side of my upper arm like nerve pain that went from my elbow up to almost my underarm area about 10 days after my first shot (4/7/21); 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), administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 48 years as 1st dose, single dose for covid-19 immunisation. Relevant medical history included: "Constipation chronic" (unspecified if ongoing), notes: chronic constipation with silent reflux; "silent reflux" (unspecified if ongoing), notes: chronic constipation with silent reflux; "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "several antibiotics- sulfa" (unspecified if ongoing), notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin.; Doxycycline, notes: several antibiotics- sulfa, doxycycline, macrobid, and erythromycin.  The following information was reported: PAIN IN EXTREMITY (non-serious onset 07Apr2021), outcome "not recovered", described as "I had pain on the interior side of my upper arm like nerve pain that went from my elbow up to almost my underarm area about 10 days after my first shot (4/7/21)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Constipation, Vomiting
Clinical narrative: Constipation; Back pain: second dose; Vomiting: second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 10:30 (Lot number: EW0170) at the age of 50 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE taken for headache. Vaccination history included: Bnt162b2 (First dose, Batch/lot number:ER8733, Dosage text:injection, 0.3ML, right upper arm, Caller states she received the vaccine, around 11.00 or 11.30), administration date: 28Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: CONSTIPATION (non-serious) with onset 28Apr2021, outcome "recovering", described as "Constipation"; BACK PAIN (non-serious) with onset 28Apr2021, outcome "recovered" (02May2021), described as "Back pain: second dose"; VOMITING (non-serious) with onset 28Apr2021, outcome "recovered" (28Apr2021), described as "Vomiting: second dose". Therapeutic measures were taken as a result of constipation.  Additional information: Caller states she has no primary care provider. Caller states her constipation has improved, but not naturally, she has had to take stuff. She said she (50 years old female) her boyfriend (52 years old male) and sister (60 years old) are experiencing bad constipation after the Pfizer covid vaccine. Her doctor has prescribed laxatives and they are taking 8-9 prunes a day. Caller states she might have taken a pain killer like Aleve for headache or something maybe one or two pills. Caller declines having a headache after her Pfizer Covid Vaccine. Constipation; Vomiting: Caller states the constipation started last week on Wednesday, it was really bad, she even started vomiting with back pain. Caller states the vomiting and back pain started on the same day as her constipation. Caller states when she got home, she thought she was having her period or food poisoning. Caller states she vomited 3 times and then she was constipated. Back Pain: Caller states that she had back pain that began 28Apr2021 and it would come and go. Caller states it is gone as of now. Caller states the last time she had back pain was two days ago, 02May2021. Caller states she has received completely.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510559 Same Vaccine/event, different  patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Fatigue, Headache, Nausea
Clinical narrative: Missed second COVID Vaccine dose, has an appointment to today to get the second dose; headache; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 66 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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Missed second COVID Vaccine dose, has an appointment to today to get the second dose"; HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "headache"; FATIGUE (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "fatigue"; NAUSEA (non-serious) with onset 26Mar2021, outcome "recovered" (Apr2021), described as "nausea".  Additional information: The caller stated after her first dose of the vaccine on 26Mar2021 she had a headache for 3 weeks, fatigue, and nausea. She asked if these symptoms are pretty consistent after the second dose for people that experienced them with the first? She stated she had a family emergency trip to take care of her mom and never go the second dose. Today is day 39 and she is on her was to an ap-pointment at 5:00 to get the second dose. The caller enquired if the vaccine wass still effective if it is given after 3 weeks. She asked, ifo nedon't get the second dose by 6 weeks do one had tostart over in the future?. Caller reports she took her first covid vaccine on 26Mar2021 about 29 days ago and she did not get the second dose because she had to come to # to take care of her mother. Caller reports she read at an online site she can have the shot up to 42 days after the first but, the Pfizer site reports it has to be 3 weeks. She has appointment to get the shot in 45 minutes at a pharmacy. Caller wants to know would it be valid to get the second shot and would it create an immunity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.