chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Nerve injury, Vaccination site joint movement impairment
Clinical narrative: pain in his left shoulder; this pain "seems to be moving around", "in the tendons of the upper muscles", but generally is "on top of the shoulder".; "cannot put his arm in his sleeve" or "put his arm over his head when sleeping".; his HCP suggested that the vaccination provider may have "hit a nerve" during the injection.; he can't sleep at night; This is a spontaneous report received from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation.  The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (LOT:EN6201) on 12Feb2021 in left arm for covid-19 immunisation and had no adverse effect. Prior Vaccinations (within 4 weeks) was none. The patient didn't experience anything from the first dose, yet since the second dose he has been having pain in his left shoulder on 05Mar2021. He specified this pain has being persisting for 10 weeks. He added he cannot extend or use his left arm since it caused agonizing pain in his shoulder joint.  He explained he therefore cannot put his arm in his sleeve or put his arm over his head when sleeping". He mentioned when his arm is down he is fine. He added this pain seemed to be moving around, in the tendons of the upper muscles, but generally was on top of the shoulder. He went to the doctor and he said at 6 weeks in, his HCP suggested that the vaccination provider may have hit a nerve during the injection. Yesterday he had an X-ray taken because it was almost like it was frozen and the doctor looked at it and didn't see anything wrong, yet he said he still has this excruciating pain. He explained he was recommended to apply an over the counter Bio-Freeze, which does do much for the pain. Patient avoids taking pain killers, like Tylenols, because he is afraid of the side effects that may results from these drugs. He can't sleep at night and he can't move his hand to move it under his head or if he puts on a shirt it is agonizing. No emergency Room. Physician Office visit, said the person that injected it must have nicked a nerve. Treatment included Bio-Freeze (Lot: 800621-66 Expiration: JAN2024), he tried to do that but it had little effect. The outcome was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: pain in his left shoulder; this pain "seems to be moving around", "in the tendons of the upper muscles", but generally is "on top of the shoulder".; "cannot put his arm in his sleeve" or "put his arm over his head when sleeping".; his HCP suggested that the vaccination provider may have "hit a nerve" during the injection.; he can't sleep at night; This is a spontaneous report received from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation.  The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (LOT:EN6201) on 12Feb2021 in left arm for covid-19 immunisation and had no adverse effect. Prior Vaccinations (within 4 weeks) was none. The patient didn't experience anything from the first dose, yet since the second dose he has been having pain in his left shoulder on 05Mar2021. He specified this pain has being persisting for 10 weeks. He added he cannot extend or use his left arm since it caused agonizing pain in his shoulder joint.  He explained he therefore cannot put his arm in his sleeve or put his arm over his head when sleeping". He mentioned when his arm is down he is fine. He added this pain seemed to be moving around, in the tendons of the upper muscles, but generally was on top of the shoulder. He went to the doctor and he said at 6 weeks in, his HCP suggested that the vaccination provider may have hit a nerve during the injection. Yesterday he had an X-ray taken because it was almost like it was frozen and the doctor looked at it and didn't see anything wrong, yet he said he still has this excruciating pain. He explained he was recommended to apply an over the counter Bio-Freeze, which does do much for the pain. Patient avoids taking pain killers, like Tylenols, because he is afraid of the side effects that may results from these drugs. He can't sleep at night and he can't move his hand to move it under his head or if he puts on a shirt it is agonizing. No emergency Room. Physician Office visit, said the person that injected it must have nicked a nerve. Treatment included Bio-Freeze (Lot: 800621-66 Expiration: JAN2024), he tried to do that but it had little effect. The outcome was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypovitaminosis, Neoplasm malignant
Clinical narrative: rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blepharospasm, Burning sensation, Dysuria, Fatigue
Clinical narrative: rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Insomnia, Musculoskeletal stiffness, Pain in extremity, Paraesthesia oral
Clinical narrative: rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Viral test, Visual impairment
Clinical narrative: rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Hyperhidrosis, Language disorder
Clinical narrative: not talking right; sweaty; appeared disoriented; This is a spontaneous report from a non-contactable consumer. A 13-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Jun2021 11:00 (Batch/Lot Number: EW0171) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Unknown if Covid prior vaccination. The patient experienced not talking right, sweaty, appeared disoriented on 09Jun2021 11:30, was transferred to a clinic/hospital resulted in Emergency room visit. Treatment received first aid, vitals. The outcome of event unknown. Patient has not been tested for COVID-19 Since the vaccination.  No follow-up attempts are Possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Chest discomfort, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened; Sore left underarm; extreme soreness in underarm area (lymph nodes she assumed)  Lymph node pain; ad the tightness in chest; Slight trouble breathing; There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2) at 51-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 20:00 (Batch/Lot Number: ER8736) as DOSE, 2 SINGLE for covid-19 immunisation. No pregnant. Medical history included Allergies, obesity, Exercise-induced asthma (diagnosed), Sensitive to Codeine product. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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. Concomitant medications included chlorpheniramine maleate; naproxen sodium (ALEVE). Historical Vaccine included BNT162B2 on 01Apr2021 at 51-years-old for COVID-19 Immunization (Dose Number : 1, Anatomical Location : Arm Left, Batch/lot number : ER8734, Start time: 08:00 PM) experienced Chills in the early evening first, fever overnight, Lethargic for approx a week. The second vaccine hit much, much harder. The patient experienced racing heartbeat overnight, vertigo, exhaustion, foggy headedness/ headaches, vision acuity lessened, extreme soreness in underarm area (lymph nodes she assumed). She still had the tightness in chest and also the sore left underarm, slight vertigo, and mild headaches, exhaustion, slight trouble breathing. The knots and soreness were still in left armpit. Right armpit was fine. There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R on 13May2021 15:00 with outcome of not recovered. The events were serious due to disability. Trying to get in to see a primary doctor for referral to a cardiologist, which is proving difficult. The patient hoped the symptoms can be lessened. She felt none of this prior to vaccines. The events resulted in Doctor or other healthcare professional office/clinic visit. Not resulted hospitalization prolonged, Treatment received: Unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Heart rate increased, Lymph node pain, Muscle tightness, Vertigo
Clinical narrative: racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened; Sore left underarm; extreme soreness in underarm area (lymph nodes she assumed)  Lymph node pain; ad the tightness in chest; Slight trouble breathing; There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2) at 51-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 20:00 (Batch/Lot Number: ER8736) as DOSE, 2 SINGLE for covid-19 immunisation. No pregnant. Medical history included Allergies, obesity, Exercise-induced asthma (diagnosed), Sensitive to Codeine product. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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. Concomitant medications included chlorpheniramine maleate; naproxen sodium (ALEVE). Historical Vaccine included BNT162B2 on 01Apr2021 at 51-years-old for COVID-19 Immunization (Dose Number : 1, Anatomical Location : Arm Left, Batch/lot number : ER8734, Start time: 08:00 PM) experienced Chills in the early evening first, fever overnight, Lethargic for approx a week. The second vaccine hit much, much harder. The patient experienced racing heartbeat overnight, vertigo, exhaustion, foggy headedness/ headaches, vision acuity lessened, extreme soreness in underarm area (lymph nodes she assumed). She still had the tightness in chest and also the sore left underarm, slight vertigo, and mild headaches, exhaustion, slight trouble breathing. The knots and soreness were still in left armpit. Right armpit was fine. There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R on 13May2021 15:00 with outcome of not recovered. The events were serious due to disability. Trying to get in to see a primary doctor for referral to a cardiologist, which is proving difficult. The patient hoped the symptoms can be lessened. She felt none of this prior to vaccines. The events resulted in Doctor or other healthcare professional office/clinic visit. Not resulted hospitalization prolonged, Treatment received: Unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Visual impairment
Clinical narrative: racing heartbeat overnight; vertigo; exhaustion; foggy headedness; Headaches; Vision acuity lessened; Sore left underarm; extreme soreness in underarm area (lymph nodes she assumed)  Lymph node pain; ad the tightness in chest; Slight trouble breathing; There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2) at 51-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 20:00 (Batch/Lot Number: ER8736) as DOSE, 2 SINGLE for covid-19 immunisation. No pregnant. Medical history included Allergies, obesity, Exercise-induced asthma (diagnosed), Sensitive to Codeine product. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. 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. Concomitant medications included chlorpheniramine maleate; naproxen sodium (ALEVE). Historical Vaccine included BNT162B2 on 01Apr2021 at 51-years-old for COVID-19 Immunization (Dose Number : 1, Anatomical Location : Arm Left, Batch/lot number : ER8734, Start time: 08:00 PM) experienced Chills in the early evening first, fever overnight, Lethargic for approx a week. The second vaccine hit much, much harder. The patient experienced racing heartbeat overnight, vertigo, exhaustion, foggy headedness/ headaches, vision acuity lessened, extreme soreness in underarm area (lymph nodes she assumed). She still had the tightness in chest and also the sore left underarm, slight vertigo, and mild headaches, exhaustion, slight trouble breathing. The knots and soreness were still in left armpit. Right armpit was fine. There was tightness in either muscles or lungs in the area, internally, below stern, slightly L&R on 13May2021 15:00 with outcome of not recovered. The events were serious due to disability. Trying to get in to see a primary doctor for referral to a cardiologist, which is proving difficult. The patient hoped the symptoms can be lessened. She felt none of this prior to vaccines. The events resulted in Doctor or other healthcare professional office/clinic visit. Not resulted hospitalization prolonged, Treatment received: Unknown. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, Pulmonary thrombosis
Clinical narrative: Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dose on 26Apr2021; This is a spontaneous report from a contactable consumer(patient).  A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 at his 52-year-old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. He previously received his first dose BNT162B2 for Covid-19 immunization on 27Feb2021 at his 52-year-old. The patient experienced stroke on 07May2021 with outcome of unknown , had clots in his lungs/blood clots on an unspecified date with outcome of unknown.  The clinical course was reported as follows: After her received his second dose of the Pfizer COVID-19 vaccine he ended up with a stroke. He had clots in his lungs and one broke off and gave him the stroke. He was just looking to see if there have any information about long term events occurring with blood clots, like is this a one time event or is there a potential for it to keep happening now that he had the vaccine in his system. He received his first dose on 27Feb2021 and second dose on 26Apr2021 and had stoke on 07May2021. He had a stroke after Pfizer shot, now coincidentally he had no other health issues. He did not know if it was related to vaccine COVID may not have been. He was healthy 52 year old male, no medicines no nothing headed with the stroke, they developed a blood clot in his lung ended up with the stroke.   Information about batch/ lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Trigeminal neuralgia, Urinary tract infection
Clinical narrative: Trigeminal neuralgia; UTIs; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, at age of 59 year sold, no pregnant), dose 1 on 22Mar2021 01:00 (Lot Number: 02242639) and dose 2 on 22Apr2021 02:00 (Lot Number: EN6208) both via an unspecified route of administration, administered in left arm as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis, neck issues. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medications included morphine sulfate (KADIAN); diazepam; adalimumab (HUMIRA); topiramate (TOPAMAX). The patient I had UTIs for 2 months on 03Apr2021, ended up in ER with Trigeminal neuralgia on an unspecified date. Seeing Neurologist now on many additional medications now. Still have not recovered. Since the vaccination, the patient not had been tested for COVID-19. Treatment received included Steroids, antibiotics, CT scan, face Steroids inje. The AE resulted in Emergency room/department or urgent care. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: got paralyzed; This is a spontaneous report from a contactable consumer. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer reported that she had heard that the patient had reactions to the Covid-19 vaccine. The patient had a reaction where they literally got paralyzed. The consumer did not provide any details of the patient that was paralyzed after receiving the Covid-19 vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Magnetic resonance imaging, Pain
Clinical narrative: fevers; pain in back; Diagnosed with pancreatitis/abdominal pain/She thought it was muscle pain; aches/She had the aches partially on Wednesday; chills; This is a spontaneous report from a contactable consumer (patient's husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 07Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included she was not on medications or anything else. She had no medical conditions.  She was otherwise healthy and she did not have any issues apart from knee surgery here and things you get when moving through age, nothing abnormal or noticeable. She does not drink. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) If applicable, other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The patient's concomitant medications were not reported. She went and got the second vaccine on Monday (07Jun2021) and had chills, aches, and all of those things that were associated with it.  She also had abdominal pain that came on as well.  She thought it was muscle pain. Caller stated this was on Tuesday night (08Jun2021), and then Wednesday night she went to the ER.  She was now diagnosed with pancreatitis.  Chills and aches: she got the shot and it started around 6 o'clock at night or 5 o'clock at night, somewhere around there which was about 6 hours afterwards.  After the second vaccine shot.  It was Monday 07Jun2021 she received it. Caller adds she was in the hospital right now.  Chills and aches, abdominal pain, pain in back, fever: they went away probably in the middle of the night between 08Jun2021 and 09Jun2021. So, she got the shot on 07JUN2021 around 6 o'clock and chills and aches through Tuesday. She had the aches partially on Wednesday 09Jun2021. At the end of the day, she felt better with the fever and aches but her pain was excruciating in the abdomen and back. Caller clarified this all started at the same time.  She thoughts it was muscle pain and not anything else going on. Caller adds the abdominal pain was still going on.  It was subsiding because they were kind of getting it under control but she was in a lot of pain right now. She was admitted yesterday morning (09Jun2021) around 3 or 4 o'clock, it was early, maybe 5 o'clock. Diagnosed with pancreatitis: it was the day she went in, was yesterday (09Jun2021). Investigations: she had lab blood work, ultrasound, MRI. Treatment, Investigations: caller stated pancreatitis does not have treatment besides managing the pain, the MRI and the ultrasound revealed no blockages or masses or cysts of organs, and no apparent cause of the pancreatitis. Outcome of the events was unknown.  Information for lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis, Pyrexia, Ultrasound abdomen
Clinical narrative: fevers; pain in back; Diagnosed with pancreatitis/abdominal pain/She thought it was muscle pain; aches/She had the aches partially on Wednesday; chills; This is a spontaneous report from a contactable consumer (patient's husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 07Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included she was not on medications or anything else. She had no medical conditions.  She was otherwise healthy and she did not have any issues apart from knee surgery here and things you get when moving through age, nothing abnormal or noticeable. She does not drink. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) If applicable, other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The patient's concomitant medications were not reported. She went and got the second vaccine on Monday (07Jun2021) and had chills, aches, and all of those things that were associated with it.  She also had abdominal pain that came on as well.  She thought it was muscle pain. Caller stated this was on Tuesday night (08Jun2021), and then Wednesday night she went to the ER.  She was now diagnosed with pancreatitis.  Chills and aches: she got the shot and it started around 6 o'clock at night or 5 o'clock at night, somewhere around there which was about 6 hours afterwards.  After the second vaccine shot.  It was Monday 07Jun2021 she received it. Caller adds she was in the hospital right now.  Chills and aches, abdominal pain, pain in back, fever: they went away probably in the middle of the night between 08Jun2021 and 09Jun2021. So, she got the shot on 07JUN2021 around 6 o'clock and chills and aches through Tuesday. She had the aches partially on Wednesday 09Jun2021. At the end of the day, she felt better with the fever and aches but her pain was excruciating in the abdomen and back. Caller clarified this all started at the same time.  She thoughts it was muscle pain and not anything else going on. Caller adds the abdominal pain was still going on.  It was subsiding because they were kind of getting it under control but she was in a lot of pain right now. She was admitted yesterday morning (09Jun2021) around 3 or 4 o'clock, it was early, maybe 5 o'clock. Diagnosed with pancreatitis: it was the day she went in, was yesterday (09Jun2021). Investigations: she had lab blood work, ultrasound, MRI. Treatment, Investigations: caller stated pancreatitis does not have treatment besides managing the pain, the MRI and the ultrasound revealed no blockages or masses or cysts of organs, and no apparent cause of the pancreatitis. Outcome of the events was unknown.  Information for lot number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: had COVID tested post vaccination by nasal swab and revealed positive result; had COVID tested post vaccination by nasal swab and revealed positive result; Had headaches; no appetite on eating; This is a spontaneous report from a contactable consumer (patient) who reported that a 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 16May2021 (Batch/Lot number was not reported) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not diagnosed COVID prior to vaccination. Patient had COVID tested by nasal swab post vaccination and revealed positive result in May2021. The patient experienced headaches, no appetite on eating in May2021. Lasted for at least two weeks. Outcome of the events was unknown.   No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Feeling of body temperature change, Joint swelling, Lymphadenopathy, Movement disorder
Clinical narrative: getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She had a rash on her head, neck, and back/broke out in a rash in her scalp, chest, and back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had a rash on her head, neck, and back. She took Benadryl and it went away. She broke out in a rash in her scalp, chest, and back after the first dose she received of the Pfizer Covid 19 vaccine. She took Benadryl and symptoms went away and then nothing with the second dose. The outcome of the event was recovered.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: supracavicular fossa masses; This is a spontaneous report from a contactable consumer via a sales representative.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced supracavicular fossa masses on an unspecified date with outcome of unknown.    No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: appear blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0172) (at the age of 29-years-old) as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) on 23Apr2021 (at the age of 29-years-old) in the left arm for COVID-19 immunisation. On 15May2021, patient reported appearance of blood clot in her lungs. The event resulted in Emergency room/department or urgent care. The patient was given Eliquis as treatment for the event. The event was assessed as non-serious. Outcome of event was unknown. Since the vaccination, patient has been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she receive both of the doses of the Pfizer back in April and returned home in the beginning of June and developed symptoms when at home and infected her family member; she receive both of the doses of the Pfizer back in April and returned home in the beginning of June and developed symptoms when at home and infected her family member; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jun2021, the patient experienced she receive both of the doses of the Pfizer back in April and returned home in the beginning of June and developed symptoms when at home and infected her family member. It was reported that there was a Pfizer vaccination infection breakthrough in a patient who was hospitalized and also infected her family member while she was doing the required mandatory quarantine at home upon arrival. It was stated that "this is the Public announcement, she receive both of the doses of the Pfizer back in April and returned in the beginning of June and developed symptoms when at home and infected her family member, so they were not exactly in the announcement". Reported asked on where to link the announcement to Pfizer to look at or where the reporter could relate the information to and further stated that in the announcement it didn't say Diarrhea to what kind of Diarrhea or whatsoever it didn't really go into detail, except telling the public that it has to do with the Pfizer vaccination. The patient underwent lab tests and procedures which included COVID-19 test: positive on Jun2021. The outcome of the events was unknown.    Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: rectal bleeding; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced rectal bleeding on an unspecified date. Outcome of the event was unknown.  Information on batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: My daughter has developed a rash on her stocking; having high fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 08Jun2021 at 15:00 as dose 2, single (at the age of: 15-year-old) for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in right arm. Medical history included migraine and asthma. The patient's concomitant medications were not reported. No other vaccine administered in last four weeks. The patient had diagnosed with COVID prior vaccination and not diagnosed post vaccination, patient had not tested with COVID. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 10Jun2021 at 15:00 The patient experienced she has developed a rash on her stocking and having high fever. Therapeutic measures were taken as Tylenol and benadryl as a result of she has developed a rash on her stocking, having high fever. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The outcome of all event was not recovered.  Follow up attempts are needed, Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dyspnoea, Throat tightness
Clinical narrative: angio-edema to eyes, face lips; trouble breathing; closed throat; This is a spontaneous report from a contactable consumer (patient reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in left arm, on 09Jun2021 at 13:30 (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid. The patient has known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) on 19May2021 at 10:30 AM, left arm, for COVID-19 immunisation and the patient experienced hives, rash and itching  which was not related to vaccine at the time. On 09Jun2021 at 16:30, it was reported that the patient experienced angio-edema to eyes, face lips, closed throat and trouble breathing. The patient received steroid, diphenhydramine (BENADRYL) and famotidine (PEPCID). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye irritation, Eye pruritus, Swelling face, Throat tightness
Clinical narrative: angio-edema to eyes, face lips; trouble breathing; closed throat; This is a spontaneous report from a contactable consumer (patient reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in left arm, on 09Jun2021 at 13:30 (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid. The patient has known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) on 19May2021 at 10:30 AM, left arm, for COVID-19 immunisation and the patient experienced hives, rash and itching  which was not related to vaccine at the time. On 09Jun2021 at 16:30, it was reported that the patient experienced angio-edema to eyes, face lips, closed throat and trouble breathing. The patient received steroid, diphenhydramine (BENADRYL) and famotidine (PEPCID). The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: severe ear problem/cannot hear; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a severe ear problem. Further clarified that the patient was not in pain but cannot hear. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: Bad Shortness of Breath; Severe asthma exacerbation; Elevated D-Dimer; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0185) at the age of 26 years old, as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing asthma (she has had this condition her whole life) and ongoing allergy to polysorbate. There were no concomitant medications. Historical vaccination included bnt162b2 for COVID-19 immunization received on unspecified date (Dose number: 1 and Lot Number: EW0183). The patient wanted to make sure that Pfizer is aware about her reaction that she was in the hospital for. The patient had severe asthma. After her second dose of the vaccine she developed bad shortness of breath. She used her regular asthma treatments. She ended up in the hospital for severe asthma exacerbation due to the inflammatory response of the vaccine. Stated that maybe Pfizer needs to look into more studies with asthmatics. The patient stated that her symptoms started the same day as her second dose of the vaccine. She was admitted to the hospital this past Tuesday, 08Jun2021 and was discharged last night (09Jun2021). She stated that she was pretty sure that it is the vaccine that caused these events. She states she had an elevated D-Dimer on Jun2021; she believes this was related to the vaccine also. The event bad shortness of breath required emergency room visit. The patient was hospitalized due to bad shortness of breath and severe asthma exacerbation from 08Jun2021 to 09Jun2021. Outcome of the events was unknown. No other vaccines received 4 weeks prior to first COVID vaccination.   No follow-up attempts are possible. No further information is expected.