chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: tired and really weak; tired and really weak; She was glad she did not have an appetite; really cold/the chills are like she is sitting on ice; Loss of taste; nauseated; she vomited nothing come out except yellow stuff she was spitting up from her stomach.; Chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) (at the age of 72-year-old) as single dose for COVID-19 immunisation.  Medical history included problem with her blood pressure and active TB (tuberculosis), both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported loss of taste began on Sunday (on 18Apr2021), when woke up Sunday she was nauseated, she didn't have anything to eat so, when she vomited, nothing come out except yellow stuff she was spitting up from her stomach. She clarified the loss of taste, nausea and vomiting began on Sunday 18Apr2021 and that were all ongoing. She said that chills started the day of the shot (on 15Apr2021). She felt tired and really weak and she was really cold. She said the chills were like she was sitting on ice, she confirmed they are ongoing. She was glad she did not have an appetite. The patient outcome of the events was not recovered (she said all of that was persisting just about the same).  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Vomiting
Clinical narrative: tired and really weak; tired and really weak; She was glad she did not have an appetite; really cold/the chills are like she is sitting on ice; Loss of taste; nauseated; she vomited nothing come out except yellow stuff she was spitting up from her stomach.; Chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) (at the age of 72-year-old) as single dose for COVID-19 immunisation.  Medical history included problem with her blood pressure and active TB (tuberculosis), both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported loss of taste began on Sunday (on 18Apr2021), when woke up Sunday she was nauseated, she didn't have anything to eat so, when she vomited, nothing come out except yellow stuff she was spitting up from her stomach. She clarified the loss of taste, nausea and vomiting began on Sunday 18Apr2021 and that were all ongoing. She said that chills started the day of the shot (on 15Apr2021). She felt tired and really weak and she was really cold. She said the chills were like she was sitting on ice, she confirmed they are ongoing. She was glad she did not have an appetite. The patient outcome of the events was not recovered (she said all of that was persisting just about the same).  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Herpes zoster, Peripheral swelling, Pharyngeal swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported.  The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: she took the band aid off and it is still itching; This is spontaneous report from contactable consumer (Patient). A unspecified age of female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: unknown), via an unspecified route of administration, administered on 06Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced itching at injection site, patient states she has a minor side effect, she remembers the pharmacist said not to rub it and she took the band aid off and it is still itching. Patient asking if she can put hydrogen peroxide or hydrocortisone cream on it? States it does say there may be itching on the paper, but there is no redness. The patient lab data and other investigations not reported. The outcome of the event was unknown.  Communication: Advised patient her physician would be the best person to contact to make decisions about appropriate treatment options.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Headache, Hypersomnia
Clinical narrative: She slept the entire day; Nausea; Headache; Her arm was sore where they gave the shot.; She felt dizzy which lasted 5-6 minutes.; She had a reaction where her arms felt funny.; Her body started heating up more and more; This is a spontaneous report from a contactable consumer (patient) via telephonic call. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 15:00 (Batch/Lot Number: EW0164) as single dose in arm left (at 57-year-old) for COVID-19 immunization. Medical history included ongoing seasonal and chemical allergies. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, and no prior vaccinations within 4 weeks. She went to the state fair grounds. It was put on by the local agency. She gained the COVID 20lbs. She does have seasonal and chemical allergies so maybe that made her have a hypersensitive reaction to it. When she got the shot on 18Apr2021 she felt like she was fine, and then less than 5 minutes later, probably about 3 minutes later she started to feel very funny. She had a reaction where her arms felt funny. Her body started heating up more and more. She felt dizzy which lasted 5-6 minutes. She hasn't recovered completely. Then, she got dizzy and got a headache. Her arm was sore where they gave the shot. On 19Apr2021 morning, she had a tiny headache right after the shot and dizziness that went away. Her head could clear up a little more though. She had nausea and was very nauseous on 19Apr2021 night. The nausea went away after 3 hours. On 19Apr2021 (Monday), she had dizziness again. Currently, she felt fine. On 20Apr2021 (Tuesday), she slept the entire day. She didn't wake up until 4. She got the vaccine in her left arm which is the side she sleeps on. She went and got a physical before the vaccine to make sure she was in good shape. She did not go to the ER or physicians office. No relevant test. The outcome of events nausea, and headache was resolved on 19Apr2021; of event vaccination site pain was resolved on 20Apr2021; of events dizziness and feeling abnormal was resolving, while of other events was unknown. communication: The caller was provided Medical Information's number of (#), option 3, and placed in queue due to high call volumes.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: She slept the entire day; Nausea; Headache; Her arm was sore where they gave the shot.; She felt dizzy which lasted 5-6 minutes.; She had a reaction where her arms felt funny.; Her body started heating up more and more; This is a spontaneous report from a contactable consumer (patient) via telephonic call. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 15:00 (Batch/Lot Number: EW0164) as single dose in arm left (at 57-year-old) for COVID-19 immunization. Medical history included ongoing seasonal and chemical allergies. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, and no prior vaccinations within 4 weeks. She went to the state fair grounds. It was put on by the local agency. She gained the COVID 20lbs. She does have seasonal and chemical allergies so maybe that made her have a hypersensitive reaction to it. When she got the shot on 18Apr2021 she felt like she was fine, and then less than 5 minutes later, probably about 3 minutes later she started to feel very funny. She had a reaction where her arms felt funny. Her body started heating up more and more. She felt dizzy which lasted 5-6 minutes. She hasn't recovered completely. Then, she got dizzy and got a headache. Her arm was sore where they gave the shot. On 19Apr2021 morning, she had a tiny headache right after the shot and dizziness that went away. Her head could clear up a little more though. She had nausea and was very nauseous on 19Apr2021 night. The nausea went away after 3 hours. On 19Apr2021 (Monday), she had dizziness again. Currently, she felt fine. On 20Apr2021 (Tuesday), she slept the entire day. She didn't wake up until 4. She got the vaccine in her left arm which is the side she sleeps on. She went and got a physical before the vaccine to make sure she was in good shape. She did not go to the ER or physicians office. No relevant test. The outcome of events nausea, and headache was resolved on 19Apr2021; of event vaccination site pain was resolved on 20Apr2021; of events dizziness and feeling abnormal was resolving, while of other events was unknown. communication: The caller was provided Medical Information's number of (#), option 3, and placed in queue due to high call volumes.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; soreness at the injection site; This is a spontaneous report from a contactable consumer (reporter's friend). A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified dates (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The 1st dose was very mild symptoms with a little fatigue and with the 2nd dose of the Pfizer vaccine, her friend had no headache or anything but had fatigue; her friend had soreness at the injection site and fatigue. The outcome of the events as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: side effects similar to covid 19 symptoms; This is a spontaneous report from a contactable consumer.     A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced side effects similar to covid 19 symptoms on an unspecified date with outcome of unknown. The patient get tested for covid 19 but the result was unknown.  Information about Lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: have the bruises around her finger and her fore arm; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of an unspecified age received second dose of (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. It's reported after the second dose when she woke up "today" she have the bruises around her finger and her fore arm. The outcome of the event was unknown.  Comment: As reporter hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Pain in his body and head; Pain in his body and head; His muscles are hurting; This is a spontaneous report from a Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included diabetes. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's concomitant medications were not reported. since the 2nd dose he has had pain in his body and head and said it's not going away and that his muscles were hurting. The outcome of pain in his body and head was not recovered while his muscles are hurting was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache for a week after the vaccine; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient did not received any other vaccine prior to COVID vaccine. The patient experienced severe headache for a week after the vaccine on Apr2021 which resulted in doctor's clinic visit. Prescription migraine medication was received as treatment for the event. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. Outcome of the event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms
Clinical narrative: headaches; woke up with severe Charlie horses in legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 16:30 (Batch/Lot Number: EW0150) at single dose in arm left (at 64-yaer-old) for COVID-19 immunisation. The second dose Pfizer COVID vaccine was scheduled for 23Apr2021 (this Friday). The patient's medical history and concomitant medications were not reported. No medical history (including any illness at time of vaccination), no family medical history relevant to AE. Back in 2009 she had the swine flu shot and that was because caller had new grand daughter baby and really bad if babies get it. Caller got the swine flu shot and had some pain in the kidney can not tell which side because does not remember. Reports it was momentarily did not go to doctor. Caller did report it to the Doctor. Doctor said the vaccine does not cause that. The pain in kidney was just there and done. The day of the first dose Pfizer COVID vaccine (02Apr2021) patient woke up in the middle of the night with severe Charlie horses in legs. The patient said she did not normally have Charlie horses but had had them before. She can not say if this was due to the Pfizer COVID vaccine but did have the Charlie horses the first night after receiving the first dose Pfizer COVID Vaccine. The day after receiving the first dose Pfizer COVID vaccine (03Apr2021) caller started having headaches, it off and on every day usually right in the temples and kind of moves up. It's mild and patient did not take anything for it. It's not normal for the patient. The next day started with that mild headache. Pain in her honestly quite concerned about taking the second dose Pfizer COVID vaccine. She did not know what was in Pfizer COVID vaccine or what it's doing to her. Patient was positive within self this has to do with the vaccine, did not get headaches and had one. No relevant test. The outcome of event headaches was not resolved, of event charlie horses in legs was resolved completely with no issue on 02Apr2021.   Referred to doctor. The caller was provided with phone number of :(Withheld) option 3 prior to attempted warm transfer. Unable to warm transfer due to high call volume.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: extremely tired; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7534, expiration date: 31Jul2021) via an unspecified route of administration at arm right on 20Mar2021 14:00 at age of 50-year-old at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2018, ongoing high cholesterol from 2018. Patient had no history of previous immunization with the Pfizer vaccine, no additional administered vaccines, no prior vaccinations within 4 weeks. Patient had no family medical history relevant to the events. Concomitant medications were not reported. It was reported that patient took high blood pressure and cholesterol medication. During the original call, patient's husband mentioned wife had the first shot and her arm was killing her, he thought the guy who gave it hit an artery or something. Caller handed the phone to his wife and she reported her symptoms of the Pfizer COVID vaccine. Patient stated she had arm pain on 20Mar2021 and felt extremely tired on 10Apr2021. It was explained she couldn't shake the tired feeling and it lasted for the week. She said she was still tired but not as tired as last week. Caller stated she has recovered with lasting effects. Patient did not treat her symptoms in any way. Patient received second vaccine in the right upper arm on 10Apr2021 14:00 (Lot number ER8734, Expiration date 31Jul2021). Outcome of arm pain was recovered on 22Mar2021, of extremely tired was recovered on 16Apr2021.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: extreme chills; body was shaking; teeth chattering; muscles were seizing; freezing/she had to get in the bath she was so cold; soreness in in her arm; body aches; headache; tired; felt like she got hit by a truck last night, she felt terrible; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8735, expiration date unknown) via an unspecified route of administration at left upper arm on 20Apr2021 at 11 am Mountain time at age of 51-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Patient previously received 1st dose of BNT162B2 on 30Mar2021 (Batch/lot number: ER8735) on left upper arm for COVID-19 Immunization. She didn't have any reactions with the first dose. There was no family medical history relevant to the events. Caller called about the Pfizer COVID vaccine second dose. She stated that last night on 20Apr2021 around 12 hours after receiving the 2nd dose she had extreme chills, her whole body was shaking, her teeth were chattering, muscles were seizing, and she was freezing. She stated that she had to get in the bath she was so cold. She stated getting the vaccine at 11 am mountain time. 12 hours after, later she was freezing, she had body aches, headaches, and she got scared, so she got up and read the pamphlet. She said that it was more than a little chilly, her whole body was shaking, teeth chattering, she stated it was bad. She did state that she felt okay today. Chills resolved this morning on 21Apr2021, probably about 1AM. She stated that she still had soreness in in her arm, was tired and she still had a headache. She stated that they were improved. She stated that she felt like she got hit by a truck last night, she felt terrible. She stated the body aches were still on going but they were improved. Patient didn't visit emergency room and physician office. Onset date of the events was 20Apr2021. Outcome of events extreme chills, "body was shaking", teeth chattering, "muscles were seizing", freezing was recovered on 21Apr2021, of events soreness in in her arm, body aches, headache, tired was recovering, of "felt like she got hit by a truck last night, she felt terrible" was unknown.  No follow-up attempts are possible; information about lot/batch number requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, Tremor
Clinical narrative: extreme chills; body was shaking; teeth chattering; muscles were seizing; freezing/she had to get in the bath she was so cold; soreness in in her arm; body aches; headache; tired; felt like she got hit by a truck last night, she felt terrible; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8735, expiration date unknown) via an unspecified route of administration at left upper arm on 20Apr2021 at 11 am Mountain time at age of 51-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Patient previously received 1st dose of BNT162B2 on 30Mar2021 (Batch/lot number: ER8735) on left upper arm for COVID-19 Immunization. She didn't have any reactions with the first dose. There was no family medical history relevant to the events. Caller called about the Pfizer COVID vaccine second dose. She stated that last night on 20Apr2021 around 12 hours after receiving the 2nd dose she had extreme chills, her whole body was shaking, her teeth were chattering, muscles were seizing, and she was freezing. She stated that she had to get in the bath she was so cold. She stated getting the vaccine at 11 am mountain time. 12 hours after, later she was freezing, she had body aches, headaches, and she got scared, so she got up and read the pamphlet. She said that it was more than a little chilly, her whole body was shaking, teeth chattering, she stated it was bad. She did state that she felt okay today. Chills resolved this morning on 21Apr2021, probably about 1AM. She stated that she still had soreness in in her arm, was tired and she still had a headache. She stated that they were improved. She stated that she felt like she got hit by a truck last night, she felt terrible. She stated the body aches were still on going but they were improved. Patient didn't visit emergency room and physician office. Onset date of the events was 20Apr2021. Outcome of events extreme chills, "body was shaking", teeth chattering, "muscles were seizing", freezing was recovered on 21Apr2021, of events soreness in in her arm, body aches, headache, tired was recovering, of "felt like she got hit by a truck last night, she felt terrible" was unknown.  No follow-up attempts are possible; information about lot/batch number requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Oropharyngeal pain
Clinical narrative: Sore throat; Ear infection; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) on 01Apr2021 at age of 69-year-old via an unspecified route of administration at arm right at single dose for COVID-19 immunization. Patient said she received the shot at 11 am or 12 pm that day. Medical history was reported as none. The caller declined being sick at the time of vaccination. Concomitant medications (other products) was reported as none. There was no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). The caller said she was supposed to get another shot tomorrow but her doctor and her pharmacist didn't recommend it because she had a very sore throat and an ear infection. She was calling to try to reschedule her appointment. She said both the sore throat and the ear infection started a week ago, maybe a week and a half ago. She said she has been using sprays out of the drug store and the pharmacist was showing her different things to use because she was waiting for her doctor's appointment. She said she just had a physical in Mar2021 and she didn't think she has anything to report. She says she was trying to wait another week because she wanted to get in with her doctor before she gets all of that. Events were still persisting at time of reporting. Patient received pharmacy's Oral Relief for sore throat. When probed for any NDC/UPC, Lot number or expiry date, the caller explained she didn't have her glasses with her right now and stated she wouldn't be able to read all of that stuff. It was also reported that the events didn't require a visit to emergency room or physician office (as reported). She said she was just trying to patch her stuff up at home. Patient said maybe this didn't come from the shot, she didn't know. Outcome of sore throat and ear infection was not recovered.  The caller was referred to her place of vaccination or her local health department for second dose rescheduling guidance.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.   A 77-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medication(s) included eltrombopag olamine (PROMACTA) taken for an unspecified indication from an unspecified date to an unspecified date, then from 14Apr2021 to an unspecified date.  The patient experienced diarrhea on an unspecified date with outcome of not resolved.  Patient reports that he is currently holding his Promacta per his doctor. He received his COVID-19 vaccine and was experiencing diarrhea. On 14Apr2021 patient has resumed his daily Promacta after being treatment on hold. He continues to have diarrhea and did received his second COVID-19 vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Movement disorder, Muscle spasms, Myalgia, Spinal pain
Clinical narrative: Medical history included ongoing hypersensitivity , ongoing asthma. The patient concomitant medications included products for allergy. The patient experienced debilitating back, spinal and muscular pain in his back on an unspecified date with outcome of recovering , not really able to move at all on an unspecified date with outcome of unknown , he has cramps on an unspecified date with outcome of unknown.  The clinical course was as follows 24 hours after the vaccine, he developed debilitating back, spinal and muscular pain in his back for at least 72 hours. He was not really able to move at all.  It got better to the point he can function now, but he is still getting it.  He has cramps, back aches, spinal aches, muscles aches from it still. They have Improved but not resolved. He didn't receive treatment for them. The only thing he did take is Advil it kind of helped. He knows it is contraindicated for 6 weeks after the vaccine , so he tried not to take it. He only took it for the debilitating pain. The events were assessed as non-serious.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Dark urine/The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0164) at single dose, in the left upper arm, on 19Apr2021, at 09:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included fast heart rate and gastrooesophageal reflux disease. The patient previously, on 26Mar2021, at the age of 32-years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8732) at single dose, in the left upper arm, for COVID-19 immunisation. Concomitant medications included atenolol 50 mg once a day, from an unspecified date (he started it probably 10 years before this report) and ongoing, for fast heart rate and pantoprazole 40 mg once a day from an unspecified date (he started it probably 10 years before this report) and ongoing, for gastrooesophageal reflux disease. On 19Apr2021, at 19:00, the patient experienced dark urine and other symptoms (unspecified). The adverse event was described as "patient had the second dose of the vaccine on Monday morning 19Apr2021, and he noticed the dark urine Monday evening. The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back. It has fluctuated a little bit during the last day and a half but hasn't gone away at any point. Most of his other symptoms he had were in line with what he had read about with the vaccine". No seriousness criteria reported. Physician office visit and emergency room visit were not required. Clinical outcome of the adverse event at time of this report was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diabetes mellitus, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Doesn't have any feeling in pinky; tired; tingling pinky/tingling hand; Left pinky was completely numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at noon, (Lot Number: EW0158; Expiration Date: 31Jul2021), as 0.3 mL single, for COVID-19 immunisation. Medical history included hyperthyroidism from Aug2013 and ongoing, illness anxiety disorder (grandmother), ongoing brain neoplasm, ongoing drug hypersensitivity, ongoing hypersensitivity (a lot of unspecified allergies). Concomitant medication included methimazole (unknown manufacturer) for hyperthyroidism from Aug2013 and ongoing. The patient experienced doesn't have any feeling in pinky (non-serious) on 21Apr2021 with outcome of unknown, tired (non-serious) on 21Apr2021 with outcome of not recovered, tingling pinky/tingling hand(non-serious) on 21Apr2021 with outcome of unknown, left pinky was completely numb (non-serious) on 21Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: unknown result (all the time for hyperthyroidism ), blood test: unknown result in Apr2021, diabetes mellitus: unknown result (two times), diabetes mellitus: 600 in Apr2021 (considered prediabetic), thyroid function test: slightly high on unknown date (but under control).  Therapeutic measures were taken as a result of left pinky was completely numb and included rub and shook. Clinical course: within 10-15 minutes after vaccination the patient started to feel pinky tingling, then her hand started tingling. 30 minutes after the pinky, she started to have a tingly hand. She also felt tired.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss, Thyroid function test
Clinical narrative: Doesn't have any feeling in pinky; tired; tingling pinky/tingling hand; Left pinky was completely numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at noon, (Lot Number: EW0158; Expiration Date: 31Jul2021), as 0.3 mL single, for COVID-19 immunisation. Medical history included hyperthyroidism from Aug2013 and ongoing, illness anxiety disorder (grandmother), ongoing brain neoplasm, ongoing drug hypersensitivity, ongoing hypersensitivity (a lot of unspecified allergies). Concomitant medication included methimazole (unknown manufacturer) for hyperthyroidism from Aug2013 and ongoing. The patient experienced doesn't have any feeling in pinky (non-serious) on 21Apr2021 with outcome of unknown, tired (non-serious) on 21Apr2021 with outcome of not recovered, tingling pinky/tingling hand(non-serious) on 21Apr2021 with outcome of unknown, left pinky was completely numb (non-serious) on 21Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: unknown result (all the time for hyperthyroidism ), blood test: unknown result in Apr2021, diabetes mellitus: unknown result (two times), diabetes mellitus: 600 in Apr2021 (considered prediabetic), thyroid function test: slightly high on unknown date (but under control).  Therapeutic measures were taken as a result of left pinky was completely numb and included rub and shook. Clinical course: within 10-15 minutes after vaccination the patient started to feel pinky tingling, then her hand started tingling. 30 minutes after the pinky, she started to have a tingly hand. She also felt tired.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Viral infection
Clinical narrative: Had a virus; Missed appointment for second dose of Covid Vaccine; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for 2 patients (himself and wife). This is the 1st of 2 reports.   This male patient of an unspecified age received the 1st dose of (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Mar2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a virus on an unspecified date with outcome of unknown and missed appointment for second dose Covid Vaccine on 19Apr2021. The reporter stated they were told they will be rescheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :Same reporter/event/drug, different patients
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Minimal local discomfort at injection site; This is a spontaneous report received from contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that he experienced minimal local discomfort at injection site following his Covid-19 vaccination on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Viral infection
Clinical narrative: Had a virus; Missed appointment for second dose; This is a spontaneous report from a non-contactable consumer (patient's husband). This consumer reported similar events for 2 patients (himself and wife). This is the 2nd of 2 reports. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 29Mar2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a virus (viral infection) (medically significant) on an unspecified date with outcome of unknown and missed appointment for second dose on 19Apr2021. The reporter stated they were told they will be rescheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021471065 Same reporter/event/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report received from contactable consumer (patient). A female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had her second shot yesterday (20Apr2021), of the Pfizer shot and today (21Apr2021) she had started coughing. She stated it was from time to time, not all the time. The outcome of the evet was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Pain in extremity
Clinical narrative: Hives all over her body/hives were very itchy and almost like welts; didn't feel great; Crazy Fatigue; Headache; Severe Arm Pain; couldn't sleep it was that bad; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received  (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. There were no prior vaccinations within 4 weeks and no Family Medical History Relevant to adverse events. The patient states she got the first vaccine on 16Apr2021 around noon and she did develop pretty bad symptoms. The patient had crazy fatigue, headache, severe arm pain, couldn't sleep it was that bad and didn't feel great on 16Apr2021, 2-3 hours after she left the site. She has hives all over her body. She doesn't know if it has anything to do with it or not. The patient stated that the hives were very itchy and almost like welts. The hives started to develop last night (20Apr2021) and today (21Apr2021) they were way worse. She hasn't taken any BENADRYL yet, she wanted to make sure that was okay to take and wants to know if that is a normal reaction to the vaccine. There were no additional vaccines administered on same date of the Pfizer. The patient received TYLENOL as treatment. The adverse events did not require a visit to Emergency Room or Physician Office. The outcome of event Crazy Fatigue and didn't feel great was recovering, of event headache was recovered on 19Apr2021, of event severe arm pain, couldn't sleep it was that bad was recovered on 20Apr2021, of event Hives all over her body/hives were very itchy and almost like welts was not recovered.   No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over her body/hives were very itchy and almost like welts; didn't feel great; Crazy Fatigue; Headache; Severe Arm Pain; couldn't sleep it was that bad; This is a spontaneous report from a contactable consumer (patient).  A 28-year-old female patient received  (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. There were no prior vaccinations within 4 weeks and no Family Medical History Relevant to adverse events. The patient states she got the first vaccine on 16Apr2021 around noon and she did develop pretty bad symptoms. The patient had crazy fatigue, headache, severe arm pain, couldn't sleep it was that bad and didn't feel great on 16Apr2021, 2-3 hours after she left the site. She has hives all over her body. She doesn't know if it has anything to do with it or not. The patient stated that the hives were very itchy and almost like welts. The hives started to develop last night (20Apr2021) and today (21Apr2021) they were way worse. She hasn't taken any BENADRYL yet, she wanted to make sure that was okay to take and wants to know if that is a normal reaction to the vaccine. There were no additional vaccines administered on same date of the Pfizer. The patient received TYLENOL as treatment. The adverse events did not require a visit to Emergency Room or Physician Office. The outcome of event Crazy Fatigue and didn't feel great was recovering, of event headache was recovered on 19Apr2021, of event severe arm pain, couldn't sleep it was that bad was recovered on 20Apr2021, of event Hives all over her body/hives were very itchy and almost like welts was not recovered.   No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Vomiting
Clinical narrative: Headache; Diarrhea; Vomiting; she is sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that she just got Covid vaccine a couple of hours ago and that she was vomiting and its coming out the other end, she had vomiting and diarrhea. She further stated after getting the Covid shot about 2 hours ago, she experienced vomiting, diarrhea and headache on 21Apr2021. Some other person (details unavailable) came on phone and mentioned the patient got the vaccine shot and she was sick, experiencing vomiting and diarrhea and asked if this was normal. The person mentioned the experience was terrible and wanted to know if she needed to go to the hospital and if this was a normal side effect. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only one arm was sore for a day; This is a spontaneous report from a contactable consumer reported for herself.   A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (reported as 3:00 o clock) (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation.  Medical history included blood pressure high, osteoarthritis and fibromyalgia from an unknown date and ongoing. Concomitant medications included amlodipine taken for blood pressure high from an unspecified start date and ongoing; meloxicam taken for osteoarthritis, fibromyalgia from an unspecified start date and ongoing. Historical Vaccine included Flu shot and experienced sore. There were no additional vaccines administered on same date of the Pfizer suspect and no Prior Vaccinations within 4 weeks. The patient stated with the first vaccine, only one arm was sore for a day. But overall she was okay. The outcome of event was recovered on an unspecified date.    No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: sensation like feeling the vaccine run through his  body later clarified that he felt like it was running through/traveling in his legs arms and chest; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (reported as left shoulder) on 20Mar2021 16:30 (Lot Number: ER2613) as single dose for covid-19 immunisation.  The patient medical history included hard of hearing. The patient's concomitant medications included unspecified medications. The patient previously received the flu vaccine earlier last year in October or so.  There was no prior Vaccinations (within 4 weeks) prior to the first administration date or the same date. The patient received his first vaccine 20Mar2021 and reported that when the provider pushed the needle in slowly and pushed the syringe in slowly that he felt a sensation like he could feel the vaccine running through his body he later clarified that he felt like it was running through/traveling in his legs arms and chest. He did not know if it was normal and he thought he should tell somebody. This sensation only lasted for a minute or two and then it was gone. He sat down and waited 15 minutes after he received the vaccine and then he did not feel anything after he left the injection site. He did not receive any treatment. This event did not require a visit to emergency room or physician office. He received his second vaccination 10Apr2021 and the lot number was EW0162.   No follow-up attempts are needed. No further information is expected.