chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Lymphadenopathy, Metabolic function test, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Left side of neck swollen lymph nodes; fatigue; This is a spontaneous report from a contactable other hcp.    A 53-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 2 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as dose 2, single for covid-19 immunisation. Medical history included, sinusitis placed on Ceftin 500 mg BID (Twice a day)x21 days, otitis media, placed on Ceftin 500 mg BID (twice a day)x 21 days, thyroid mass patient was seeing endocrinologist but HCP is not sure patient has seen them since 2015 , hypothyroidism patient takes Synthroid , hypertension, sepsis. Patient has a niece with a haematological symptom, anxiety. Concomitant medication(s) included cefuroxime axetil (CEFTIN [CEFUROXIME AXETIL]) taken for sinusitis, otitis media; escitalopram oxalate (LEXAPRO) taken for anxiety, depression; estradiol (ESTRADIOL); hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]; levothyroxine sodium (SYNTHROID) taken for hypothyroidism,; lisinopril (LISINOPRIL) taken for hypertension; vitamin d3 (VITAMIN D3) taken for vitamin d decreased; prednisone (PREDNISONE) taken for arthralgia, swelling, headache from 05Jan2021 to an unspecified stop date. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, the patient experienced left side of neck swollen lymph nodes and fatigue on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included antinuclear antibody: normal on 05Jan2021, blood uric acid: normal on 05Jan2021, computerised tomogram: normal on 08Jan2021, c-reactive protein: 5.0 on 05Jan2021 High, full blood count: normal on 05Jan2021, metabolic function test: normal on 05Jan2021, red blood cell sedimentation rate: 30 on 05Jan2021 High, rheumatoid factor: normal on 05Jan2021, vitamin d: 20 on 05Jan2021 Low. Therapeutic measures were taken as a result of left side of neck swollen lymph nodes (lymphadenopathy), fatigue (fatigue
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D
Clinical narrative: Left side of neck swollen lymph nodes; fatigue; This is a spontaneous report from a contactable other hcp.    A 53-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 2 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as dose 2, single for covid-19 immunisation. Medical history included, sinusitis placed on Ceftin 500 mg BID (Twice a day)x21 days, otitis media, placed on Ceftin 500 mg BID (twice a day)x 21 days, thyroid mass patient was seeing endocrinologist but HCP is not sure patient has seen them since 2015 , hypothyroidism patient takes Synthroid , hypertension, sepsis. Patient has a niece with a haematological symptom, anxiety. Concomitant medication(s) included cefuroxime axetil (CEFTIN [CEFUROXIME AXETIL]) taken for sinusitis, otitis media; escitalopram oxalate (LEXAPRO) taken for anxiety, depression; estradiol (ESTRADIOL); hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]; levothyroxine sodium (SYNTHROID) taken for hypothyroidism,; lisinopril (LISINOPRIL) taken for hypertension; vitamin d3 (VITAMIN D3) taken for vitamin d decreased; prednisone (PREDNISONE) taken for arthralgia, swelling, headache from 05Jan2021 to an unspecified stop date. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, the patient experienced left side of neck swollen lymph nodes and fatigue on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included antinuclear antibody: normal on 05Jan2021, blood uric acid: normal on 05Jan2021, computerised tomogram: normal on 08Jan2021, c-reactive protein: 5.0 on 05Jan2021 High, full blood count: normal on 05Jan2021, metabolic function test: normal on 05Jan2021, red blood cell sedimentation rate: 30 on 05Jan2021 High, rheumatoid factor: normal on 05Jan2021, vitamin d: 20 on 05Jan2021 Low. Therapeutic measures were taken as a result of left side of neck swollen lymph nodes (lymphadenopathy), fatigue (fatigue
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Taste disorder
Clinical narrative: taste buds change; bone hurts; headache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced taste buds change, bone hurts, headache on an unspecified date. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Taste disorder
Clinical narrative: has a second dose of the vaccine this 09Mar and having a appointment for 01Mar of Prolia Shot; she got experienced bone hurts, headache and taste buds change; she got experienced bone hurts, headache and taste buds change; she got experienced bone hurts, headache and taste buds change; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single DOSE for covid-19 immunisation. The patient medical history concomitant medications were not and reported. It was reported that, Caller called and said that she got the 1st dose of Covid 19 Vaccine and has a second dose of the vaccine this 09Mar and having a appointment for 01Mar of Prolia Shot, Caller also mentioned that she got experienced bone hurts, headache and taste buds change. The outcome of the events was unknown on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: dizziness, room tilting  filling, no room spinning, very bad headache and nausea when moving
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dizziness, Fatigue, Headache, Pruritus
Clinical narrative: The first shot that I received on 9/24/2021 was the first adverse reaction.  I started to itch in my upper torso and face.  I was so uncomfortable.  I was itchy all day long.  I can not take Benadryl during the day because it knocks me out.  I still had to function so I was uncomfortable all day.  I was itchy for a whole week.  The next week was not bad. THEN when I went to take the second shot, I told the Pharmacist about the itching but he brushed it off and said that itching is NOT a side effect, although the pamphlet that he provided to me said that it is.  You all might want to educate the person's giving the shot on the side effects.  THE SECOND DOSE was given o me on 10/15/2021.  I woke up the next day and guess what. Yes I was itchy, but it also effected my  reaction time and I felt like I was going in circles.  I felt dizzy and tired.  Yesterday was really tough.  I should not have been on the road.  I felt like I was going to blank out but i was not.  I spoke to my PCP about it.  She tried to prescribe me a medicine that would help with the itching and would not make me drowsy, but it interfered with my heart meds.  I also ended it with yeast meds because the itching was affecting my private area.  I do not have a yeast infection but she though that it would help the itching.  I feel like vaccine and I do not agree.  I am afraid to drive right now.  I an just waiting for these effects to end.  I have a headache that will not go away and my neck hurts badly.  My stomach feel like I am on a boat constantly. I do not want ANOTHER DOSE of that vaccine.  I will now list Covid Vaccine as a medicine that I am allergic to.  You should not have to take a vaccine and turn
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: The first shot that I received on 9/24/2021 was the first adverse reaction.  I started to itch in my upper torso and face.  I was so uncomfortable.  I was itchy all day long.  I can not take Benadryl during the day because it knocks me out.  I still had to function so I was uncomfortable all day.  I was itchy for a whole week.  The next week was not bad. THEN when I went to take the second shot, I told the Pharmacist about the itching but he brushed it off and said that itching is NOT a side effect, although the pamphlet that he provided to me said that it is.  You all might want to educate the person's giving the shot on the side effects.  THE SECOND DOSE was given o me on 10/15/2021.  I woke up the next day and guess what. Yes I was itchy, but it also effected my  reaction time and I felt like I was going in circles.  I felt dizzy and tired.  Yesterday was really tough.  I should not have been on the road.  I felt like I was going to blank out but i was not.  I spoke to my PCP about it.  She tried to prescribe me a medicine that would help with the itching and would not make me drowsy, but it interfered with my heart meds.  I also ended it with yeast meds because the itching was affecting my private area.  I do not have a yeast infection but she though that it would help the itching.  I feel like vaccine and I do not agree.  I am afraid to drive right now.  I an just waiting for these effects to end.  I have a headache that will not go away and my neck hurts badly.  My stomach feel like I am on a boat constantly. I do not want ANOTHER DOSE of that vaccine.  I will now list Covid Vaccine as a medicine that I am allergic to.  You should not have to take a vaccine and turn
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tinnitus
Clinical narrative: My daily tinnitus increased greatly; the frontal headaches; dizziness returned; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266, Expiry Date: Not Reported), via an unspecified route, administered in Left Arm on 22Feb2021 at 08:45, as dose 2, single for covid-19 immunisation; and topiramate (TOPIRAMATE, batch/lot number: Unknown, Dose: Unknown), via an unspecified route of administration, on an unspecified start and stop date, for an unspecified indication. The patient was not pregnant at the time of vaccination. The patient medical history included complex regional pain syndrome (CPRS), neutropenia, leukopenia, sustained concussion from Feb2018 for two years, frontal headaches not ongoing, dizziness when bending over which was not ongoing; and ongoing tinnitus. The patient's concomitant medications in two weeks included only 2 tablets, a week prior as sleep aid. The patient did not receive other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies. On 23Feb2021 at 6:00 AM, the patient's frontal headaches and dizziness returned, and daily tinnitus increased greatly. The patient reported two days after onset, the headache and dizziness have decreased in severity but not the tinnitus. The patient had all the same reactions with Topiramate. The patient anticipated that the patient would return to normal. The patient did not receive any treatment for the reported events. Outcome of the event tinnitus was not resolved and the outcome all other events was resolving.   No follow-up attempts are possible. No further information is expected
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Urticaria papular
Clinical narrative: Diffuse maculopapular urticarial eruption, hives, not including oropharynx; no anaphylaxis, no abdominal pain or dizziness or vomiting
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient hospitalized with covid 10/22/21
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms
Clinical narrative: Severe leg (Arterial cramping) When trying to lay down (20 minutes at a time, lasted 6 hours.  I have had several other instances of the cramping.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: chills; soreness in my arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, soreness in my arm on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer via a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that, got the first dose of the Covid19 vaccine today 24Feb2021. She said that on an unspecified date her arm sore and asked if she can take Ibuprofen, Tylenol, or Advil. The outcome for the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration
Clinical narrative: RN received covax 26Jan and the second covax on 09Feb 14 days after the first one.; burning sensation to skin and feet; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received Covax on 26jan and the second covax on 09feb 14 days after the first one. She also experienced burning sensation to skin and feet on an unspecified date of 2021. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: she had headache and was tired; she had headache and was tired; This is a spontaneous report from Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and was tired. The outcome of the events was unknown.  Information regarding the batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had 2 warts or calluses on each ring finger for years/I had my second COVID shot Saturday and by Sunday night they were completely gone; This is a spontaneous report received from a contactable consumer (patient herself). A patient of unspecified age and gender received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient reported that patient had 2 warts or calluses on each ring finger for years and after patient had the second covid shot on Saturday, by Sunday night they were completely gone. Patient thinks there is another use possibly for the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Soreness in her arm; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date at 08:15 (at the age73-years-old) as dose 1, single for COVID-19 immunization.Patient medical history included hyperthyroidism and low vitamin D.Concomitant medication(s) included methimazole tablet, 10 mg, taken orally for hyperthyroidism and cholecalciferol (VITAMIN D [COLECALCIFEROL]) 2400 mg oral, taken daily (Taken about 3 years, 2000mg tablet 400mg is gelcap, takes 2 separate pills) for low vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient developed little soreness in her arm. The adverse event does not result in visit to emergency room or physician office. she goes to an endocrinologist once a year for her blood work. On an unspecified date, the patient underwent lab tests which included blood work with unknown results. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tenderness
Clinical narrative: Arm was a little tender you know maybe a tinge tired; tinge tired; This is a spontaneous report from a contactable consumer (Patient). A 65-years old male consumer patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VAC-CINE, Solution for injection, Batch/lot no: EN5318 and Expiry date was unknown), via an unspecified route of administration, (age at vaccination was 65 years) on an unspecified date, as a DOSE 1, SINGLE for COVID-19 immunization. The patient's Medical history and concomitant medications were not reported. Patient stated, he received the first dose of the vaccine and he was asking agent if there was any flexibility between taking the first dose and the second dose because the second dose he might not get it on 21st day as recommended for the COVID-19 vaccine, he was so sorry he forgot to tell you that this was for the COVID 19 vaccine. He has the flight on his 20 th day after the first dose, so he might not get it after taking, he might not get it on the 21st day as recommended, so he was finding to take the vaccine the second dose on the 19th day, there might be more side effects that he might report right after his first dose. "When paraphrased the above concern, Patient stated, "No, he was sorry might be he didn't explain that. He was reading up in literature, he was scheduled to be on the flight on the 21st day, so he just wanted to see if he could get day or two early and he got up to website and it sounded like on the fact sheet, as early as 19 days was okay but no from the first shot he really didn't have any side effects. On an unknown date the arm was a little tender and might be a tinge tired but that could have been 'in his head' no. The Outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contraindication to vaccination, Headache, Pain, Teething
Clinical narrative: get a wisdom tooth pulled; Chills; teeth hurting; headache; achy feeling all over; she took the Ibuprofen prior to going and wants to know if is going to be compromising the vaccine/took Ibuprofen at 08:00 and got her first dosage around noon; This is a spontaneous report received from a contactable consumer or other non hcp. A 71-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6202) via an unspecified route of administration in Arm Left on 04Mar2021(age at vaccination 71years old) as single dose for covid-19 immunisation and ibuprofen (IBUPROFEN), via an unspecified route of administration from 04Mar2021 (Batch/Lot Number: OHE2514A; Expiration Date: May2022) to 04Mar2021, at unspecified dose for an unspecified indication. Medical history included covid-19 and virus earlier. There were no concomitant medications. The patient experienced get a wisdom tooth pulled on an unspecified date, headache, achy feeling all over on 05Mar2021 07:00, she took the ibuprofen prior to going and wants to know if is going to be compromising the vaccine/took ibuprofen at 08:00 and got her first dosage around noon on 04Mar2021, chills on an unspecified date, teeth hurting on an unspecified date. Additional information reported as side effects from the first dose of the Pfizer vaccine on 04Mar2021, morning at 7am she started experiencing, it started with a severe headache that woke up her and just an achy feeling all over, so that morning she took 2 Tylenol, still had the achy feeling some chills, but she is always cold, headache was subsiding. she also had a wisdom tooth that needs to come out that causing pain from this tooth that may not be related to the vac-cine. All her teeth were aching when she had covid virus and earache and teeth hurting was her first indication she had covid and experiencing all of the teeth aching, it could have been coincidental, she had teeth ache, congestion. She never had a fever, oxygen was normal, but aches and pains were like a super flu that kept me in bed for two weeks. Therapeutic measures were taken as a result of get a wisdom tooth pulled. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wisdom teeth removal
Clinical narrative: get a wisdom tooth pulled; Chills; teeth hurting; headache; achy feeling all over; she took the Ibuprofen prior to going and wants to know if is going to be compromising the vaccine/took Ibuprofen at 08:00 and got her first dosage around noon; This is a spontaneous report received from a contactable consumer or other non hcp. A 71-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6202) via an unspecified route of administration in Arm Left on 04Mar2021(age at vaccination 71years old) as single dose for covid-19 immunisation and ibuprofen (IBUPROFEN), via an unspecified route of administration from 04Mar2021 (Batch/Lot Number: OHE2514A; Expiration Date: May2022) to 04Mar2021, at unspecified dose for an unspecified indication. Medical history included covid-19 and virus earlier. There were no concomitant medications. The patient experienced get a wisdom tooth pulled on an unspecified date, headache, achy feeling all over on 05Mar2021 07:00, she took the ibuprofen prior to going and wants to know if is going to be compromising the vaccine/took ibuprofen at 08:00 and got her first dosage around noon on 04Mar2021, chills on an unspecified date, teeth hurting on an unspecified date. Additional information reported as side effects from the first dose of the Pfizer vaccine on 04Mar2021, morning at 7am she started experiencing, it started with a severe headache that woke up her and just an achy feeling all over, so that morning she took 2 Tylenol, still had the achy feeling some chills, but she is always cold, headache was subsiding. she also had a wisdom tooth that needs to come out that causing pain from this tooth that may not be related to the vac-cine. All her teeth were aching when she had covid virus and earache and teeth hurting was her first indication she had covid and experiencing all of the teeth aching, it could have been coincidental, she had teeth ache, congestion. She never had a fever, oxygen was normal, but aches and pains were like a super flu that kept me in bed for two weeks. Therapeutic measures were taken as a result of get a wisdom tooth pulled. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Dizziness, Eating disorder, Fatigue, Feeling abnormal
Clinical narrative: Vertigo; Nausea; Tired; Vomiting; Has not been able to really eat; Dizzy; He still feel sensation through his leg and his arms; He must have lost 10 pounds; This is a spontaneous report from a contactable consumer (wife of patient). A 75-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiry date: Jun2021), via an unspecified route of administration on 24Feb2021 (at age of 75-years-old) as dose 2, single for covid-19 immunization. Medical history included high blood pressure. Concomitant medication(s) included irbesartan (IRBESARTAN) taken for high blood pressure, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced vertigo, nausea, tired, vomiting, has not been able to really eat, dizzy, he still feel sensation through his leg and his arms and he must have lost 10 pounds. The caller stated that she was calling for her husband and they both had the bnt162b2 vaccine for the covid. On Wednesday 24Feb2021, they both had second shot. He had gotten a vertigo, the first two days of the second shot he had a 'queasy' arm and very tired, on Friday the third day he started getting severe vertigo, nausea, vomiting, it was until Sunday and Monday it came back again so he had not been able to really eat and now he was little bit dizzy, the caller just want to tell he still felt sensation through his leg and his arms. Reporter stated, he must have lost 10 pounds, he was about 5 feet 11.5 inches, and he used to be 184 pounds, hadn't eaten. Reporter stated, any treatment that they spoke to the doctor about 2-3 times, the doctor gave the patient an anti-nausea medication and he was also taking Bonine. The patient underwent lab tests and procedures which included body height: about 5 feet 11.5 inches on an unspecified date, weight: 10 lbs on an unspecified date, lost 10 pounds, weight: 184 lbs on an unspecified date, used to be 184 pounds. Therapeutic measures were taken as a result of nausea. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting, Weight, Weight decreased
Clinical narrative: Vertigo; Nausea; Tired; Vomiting; Has not been able to really eat; Dizzy; He still feel sensation through his leg and his arms; He must have lost 10 pounds; This is a spontaneous report from a contactable consumer (wife of patient). A 75-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiry date: Jun2021), via an unspecified route of administration on 24Feb2021 (at age of 75-years-old) as dose 2, single for covid-19 immunization. Medical history included high blood pressure. Concomitant medication(s) included irbesartan (IRBESARTAN) taken for high blood pressure, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced vertigo, nausea, tired, vomiting, has not been able to really eat, dizzy, he still feel sensation through his leg and his arms and he must have lost 10 pounds. The caller stated that she was calling for her husband and they both had the bnt162b2 vaccine for the covid. On Wednesday 24Feb2021, they both had second shot. He had gotten a vertigo, the first two days of the second shot he had a 'queasy' arm and very tired, on Friday the third day he started getting severe vertigo, nausea, vomiting, it was until Sunday and Monday it came back again so he had not been able to really eat and now he was little bit dizzy, the caller just want to tell he still felt sensation through his leg and his arms. Reporter stated, he must have lost 10 pounds, he was about 5 feet 11.5 inches, and he used to be 184 pounds, hadn't eaten. Reporter stated, any treatment that they spoke to the doctor about 2-3 times, the doctor gave the patient an anti-nausea medication and he was also taking Bonine. The patient underwent lab tests and procedures which included body height: about 5 feet 11.5 inches on an unspecified date, weight: 10 lbs on an unspecified date, lost 10 pounds, weight: 184 lbs on an unspecified date, used to be 184 pounds. Therapeutic measures were taken as a result of nausea. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body aches; chills.; This is a spontaneous report from a contactable other hcp (nurse). A female patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6202), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 as DOSE 1, SINGLE for covid-19 immunisation; Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications include dexamethasone acetate (DECADRON [DEXAMETHASONE ACETATE]), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to 28Feb2021, and then today she had to restart Decadron for 3 days, so 9Mar2021-11Mar2021 for migraine and allergies were not reported. The patient experienced body aches, chills on Feb2021. Caller will have second Pfizer Covid vaccine on 13Mar2021. Caller started taking Decadron for Migraines today, 09Mar2021 until 11Mar2021. Asking if Decadron will interfere with the vaccine. Caller started taking Decadron for Migraines/ Asking if Decadron will interfere with the vaccine and also asking did she deactivate it by taking the Decadron or will it with the second round or what. The patient clarifies that she had Chills and Body Aches after the first vaccine; however, she does not want to complete a safety report, she just wants to know about the Decadron. The patient took her first vaccine on 20Feb2021. A few days later, she took Decadron, which is a steroid, from 26Feb to 28Feb2021. Also she took one today, with an additional 2 doses in the next 3 days (that's 09Mar to 11Mar, in total) before her next vaccine dose and Caller started taking Decadron for Migraines today, 09Mar2021 until 11Mar2021. Asking if  will interfere with the vaccine which will be on 13Mar2021. She was also asking whether this would affect her having been vaccinated. The clinical outcome for the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient/himself). A 53-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201, expiry date: unknown), at the age of 53, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9263), on an unspecified date, for COVID-19 immunization (patient experienced diarrhea). The patient's medical history and concomitant medications not reported. On unspecified date, patient had a very sore arm at injection site, flu-like body aches (no fever) and  diarrhea (day 2). The same thing reported after first shot. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: arm pain; received the Pfizer vaccine as a 2nd dose today. It was later f0ound out that they received the Moderna vaccine as a 1st dose; This is a spontaneous report from a contactable+ Pharmacist. This Pharmacist reported for a patient. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021) via an unspecified route of administration on 11Mar2021, left deltoid at 15:30 (age at vaccination 56-year-old) as dose 2, 0.3 ml single for covid-19 immunization and co-suspect covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 12Feb2021 15:30 (Batch/Lot number was not reported) to 12Feb2021 15:30, at DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced received the Pfizer vaccine as a 2nd dose today. it was later found out that they received the Moderna vaccine as a 1st dose (wrong product administered) on 11Mar2021, arm pain. The patient taking Covid 19 Vaccine for protection from Covid 19. The issue was due to a language barrier. Reporter was asked 3 times and they mentioned Pfizer was the vaccine they received. Reporter is asking for any recommendations regarding the situation. Reporter states the doctor is not the one who gave the shot, she was. Provides this as patients regular doctor. Reporter states the patient has been there 20-30 minutes and seems to be doing fine. Reporter states they contacted Moderna, and they said do not repeat the shot but to confirm with Pfizer also. Causality captured as confirmed and provided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Muscle spasms, Pain in extremity, Product dose omission issue
Clinical narrative: Missed dose/ Missed a dose of medication; Leg cramps and aches; Leg cramps and aches; This is a spontaneous report from a contactable consumer based on the information by Pfizer (Mrf. Con-trol Number: 2021IN000980). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unknown route of administration on 03Feb2020 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and taking ruxolitinib phosphate (JAKAFI, tablet, Lot Number: 9959035) via orally from 19Feb2015 to an unknown date, at 10 mg, daily for an unknown indication. The patient medical history was not reported. Concomitant medications included calcium, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and multivitamin taken for an unspecified indication, start and stop dates were not reported. The patient experienced missed dose/ missed a dose of medication, leg cramps and aches on an unspecified date. At the time of the report, action taken on JAKAFI was unknown. The outcome was unknown for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: UNK
Symptoms: Adverse reaction
Clinical narrative: Potential AE realized after call (possible drug interaction); This is a spontaneous report received from contactable consumer, Pfizer sponsored program CEP 159558 via medical information team.  A contactable male consumer (patient) of an unspecified age reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization, patient also took aspirin [acetylsalicylic acid] (Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at 3 DF for headache. Medical history included headache from an unknown date and unknown if ongoing (he had a headache and took 3 pcs of aspirin 20 minutes before the vaccination). Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced Potential AE realized after call (possible drug interaction). It was reported that, the patient received the Pfizer-BioNTech COVID-19 Vaccine second dose. On the way to get the vaccine, patient mentioned he had a headache and took 3 pcs of aspirin 20 minutes before the vaccination. Caller proceeded with the shot and was now asking if this would have compromised the efficacy of his vaccine. The patient was wondering if he ruined his vaccine due to taking aspirin. No information found on additional steps or a third dose and referred to HCP for guidance. Action taken with co-suspect aspirin was unknown. Outcome of the event was unknown.  There were not any unaddressed medical questions referred or forwarded to Medical Information. Unknown if the Reporter a Healthcare Professional (HCP). The Reporter contact information available to you or a sub-contracted party: Yes Unknown if the reporter the prescribing HCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in injection arm 10 days out; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and auto-immune issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Any other vaccines taken within four weeks prior to the vaccination was not reported. Concomitant medications included asthma inhaler (unspecified) from an unknown date and unknown if ongoing. On 12Mar2021 at 22:00, the patient experienced severe pain in injection arm 10 days out. It was so severe and if it did not stop, the patient would not be getting another shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in injection arm 10 days out was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Circumstance or information capable of leading to medication error, Headache, Myalgia
Clinical narrative: I am on a blood thinner and after reading the brochure that's, there is a precaution of not to take it; muscle soreness; headache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration on 25Feb2021 (at the age of 77-year-old) as a DOSE 1, SINGLE for COVID-19 immunisation; received rosuvastatin calcium (CRESTOR), via an unspecified route of administration on an unspecified date as dose Unknown use for blood thinner. The patient medical history and concomitant medications were not reported. The patient reported that he received 1st Pfizer Covid Vaccine 3 weeks ago from the day of report and was set to take 2nd dose next day on 18Mar2021. He was experienced muscle soreness and headache for the last week and a half. The patient also reported that he took a blood thinner (Crestor) and was concerned if it would cause any problems. He was on a blood thinner and after reading the brochure there was a precaution of not to take it. The patient was okay and just wanted to make sure that that was okay to take the second shot which was on next day. Outcome of the events was unknown.  The lot and batch number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: very tired; body pain; sore arm; Chills; This is a Spontaneous report based on the information received by Pfizer (Manufacturer Control No: 21K-163-3805390-00). A contactable 69-year-old female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267) via intramuscular route of administration on 26Feb2021 (at 69-year-old), as dose 2, single for COVID-19 immunization and adalimumab (Humira) for crohn's disease via subcutaneous route on an unknown date in 2017 at a dose of 40 mg, 2x/week. The patient's medical history included tobacco user from 1960 to 1981, alcohol use from 1970 to an unknown date alcohol use a glass of wine occasionally (Started 1970) and lyme disease from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included iron taken for supplementation therapy, start and stop date were not reported; vitamin D3 taken for supplementation therapy, start and stop date were not reported; cyamopsis tetragonoloba gum (Benefiber fiber supplement) taken for supplementation therapy, start and stop date were not reported; acetylsalicylic acid (Aspirin (E.C.)) taken for cardiac disorder, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Feb2021 (at 69-year-old), at single dose for COVID-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 26Feb2021, the patient experienced very tired, body pain, sore arm and chills. On 27 Feb 2021 the patient resolved.  No follow-up attempts were possible. No further information was expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.    A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Mar2021 (at the age of 74-year-old), in arm left as dose 2, single for COVID-19 immunization. And co-suspect reported as zinc, oral from an unspecified date (Batch/Lot Number: DBTE820N6009; Expiration Date: Aug2022) to an unspecified date, at 50 mg, 1x/day for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, on 06Feb2021 (at the age of 74-year-old), as dose 1, single for COVID-19 immunization. Patient received first and second dose of Pfizer covid-19 vaccine. Patient said that she only vomited once which was 3-4 days later after getting the second dose of the vaccine. Patient reported that it was on 04Mar2021, which was two days later that she vomited. Patient said that she had been taking a lot of vitamins, she studied vitamins to take once the pandemic started and had been taking a lot more. Patient reported that the Zinc she had taken is 50mg, and it once a day by mouth. Patient clarified that the Zinc wasuj made by store, she bought two bottles and they both have the same numbers. Patient said that she found out she should did not take the Zinc on an empty stomach. Patient had already went to get her second dose they could not find her in the system. Patient said after the first dose they gave her, her birth date was incorrect and she needs to correct that, they did not correct it because it was wrong on her second dose. Patient said that she did have a comment in regards to her dose of the second vaccine. Patient reported that she did vomit but that could had been because she drank her Zinc vitamin without eating breakfast, so on an empty stomach. Patient said this happened shortly after she got the vaccine, but she did not think it could be attributed to COVID vaccine, but maybe a lot of people are thinking from COVID vaccine or Zinc. Patient looked it up on Google, and regarding Zinc it said that the product needed to be drank with food, a full stomach, not on an empty. Patient never had vomited, it was very seldom, and it was listed as one of symptoms of COVID, clarified to COVID vaccine, hopefully not that. Patient clarified that she would like to know if others had commented that vomiting after second dose of the COVID vaccine, though that could have been the Zinc that she took on an empty stomach. Patient said that her vaccine card information and they made many mistakes. Treatment was not received as a result of AE. The clinical outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report based on the information received from contactable consumer/patient (report number: UNT-2021-004365). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not provided), at the age of 54, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient took oral Orenitram (treprostinil diolamin) from Sep 2020 to an unspecified date, at unspecified dose and ongoing; oral Orenitram (treprostinil diolamin) 0.125mg, extended release, from an unspecified date to an unspecified date, at unspecified dose and ongoing and oral Orenitram (treprostinil diolamin) 3.625mg, 3x/day for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. On an unknown date, patient was very sick. She reported she received the COVID-19 vaccine and became very sick for 8 days afterward. PO Orenitram dose was not changed due to the event of illness. The reporter did not provide causality for the event of illness. At the time of report, the outcome of illness recovered. No follow-up attempts needed. Information about batch/lot number cannot be obtained.