chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Weird symptoms in my head, hurting like very bad; Terrible pain to my head; Nose is very stuffy; Tired; I don't feel good at all; Little bit of chest pain; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 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. Consumer stated, I am just calling because I had a vaccine two days ago, my first dose of the Pfizer BioNTech and I have been having like I don't know like weird symptoms in my head, hurting like very bad and my nose is very stuffy, just tired everyday like I don't feel good at all. I want to just make sure that it is okay if I get a second dose because I don't know if this is from the vaccine, but I got the vaccine at pharmacy and then ever since, I had the vaccine I have been having terrible pain to my head, like a little bit of chest pain, like dizziness, shortness of breath. So, it's kind of like concerns me a little bit. Consumer further stated, I have the numbers here. I just wanted to make sure like you know people that get reaction to the Covid Vaccine because I hear a lot of bad things like sometimes, I hear that it can cause like your heart to swell up (further clarification unknown). The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion
Clinical narrative: Weird symptoms in my head, hurting like very bad; Terrible pain to my head; Nose is very stuffy; Tired; I don't feel good at all; Little bit of chest pain; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 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. Consumer stated, I am just calling because I had a vaccine two days ago, my first dose of the Pfizer BioNTech and I have been having like I don't know like weird symptoms in my head, hurting like very bad and my nose is very stuffy, just tired everyday like I don't feel good at all. I want to just make sure that it is okay if I get a second dose because I don't know if this is from the vaccine, but I got the vaccine at pharmacy and then ever since, I had the vaccine I have been having terrible pain to my head, like a little bit of chest pain, like dizziness, shortness of breath. So, it's kind of like concerns me a little bit. Consumer further stated, I have the numbers here. I just wanted to make sure like you know people that get reaction to the Covid Vaccine because I hear a lot of bad things like sometimes, I hear that it can cause like your heart to swell up (further clarification unknown). The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Fatigue; joint in knuckles are aching; headache; sinus pressure; This is a spontaneous report from a contactable consumer(patient). The consumer reported that, a 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot Number: EW0176 and expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 26Apr2021(age at vaccination 54- years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history include Known allergies to Penicillin and concomitant medication were not reported. On 01 Jun2021, patient experienced Fatigue, joint in knuckles are aching, headache, sinus pressure. For the treatment he received Advil and Benadryl. Patient has not any other vaccine in four weeks and no other medications in two weeks. The patient stated that he had not been diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab/ Rapid Test): negative on 02Aug2021. Outcome of the events was not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Cough, Influenza, Productive cough
Clinical narrative: he has flu and cough; he has flu and cough; he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm; he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number was not reported) via an unspecified route of administration on 30Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced he has flu and cough, he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm. The clinical course reported as follows, caller received the first dose of the Pfizer Covid-19 vaccine on 30Jul2021, his appointment for the second dose is scheduled tomorrow 20Aug2021, but he will not assist because he has flu and cough, he does not want to go out because although he does not feel dizzy and has smell he has little cough and phlegm. He would like to know how to change his appointment for the second dose of the vaccine as he recovers. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Rash, Throat tightness
Clinical narrative: Second Moderna vaccine: I took Zyrtec and Zantac the day before and the day of the vaccine. I went to a hospital following the Publix pharmacist  and PCP recommendation. My PCP gave me a Rx for an epipen.  My throat tighten up suddenly right after I got the shot . I felt like it was very hard to swallow. No shortness of breath. No cough. No tachycardia or warmth sensation either. They took me to ER and they administered IV Solumedrol/Pepcid. I felt much better after 15 minutes but the sensation in my throat didn?t go away completely until 5 hrs later. Next morning I had a rash on my face and neck that went away with Benadryl 100 mg.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Off label use, Oropharyngeal pain, Product use issue
Clinical narrative: Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; headache / head started hurting; fever; cough; sore throat; This is a spontaneous report from contactable consumer. This consumer (patient's parent) reported for her son. A 10-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 13Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported by reporter that, her "son is 10 years of age almost eleven". He got vaccinated last Friday the 13th, then on Sunday night his "head started hurting and then on Monday morning he woke up with a headache and a sore throat and it lasted until last night." The patient additionally experienced fever and cough on an unspecified date in Aug2021. The reporter was concerned as her son will be 11 in January but she really, could not wait a year and half and she know it would not be a year and half but she was like panic. As per reporter, the reactions are all gone now. The reporter added the patient was all fine now and she was not worried. Added "we did have to take him to get a Covid test". Reporter was not willing to complete the report, so no further probing was done. Limited information available over the call. The outcome of the events was reported as resolved on an unspecified date in Aug2021.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; headache / head started hurting; fever; cough; sore throat; This is a spontaneous report from contactable consumer. This consumer (patient's parent) reported for her son. A 10-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 13Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported by reporter that, her "son is 10 years of age almost eleven". He got vaccinated last Friday the 13th, then on Sunday night his "head started hurting and then on Monday morning he woke up with a headache and a sore throat and it lasted until last night." The patient additionally experienced fever and cough on an unspecified date in Aug2021. The reporter was concerned as her son will be 11 in January but she really, could not wait a year and half and she know it would not be a year and half but she was like panic. As per reporter, the reactions are all gone now. The reporter added the patient was all fine now and she was not worried. Added "we did have to take him to get a Covid test". Reporter was not willing to complete the report, so no further probing was done. Limited information available over the call. The outcome of the events was reported as resolved on an unspecified date in Aug2021.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: Patient has been experiencing fasciculations of her face in front of her left ear area since 2-3 days after she received the vaccine.  No numbness, tingling or weakness is present.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Neck pain
Clinical narrative: Neck pain followed my eye orbital pain and swollen left eye soreness to the touch. Sore when I blink. Bone around eye socket is sore. Nothing injury related. No recent accidents.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Nausea
Clinical narrative: Extreme High Blood pressure Nausea
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Malaise, Paraesthesia
Clinical narrative: After receiving the vaccine, I was told to sit out in the waiting area right after. About a couple minutes pass I started to feel hot and sweaty. I went to look at my phone but only could see a blur. When I went to look up, I made eye contact with the person working behind the pharmacy counter. I told him I didn't feel well. By the time he came over, I saw black. By the time I came to, people were around me. I immediately threw up. I was still hot, and felt a tingling feeling all through out my body. I was told to sit there longer. I sat there for about 45 minutes before the feeling went away. Once that happened I left.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: After receiving the vaccine, I was told to sit out in the waiting area right after. About a couple minutes pass I started to feel hot and sweaty. I went to look at my phone but only could see a blur. When I went to look up, I made eye contact with the person working behind the pharmacy counter. I told him I didn't feel well. By the time he came over, I saw black. By the time I came to, people were around me. I immediately threw up. I was still hot, and felt a tingling feeling all through out my body. I was told to sit there longer. I sat there for about 45 minutes before the feeling went away. Once that happened I left.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: peanut butter tasted moldy, bell peppers and lettuce had the identical taste as well, jalapeño peppers also have the identical taste; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) on 10May2021 14:00 (Lot Number: Ew0153, at the age of 48-years-old) as dose 1, single and on 02Jun2021 14:00 (Lot Number: Ew0164, at the age of 48-years-old) as dose 2, single, both via an unspecified route of administration, administered in the left arm for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), spinal stenosis, and COVID-19 (reported as If covid prior vaccination: Yes). Concomitant medications included gabapentin; hydrocodone; piperazine citrate (CITRAZINE) all taken for an unspecified indication, start and stop date were not reported. Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced peanut butter tasted moldy, bell peppers and lettuce had the identical taste as well, jalapeño peppers also have the identical taste on an unspecified date in 2021. Three days after initial vaccine, on 13May2021, Patient noticed peanut butter tasted moldy. After a week, patient found bell peppers and lettuce had the identical taste as well. Four weeks after, on 12Jun2021, patient noticed jalapeño peppers also have the identical taste. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Tinnitus; chest palpitations; shoulder pain; diarrhea; total back pain; muscular pain; exhaustion; foggy brain; smell of smoke; This is a spontaneous report from a contactable consumer (patient herself). A 64-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: R8732), via an unspecified route of administration, administered in Arm Right on 01Apr2021 12:00 (age ta vaccination: 64 years) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 12:00 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included bees allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08May2021 01:00, the patient experienced tinnitus, chest palpitations, shoulder pain, diarrhea, total back pain, muscular pain, exhaustion, foggy brain and smell of smoke. The patient was treated with steroid for the adverse events. The adverse events resulted in physician's office visit. The patient was diagnosed with COVID-19 prior to vaccination but was not tested since vaccination. The outcome of all the events was not recovered. The device date was 24Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Smoke sensitivity, Tinnitus
Clinical narrative: Tinnitus; chest palpitations; shoulder pain; diarrhea; total back pain; muscular pain; exhaustion; foggy brain; smell of smoke; This is a spontaneous report from a contactable consumer (patient herself). A 64-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: R8732), via an unspecified route of administration, administered in Arm Right on 01Apr2021 12:00 (age ta vaccination: 64 years) as DOSE 2, SINGLE; dose 1 via an unspecified route of administration, administered in Arm Right on 11Mar2021 12:00 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included bees allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08May2021 01:00, the patient experienced tinnitus, chest palpitations, shoulder pain, diarrhea, total back pain, muscular pain, exhaustion, foggy brain and smell of smoke. The patient was treated with steroid for the adverse events. The adverse events resulted in physician's office visit. The patient was diagnosed with COVID-19 prior to vaccination but was not tested since vaccination. The outcome of all the events was not recovered. The device date was 24Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: a little tired; her arm is sore; received a dose of the Johnson and Johnson vaccine on 02Apr2021/received her first dose of the Pfizer covid 19 vaccine on 25Aug2021; received a dose of the Johnson and Johnson vaccine on 02Apr2021/received her first dose of the Pfizer covid 19 vaccine on 25Aug2021; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 68-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Caller reported that she received a dose of the Johnson and Johnson vaccine on 02Apr2021 (Dose: 1st (Johnson and Johnson Covid vaccine)). The patient received a dose of the johnson and johnson vaccine on 02apr2021/received her first dose of the pfizer covid 19 vaccine on 25aug2021 (off label use) and (interchange of vaccine products). Patient was a little tired and her arm was sore on an unspecified date in Aug2021. It was reported that, she was at withheld last night when she heard the announcement that the Pfizer covid 19 vaccine was available there. Caller went to ask questions about the vaccine on behalf of her unvaccinated niece and was informed by the pharmacist that the J&J vaccine was not effective against the delta variant and she should receive a dose of the Pfizer covid 19 vaccine. Caller also said that she did not have any side effects after her dose of the J&J vaccine. Caller asked if she should receive the second dose of the Pfizer vaccine. It was reported that daughter was upset that she got the other shot, states she and her daughter had gotten Johnson and Johnson vaccine with her. Informed caller that Pfizer was the manufacture of the vaccine; the distribution of the vaccine was determined at the state and local levels. Recommended if caller was concerned about the information she received from the local pharmacist, to pass her concern through the chain of command or through the state/local health departments as Pfizer was the manufacture of the vaccine; the distribution of the vaccine was determined at the state and local levels. After Pfizer Covid vaccine, patient wanted to know if she needs to be worried or not. The reporter wanted to know if there could be any interaction or anything between the two vaccines. Outcome of events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eyelid ptosis, Facial spasm, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Intense burning at injection site; Hemi facial spasm - Right side; ptosis; Intense burning at injection site/Hemi facial spasm-Right side, ptosis/Both are continuing to this date and have worsened; This is a spontaneous report from a contactable other health professional (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 12:30 ((at the age of 59 years)) as dose 1, single, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 12:30 (at the age of 59 years) as dose 2, single, both for covid-19 immunization. Medical history included hypothyroid, hashimotos disease, high cholesterol and headaches, all from an unknown date and unknown if ongoing. Patient had allergies to vantin [cefpodoxime proxetil] and tetanus. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gabapentin, metoprolol, atorvastatin, and thyroid (ARMOUR THYROID), all taken for an unspecified indication. On an unknown date in 2021, the patient experienced intense burning at injection site, hemi facial spasm-right side and ptosis. It was reported that, the events were continuing till date and had worsened. Since the vaccination, the patient had been tested for COVID-19 and underwent lab tests and procedures which included nasal swab test: negative, on an unknown date in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and patient received treatment with increased amount of gabapentin. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia universalis, Paraesthesia, Pruritus
Clinical narrative: alopecia universalis; itching and tingling of skin on my abdomen, arms, chest and legs; tingling of skin on my abdomen, arms, chest and legs; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: ep6955) via an intramuscular route of administration, administered on left arm on 19Mar2021 09:00 am (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6202) via an intramuscular route of administration on 26Feb2021 as dose 1, single for COVID-19 immunisation and experienced ongoing alopecia universalis, hair sloughed/slick bald head, alopecia areata which had been in remission for 5months. The patient's medical history includes alopecia arreata, auto immune disease and thyroid disease. Facility type of vaccine is Hospital. The patient's concomitant medications were not reported. Patient stated she has alopecia arreata which had been in remission for 5 months. She had a full head of hair growing very well. After the first injection, 7-10 days later her hair sloughed on 06Mar2021. It took only 2-3 days to fall out completely to a slick bald head. After the 2nd dose, she noticed hair loss of eyebrows, eyelashes, nose hair, and all body hair. Also, profound itching and tingling of skin on her abdomen, arms, chest and legs. Her diagnosis has been upgraded to alopecia universalis. Patient received therapeutic medications and steroid scalp injections. The outcome of events was not recovered.      No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Heart palpitations; tachycardia; This is a spontaneous report from a contactable consumer. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration, administered in Arm Left on 23Jan2021 13:30 as DOSE 1, SINGLE (at the age of 41-year-old) for covid-19 immunisation. Medical history included seasonal allergy, back pain, insomnia. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (HAILEY 24 FE); montelukast; doxepin; carisoprodol. The patient received second dose of bnt162b2 on 23Jan2021 (lot number- EL9266) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan2021, the patient experienced heart palpitations/tachycardia at rest/bedtime. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events. Patient received the treatment of Atenolol 25mg. The outcome of the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Intermenstrual bleeding
Clinical narrative: Sweaty; Horrible Headache; Entire body aches and pains; Specific Joint pain - finger joints and big toe joints; really bad soreness under her rib cage; spotting; Chills; Arm pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 46-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3184), via an unspecified route of administration on 29Aug2021 (Age at vaccination: 46-years-old) as second dose for covid-19 immunization. (Vaccination facility: Pharmacy) Vaccine was not administered at Facility. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for hypothyroidism from an unspecified start date and ongoing (started 10 years ago). Historical vaccine included first dose of BNT162B2 (Batch/lot number: FA7485) on 09Aug2021 (Age at vaccination: 46-years-old) for Covid-19 Immunization. Did not receive additional vaccine on Same Date of the Pfizer Suspect. Prior vaccine within 4 weeks was reported as none. On 30Aug2021 patient experienced chills, horrible headache, entire body aches and pains, specific joint pain finger joints and big toe joints, really bad soreness under her rib cage, spotting on 31Aug2021 patient experienced sweaty. arm pain on 29Aug2021. It was reported she is supposed to report any adverse effects Pfizer. She needs to for her and her daughter. She is a Pfizer employee. She thinks phone is infected with a virus. She called and they said that someone was listening to them. She got her second dose and she didn't realize she was supposed to call for her first dose. She thought they were the regulars side effects. She had it on Sunday. 4:30 on Sunday she got the vaccine. She was fine until 12:30 and then she started getting chills. Chills: She thinks they are gone. She is still sweaty but she can get warm now. Treatment a blanket. Sweaty: In the middle of the night 31Aug2021, she was sleeping in the am. Not received treatment. Adverse events not resulted in Emergency Room and Physician Office visit. Patient received treatment for Arm pain, Really bad soreness under her rib cage, Specific Joint pain finger joints and big toe joints, Entire body aches and pains with Tylenol and Motrin and for event Horrible Headache treatment was Tylenol. For events Sweaty and spotting patient did not receive any treatment. The outcome for the event Chills, really bad soreness under her rib cage was resolved on 31Aug2021 For Sweaty, Arm pain, spotting outcome was not resolved And for Entire body aches and pains, Specific Joint pain finger joints and big toe joints outcome was reported as resolving and for remaining events outcome was reported as unknown at the time of this report.  ~ Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain, Pain in extremity
Clinical narrative: Sweaty; Horrible Headache; Entire body aches and pains; Specific Joint pain - finger joints and big toe joints; really bad soreness under her rib cage; spotting; Chills; Arm pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 46-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3184), via an unspecified route of administration on 29Aug2021 (Age at vaccination: 46-years-old) as second dose for covid-19 immunization. (Vaccination facility: Pharmacy) Vaccine was not administered at Facility. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for hypothyroidism from an unspecified start date and ongoing (started 10 years ago). Historical vaccine included first dose of BNT162B2 (Batch/lot number: FA7485) on 09Aug2021 (Age at vaccination: 46-years-old) for Covid-19 Immunization. Did not receive additional vaccine on Same Date of the Pfizer Suspect. Prior vaccine within 4 weeks was reported as none. On 30Aug2021 patient experienced chills, horrible headache, entire body aches and pains, specific joint pain finger joints and big toe joints, really bad soreness under her rib cage, spotting on 31Aug2021 patient experienced sweaty. arm pain on 29Aug2021. It was reported she is supposed to report any adverse effects Pfizer. She needs to for her and her daughter. She is a Pfizer employee. She thinks phone is infected with a virus. She called and they said that someone was listening to them. She got her second dose and she didn't realize she was supposed to call for her first dose. She thought they were the regulars side effects. She had it on Sunday. 4:30 on Sunday she got the vaccine. She was fine until 12:30 and then she started getting chills. Chills: She thinks they are gone. She is still sweaty but she can get warm now. Treatment a blanket. Sweaty: In the middle of the night 31Aug2021, she was sleeping in the am. Not received treatment. Adverse events not resulted in Emergency Room and Physician Office visit. Patient received treatment for Arm pain, Really bad soreness under her rib cage, Specific Joint pain finger joints and big toe joints, Entire body aches and pains with Tylenol and Motrin and for event Horrible Headache treatment was Tylenol. For events Sweaty and spotting patient did not receive any treatment. The outcome for the event Chills, really bad soreness under her rib cage was resolved on 31Aug2021 For Sweaty, Arm pain, spotting outcome was not resolved And for Entire body aches and pains, Specific Joint pain finger joints and big toe joints outcome was reported as resolving and for remaining events outcome was reported as unknown at the time of this report.  ~ Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Dizziness, Dyspnoea
Clinical narrative: breathing heavy; lightheaded and dizzy; my BP to 188/110; Within 2 minutes of vaccine my heart was pounding out of my chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number FC3180, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 31Aug2021 10:15 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. Concomitant medication(s) included ibuprofen, calcium, vitamin d nos, fish oil, curcuma longa (TURMERIC), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine taken in four weeks. The patient previously took duloxetine (CYMBALTA) and meloxicam (MOBIC) combined and experienced allergy. On 31Aug2021, within 2 minutes of vaccine, the patient experienced her heart was pounding out of her chest. She told the nurse who monitored her. By heart rate went to 135 and her BP to 188/110. She was lightheaded, dizzy and was breathing heavy. The Dr came and they put her in a wheelchair and took her to ER. They did an ekg and was normal but her HR spikes to 118 so they did blood work and released her a few hours later. Event onset time was reported as 10:45 AM. The patient did not receive any treatment for the events. The patient had not tested covid post vaccination. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: breathing heavy; lightheaded and dizzy; my BP to 188/110; Within 2 minutes of vaccine my heart was pounding out of my chest; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number FC3180, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 31Aug2021 10:15 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. Concomitant medication(s) included ibuprofen, calcium, vitamin d nos, fish oil, curcuma longa (TURMERIC), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine taken in four weeks. The patient previously took duloxetine (CYMBALTA) and meloxicam (MOBIC) combined and experienced allergy. On 31Aug2021, within 2 minutes of vaccine, the patient experienced her heart was pounding out of her chest. She told the nurse who monitored her. By heart rate went to 135 and her BP to 188/110. She was lightheaded, dizzy and was breathing heavy. The Dr came and they put her in a wheelchair and took her to ER. They did an ekg and was normal but her HR spikes to 118 so they did blood work and released her a few hours later. Event onset time was reported as 10:45 AM. The patient did not receive any treatment for the events. The patient had not tested covid post vaccination. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction long term unfortunately with sac reduction; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm on 11Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient had unspecified medical history and unspecified concomitant drugs. Patient did not receive other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient had no known allergies. The patient experienced erectile dysfunction long term (erectile dysfunction: disability, medically significant; scrotal disorder: disability) on 14Jun2021 with outcome of not recovered. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Feeling abnormal, Headache, Immune system disorder
Clinical narrative: very spotted and almost look like blood clotting under the skin; Headache; Bruising from her waist all the way down to her ankles; She has a low, lower immune system.; She actually lost a few pounds just a couple weeks after; She started feeling tired; Two days later the bruising started swelling up; She wasn't feeling good.; This is a spontaneous report received from a contactable consumer (parent).  A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) age at vaccination of 16-years-old, as single dose, for covid-19 immunisation.  Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, about four days later vaccination, the patient had like bruising from her waist all the way down to her ankles. It was unknow if it was clotting or if it was bruising but they were all over her legs. So, patient went to the hospital because mother didn't know it looks really odd. It was very spotted and almost look like blood clotting under the skin, not like typical bruising. She has a low, lower immune system. Patient weight was about 100 pounds but she actually lost a few pounds just a couple weeks after because she wasn't feeling good since the first shot. So, she is down to like 96 right now and ever since that we have this. The patient started feeling tired and headache and everything probably within the day and then about two days later the bruising started swelling up and then three and four days and five days just the bruises kept coming. So, they were it was like a couple of new bruises on her legs everyday and then about the fifth day the bruising stop and kind of just kind of disappear it from there. No treatments were administered for the events. Outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Immunology test, Swelling, Thrombosis, Weight, Weight decreased
Clinical narrative: very spotted and almost look like blood clotting under the skin; Headache; Bruising from her waist all the way down to her ankles; She has a low, lower immune system.; She actually lost a few pounds just a couple weeks after; She started feeling tired; Two days later the bruising started swelling up; She wasn't feeling good.; This is a spontaneous report received from a contactable consumer (parent).  A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) age at vaccination of 16-years-old, as single dose, for covid-19 immunisation.  Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, about four days later vaccination, the patient had like bruising from her waist all the way down to her ankles. It was unknow if it was clotting or if it was bruising but they were all over her legs. So, patient went to the hospital because mother didn't know it looks really odd. It was very spotted and almost look like blood clotting under the skin, not like typical bruising. She has a low, lower immune system. Patient weight was about 100 pounds but she actually lost a few pounds just a couple weeks after because she wasn't feeling good since the first shot. So, she is down to like 96 right now and ever since that we have this. The patient started feeling tired and headache and everything probably within the day and then about two days later the bruising started swelling up and then three and four days and five days just the bruises kept coming. So, they were it was like a couple of new bruises on her legs everyday and then about the fifth day the bruising stop and kind of just kind of disappear it from there. No treatments were administered for the events. Outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sales representative.  A patient of unspecified age and gender received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient tested positive for COVID-19 on an unspecified date.  The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The patient outcome of the events was unknown.   The event positive for COVID-19 occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Measles, Pruritus, Rash
Clinical narrative: Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration, administered in arm right on 13Jun2021 15:00 (Lot Number: EWO185) at the age of 54 years old as single dose for covid-19 immunisation. Other medical history: No. The patient previously took alatrofloxacin mesylate (TROVAN) and experienced allergy, and previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 23May2021 15:00 (Lot Number: EWO185) at the age of 54 years old, for covid-19 immunisation. There was no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. And the patient had other medications in two weeks. On 14Jun2021 10:00, the patient experienced torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so. No treatment was received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; tightness in chest; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:00 (Lot Number: EN6207, expiration date unknown) at age of 47 years old as a single dose, 2nd dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: EP6955, expiration date unknown) as at age of 47 years old a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. There were no medical history or concomitant medications. The patient tested positive for covid and tightness in chest, both on 07Sep2021. The patient underwent lab tests and procedures which included rapid COVID-19 test: positive (Nasal Swab) on 07Sep2021. The outcome of 'tested positive for covid and tightness in chest' was not recovered. Clinical course: Tested positive for COVID on 07Sep2021. Experiencing headache, tightness in chest, stuffy nose. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no covid prior vaccination. No treatment received for the events ('tested positive for covid and tightness in chest' ). There were no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: felt like she was going to faint/collapse; felt hot; sweating really bad; This is a spontaneous report from a contactable consumer (patient-dental assistant).  A 57-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FE3592) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on unknown date (lot# 3180 -there are no letters before the numbers) for COVID-19 immunization and had no reaction. Then, the 2nd dose on unknown date. Within 2 minutes after receiving the second dose, she had a bad feeling go through her body as she felt hot, sweating really bad, and felt like she was going to faint/ collapse. She sat there 45 minutes to ride it out and it eased up in a few minutes.  She didn't want to drive until she knew she was good. She was wondering if Pfizer recommends, she go forward with the booster in 8 months. Outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.