chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Musculoskeletal discomfort, Pain, Pain in extremity, Skin disorder
Clinical narrative: it seems like she has arthritis; sore arm,cannot move her thumbs; her right heel and right knee beginning to hurt,elbowpain; it is getting worse and starting to travel to her wrists; her neck started making a kind of cracking noise; her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red;; after the 5th of April, she has felt like a 90 year old person; massive body pains; she can't drive because she can't bend her thumbs; her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red;; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150, Expiry Date: Unknown) via an unspecified route of administration in left arm on 05Apr2021 at 12:16 (at the age of 48 years-old) as dose 2, single for COVID-19 immunization. Patient medical history included alpha tryptasemia (a hereditary condition called alpha tryptasemia where her tryptase 22 is triplication of the gene). The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number Batch/Lot Number EN6206) via an unspecified route of administration on 15Mar2021 as single for COVID-19 immunization. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. The patient experienced it seems like she has arthritis, sore arm, her right heel and right knee beginning to hurt, some pain left elbow, nodules (bumps) on left elbow, cannot move her thumbs, it is getting worse and starting to travel to her wrists,  her neck started making a kind of cracking noise (remained the same since it began and it has been probably 4 weeks since that started), her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red, after the 5th of April, she has felt like a 90 year old person , massive body pains , she can't drive because she can't bend her thumbs on an unspecified date, her left elbow that she has two little pea sized bumps and when she presses them it hurts and they are red on 19Apr2021. She experienced an adverse reaction and is unable to get medical care because she can't get an appointment and is just calling to see if there is something to do that Pfizer can advise her. she reported that she cannot drive because she can't bend her thumbs. The report is not related to as study or programme. No investigation assessment was done. The outcome of events were unknown.  Follow-up attempts are needed.further information is expected..
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mass, Pain
Clinical narrative: Extreme fatigue; body ache; dull headache; shakes; chills; swelling; itchiness at injection site; Lump; This is a spontaneous report from a contactable consumer or other non hcp.    A 61-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 09:15 (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunisation. Medical history included bronchitis chronic, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ; salbutamol (ALBUTEROL HFA). The patient previously took bnt162b2 for covid-19 immunisation, percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity.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. the patient received within 2 weeks of vaccination Triamterene hctz. Albuterol, steroid.It was reported that, on 26Apr2021 the patient experienced Extreme fatigue, body ache, dull headache, shakes, chills, lump, swelling, itchiness at injection site. No treatment was received and patient was not hospitalized. On an unspecified date in 2021, the patient was recovered from the events   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tremor, Vaccination site pruritus
Clinical narrative: Extreme fatigue; body ache; dull headache; shakes; chills; swelling; itchiness at injection site; Lump; This is a spontaneous report from a contactable consumer or other non hcp.    A 61-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 09:15 (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunisation. Medical history included bronchitis chronic, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ; salbutamol (ALBUTEROL HFA). The patient previously took bnt162b2 for covid-19 immunisation, percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity.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. the patient received within 2 weeks of vaccination Triamterene hctz. Albuterol, steroid.It was reported that, on 26Apr2021 the patient experienced Extreme fatigue, body ache, dull headache, shakes, chills, lump, swelling, itchiness at injection site. No treatment was received and patient was not hospitalized. On an unspecified date in 2021, the patient was recovered from the events   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Rash, Urticaria
Clinical narrative: flushing with redness; flushing with redness; small hives on my face and neck; still have a small visible rash on my forehead; This is a spontaneous report from a contactable other hcp. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Right on 08May2021 01:30 (at the age of: 51-years-old) as dose 1, single for covid-19 immunisation. Pregnant at Time of Vaccination was reported as No. Medical history included asthma, polycystic ovaries, metabolic syndrome and hypertension from an unknown date and unknown if ongoing. The patient is allergic to Latex and Hydrochlorothiazide. Concomitant medication(s) included ergocalciferol (VIT D); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) and trametes versicolor (TURKEY TAIL MUSHROOM) taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was reported that she had Mod-Sev Asthma, so brought her EpiPen with her just in case. she did not have any breathing problems. However, at approx 30 mins post inj on 08May2021 12:00 PM she experienced flushing with redness and small hives on her face and neck. This resolved in about 10 mins, but recurred intermittently for a few hours, though each time it decreased in intensity and duration. she still have a small visible rash on her forehead. The patient did not receive any other treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered/resolved with Sequel on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: has continued to experience a gnawing joint pain in her arm; Fever; Chills; Body aches; Vomiting; Diarrhea; Headache; Fatigue; Soreness in left arm where she received the vaccine; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0162), via an unspecified route of administration on 23Apr2021 (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient stated that she has normal to have lingering sensation from shoulder to elbow and the worst is down the arms. The patient medical history was not reported. Concomitant medication(s) included naproxen sodium (ALEVE) taken for headache, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533) 1st dose on 05Apr2021 (at the age of 48-year-old), administration site (left arm) for COVID-19 immunisation and experienced Headache and soreness in the left arm where she received the vaccine. After the 12 hours second dose the patient experienced on an unspecified date the patient experienced continued to experience a gnawing joint pain in her arm, on 23Apr2021 fever, chills, body aches, vomiting, diarrhea, joint pain, fatigue, Headache, soreness in left arm where she received the vaccine. The caller was calling about the Pfizer covid-19 shot. The caller got her second dose on 23Apr2021, and she had every side effect except shortness of breath. The caller has a lingering reaction, she has the joint pain in her arms and hands its gnawing pain from her shoulders to her finger tie sit tingling the same feeling as the body aches but it never went away in her arms and her fingers. The outcome of gnawing joint pain in her arm was unknown and rest of events recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021561630 similar report from same reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: has continued to experience a gnawing joint pain in her arm; Fever; Chills; Body aches; Vomiting; Diarrhea; Headache; Fatigue; Soreness in left arm where she received the vaccine; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0162), via an unspecified route of administration on 23Apr2021 (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient stated that she has normal to have lingering sensation from shoulder to elbow and the worst is down the arms. The patient medical history was not reported. Concomitant medication(s) included naproxen sodium (ALEVE) taken for headache, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533) 1st dose on 05Apr2021 (at the age of 48-year-old), administration site (left arm) for COVID-19 immunisation and experienced Headache and soreness in the left arm where she received the vaccine. After the 12 hours second dose the patient experienced on an unspecified date the patient experienced continued to experience a gnawing joint pain in her arm, on 23Apr2021 fever, chills, body aches, vomiting, diarrhea, joint pain, fatigue, Headache, soreness in left arm where she received the vaccine. The caller was calling about the Pfizer covid-19 shot. The caller got her second dose on 23Apr2021, and she had every side effect except shortness of breath. The caller has a lingering reaction, she has the joint pain in her arms and hands its gnawing pain from her shoulders to her finger tie sit tingling the same feeling as the body aches but it never went away in her arms and her fingers. The outcome of gnawing joint pain in her arm was unknown and rest of events recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021561630 similar report from same reporter
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Papule, Pruritus, Skin disorder
Clinical narrative: Little bumps on my fingers, palms left shoulder and a patch of them on my left upper back. They itched but not too severe.; Little bumps on my fingers, palms left shoulder and a patch of them on my left upper back. They itched but not too severe.; Little bumps on my fingers, palms left shoulder and a patch of them on my left upper back. They itched but not too severe.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0176, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (at the age of 30 year old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included psoriasis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07May2021 at 08:30 the patient experienced little bumps on fingers, palms left shoulder and a patch of them on left upper back. They itched but not too severe. The outcome for the events was recovered on an unspecified date in May2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Malaise, Nasopharyngitis, Productive cough
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on May 11, 2021, single dose, for COVID-19 immunization. Medical history not reported. Concomitant medications reported as none. On an unspecified date in 2021, patient experienced cold-like symptoms, phlegm, coughing, felt sick and had back pain from her persistent coughing. Patient confirmed receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine May 11, 2021 and felt sick on the following Friday. She explained she's experienced cold-like symptoms, phlegm and coughing. She added she has back pain from her persistent coughing. She asked what medication can she take to relive her symptoms. And if Tylenol or cough medicines could be used to treat her symptoms post-vaccination. Verbatim and Event Description: Patient took 1st dose of COVID-19 vaccine May 11, 2021 and then that Friday she felt like she had a cold with a cough and phlegm. She wonders what she can take that will not decrease the efficacy of the vaccine. The outcome of all the events: unknown. No follow-up attempts completed. Information about batch/lot number cannot be obtained, despite being requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching all over for the past month.; Hives and itching all over for the past month.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 11Apr2021 at 15:45 (at the age of 54-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included montelukast (MANUFACTURER UNKNOWN) and latanoprost (MANUFACTURER UNKNOWN) taken for an unspecified indication received within 2 weeks of vaccination. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnancy at time of vaccination. Patient had no known allergies. On 26Apr2021, the patient reported hives and itching all over for the past month. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The clinical outcome not recovered for the events.  Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer (parent). A 12-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0172), at the age of 12, via an unspecified route of administration, in right arm, on May 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The parent called on behalf of her son who is 12 years old. The patient received his first dose. The consumer wanted to know if her son experienced a reaction to the vaccine, should he get second dose. He has not eaten all day. He did not shower before the hives. He did not do anything different or do anything different. The patient did not take any other product. The parent spoke with her son's primary care provider. The doctor does not think this reaction was from the vaccine but she believes it could be related to the vaccine. On May 14, 2021, patient had a sore arm. On May 17, 2021, he had itching, felt something in his throat and hives. Treatment was received for the event hives. The patient did not go for any investigation assessment. The parent gave the antihistamine; and the hives are going down slowly. Parent asked was there anything else to alleviate her son's discomfort and itchiness. The outcome of urticaria, oropharyngeal discomfort: recovering; while other events: unknown. Follow-up (Jul 5, 2021): Follow-up attempts completed. No further information expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother/reported for her son). A 14-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0169, expiration date: unknown), at the vaccination age of 14, via an unspecified route of administration, in left arm, on May 14, 2021, at 11:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Since Saturday, May 15, 2021, at 00:00 am, patient could not taste anything. No treatment received for the adverse event. The device date reported as May 17, 2021. The outcome of the event: not resolved. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# ER8736), via an unspecified route of administration, on Apr 29, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient had bronchitis on May 14, 2021. Reportedly, patient was supposed to get 2nd dose tomorrow, May 18, 2021, and wanted to know if she can get the vaccine while taking prednisone or if she needs to wait until she finishes before getting the vaccine. Therapeutic measures taken as a result of event included prednisone. She started taking it on Friday, May 14, 2021. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Overdose
Clinical narrative: she received more than the standard dose; tired; chest pain when she took a breath; This is a spontaneous report from a contactable consumer or other non hcp. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), via an unspecified route of administration on 15May2021 (Lot Number: EW0176, at the age of: 28-year-old) as dose 2, single for COVID-19 immunisation. There were no medical history and concomitant medication. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), via unspecified route of administration on 22Apr2021 (Lot Number: ER8731, at the age of: 28-year-old) as dose 1, single for COVID-19 immunisation. It was reported that she first got the shot and then a little bit later they went to a late lunch, and she was sitting there and said her chest was hurting and she was starting to get worried, it was the middle of her chest. When she breathed in, she said it will be okay. She told her that also happened to the caller's father-in-law, he had some chest pain after his shot and later on he was okay after that she was tired. It was not any bad reaction. She was a healthy person, she told her daughter to get up and walk around maybe its gas but that didn't help, she was having some chest pain, but it did go away and so far she has been okay. She just told her daughter grandpa had it too and it went away. She was trying to understand, she was not a nurse, so she did not understand stuff like that. The pharmacy did not say how much her daughter was given, she thought it was minimal, not like a double dose anything but it was more than what would be the standard dosage, she was not sure how much it was, and she did not want to say because she could not remember. She thinks the pharmacy would have had to document it too, that she got more. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Diarrhoea, Lip swelling, Muscle spasms, Muscle twitching
Clinical narrative: diarrhea; lip swelling; slight muscle twitching in the left leg; Caller reported bottom lip rash and puffiness.; Caller reported bottom lip rash and puffiness.; had a cramps in both legs and slight muscle twitch in the left leg; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included apple cider vinegar, calcium, iron. The patient previously took allegra (180 mg, Lot: 1145968, Expiration: Aug2014). The patient reported bottom lip rash and puffiness, had a cramps in both legs and slight muscle twitch in the left leg on 15May2021, diarrhoea, lip swelling, slight muscle twitching in the left leg on an unspecified date. Treatment received for events. Clinical information includes; Two days prior, 15May2021 the caller noticed her bottom lip was getting rashy and puffy.  The caller stated around the edges of lip has a little rash. Noticed calf cramps in both legs: Also, during the same time two days ago on 15May2021, the caller noticed calf cramps in both legs.  The caller thought that was maybe a lack of Magnesium and the caller took Magnesium and Calcium tablets. Had slight muscle twitching in the left leg: The caller had slight muscle twitching in the left leg. The caller reports this was a slight muscle twitch on and off, not all day, just a little twitch. Drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine: The caller drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine.  The caller stats the diarrhea only lasted for one day. The outcome of event had a cramps in both legs and slight muscle twitch in the left leg was recovered on 16May2021, slight muscle twitching in the left leg was not recovered, diarrhoea, lip swelling, bottom lip rash and puffiness was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema
Clinical narrative: diarrhea; lip swelling; slight muscle twitching in the left leg; Caller reported bottom lip rash and puffiness.; Caller reported bottom lip rash and puffiness.; had a cramps in both legs and slight muscle twitch in the left leg; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included apple cider vinegar, calcium, iron. The patient previously took allegra (180 mg, Lot: 1145968, Expiration: Aug2014). The patient reported bottom lip rash and puffiness, had a cramps in both legs and slight muscle twitch in the left leg on 15May2021, diarrhoea, lip swelling, slight muscle twitching in the left leg on an unspecified date. Treatment received for events. Clinical information includes; Two days prior, 15May2021 the caller noticed her bottom lip was getting rashy and puffy.  The caller stated around the edges of lip has a little rash. Noticed calf cramps in both legs: Also, during the same time two days ago on 15May2021, the caller noticed calf cramps in both legs.  The caller thought that was maybe a lack of Magnesium and the caller took Magnesium and Calcium tablets. Had slight muscle twitching in the left leg: The caller had slight muscle twitching in the left leg. The caller reports this was a slight muscle twitch on and off, not all day, just a little twitch. Drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine: The caller drank some really strong tea a while back during the first week of the month and had diarrhea, not sure if related to the first dose Pfizer Covid Vaccine.  The caller stats the diarrhea only lasted for one day. The outcome of event had a cramps in both legs and slight muscle twitch in the left leg was recovered on 16May2021, slight muscle twitching in the left leg was not recovered, diarrhoea, lip swelling, bottom lip rash and puffiness was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site bruising
Clinical narrative: "little welts, like big zits" coming up on her arm where she received the injection and noticed bumps all over body; She is still bruised from it around the injection site.; noticed bumps all over body; This is a spontaneous report from a contactable consumer (patient).  A 51-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EV-7176 and expiry date was not reported), via an unspecified route of administration into left arm on 11May2021 as Dose 1, single (Age at vaccination: 51-year-old) for COVID-19 immunization. Medical history included body aching and a panic attack and went to the hospital, but then remembered that was before the vaccine. Family history was not reported. The patient did not receive any concomitant medications. On 12May2021, the patient had "little welts, like big zits" coming up on her arm where she received the injection. She noticed the next day that she had bumps on her body. She is still getting more bumps which got worsened. They are like great big zits. The patient had bruise at injection site. The patient still had bruising at injection site. The patient did not had any lab test done. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypersensitivity, Lip swelling, Rash
Clinical narrative: if she could take a different vaccine (from another manufacturer) for her second dose since she had an allergic reaction to the first dose of the Pfizer vaccine; her bottom lip started swelling; rash; she had an allergic reaction to the first dose of the Pfizer vaccine; This is a spontaneous report from contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13May2021 at 16:00 (age at vaccination: 53 years), as dose 1, single dose for COVID-19 immunization. The patient taking Covid Vaccine as she wanted to be protected because she works at a store. The patient's medical history and concomitant medications were not reported. The patient did not have family medical history relevant to adverse events. The patient asked if she could take a different vaccine (from another manufacturer) for her second dose since she had an allergic reaction to the first dose of the Pfizer vaccine On an unspecified date in May2021. The patient reported (with assistance of her daughter as interpreter) that she received her first vaccine dose and afterwards her bottom lip started swelling and she started having a rash on 14May2021. She was told by her HCP that she should not get the second dose for fear her throat would close up. She now asked if it was possible or ok to get the second dose from a different manufacturer to complete the series. The patient received Methylprednisolone 4mg 6 Day Treatment and Fexofenadine 180mg as treatment. The adverse events did not require a visit to emergency room; however, it was resulted in physician office. The patient asked, so since her doctor said she couldn't take the second dose of the Pfizer vaccine, could she take a different vaccine than Pfizer for the second shot. Outcome of the event her bottom lip started swelling and rash was recovered on 15May2021 and for all other events, it was unknown.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Weight decreased
Clinical narrative: Continuous loss of weight; extended fatigue; digestive issues; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731), dose 2 via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 2, SINGLE (at the age of 62-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 as DOSE 1, SINGLE (at the age of 62-years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Apr2021, the patient experienced continuous loss of weight, extended fatigue, and digestive issues. The patient received no treatment for the adverse event. The event was considered non-serious and did not result in death/life threatening/ caused/prolonged hospitalization/disabling/incapacitating/congenital anomaly/birth defect. The Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; Swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination.; This is a spontaneous report from a contactable consumer. This 33-year-old male consumer (patient) reported that who patient received bnt162b2 (BNT162B2 solution for injection, dose 1 via an unspecified route of administration at arm left on 15Apr2021 15:00 (at the age of 33-years-old) (Lot Number: EW0161) as single 1 dose, for covid-19 immunisation. Medical history included n/a from an unknown date and unknown if ongoing. Concomitant medication(s) included fish oil (FISH OIL). l-arginine acetate (L-ARGININE ACETATE). ascorbic acid, tocopherol (VITAMIN C + E) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had no allergies. Other medications the patient received within 2 weeks of vaccination: Multivitamin, fish oil, l-arginine, vitamin c/e. On 15Apr2021 15:30 the patient experienced swollen lymph node, arm soreness, difficulty breathing, and general malaise for 4-5 hours after the vaccination. No treatment was taken for the adverse events. Outcome of the events was recovered in 2021.    Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash break out and itching; rash break out and itching; This is a spontaneous report received from a contactable consumer (patient). A 92-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via unspecified route of administration in Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This was following the rash break out and itching he had experienced after getting the 1st dose of the vaccine. The patient also mentioned that his dermatologist had advised him not to take the 2nd dose as side effects after the 2nd dose may be more intense compared to that of the 1st dose. He would also like to confirm this information. The caller was calling about the covid vaccine. The caller had the first shot in January at his retirement home. 3 to 5 days after the vaccine the caller broke out into a rash. The caller then had itching all around his waist and back. When the caller went to the dermatologist, the doctor told the caller not to get the second dose. How safe was it with the one shot? Can the caller give it to his grand kids and his grandkids give it to him with just the one shot? Would it be safe to get the second shot? Is there any type of pre-testing or half shot that the caller can get. I have a question I had my 1st shot back in January and 5 days later I broke out into rash and had itching which lasted about 6 months and I am over it, but I am wondering was there a way of seeing, whether I could have the 2nd shot. The outcome of the events was unknown.  Follow-up attempts not completed. Information about lot/batch number cannot be obtained. No further information was expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Small fever, sore throat, and general malaise; Small fever, sore throat, and general malaise; Small fever, sore throat, and general malaise; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in left arm on 05May2021 17:00 (at the age of 33-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug Store. The patient medical history was not reported. The patient had no allergies. Concomitant medications (within 2 weeks of vaccination) included fish oil, arginine hydrochloride (L ARGININE [ARGININE HYDROCHLORIDE]) and vitamin c/e. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 17:30 the patient experienced small fever, sore throat, and general malaise. Small fever, sore throat, and general malaise lasted for 18-24 hours after vaccination. The outcome of the events was recovered on an unspecified date in May2021.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Vaccination site irritation, Vaccination site mass
Clinical narrative: arm is sore and irritated; arm is sore and irritated; lump at the injection site on his right arm; Soreness that radiates from his right shoulder to his neck; Soreness that radiates from his right shoulder to his neck; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) (age at the time of vaccination 40 years) via unspecified route of administration, administered in arm right in 12May2021 around 17:30-18:00 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was none. Caller reports that a magnet and or a quarter sticks to their body at their vaccine injection site on 16May2021. He reports that this was something that multiple people are experiencing as there are reports on social media about this. Caller asking what was in the vaccine that makes metal or magnets stick to them. Caller also reports having a lump at the injection site on his right arm as well as soreness that radiates from his right shoulder to his neck on 12May2021. Caller states the first shot was a week ago, and his arm was sore and irritated on an unspecified date. Caller states that he had seen things posted on social media. Caller states he wonders why quarters and magnets will stick the injection site. Stated he knows that was not normal. Stated they say they used needles that have been magnetized, but he has had a lot of shots in his life and this was not normal. Caller states yes, this was a safety concern, it was not normal. The patient did not receive any treatment for the events and stated he takes his normal medication but nothing for the events. AE(s) does not require a visit to emergency room/physician office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. The outcome of the events lump at the injection site on his right arm, soreness that radiates from his right shoulder to his neck was not recovered and unknown for other events.   Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: Allergic reaction; Itchy; Tingly tongue, gums, and lips; Tingly tongue, gums, and lips; Tingly tongue, gums, and lips; Swollen arm; Sore and upset all over; 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 (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. It was reported that Caller states that she already received her first dose of the Pfizer BioNtech COVID-19 vaccine. She states that she experienced itchy, tingly tongue, gums, and lips 20 minutes after receiving the first dose and it lasted for 2-3 days. She is asking if she can receive the first dose after having an allergic reaction to the 2nd dose. Caller mentioned that she took some antihistamines and that it what was given to her but the side effects are still there and it did not stop it, and stayed that way for 2-3 days. She is asking if we have data on how many people has had this particular reaction before. She states that she had done some allergy testing before, years ago, but she had no problem with any other vaccine. She clarified the problem that was not completely normal as she started having itchy, tingly stuff with her tongue, gums, and lips. She was informed this was not a typical reaction. It started 20 minutes after the injection. She had to stay there a while and was given Benadryl. After the Benadryl it did not get any better, but it did not get any worse. She had this reaction go on for two days. This was not typical. The outcome of the events was unknown on an unspecified date. Therapeutic measures were taken as a result of allergic reaction (hypersensitivity), itchy (pruritus), tingly tongue, gums, and lips (paraesthesia oral), tingly tongue, gums, and lips (paraesthesia oral), tingly tongue, gums, and lips (paraesthesia oral) , swollen arm (peripheral swelling), sore and upset all over (pain). Follow-up attempts are needed; information about lot/batch number has been requested. Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Reading disorder
Clinical narrative: an allover body rash; The caller states it is hard to read; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on 28Apr2021 at 12:00 p.m. (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. Prior and since vaccination patient has not been tested for COVID-19. No, other vaccine in four weeks. The patient medical history and concomitant medications were not reported. Patient didn't had any known allergies. On 29Apr2021 at 12:00 a.m. the patient experienced an all over body rash and on unspecified date of 2021 the caller states it was hard to read. Therapeutic measures were taken as a result of an all over body rash. The caller was a consumer reporting patient has questions and was hoping Pfizer can help. After the caller received patient first dose Pfizer Covid 19 Vaccine, the caller had an all over body rash. The patient has been to doctors visits. patient was now scared to received the second dose Pfizer Covid 19 Vaccine and is not sure what to do. Patient received the treatment for events. On 19Jul2021, this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. The outcome of events is not recovered.  Follow-up attempts completed. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site erythema, Vaccination site mass
Clinical narrative: Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Swelling at injection site - white lump with redness swelling going down my arm; Fatigue; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old-non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration, administered in left arm on 14May2021 at 14:30 (at the age of 54-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included known Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration in left arm on 20Apr2021 at 13: 30, (at the age of 54-year-old) as DOSE 1, SINGLE, for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient experienced swelling at injection site, white lump with redness swelling going down my arm; fatigue, muscle aches and chills on 17May2021 at 06:00. The patient was not received any treatment for events. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.