chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost their smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "lost their smell".  Additional information: It was reported that, both kids of reporter got their vaccination the 5 to 11:00 and they lost their smell and reporter didn't know if it was aware that was probably a side effect of it and didn't know if it is needed to know about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883348 for Same reporter / drug / event, different patients.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Palpitations, Pyrexia, Vomiting
Clinical narrative: chills; My son was given the ohizer booster at 9:30 am at 2 am in the morning my son was screaming his head hurts; heart racing/Palpitations; started vomiting profusely; He had a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Phizer, administration date: 30Dec2021, when the patient was 16 years old; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, No adverse event), when the patient was 16 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, No adverse event), when the patient was 16 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "My son was given the ohizer booster at 9:30 am at 2 am in the morning my son was screaming his head hurts"; PALPITATIONS (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "heart racing/Palpitations"; VOMITING (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "started vomiting profusely"; PYREXIA (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "He had a fever". Therapeutic measures were not taken as a result of chills, headache, palpitations, vomiting, pyrexia.  Follow-up attempts have been completed and no further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test positive
Clinical narrative: Rash on both hands; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Osteoarthritis" (unspecified if ongoing), notes: Other medical history: Osteoarthritis; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "Bone Spurs: Osteophyte" (unspecified if ongoing), notes: Other medical history: Bone Spurs; "Diverticulitis" (unspecified if ongoing), notes: Other medical history: Diverticulitis; "adhesive tape" (unspecified if ongoing), notes: Known allergies: adhesive tape. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; BUDESONIDE; ALPRAZOLAM; ESCITALOPRAM; SERTRALINE HYDROCHLORIDE; TRIAMTERENE HCTZ; PANTOPRAZOLE; METHOCARBAMOL; MONTELUKAST; KLOR-CON M20; ONDANSETRON; LISINOPRIL; MELOXICAM; OXYCODONE AND ACETAMINOPHEN; TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]; GABAPENTIN; VITAMIN D3; VITAMIN C ACID; FLUTICASONE; BREO ELLIPTA. Past drug history included: Cephalosporin, reaction(s): "Known allergies: Cephalosporins", notes: Known allergies: Cephalosporins; Gentamicin, reaction(s): "Known allergies: Gentamicin", notes: Known allergies: Gentamicin; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Floroquinolones, reaction(s): "Known allergies: Floroquinolones", notes: Known allergies: Floroquinolones; Asparagus, reaction(s): "Known allergies: Asparagus", notes: Known allergies: Asparagus. The following information was reported: RASH (non-serious) with onset 16Mar2021, outcome "recovered", described as "Rash on both hands". The event "rash on both hands" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The AE treatment received as a Triamcinolone Cream, No covid prior vaccination, tested for covid post vaccination with nasal swab on 30Dec2021 and covid test result was positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "dry cough" (unspecified if ongoing), notes: Hello I have had a dry cough for about 18 years that no one has been able to find a cure for. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together".  Additional Information: patient reported that, I have had a dry cough for about 18 years that no one has been able to find a cure for. When I had my first Pfizer vaccine for COVID-19 within hours I stopped coughing all together! A few months after the 2nd dose the coughing slowly started returning. I was disappointed after the booster that my coughing did not stop. What is in your dose that stopped my coughing and how can I get regular use of it? PQC present was reported as, no. AE present was reported as, yes. This case was reported as, non-serious.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness in my left upper arm which lasted for 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number: EL1283), intramuscularly, administered in left arm, administration date 28Jan2021 at 11:00  at the age of 72 years as dose 1, single for COVID-19 immunisation. Relevant medical history included mitral valve regurgitation; ongoing mild asthma started in 1953; ongoing hypertension mild (controlled) started in 1980; ongoing asymptomatic brain cavernoma (no symptoms) started Feb2021 (as reported); penicillin allergy; chocolate allergy; COVID-19 with very mild symptoms from 28Sep2020 (tested positive) until 28Oct2020 (tested negative); ongoing "thyroid" (as reported); sulfa allergy and thyroidectomy started in Oct2004. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start date: 2004 (ongoing); verapamil taken for increased blood pressure (ongoing); carvedilol (COREG) taken for increased blood pressure (ongoing); calcium, zinc and vitamin D. The patient was previously given contrast iodine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 at 04:00am, the patient experienced slight soreness in her left upper arm which lasted for 24 hrs. The patient did not receive any treatment due to the event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 31Jan2021 at 04:00.   No follow-up attempts are possible. No further information is expected.  Follow-up (21Apr2021): This is a spontaneous follow-up report from a contactable consumer in response to Non-HCP letter sent. Updated information: dose 1 vaccine details (lot number, route of administration, administration time, age at vaccination and dose description in the narrative), relevant medical history and concomitant details, and event end date.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only sore arm(extreme); This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program. A 77-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) administered in Left arm (Lot number EN5318), via intramuscular route of administration on 04Feb2021 10:30 AM as single dose, second dose administered in Left arm (Lot number EN6202), via intramuscular route of administration on 25Feb202110:15 AM as single dose at the age of 77 years for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received two Cortisone injections in the shoulders and wants to know if it's ok to get the Cortisone shot while taking the vaccine. The event outcome unknown.  Additional information: On 25Feb2021, the patient again experienced sore arm.Patient medical History (including any illness at the time of vaccination)was none. Prior vaccinations (within 4 weeks) was None.Concomitant drugs was none.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This is a follow-up spontaneous report from a contactable consumer. Updated information included: Patient age at the time of vaccination, Lot number, Administration time, Anatomical site of injection, Route of administration for dose 1, dosage regimen for dose 2.  No follow-up attempts are possible. No further information is expected.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure increased, Body temperature, Body temperature increased, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 12:30 (Lot number: EL9262) at the age of 71 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN; VITAMINS A & D; YES 2 ZINC. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Experiencing elevated BP"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Stiff neck and back muscles unable to turn head or sleep on back"; BLOOD GLUCOSE ABNORMAL (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "FBS/Glucose."; BODY TEMPERATURE INCREASED (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Elevated temp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures included OTC Acetemophin and Ibuprofen, Rx. Muscle Relaxan. Follow up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: went back for the second dose and was told they didn't have the vaccine to give; went back for the second dose and was told they didn't have the vaccine to give; This case is considered invalid as info not qualifying for AE reporting- all other sources, as there is no indication that the patient experienced an event under BNT162B2.   This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), 1st dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was told to go back in two weeks for the second dose, went back for the second dose and was told they didn't have the vaccine to give. The outcome of event was unknown.   Information on the lot/batch number has been requested.  Follow-up (21Apr2021): This is a follow up-spontaneous report received from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via follow-up letter which included that:  No information available on follow-up, No new medically significant AE/SD reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021200720 similar report from same reporter
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Nasopharyngitis
Clinical narrative: Cold; chills; Discomfort; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration on 08Feb2021 (at 79-years age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284), on Jan2021 12:00 PM as single dose for covid-19 immunisation. The patient medical history were not reported and no known allergies. The concomitant medications were reported. The patient was not tested positive to covid prior and post vaccination. The patient had not received any other vaccines within prior to the COVID vaccine. The patient experienced cold chills and discomfort occurs intermittently throughout the day and night on 09Feb2021. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The patient consider the Pfizer product had a causal effect to the adverse event. The event outcome was not resolved.  Follow-up(27Apr2021): This is a follow up-spontaneous report from a contactable Physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: event details and narrative description. Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose, Vomiting
Clinical narrative: they administered 15 ml instead of the full dose of 30 ml; they administered 15 ml instead of the full dose of 30 ml; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EL9265) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "allergic to Fentanyl". The following information was reported: PRODUCT PREPARATION ISSUE (non-serious), UNDERDOSE (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "they administered 15 ml instead of the full dose of 30 ml"; VOMITING (non-serious) with onset 26Feb2021, outcome "unknown", described as "vomiting". Additional information- It was reported that  patient got the first dose yesterday; and since she is allergic to Fentanyl they administered 15 ml instead of the full dose of 30 ml; asked if she will be receiving the full dose of 30 ml on her second and make up for the deficit from her 1st dose' coded as 'no adverse effect' and 'vomiting' coded as 'vomiting'  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: severe fatigue for 2 days; moderate injection site pain ~12 hours after injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 15:00 (Lot number: ER8732) at the age of 52 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "recovered" (2021), described as "moderate injection site pain ~12 hours after injection"; FATIGUE (non-serious) with onset 28Mar2021, outcome "recovered" (Mar2021), described as "severe fatigue for 2 days". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional Information: The patient had no known allergies, that is no allergies to medications, food, or other products. The patient was not tested covid prior and post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was treated with ibuprofen 600mg q6h for the adverse events.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Skin mass, Sluggishness
Clinical narrative: tired/some fatigue; had what she voiced as a knot form on her arm/had a huge knot on her arm that was feverish; sluggish; looked like a golf ball under her arm it was red and warm to touch and painful.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EL9265) at the age of 69 years as dose 2, single for covid-19 immunization.  Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: on a breast cancer drug trial and has been on it for 17 years. The patient was on a breast cancer drug trial and has been on it for 17 years. Breast cancer trial medicine: estriol 2mg-estradial 0.25mg, estrone 0.25mg, bhea 5mg, testosterone 0.75mg progesterone 200 mg. 200mg of progesterone, they can't put this in the other capsule so they have to make it as a separate capsule but it was all one medication. Concomitant medication(s) included: LEVOTHYROXINE SODIUM (ongoing); MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, lot EL1283, expiration date. unknown), administration date: 19Jan2021 on upper left arm, for Covid-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired/some fatigue"; NODULE (non-serious), outcome "unknown", described as "had what she voiced as a knot form on her arm/had a huge knot on her arm that was feverish"; SLUGGISHNESS (non-serious), outcome "unknown", described as "sluggish"; SKIN MASS (non-serious), outcome "unknown", described as "looked like a golf ball under her arm it was red and warm to touch and painful.".  Additional information: No investigation assessment was performed. After the patient got the second vaccine she was sluggish and had a huge knot on her arm that was feverish. The patient felt sluggish within a day or two after second vaccine. After the second vaccine the patient had what looked like a golf ball under her arm it was red and warm to touch and painful. The patient was really tired and that lasted a week or more and then it subsided after about 2 weeks, she was guessing.  Communication: PC filed. The patient was provided with USMI's phone number, option 3, and hours of operation of Monday through Friday 8AM to 8PM, 9 am to 3pm Saturday and Sunday, EST, prior to cold transfer due to a high call volume.  Description of Product Complaint: The patient tried one prescription, diphenoxylate atropine 2.5 mg tablets and it didn't do it, it would slow down the diarrhea but would not stop it. This medicine is in a pharmacy bottle, unknown lot, expiration date 15Feb22.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP6955) at the age of 72 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EN6201), administration date: 23Feb2021, when the patient was 72 years old, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 15Mar2021, outcome "unknown", described as "Migraine headache/have had a constant headache for the last two weeks". Additional information: The patient is wondering if there's something he can take to get rid of it. He doesn't know how he can get rid of this headache. When probed for medical conditions and laboratory test performed, he stated that no medical condition and no relevant lab test performed. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Food poisoning, Illness, Malaise
Clinical narrative: Food poisoning; She is still weak; Not totally feeling well; I am still not as up to par as I was at the first time; I got sick from eating something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD POISONING (non-serious), outcome "unknown", described as "Food poisoning"; ASTHENIA (non-serious), outcome "unknown", described as "She is still weak"; MALAISE (non-serious), outcome "unknown", described as "Not totally feeling well"; ILLNESS (non-serious), outcome "unknown", described as "I am still not as up to par as I was at the first time; I got sick from eating something".  Additional information: Patient stated she didn't get sick from the vaccine, she got sick from eating something that last week, that week. The patient was due to get the shot tomorrow, she was not quite up to par but she was real close, so patient was asking if it was still okay for her to get the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported Information: removed event "missed dose"
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. This is one of 3 reports.  A female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391051 Same reporter/suspect product/event, different patient.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021469753 (Pfizer). A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:45 (Lot number: ER8735) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Amoxicillin" (unspecified if ongoing), notes: Known allergies: Amoxicillin; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Had Covid a while ago" (unspecified if ongoing), notes: Caller clarifies that the patient had Covid prior to receiving the vaccine.; "tingling in his face" (not ongoing), notes: patient had Covid, he had tingling in his face which resolved in two days. Concomitant medication(s) included: OMEPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; IBUPROFEN. The following information was reported: PARAESTHESIA (non-serious) with onset 06Apr2021 14:15, outcome "not recovered", described as "Tingling and slight numbness started in face roughly 25 min after injection/Tingling that radiated in his hands, arms, and legs"; FEELING ABNORMAL (non-serious) with onset 06Apr2021 14:15, outcome "not recovered", described as "Its just feel weird"; HYPOAESTHESIA (non-serious) with onset 06Apr2021 14:15, outcome "recovered" (2021), described as "Tingling and slight numbness started in face roughly 25 min after injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, feeling abnormal, hypoaesthesia. Additional information: When the patient had Covid, he had tingling in his face which resolved in two days. Since the vaccination, the patient was not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first vaccination, he has the same tingling. The patient had tingling and slight numbness (fizzing) and within a few hours, the patient had the tingling radiating down his arms and legs. Started in the face roughly 25 minutes after injection. Spread to upper body later in the day. Still present 3 days later. There was tingling but no numbness. The patient still has this (tingling) a little bit. No physical signs of any rash or redness at injection sight or elsewhere. Did not appear to be Bell's Palsy as patient had complete control over my face. It just feels weird. She had not heard of this side effect of the vaccine and this was new to her. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Formication, Skin lesion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 11:00 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE, administration date 03Jan2021; ZOLOFT; XANAX. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine. The following information was reported: FEELING HOT (non-serious) with onset 20Jan2021, outcome "not recovered", described as "Heat radiating through body"; SKIN LESION (non-serious) with onset 23Jan2021, outcome "not recovered", described as "Skin lesion under left breast"; FORMICATION (non-serious) with onset 23Jan2021, outcome "not recovered", described as "feel sensations under my skin, like insects crawling under skin"; FATIGUE (non-serious), outcome "not recovered", described as "Slight exhaustion". The events "heat radiating through body", "skin lesion under left breast", "feel sensations under my skin, like insects crawling under skin" and "slight exhaustion" were evaluated at the physician office visit. Therapeutic measures were taken as a result of feeling hot, skin lesion, formication, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. One first day felt heat radiating through body, no fever. Three days after 1st vaccine dose noticed a skin legion under left breast. Started to feel sensations under patient skin, like insects crawling under skin. After the 2nd dose. Skin Legions began forming in arm pits and then spread on upper torso. The legions are irritating, flat red inflamed about the size of a penny all over front torso. Feeling of something crawling under skin was now sharp stabbing pain on legion areas- like needles poking patient body. Patient had no fever or other side effects. Slight exhaustion a few days after initially receiving vaccine. Therapeutic measures were taken as a result of the events which included treatment with oral steroid and topical prescription lotions. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache for 24 hours with lesser intensity headache persisting now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 14:15 (Lot number: SL9267) at the age of 68 years as dose 1, single and administered in arm left, administration date 16Mar2021 14:15 (Lot number: EN6207) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "elevated lipids" (unspecified if ongoing); "Allergies to medications" (unspecified if ongoing); "Allergies to food" (unspecified if ongoing); "Allergies to other products" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; TERBINAFINE. The following information was reported: HEADACHE (non-serious) with onset 17Mar2021 12:00, outcome "not recovered", described as "Severe headache for 24 hours with lesser intensity headache persisting now". Therapeutic measures were not taken as a result of headache.  Additional Information: The headache was the worst patient have ever had that was not a full blown migraine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Within three hours sore arm; Within 6 hours waves of being tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 08:30 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovered" (07Mar2021), described as "Within three hours sore arm"; FATIGUE (non-serious) with onset 06Mar2021, outcome "recovered" (07Mar2021), described as "Within 6 hours waves of being tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of the vaccination. On 06Mar2021, the patient experienced a sore arm within three hours and waves of being tired within 6 hours of the first shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 66-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced dizziness, with outcome of unknown. Additional information: Patient had no symptoms after first dose except a short period of dizziness (less than 30 seconds). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021401211 same reporter/drug/patient, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: feels very sleepy; sinus post nasal drip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "feels very sleepy"; RHINORRHOEA (non-serious), outcome "unknown", described as "sinus postnasal drip". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: She stated that she took the first vaccine and asked if it made you drowsy. She further stated that she feels very sleepy and knows people who took it but did not feel sleepy rather just had pain in their arm. She also mentioned that she took Zyrtec after the vaccine because she had sinus postnasal drip and was going to go to sleep. She also confirmed that her doctors know that she takes this and Losartan. The caller asked if you can take Zyrtec and Losartan with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Left arm was extremely sore; Had a bad headache the first night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 07:45 (Lot number: EW0161) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6207, Anatomical site: Left arm, Administration time: 07:45 AM), administration date: 19Mar2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Left arm was extremely sore"; HEADACHE (non-serious) with onset 09Apr2021, outcome "recovered" (10Apr2021), described as "Had a bad headache the first night.". Therapeutic measures were not taken as a result of pain in extremity, headache.   Additional information: The patient had not reported any other health issues, had no known allergies to medications, food or other products. 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. On 10Apr2021, after dose 2, the patient experienced the left arm was extremely sore for 2 days (duration) and had a bad headache on the first night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Left side, jaw is sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 10:00 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN JAW (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Left side, jaw is sore.". Therapeutic measures were taken as a result of pain in jaw.  Additional Information: The patient Left side jaw was sore, Pretty steady and also wife has same feeling. She got her shot right after patient. On day 3 Jaw still sore and started treatment with ibuprofen. Patient had no known allergies. Patient did not receive any medications within two weeks of vaccination and also did not receive any vaccine within four weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404247 Same reporter/drug/event, diff pt
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 16:00 (Lot number: ER8730) at the age of 18 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Von Willebrand's disease" (unspecified if ongoing), notes: very mild von Willebrand. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE lot number: EN6202anatomical site: right arm administration site: 14:00), administration date: Feb2021, when the patient was 18 years old, for COVID-19 immunisation, reaction(s): "Tiredness". The following information was reported: DYSGEUSIA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "anything patient eats that has been cooked or is warm, tastes like metal"; PAROSMIA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "anything patient eats that has been cooked or is warm, smells like metal". The events "anything patient eats that has been cooked or is warm, tastes like metal" and "anything patient eats that has been cooked or is warm, smells like metal" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia, parosmia. Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medication, food or any other products. On 27Mar2021, after the second dose, the patient experienced that anything he ate that had been cooked or was warm, tasted and smelled like metal. This was on going for 3 weeks at the time of report. The patient had been consulted by doctor and an allergist but nobody had any input on the reaction. The events resulted in doctor or other health care professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tasted and smelled like metal was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Premenstrual syndrome
Clinical narrative: Missed menstrual cycle; PMS systems present for 10 days and no cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8733) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number :EN6208 Administration time : 13:00Anatomical location: Right arm), administration date: 12Mar2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 07Apr2021, outcome "unknown", described as "Missed menstrual cycle"; PREMENSTRUAL SYNDROME (non-serious) with onset 07Apr2021, outcome "unknown", described as "PMS systems present for 10 days and no cycle.". Therapeutic measures were not taken as a result of menstruation delayed, premenstrual syndrome.  Additional information: It was reported that, patient was not allergic to medications, food, or other products. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection". The event "sinus infection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sinusitis.  Additional information: She had her first dose of Pfizer-BioNTech COVID-19 Vaccine almost 3 weeks ago. She was scheduled to get her second dose of Pfizer-BioNTech COVID-19 Vaccine on 14Apr2021. She has some kind of sinus infection and saw her doctor last night. She was currently on antibiotics for the sinus infection. She asked for information on if having the sinus infection or being on antibiotics would be a problem with getting the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 13:30 (Lot number: ER2613) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Allergic to penicillin; "Accident" (unspecified if ongoing), notes: auto accident in 97; "Neck pain" (unspecified if ongoing), notes: Chronic neck pain due to auto accident in 97. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021 13:35, outcome "recovered" (2021), described as "Dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.