chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Magnetic resonance imaging head normal, Migraine, Sinusitis, Tension headache
Clinical narrative: Headaches; Sinus/tension headache; Sinus/tension headache; Get pain that increases through out the day in my upper and lower sinuses; Pain in all of my upper teeth; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: Ew0170), via an unspecified route of administration, administered in Arm Right on 30Apr2021 08:45 as 2nddose, single for covid-19 immunisation. Historical vaccination was BNT162b2 (CONMINTARY, Solution for injection, Lot No: Er8737,), via an unspecified route of administration, administered in Right arm on 07Apr2021 at12:45 PM as 1stdose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced headaches on, sinus/tension headache on, sinus/tension headache on 01May2021 12:00, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth on May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included computerized tomogram: clear in 2021, sars-cov-2 test: negative   on 29May2021.  Therapeutic measures were taken as a result of headaches, sinus/tension headache, sinus/tension headache, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth. The adverse event result in visit to emergency room. Treatment was received. Upon follow-up on 12Jul2021 attempts are completed. No further information is expected. Device date was 04Jun2021.The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in my ears; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received the 1st dose received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and had no issue. The patient experienced "ringing in my ears" on an unspecified date. It was reported that the patient regretted taking the Pfizer shot. The first shot went fine. After the second shot, the patient have had ringing in ears. The patient went to family doctor and was told there isn't anything that can be done about it. The patient knew others that have the same thing going on. The patient never had any issues prior to taking the shot. The patient reported that is why they sign a release form. The patient reported would never again take any booster shots in the future. Outcome of the event was unknown.  Information about lot/batch no has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: current_age 15; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 15-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included   from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced current_age 15 (off label use), left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days on 01Jun2021 with outcome of recovering.  No follow-up attempts are possible. No further information is expected.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Wheezing
Clinical narrative: extreme foot swelling in both feet; horrible lung wheezing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0196), via an unspecified route of administration in left arm on 10Jun2021 at 15:00 (at the age of 37-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history of the patient included asthma. The patient had no known allergies. There were no concomitant medications. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: Ew0187), via an unspecified route of administration in right arm on 17May2021 at 12:00 (at the age of 37-years-old) as single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The patient reported that on 10Jun2021 at 16:00 an hour after receiving the second vaccine, patient had extreme foot swelling in both feet, and horrible lung wheezing after 40 hours. The events lead to the emergency room. Therapeutic measures were taken as a result of events that included Prednisone. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Off label use, Pain in extremity
Clinical narrative: just after I received my shot my arm is feeling numb and sore; Inappropriate schedule of vaccine administered; Off label use; received my second shot 3 weeks ago in my left arm and my left arm continues to be numb; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0221), via an unspecified route of administration, administered in Arm Left on 03Jun2021 (at age of 61-year-old), as dose 2, single for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6775), via an unspecified route of administration, administered in Arm Left on 28Feb2021, as dose 1, single for covid-19 immunisation and no reactions were reported. On 03Jun2021, just after he received shot, the patient experienced arm was feeling numb and sore, inappropriate schedule of vaccine administered, off label use. Therapeutic measures were taken as a result of events included advil. The outcome of the events was unknown.   Follow-up attempts were possible. Further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I haven't gotten my periods since my first dose of vaccine which was 3 months ago; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021, as a single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that consumer stated, she has not gotten her periods since her first dose of vaccine which was 3 months ago, yeah, she was little bit concerned. It was further stated, it's the first shot and she was not pregnant, and have taken several tests. Outcome of the event was unknown.  Information regarding the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Pt. reported experiencing headaches described as "odd, throbbing"headaches that decrease when laying down; This is a spontaneous report from a contactable other health professional and a consumer (patient) via a Pfizer sponsored program Optum Xeljanz Program. A 40-year-old female patient received BNT162B2 (reported as "COVID-19 VACCINE"), via an unspecified route of administration on an unspecified date, at an unspecified age, as unknown dose number as single dose (Batch/Lot number was not reported) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 16Jun2021, at 11 mg for an unspecified indication. The patient medical history included eye surgery on an unspecified date. Concomitant medications were not reported. The patient reported experienced headaches described as "odd, throbbing" headaches that decrease when laying down on an unspecified date. The patient reported received COVID vaccine and underwent eye surgery prior to starting Xeljanz stated those may contribute to headaches. The action taken for tofacitinib citrate was unknown. The outcome of event was unknown.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I am experiencing a lot of itchiness after getting the second dose of the Pfizer; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient had no reaction on previous exposure to drug. On unspecified date, Consumer stated the concern, the patient experienced a lot of itchiness after getting the second dose of the Pfizer and wondered like is that normal or at a certain point is there something you guys are supposed to do about it. Consumer was informed about the role of Pfizer Drug Safety and also informed that for the question Pfizer Medical Information is the right department to answer the question. The clinical outcome of event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Caller states that she only experienced a little soreness with the first dose; This is a spontaneous report from a contactable consumer or other non health care professional. A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at vaccination: 67 years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little soreness with the first dose. she was supposed to receive the second dose in the same or different arm. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Idiopathic urticaria, Rash, Rash papular, Rash pruritic
Clinical narrative: A small papule like hive started on arms and legs, and spread all over body (similar to chicken pox) over the next 3 days. Very itchy no discernible cause- no new medicine, no new skin products . Had a biopsy and they were confirmed to be idiopathic urticaria. Was asked if I had any vaccines lately, confirmed I had the second dose of Pfizer 3 and a half weeks earlier. Hives lasted about 1.5 months. Second dose also cause toes to swell a few hours after the vaccine was administered, but lasted only for a few hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Nausea, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Nausea/vomiting, tingling lips, tongue, throat, difficulty swallowing. Went to the ER and received 2 rounds of epi, IVP benadryl, solu medrol, pepcid, and a liter of fluid.  Rebound reaction 7/28 difficulty breathing, difficulty swallowing, tingling lips and in throat. Epipen used and then in the ER recieved another epi, IV steriods, benadryl, pepcid, liter of fluids, and a breathing treatment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea/vomiting, tingling lips, tongue, throat, difficulty swallowing. Went to the ER and received 2 rounds of epi, IVP benadryl, solu medrol, pepcid, and a liter of fluid.  Rebound reaction 7/28 difficulty breathing, difficulty swallowing, tingling lips and in throat. Epipen used and then in the ER recieved another epi, IV steriods, benadryl, pepcid, liter of fluids, and a breathing treatment.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeat
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase decreased, Blood bilirubin, Blood creatinine, Blood immunoglobulin E
Clinical narrative: Patient came in to Health Unit on 04/27/21 with a complaint of headaches. Post mediacl officer (PMO) examened patient. Vital signs: BP-155/78, 128/83, HR-52, O2-100% on RA, T-36.7 C, RR-16. GCS 15/15, PERL. PMO referred patient to a neurologist - assessment GCS 15/15, PERL, no abnormatities detected. Neurologist ordered blood tests, and prescribed Naproxen 550 mg when suffering from a headache. Patient came back for multiple follow ups with persisting headaches. PMO referred to neurologist who ordered an MRI Head and prescribed UltraCod 500/30 mg BD. Conclusion from MRI: No indication of brain pathologyhas been obrained, relatively large retention cyst in the right maxillary cavity. Patient came back to Health Unit for MRI results. Patient continued to take UltraCod 500/30 mg tablets for 2 weeks. A check up on the 06/14/21 - patient stated that all headaches have subsided now. Has not had any headaches reacently. Spoke to patient over the phone on 04/08/21 - patient has not had any headaches now and said "everything had gone away overnight".
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood urea, C-reactive protein, Full blood count, Glomerular filtration rate
Clinical narrative: Patient came in to Health Unit on 04/27/21 with a complaint of headaches. Post mediacl officer (PMO) examened patient. Vital signs: BP-155/78, 128/83, HR-52, O2-100% on RA, T-36.7 C, RR-16. GCS 15/15, PERL. PMO referred patient to a neurologist - assessment GCS 15/15, PERL, no abnormatities detected. Neurologist ordered blood tests, and prescribed Naproxen 550 mg when suffering from a headache. Patient came back for multiple follow ups with persisting headaches. PMO referred to neurologist who ordered an MRI Head and prescribed UltraCod 500/30 mg BD. Conclusion from MRI: No indication of brain pathologyhas been obrained, relatively large retention cyst in the right maxillary cavity. Patient came back to Health Unit for MRI results. Patient continued to take UltraCod 500/30 mg tablets for 2 weeks. A check up on the 06/14/21 - patient stated that all headaches have subsided now. Has not had any headaches reacently. Spoke to patient over the phone on 04/08/21 - patient has not had any headaches now and said "everything had gone away overnight".
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Magnetic resonance imaging head abnormal, Paranasal cyst, Specialist consultation
Clinical narrative: Patient came in to Health Unit on 04/27/21 with a complaint of headaches. Post mediacl officer (PMO) examened patient. Vital signs: BP-155/78, 128/83, HR-52, O2-100% on RA, T-36.7 C, RR-16. GCS 15/15, PERL. PMO referred patient to a neurologist - assessment GCS 15/15, PERL, no abnormatities detected. Neurologist ordered blood tests, and prescribed Naproxen 550 mg when suffering from a headache. Patient came back for multiple follow ups with persisting headaches. PMO referred to neurologist who ordered an MRI Head and prescribed UltraCod 500/30 mg BD. Conclusion from MRI: No indication of brain pathologyhas been obrained, relatively large retention cyst in the right maxillary cavity. Patient came back to Health Unit for MRI results. Patient continued to take UltraCod 500/30 mg tablets for 2 weeks. A check up on the 06/14/21 - patient stated that all headaches have subsided now. Has not had any headaches reacently. Spoke to patient over the phone on 04/08/21 - patient has not had any headaches now and said "everything had gone away overnight".
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: fever; Chills; Body aches; Bad headache; Muscle pain; This is a spontaneous report from contactable consumer (Patient) reporting herself.  A female patient of an unspecified age received second dose of BNT162B2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021 at 14:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced a bad reaction experiencing which included fever, chills, body aches, muscle pain and a bad headache. During the call she stated that she should take Advil because she was in "much pain" more than she can get used to just to get by. Patient wanted to know if the side effects that she was presenting could be due to the Pfizer´s COVID-19 vaccine or due to something else. Caller disconnected during holding time and was unreachable at call back number provided. Therapeutic measures were taken due to the events. The outcome of the event s was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Pain
Clinical narrative: felt tired; She had the Pfizer COVID vaccine and had pain and suffering; had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect; This a spontaneous report from a contactable consumer. This consumer reported for herself that. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not provided) via an unspecified route of administration on 03Jul2021 as single dose for COVID-19 immunization. Medical history included cramps in uterus, pelvic pain, cramps in the brain, cramps in the calves in her legs and mentions she has a fracture and has bleeding and intentional injuries. Concomitant medications were not provided. On 04Jul2021, felt tired, She had the Pfizer COVID vaccine and had pain and suffering and had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect. It was reported that Caller says that she was trying to explain to this agent that she got the vaccination, the 1st dose, on Saturday and then on Sunday she felt tired, which was a normal effect, but also she had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect. It was a severe leg cramp on her left calf. Caller begins to get loud and hard to understand. She thinks that it was because of the location where they put in the needles and that causes that type of pain and suffering. Caller becomes irate and yells that this was not a vaccination side effect. She remains irate and says just do whatever, she doesn't believe that this was a side effect. She had the Pfizer COVID vaccine and had pain and suffering and that was not a side effect of any vaccination. Caller begins to yell at this agent, and an attempt was made to calm down caller. Caller states, whatever miss, whatever and she says that this was no side effect. She says she tried to explain this to someone, and they said to take Tylenol for the pain before. She is having pain and suffering. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Immunosuppressant drug level decreased
Clinical narrative: Severely immunosuppressed on a medicine suppressing her immunity; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the physician stated she took both doses of Pfizer's COVID vaccine and was severely immunosuppressed on a medicine suppressing her immunity. Caller stated she didn't have any immune response and knows Pfizer was conducting a 3rd dose on people like her. Caller was asking where she can participate in the study. The clinical outcome of the event was unknown.  Follow up (29Jul2021): 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 have been completed and no further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: extreme fatigue; rash on his arm; Itching; This is a spontaneous report received from a contactable consumer, the patient. This case is reported for first dose. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in 2021 (as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose a couple of weeks ago and he was experiencing extreme fatigue and rash on his arm. The rash comes and goes. Adds at one point he thought he was having liver or kidney problems but it all checked out. He has been itching over a week. The patient knew he would experience some kind of reaction. Outcome of the event was unknown. Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: extreme fatigue; rash on his arm; Itching; This is a spontaneous report received from a contactable consumer, the patient. This case is reported for first dose. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in 2021 (as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose a couple of weeks ago and he was experiencing extreme fatigue and rash on his arm. The rash comes and goes. Adds at one point he thought he was having liver or kidney problems but it all checked out. He has been itching over a week. The patient knew he would experience some kind of reaction. Outcome of the event was unknown. Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swelling of the face; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. This report not related to a study or programme. It was reported that, when she received her first shot, she received a fact sheet from Pfizer. On page 3 of the report, it has risks, allergies, and signs of a severe allergic reaction. It lists 5 things. One of them was swelling of the face and throat. Then when she went down the page it has side effects that have been reported, and it says non-severe, was swelling of the face. She wants to know if it is severe or non-severe. She does have a lot of allergies and she gets swelling of the face fairly often. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Very bad flu-like illness; Fever; This is a spontaneous report from a Pfizer sponsored program . A contactable 50-year-old female consumer (patient) reported for herself. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient (50 years old) mentioned that she had the Pfizer BioNTech COVID-19 vaccine last April and experienced typical symptoms you hear like very bad flu-like illness for a good 24-36 hours and then fever, what they have been reporting in the news, so caller thought it was not necessary to report her experience". Caller mentioned that she knows "some people do get strong reactions and some people did not, but she cannot do that to her daughter. The clinical outcome of the events was unknown.   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-2021857083 same reporter/drug, different patient/AE;US-PFIZER INC-2021857084 same reporter/drug, different patient/AE;US-PFIZER INC-2021857081 same reporter/drug, different patient/AE;US-PFIZER INC-2021857082 same reporter/drug, different patient/AE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Nasopharyngitis, Pain in extremity, Rhinorrhoea
Clinical narrative: Sore arm for both of her arms; Runny nose; Cold/chills; Cold/chills; But she is not sure if she is going to get it; This is a spontaneous report from a contactable consumer or other non hcp.  A 7-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 07Jun2021 (at the age of 7-decade-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified day in 2021, the patient experienced sore arm for both of her arms, runny nose, cold/chills, but she is not sure if she is going to get it. Caller is a consumer, did not share their first and last name, nor their age or zipcode. After getting her 1st dose up until today (1 month after getting the vaccine), she still felt sore arm for both of her arms, runny nose and cold/chills. In line with this, she would like to know if this side effect are normal side effects being experienced after a month of getting the vaccine. She reported she was having a problem with the arm that she got her injection in but also the other arm hurts.  She is supposed to get her second dose today (it has been 30 or 31 days since the first dose) but she is not sure if she is going to get it because she still has pain and she has heard the side effects after the second dose can be worse. Patient was willing to provide her first name and city and stated and said she was in her 60s. However, the patient did not want to see a physician, instead she wanted to speak to a manager or someone higher than the person speaking to her to confirm the information. In line with this, she is concerned as to what would happen if she would not get her 2nd dose due to this side effect she is experiencing after the first one. The patient is concerned that the adverse effect had lasted so long. She wanted to know if she decides not to get the second one, would she be protected. She also asks if she did not get it today, would it still be okay to get later.  Outcome of the event Circumstance or information capable of leading to medication error was unknown and outcome of the other events were not recovered.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Myalgia
Clinical narrative: had a problem with reaching, with lifting things; the muscles behind my things, same thing. It hurts; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporters girlfriends daughter) that:   A 5-decade-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER BIOTECH OVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on unspecified date for COVID-19 immunization and patient experienced she could not lift her arm. It was reported patient received both doses of the vaccine. She said she has talked with a pharmacist who recommended calling Pfizer and that she has experienced her symptoms for five months. The caller stated that after the first vaccine she felt like she could not lift her arm. After the second shot, she felt like she had a problem with reaching, with lifting things. she felt the muscles behind her things, same thing. It hurts. she was given Mobic, took that for six days then my blood pressure went up and caller started getting headaches and then right hand went numb and burns off and on. She has been to physical therapy, but is unsure if that is helping, and was told to see a rheumatologist and a neurologist. The caller reports also that she hasn't "slept for nights", that she is a side sleeper and keeps turning from one side to the other. Caller is wanted to ask if her symptoms have been reported and wanted to know length of time of the symptoms and what she should do. also shared her girlfriend's daughter is much younger, in her forties, but is having the same things. Her daughter told her to ride it out for six months and was also told that skinny people had a harder time after the vaccine. Caller said she had never heard of such a thing and asked if weight affected symptoms. The outcome for the event was reported as unknown at the time of his report.  Information about lot/batch number has been requested.  Follow-up (28JUL2021): 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 have been completed and no further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus - Loud sound in ears.; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0181) via unspecified route in the right arm on 09Jun2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. Patient had no known allergies. Patient did not receive other vaccine within four weeks prior to COVID-19 vaccination. Patient did not have COVID-19 prior to vaccination. On 10Jun2021 at 03:00, patient experienced tinnitus - loud sound in ears. The patient reported that the first dose caused strong reaction of tinnitus the night he had the first dose. It subsided and there were no lasting side effects. No treatment was received for the event. The outcome of the event was recovered on unspecified date. The patient was COVID tested post vaccination via Nasal Swab, RT-PCR, on 11Jun2021, with result of negative.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100965985 Same patient,  different dose,  different event (split)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Parosmia, Taste disorder
Clinical narrative: Strange taste of smell after first dose of vaccine; Strange taste of smell after first dose of vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, 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's medical history included covid-19 two months prior to the vaccine administration. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced strange taste of smell after first dose of vaccine. The patient underwent lab tests and procedures which included covid-19 which was positive on an unknown date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I am just wondering, I had sore arm; I was scared to get the shot but I went to had it; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0178), dose 1 via an unspecified route of administration on 16Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In Jun2021, the patient experienced "I am just wondering, I had sore arm; I was scared to get the shot but I went to had it". The patient received the second dose of bnt162b2 on 07Jul2021 for COVID-19 immunization. She was scared to get the shot but she went to had it and got it anyways because of "fear of Mom" (not clarified). The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: a friend who got both doses and she was unable to get out of bed; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date and received second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that she had a friend who got both doses, and she was unable to get out of bed, caller had to do everything for her, like food shopping, caller was trying to get her to go to a doctor but she was refusing. Caller was wondering if anyone at Pfizer has heard of an experience like the one she was having. Caller stated that she was having a delayed side effect. Caller stated that she got her Pfizer COVID vaccine at the end of March or early April, and she had nothing at all in terms of side effects. Caller stated that starting late May, or in early June, she started having strange side effects. Caller has a doctor's appointment today, but the doctors don't know anything about this, she has already asked her primary care and no one knows what she is talking about. Caller would like to speak with someone who could answer side effect questions for her. Caller was looking to see if there is any information about delayed side effects. The outcome of event was unknown.  Information about lot and batch number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congested; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's child). A child patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (first dose) on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced congested. The reporter is the parent of a child who called doctor's office who told her to call Pfizer. Her child had the second Pfizer COVID-19 shot and was congested. Caller does not know if that was a reaction. She wanted to speak to someone to answer her questions about the child being congested after the second Pfizer Covid shot. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in the foot; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included cardiac disorder from an unknown date and unknown if ongoing. Concomitant medication included amiodarone (AMIODARONE) taken for cardiac disorder, start and stop date were not reported; metoprolol (METOPROLOL) taken for cardiac disorder, start and stop date were not reported.  The patient experienced numbness in the foot on 16May2021. The patient stated that he wanted to get the vaccine and be protected but don't know if Pfizer caused this or not. The patient received only one vaccine and then that lady asked about medicine he was taking and he just wondering if that Pfizer shot-would it matter what kind of medicine he was on.  the patient thought Could they have a side effect both of them together causing numbness in his foot. The patient states he experienced numbness after the first shot of the Covid vaccine and wanted to know is there anyone else who complained about this. got vaccine on 26Apr2021, only got the first vaccine. Has been to the doctor a couple of times because of it. The outcome of the event was reported as not recovered. No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Breast pain, Chest pain, Electrocardiogram
Clinical narrative: pain and swelling in her arm; pain and swelling in her arm; Pain in left breast; chest pain; back pain; rush in head; headaches; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jun2021 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, spinal deformity from an unknown date and unknown if ongoing She had an X-ray years ago and found that she had a little bit of protrusion in the lower back and spine. It wasn't anything with the shot, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for hypertension, start and stop date were not reported; zinc (ZINC) taken for vitamin supplementation from an unspecified start date and ongoing; calcium carbonate (CALTRATE [CALCIUM CARBONATE]) taken for vitamin supplementation from an unspecified start date and ongoing; ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIVITAMIN ) taken for vitamin supplementation from an unspecified start date and ongoing.  The patient experienced headaches, rush in head on 30Jun2021, pain and swelling in her arm on an unspecified date, back pain on 10Jul2021, pain in left breast on an unspecified date. The patient underwent lab tests and procedures which included blood test: fine   on, electrocardiogram: fine on. the outcome of all the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: pain and swelling in her arm; pain and swelling in her arm; Pain in left breast; chest pain; back pain; rush in head; headaches; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jun2021 (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, spinal deformity from an unknown date and unknown if ongoing She had an X-ray years ago and found that she had a little bit of protrusion in the lower back and spine. It wasn't anything with the shot, vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for hypertension, start and stop date were not reported; zinc (ZINC) taken for vitamin supplementation from an unspecified start date and ongoing; calcium carbonate (CALTRATE [CALCIUM CARBONATE]) taken for vitamin supplementation from an unspecified start date and ongoing; ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIVITAMIN ) taken for vitamin supplementation from an unspecified start date and ongoing.  The patient experienced headaches, rush in head on 30Jun2021, pain and swelling in her arm on an unspecified date, back pain on 10Jul2021, pain in left breast on an unspecified date. The patient underwent lab tests and procedures which included blood test: fine   on, electrocardiogram: fine on. the outcome of all the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Jul-2021 from a Pharmacist.  This case involves a two-month-old female patient while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] reported that she inadvertently administered intramuscularly only the liquid (dtap-ipv) component of the pentacel vaccine with no adverse event (product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 22-Jul-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ434ABA (box) and expiry date 08-Mar-20222] (unknown latency) via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported that, "Pharmacist stated that yesterday (22 Jul 2021), the patient was inadvertently administered intramuscularly only the liquid (DTaP-IPV) component of the Pentacel vaccine, and not the lyophilized (Hib) component of the vaccine.  Pharmacist did not have information on where on the body the vaccine was administered, did not have information on whether any concomitant vaccines were administered, and did not have information on which dose in the series this was. Product used: Used. Still using product: No".  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product colour issue
Clinical narrative: Fluzone High-Dose Quadrivalent the vaccine was a bright green serum that was injected, no AE; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a consumer via Medical Information  (Reference number- 00694840).  This case involves a 72 year old female patient who was vaccinated with the bright green serum INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included COVID (coronavirus disease)-19 VACCINE for Prophylactic vaccination.  In Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ4888A and expiry date: 30-Jun-2021) (Frequency: once) via an intramuscular route in the right arm (product colour issue) for prophylactic vaccination.  It was case of product colour issue.  It was reported that "when they received the Fluzone High-Dose Quadrivalent the vaccine was a bright green serum that was injected. The Pharmacist does not have any knowledge of the vaccine being green and that the vaccine would not have been administered if it were bright green".   At the time of reporting, no adverse event was reported.   Follow-up information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a consumer via  Medical Information (Reference number- 00694840).   Case validity was updated.  Based on information received on 23-Jul-2021, the report previously considered as non-case became valid: [reason for special event reported].