chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: can't keep eyes open; ache all over; chills; they just lay down and sleep; then they are cold; they have a headache; still get this annoying thing that will pop up; This is a spontaneous report from contactable consumer. This consumer reported for a female patient (2nd cousin). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: 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 immunisation. On an unspecified date the patient experienced can't keep eyes open, ache all over, chills, they just lay down and sleep, then they are cold, they have a headache, still get this annoying thing that will pop up. Clinical course was reported as she was going to call a while back and she thought no, until she spoke with her cousin who had the same thing she went through. Report 2 of 2. Report 2 is she reporting on her cousins. She has a first cousin and her sister who live in and they had their shots pretty close the same time she did. Talking to her cousin, she has gone through the same thing and wanted her to find out if this is the same. There was a tough spell 4 days after the shot, then she was fine, then the same thing happened again for a couple of days at a time were they can't keep their eyes open because they ache all over, have chills, and then it goes away and then comes back. she adds her other cousin had the same shots and she did the same thing she had. She does not want to complete her report or complete a report on her cousins. That it has been the same for them as hers, their last shot was a few days before her second one. hey had the exact same thing happen. She does not know if maybe it is in the DNA or something. They still get this annoying thing that will pop up and they just lay down and sleep, then they are cold, then they have a headache. It does not last long, a day or a day and a half. The clinical outcome of events they just lay down and sleep, cold, headache was recovered and another still get this annoying thing that will pop up was not recovered other was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She got her 2nd Covid19 vaccine about a week ago in her right arm and her left arm hurt.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she got her 2nd covid19 vaccine about a week ago in her right arm and her left arm hurt. She got her 2nd Covid19 vaccine about a week ago in her right arm and her left arm hurts. And if you get her to the medical information, I tried to give her the phone number but she declined it. If you can transfer her over there to find out if that is from the Covid19 vaccine. Consumer hung up the call before it could be transferred to Pfizer Drug Safety. Call Back was done but it was unsuccessful. Hence, limited information available over the call. Thus, product  details (LOT#, NDC#, UPC# and expiry date) and pharmacy details could not be probed over the call. The outcome of event was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelets dropped to 6,000. Dr. stated that she felt it was vaccine induced; This is a spontaneous report based on the information received by Pfizer from (Reference ID: NVSC2021US113694_NS). A contactable physician reported for a patient.  A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced platelets dropped to 6,000 dr. stated that she felt it was vaccine induced. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: severe muscle pain; numbness in both my arms and both my legs; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 12May2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe muscle pain and numbness in both arms and legs on 13May2021 (within 24 hours of the shot). The patient stated that, I am still experiencing pain and set to begin physical therapy this week with hopes that it helps restore my strength in my arms and legs as I am slowly losing strength to carry out daily activities. This is a first time occurrence for me, no history of any muscle pain in the past. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Eye pain, Oropharyngeal pain, Vaccination site rash
Clinical narrative: Rash at injection site; 2 days after: sore throat; Eye pain in one eye that lasted for a half hour; 3 bloody nose events; This is a spontaneous report from a contactable consumer (patient and patients mother). A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0180), dose 2 via intramuscular, administered in Left upper arm on 03Jun2021 15:00 (age at vaccination 13-year-old) as dose 2, single for covid-19 immunisation. The patient had no other medical history and no concomitant medications. The patient had no known allergies. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183), dose 1 via intramuscular, administered in Biceps/ Upper arm Left on 13May2021 17:30 (age at vaccination 13-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Jun2021 17:45 the patient experienced eye pain in one eye that lasted for a half hour, 3 bloody nose events within 4 hrs after vaccine, on 05Jun2021 (2 days after) the patient had sore throat. On 06Jun2021 the patient experienced Rash at injection site (covid arm). 3 bloody nose events within 4 hrs after vaccine required visit to consultation with primary care doctor. The patient did not receive any treatment for the events. Seriousness of the event was reported as non-serious. No relevant tests were done. The outcome of the events eye pain in one eye that lasted for a half hour, 3 bloody nose events, Rash at injection site was recovered on unspecified date in 2021 and sore throat was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased, Influenza like illness
Clinical narrative: Pulse rapid; Dizziness; Weakness; Feeling abnormal; Flu like symptoms; This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number and Expiration date was not reported) via intramuscular route of administration (age at vaccination 65-year) on 06Feb2021 as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA) received via subcutaneous route of administration from Sep2018 (Batch/Lot number: Unknown) and ongoing, as 40 mg, 1 in 2 weeks for ankylosing spondylitis, rheumatoid arthritis. Medical history included alcoholism (Alcohol use occasionally, four to five glass of wines per week) from 1973 to an unknown date; tobacco use from 2002 to 2007; Premature Atrial Contractions and Penicillin Allergy Manifested by Tissue Swelling, both from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient experienced pulse rapid, dizziness and weakness on 07Feb2021; flu like symptoms and feeling abnormal in 2021. It was reported that in 2021, the patient experienced flu like symptoms and feeling like been run over by truck. On 07Feb2021, the patient experienced rapid heart rate, dizziness and weakness. On 12Apr2021, the patient experienced HUMIRA was not effective as before, joint pain and joint stiffness. In Apr2021, the rapid heart rate, dizziness and weakness resolved. COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 06Feb2021, patient COVID-19 Vaccine manufactured by Pfizer. On 05Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. Therapeutic measures were taken as a result of the adverse events, as reported the patient was treated with PREDNISONE. The action taken in response to the events for adalimumab was unknown. The clinical outcome of pulse rapid, dizziness and weakness, was recovered on an unspecified date in Apr2021, while the outcome of other events was not recovered.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter & as causality for the events of rapid heart rate, dizziness, HUMIRA was not effective as before, joint pain, flu like symptoms, weakness, joint stiffness and feeling like been run over by truck with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Hypoaesthesia, Pyrexia
Clinical narrative: I feel like I was cold; Low grade fever; Have some numbness in my right fingers; This is a spontaneous report from a contactable consumer (patient). An unspecified age of female patient started to receive Bnt162b2 (BNT162B2; Formulation: Solution for injection; Lot number: It looks like EWO175) via unknown route of administration from unknown date with 2nd dose on left arm for COVID-19 immunization. Patient's Medical includes i have arthritis pretty badly so you know that may not be anything to do with shot I don't know. Concomitant medications were not reported. It was reported that "I had my second Pfizer shot yesterday afternoon around 2:00 or 2:30 and today about 3:00 I had I feel like I was cold. So, I took my temperature, and my temperature was 99.7 and then about 15-20 minutes later it was 100.2 and I have taken it again in the last hour might be so I saw that fever is the common side effect, so I did know if I needed to take an aspirin or something or what. And I had some numbness, both shot in my left arm, but I have some numbness in my right fingers, but I am elderly my date of birth is 1936 and I have arthritis pretty badly so you know that may not be anything to do with shot I don't know. I am running a low-grade fever so I just wandered if I need to take an aspirin or something." When confirmed vaccine as Pfizer Covid-19 Vaccine, consumer stated, "Yes and I just has the second one yesterday." When asked to probe further questions, Consumer stated "I am just trying to find out that if I need the second Aspirin or something about for the fever that is it.". The outcome of the events was "unknown". Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: She reports that her arm has become "magnetic" at the site of the two doses of the pfizer vaccine were injected.; This is a spontaneous report from a contactable consumer. A 28-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on an unspecified date single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had any known allergy. It was unknown, if patient received other vaccine in four weeks or any other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 since vaccination. On 14Jun2021, the patient reported that her arm has become "magnetic" at the site of the two doses of the Pfizer vaccine were injected. Patient MD friend contacted her to let her know that her MA was reporting that she saw on social media that people who received the Pfizer vaccine have become magnetic. The patient subsequently tried to stick various metal objects to her left arm, over the deltoid and noted that they stuck. She reported that her arm has become "magnetic" at the site of the two doses of the Pfizer vaccine were injected. Patient sent three pictures of her arm where a paperclip, small key and a small magnet seem to be balanced over the deltoid muscle/"stuck" to her. Treatment received was unknown. The clinical outcome of event was reported as unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Poking symptom on my left heart; This is a spontaneous report from a contactable consumer (patient). This consumer reported that, a patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced poking symptom on my left heart on Jun2021. It was reported that patient took the Pfizer vaccine (Unspecified vaccine) last, yesterday around 4 pm at one of the locations and from this morning and patient stated to have, it's something, like a poking symptom on his left heart. Patient was wondering if need to be taken care of at the hospital or can just wait to see. Later Consumer stated, so, right now it's already 8 pm, so, don't have any, this phone number patient can't use it. So, do they want the patient to call like hospital or emergency room and ask about symptom or do they happen to know if this was a serious symptom, or the patient don't have to worry about it. Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call. Reporter seriousness for Poking symptom on my left heart: Unspecified. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dysgeusia, Headache, Illness
Clinical narrative: Chills; Migraine; Diarrhea; very sick; Headache; metallic taste in my mouth; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW019), via an unspecified route of administration on 26Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, Patient took the Pfizer vaccine at withheld and felt right away that there's a metallic taste in mouth and then had nausea, vomited once and then on 27Jun2021 patient had the chills, got migraine, patient was vomiting and there's diarrhea, and asked what can be taken for headache. Patient asked whether to take Advil. patient cannot support it anymore. Patient was very sick and cannot answer. Consumer was unwilling to complete the report therefore further probing could not be done. Hence limited information available over the call. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Chills; Migraine; Diarrhea; very sick; Headache; metallic taste in my mouth; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW019), via an unspecified route of administration on 26Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, Patient took the Pfizer vaccine at withheld and felt right away that there's a metallic taste in mouth and then had nausea, vomited once and then on 27Jun2021 patient had the chills, got migraine, patient was vomiting and there's diarrhea, and asked what can be taken for headache. Patient asked whether to take Advil. patient cannot support it anymore. Patient was very sick and cannot answer. Consumer was unwilling to complete the report therefore further probing could not be done. Hence limited information available over the call. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient experienced blurry vision on 27Jun2021. When probed for the concern, patient stated patient got 2nd shot of Pfizer Covid Vaccine on Thursday on 24Jun2021 and today on 27Jun2021 patient was just experiencing blurry vision. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I have a huge amount of swelling in my arm pit area; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EW0185, Expiration date: not reported), via an unspecified route of administration on 25Jun2021 as dose number unknown, single for Covid -19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on Friday on an unspecified date and experienced a huge amount of swelling in arm pit area. The patient wanted to know if it common for people to get swelling in the arm area after the vaccine. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181), dose 1 via an unspecified route of administration on 11Jun2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, a week later, the patient experienced fever, chills, headache, shortness of breath and still having all issues. Outcome of the event was unknown.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: a patient was administered an  IPOL two days after it was expired/ No AE; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a other health care professional via physician via phone via Global Medical Information (GMI) number: 00696908.  This case involves a 15 years old male patient who was administered an IPV (VERO) [IPOL] two days after it was expired (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination and METHYLPREDNISOLONE (PD).  On 19-Jul-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot R1D972M, expiry date: 17-Jul-2021, Frequency: once, strength: standard, via intramuscular route in the deltoid (unsure which side) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine administered (latency: same day).  It was reported "Caller administered IPOL two days after it expired, she wants to know what she should do now, is the dose valid, is there any interaction with using an expired vaccine, when should she notify the patient. Caller states the patient did not report any adverse events."  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 the 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: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: The patient has received one polio vaccine prior to the administration of QUADRACEL.with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse via Global Medical Information (GMI) (Reference number- 00699306) and transmitted to Sanofi on 27-Jul-2021.  This case involved 5-year-old and unknown gender patient has received one polio vaccine prior to the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (extra dose administered)  The patient's past vaccination(s) included Pentacel at 18 months old for prophylactic vaccination.  Relevant medical history, medical treatment(s) concomitant medication and family history were not provided.   On an unknown date, the patient has received one polio vaccine prior to the administration of dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination (extra dose administered)  It was reported that, "Nurse called in regard to a patient that is due to be vaccinated for Tetanus and Polio. The patient has had one dose of QUADRACEL. The nurse would like to know if the patient can get an additional dose of QUADRACEL to satisfy this requirement? This information is limited due to possible AE (adverse event) identified after the call disconnected. Unknown reason for off schedule administration. Possible delay in dose. Nurse called in regard to a 5-year-old patient that is due to be vaccinated for Tetanus and Polio".  This was an actual medication error case due to extra dose administered (latency: same day)  At the time of reporting 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 the 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of ACT-HIB/no AE; Initial information was received on 27-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via global medical information (GMI) (Reference number- 00699546).  This case involves a child patient of unknown age and gender who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that "If a child receives an expired 1st dose of your HIB vaccine, do you recommend giving a replacement 1st dose? Would they receive any protection at all despite being expired? Would this change timing of the next dose? Lastly, Do you have any studies showing extended stability data beyond the expiration date? If about 20 days expired, can it be used?".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the 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.  There will be no information available on batch number for this case.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Cough, Neck pain
Clinical narrative: Heart Palpitations. Random  Sharp pain around left side of chest area and even left side of neck and left back side.  Strange feeling in chest area which makes me cough frequently.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations. Random  Sharp pain around left side of chest area and even left side of neck and left back side.  Strange feeling in chest area which makes me cough frequently.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Lacrimation increased, Ocular hyperaemia
Clinical narrative: About eight hours later, extreme fatigue, fever, chills, shivering, headache, body aches, red watery eyes
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: About eight hours later, extreme fatigue, fever, chills, shivering, headache, body aches, red watery eyes
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Chest X-ray, Chest discomfort, Electrocardiogram QT prolonged, Full blood count
Clinical narrative: AROUND 2100 MY SON C/O FEELING LIKE SOMEONE WAS SQUEEZING HIS HEART AND FEELING NAUSEATED. THE EKG ON HIS SMART WATCH WAS SHOWING SOME INVERTED, LONGATED WAVES. SO, I TOOK HIM TO THE HOSPITAL, EMERGENCY ROOM.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Troponin
Clinical narrative: AROUND 2100 MY SON C/O FEELING LIKE SOMEONE WAS SQUEEZING HIS HEART AND FEELING NAUSEATED. THE EKG ON HIS SMART WATCH WAS SHOWING SOME INVERTED, LONGATED WAVES. SO, I TOOK HIM TO THE HOSPITAL, EMERGENCY ROOM.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: Pain, sensitivity, and heat where vaccine wad injected. Major pain in the muscle the following days, pain is in the muscle and spreading over my shoulder, the same amount of pain as if I pulled muscles or pinched a nerve, I cannot use my right arm.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Rash, Rash erythematous
Clinical narrative: A red rash broke out on her arm that had the injection and also on her torso. Per the patient "her arm became red and blew up".; A red rash broke out on her arm that had the injection and also on her torso. Per the patient "her arm became red and blew up".; A red rash broke out on her arm that had the injection and also on her torso. Per the patient "her arm became red and blew up".; This spontaneous report was received from a nurse prescriber, concerning a 74-year-old female patient. The patient's previous drug reactions and allergies included sulfamethoxazole (+) trimethoprim (BACTRIM) and contrast media. No information was provided regarding the patient's pertinent medical history or concomitant medications.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route (IM) (dose, frequency, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prevention of pneumonia.  On approximately July 2011 reported as "10 years ago", the patient experienced a red rash broke out on her arm that had the injection and also on her torso (rash erythematous and vaccination site rash). According to the reporter, the patient's arm became red and blew up (vaccination site inflammation). It was unknown if the patient sought medical attention, if she received a treatment for the events or had any laboratory diagnostics or studies performed.  At the time of the report, the outcome of the events was unknown.  The causal relationship between the aforementioned events and the suspect vaccine was related.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain, Pruritus
Clinical narrative: small shingles on my back; itchy; burn pain / hate the burning pain I thought it was a spider bite; it blister up a Lil; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pruritus, pain burning and blister. On an unknown date, the outcome of the shingles, pruritus, pain burning and blister were unknown.   It was unknown if the reporter considered the shingles, pruritus, pain burning and blister to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient had shingles previously before getting the current shingles and patient stated that the previous shingles was worse than current one. The patient received the 1st dose of Shingles vaccine and patient experienced small shingles on back. The reporter mentioned that the shingles was itchy and burn pain. The patient would go for his/her 2nd dose in September. The patient stated that he/she hate burning pain and stated that he/she thought it was spider bite first but it blister up lil.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shot/ less than two weeks later he got shingles.; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient's children. The age at vaccination was not reported. The patient got the shot and less than two weeks later he got shingles. The follow-up would not possible as no contact details were available.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Condition aggravated, Herpes zoster, Incomplete course of vaccination
Clinical narrative: loose of vision in one eye; shingles; first dose /December of 2020/not had his second dose; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (5 years before the date of reporting) and heart attack. Concurrent medical conditions included bone marrow disorder, coronary stent placement, neuropathy, cancer and pancreatic disorder. Concomitant products included chemotherapy, nos (Chemotherapy).   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the loss of vision, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the loss of vision and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not applicable for 2nd dose. The patient received first dose of Shingrix and now currently experiencing shingles and had loss of vision in one eye and was seeking care. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to seek guidance, as to when he should receive his second dose of Shingrix. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired second dose of Havrix was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Havrix. On 26th July 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received an expired dose of Havrix and was later discovered, which led to expired vaccine used. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given a third dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 28th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The nurse reported that, the patient was accidently administered third dose of Shingrix, which led to extra dose administered. The nurse wanted to know if the patient might have any complications.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on Oct 23 2020 / has not received the 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.   The pharmacist asked should patient receive the 2nd dose of Shingrix at the time of reporting. Till the time of reporting the patient did not receive the 2nd dose of Shingrix,which led to incomplete course of vaccination. The reporter consented to follow up. The HCP (health care professional) declined to leave any additional patient details.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Cold sweat, Headache, Pain, Pyrexia
Clinical narrative: PAIN ALL OVER BODY; BONE PAIN/COULD FEEL EACH ONE OF BONES BECAUSE THEY WERE HURTING SO BAD; COLD SWEAT; FEVER THAT WOULD NOT GO DOWN; EXTREME HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pain all over body, bone pain/could feel each one of bones because they were hurting so bad, cold sweat, fever that would not go down, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever that would not go down, and the outcome of pain all over body, cold sweat, bone pain/could feel each one of bones because they were hurting so bad and extreme headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a parent via a company representative concerned a 27year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021 (Monday), the patient experienced sore throat, body aches with no fever. It was reported that the patient had over the counter medication, but he still felt ill. On 28-JUL-2021 (Wednesday), the patient tested positive for covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187932.; Sender's Comments: V0: 20210800788-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a female patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history and no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date was not reported, administered into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-JUL-2021, the patient lost sense of smell (suspected covid-19 infection) and suspected clinical vaccination failure. On 28-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801295-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related.The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Nausea, Pain in extremity
Clinical narrative: STUFFY NOSE NEXT DAY OF VACCINATION; ARM HURTING; NAUSEA; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced stuffy nose next day of vaccination, arm hurting, nausea, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stuffy nose next day of vaccination, arm hurting, nausea, and tired. This report was non-serious. This case, from the same reporter is linked to 20210801898.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Peripheral swelling
Clinical narrative: SWELLING IN BOTH CALVES; HEADACHE; TIREDNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced tiredness. On 10-JUN-2021, the subject experienced swelling in both calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, tiredness, and swelling in both calves. This report was non-serious. This case, from the same reporter is linked to 20210800565.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210801525.