chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received booster dose 5 months after second dose instead of 6 months; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received booster dose 5 months after second dose instead of 6 months) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031A21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received booster dose 5 months after second dose instead of 6 months). On 25-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received booster dose 5 months after second dose instead of 6 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-366716 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Fever 100°F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever 100°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever 100°F). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever 100°F.         No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-367562 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Migraine
Clinical narrative: the left one is swollen and I don't know how to explain it except it's "thicker".; migraine; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on 03Mar2021 as dose 2, single for covid-19 immunisation. Medical history included knee replacements and migraine. Concomitant medicine were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced the left one is swollen and i don't know how to explain it except it was "thicker" and migraine . Caller enquired whether the patient can take an Aleve for a migraine. It is 4 days after the vaccine. The migraine was not necessary due to the vaccination it was not unusual for the patient to get them (not clarified if having migraine before vaccine, hence conservatively captured as an event in the tab. The patient have had trouble with knee replacements and the right one was fine, the left one was swollen and do not know how to explain it except it was thicker. Consumer stated that patient received second dose of Pfizer Vaccine and understand that the patient was not supposed to be taking any pain relievers before the patient got the second vaccine which patient did not but the patient had issues with migraine can the patient take Aleve, the patient got the second dosage on Wednesday the third. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: dizziness; Severe fatigue; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198, NDC number and expiry date: unknown), via an unspecified route of administration on 03Mar2021 at 10:00 (at the age of 83-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included radiotherapy. She started the radiation about 3-4 weeks ago and she had 10 sessions. She clarified that she finished the radiation treatments about 25Feb2021. She was 83 and was immune compromised. Concomitant medications were not reported. It was reported that on 03Mar2021, the patient experienced dizziness. She said in the morning it was better. She felt dizziness and she was wondering if that was normal. Till 08Mar2021 and it was still going on, it had subsided. She clarified it had not completely gone away, it was ongoing but improved. She said she also had a question; she was 83 and she is immune compromised, so these were not new symptoms to her. On 03Mar2021, she started with fatigue, extreme fatigue and a little dizziness and no temperature and maybe a little muscle pain but nothing to really be concerned with regard to the shot. She said the fatigue began right away after the shot and lasted for about 2-3 days. She reported that out from Wednesday to Thursday to Friday to Saturday that was 3 days she thought. She said extreme fatigue was recovered but she would say fatigue was ongoing but improved. She was scheduled for the second dose on 24Mar2021 which was a Wednesday, and her question was if it was possible to postpone the second dose about 10 days or 2 weeks and get it when she comes back after her trip because she was supposed to get the second shot a day before she travels. She asked if reactions to the second vaccine dose expected to be worse than they were from the first. The outcome of the events dizziness and severe fatigue was resolving and for muscle pain was unknown.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Ear pain, Gastrooesophageal reflux disease, Lymphadenopathy, Upper-airway cough syndrome
Clinical narrative: Postnasal drip; Reflux; Glands on the left side are swollen; Ear hurts a little bit; uncomfortable; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced postnasal drip, reflux, glands on the left side are swollen, ear hurts a little bit, uncomfortable. Patient has to receive her second vaccine tomorrow and had a lot of post-nasal drip and also had reflux. And occasionally, at times in the past, she got swollen glands. So right now, her glands on the left side were swollen, her ear hurts a little bit. Certainly, they don't want you to have the COVID if you get the vaccine. But what about, she doesn't think it was a viral or bacterial infection, but she doesn't know if it was a danger for her to get the Pfizer vaccine tomorrow, her second one. Clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site has been slightly sore for almost a week; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced injection site has been slightly sore for almost a week. It was reported that the received the first dose of Pfizer Covid-19 vaccine this morning and later today he had a dental procedure done. His dentist will prescribe an antibiotic. The patient wanted to know if he could take the medication after receiving the 1st dose. It was reported that the patient stated his injection site has been slightly sore for almost a week. It wasn't sore for the first couple days and has developed some soreness. The patient stated soreness isn't bad and does not want to talk about it. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: chills; muscle and joint pain; muscle and joint pain; tiredness; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of 60-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729), dose 1 via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunization. Medical history included hernia repair, prostatomegaly from an, neck surgery. On an unspecified indication patient had Concomitant medication(s) included hydromorphone hydrochloride (DILAUDID) taken for pain; oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]); terazosin; finasteride (PROSCAR); nortriptyline; lubiprostone taken for an unspecified indication, start and stop date were not reported; ketorolac; omeprazole; pregabalin (LYRICA); paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; tizanidine hydrochloride (ZANAFLEX) as start and stop date were not reported. On an unspecified date, patient experienced chills, muscle and joint pain, muscle and joint pain, tiredness. The outcome reported was unknown. No follow up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable physician. A 27-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Patient Age at Time of Vaccination:27) as a second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received historical vaccine of first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot EK9237 expiry: 30Apr2021) via an unspecified route of administration on arm left on 29Dec2020 10:00 as a first dose for covid-19 immunisation.Time vaccination was given: 10:00 (24 hour clock). On an unspecified date the patient experienced fever. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Causal Relationship: there is a reasonable possibility that the event is related to suspect products. Events were reported as non- serious. The outcome for the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Ageusia, Diarrhoea, Dry mouth
Clinical narrative: diarrhea; extreme dry mouth; loss of taste; brain fog; fatigue; sharp stomach pains; bloating; reflux; intermittent laryngitis; This is spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 at 14:15 pm (age at vaccination was 59 years) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol from an unknown date. Concomitant medications included fenofibrate, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and progesterone all taken for an unspecified indication. The patient previously took tetanus and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Mar2021 at 16:15 pm (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization and 3 days after 1st dose, the patient experienced stomach pains, bloating, diarrhea, headache & dry mouth w/loss of taste which lasted for 13 days. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021, 2 days after 2nd dose, the patient experienced extreme dry mouth, loss of taste, brain fog, fatigue, sharp stomach pains, bloating, reflux, diarrhea, intermittent laryngitis, still had the symptoms. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test (nasal swab): negative on 09Apr2021, MRI (Magnetic resonance imaging) and abdominal ultrasound with unknown results on an unspecified date. The patient received treatment for the events. The patient had a restricted diet. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Laryngitis, Magnetic resonance imaging
Clinical narrative: diarrhea; extreme dry mouth; loss of taste; brain fog; fatigue; sharp stomach pains; bloating; reflux; intermittent laryngitis; This is spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 at 14:15 pm (age at vaccination was 59 years) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol from an unknown date. Concomitant medications included fenofibrate, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and progesterone all taken for an unspecified indication. The patient previously took tetanus and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Mar2021 at 16:15 pm (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization and 3 days after 1st dose, the patient experienced stomach pains, bloating, diarrhea, headache & dry mouth w/loss of taste which lasted for 13 days. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021, 2 days after 2nd dose, the patient experienced extreme dry mouth, loss of taste, brain fog, fatigue, sharp stomach pains, bloating, reflux, diarrhea, intermittent laryngitis, still had the symptoms. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test (nasal swab): negative on 09Apr2021, MRI (Magnetic resonance imaging) and abdominal ultrasound with unknown results on an unspecified date. The patient received treatment for the events. The patient had a restricted diet. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ultrasound abdomen
Clinical narrative: diarrhea; extreme dry mouth; loss of taste; brain fog; fatigue; sharp stomach pains; bloating; reflux; intermittent laryngitis; This is spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 at 14:15 pm (age at vaccination was 59 years) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol from an unknown date. Concomitant medications included fenofibrate, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and progesterone all taken for an unspecified indication. The patient previously took tetanus and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Mar2021 at 16:15 pm (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization and 3 days after 1st dose, the patient experienced stomach pains, bloating, diarrhea, headache & dry mouth w/loss of taste which lasted for 13 days. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021, 2 days after 2nd dose, the patient experienced extreme dry mouth, loss of taste, brain fog, fatigue, sharp stomach pains, bloating, reflux, diarrhea, intermittent laryngitis, still had the symptoms. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test (nasal swab): negative on 09Apr2021, MRI (Magnetic resonance imaging) and abdominal ultrasound with unknown results on an unspecified date. The patient received treatment for the events. The patient had a restricted diet. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm was hurting; elbow was hurting; This is a spontaneous report from a contactable consumer (patient friend).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm was hurting and elbow was hurting on unspecified date. The reporter stated that the patient had the shot about 50 days ago and her arm was hurting and then complained her elbow was hurting yesterday. She did not think it was related to the vaccine. The outcome of the events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: severe joint pain in her arm; so severe that she can't move her arm; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 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. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the patient experienced severe joint pain in her arm and so severe that she can't move her arm. The patient had never experienced something this severe before in her life. The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain and swelling; Injection site pain and swelling; This is a spontaneous report from a contactable consumer (patient). This 69-year-old Male consumer reported in response to consumer letter sent via follow-up letter which included that:  A 69-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration on 01Mar2021 (69-year-old at the time of vaccination) as dose 2, single for Covid-19 immunization. Medical history included Seasonal pet allergies from 04Jan1968 to an unknown date, asthma from an unknown date and unknown if ongoing, bronchitis chronic from an unknown date and unknown if ongoing, obesity from 1990 to an unknown date, uterine cancer from 2018 to an unknown date, Skin rash from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration on 08Feb2021 (69-year-old at the time of vaccination) as dose 1, single for covid-19 immunization and experienced injection site pain, swelling and mild headache, sensitivity to light. On 01Mar2021, the patient experienced injection site pain, swelling. The patient did not received any treatment. The outcome of events recovered on unspecified date on 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: my arm itched a little bit; This is a spontaneous report from a Pfizer sponsored program Support. Report from a non-contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced my arm itched a little bit. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in her leg; This is a spontaneous report from a non-contactable Consumer or other non-HCP (patient) communicated to Pfizer-sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 19May2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24May2021, after 5 days, the patient developed a rash in her leg. The reporter reported that, after 5 days, she developed a rash in her leg. She called in because she rescheduled her second dose of the vaccine from June 11 to June 18 to allow the rash to heal. She wanted to know if that is okay and if the efficacy will be the same. Caller refused to provide her mailing address and phone number. Outcome of the event was unknown at the time of this report. Information on the lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Extra dose administered, Fatigue, Rash, Rash erythematous
Clinical narrative: Tired, slight chest pains, low fever. Red rash on my left cheek; I also remembered that I had those red rashes after my second does COVID vaccine shot.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Tired, slight chest pains, low fever. Red rash on my left cheek; I also remembered that I had those red rashes after my second does COVID vaccine shot.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Cardiac disorder, Chills, Headache, Hyperhidrosis
Clinical narrative: shaking, chills, strong headache, nausea, cardiac colic, sweating profusely, lower leg's viens increased in size
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vein disorder
Clinical narrative: shaking, chills, strong headache, nausea, cardiac colic, sweating profusely, lower leg's viens increased in size
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Patient fainted briefly about 12 hours after receiving the vaccine. Patient had muscle spasms in her hands before fainting. Patient also experienced nausea, fever, headache, and chills.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted briefly about 12 hours after receiving the vaccine. Patient had muscle spasms in her hands before fainting. Patient also experienced nausea, fever, headache, and chills.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Burning sensation, Condition aggravated, Herpes simplex
Clinical narrative: Arm soreness starting night of first day (05/08/21), rash begins to appear.  Morning (5/09/21) continued larger area of soreness with swelling at injection site, rash grows in size at injection site to 2 inches diameter.  Rash persists for 5 (five) weeks after injection growing to largest size (4-5 inches) 7 days after administration.  Subcutaneous itching begins at day 2 after vaccine at injection site.  Subcutaneous itching worsens for four weeks after administration.  Arm soreness is replaced by dull persistent ache around injection site with shooting pains, joint and muscle pain sporadically throughout left arm continuing to the present day (11/04/21).  Ache in left shoulder lower deltoid has become ...constant, chronic and more intense which is limiting and restricting my ability to lift, clutch, strain, or push objects. Deep tissue muscle ache, joint discomfort and emanating sharp pains are now constant even when arm is completely at rest.  Emanating sharp pains are often accompanied by a burning sensation that began to appear around (07/01/21) but has become more noticeable and constant, especially in and around the left elbow and sometimes shoulder and wrist.  My left arm seems to have waning strength and what feels similar to soft tissue tears in both the shoulder and now the elbow and forearm.   Acute pain/discomfort persists at bottom of left deltoid in deep muscle tissue/tendon connection.  Within three days following the administration of the Moderna vaccine I experienced a series of persistent and spreading HSV2 outbreaks that were as severe and worse than any I'd experienced prior.  I had not needed to take a daily course of ValAcyclovir prior to getting the Moderna vaccine for many months.   Once the outbreaks began I was forced to take the medication twice daily and continue to take it daily as the prodrome is now a constant feeling indicating an outbreak is imminent.  The Valacylovir severely affects my digestive track causing diarrhea but there is no alternative.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Injection site discomfort, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Arm soreness starting night of first day (05/08/21), rash begins to appear.  Morning (5/09/21) continued larger area of soreness with swelling at injection site, rash grows in size at injection site to 2 inches diameter.  Rash persists for 5 (five) weeks after injection growing to largest size (4-5 inches) 7 days after administration.  Subcutaneous itching begins at day 2 after vaccine at injection site.  Subcutaneous itching worsens for four weeks after administration.  Arm soreness is replaced by dull persistent ache around injection site with shooting pains, joint and muscle pain sporadically throughout left arm continuing to the present day (11/04/21).  Ache in left shoulder lower deltoid has become ...constant, chronic and more intense which is limiting and restricting my ability to lift, clutch, strain, or push objects. Deep tissue muscle ache, joint discomfort and emanating sharp pains are now constant even when arm is completely at rest.  Emanating sharp pains are often accompanied by a burning sensation that began to appear around (07/01/21) but has become more noticeable and constant, especially in and around the left elbow and sometimes shoulder and wrist.  My left arm seems to have waning strength and what feels similar to soft tissue tears in both the shoulder and now the elbow and forearm.   Acute pain/discomfort persists at bottom of left deltoid in deep muscle tissue/tendon connection.  Within three days following the administration of the Moderna vaccine I experienced a series of persistent and spreading HSV2 outbreaks that were as severe and worse than any I'd experienced prior.  I had not needed to take a daily course of ValAcyclovir prior to getting the Moderna vaccine for many months.   Once the outbreaks began I was forced to take the medication twice daily and continue to take it daily as the prodrome is now a constant feeling indicating an outbreak is imminent.  The Valacylovir severely affects my digestive track causing diarrhea but there is no alternative.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Laboratory test, Mobility decreased, Myalgia, Pain
Clinical narrative: Arm soreness starting night of first day (05/08/21), rash begins to appear.  Morning (5/09/21) continued larger area of soreness with swelling at injection site, rash grows in size at injection site to 2 inches diameter.  Rash persists for 5 (five) weeks after injection growing to largest size (4-5 inches) 7 days after administration.  Subcutaneous itching begins at day 2 after vaccine at injection site.  Subcutaneous itching worsens for four weeks after administration.  Arm soreness is replaced by dull persistent ache around injection site with shooting pains, joint and muscle pain sporadically throughout left arm continuing to the present day (11/04/21).  Ache in left shoulder lower deltoid has become ...constant, chronic and more intense which is limiting and restricting my ability to lift, clutch, strain, or push objects. Deep tissue muscle ache, joint discomfort and emanating sharp pains are now constant even when arm is completely at rest.  Emanating sharp pains are often accompanied by a burning sensation that began to appear around (07/01/21) but has become more noticeable and constant, especially in and around the left elbow and sometimes shoulder and wrist.  My left arm seems to have waning strength and what feels similar to soft tissue tears in both the shoulder and now the elbow and forearm.   Acute pain/discomfort persists at bottom of left deltoid in deep muscle tissue/tendon connection.  Within three days following the administration of the Moderna vaccine I experienced a series of persistent and spreading HSV2 outbreaks that were as severe and worse than any I'd experienced prior.  I had not needed to take a daily course of ValAcyclovir prior to getting the Moderna vaccine for many months.   Once the outbreaks began I was forced to take the medication twice daily and continue to take it daily as the prodrome is now a constant feeling indicating an outbreak is imminent.  The Valacylovir severely affects my digestive track causing diarrhea but there is no alternative.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Arm soreness starting night of first day (05/08/21), rash begins to appear.  Morning (5/09/21) continued larger area of soreness with swelling at injection site, rash grows in size at injection site to 2 inches diameter.  Rash persists for 5 (five) weeks after injection growing to largest size (4-5 inches) 7 days after administration.  Subcutaneous itching begins at day 2 after vaccine at injection site.  Subcutaneous itching worsens for four weeks after administration.  Arm soreness is replaced by dull persistent ache around injection site with shooting pains, joint and muscle pain sporadically throughout left arm continuing to the present day (11/04/21).  Ache in left shoulder lower deltoid has become ...constant, chronic and more intense which is limiting and restricting my ability to lift, clutch, strain, or push objects. Deep tissue muscle ache, joint discomfort and emanating sharp pains are now constant even when arm is completely at rest.  Emanating sharp pains are often accompanied by a burning sensation that began to appear around (07/01/21) but has become more noticeable and constant, especially in and around the left elbow and sometimes shoulder and wrist.  My left arm seems to have waning strength and what feels similar to soft tissue tears in both the shoulder and now the elbow and forearm.   Acute pain/discomfort persists at bottom of left deltoid in deep muscle tissue/tendon connection.  Within three days following the administration of the Moderna vaccine I experienced a series of persistent and spreading HSV2 outbreaks that were as severe and worse than any I'd experienced prior.  I had not needed to take a daily course of ValAcyclovir prior to getting the Moderna vaccine for many months.   Once the outbreaks began I was forced to take the medication twice daily and continue to take it daily as the prodrome is now a constant feeling indicating an outbreak is imminent.  The Valacylovir severely affects my digestive track causing diarrhea but there is no alternative.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Loss of consciousness, Musculoskeletal stiffness, Panic attack, Vomiting
Clinical narrative: After administering the 2 vaccines for the patient (covid vaccine and Flu vaccine) the patient stated she feel dizzy and gonna stay in the immunization room till she feels better, then she started to have body stiffness and like black out for 45 seconds , I held her not to fall and injure herself . the pharmacy associates called ambulance and called for code white. customer was still alert , I put her on the floor on her side as instructed by ambulance team .she started vomiting, I cleaned her mouth and made sure she can breath. the ambulance team came, she was alert and communicated with them. they identified the situation as panic attack. the customer stayed in the immunization room with a member of management  to take her statement till someone of family members came for her.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node swelling in arm pit of the arm receiving the vaccine. Large tennis-ball sized lump appeared, which was moderately sore.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Coronary arterial stent insertion, Coronary artery occlusion, Electrocardiogram abnormal
Clinical narrative: Myocardial Infarction descending anterior artery total blockage.  Severe middle chest pain.  Clot cleared with Catheter Stent procedure
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial Infarction descending anterior artery total blockage.  Severe middle chest pain.  Clot cleared with Catheter Stent procedure
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Two and a half days after receiving the booster vaccination, my arm (near sight of injection) swelled up a lot (from shoulder to almost my elbow) and was extremely painful and was red in color and very hot to the touch. I've been icing my arm. I phoned my doctor, and I am waiting for her to call me back.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt state left arm was redness and swelling and some itching after receiving the pneumovax and flu shot. Pt had flu shots before without reaction. Could be pneumovax.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: After about a week I got Bells palsey
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Pain
Clinical narrative: None stated.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Echocardiogram abnormal, Exposure to vaccinated person
Clinical narrative: A male who did not receive the COVID-19 vaccination developed chest pain and pericarditis after being in the same space as ten vaccinated people on a daily basis. The male had to be prescribed one medication to alleviate the symptoms. Echo limited showed the pericarditis. The male also gets an upset stomach and a feeling of lightheadedness every time he goes near at least six of the vaccinated people. After the male self-isolates for several days, his symptoms clear. Then as soon as he goes near the vaccinated people, his symptoms return.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: A male who did not receive the COVID-19 vaccination developed chest pain and pericarditis after being in the same space as ten vaccinated people on a daily basis. The male had to be prescribed one medication to alleviate the symptoms. Echo limited showed the pericarditis. The male also gets an upset stomach and a feeling of lightheadedness every time he goes near at least six of the vaccinated people. After the male self-isolates for several days, his symptoms clear. Then as soon as he goes near the vaccinated people, his symptoms return.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Platelet count decreased, Purpura, Thrombocytopenia
Clinical narrative: Petechiae and diffuse subcutaneous purpura on left arm
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue
Clinical narrative: severe depression, fatigue and braking fog
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received a booster dose of Moderna in the amount of 0.5mL vs. 0.25mL
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain, shortness of breath
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Muscle contracture, Respiratory tract irritation
Clinical narrative: Dry cough for a month. Felt like lungs were irritated and muscles were contracting to cough constantly. Cough has calmed down after a month, but still comes back infrequently.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Genital burning sensation, Genital paraesthesia
Clinical narrative: Testicle burning and tingling
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dysmenorrhoea, Emotional distress, Headache, Influenza like illness
Clinical narrative: Right away I started getting period cramps. I got my period a week and a half EARLY after having very steady period for a long time. I had horrible period symptoms: bag cramps, the WORST acne I?ve even had, headaches, and was very emotional.   I also received flu like symptoms for 24 hours the next morning. Body aches, headache, runny nose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Rhinorrhoea
Clinical narrative: Right away I started getting period cramps. I got my period a week and a half EARLY after having very steady period for a long time. I had horrible period symptoms: bag cramps, the WORST acne I?ve even had, headaches, and was very emotional.   I also received flu like symptoms for 24 hours the next morning. Body aches, headache, runny nose.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal cardiac arrest, Stillbirth
Clinical narrative: Was 33weeks and 6 days pregnant on 9/23/21 that morning I had a non stress test done to monitor my baby as I got them done twice weekly and she was perfectly fine. I got my second covid vaccine that afternoon. Sometime after that and sunday morning my babies heart stopped beating and I had to deliver her stillborn. The autopsy and placenta pathology came back normal. Vaccine is only cause.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Urticaria
Clinical narrative: Chronic hives, joint pain, joint swelling
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: a total of 0.5mL was given instead of 0.25mL for the third dose as a booster. There were no adverse events up to 20min after dose was given which was when patient left. He was given pharmacy phone number/card in case there were unusual adverse effects afterwards.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Eye pain, Fibrin D dimer, Full blood count normal, Headache
Clinical narrative: Anaphylaxis 1 hour later (hives tightness in throat) given Benadryl at home. Symptoms subsided 15 minutes later. Severe  leg cramps for 5 days post vaxxed. Severe head pain behind right eye starting one day after vaccine and subsiding 3 days later.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Throat tightness, Urticaria
Clinical narrative: Anaphylaxis 1 hour later (hives tightness in throat) given Benadryl at home. Symptoms subsided 15 minutes later. Severe  leg cramps for 5 days post vaxxed. Severe head pain behind right eye starting one day after vaccine and subsiding 3 days later.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Tachycardia, Throat irritation, Urticaria
Clinical narrative: Hives, cotton mouth, tachycardia (150?s), and itchy throat. Treated with Benadryl and epi.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Nausea, heart palpitations  it?s been 5 days and still have symptoms
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: feeling aches; tired; fever; This case was reported by a nurse via other manufacturer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included colecalciferol (Vitamin D3) unknown for product used for unknown indication, vitamin B substances nos (Vitamin B Complex) for product used for unknown indication, lenvatinib mesilate (Lenvima) (batch number 1112974, expiry date 31st August 2023) for product used for unknown indication, naproxen (Aleve) for product used for unknown indication and pembrolizumab (Keytruda) for product used for unknown indication.   Concurrent medical conditions included drug allergy (Cefaclor, cephalosporine, neuromuscular blockers, steroidal, penicillanic, sulfone BL Beta lactamase inhibiters, penicillin).   On an unknown date, the patient received Shingles vaccine, Vitamin D3 at an unknown dose and frequency and Vitamin B Complex at an unknown dose and frequency. On 9th March 2021, the patient started Lenvima 20 mg once daily (20 mg daily). On an unknown date, the patient started Aleve at an unknown dose and frequency and Keytruda at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Vitamin D3, the patient experienced pain, tiredness and fever. The action taken with Vitamin D3 was unknown. The action taken with Vitamin B Complex was unknown. The action taken with Lenvima was unknown. The action taken with Aleve was unknown. The action taken with Keytruda was unknown. On an unknown date, the outcome of the pain, tiredness and fever were unknown.   It was unknown if the reporter considered the pain, tiredness and fever to be related to Shingles vaccine and Vitamin D3.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingle shot and was feeling aches, tired and had fever. Wanted to know if it was OK to skip the dose consulted to take continuously and reach out to MD to discuss further information was provided. The patient was taking vitamin b-complex , Vitamin D3, Lenvima, Keytruda and Aleve at or around the time of the event  It was unknown if the reporter considered the pain, tiredness and fever to be related to Vitamin B Complex, Lenvima, Aleve and Keytruda.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: BODY ACHES; SORE THROAT; TIGHTNESS IN THE THROAT; CHILLS; FATIGUE; BAD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight was 185 pounds, and height was 73 inches. The patient's concurrent conditions included: pollen allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy and had no medical conditions. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced sore throat. On 02-NOV-2021, the patient experienced tightness in the throat. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fatigue. On 02-NOV-2021, the patient experienced bad headache. On 02-NOV-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, bad headache, and fever, and the outcome of sore throat, tightness in the throat and fatigue was not reported. This report was non-serious.