chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dry eye, Headache, Hyperhidrosis
Clinical narrative: Severe side effects for the first shot and slight side effects to the first shot. For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a; and I had headaches, severe shoulder pain, and neck stiffness and pain.; severe shoulder pain, and neck stiffness and pain.; neck stiffness and pain.; neck stiffness and pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: fu0176) at the age of 33 years as dose 2, single for covid-19 immunisation.The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number-fw0178, lot unknown-False, administration date=03Aug2021,administration time=06:00 PM, dose number-1, vaccine location=Left arm), administration date: 03Aug2021, when the patient was 33 years old, for COVID-19 IMMUNISATION. The following information was reported: Eye infection(non-serious) with onset 25Aug2021,outcome "recovering", described as "Severe side effects for the first shot and slight side effects to the first shot.For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a"Headache(non-serious) with onset 25Aug2021,outcome "recovering", described as "and I had headaches, severe shoulder pain, and neck stiffness and pain."; Arthralgia(non-serious) with onset 25Aug2021,outcome "recovering", described as "severe shoulder pain, and neck stiffness and pain."; musculoskeletal Stiffness(non-serious), Neck pain (non-serious) all with onset 25Aug2021, outcome "recovering" and all described as "neck stiffness and pain.". Therapeutic measures were not taken as a result of eye infection, headache, arthralgia, musculoskeletal stiffness, neck pain.  Additional Information:Severe side effects for the first shot and slight side effects to the first shot.For the second shot,I have had severe headaches, dry eyes, a fever, and chills.It has been 48 hours since my shot, and I am still exhibiting effects. At 5 AM this morning, I woke up drenched in sweat while uncontrollably shivering.I have had to resort to taking Tylenol and Advil to try to curb the severe headaches.My injection site is extremely sore to the point that I was unable to lift my arm above my waist yesterday.I have also had severe joint stiffness and pain.For the first shot,I contracted an eye infection in the eye on the same side as the injection,and I had headaches, severe shoulder pain, and neck stiffness and pain.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Pyrexia, Vaccination site pain
Clinical narrative: Severe side effects for the first shot and slight side effects to the first shot. For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a; and I had headaches, severe shoulder pain, and neck stiffness and pain.; severe shoulder pain, and neck stiffness and pain.; neck stiffness and pain.; neck stiffness and pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: fu0176) at the age of 33 years as dose 2, single for covid-19 immunisation.The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number-fw0178, lot unknown-False, administration date=03Aug2021,administration time=06:00 PM, dose number-1, vaccine location=Left arm), administration date: 03Aug2021, when the patient was 33 years old, for COVID-19 IMMUNISATION. The following information was reported: Eye infection(non-serious) with onset 25Aug2021,outcome "recovering", described as "Severe side effects for the first shot and slight side effects to the first shot.For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a"Headache(non-serious) with onset 25Aug2021,outcome "recovering", described as "and I had headaches, severe shoulder pain, and neck stiffness and pain."; Arthralgia(non-serious) with onset 25Aug2021,outcome "recovering", described as "severe shoulder pain, and neck stiffness and pain."; musculoskeletal Stiffness(non-serious), Neck pain (non-serious) all with onset 25Aug2021, outcome "recovering" and all described as "neck stiffness and pain.". Therapeutic measures were not taken as a result of eye infection, headache, arthralgia, musculoskeletal stiffness, neck pain.  Additional Information:Severe side effects for the first shot and slight side effects to the first shot.For the second shot,I have had severe headaches, dry eyes, a fever, and chills.It has been 48 hours since my shot, and I am still exhibiting effects. At 5 AM this morning, I woke up drenched in sweat while uncontrollably shivering.I have had to resort to taking Tylenol and Advil to try to curb the severe headaches.My injection site is extremely sore to the point that I was unable to lift my arm above my waist yesterday.I have also had severe joint stiffness and pain.For the first shot,I contracted an eye infection in the eye on the same side as the injection,and I had headaches, severe shoulder pain, and neck stiffness and pain.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Eye infection, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe side effects for the first shot and slight side effects to the first shot. For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a; and I had headaches, severe shoulder pain, and neck stiffness and pain.; severe shoulder pain, and neck stiffness and pain.; neck stiffness and pain.; neck stiffness and pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 18:00 (Lot number: fu0176) at the age of 33 years as dose 2, single for covid-19 immunisation.The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number-fw0178, lot unknown-False, administration date=03Aug2021,administration time=06:00 PM, dose number-1, vaccine location=Left arm), administration date: 03Aug2021, when the patient was 33 years old, for COVID-19 IMMUNISATION. The following information was reported: Eye infection(non-serious) with onset 25Aug2021,outcome "recovering", described as "Severe side effects for the first shot and slight side effects to the first shot.For the second shot, I have had severe headaches, dry eyes, a fever, and chills. It has been 48 hours since my shot, a"Headache(non-serious) with onset 25Aug2021,outcome "recovering", described as "and I had headaches, severe shoulder pain, and neck stiffness and pain."; Arthralgia(non-serious) with onset 25Aug2021,outcome "recovering", described as "severe shoulder pain, and neck stiffness and pain."; musculoskeletal Stiffness(non-serious), Neck pain (non-serious) all with onset 25Aug2021, outcome "recovering" and all described as "neck stiffness and pain.". Therapeutic measures were not taken as a result of eye infection, headache, arthralgia, musculoskeletal stiffness, neck pain.  Additional Information:Severe side effects for the first shot and slight side effects to the first shot.For the second shot,I have had severe headaches, dry eyes, a fever, and chills.It has been 48 hours since my shot, and I am still exhibiting effects. At 5 AM this morning, I woke up drenched in sweat while uncontrollably shivering.I have had to resort to taking Tylenol and Advil to try to curb the severe headaches.My injection site is extremely sore to the point that I was unable to lift my arm above my waist yesterday.I have also had severe joint stiffness and pain.For the first shot,I contracted an eye infection in the eye on the same side as the injection,and I had headaches, severe shoulder pain, and neck stiffness and pain.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: developed rash and itching on her entire arms; developed rash and itching on her entire arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 13:55 (Lot number: EW0169, Expiration Date: Aug2021) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD", start date: 2018 (unspecified if ongoing); "Diabetic", start date: 2017 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose:  05May2021, Lot: EN6204, expiry date: Jun2021, Left arm , DOSE 1, SINGLE), administration date: 05May2021, for COVID-19 Immunisation; Bnt162b2 (Second dose :26May2021, Lot: EN6204, expiry date, Jun2021 Left arm, DOSE 2,SINGLE), administration date: 26May2021, for COVID-19 Immunisation. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 25Aug2021 16:30, outcome "not recovered" and all described as "developed rash and itching on her entire arms".  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.  Additional information: The Patient's Age at Time of Vaccination in Months was 51 years. The Vaccine did not Administered at Facility. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations not available. The patient did not require Emergency Room or Physician Office visit. The patient did not receive any other vaccination prior within 4 weeks of vaccination. There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Adverse event following prior vaccinations.  The COPD and Diabetes were the Medical history including any illness at time of vaccination. There were not any family Medical History Relevant to AE. There were no relevant Tests  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: tightness of chest; difficulty of breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tightness of chest"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty of breathing". Clinical course: The patient got a pneumococcal vaccine shot last 2001/2002 however she is unsure of the brand. She experienced difficulty of breathing and tightness of chest. The patient is concerned that she might experience the same side effects with the Pfizer BioNTech Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: After 2nd dose, I got fever; rash after second dose (around the vaccination area); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 12:30 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dry eye" (unspecified if ongoing). Concomitant medication(s) included: FLUOROMETHOLONE taken for dry eye (ongoing); RESTASIS taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (1st dose , lot number FA7484, Route, Anatomical Location: left arm, Time: 12:30 PM), administration date: 04Aug2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I was feeling tired".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "After 2nd dose, I got fever"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash after second dose (around the vaccination area)".  Additional information: pro-vaccination, Illness/AE, Relevant Tests, AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) was None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. It was reported that all events occurred the same day as she was given the second dose. No other vaccines given the same day and no problems with vaccines in the past.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110877 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110878 Same reporter, different patient, same drug/event (split)
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: a lot of rash on his back and shoulder; hives on his back and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Jul2021 14:00 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing), notes: diagnosed 3 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Arm left), administration date: 02Jun2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 13Jul2021, outcome "not recovered", described as "a lot of rash on his back and shoulder"; URTICARIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "hives on his back and shoulders".  Additional information: Reporter stated that about a month and a half ago she and her family received the Pfizer Covid-19 vaccine, the day after receiving the second dose of the vaccine, her husband began to experience an allergy in the back and shoulders, he had many hives. Reporter stated that this reaction did not present with the first dose and the other members of her family did not have this reaction either. Reporter stated that patient had (not every day) a lot of rashes on his back and big hives on his back and shoulders. The next day after the second dose of the vaccine, he had an allergic reaction. Reporter stated that patient was still experiencing this reaction. Reporter stated that patient had rash and hives showed up the next day after the second dose and had been putting rubbing alcohol on his hives and rash, and they went away. But they keep going away and coming back. It is not constant. They keep coming and going.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: The day after the vaccine and currently I keep getting sharp pains in the center of my chest just behind the sternum.; It has interfered with my everyday activities as well as my sleep; It has interfered with my everyday activities as well as my sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 11:00 (Lot number: FC3180) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 21Aug2021 08:00, outcome "not recovered", described as "The day after the vaccine and currently I keep getting sharp pains in the center of my chest just behind the sternum."; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), SLEEP DISORDER (non-serious) all with onset 21Aug2021 08:00, outcome "not recovered" and all described as "It has interfered with my everyday activities as well as my sleep". The events "the day after the vaccine and currently i keep getting sharp pains in the center of my chest just behind the sternum.", "it has interfered with my everyday activities as well as my sleep" and "it has interfered with my everyday activities as well as my sleep" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of chest pain, loss of personal independence in daily activities, sleep disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient known allergies was not reported.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Hyperhidrosis, Nightmare
Clinical narrative: Fever; severe body aches; sweating; nightmares; headache; fever blisters inside and outside of mouth; rapid heartbeat; foggy brain; Date of start of drug: 03Aug2021, Dose Number: 1; Date of start of drug: 03Aug2021, Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 13:00 (Lot number: FC3180) at the age of 60 years as dose 1, single and administered in arm left, administration date 03Aug2021 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; STATIN [ATORVASTATIN CALCIUM]. The following information was reported: OVERDOSE (non-serious) with onset 03Aug2021, outcome "unknown", described as "Date of start of drug: 03Aug2021, Dose Number: 1; Date of start of drug: 03Aug2021, Dose Number: 2"; PYREXIA (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "severe body aches"; HYPERHIDROSIS (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "sweating"; NIGHTMARE (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "nightmares"; HEADACHE (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "headache"; ORAL HERPES (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "fever blisters inside and outside of mouth"; HEART RATE INCREASED (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "rapid heartbeat"; FEELING ABNORMAL (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "foggy brain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, hyperhidrosis, nightmare, headache, oral herpes, heart rate increased, feeling abnormal.  Additional information: The patient has not tested positive for COVID-19 since and post having the vaccine.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Overdose, Pain, Pyrexia
Clinical narrative: Fever; severe body aches; sweating; nightmares; headache; fever blisters inside and outside of mouth; rapid heartbeat; foggy brain; Date of start of drug: 03Aug2021, Dose Number: 1; Date of start of drug: 03Aug2021, Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 13:00 (Lot number: FC3180) at the age of 60 years as dose 1, single and administered in arm left, administration date 03Aug2021 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; STATIN [ATORVASTATIN CALCIUM]. The following information was reported: OVERDOSE (non-serious) with onset 03Aug2021, outcome "unknown", described as "Date of start of drug: 03Aug2021, Dose Number: 1; Date of start of drug: 03Aug2021, Dose Number: 2"; PYREXIA (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "severe body aches"; HYPERHIDROSIS (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "sweating"; NIGHTMARE (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "nightmares"; HEADACHE (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "headache"; ORAL HERPES (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "fever blisters inside and outside of mouth"; HEART RATE INCREASED (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "rapid heartbeat"; FEELING ABNORMAL (non-serious) with onset 24Aug2021 03:00, outcome "not recovered", described as "foggy brain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, hyperhidrosis, nightmare, headache, oral herpes, heart rate increased, feeling abnormal.  Additional information: The patient has not tested positive for COVID-19 since and post having the vaccine.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She got an allergy after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "She got an allergy after the second vaccine".   Additional information: It was reported that the caller on the line who is reporting side effects for her husband. She is calling on behalf of her husband. Her husband and all her family received the Pfizer COVID 19 BioNtech vaccine. Her husband was the only one with a reaction. The next day after the second dose of the vaccine, he had an allergic reaction. He has a rash and hives especially on his back and shoulder. He is still experiencing this reaction. She called to get it reported, and asked what to do about the side effects. She got an allergy after the second vaccine. She is just worried about this reaction and that there might be an allergy. Her husband did not have a prescribing doctor. There were a lot of hives. The rash and hives showed up the next day after the second dose. His second dose was 12Jul2021, and his first one was 02Jun2021. They have been putting rubbing alcohol on his hives and rash, and they went away. But they keep going away and coming back. It is not constant. They keep coming and going. She was worried because he has had the rash since he had the vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular, Oligomenorrhoea
Clinical narrative: unusual intense cramping; Early period; extended period; spotting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 12:00 (Lot number: ewo183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NEXUS [AMLODIPINE]; VITAMIN D [COLECALCIFEROL]; IRON. The following information was reported: DYSMENORRHOEA (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "unusual intense cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "Early period"; OLIGOMENORRHOEA (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "extended period"; INTERMENSTRUAL BLEEDING (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "spotting". Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular, oligomenorrhoea, intermenstrual bleeding. Additional information: Reaction/event as reported by primary source: Early period, extended period, spotting, unusual intense cramping. Happened to the reporter herself and daughter at the same time after vaccine. No prolonged hospitalization and no treatment received. Facility where the most recent COVID-19 vaccine was administered was available. Start Date/Time: Pfizer 2Aug2021 12:00 PM. 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. Since the vaccination, the patient has not been tested for COVID-19. Known allergies to penicillin.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110884 Same Vaccine/event, different  patient.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: getting sick; dizzy; weak; tired; sore throat; headache; chills; fever; everything stopped--my normal activity except going to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Lot number: EW0198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Appendix removal" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot EW0181), administration date: 21Jul2021, for COVID-19 immunisation, reaction(s): "Tiredness", "not in the mood of doing anything". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "everything stopped--my normal activity except going to work". Therapeutic measures were taken as a result of fatigue, oropharyngeal pain, headache.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Oropharyngeal pain, Pyrexia
Clinical narrative: getting sick; dizzy; weak; tired; sore throat; headache; chills; fever; everything stopped--my normal activity except going to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Lot number: EW0198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Appendix removal" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot EW0181), administration date: 21Jul2021, for COVID-19 immunisation, reaction(s): "Tiredness", "not in the mood of doing anything". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "getting sick"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "everything stopped--my normal activity except going to work". Therapeutic measures were taken as a result of fatigue, oropharyngeal pain, headache.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itching, warm around injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Systemic: pain in opposite arm of injection-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pain/tingling in opposite side arm
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Additional Details: mild itching, benadryl was given and patient was completely fine after 30minutes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Diluent Administered Instead of Vaccine-
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Influenza like illness, Pain
Clinical narrative: Metallic taste in mouth right after that shot.  Flu like symptoms for the next 36 hours including fever, chills, soreness/body aches and headache.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Metallic taste in mouth right after that shot.  Flu like symptoms for the next 36 hours including fever, chills, soreness/body aches and headache.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Pt came into the pharmacy after receiving the vaccine on 2/1 with a localized reaction.  Itching, swollen area about 2 inches below the injeciton site.  Pt is flushed, has fatigue, fever and does not feel well.  I instructed her to ice the area, take benadryl and ibuprofen and to monitor area for worsening of symptoms.  Also to seek medical attention if airway is compromised.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lethargy, Local reaction, Malaise, Pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Pt came into the pharmacy after receiving the vaccine on 2/1 with a localized reaction.  Itching, swollen area about 2 inches below the injeciton site.  Pt is flushed, has fatigue, fever and does not feel well.  I instructed her to ice the area, take benadryl and ibuprofen and to monitor area for worsening of symptoms.  Also to seek medical attention if airway is compromised.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Pt came into the pharmacy after receiving the vaccine on 2/1 with a localized reaction.  Itching, swollen area about 2 inches below the injeciton site.  Pt is flushed, has fatigue, fever and does not feel well.  I instructed her to ice the area, take benadryl and ibuprofen and to monitor area for worsening of symptoms.  Also to seek medical attention if airway is compromised.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 82.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient came in for possible stroke and was positive for COVID.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PATIENT PASSED AWAY ON HOSPICE SERVICES ON 1/4/2022
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient fell on the floor due a dizzy spell after about 2-3 minutes of getting the shot. Patient got up by himself without any assistance and was brought into the consultation room for monitoring and observation. He said he was nervous about the shot that made him have the spell. I called EMS and after about 20 minutes or so, they came and monitored the patients blood pressure and vitals for about 20 more minutes. The patient declined going with the ambulance but received care from them.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Increased upper airway secretion
Clinical narrative: Persistent cough, with no fever, won?t go away, lots of Mucus in the throat.  Much more frequent headaches, 3-4 days a week.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Numbness down right thigh. MRI reveals no nerve damage. Treatment is exercise and stretching, no change. Severe pain in left shoulder. No treatment other than Motrin.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient presented with a psych eval and was positive for COVID
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PT PASSED AWAY WITH COMFORT MEASURES IN PLACE ON 1/8/2022
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration, Injection site bruising, Rash, Shoulder injury related to vaccine administration
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: low injection site- extremity numbness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atypical pneumonia, Blood creatinine increased, COVID-19, Computerised tomogram head normal
Clinical narrative: Patient is fully vaccinated.  COVID + on 1/17/2022 at admission to hospital. 66y.o. male who came with syncopal episode. Patient stated that patient was taking shower when he felt lightheaded and sat down in shower chair. Patient is also complaining for cough, tiredness and weakness started a few days ago. Pt CT chest showed, No CT evidence for central or segmental Pulmonary Embolism.  Multiple foci focal bilateral groundglass opacities likely reflective of infectious/inflammatory process including atypical pneumonia such as Covid 19. Cr 1.89. Hg 7.2. D dimer 4,471. Normal troponin. CT head: No acute intracranial findings are identified.Patient did complete a short course of remdesivir but did not require further inpatient treatment due to him not being hypoxic.On admission and occult stool was positive however patient denies any acute GI bleed. Patient was discharged to home.  Stable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Dizziness, Fatigue, Fibrin D dimer
Clinical narrative: Patient is fully vaccinated.  COVID + on 1/17/2022 at admission to hospital. 66y.o. male who came with syncopal episode. Patient stated that patient was taking shower when he felt lightheaded and sat down in shower chair. Patient is also complaining for cough, tiredness and weakness started a few days ago. Pt CT chest showed, No CT evidence for central or segmental Pulmonary Embolism.  Multiple foci focal bilateral groundglass opacities likely reflective of infectious/inflammatory process including atypical pneumonia such as Covid 19. Cr 1.89. Hg 7.2. D dimer 4,471. Normal troponin. CT head: No acute intracranial findings are identified.Patient did complete a short course of remdesivir but did not require further inpatient treatment due to him not being hypoxic.On admission and occult stool was positive however patient denies any acute GI bleed. Patient was discharged to home.  Stable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Infection, Inflammation, Lung opacity, Occult blood positive
Clinical narrative: Patient is fully vaccinated.  COVID + on 1/17/2022 at admission to hospital. 66y.o. male who came with syncopal episode. Patient stated that patient was taking shower when he felt lightheaded and sat down in shower chair. Patient is also complaining for cough, tiredness and weakness started a few days ago. Pt CT chest showed, No CT evidence for central or segmental Pulmonary Embolism.  Multiple foci focal bilateral groundglass opacities likely reflective of infectious/inflammatory process including atypical pneumonia such as Covid 19. Cr 1.89. Hg 7.2. D dimer 4,471. Normal troponin. CT head: No acute intracranial findings are identified.Patient did complete a short course of remdesivir but did not require further inpatient treatment due to him not being hypoxic.On admission and occult stool was positive however patient denies any acute GI bleed. Patient was discharged to home.  Stable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope, Troponin normal
Clinical narrative: Patient is fully vaccinated.  COVID + on 1/17/2022 at admission to hospital. 66y.o. male who came with syncopal episode. Patient stated that patient was taking shower when he felt lightheaded and sat down in shower chair. Patient is also complaining for cough, tiredness and weakness started a few days ago. Pt CT chest showed, No CT evidence for central or segmental Pulmonary Embolism.  Multiple foci focal bilateral groundglass opacities likely reflective of infectious/inflammatory process including atypical pneumonia such as Covid 19. Cr 1.89. Hg 7.2. D dimer 4,471. Normal troponin. CT head: No acute intracranial findings are identified.Patient did complete a short course of remdesivir but did not require further inpatient treatment due to him not being hypoxic.On admission and occult stool was positive however patient denies any acute GI bleed. Patient was discharged to home.  Stable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, Pharyngeal swelling, Pruritus, Rash, Urticaria
Clinical narrative: Hives, rash, itchiness, muscle fatigue, and and instance if throat swelling starting 12 days after receiving third moderna COVID-19  vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Chest pain, Chills, Cough
Clinical narrative: Patient is fully vaccinated.  COVID + at ED visit 1/17/2022.  50-year-old female presents to the emergency department complaining of chest pain, shortness of breath, body aches, diarrhea, nausea for the last 2 to 3 days.  Symptoms progressively worsening.  Her chest pain is worse with coughing.  Numerous family members are sick with COVID.  She also has fever and chills.  Denies leg pain or swelling, denies history of DVT/PE.  No abdominal pain or constipation.  BP 173/70  | Pulse 64  | Temp 99.7 °F (37.6 °C) (Oral)  | Resp (!) 8  | Ht 165.1 cm (5' 5")  | Wt 98 kg (216 lb)  | LMP 11/10/2009  | SpO2 100%  | BMI 35.94 kg/m² Elevated troponin. EKG: Normal sinus rhythm, possible left atrial enlargement, possible anterior infarct age undetermined. CXR: No acute cardiothoracic process.She was given IV fluids, Toradol, Robaxin, Tessalon, Zofran. Discharged from ED.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Electrocardiogram, Nausea, Pain
Clinical narrative: Patient is fully vaccinated.  COVID + at ED visit 1/17/2022.  50-year-old female presents to the emergency department complaining of chest pain, shortness of breath, body aches, diarrhea, nausea for the last 2 to 3 days.  Symptoms progressively worsening.  Her chest pain is worse with coughing.  Numerous family members are sick with COVID.  She also has fever and chills.  Denies leg pain or swelling, denies history of DVT/PE.  No abdominal pain or constipation.  BP 173/70  | Pulse 64  | Temp 99.7 °F (37.6 °C) (Oral)  | Resp (!) 8  | Ht 165.1 cm (5' 5")  | Wt 98 kg (216 lb)  | LMP 11/10/2009  | SpO2 100%  | BMI 35.94 kg/m² Elevated troponin. EKG: Normal sinus rhythm, possible left atrial enlargement, possible anterior infarct age undetermined. CXR: No acute cardiothoracic process.She was given IV fluids, Toradol, Robaxin, Tessalon, Zofran. Discharged from ED.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Patient is fully vaccinated.  COVID + at ED visit 1/17/2022.  50-year-old female presents to the emergency department complaining of chest pain, shortness of breath, body aches, diarrhea, nausea for the last 2 to 3 days.  Symptoms progressively worsening.  Her chest pain is worse with coughing.  Numerous family members are sick with COVID.  She also has fever and chills.  Denies leg pain or swelling, denies history of DVT/PE.  No abdominal pain or constipation.  BP 173/70  | Pulse 64  | Temp 99.7 °F (37.6 °C) (Oral)  | Resp (!) 8  | Ht 165.1 cm (5' 5")  | Wt 98 kg (216 lb)  | LMP 11/10/2009  | SpO2 100%  | BMI 35.94 kg/m² Elevated troponin. EKG: Normal sinus rhythm, possible left atrial enlargement, possible anterior infarct age undetermined. CXR: No acute cardiothoracic process.She was given IV fluids, Toradol, Robaxin, Tessalon, Zofran. Discharged from ED.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: Patient presented to emergency department on 11/15/2021 with shortness of breath and was found to be COVID-19 positive. He was treated with dexamethasone and remdesivir. He required 6L of oxygen and intermittent use of BIPAP.  He was discharged home on 12/31/2021 with home health care.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm was very red, hot and a little swollen at the injection site
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Blood creatinine increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is fully vaccinated.  COVID + on admission to hospital.  84-year-old female who presented to the hospital with altered mental status, found to be in the setting of acute hypoxic respiratory failure due to covid 19 pneumonia. CXR: Findings suggest mild pulmonary vascular congestion with a right basilar airspace opacity and a small to moderate right pleural effusion. She was treated with supplemental oxygen, IV steroids, breathing treatments.  She was also treated with IV remdesivir And completed the full 5 day course.  Her mentation improved back to baseline.  She also had a TIA and was provided with IV hydration, which improved her AKI. Cr 1.25. D-dimer is elevated. Discharged -home care services.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Fibrin D dimer increased, Lung opacity, Mental status changes, Pleural effusion
Clinical narrative: Patient is fully vaccinated.  COVID + on admission to hospital.  84-year-old female who presented to the hospital with altered mental status, found to be in the setting of acute hypoxic respiratory failure due to covid 19 pneumonia. CXR: Findings suggest mild pulmonary vascular congestion with a right basilar airspace opacity and a small to moderate right pleural effusion. She was treated with supplemental oxygen, IV steroids, breathing treatments.  She was also treated with IV remdesivir And completed the full 5 day course.  Her mentation improved back to baseline.  She also had a TIA and was provided with IV hydration, which improved her AKI. Cr 1.25. D-dimer is elevated. Discharged -home care services.