chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Influenza like illness, Pain, Pulmonary pain
Clinical narrative: her head got under so much pressure / felt like it was going to blow up.; dizzy and very distracted with the head pressure; very distracted with the head pressure; blood vessel in her nose burst in her nostril; spent 5 days in bed; spent 5 days in bed with fever; chills; feeling like she had the flu; side effects including / respiratory; Her lung / hurt.; body hurt.; had a headache; was worried / to have a stroke because her brother had a stroke years ago.; This case was reported by a consumer via call center representative and described the occurrence of head pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (family history) and family history of seizure.   On 24th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2020, less than a day after receiving Shingrix, the patient experienced head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of. On an unknown date, the outcome of the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of were recovered/resolved.   It was unknown if the reporter considered the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of to be related to Shingrix.  Additional details were received as follows: After vaccination with Shingrix, within 20 minutes the patient headed towards home and her head got under so much pressure that it felt like it was going to blow up. The patient was dizzy and very distracted with the head pressure.  The blood vessel in her nose burst in her nostril.  She spent 5 days in bed with a fever, chills and everything we list as side effects including feeling like she had the flu, respiratory and fever with chills, lung and body hurt.  The patient was worried that she was going to have a stroke because her brother had a stroke years ago.  She had a headache and two weeks later everything resolved and she got her strength back.  She was wondering at the time if her symptoms were COVID related but she was not exposed to anyone and was very careful. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory symptom, Vascular rupture
Clinical narrative: her head got under so much pressure / felt like it was going to blow up.; dizzy and very distracted with the head pressure; very distracted with the head pressure; blood vessel in her nose burst in her nostril; spent 5 days in bed; spent 5 days in bed with fever; chills; feeling like she had the flu; side effects including / respiratory; Her lung / hurt.; body hurt.; had a headache; was worried / to have a stroke because her brother had a stroke years ago.; This case was reported by a consumer via call center representative and described the occurrence of head pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (family history) and family history of seizure.   On 24th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2020, less than a day after receiving Shingrix, the patient experienced head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of. On an unknown date, the outcome of the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of were recovered/resolved.   It was unknown if the reporter considered the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of to be related to Shingrix.  Additional details were received as follows: After vaccination with Shingrix, within 20 minutes the patient headed towards home and her head got under so much pressure that it felt like it was going to blow up. The patient was dizzy and very distracted with the head pressure.  The blood vessel in her nose burst in her nostril.  She spent 5 days in bed with a fever, chills and everything we list as side effects including feeling like she had the flu, respiratory and fever with chills, lung and body hurt.  The patient was worried that she was going to have a stroke because her brother had a stroke years ago.  She had a headache and two weeks later everything resolved and she got her strength back.  She was wondering at the time if her symptoms were COVID related but she was not exposed to anyone and was very careful. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Feeling abnormal
Clinical narrative: felt lightheaded and a "little off" after doing errands at lunch about 2 hours after taking vaccine. BP was 190/110 while at work and was sent to the ER. BP there was 209/125. Was given Nifedipine CR 30 mg at 17:49. Discharged from ER with primary care follow up on 12/21. BP 4 months prior to vaccination was recorded at 168/110 at office visit.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: having a shingles episode mid-vaccination (prior to second dose); This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient was concerned whether or not having a shingles episode mid-vaccination prior to second dose would lower the efficacy of Shingrix. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Panic attack, Wrong product administered
Clinical narrative: The patient presented to the clinic for a Prevnar 13 vaccine. Menactra was incidently administered. There was no adverse reaction to the vaccine for a 20min observation time in the clinic.  Patient did express feeling light-headed but was also understandably upset by the occurrance and believed she was having a minor panic attack. Her vital signs were checked and were stable, no shortness of breath or dyspnea. No signs or symptoms of an allergic reaction were noted. The patient completed an observation period and left the clinic alert, oriented and ambualtory as she arrived.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix vaccination in early October 2020 and she experienced arm pain. The pain continued for weeks, but was resolved. The reporter did not consent to follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Flushing, Heart rate increased
Clinical narrative: 6 min post injection felt cold, lightheaded, HR increased to 155, and became flushed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dyspnoea, Respiratory rate increased, Throat tightness
Clinical narrative: c/o "I can't breathe, feels like my throat is closing" VS taken. Pt crying, breathing rapidly possibly hyperventilating. Epi IM given, VS taken. Hospital emergency activated. Rapid team arrived assessing pt. Rapid team escorted pt via gurney for further observation.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Vaccination failure
Clinical narrative: receiving both doses of the Shingrix vaccine she has been getting shingles/ suspected Vaccination failure; receiving both doses of the Shingrix vaccine she has been getting shingles; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 9th July 2019, refer case US2020AMR246180).   On 4th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The patient reported that since receiving both doses of the Shingrix vaccine she had been getting shingles every 2 months. Patient reported pain at the injection site during administration of both doses of Shingrix and said it lasted a few seconds and then resolved. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246180:same patient
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Bradycardia, Presyncope, Skin discolouration
Clinical narrative: Vasovagal reaction  ashen color bradycardia for approx 1-2 minutes decreased B/P 90/60 with full recovery with ingestion of orange juice and recumbency
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Oral herpes
Clinical narrative: she developed feeling hot; developed a cold sore; developed shivering; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cold sores (cold sore related to stress).   On 7th December 2020, the patient received the 1st dose of Shingrix .5 ml. On 7th December 2020, less than a day after receiving Shingrix, the patient experienced cold sores (serious criteria clinically significant/intervention required) and shivering (serious criteria clinically significant/intervention required). On 8th December 2020, the patient experienced feeling hot (serious criteria clinically significant/intervention required). The patient was treated with acyclovir and paracetamol (Acetaminophen). On 8th December 2020, the outcome of the shivering and feeling hot were recovered/resolved. On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores, shivering and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient developed a cold sore (previous history of cold sore related to stress), this cold sore was still ongoing and being treated with acyclovir. The patient developed shivering and was treated this with acetaminophen. The patient also developed feeling hot. The reporter does not have vaccine information for this adverse event. The reporter consented to follow up. This case is linked to the case US2020245649, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245649:same reporter
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: She experienced nausea.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: patient became dizzy, nauseated, received vaccine 10:00, at 10:09 patient became dizzy, lightheaded, nauseated, bp 125/85 p-85, sat 100%, 10:14 134/91 99% sat on room air, P- 98, 1020- BP 155/92, 1025 - 142/87, 1029- 98% on room air P-98, 1030- 129/91, 1047- sat 99% on room air, P- 89, 134/92, patient still feeling nauseated and dizzy transferred to Urgent Care
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Rash
Clinical narrative: After receiving dose of COVID 19 vaccine patient reports the following: rash to both arms, right neck. Heart rate increased to 102. Reports slight shortness of breath. ER visit- administered Benadryl/Solumedrol IM
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hot flush, Oral discomfort, Oral pruritus, Paraesthesia oral
Clinical narrative: hot flushed, temporary weakness, temporary itching throat and back.  lips tingling, lump in throat.  10 mins after injection symptoms started.  all resolved except tingling in lips which persisted to the next day.  area around mouth is itchy/burning  but no other symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Sensation of foreign body, Throat irritation
Clinical narrative: hot flushed, temporary weakness, temporary itching throat and back.  lips tingling, lump in throat.  10 mins after injection symptoms started.  all resolved except tingling in lips which persisted to the next day.  area around mouth is itchy/burning  but no other symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling hot, Flushing, Paraesthesia oral, Pruritus
Clinical narrative: hot flushed, temporary weakness, temporary itching throat and back.  lips tingling, lump in throat.  10 mins after injection symptoms started.  all resolved except tingling in lips which persisted to the next day.  area around mouth is itchy/burning  but no other symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Throat irritation
Clinical narrative: hot flushed, temporary weakness, temporary itching throat and back.  lips tingling, lump in throat.  10 mins after injection symptoms started.  all resolved except tingling in lips which persisted to the next day.  area around mouth is itchy/burning  but no other symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Impaired work ability, Pain
Clinical narrative: 12/16/2020 WENT TO SLEEP AT 10PM 12/17/2020 - WOKE UP ABOUT 1:00 AM;  101 TEMP, SHAKING, CHILLS, BODY ACHES, RIGHT ARM VERY SORE, TRIED TO GO BACK TO SLEEP 12/18/2020 - FATIGUE, BODY ACHES, TEMP SUBSIDED; EVENING FELT SHAKY; 'CALLED OUT OF WORK' (NIGHTSHIFT NURSE) 12/19/2020 - ALL SYMPTOMS SUBSIDED 09/2020-10/2020 HAD FLU SHOT 'CANT REMEMBER EXACT DATE'
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: 12/16/2020 WENT TO SLEEP AT 10PM 12/17/2020 - WOKE UP ABOUT 1:00 AM;  101 TEMP, SHAKING, CHILLS, BODY ACHES, RIGHT ARM VERY SORE, TRIED TO GO BACK TO SLEEP 12/18/2020 - FATIGUE, BODY ACHES, TEMP SUBSIDED; EVENING FELT SHAKY; 'CALLED OUT OF WORK' (NIGHTSHIFT NURSE) 12/19/2020 - ALL SYMPTOMS SUBSIDED 09/2020-10/2020 HAD FLU SHOT 'CANT REMEMBER EXACT DATE'
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Pruritus, Urticaria
Clinical narrative: Patient pre-medicated with diphenhydramine due to infusion-type reactions in past.  Patient with hoarse voice, itchiness to upper back, arms, and face, hives on bilateral arms.  Per health system protocol (patient is health system employee) Patient administered diphenhydramine, famotidine, methylprednisolone succinate, epinephrine.  All symptoms resolved by 1440.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Oropharyngeal pain, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: Patient pre-medicated with diphenhydramine due to infusion-type reactions in past.  Patient with hoarse voice, itchiness to upper back, arms, and face, hives on bilateral arms.  Per health system protocol (patient is health system employee) Patient administered diphenhydramine, famotidine, methylprednisolone succinate, epinephrine.  All symptoms resolved by 1440.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Patient pre-medicated with diphenhydramine due to infusion-type reactions in past.  Patient with hoarse voice, itchiness to upper back, arms, and face, hives on bilateral arms.  Per health system protocol (patient is health system employee) Patient administered diphenhydramine, famotidine, methylprednisolone succinate, epinephrine.  All symptoms resolved by 1440.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Bradycardia, Cold sweat, Dysphagia, Fatigue
Clinical narrative: 18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  Loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Hyperhidrosis, Loss of consciousness, Metabolic function test normal, Mydriasis
Clinical narrative: 18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  Loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pulse abnormal, Sensation of foreign body, Throat clearing, Tryptase
Clinical narrative: 18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  Loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Syncope
Clinical narrative: 18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  Loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Injection site warmth
Clinical narrative: Tingling in right arm where vaccine was given. Hot at the site in her "R" hand. Still tingling 45 minutes after. Following up with Telemedicine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle strain
Clinical narrative: 56 yo male patient reports his left deltoid feels like a muscle strain after receiving his first dose of the shingles vaccine on 19 Oct 2020. He received his second dose today.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Headache, Injection site swelling, Pyrexia
Clinical narrative: allergy to the vaccine; High fever; Headache; Arms swollen at the injection site; This is a spontaneous report from a contactable physician reporting for self. This 42-year old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on 05Dec2020 at single dose for immunization. The patient stated that it was a pneumococcal vaccine (unspecified PREVENAR, PREVENAR 13 or unspecified vaccine) as she did not know there was a difference. For the indication, the patient stated that because she turned 40 and she might be high risk to get it because she worked in the hospital. The patient medical history and concomitant medications were not reported. The patient experienced high fever, headache, arms swollen at the injection site. The patient mentioned an allergy to the vaccine, that caused her high fever, headache and her arms swollen at the injection site. Patient reported no treatment. Reporter assessed events high fever, arms swollen at the injection site related to the products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Lethargy, Pyrexia
Clinical narrative: Left arm erythema at injection site, lethargy, fever
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Pyrexia, Rash, Urticaria
Clinical narrative: Allergic reaction; In my arms I had like a rash and had like a reaction; In my arms I had like a rash; Intense fever; Chills; Headache; Hives; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable Physician (patient). A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced allergic reaction; in my arms I had like a rash and had like a reaction, intense fever, chills, headache and hives. The events were non-serious with outcome of unknown.  No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt received Covid vaccine and afterward developed hives on chest and arms
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Palpitations
Clinical narrative: Warm feeling throughout body, heart race last 10secs; Warm feeling throughout body, heart race last 10secs; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). This 48-year-old female patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for immunisation. Relevant medical history included allergy to mold and to ragweed. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from 2020 and montelukast sodium (SINGULAIR); these medications were received by the patient within 2 weeks of vaccination. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. The patient was not pregnant at the time of vaccination. The facility where the vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive corrective treatments for the reported events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. At the time of the report, the outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Retching
Clinical narrative: Employee experienced headache and dry heaving
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient administered Covid vaccine shot 1 today and site of injection "hurt more than any other shot"; This is a spontaneous report from a contactable nurse.  A male patient of an unspecified age (reported as 28, unknown unit) received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient administered the COVID vaccine shot 1 on 15Dec2020 and site of injection "hurt more than any other shot" on an unspecified date in Dec2020. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperventilation, Pruritus, Swollen tongue
Clinical narrative: Patient complaint of itchiness, shortness of breath,tongue swelling, hyperventilating. Epipen was administered at 3:20pm
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain
Clinical narrative: Body aches; cold symptoms; fatigue x 24 hours.   ibuprofen
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Widespread Pain; diarrhea; fever; vomiting; This is a spontaneous report from a non-contactable other healthcare professional. An 85-year-old female (non-pregnant) patient received first dose bnt162b2, intramuscularly on right arm on 14Dec2020 at 14:00 at single dose for immunization. Medical history included High cholesterol (no cholesterol lowering medication) edema, dementia, and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA) on 30Nov2020 for immunization within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination included daily vitamin, diuretic, dementia medication, anti inflammatory.  On 14Dec2020, the patient experienced widespread pain, diarrhea, fever, vomiting. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not resolved.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Headache, fever, chest congestion, cough, malaise, fatigue
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Headache, fever, chest congestion, cough, malaise, fatigue
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia
Clinical narrative: Fast heart rate; Leg numbness; Hand numbness; This is a spontaneous report from a contactable consumer (patient).  This 21-year-old male patient received the first dose of bnt162b2 (BNT162B2) (Lot # EH9899), via an unspecified route of administration at single dose in the left arm on 15Dec2020 12:00 PM at hospital for immunisation. The patient medical history and concomitant medications were not reported. On 16Dec2020 04:00 AM, the patient experienced fast heart rate, leg numbness, hand numbness. No treatment required. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache; muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable physician reporting for herself.   A 44-years-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer product), intramuscular in the right arm on 15Dec2020 12:45 at hospital at single dose for immunisation. Medical history included was none. Concomitant medication included bupropion (unknown manufacturer). The patient experienced headache, muscle and joint aches on 15Dec2020 with outcome of not recovered. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Gradual onset of very mild rash and symptoms gradual improved with IM administration of diphenhydramine 50 mg and oral famotidine 20 mg.  The physician was questioning if the mild rash was from where the patient was scratching secondary to anxiety vs allergic reaction.  Patient was monitored for improvements.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Influenza like illness, Nausea
Clinical narrative: She is feeling dizzy, a little wonky; Feeling bad like when she is about to get the flu; Her feet feeling like gelatin; Little nausea; Headaches; This is a spontaneous report from a contactable consumer (patient).  This female patient of an unspecified age received BNT162B2 (Lot number EK5730) via an unspecified route of administration on 16Dec2020 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On 16Dec2020, the patient was feeling dizzy, a little wonky, feeling bad like when she was about to get the flu, with her feet feeling like gelatin, with a little nausea and headaches. The patient reported that when she got home after the administration, she reviewed the information provided after the vaccine and she found this information in the sheet, realizing that she was feeling that way. At the time of the report, the outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Feeling hot
Clinical narrative: Felt hot, chest felt different, BP elevated
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: Diarrhea; right arm pain; fatigue; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular at right arm on 16Dec2020 at 08:15 at single dose for immunization. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) for headache. On 16Dec2020 at 09:00, the patient experienced diarrhea, right arm pain and fatigue. The patient outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Starting 5 minutes from vaccination left sided arm numbness and tingling down the arm into the fingers. Felt the entire day. 12/21/20, symptoms improved but again returned today.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Influenza like illness, Muscular weakness
Clinical narrative: Headache; Dizzy; Front of her calves and into her feet felt a little like jello; Lightheadedness; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.   This 45-year-old female patient received on 16Dec2020 around 7:30am first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730) intramuscular in the right arm for vaccination. Medical history was none. Concomitant medications were not provided. She sat there for the 15 minutes following administration of the vaccine.After that initial 15 minutes passed she had onset of side effects. On 16Dec2020, while walking to her car, she experienced what she described as dizzy, but it was more like feeling a little wonky like when you are coming down with the flu, where she did not feel right. She was ok to drive herself home, she took a shower. She worked the following night. She noted that mostly the front of her calves and into her feet felt a little like jello. She has brief moments of lightheadedness, a little bit of nausea and a tiny bit of headache starting. The room is not spinning, she is walking fine, bending over and does not seem to be struggling at all. Outcome she initially reported as having subsided, but then reported ongoing, further details unknown. Final outcome was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headache; Dizzy; Front of her calves and into her feet felt a little like jello; Lightheadedness; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.   This 45-year-old female patient received on 16Dec2020 around 7:30am first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730) intramuscular in the right arm for vaccination. Medical history was none. Concomitant medications were not provided. She sat there for the 15 minutes following administration of the vaccine.After that initial 15 minutes passed she had onset of side effects. On 16Dec2020, while walking to her car, she experienced what she described as dizzy, but it was more like feeling a little wonky like when you are coming down with the flu, where she did not feel right. She was ok to drive herself home, she took a shower. She worked the following night. She noted that mostly the front of her calves and into her feet felt a little like jello. She has brief moments of lightheadedness, a little bit of nausea and a tiny bit of headache starting. The room is not spinning, she is walking fine, bending over and does not seem to be struggling at all. Outcome she initially reported as having subsided, but then reported ongoing, further details unknown. Final outcome was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever and that's all
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After sitting and waiting the 15 minutes, I left and as I was walking, I had the strongest taste of metal in my mouth.  It lasted for about a minute, then slowly went away.; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received first dose of bnt162b2 (BNT162B2; lot EK5730), via an unspecified route of administration on 16Dec2020, at 11:00 AM at single dose (right arm) for immunization. Medical history included asthma, hypertension (HTN), and allergies penicillin (PCN), medications, food or other products, many seasonal items, grass, trees, molds, dust mites, carrots, apples, celery, and walnuts. The patient did not received any other vaccines within four weeks prior to Covid vaccine. Concomitant medications were not reported. Patient reported that she had other medications received within 2 weeks of vaccination.  On 16Dec2020, at 11:15 AM, after sitting and waiting the 15 minutes, the patient left and as she was walking, she had the strongest taste of metal in her mouth. It lasted for about a minute, then slowly went away. There was no treatment for the event. The patient did not have Covid prior the vaccination and was not Covid tested post vaccination. Outcome of event was recovered on 16Dec2020.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypertension, Tachycardia
Clinical narrative: Anxious, tachycardiac and hypertensive.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: felt very warm, overheated; clammy; started feeling slightly light headed; Thought I would pass out; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2; lot:eh9899) via an unspecified route of administration in the left arm on 16Dec2020 10:00 at a single dose for immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL) for an unspecified indication. On 16Dec2020 11:30, the patient started feeling slightly light headed and thought she was going to pass out. On 16Dec2020 11:50, she felt very warm, overheated and clammy. The patient sat down, attempted to eat her lunch and the events slowly subsided. The patient's blood pressure and pulse were checked on 16Dec2020 and they were relatively normal. The events were reported as non-serious and the patient did not receive treatment for the reported events. Outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm lasting about 24 hours post injection.  Ibuprofen
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: received the vaccine on 12/18, 12/19 woke up with a headache and fatigue: lasted until the end of the day.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Pyrexia
Clinical narrative: mild fever; chest pressure; dizziness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received dose number 1 of BNT162B2 (solution for injection, lot number Eh9899/expiration date unknown) via an unspecified route of administration on her right arm on 16Dec2020 at a single dose for immunisation. Medical history included penicillin allergy and allergies to gluten. Concomitant medications were not reported. The patient experienced chest pressure and dizziness that later turned into a mild fever on 16Dec2020; all of which prompted visit to the emergency room/department or urgent care. The patient received Tylenol for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. She was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the event was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Circum-oral numbness; This is a spontaneous report from a contactable consumer reporting for himself (patient). This 59-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 15Dec2020 at 18:00 at single dose for immunisation. Relevant medical history included penicillin allergy. Concomitant medications were not reported. On 15Dec2020 at 18:30, the patient experienced circum-oral numbness. The patient did not receive corrective treatments for the reported event. The facility where the vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination he had not been tested for COVID-19. The outcome of the event was unknown.  The information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Tachycardia
Clinical narrative: tachycardia, flushing
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pruritus, Pyrexia
Clinical narrative: a fever of 99.5; body chills/chills; Not feeling well; Body itch; Pain; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable healthcare professional (patient). A 36-year-old male patient received BNT162B2 (lot number: not provided) solution for injection, via an unspecified route of administration on 15Dec2020 at a single dose for an unspecified indication. Patient has no medical history. There were no concomitant medications. The patient reported having a fever of 99.5 and body chills/chills after getting the Covid vaccine yesterday (15Dec2020). This was the first dose. The patient reported he was not feeling well, he had body itch, and pain on 15Dec2020. Patient stated he was just trying to think, he actually was feeling like drinking a lot of water and probably have some Tylenol. He asked if he should have the Tylenol or not really. The reason he was calling was because he was trying to figure out what was going on with his system before he do whole 8 to 10 minutes thing. He asked if this was required to find out if he could just drink some water and just take the Tylenol. He just wants the answer before he goes any further. Patient reported he was taking Tylenol for fever and chills. He reported he was in pain and he just needed to see if everything was alright. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Photosensitivity reaction, Vertigo
Clinical narrative: Patient states that after receiving the vaccine she felt lightheaded and dizzy.  In the days following the vaccine she has experienced periods of vertigo and photosensitivity.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site soreness - no treatment required.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Swelling of eyelid
Clinical narrative: swollen eyelids; cotton mouth; This is a spontaneous report from a contactable Nurse. A 43-year-old male patient received first dose of BNT162B2 (lot number EK5730), intramuscular on 16Dec2020 09:30 at a single dose in left arm for immunization. Medical history included smoker, overweight and known allergies with PCN. The patient's concomitant medications were not reported. The patient experienced swollen eyelids and cotton mouth on 16Dec2020 with outcome of recovered on an unknown date in Dec2020. The patient was given Benadryl and was under observation. The event was assessed as no-serious and did not caused hospitalization.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild sore arm at injection site; This is a spontaneous report from a contactable pharmacist. A 29-year-old male patient received bnt162b2 (BNT162B2), intramuscular (Arm Left) on 16Dec2020 11:00 at single for an unspecified indication. There were no relevant medical history and concomitant medications. The patient experienced Mild Sore arm at injection site on 16Dec2020 15:00. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RED,SWOLLEN, HOT
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: developed soreness at injection site 3-4 hours after the injection; This is a spontaneous report from a contactable consumer.   A 50-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 15Dec2020 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced soreness at injection site 3-4 hours after the injection on 15Dec2020. The outcome of the event was unknown.  Information about Lot/Batch no has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Injection site erythema, Myalgia
Clinical narrative: The night after receiving the vaccine, I developed fever, severe muscle aches, nausea, headache, and a red area on my arm.  These symptoms progressively got worse through the next day.  Fever got up to 102.  On 12/20/2020, I felt some better with temp 100.2 headache and body aches.  Today is better with temp just 99.4.  Still have minor headache and some chills.  There is still a pinkish/red area about 2 inches long and 1 inch wide on my arm where the vaccine was given.   I did have a covid exposure at work last week and the employee health is going to test me before I go back to work.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: The night after receiving the vaccine, I developed fever, severe muscle aches, nausea, headache, and a red area on my arm.  These symptoms progressively got worse through the next day.  Fever got up to 102.  On 12/20/2020, I felt some better with temp 100.2 headache and body aches.  Today is better with temp just 99.4.  Still have minor headache and some chills.  There is still a pinkish/red area about 2 inches long and 1 inch wide on my arm where the vaccine was given.   I did have a covid exposure at work last week and the employee health is going to test me before I go back to work.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash starting behind ears, moving to neck and trunk. Patient took a 2nd generation antihistamine (unsure which one) and this has helped with the itching. Rash is still present.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: Rash starting behind ears, moving to neck and trunk. Patient took a 2nd generation antihistamine (unsure which one) and this has helped with the itching. Rash is still present.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Moderate abdominal cramping; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old male patient receive the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine batch/lot number: Eks730), via an unspecified route of administration on the arm left on 16Dec2020 16:15 at a single dose for immuninzation at the hospital.  Medical history was reported as none. The patient had no allergies to medications, food, or other products.  There were no concomitant medications. Prior to vaccination, the patient not diagnosed with COVID-19 and the patient has not been tested for COVID-19 since the vaccination. On 16Dec2020 17:30, the patient experienced moderate abdominal and diarrhea. The patient did not receive any treatments for the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Vaccine leaked out around the hub therefore full dose not given