chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Took the modern shot and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 MRNA-1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and MODERNA (MRNA RIBONUCLEIC ACID VACCINE). On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient received the Shingles vaccine and took moderna shot and got shingles. It was unknown if the reporter considered the shingles to be related to MODERNA. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. In Source document, suspect was reported as Modern shot which was typo error, however it was captured as Moderna vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on November 19th 2019 / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The pharmacist reported about the late 2nd dose. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. The vaccine administration facility was the same as primary reporter. Lot number and expiration date of the vaccines were not provided.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Engerix-B on 13/SEP/2020 / the second on 31/JAN/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 13th September 2020).   On 31st January 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 31st January 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient wanted to receive the third dose on 26th April 2021 however the patient did not receive dose three at the moment of the reporting. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: neuropathy / following administration of Shingrix; Radiating Nerve Pain arm on injection arm; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hyperparathyroidism. Concurrent medical conditions included osteoporosis.   On 1st February 2021, the patient received Shingrix. On 1st February 2021, less than a day after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and nerve pain. On an unknown date, the outcome of the neuropathy and nerve pain were unknown.   It was unknown if the reporter considered the neuropathy to be related to Shingrix. The reporter considered the nerve pain to be unrelated to Shingrix.  Additional details were provided as follows: The patient was healthy. The reporter reported neuropathy or nerve pain following administration of Shingrix vaccine. The patient experienced nerve pain that radiated down her arm following Shingrix vaccine. The reporter stated that she did not think that the nerve pain was from the Shingrix vaccine but called to see if there was any additional data about this adverse event. The reporter consented to follow up. Discrepancy: The reaction end date of nerve pain was provided as 26th April 2021 (which was also report date), however reaction outcome was marked as unknown, hence the outcome was captured as unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 1 of Shingrix Dec 25th 2019 / because of Covid situation patient did not come back for dose 2; This case was reported by a pharmacist and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shngrix on 25th December 2019, batch no T44C7 and expiry date 25 February 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. All patient identifiers were reported as well as batch number and expiration date. The reporter informed patient had received dose of Shingrix and because of Covid situation patient did not come back for dose 2. No further details provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: First dose / on oct 2019 / did not receive the second dose due to Covid; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid-19. The reporter wanted to know that if patient needs to take the next dose or revaccinate. No other details of the vaccine available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was erroneously administered a Shingrix vaccine; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was erroneously administered a Shingrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Wrong product administered
Clinical narrative: Administered by mistake a dose of Pediarix / Intended doses to be given / were Kinrix and Proquad; Pediarix and Ipol given concomitantly; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 47CX9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) for prophylaxis.   On 26th April 2021, the patient received the 4th dose of Pediarix, Pediarix Pre-Filled Syringe Device and IPOL. On 26th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and accidental overdose. The action taken with IPOL was unknown. On an unknown date, the outcome of the wrong vaccine administered and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Physician reported that the patient had been administered by mistake a dose of Pediarix as a 4th dose in the series of DTaP along with Ipol vaccine, intended doses to be given to the patient were Kinrix and Proquad, which led to wrong vaccine administered and accidental overdose. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Hypoaesthesia oral
Clinical narrative: HEART STARTED RACING; LIPS FELT NUMB; LIGHT HEADED; LIPS FELT TINGLY; BLOOD PRESSURE INCREASED TO 145-165/120-135; OXYGEN SATURATION DECREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included appendix surgery, and concurrent conditions included blood pressure fluctuation (on MAR-2021, the patient's blood pressure (BP) was 110-115), and seasonal allergies. 09-APR-2021, patient took an antihistamine (Allegra) for seasonal allergies before vaccine shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 09-APR-2021 at 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fexofenadine hydrochloride for seasonal allergies. On 09-APR-2021, within the first 15 minutes of vaccination, the patient felt numb and tingly lips and was light headed. The patient waited another 30 minutes at the vaccine center just to be sure symptoms should not progress further. The patient was light headed all day. On same day around 21:00, while laying in bed, patients heart started racing. As patient had pulse oximeter at home so used and resting heart rate was 115 and oxygen level 91. It was reported that patients normal heart rate and oxygen usually remains 75-80 and 95-97 respectively. Patients' blood pressure (BP) had been normal to low all of life, so the sudden spike was completely uncharacteristic. Then Patient called an ambulance at that time patients BP was 145-165/120-135. On 10-APR-2021, initially patient declined to go to hospital, but as patients heart rate was so bad then went to emergency room (ER). The patient waited from 12-4 a.m, but hospital was overrun so not got admitted. So checked BP every hour and it was consistently not drop below 145 systolic and heart rate was over 115. Then patient went to home. On 10-APR-2021, all day, patients heart rate was high, so patient bought a BP cuff to test BP, and it was still 145 systolic range. On 10-APR-2021 at night the patients BP and heart rate started to come down to 135/95.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart started racing, and blood pressure increased to 145-165/120-135, and the outcome of lips felt numb, light headed, lips felt tingly and oxygen saturation decreased was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s -blood pressure increased to 145 -165/120-135. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Palpitations, Paraesthesia oral
Clinical narrative: HEART STARTED RACING; LIPS FELT NUMB; LIGHT HEADED; LIPS FELT TINGLY; BLOOD PRESSURE INCREASED TO 145-165/120-135; OXYGEN SATURATION DECREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included appendix surgery, and concurrent conditions included blood pressure fluctuation (on MAR-2021, the patient's blood pressure (BP) was 110-115), and seasonal allergies. 09-APR-2021, patient took an antihistamine (Allegra) for seasonal allergies before vaccine shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 09-APR-2021 at 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fexofenadine hydrochloride for seasonal allergies. On 09-APR-2021, within the first 15 minutes of vaccination, the patient felt numb and tingly lips and was light headed. The patient waited another 30 minutes at the vaccine center just to be sure symptoms should not progress further. The patient was light headed all day. On same day around 21:00, while laying in bed, patients heart started racing. As patient had pulse oximeter at home so used and resting heart rate was 115 and oxygen level 91. It was reported that patients normal heart rate and oxygen usually remains 75-80 and 95-97 respectively. Patients' blood pressure (BP) had been normal to low all of life, so the sudden spike was completely uncharacteristic. Then Patient called an ambulance at that time patients BP was 145-165/120-135. On 10-APR-2021, initially patient declined to go to hospital, but as patients heart rate was so bad then went to emergency room (ER). The patient waited from 12-4 a.m, but hospital was overrun so not got admitted. So checked BP every hour and it was consistently not drop below 145 systolic and heart rate was over 115. Then patient went to home. On 10-APR-2021, all day, patients heart rate was high, so patient bought a BP cuff to test BP, and it was still 145 systolic range. On 10-APR-2021 at night the patients BP and heart rate started to come down to 135/95.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart started racing, and blood pressure increased to 145-165/120-135, and the outcome of lips felt numb, light headed, lips felt tingly and oxygen saturation decreased was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s -blood pressure increased to 145 -165/120-135. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: U
Vaccine: COVID19
Symptoms: Head injury, Pain, Syncope
Clinical narrative: FAINTED; HEAD SMACKED; WHOLE BODY HURT; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, administered 1 total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced fainted while taking a pee 15 hours post-shot and smacked my head. Whole body hurt for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, body pain and head smacked was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210422129-COVID-19 VACCINE AD26.COV2.S-Fainted, Head smacked. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Head discomfort, Headache, Joint swelling
Clinical narrative: PRESSURE IN LEFT REAR SIDE OF HEAD; SEVERE HEADACHE; BAKER CYST; SHOULDER SWOLLEN LIKE A BALL; RIGHT ARM STARTED TO SWELL AND TIGHT; ARM PAIN AND SEVERE LEG PAIN BEHIND LEFT KNEE AND SWOLLEN; NAUSEOUS; SEVERE BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bladder surgery, and concurrent conditions included hypertension, frozen shoulder, and bladder problem. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. Concomitant medications included mirabegron for bladder problem, amitriptyline hydrochloride for frozen shoulder, naproxen for frozen shoulder, and losartan for hypertension. On 28-NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 13-MAR-2021, the subject experienced severe back pain. On 13-MAR-2021, the subject experienced nauseous. On 15-MAR-2021, the subject experienced shoulder swollen like a ball. On 15-MAR-2021, the subject experienced right arm started to swell and tight. On 15-MAR-2021, the subject experienced arm pain and severe leg pain behind left knee and swollen. On 26-MAR-2021, the subject experienced baker cyst. Laboratory data included: Doppler scan (NR: not provided) no clots in arm or leg, had a 5 cm Baker cyst behind left leg. On 28-MAR-2021, treatment medications included: sulfamethoxazole/trimethoprim. On 05-APR-2021 15:00, treatment medications included: cortisone. On 06-APR-2021, the subject experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Normal. On 13-APR-2021, the subject experienced pressure in left rear side of head. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe back pain on 14-APR-2021, shoulder swollen like a ball, and right arm started to swell and tight on 03-APR-2021, nauseous, and severe headache on 07-APR-2021, was recovering from arm pain and severe leg pain behind left knee and swollen, and pressure in left rear side of head, and had not recovered from baker cyst. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Synovial cyst
Clinical narrative: PRESSURE IN LEFT REAR SIDE OF HEAD; SEVERE HEADACHE; BAKER CYST; SHOULDER SWOLLEN LIKE A BALL; RIGHT ARM STARTED TO SWELL AND TIGHT; ARM PAIN AND SEVERE LEG PAIN BEHIND LEFT KNEE AND SWOLLEN; NAUSEOUS; SEVERE BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bladder surgery, and concurrent conditions included hypertension, frozen shoulder, and bladder problem. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. Concomitant medications included mirabegron for bladder problem, amitriptyline hydrochloride for frozen shoulder, naproxen for frozen shoulder, and losartan for hypertension. On 28-NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 13-MAR-2021, the subject experienced severe back pain. On 13-MAR-2021, the subject experienced nauseous. On 15-MAR-2021, the subject experienced shoulder swollen like a ball. On 15-MAR-2021, the subject experienced right arm started to swell and tight. On 15-MAR-2021, the subject experienced arm pain and severe leg pain behind left knee and swollen. On 26-MAR-2021, the subject experienced baker cyst. Laboratory data included: Doppler scan (NR: not provided) no clots in arm or leg, had a 5 cm Baker cyst behind left leg. On 28-MAR-2021, treatment medications included: sulfamethoxazole/trimethoprim. On 05-APR-2021 15:00, treatment medications included: cortisone. On 06-APR-2021, the subject experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Normal. On 13-APR-2021, the subject experienced pressure in left rear side of head. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe back pain on 14-APR-2021, shoulder swollen like a ball, and right arm started to swell and tight on 03-APR-2021, nauseous, and severe headache on 07-APR-2021, was recovering from arm pain and severe leg pain behind left knee and swollen, and pressure in left rear side of head, and had not recovered from baker cyst. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: PRESSURE IN LEFT REAR SIDE OF HEAD; SEVERE HEADACHE; BAKER CYST; SHOULDER SWOLLEN LIKE A BALL; RIGHT ARM STARTED TO SWELL AND TIGHT; ARM PAIN AND SEVERE LEG PAIN BEHIND LEFT KNEE AND SWOLLEN; NAUSEOUS; SEVERE BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bladder surgery, and concurrent conditions included hypertension, frozen shoulder, and bladder problem. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. Concomitant medications included mirabegron for bladder problem, amitriptyline hydrochloride for frozen shoulder, naproxen for frozen shoulder, and losartan for hypertension. On 28-NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 13-MAR-2021, the subject experienced severe back pain. On 13-MAR-2021, the subject experienced nauseous. On 15-MAR-2021, the subject experienced shoulder swollen like a ball. On 15-MAR-2021, the subject experienced right arm started to swell and tight. On 15-MAR-2021, the subject experienced arm pain and severe leg pain behind left knee and swollen. On 26-MAR-2021, the subject experienced baker cyst. Laboratory data included: Doppler scan (NR: not provided) no clots in arm or leg, had a 5 cm Baker cyst behind left leg. On 28-MAR-2021, treatment medications included: sulfamethoxazole/trimethoprim. On 05-APR-2021 15:00, treatment medications included: cortisone. On 06-APR-2021, the subject experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Normal. On 13-APR-2021, the subject experienced pressure in left rear side of head. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe back pain on 14-APR-2021, shoulder swollen like a ball, and right arm started to swell and tight on 03-APR-2021, nauseous, and severe headache on 07-APR-2021, was recovering from arm pain and severe leg pain behind left knee and swollen, and pressure in left rear side of head, and had not recovered from baker cyst. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Headache
Clinical narrative: headaches starting after second vaccine persisting til current time, painful urination starting 4/21 cause not confirmed by doctor
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure measurement, Dizziness, Heart rate, Respiratory rate
Clinical narrative: Patient received the Moderna vaccine and proceeded to the 15 minutes waiting area. After sitting down for 2-3 minutes she was noted by her husband to be feeling lightheaded. She proceeded to slump over on the chair and fainted. Emergency and 911 was called. She was placed on the stretcher and attached to the monitor, vital signs were obtained. Initial, BP 107/60, HR 80, RR 16, SpO2 98% on room air. Blood sugar obtained 77.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient received the Moderna vaccine and proceeded to the 15 minutes waiting area. After sitting down for 2-3 minutes she was noted by her husband to be feeling lightheaded. She proceeded to slump over on the chair and fainted. Emergency and 911 was called. She was placed on the stretcher and attached to the monitor, vital signs were obtained. Initial, BP 107/60, HR 80, RR 16, SpO2 98% on room air. Blood sugar obtained 77.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Electrocardiogram, Hypoaesthesia, Hypoaesthesia oral, Liver function test increased
Clinical narrative: Pins and needles in toes started first, over the course of the month numbness became the main complaint and has spread to calves, weak ankles.  Pins and needles in fingers started the weekend after the first shot. Over the past month it has moved into tingling in the arms and numbness in fingers, back of hands.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles in toes started first, over the course of the month numbness became the main complaint and has spread to calves, weak ankles.  Pins and needles in fingers started the weekend after the first shot. Over the past month it has moved into tingling in the arms and numbness in fingers, back of hands.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt called on 4/23/21 to call Center. Pt got Moderna vaccine  second dose on 4/22/21. Pt complains of right lump in the arm at the injection site, swollen, warm, size of marble and purple in color, onset 4/23/21 this morning, pain 9/10 constant. Pt also states feeling warm/feverish but no temp taken. Pt states she has moderate-severe asthma and diabetes. Pt advised to go to ED/urgent care to have the arm . Pt verbalized understanding
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pt called on 4/23/21 to call Center. Pt got Moderna vaccine  second dose on 4/22/21. Pt complains of right lump in the arm at the injection site, swollen, warm, size of marble and purple in color, onset 4/23/21 this morning, pain 9/10 constant. Pt also states feeling warm/feverish but no temp taken. Pt states she has moderate-severe asthma and diabetes. Pt advised to go to ED/urgent care to have the arm . Pt verbalized understanding
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: extreme pain & swelling with some redness & warmth in left wrist & hand
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, X-ray
Clinical narrative: extreme pain & swelling with some redness & warmth in left wrist & hand
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: Patient called pharmacy 04/28/21 in the morning stating that she was having a reaction from the Moderna  vaccine given 4/23/21.  She stated that on Sunday 4/25/21, she began developing a raised, itchy rash.  The symptoms have not subsided.  The rash began on the arm vaccine was given and has now spread over body.  She had not taken Benadryl the last couple of days.  She was instructed to take 1 or 2 capsules of 25mg diphenhydramine every four to six hours to see if that alleviated the itchiness.  If the rash continued to spread, she was instructed to call her physician to be seen.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: 11 days after the injection a large red patch appeared suddenly  around injection site after lifting something heavy. It is hot to the touch, swollen and slightly itchy. The muscle feels tender and sore. Patch is about 2.5 inches in diameter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: 11 days after the injection a large red patch appeared suddenly  around injection site after lifting something heavy. It is hot to the touch, swollen and slightly itchy. The muscle feels tender and sore. Patch is about 2.5 inches in diameter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Biopsy, Blood test, Condition aggravated, Contusion
Clinical narrative: Rash appeared after first shot on January 18 in my groin area and then again after second shot on February 8, 2021.  Rash disappeared by March 15. It reappeared as hives on April 7. New hives would appear each morning with severe itching. Over time they would go through 4 states - bright pink and itch, splotchy red, red, and then bruise. I was diagnosed with urticarial vasculitis on April 23 by a dermatologist and now I have seen a rheumatologist that confirms it.  I am on steroids to suppress the hives that can cause damage to my blood vessels and organs.  I am on Plaquenil for at least a year and Dapsone.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Haemorrhage, Metabolic function test, Pruritus, Rash
Clinical narrative: Rash appeared after first shot on January 18 in my groin area and then again after second shot on February 8, 2021.  Rash disappeared by March 15. It reappeared as hives on April 7. New hives would appear each morning with severe itching. Over time they would go through 4 states - bright pink and itch, splotchy red, red, and then bruise. I was diagnosed with urticarial vasculitis on April 23 by a dermatologist and now I have seen a rheumatologist that confirms it.  I am on steroids to suppress the hives that can cause damage to my blood vessels and organs.  I am on Plaquenil for at least a year and Dapsone.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria, Urticarial vasculitis
Clinical narrative: Rash appeared after first shot on January 18 in my groin area and then again after second shot on February 8, 2021.  Rash disappeared by March 15. It reappeared as hives on April 7. New hives would appear each morning with severe itching. Over time they would go through 4 states - bright pink and itch, splotchy red, red, and then bruise. I was diagnosed with urticarial vasculitis on April 23 by a dermatologist and now I have seen a rheumatologist that confirms it.  I am on steroids to suppress the hives that can cause damage to my blood vessels and organs.  I am on Plaquenil for at least a year and Dapsone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product reconstitution quality issue, Unevaluable event
Clinical narrative: Error: Incorrect Reconstitution
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Head discomfort, Nausea, Rash
Clinical narrative: severe chills, nausea, skin irritation and rashes, pressure at back of head, light-headedness: intermittent chills, come in early evening, then again the next morning. This has happened at least once a week since the second vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: severe chills, nausea, skin irritation and rashes, pressure at back of head, light-headedness: intermittent chills, come in early evening, then again the next morning. This has happened at least once a week since the second vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Induration, Limb discomfort
Clinical narrative: Red circle on upper part of my arm, warm to the touch and hard.  It has gotten better each day.  Headache as well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Huge feverish rash in same place injection was given. Very hot to touch. Itchy, and red bumps. Stiff joints and muscles all over esp. in legs, arms, and neck
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Ocular discomfort
Clinical narrative: Just sort of 2 weeks after vaccine, I started feeling discomfort in my right eye.  Later that week, was diagnosed with ocular shingles, which is very rare for someone my age.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Vaginal odour
Clinical narrative: I had a uterine ablation approximately 6 years ago and rarely menstrate.  But the day after the vaccine I started menstruation but it has been heavy, terrible odor and had lasted several days now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: The next day after I received my 2nd shot, I was tired and had a headache when I work up. Then when I got to work my whole body started to hurt and I was getting nauseous. I left work and went home around 3pm and once I was home I started getting the chills and then would start sweating all night. The injection site is still super painful and I still have a headache, but the flu like symptoms have subsided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pain
Clinical narrative: The next day after I received my 2nd shot, I was tired and had a headache when I work up. Then when I got to work my whole body started to hurt and I was getting nauseous. I left work and went home around 3pm and once I was home I started getting the chills and then would start sweating all night. The injection site is still super painful and I still have a headache, but the flu like symptoms have subsided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypertension, Wheezing
Clinical narrative: Patient with chills and wheezing.  Pt says she is a very active person and doesn't like to sit down. The patient was brought back to the provider tent and examined. BP 154/93 P 73 RR 18 PO2 99% RA. Patient was provided water and cookie but refused.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Patient self-scheduled for Dose 2 after receiving 1st dose  at a pharmacy.  First dose was Moderna and 3 weeks 5 days after received Pfizer vaccine at the Health Department Clinic.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Pain, Pruritus
Clinical narrative: Pt called call center on 4/23/2021 regarding of covid vaccine side effects. Verified pt with 2 identifiers. Pt reports c/o bad rash on neck, back, the right side of upper leg and hip after covid vaccination. Pt feels dizziness and weakness since this morning. Pt got 2nd vaccination(Moderna) at on 4/22/2021. Pt states she got some rashes after 1st vaccination as well. Pt feels itches, burning sensation and pain with bad rashes. Pt tooke OTC allergy pills but it's not helpful per pt. Noted hx of hyperthyroid and taking levothyroxine. Noted no health issues except covid side effects. Noticed pt to go to ED or call 911 for further evaluations d/t pt shows 2 parts of emergency covid vaccine side effects. Pt is educated of covid side effects. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pt called call center on 4/23/2021 regarding of covid vaccine side effects. Verified pt with 2 identifiers. Pt reports c/o bad rash on neck, back, the right side of upper leg and hip after covid vaccination. Pt feels dizziness and weakness since this morning. Pt got 2nd vaccination(Moderna) at on 4/22/2021. Pt states she got some rashes after 1st vaccination as well. Pt feels itches, burning sensation and pain with bad rashes. Pt tooke OTC allergy pills but it's not helpful per pt. Noted hx of hyperthyroid and taking levothyroxine. Noted no health issues except covid side effects. Noticed pt to go to ED or call 911 for further evaluations d/t pt shows 2 parts of emergency covid vaccine side effects. Pt is educated of covid side effects. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a week.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia oral
Clinical narrative: Tingliny tongue within 10 minutes of vaccine.  Allegra given. Felt better after approx 20 minutes.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Itchy, swelling, tenderness, redness
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Inflammation, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocardial fibrosis
Clinical narrative: Patient devloped myopericarditis confirmed by MRI 2 days following 2nd dose of vaccination, COVID negative, Respiratory panel negative
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Red blood cell sedimentation rate normal, Respiratory viral panel, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Patient devloped myopericarditis confirmed by MRI 2 days following 2nd dose of vaccination, COVID negative, Respiratory panel negative
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Viral test negative
Clinical narrative: Patient devloped myopericarditis confirmed by MRI 2 days following 2nd dose of vaccination, COVID negative, Respiratory panel negative
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: ER futher eval.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: ER futher eval.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient states that approximately 5 minutes after she received Pfizer vaccine (1st dose), she began to feel nauseous and notified observer. Observer notified RN and gave patient a bottle of water. RN assessed patient and notified EMS on scene.
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Patient states that approximately 5 minutes after she received Pfizer vaccine (1st dose), she began to feel nauseous and notified observer. Observer notified RN and gave patient a bottle of water. RN assessed patient and notified EMS on scene.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Unevaluable event
Clinical narrative: There were no adverse reactions took place .
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Dizzy, headache, fever, body pain, chest w
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Apnoea, Livedo reticularis, Oxygen saturation decreased, Respiratory rate increased
Clinical narrative: Patient had increased respirations, SpO2 declined, 15 seconds of apnea, mottling to BLE, minimally responsive
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Red rash by injection site and also red rash by her lower neck.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye infection, Fatigue, Head discomfort, Pyrexia
Clinical narrative: I am still feeling effects. Tired, fever, head pressure and ear pain. And then today 4/28/21 almost a week later I now have an eye infection.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Flushing, Headache, Nausea
Clinical narrative: He got the vaccine, and when he woke up the 2nd day his throat felt dry and felt like it was sore.  His arm felt sore as if somebody hit him several times, very sore.  I felt sick, felt queasy, nauseous wanting to vomit but did not.  He felt really tired, fatigued because he didn't get any sleep that night.  He went all day feeling terrible, nauseous, felt like being through the ringer an flushed, which went on for 2-3 days.  He now feels a lot better, but felt like he was getting the flu.  He did not take anything for it and did take some medicine to help him sleep and did get a lot of rest and sleep.  He did drink a lot of liquids to keep his throat lubricated.  He also did have a throbbing headache, which he normally does not get headaches and felt terrible.  He did take some aspirin for that.  The symptoms have all resolved and feels perfectly fine now.     Stated that he has never felt so bad in his life.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: He got the vaccine, and when he woke up the 2nd day his throat felt dry and felt like it was sore.  His arm felt sore as if somebody hit him several times, very sore.  I felt sick, felt queasy, nauseous wanting to vomit but did not.  He felt really tired, fatigued because he didn't get any sleep that night.  He went all day feeling terrible, nauseous, felt like being through the ringer an flushed, which went on for 2-3 days.  He now feels a lot better, but felt like he was getting the flu.  He did not take anything for it and did take some medicine to help him sleep and did get a lot of rest and sleep.  He did drink a lot of liquids to keep his throat lubricated.  He also did have a throbbing headache, which he normally does not get headaches and felt terrible.  He did take some aspirin for that.  The symptoms have all resolved and feels perfectly fine now.     Stated that he has never felt so bad in his life.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: J&J on 4/12/2021- other details unknown   Fatigue, significant, prevents daily activity Headache, Arthralgia
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: After the patient was administered the vaccine, she walked to the 15 min post-vaccine waiting area and sat down. After ~5-10 minutes her dad told me she  wasn't feeling well. I went straight to the patient who was still sitting, looking pale and being fanned by her mother. I said let's lay her down but she lost conciousness right then so I just caught her in her chair.  A technician  called 911. An associate took over holding the patient in her chair. We raised her feet on to another chair, her mother continued to fan her face. I sent another associate to meet the responders at the front door and bring them to us. Patient was breathing throughout. She started to regain conciousness before the responders arrived. They checked her out and gave her permission to go home with her parents.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Cold sweat, Dizziness, Injection site mass
Clinical narrative: Pt called Call center 4/23/2021 regarding of covid vaccine side effect. Noted c/o dizziness, abdominal cramping and fever(pt didn't check temperature, but pt feels cold sweats and lots of chills) today. Pt got 2nd covid vaccine(Moderna) 4/22/2021. Pt said she felt fine yesterday however from this morning pt feels dizziness as long as pt has to lay down, abdominal cramping, fever, lump at left arm injection site. Pt is taking ibuprofen. Noted hx of anxiety, insomnia, depression per pt and no allergies. Informed pt to go to ED or call 911 d/t pt shows 3 parts of emergency side effects of covid vaccine. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED. Pt is educated of covid side effects. Pt verbalized understanding.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Pt called Call center 4/23/2021 regarding of covid vaccine side effect. Noted c/o dizziness, abdominal cramping and fever(pt didn't check temperature, but pt feels cold sweats and lots of chills) today. Pt got 2nd covid vaccine(Moderna) 4/22/2021. Pt said she felt fine yesterday however from this morning pt feels dizziness as long as pt has to lay down, abdominal cramping, fever, lump at left arm injection site. Pt is taking ibuprofen. Noted hx of anxiety, insomnia, depression per pt and no allergies. Informed pt to go to ED or call 911 d/t pt shows 3 parts of emergency side effects of covid vaccine. Pt declined the offer to call 911 on behalf of pt but pt states she will go to ED. Pt is educated of covid side effects. Pt verbalized understanding.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia
Clinical narrative: Extreme numbness in hands that is worsening over time. Causes extreme pins/needles, aching and inability to hold basic objects like a cell phone. Attempting to see a doctor for this immediately.  Originally had this in December -- presumably with COVID that never got diagnosed. Worsened after 1st shot, worsened dramatically after 2nd shot.