chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 17 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 10-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 13 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 11-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 1.58
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 19 months old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 07-APR-2021, the patient was administered improperly stored measles, mumps, and rubella (wistarra 27-3) virus vaccine, live(M-M-R II) (lot # was reported as S028915, expiration date was reported as 16-SEP-2021, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 months old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-MAR-2021, the patient was administered improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # was reported as S028915, expiration date was reported as 16-SEP-2021, strength, dose, frequency and route unknown, therapy type: rHA) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Sex: U
Vaccine: TDAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received their fifth dtap; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old patient who received DTPa (DTPa vaccine) for prophylaxis.   Previously administered products included DTPa Vaccine (received 4 doses on an unknown date).   On an unknown date, the patient received the 5th dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The Nurse reported that the patient had not and never received their fifth DTPa so per CDC guidelines they should get DTPa, which led to incomplete course of vaccination. The reporter did not consent to follow up. The HCP declined to provide additional information and cannot confirm that the missed Dtap was Infanrix.  Boostrix had not been administered to the patient yet.  The HCP declined follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Impaired work ability, Injection site erythema, Injection site infection
Clinical narrative: ER visit because of the throat swelling; Along with tongue swelling; Making breathing difficult; Redness in the arm / looked like an infection / Another visit to the ER; Arm / swelling- "blew up like a balloon / Swelling and redness in the shot area; Reaction continued with a redness in the arm / looked like an infection / redness in the shot area; There were body aches; Took off work days / loss of work time; This case was reported by a consumer via call center representative and described the occurrence of injection site infection in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Shingrix. On 18th May 2021, less than a day after receiving Shingrix, the patient experienced injection site infection, injection site swelling, injection site erythema, general body pain and activities of daily living impaired. On 19th May 2021, the patient experienced throat swelling, swollen tongue and difficulty breathing. The patient was treated with benadryl (nos) (Benadryl) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient received vaccine on Tuesday in the doctor's office and experienced the reaction of the shot in the arm as a swelling, which was blew up like a balloon. There were body aches and the patient took off work days. On Wednesday night, 19th May 2021, there was an ER (emergency room) visit because of the throat swelling making breathing difficult along with tongue swelling and there was no hospital admission on this date. The patient was assigned an OTC (over the counter), Benedryl, over the weekend, the patient reported that the arm did not get better. The reaction continued with a redness in the arm and it was looked like an infection. The patient had another visit to the emergency room on Saturday night, 22nd May 2021, and she was not admitted to the hospital. The patient was administered an antibiotic. The patient was upset and wanted the company to know about these details, she expressed concern over the costs of emergency room visits, loss of work time, and cost of co-pays paid. The patient expressed a desire to possible have reimbursements. The reporter consented to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Pain, Peripheral swelling, Pharyngeal swelling
Clinical narrative: ER visit because of the throat swelling; Along with tongue swelling; Making breathing difficult; Redness in the arm / looked like an infection / Another visit to the ER; Arm / swelling- "blew up like a balloon / Swelling and redness in the shot area; Reaction continued with a redness in the arm / looked like an infection / redness in the shot area; There were body aches; Took off work days / loss of work time; This case was reported by a consumer via call center representative and described the occurrence of injection site infection in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Shingrix. On 18th May 2021, less than a day after receiving Shingrix, the patient experienced injection site infection, injection site swelling, injection site erythema, general body pain and activities of daily living impaired. On 19th May 2021, the patient experienced throat swelling, swollen tongue and difficulty breathing. The patient was treated with benadryl (nos) (Benadryl) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient received vaccine on Tuesday in the doctor's office and experienced the reaction of the shot in the arm as a swelling, which was blew up like a balloon. There were body aches and the patient took off work days. On Wednesday night, 19th May 2021, there was an ER (emergency room) visit because of the throat swelling making breathing difficult along with tongue swelling and there was no hospital admission on this date. The patient was assigned an OTC (over the counter), Benedryl, over the weekend, the patient reported that the arm did not get better. The reaction continued with a redness in the arm and it was looked like an infection. The patient had another visit to the emergency room on Saturday night, 22nd May 2021, and she was not admitted to the hospital. The patient was administered an antibiotic. The patient was upset and wanted the company to know about these details, she expressed concern over the costs of emergency room visits, loss of work time, and cost of co-pays paid. The patient expressed a desire to possible have reimbursements. The reporter consented to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: ER visit because of the throat swelling; Along with tongue swelling; Making breathing difficult; Redness in the arm / looked like an infection / Another visit to the ER; Arm / swelling- "blew up like a balloon / Swelling and redness in the shot area; Reaction continued with a redness in the arm / looked like an infection / redness in the shot area; There were body aches; Took off work days / loss of work time; This case was reported by a consumer via call center representative and described the occurrence of injection site infection in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Shingrix. On 18th May 2021, less than a day after receiving Shingrix, the patient experienced injection site infection, injection site swelling, injection site erythema, general body pain and activities of daily living impaired. On 19th May 2021, the patient experienced throat swelling, swollen tongue and difficulty breathing. The patient was treated with benadryl (nos) (Benadryl) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the injection site infection, injection site swelling, injection site erythema, general body pain, activities of daily living impaired, throat swelling, swollen tongue and difficulty breathing to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient received vaccine on Tuesday in the doctor's office and experienced the reaction of the shot in the arm as a swelling, which was blew up like a balloon. There were body aches and the patient took off work days. On Wednesday night, 19th May 2021, there was an ER (emergency room) visit because of the throat swelling making breathing difficult along with tongue swelling and there was no hospital admission on this date. The patient was assigned an OTC (over the counter), Benedryl, over the weekend, the patient reported that the arm did not get better. The reaction continued with a redness in the arm and it was looked like an infection. The patient had another visit to the emergency room on Saturday night, 22nd May 2021, and she was not admitted to the hospital. The patient was administered an antibiotic. The patient was upset and wanted the company to know about these details, she expressed concern over the costs of emergency room visits, loss of work time, and cost of co-pays paid. The patient expressed a desire to possible have reimbursements. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Had pain at injection site of left arm which resolved; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient had pain at injection site of left arm after vaccination. For tolerance with 2nd dose refer case US2021AMR112032. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR112032:Same reporter, Same patient. 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only received the first dose of Shingrix in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date in 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 information was provided as follows: The case was reported by patient herself. 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 declined to provide health care professional information. The reporter did not consent to follow up. This case is linked to case US2021112519 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021112519:Same reporter. Husband's case.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only received the first dose of Shingrix in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date in 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 information was provided as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide health care professional information. The reporter did not consent to follow up. This case is linked to case US2021112517 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021112517:Same reporter. Wife's case.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received / a dose of Bexsero that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA13CA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th March 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported as follows: The age at vaccination was not reported On 29th March 2021 patient received Bexsero which was expired on 28th February 2021. The reporter did not consent to follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Influenza like illness, Oral herpes
Clinical narrative: 14 hrs after the vaccine, developed flu symptoms.  beginning at 14 hrs, started taking temperature and did so every half-hour.   At hour 18, temp was 100.9, 30 min later, 101.5, 30 min later, 102.0, 30 min later, 102.7.  when temp reached 1019, spouse began to administer cold-wet cloth to heated areas, e.g., stomach and lower back, spouse continued until for 45 min, until temp dropped to 101.5.  checked temp every hour after that, until dropped below 100.0.  Temp returned to normal roughly 25 hrs after vaccine administration. 68 hrs after vaccine administration, developed cold sores.  Normally, the cold sore would manifest in an area no more than 5% of upper lip area,  After the COVID vaccine, the cold sore covered 35% of upper lip area, and lasted about 24 hours longer than it normally would.  lasted 5 days vice 3 - 4 days, normally.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Headache, Pain in extremity
Clinical narrative: Headache, light headed, feeling hot without fever, arm soreness fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Magnetic resonance imaging, Muscle contracture, Muscle spasms
Clinical narrative: Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and glands lasted for 2 days. Three days later, tremors feeling possible seizure but did not have one. Additionally stated to have muscle spasms, weakness and muscle contractures mainly right side extremities and lower back and pelvis area started. The muscle spasms have continued to occur just not every day any more. I had muscle spasms in my leg last night so would not say all symptoms have resolved yet.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and glands lasted for 2 days. Three days later, tremors feeling possible seizure but did not have one. Additionally stated to have muscle spasms, weakness and muscle contractures mainly right side extremities and lower back and pelvis area started. The muscle spasms have continued to occur just not every day any more. I had muscle spasms in my leg last night so would not say all symptoms have resolved yet.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cautery to nose, Computerised tomogram abnormal, Coronary artery thrombosis, Death, Electrocardiogram abnormal
Clinical narrative: He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Laboratory test, Myocardial infarction, Nasal cavity packing, Thrombosis
Clinical narrative: He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis mesenteric vessel
Clinical narrative: He received both doses March 2021. second dose on 3/26. on 4/26 presented to ER with Epistaxis, came to about a month after Pfizer series pt went to Hospital ER 3 times that week for care of what was thought nose bleeds from picking, and later ENT for care that required travel. Pt stopped Plavix use and 6 days later on 5/1 returned to Hospital ER with serious symptoms, developed multiple thrombotic events that lead to clotting of leg/bowel/coronary. Transferred to Hospital on 5/1/2021. Multiple MI events and expired at Hospital on 5/3/2021
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: After standing up from the toilet early in the morning, fainted and fell on bathroom floor. No injuries were sustained. After regaining consciousness less than 1 minute later, sat up and breathed and focused for about 2 minutes until mentally clear. Relocated with assistance to couch, drank water, ate a slice of toast.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Feeling abnormal, Feeling hot, Headache
Clinical narrative: My arm was never really sore after injection and I assumed I had no reactions.  However, exactly one week after the covid injection my left arm, at the shots location, it started it itch, became slightly red like a rash and was a bit hard and swollen.  During the week after the injection a few days later I started to get hot and clammy and a bit weak feeling several times a day  (age is 72) which I had not experienced before.  I've also begun to have headaches almost daily and just feel quite physically and mentally off since that week.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Induration, Injection site pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: My arm was never really sore after injection and I assumed I had no reactions.  However, exactly one week after the covid injection my left arm, at the shots location, it started it itch, became slightly red like a rash and was a bit hard and swollen.  During the week after the injection a few days later I started to get hot and clammy and a bit weak feeling several times a day  (age is 72) which I had not experienced before.  I've also begun to have headaches almost daily and just feel quite physically and mentally off since that week.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21.  My arm soreness never subsided by the day of my second dose, which was on 4/24/21 at 12:00 p.m.  Here we are on 5/27 & the soreness still has not gone away.  It's been 8 weeks and it's actually gotten worse the last 2-3 days.  I can't find information on this particular situation anywhere.  My arm is not swollen or red and there are no hard bumps or anything like that in the area.  It's just sore whenever I move it.  This is not right.  Please let me know what to do.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, sore arm.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Client became lightheaded and clammy.  Responsive to verbal and tactile stimulation.  No loss of consciousness.  Alert, aware and responsive.  Skin noted to be moist and clammy to touch.  Pale complexion.  Dad was present during event.  Dad stated client was recovering from COVID-19.  Had his last negative test on 5/14/2021.  Dad did not want 911 services activated, however, he stated and nursing also advised that he take client to see his PCP.  Upon exit, client was alert, verbal and ambulatory.  No sign of acute distress.  Exit at 3:47pm.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: PAIN ON THE SHOULDER (ON VACCINATION DAY); MILD HEADACHE (DAY AFTER VACCINATION); FEVER (DAY AFTER VACCINATION); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced pain on the shoulder (on vaccination day), mild headache (day after vaccination), and fever (day after vaccination). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the shoulder (on vaccination day), mild headache (day after vaccination), and fever (day after vaccination). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown exp:unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a pulmonary embolism. She was hospitalized on an unspecified date and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210547188 -covid-19 vaccine ad26.cov2. s-Pulmonary embolism. This event is considered un-assessable. The event 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.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: TIRED; MUSCLE ACHES; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's past medical history included bladder removal, and polyp removed from colon, and concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included no known allergies and illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tired. On 24-MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and muscle aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Pain in extremity, Sinusitis
Clinical narrative: BRONCHITIS; SINUS INFECTION; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZIA, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bronchitis. On APR-2021, the subject experienced sinus infection. On APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bronchitis, and sinus infection, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210537574.
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability
Clinical narrative: COULD NOT STAND UP; COULD NOT WALK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced could not stand up. On 20-MAY-2021, the subject experienced could not walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not stand up and could not walk was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC EFFECT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cold sore of herpex, and concurrent conditions included cold sore on lips, and cold sore on tongue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic effect was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: Chest pain an hour later; Little bit of soreness immediately; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain an hour later) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Narcolepsy and Endometriosis. Concomitant products included AMITRIPTYLINE, BUSPIRONE, GABAPENTIN (NEURONTIN) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain an hour later) (seriousness criterion medically significant) and PAIN (Little bit of soreness immediately). On 13-Apr-2021, CHEST PAIN (Chest pain an hour later) and PAIN (Little bit of soreness immediately) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include birth control pills. Treatment medication included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-128681 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Vision blurred
Clinical narrative: seizure; completely blurry vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) and VISION BLURRED (completely blurry vision) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 16-Mar-2021 to 25-Apr-2021 and COVID-19 from 28-Dec-2020 to 16-Feb-2021. Concurrent medical conditions included Drug allergy (Allergy to NSAIDS), Penicillin allergy, Drug allergy (Allergy to Tramadol), Drug allergy (Allergy to Wellbutrin) and Allergy to antibiotic (Allergy to cephalexin antibiotics).    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISION BLURRED (completely blurry vision) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 12-May-2021 due to SEIZURE and VISION BLURRED. At the time of the report, SEIZURE (seizure) had not resolved and VISION BLURRED (completely blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced 3 episodes of seizure on 13-May-2021 and another 2 episodes of seizure on 14-May-2021.  The patient stated that the doctor advised him not to receive the second vaccination dose.  The patient was hospitalized right after the events. At the time of reporting, the patient was still in the hospital. Additional treatment details  were  not provided.  Concomitant medication information was not provided.  Company comment: Very little information has been provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Very little information has been provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Critical illness, Nausea, Oxygen saturation
Clinical narrative: Severely ill; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRITICAL ILLNESS (Severely ill) (seriousness criteria hospitalization and medically significant), PAIN (Body aches) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). At the time of the report, CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive. On an unknown date, Oxygen saturation: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.   Patient had COVID before vaccine.after her isolation was over she received 1st dose; she got severely ill; she had  fever, chills , body aches , nausea , and she was in the hospital on temporally oxygen.   Patient wants to know when she can get the 2nd dose of the vaccine and is it safe to take second vaccine?; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severely ill; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRITICAL ILLNESS (Severely ill) (seriousness criteria hospitalization and medically significant), PAIN (Body aches) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). At the time of the report, CRITICAL ILLNESS (Severely ill), PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive. On an unknown date, Oxygen saturation: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.   Patient had COVID before vaccine.after her isolation was over she received 1st dose; she got severely ill; she had  fever, chills , body aches , nausea , and she was in the hospital on temporally oxygen.   Patient wants to know when she can get the 2nd dose of the vaccine and is it safe to take second vaccine?; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's history of COVID  infection just before the vaccination remains a confounder.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Echocardiogram, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Heart pain; pneumonia-like symptoms; Flue symptoms; Aching; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue). At the time of the report, ANGINA PECTORIS (Heart pain), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Echocardiogram: normal (normal) normal.         The patient went to emergency department and everything was normal. The reporter stated that the patient was better with nitroglycerine.  No concomitant medications were reported.  Treatment for the events included nitroglycerine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom
Clinical narrative: Heart pain; pneumonia-like symptoms; Flue symptoms; Aching; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue). At the time of the report, ANGINA PECTORIS (Heart pain), RESPIRATORY SYMPTOM (pneumonia-like symptoms), INFLUENZA LIKE ILLNESS (Flue symptoms), MYALGIA (Aching) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Echocardiogram: normal (normal) normal.         The patient went to emergency department and everything was normal. The reporter stated that the patient was better with nitroglycerine.  No concomitant medications were reported.  Treatment for the events included nitroglycerine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.