chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Large local allergic reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Sep-2022 Reporter's Comment: This case was reported by a other health professional via  interactive digital media. It was reported that the patient developed a large local allergic reaction to first Shingrix dose. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA730A, expiry date 30th September 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The pharmacist reported that the patient was administered the Menveo lyophilized portion, which had been reconstituted with sterile water.  The Vaccine administration facility was the same as primary reporter. The expiration date was Sep 2023 so used last day of month on form. The reporter consent to follow up via email. Additional Supportive Information: The patient was administered Menveo lyophilized portion reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: 36 week pregnant patient received an expired dose; 6 week pregnant patient received an expired dose; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number N959G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was October 2022. The patient received FluLaval Quadrivalent 2022-2023 season at week 36 of the pregnancy. On 19th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown. The pregnancy was ongoing.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a 36 weeks pregnant patient received an expired dose of Flulaval, the vaccine expired on 30th June 2022. The consent for follow-up was not asked. Additional Supportive Information: A pregnant patient received an expired dose of Flulaval, which led vaccine exposure during pregnancy and expired vaccine used.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Pain at the injection site; Hives at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site hives. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site hives was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter reported that the patient received a dose of Shingrix vaccine. The reporter stated that after Shingrix vaccine the patient experienced pain at the injection site. In Sep 2022, few days after receiving Shingrix patient had hives at the injection site. The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: plantar wart disappeared; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included plantar warts.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter was the patient's wife's friend. She states that the patient's plantar wart disappeared after receiving SHINGRIX. She did not know if it was after his first or second dose.  The reporter did not consent to follow-up Additional supportive information: This case has been linked with case US2022134442 reported by same reporter.; Sender's Comments:  US-GSK-US2022134442:Same reporter
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 08Aug2022 and 2nd dose recieved on 09Sep2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 14th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th September 2022, the patient received the 2nd dose of Shingrix. On 9th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The Pharmacist reports patient received first dose of Shingrix on 8th August 2022, and second dose was administered on 9th September 2022.   The patient was not immunocompromised.   The reporter give consent to follow up. Additional Supportive Information: The patient received second dose earlier than the recommended interval, which lead to shortening of vaccination schedule.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Mobility decreased, Walking aid user
Clinical narrative: May have Guillain-Barre Syndrome; Could not walk for 2 weeks; Could not turn over in bed/ bend over; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 19th July 2022, less than a day after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), unable to walk and mobility decreased. On 2nd August 2022, the outcome of the mobility decreased was recovered/resolved. On 16th September 2022, the outcome of the unable to walk was recovered/resolved. On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome, unable to walk and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The reporter was the patient and reports she received her first Shingrix vaccine in right arm. The patient could not walk for 2 weeks after receiving the Shingrix vaccine.  The patient could not even turn over in bed for 2 weeks.  The reporter reports about 2 weeks after receiving the Shingrix she could begin to walk with a cane and walker. The reporter reports she still could not bend over to picked something off the floor. The reporter reported that on 6th Sep 2022 patient was able to walked with out the walker or cane. The reporter felt she may had guillain-barre syndrome.   The patient would to saw her HCP tomorrow.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: 1st dose on 04May2021, 2nd not received; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 4th May 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date:20-SEP-2022 Reporter's Comment: The case was reported by the patient. The reporter was not willing to share DOB (date of birth). The reporter reported that, she received her Shingrix vaccine in an unknown arm.  The reporter reported that, pain at the injection site for a few days.  The reporter reported that, she had not received her second Shingrix vaccine yet (Inappropriate schedule of vaccine). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: large local allergic reaction; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The patient developed a large local allergic reaction to Shingrix dose.  The reporter was concerned about administering the second dose of Shingrix. The reporter declined to provide credentials and disconnected the chat before he/she was able to get any additional information about the adverse event. The reporter did not consent to follow-up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE WAS ADMINISTERED AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 21 year old male. 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: 1855190, expiry: 24-SEP-2022) dose was not reported, administered on 28-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 21 years old. No concomitant medications were reported. On 28-JUL-2022, the patient experienced vaccine was administered after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945933, 20220948245 and 20220948255.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: THE JAB KILLED; This spontaneous report received from a consumer via social media (J&J corporate social media) via company representative concerned multiple patients of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, post receiving the vaccine, the jab killed the patients. The patients died from unknown cause of death. It was reported as "the jab killed her just like several in my family ... " It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220946006, 20220948266 and 20220948144. Sender's Comments: V0: 20220946018-covid-19 vaccine ad26.cov2.s-The jab killed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bundle branch block right, COVID-19 immunisation, Cardiomegaly, Echocardiogram, Electrocardiogram
Clinical narrative: RIGHT BUNDLE BLOCK; HEART SWELLING; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and not any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 since the vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 09:00 am to left arm for covid-19 prophylaxis. Age at time of vaccination was 60 years. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). On an unspecified date in JUL-2021, Laboratory data included: EKG (Electrocardiogram) was normal. The patient also received non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 2), (batch number: 301458A expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 22-OCT-2021 15:00 pm to left arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 2). No concomitant medications were reported. On an unspecified date in SEP-2022, laboratory data included EKG which showed right bundle block due to heart swelling (Dose number in series 2). On an unspecified date in SEP-2022, echocardiogram showed no signs of heart problems or disease.  The patient was concerned to have heart swelling after Pfizer MRNA booster which caused right bundle block. The patient had no other health changes between the Pfizer booster and the latest EKG (SEP-2022). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered with sequelae from right bundle block, and heart swelling, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACKS; This spontaneous report received from a consumer via a company representative via social media concerned multiple male patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients was athletes. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 male athletes had heart attacks. The reporter stated that " look at all the male athletes having heart attacks". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attacks was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220946006, 20220946018 and 20220948144.; Sender's Comments: V0: 20220948266 -covid-19 vaccine ad26.cov2.s-Heart attacks. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Suspected COVID-19
Clinical narrative: PHYSICALLY ILL; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer concerned a 53 year old female. The patient's weight was 78.47 kilograms, and height was 160 centimeters. The patient's concurrent conditions included: bacterial vaginosis, and drug allergy (Patient was allergic to generics of Flagyl. Generic gel makes her sick). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Non-company suspect drugs included: metronidazole (tablet, oral, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported, and (gel, route of admin was not reported, batch number: 150405 expiry: FEB-2023) dose, frequency, and therapy dates were not reported for bacterial vaginosis. No concomitant medications were reported.  On an unspecified date in JUN-2022, the patient contracted covid-19 infection (suspected covid-19 infection) (dose number in series 2) and she didn't get to the doctor until AUG-2022. Then she got her prescription. She told her doctor every time she took Metronidazole that made her physically ill (dose number in series 2). Patient went to urgent care after she could not get prescription and she was given another prescription and she was given the Metronidazole gel. She said it had been a long time since she took the pills and she only had the gel. She took one or two application and made her really sick and she discontinued. She only had rest of one gel and she only took one tube of it and the next day she noticed she was sick again and she didn't think something not taken by mouth would make her sick and she was surprised. She was given the Metronidazole gel and she thought because of gel instead of pill and would not cause allergic reaction and she was wrong. She was taking generic for a couple of years without incident and all of a sudden she became allergic. Three months since she had covid and now she can have a booster and the doctor said wait 3 months and she will get the Bivalent booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metronidazole was not reported. The outcome of the suspected covid-19 infection and physically ill was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: POSSIBLE ADVERSE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced possible adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: STOMACH SICK A LITTLE FOR A FEW DAYS AFTER SECOND SHOT; This spontaneous report received from a patient via a company representative via social media (concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: covid-19 (Patient did not leave the farm for 4 months when she got sick. Patient was able to stay home for 6 weeks because of home oxygen. After the third night, patient felt a little bit better and opted to stay home and fight it out. Patient was down for 6 weeks and could not walk around. Patient would sleep 18 hours a stretch and it was a terrible struggle to wake up. It took a year to recover. Patient was going to recover and reported that taste and smell comes and goes, body pain was 200 percent more than it was before.), copd (COPD has tripled after being sick with suspected covid-19), disabled (Patient was disabled and never go anywhere except to the doctor for diabetic check-ups), and diabetic. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1). The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. 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 patient experienced stomach sick a little for a few days after second shot (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach sick a little for a few days after second shot. This report was non-serious. This case, from the same reporter is linked to 20220949079.
Sex: M
Vaccine: COVID19
Symptoms: Nonspecific reaction, Off label use
Clinical narrative: MILD REACTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported, and dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Off label use. 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 patient experienced mild reaction, and off label dosing frequency. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild reaction and off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220945170.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS BEGAN 2 DAYS OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced side effects began 2 days out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects began 2 days out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: SEVERELY INJURED; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced severely injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severely injured was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Pyrexia, Rash
Clinical narrative: Broken out rash; Fever; Almost anaphylaxis reaction; Trouble swallowing; A spontaneous report was received from a nurse concerning a 39-year-old, female patient who experienced fever, trouble swallowing, almost anaphylaxis reaction and broken out in rash.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Jan 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 041L20A] intramuscularly for prophylaxis of COVID-19 infection.   On 30 Jan 2021, the patient experienced fever, trouble swallowing and almost anaphylaxis reaction. Treatment for the event included ibuprofen and diphenhydramine hydrochloride.   On 31 Jan 2021, the patient had broken out in rash. The patient reported taking steroids.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event of broken out in rash was unresolved.  The outcome of the events fever, trouble swallowing and almost anaphylaxis reaction were unknown. Reporter's Comments: This case concerns a 39-year-old female who experienced a serious expected event of anaphylactic reaction along with a NS unexpected event of dysphagia and NS expected events of fever and rash.  The event occurred the same day as the first dose of mRNA-1273. Treatment included ibuprofen, diphenhydramine, and steroids. 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Head discomfort, Lip swelling, Myalgia, Pruritus
Clinical narrative: mild anaphylaxis reaction; head feels heavy; itching; hives; swelling in the lips; swelling in the tongue; Mild arm soreness; A spontaneous report was received on 06 FEB 2021 from a consumer concerning an 73-years-old, male patient who received Moderna's COVID-19 vaccine and developed mild arm soreness,  mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 FEB 2021, approximately at 1:30 pm, patient received their first of two planned doses of mRNA-1273(Batch/Lot # 011M20A) intramuscular injection for the prophylaxis of COVID-19 infection.   On 05 FEB 2021, on the same day of receiving vaccine, the patient had mild arm soreness. On 06 FEB 2021, Patient experienced a mild anaphylaxis reaction at 3:30AM, Itchiness, hives, swelling of the lips and tongue, head feels heavy. Patient shared that she recently had Allergy Vaccine (Serum) last February 3rd as he knew to have an allergy to everything (he stated). Treatment for the events reported was Benadryl.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, mild arm soreness, mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy, were unknown.  ; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of ANAPHYLACTIC REACTION along with a NS unexpected event of head discomfort and NS expected events of urticaria, pruritus, myalgia, lip swelling, tongue swelling.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Benadryl. 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: mild anaphylaxis reaction; head feels heavy; itching; hives; swelling in the lips; swelling in the tongue; Mild arm soreness; A spontaneous report was received on 06 FEB 2021 from a consumer concerning an 73-years-old, male patient who received Moderna's COVID-19 vaccine and developed mild arm soreness,  mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 FEB 2021, approximately at 1:30 pm, patient received their first of two planned doses of mRNA-1273(Batch/Lot # 011M20A) intramuscular injection for the prophylaxis of COVID-19 infection.   On 05 FEB 2021, on the same day of receiving vaccine, the patient had mild arm soreness. On 06 FEB 2021, Patient experienced a mild anaphylaxis reaction at 3:30AM, Itchiness, hives, swelling of the lips and tongue, head feels heavy. Patient shared that she recently had Allergy Vaccine (Serum) last February 3rd as he knew to have an allergy to everything (he stated). Treatment for the events reported was Benadryl.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, mild arm soreness, mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy, were unknown.  ; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of ANAPHYLACTIC REACTION along with a NS unexpected event of head discomfort and NS expected events of urticaria, pruritus, myalgia, lip swelling, tongue swelling.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Benadryl. 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.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Thrombosis
Clinical narrative: blood clots/Vascular side effect; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots/Vascular side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots/Vascular side effect) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clots/Vascular side effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal.         Patient reported vascular side effect initially. She called back to update that she completed and send the adverse event form along with pictures. She states that similar to her side effects of Janssen vaccine, clots in her blood improved on withdrawing her concomitant medication estrogen pills. Her physician was linking the combination of estrogen pills with vaccine to the blood clots. Her physician wanted to know whether it was safe for her to re-start estrogen pills.  Company Comment: 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. However, the patient's concomitant medication 'Estradiol" may remain a risk factor for this event Thrombosis.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Significant follow-Up information was received which includes, vaccine information and outcome of the event.; Sender's Comments: 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. However, the patient's concomitant medication 'Estradiol" may remain a risk factor for this event Thrombosis.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Aphonia, Chest discomfort, Pharyngeal swelling, Rash
Clinical narrative: Anaphylaxis; Throat swelled almost shut; Rash on head; Hardness in the middle of the chest; Lost voice for 2 days; A spontaneous report was received from a consumer concerning a 74 year old female patient, who experienced anaphylaxis (anaphylactic reaction), throat swelled almost shut (pharyngeal swelling), rash on head (rash), hardness in the middle of the chest (chest discomfort) and lost voice (aphonia).  The patient's medical history included allergy to red dye, and drug allergy to sulfa, statins, and codeine. Product known to have been used by the patient, within two weeks prior to the events, included   lisinopril, vitamin D3, apixaban, and drug reported as biltiaverm cd (not found).  On 13 Mar 2021, approximately 1 day prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number:036A21A) for prophylaxis of COVID-19 infection.   On 14 Mar 2021, the patient experienced anaphylaxis, her throat swelled almost shut, rash on head, hardness in the middle of chest and lost voice for 2 days. She reported that her symptoms subsided after taking 3-4 Benadryl 4 hours apart, except her voice. The patient stated that she will not be taking 2nd dose of the vaccine.  Treatment information mentioned Benadryl.  Lab tests were not provided.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome for the events of anaphylaxis (anaphylactic reaction), throat swelled almost shut (pharyngeal swelling), rash on head (rash), hardness in the middle of the chest (chest discomfort) and lost voice (aphonia) was considered as recovered.; Reporter'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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore and stiff; A spontaneous report, was received from a consumer (patient), concerning herself, a 69 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and stiff (vaccination site induration and vaccination site pain).  The patient's medical history was not provided. Concomitant medications reported included ibuprofen and cefixime.  On 13 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch N0: 011M201A), intramuscularly in the right arm for the prophylaxis of COVID-19 infection.  On 14 Feb 2021, next day following the vaccine, the patient's arm was sore and stiff. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the events was not provided.   The outcome of events, sore and stiff were considered as unknown.; Reporter'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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: Anaphylactic reaction; She couldn´t breath; Hives; A spontaneous report was received from a consumer concerning a 50-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives/ urticaria, anaphylactic reaction and could not breath/ dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced hives, medically significant event anaphylactic reaction (Life Threatening) and could not breath. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, hives, anaphylactic reaction and could not breath was not reported.; Reporter'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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: COVID POSITIVE; SORENESS AFTER CLEANING; TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID POSITIVE), PAIN (SORENESS AFTER CLEANING) and FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH). On an unknown date, the patient experienced COVID-19 (COVID POSITIVE) and PAIN (SORENESS AFTER CLEANING). At the time of the report, COVID-19 (COVID POSITIVE) had resolved and PAIN (SORENESS AFTER CLEANING) and FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. On unknown dates, the patient experienced COVID POSITIVE and SORENESS AFTER CLEANING. In 2021, the patient experienced TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH. On an unknown date, COVID POSITIVE resolved.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID POSITIVE and TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH was not provided. The reporter's causality for the event(s) of SORENESS AFTER CLEANING with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of  (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose1: At 3:30 pm in upper left arm, lot: EN6208 expiry date: 30-Jun-2021) on 11-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: At 3:30 pm in upper left arm, lot: EP7533 expiry date: 31-Jul-2021) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: At 3:30 pm in upper left arm, lot: EP7533 expiry date: 31-Jul-2021) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: her legs kicked at night. hipped popped four times) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: At 3:30 pm in upper left arm, lot: EP7533 expiry date: 31-Jul-2021) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: At 3:30 pm in upper left arm, lot: EP7533 expiry date: 31-Jul-2021. Pain in my hips, knees, ankles, and tail bones.) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose2: At 3:30 pm in upper left arm and lot: EP7533 expiry date: 31-Jul-2021) on 01-Apr-2021. Past adverse reactions to the above products included Joint pain with PFIZER BIONTECH COVID-19 VACCINE; Leg discomfort with PFIZER BIONTECH COVID-19 VACCINE; Leg pain with PFIZER BIONTECH COVID-19 VACCINE; Muscle weakness with PFIZER BIONTECH COVID-19 VACCINE; No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE; Pain in arm with PFIZER BIONTECH COVID-19 VACCINE; and vomiting with PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included MAGNESIUM for Muscle relaxant, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 FATTY ACID) for Pain ankle, TOCOPHEROL (VITAMIN E) for Supplementation therapy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced (fever). At the time of the report (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2-degree Celsius Fever for 6 hours.         Patient took Tylenol as treatment for events experienced during first and second dose. All the events with Pfizer dose were occurred for four months. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, Urticaria
Clinical narrative: COVID-19; Allergy; Hives; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPERSENSITIVITY (Allergy) and URTICARIA (Hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On an unknown date, the patient experienced COVID-19 (COVID-19), HYPERSENSITIVITY (Allergy) and URTICARIA (Hives). At the time of the report, COVID-19 (COVID-19) had not resolved and HYPERSENSITIVITY (Allergy) and URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of ALLERGIES and HIVES was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.