chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in arm shortly following, by 9 pm chills and body aches. Throughout night chills, aches, tightness in chest. The following by morning (2/5) at about 9 and 10 am, BP elevated (129/93) and heart rate between 120-122, persistent tightness in chest that sometimes causes slight cough.  Fatigued.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: 24 hours after vaccine I started feeling bad. Body ache, chills itching and swelling at injection site. My fever went to 99.8. I called my mid wife and I was abole to get the temp down naturally. I did not start feeling better until 1/31.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 24 hours after vaccine I started feeling bad. Body ache, chills itching and swelling at injection site. My fever went to 99.8. I called my mid wife and I was abole to get the temp down naturally. I did not start feeling better until 1/31.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: ONset 3 AM post vaccination: rigors, fever up tp 102F, severe HA, body aches, fatigue injection site pain, edema and erythema. Ongoing for the next 24 hours without improvement, then  improved on day 2 post vaccination. Afebrile on day 3 post vaccination,  with resolution of all symptoms but fatigue, mild injection site pain and erythema, and intermittent HA (mild-moderate).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pyrexia
Clinical narrative: ONset 3 AM post vaccination: rigors, fever up tp 102F, severe HA, body aches, fatigue injection site pain, edema and erythema. Ongoing for the next 24 hours without improvement, then  improved on day 2 post vaccination. Afebrile on day 3 post vaccination,  with resolution of all symptoms but fatigue, mild injection site pain and erythema, and intermittent HA (mild-moderate).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia oral, Pruritus, Swelling, Throat clearing
Clinical narrative: Top lip tingling, swelling, itching all over body, rapid heart rate, throat felt "thick" had to keep clearing throat or drinking
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Top lip tingling, swelling, itching all over body, rapid heart rate, throat felt "thick" had to keep clearing throat or drinking
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Patient described some swelling and tingling in her injection arm. Patient denied any pain or redness in the injection arm. Patient denied any trouble breathing, chest pain or any other symptoms besides the tingling and swelling. Patient denied any required treatment or transport to the hospital.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Lymphadenopathy
Clinical narrative: swollen lymph nodes under left injection arm
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site pain, Pain
Clinical narrative: Almost daily morning headache, mostly frontal, 1-3/10 in severity. Usually improves 2-3 hours after waking up. Relieved with acetominophine. Dull, aching. No other symptoms except heaviness and tenderness over injection site.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure decreased, Chest X-ray, Electrocardiogram, Hyperhidrosis
Clinical narrative: Patient was leaving the 15 minute post-vaccine monitoring area approximately  40 minutes after vaccine administration (administration of second dose at 08:42, rapid response called at 09:21).  He became pale, lethargic, diaphoretic, incontinent of urine, and collapsed onto his walker.  A rapid response was called.  Blood pressure on arrival by team  was  50's/30's, and fluid resuscitation with 0.9% sodium chloride 500 mL was initiated while in transit to the ED.  Approximately 20 minutes later the patient's had stabilized but remained appropriately alert.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Metabolic function test, Pallor, Urinary incontinence
Clinical narrative: Patient was leaving the 15 minute post-vaccine monitoring area approximately  40 minutes after vaccine administration (administration of second dose at 08:42, rapid response called at 09:21).  He became pale, lethargic, diaphoretic, incontinent of urine, and collapsed onto his walker.  A rapid response was called.  Blood pressure on arrival by team  was  50's/30's, and fluid resuscitation with 0.9% sodium chloride 500 mL was initiated while in transit to the ED.  Approximately 20 minutes later the patient's had stabilized but remained appropriately alert.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Minor Arm soreness , as expected for 2 days.  On the 5th day a 4x4 inch area covering the vaccine sight became red, like a bad sunburn and itched.  The itchiness extended into my scalp area and followed around to the left side of my lower jaw.  The redness has lessened. the itchiness remains, but is a little less intense.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: temp at 8AM: 100.0: PRN Tylenol admin
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: COVID 19  Severe rash on upper left arm starting 14 days after vaccine administration. very mildly itchy
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, Respiratory tract congestion, Secretion discharge
Clinical narrative: A few days after the vaccination I woke up in the night with severe congestion and a feeling of needing to cough.  My body way aching so bad it felt as if I had been hit by a truck.  Secretion begin to run from my nose and had a horrible cough.  I took cough meds and laid back down but my body was so still so achy all over.  The next morning I was fatigued and sluggish causing me to have to lay around the house.  I took another dose of cough syrup.  The symptoms lasted about 3 days and dimished on its own with no more symptoms afterwards.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: A few days after the vaccination I woke up in the night with severe congestion and a feeling of needing to cough.  My body way aching so bad it felt as if I had been hit by a truck.  Secretion begin to run from my nose and had a horrible cough.  I took cough meds and laid back down but my body was so still so achy all over.  The next morning I was fatigued and sluggish causing me to have to lay around the house.  I took another dose of cough syrup.  The symptoms lasted about 3 days and dimished on its own with no more symptoms afterwards.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Fever of 102.1 on the following day, along with nausea, photosensitivity, body aches.  red swollen injection site, which on day  3 required visit with PCP and dix with cellulitis.  Red,(4inches by 4.5in) ,hot swollen,  itchy.  given  rx for Keflex.  felt well on day 5.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pruritus, Pyrexia, SARS-CoV-2 test, Skin warm
Clinical narrative: Fever of 102.1 on the following day, along with nausea, photosensitivity, body aches.  red swollen injection site, which on day  3 required visit with PCP and dix with cellulitis.  Red,(4inches by 4.5in) ,hot swollen,  itchy.  given  rx for Keflex.  felt well on day 5.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, Facial paralysis, Lacrimation increased, Lagophthalmos
Clinical narrative: 48 hours after vaccination, patient developed right sided facial droop, excessive tearing in right eye, inability to close right eye fully, inability to raise right eyebrow. Patient advised to not take 2nd vaccine dose. He was given oral corticosteroid prescription and advised to use eye lubrication ointment frequently and wear eye patch at night. He was advised to see Ophthalmologist to make sure no injury to cornea since he is unable to fully close eye and potential for eye drying at night when sleeping.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: BODY ACHES, NAUSEA, DIARRHEA
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site nodule, Pain, Pain in extremity, Pruritus
Clinical narrative: 1/27/2021 - Arm pain the first 30 hours, then all okay. On Feb 4, N/A8 days later,  felt like a knot in location of shot, red , warm to the touch, itchy and pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: 1/27/2021 - Arm pain the first 30 hours, then all okay. On Feb 4, N/A8 days later,  felt like a knot in location of shot, red , warm to the touch, itchy and pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error, No adverse event
Clinical narrative: Pre-filled syringes sent in the wrong needle. Dose must be administered intramuscular and dose was administered via subcutaneous needle.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Rec'd Moderna as second COVID-19 dose, should have rec'd Pfizer. No adverse reaction.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia, Sleep disorder
Clinical narrative: Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Bradycardia, Electrocardiogram normal, Heart rate increased, Hyperhidrosis
Clinical narrative: Pt. had syncopial episode, diaphoretic, bradycardiac, and hypotension.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Pt. had syncopial episode, diaphoretic, bradycardiac, and hypotension.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Pain
Clinical narrative: Extreme Fatigue Dizziness Fever, body aches Tingling, and numbness to the injected arm (right) Severe headache
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Extreme Fatigue Dizziness Fever, body aches Tingling, and numbness to the injected arm (right) Severe headache
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: experienced injection site pain; This case was reported by a physician and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: Age group was consider as adult as per vaccine indication. Doctor stated that a patient experienced injection site pain. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Pruritus
Clinical narrative: Right arm red, itchy, swollen with swollen lymph nodes
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: sore / around the injection site area; swollen /  around the injection site area; his left arm is hard /  around the injection site area; warm to touch around the injection site area; This case was reported by a pharmacist and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site induration and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in his left arm. The patient's left arm was hard, sore, swollen, warm to touch around the injection site area following administration. It was almost like size of pharmacist's palm of her hand.  The reporter was unsure when the symptoms began following vaccination.  The patient still had the symptoms at the time of reporting. The reporter was the one who administered Shingrix to patient.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Flushing, Headache, Pain, Vision blurred
Clinical narrative: my whole body hurts; headache; blurry vision; Im flushed; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced general body pain, headache, blurred vision and flushing. On an unknown date, the outcome of the general body pain, headache, blurred vision and flushing were unknown.   It was unknown if the reporter considered the general body pain, headache, blurred vision and flushing to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per Shingrix vaccine indication. The patient had shingles vaccine and flu vaccine at the same time.  The patient was flushed, his or her whole body hurted and had headache and blurry vision.  The patient asked did he or she need to go to the doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: small redness at the site injection; localized redness about the size of a baseball; localized redness which is is sore when I press on the site; localized reaction today with  redness and tenderness; chills / shivering; mild myalgia; injection was very painful in her shoulder joint and was sore; This case was reported by a nurse and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema, localized erythema, pain localized, tenderness, chills, myalgia and pain in joint involving shoulder region. On an unknown date, the outcome of the injection site erythema, localized erythema, pain localized and tenderness were not recovered/not resolved and the outcome of the chills, myalgia and pain in joint involving shoulder region were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, localized erythema, pain localized, tenderness, chills, myalgia and pain in joint involving shoulder region to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on her left arm. The patient experienced localized redness about the size of a baseball, which was sore when pressed on the site and also had a small redness at the site injection. The patient had localized redness and tenderness until the day of reporting. The injection was very painful in her shoulder joint and was sore for a couple of days and then resolved. The patient also had chills and shivering with mild myalgia which resolved in a day or so. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: fever; arm pain; feeling bad; This case was reported by a nurse and described the occurrence of fever in a female 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 fever, pain in arm and feeling bad. On an unknown date, the outcome of the fever, pain in arm and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain, fever and feeling bad for 3 days. The reporter did not consent to follow up. For tolerance of 2nd dose refer linked case US2020AMR246228.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246228:same patient
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Inappropriate schedule of product administration, Incorrect dose administered, Myalgia
Clinical narrative: did not mix the powder & liquid together and Patient was given just the liquid dose; did not mix the powder & liquid together and Patient was given just the liquid dose; Arm is hurting / Pain in arm / soreness in the arms/pain has been excruciating in left arm; muscle pain/pain has been excruciating; back pain / back pain is excruciating; pain/ affecting her joints/pain has been excruciating; fever after partial dose; This case was reported by a consumer and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received Shingrix. On 13th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In January 2021, the patient experienced pain in arm, fever, muscle pain, back pain and joint pain. On an unknown date, the outcome of the pain in arm, muscle pain, back pain, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle pain, back pain and joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received the adjuvant suspension component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that the nurse did not mix the two components together and only administered the liquid component. The patient experienced a fever for 2 days, joint pain, muscle pain, back pain, and arm pain that started on the same night she received the adjuvant component (less than a day after vaccination). The patient came back to physician office to get the full complete dose on 22nd January 2021, for tolerance refer case US2021016994.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021016994:same patient (FU2 and 1st dose case)- Case for dose received on 22Jan2021- full dose
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Product preparation issue, Pyrexia, Underdose
Clinical narrative: did not mix the powder & liquid together and Patient was given just the liquid dose; did not mix the powder & liquid together and Patient was given just the liquid dose; Arm is hurting / Pain in arm / soreness in the arms/pain has been excruciating in left arm; muscle pain/pain has been excruciating; back pain / back pain is excruciating; pain/ affecting her joints/pain has been excruciating; fever after partial dose; This case was reported by a consumer and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received Shingrix. On 13th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In January 2021, the patient experienced pain in arm, fever, muscle pain, back pain and joint pain. On an unknown date, the outcome of the pain in arm, muscle pain, back pain, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle pain, back pain and joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received the adjuvant suspension component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that the nurse did not mix the two components together and only administered the liquid component. The patient experienced a fever for 2 days, joint pain, muscle pain, back pain, and arm pain that started on the same night she received the adjuvant component (less than a day after vaccination). The patient came back to physician office to get the full complete dose on 22nd January 2021, for tolerance refer case US2021016994.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021016994:same patient (FU2 and 1st dose case)- Case for dose received on 22Jan2021- full dose
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: did not mix the powder & liquid together and Patient was given just the liquid dose; did not mix the powder & liquid together and Patient was given just the liquid dose; Arm is hurting / Pain in arm / soreness in the arms/pain has been excruciating in left arm; muscle pain/pain has been excruciating; back pain / back pain is excruciating; pain/ affecting her joints/pain has been excruciating; fever after partial dose; This case was reported by a consumer and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received Shingrix. On 13th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In January 2021, the patient experienced pain in arm, fever, muscle pain, back pain and joint pain. On an unknown date, the outcome of the pain in arm, muscle pain, back pain, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle pain, back pain and joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received the adjuvant suspension component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that the nurse did not mix the two components together and only administered the liquid component. The patient experienced a fever for 2 days, joint pain, muscle pain, back pain, and arm pain that started on the same night she received the adjuvant component (less than a day after vaccination). The patient came back to physician office to get the full complete dose on 22nd January 2021, for tolerance refer case US2021016994.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021016994:same patient (FU2 and 1st dose case)- Case for dose received on 22Jan2021- full dose
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Induration, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: About 1/2 hour of the vaccination, I felt mild tingling of the lips.  Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet.  I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose).  I checked my pulse ox, and it remained above 97%.  I never had rash or trouble breathing.  But  about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving.  Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips.  I also felt very cold, and had a hard time getting warm.  This also improved with the Benadryl.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: About 1/2 hour of the vaccination, I felt mild tingling of the lips.  Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet.  I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose).  I checked my pulse ox, and it remained above 97%.  I never had rash or trouble breathing.  But  about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving.  Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips.  I also felt very cold, and had a hard time getting warm.  This also improved with the Benadryl.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Hypersensitivity, Nasal discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: About 1/2 hour of the vaccination, I felt mild tingling of the lips.  Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet.  I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose).  I checked my pulse ox, and it remained above 97%.  I never had rash or trouble breathing.  But  about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving.  Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips.  I also felt very cold, and had a hard time getting warm.  This also improved with the Benadryl.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: realized that the powder was not dissolved completely; realized that the powder was not dissolved completely; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2020, the patient received Shingrix. On 29th December 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, they administered Shingrix to the patient and then realized that the powder was not dissolved completely, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. No further information provided.  The reporter did not provide address as she mentioned that she was travelling and did not have a specific address. She did not have patient's details or vaccine's details at the moment as she was driving. This case has been linked to US2020258487, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020258487:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling hot, Swollen tongue, Syncope
Clinical narrative: Anaphylactic reaction; A spontaneous report (United States) was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history included allergy to azithromycin (hives). Concomitant medications were not reported.  On 09 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 09 JAN 2021, while sitting in the waiting area, 8 to 10 minutes after the injection, the patient experienced warm feeling, tongue getting bigger and collapsed. She was given intravenous medications and health care professionals were monitoring her vitals. The patient was transported to emergency via ambulance and was given two doses of EpiPen in the ambulance and by the time she arrived hospital she was doing better and was discharged after 4 hours.  Treatment provided included EpiPen and intravenous medications.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event anaphylactic reaction was unknown.; Reporter's Comments: This case concerns a female patient of unknown age with relevant medical history of allergy to azithromycin who  received her first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection and experienced a serious medically significant unlisted event of an anaphylactic reaction within 8-10 minutes after the injection. The reaction was described as warm feeling, tongue getting bigger and collapsed. Patient was transported to ER and given two doses of EpiPen while in the ambulance.  By the time she arrived at the hospital, she was doing better and was discharged after 4 hours. Treatment also included IV medications. Based on temporal association between the use of the product and the start date of the event within 8-10 minutes after the vaccine administration, a causal relationship cannot be excluded and the event of anaphylaxis reaction is possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Loss of consciousness, Syncope
Clinical narrative: Fainted; Unconscious; A spontaneous report was received from a consumer who was also a 73-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and unconscious.  The patient's medical history was not provided. Concomitant medications were levofloxacin, metformin, amlodipine and lisinopril.    On 21 Jan 2021, prior to obtaining his vaccination, the patient took levofloxacin, metformin, amlodipine, and lisinopril.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, within minutes of receiving the vaccine, the patient fainted with his eyes open and was unconscious. His health care provider told him he was dehydrated and that might be why he fainted.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, fainting and unconscious, was considered resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 73-years-old male patient, who experienced medically significant unexpected events of Syncope and Loss of consciousness. The events occurred within minutes after first dose of mRNA-1273, lot # 012L20A. Concomitant medication included levofloxacin, metformin, amlodipine and lisinopril. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. Of note, dehydration was reported as potential contributing factor.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: woke up  15 hours after vaccine with throat swelling, drank warm water and symptoms relieved I 6-7 hour with out any medications He has a history of anaphylactic reactions to peanuts and kiwi so she does have an Epi Pen handy
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered from punctured vial that had been punctured for 5 days; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with the vaccine from a punctured vial that had been punctured for 5 days.  The patient's medical history was not provided. The concomitant medications reported included oxygen, lisinopril, hydrochlorothiazide and metformin.  On 17 Jan 2021, a vial containing mRNA-1273 was punctured.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient was administered with vaccine from the punctured vial that had been punctured for 5 days. No adverse events were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, administered with the vaccine from a punctured vial that had been punctured for 5 days was considered resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 78-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot#028L20A), reporting Expired product administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Loss of consciousness, Malaise, Nausea
Clinical narrative: Passed out, loss of unconsciousness; Aching; Felt unwell, very sick; Shaky; Feverish; Fatigue; Nauseated; A spontaneous report was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, and nauseated.  The patient's medical history was not provided. Concomitant medication was Loratadine.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, after receiving the vaccine the patient experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, nauseated.   On 29 Jan 2021, the patient was experiencing fatigue. Treatment for the event was not provided.  Action taken with the mRNA-1273 was withdrawn.   The outcome for the events, loss of consciousness, aching, shaky, feverish and nauseated was Unknown and the outcome for the events, fatigue, felt unwell, very sick was considered Not resolved.; Reporter's Comments: This case concerns a 49 year old female patient experienced a serious unexpected event of loss of consciousness and NS unexpected events of aching, fatigue, felt unwell, very sick, shaky, feverish and nauseated. The events occurred after first dose of the study medication administration on the same day.   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: Pain, Pyrexia, Tremor
Clinical narrative: Passed out, loss of unconsciousness; Aching; Felt unwell, very sick; Shaky; Feverish; Fatigue; Nauseated; A spontaneous report was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, and nauseated.  The patient's medical history was not provided. Concomitant medication was Loratadine.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, after receiving the vaccine the patient experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, nauseated.   On 29 Jan 2021, the patient was experiencing fatigue. Treatment for the event was not provided.  Action taken with the mRNA-1273 was withdrawn.   The outcome for the events, loss of consciousness, aching, shaky, feverish and nauseated was Unknown and the outcome for the events, fatigue, felt unwell, very sick was considered Not resolved.; Reporter's Comments: This case concerns a 49 year old female patient experienced a serious unexpected event of loss of consciousness and NS unexpected events of aching, fatigue, felt unwell, very sick, shaky, feverish and nauseated. The events occurred after first dose of the study medication administration on the same day.   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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pruritus, Pain in extremity
Clinical narrative: I think I have "covid vaccine arm."  I got the shot on 1/28 in the afternoon.  I was tired and my arm a little sore the next day.  Then I was fine.  On 2/4/5 at 8 at night a noticed my arm was itchy, red, lumpy, and warm at the injection site.  This morning 2/5/5 it is still itchy, warm - almost hot.  There is a two inch diameter red spot at the site.  There is still the flatish lump at the site.  I reported it to my regular doctor who gave me your contact information.   I got the shot at a workplace clinic.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: I think I have "covid vaccine arm."  I got the shot on 1/28 in the afternoon.  I was tired and my arm a little sore the next day.  Then I was fine.  On 2/4/5 at 8 at night a noticed my arm was itchy, red, lumpy, and warm at the injection site.  This morning 2/5/5 it is still itchy, warm - almost hot.  There is a two inch diameter red spot at the site.  There is still the flatish lump at the site.  I reported it to my regular doctor who gave me your contact information.   I got the shot at a workplace clinic.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Vaccination error
Clinical narrative: Administration error-seemed like most of the vaccine came out where the needle and syringe attach; most of the vaccine came out where the needle and syringe attach; A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced administration error- seemed like most of the vaccine came out where the needle and syringe attach. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unspecified date, it was reported by the health care professional that it did not seem like the patient received any of the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event of was administration error- seemed like most of the vaccine came out where the needle and syringe attach was considered recovered/resolved on an unknown date; Reporter's Comments: This case concerns a subject, who experienced a non-serious unexpected events of Vaccine underdose and Syringe Connection Issue. The events occurred at the time of first dose of the study medication administration. The events are more related to administration error rather than related to or caused by company medication. Based on the current available information, the events are assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong technique in product usage process
Clinical narrative: Patient did not receive full dose of the Moderna COVID-19 vaccine; very little got into his muscle due to the needle retracting during admission; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and did not receive a full dose.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received the second of their two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was not administered the full second dose of the vaccine, and very little got into his muscle due to the needle retracting during admission. No treatment information was provided.   Action taken with the mRNA-1273 in response to the event was not reported.  The event, did not receive a full dose, was considered resolved.; Reporter's Comments: This case concerns a male patient of unknown age who received their second of two planned doses of mRNA-1273 (Lot: unknown), reporting Wrong technique in product usage process and Incorrect dose administered.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Influenza, Nasopharyngitis, Pneumonia, Pulmonary fibrosis
Clinical narrative: scarring of the lungs; double pneumonia; cold; flu; exhausted and wiped out; Initial information received on 27-Jan-2021 regarding an unsolicited valid serious case from media via consumer or non-health care professional (Patient).  This case involves adult patient who experienced scarring of the lungs (pulmonary fibrosis), double pneumonia (pneumonia), cold (nasopharyngitis), flu (influenza) and exhausted and wiped out (fatigue), while patient received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via n unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious scarring of the lungs (pulmonary fibrosis) and double pneumonia (pneumonia) 5 times then (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious cold (nasopharyngitis), flu (influenza) and wiped out (fatigue) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, a flu shot almost killed patient over 12 years ago. The patient wanted to understand why. Therefore, studied vaccines and was shocked by what patient found. If it were not for the FGDE (Food Grade Diatomaceous Earth) and coffee enemas, patient would not have made it. Anyone who understands that understands the scarring of the lungs and that puts patient in jeopardy for the rest of life. Patient ran out of sick and vacation days so patient went back to work. It took patient a few more months to recovered and was on light duty because patient was completely exhausted and wiped out. It was only by the grace of God patient even survived. Patient had to repent for allowing the pharmaceutical industry to poison patient body. However, it began greatest portion of patient health and wellness journey.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  Information on the batch number was requested.; Sender's Comments: This case involves adult patient who experienced pulmonary fibrosis, pneumonia, nasopharyngitis, influenza and fatigue after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Paraesthesia oral, Swollen tongue, Tongue blistering
Clinical narrative: I was talking on the phone and all of the the sudden I couldn't feel my cheekbone and all the way up to the eye socket and my tongue felt like a sponge, and I couldn't breathe very good. So I got my friend to take to me to the ER and they gave me oxygen, and the next my tongue was still swollen and had blisters on it. They recommended scheduling a follow appointment with PCP.  They gave me a shot and three prednisone pills to take on a taper.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Body temperature, Body temperature increased, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever of 104; pain is okay when not moving arm and when moving pain 6-7 on pain scale; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via medical information (reference number- 00432183) and transmitted to Sanofi on 15-Jan-2021.  This case involves a 69 year old female patient who experienced pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), after she received TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing breast cancer.  On 12-Jan-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot 9LU44A, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 12-Jan-2021, the patient developed a non-serious pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), on the same day following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Relevant laboratory test results included: Body temperature - On 12-Jan-2021: 104 Pain assessment - On 12-Jan-2021: pain of 6-7 (in a scale of 10 being the worst)  It was not reported if the patient received any corrective treatment.  At the time of reporting, it was reported that fever was resolved but the arm pain remains the same when the patient was checked on 15-Jan-2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Acute headache; right behind her right eye.