chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: SWELLING IN THROAT; SWELLING IN FACE; This spontaneous report received from a consumer concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swelling in throat, and swelling in face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling in throat and swelling in face was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: WORSE COLDS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was out of quarantine last week. 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 prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced worse colds, and fever. Laboratory data (dates unspecified) included: Body temperature (not provided) Maxing out at 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worse colds, and fever. This report was non-serious. This report was associated with product complaint number 90000208328. This case, from the same reporter is linked to 20211250840.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211250766.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: NASTY COUGH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nasty cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty cough. This report was non-serious. This case, from the same reporter is linked to 20211250774. This report was associated with a product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Influenza like illness
Clinical narrative: COMPLETE AWFUL FOR NEARLY 48 HOURS; STUCK IN BED; FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced complete awful for nearly 48 hours, stuck in bed, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from complete awful for nearly 48 hours, stuck in bed, and flu like symptoms. This report was non-serious..
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: A VACCINE WAS ADMINISTERED AT ROOM TEMPERATURE 5 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a pharmacist concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced a vaccine was administered at room temperature 5 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a vaccine was administered at room temperature 5 hours after first puncture was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HAD A VERY HARD CASE OF COVID 6 MONTHS LATER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced had a very hard case of covid 6 months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a very hard case of covid 6 months later was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208229.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: HORRIBLE AND STRONG SIDE EFFECTS WORSE THAN THE VIRUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced horrible and strong side effects worse than the virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible and strong side effects worse than the virus was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Sensitive skin, Urticaria
Clinical narrative: Nine days after booster I developed some hives. The next day the hives spread across my body. My skin is extremely sensitive and if itched the hives appear 10-15 mins later. On the 22nd I began experiencing joint pain along with the hives. On the 23rd the joint pain increases and the hives still occur.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Chest pain on multiple circumstances or occurrences during exercising (hiking). Shortness of breath.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Increased upper airway secretion, Oropharyngeal pain, Rhinorrhoea, Sinusitis
Clinical narrative: On 11/16/21 I began having an extremely sore throat, runny nose, and cough. I went to my PCP on 11/19/21 and was diagnosed with a sinus infection. I was prescribed azithromycin, zyrtec, and Flonase. I finished my course of antibiotics and my throat felt better but I was still coughing. It was not a productive cough, but a dry cough. After 2 weeks of continuous coughing I went back to my PCP who said my physical exam looked normal, there was maybe a tiny amount of drainage in my throat and I was prescribed benzonatnate for my cough. Two weeks has passed since then and I still have a dry cough.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative
Clinical narrative: On 11/16/21 I began having an extremely sore throat, runny nose, and cough. I went to my PCP on 11/19/21 and was diagnosed with a sinus infection. I was prescribed azithromycin, zyrtec, and Flonase. I finished my course of antibiotics and my throat felt better but I was still coughing. It was not a productive cough, but a dry cough. After 2 weeks of continuous coughing I went back to my PCP who said my physical exam looked normal, there was maybe a tiny amount of drainage in my throat and I was prescribed benzonatnate for my cough. Two weeks has passed since then and I still have a dry cough.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Intense pain radiating from the site of injection, through shoulder into neck and down arm to hand. Tingling in arm and hand of injection. Stiff neck
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Intense pain radiating from the site of injection, through shoulder into neck and down arm to hand. Tingling in arm and hand of injection. Stiff neck
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Pain, erythema, and swelling of the arm which spread from the injection site to the lower arm below the elbow.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: Had a sore arm day after vaccine for about 2 days. Had extreme fatigue on Sunday, Dec 19. From 12/20-12/23 had a very bad headache. Started on the left side of my head and then moved to the right side and down the side and back of my head to my neck. Developed rash in various places on arms and chest 12/20 and all over abdomen 12/22
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a sore arm day after vaccine for about 2 days. Had extreme fatigue on Sunday, Dec 19. From 12/20-12/23 had a very bad headache. Started on the left side of my head and then moved to the right side and down the side and back of my head to my neck. Developed rash in various places on arms and chest 12/20 and all over abdomen 12/22
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Headache, chills, fever up to 101.9, body ache, fatigue , dirreah
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, chills, fever up to 101.9, body ache, fatigue , dirreah
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Moderate to severe inflammation, erythema, and pain L upper arm which spread to the lower R arm below the elbow.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Throat irritation
Clinical narrative: Allergy reaction (itchiness) on arms, chest, face and throat. And swollen throat. Precautions were taken by taking 2 benadryl of 25 mg each one  Symptoms lasted only a day
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Condition aggravated, Dyspnoea, Heart rate increased, Influenza like illness
Clinical narrative: This happened only after my 2nd dose. At night after going to sleeping around 10:30pm, my heart was pounding (beating heavily and fast) all night. There was no pain, but I could not sleep. It was somewhat difficult to breathe but I was having some difficulty due to the rhinitis beforehand.  In the morning, (around 8am) my heartbeat was back to normal (possibly a couple hours before). I went downstairs and sat on my couch and fell asleep for ~2 hours. After that I had flu-like symptoms the rest of the day but no fast heart beating.  This same fast heartbeat happened again (but to a lesser severity) after my booster dose on 12/1/2021. It happened after I went to sleep around 10:30pm.  I did not know this was an adverse event until after the booster dose while reading of such events online. Therefore, I did not seek medical attention. None of the doctors I had seen over the past year for my rhinitis had told me about this potential adverse reaction.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations
Clinical narrative: This happened only after my 2nd dose. At night after going to sleeping around 10:30pm, my heart was pounding (beating heavily and fast) all night. There was no pain, but I could not sleep. It was somewhat difficult to breathe but I was having some difficulty due to the rhinitis beforehand.  In the morning, (around 8am) my heartbeat was back to normal (possibly a couple hours before). I went downstairs and sat on my couch and fell asleep for ~2 hours. After that I had flu-like symptoms the rest of the day but no fast heart beating.  This same fast heartbeat happened again (but to a lesser severity) after my booster dose on 12/1/2021. It happened after I went to sleep around 10:30pm.  I did not know this was an adverse event until after the booster dose while reading of such events online. Therefore, I did not seek medical attention. None of the doctors I had seen over the past year for my rhinitis had told me about this potential adverse reaction.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: POSITIVE TEST FOR COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 23-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-DEC-2021, the patient experienced positive test for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive test for covid-19 was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lymphadenopathy, Throat irritation
Clinical narrative: Swollen lymph node on right armpit. And throat feeling scratchy and a cough
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT STATES FOLLOWING DAY AFTER BOOSTER MODERNA  EXPERIENCED SKIN REDNESS , HEAT, PAIN AND SWELLING ON RIGHT ARM AT SITE OF INJECTION. PATIENT STATES RED AREA GOT LARGER  ON DAY 3 . PATENT WAS WORRIED AND HAD A VIDEO APPOINTMENT WITH DR ON  03/22/21 . DR TOLD PATIENT HE THOUGHT  THERE WAS A POSSIBLE INFECTION AT SITE OF INFECTION PERHAPS CAUSED BY THE COVID VACCINE STORAGE. PATIENT WAS STARTED ON KEFLEX ANTIBIOTIC BY MD .  12/23/21  PATIENT SAYS REDNESS HAS   ALMOST GONE AWAY AND FEELS FINE
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Hydrops foetalis
Clinical narrative: Fetus was normal in 12 week ultrasound on 08/12/21. Went in for anatomy scan on 10/8/21 and fetus had developed hydrops fetalis. Due date unknown  At appointment on 11/10/22 fetus had fetal demise and heart stopped. Delivered stillborn. Birth weight 1 pound 10 ounces.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure abnormal, Stillbirth
Clinical narrative: Fetus was normal in 12 week ultrasound on 08/12/21. Went in for anatomy scan on 10/8/21 and fetus had developed hydrops fetalis. Due date unknown  At appointment on 11/10/22 fetus had fetal demise and heart stopped. Delivered stillborn. Birth weight 1 pound 10 ounces.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Inflammation, Neck pain, Pain
Clinical narrative: A little over 2 weeks after receiving the J&J vaccine I noticed sudden significant pain in both shoulders. The pain was a deep aching pain all around the shoulders (not one spot). Pain was different than I had ever experienced before was constant (24/7) worse first thing in AM then better after a shower. Pain ranged from 3 to 8. Over time the pain spread to collar bone/neck. Tried Advil and it had no affect. Starting trying all types of pain medicines and rubs. The only pain medication I used that had any significant effect was Aspirin. I was taking 2 Excedrin around 8:00 AM, 2 Aspirin around 2:00 PM then two Tylenol PM and two extra strength Aspirin around 10:00 PM when going to bed (to try and get some sleep). Las Lasted till normally about 2:00 AM then full pain back. Very difficult to get sleep even when med was working (still much pain)and normally sleep on side. Made an appointment at Orthopedic doctor for the shoulder pain. Dr did exam and ordered blood tests. Dr indicated it was likely shoulders and not neck. The blood tests showed non-specific inflammation and said he needed to refer me to Rheumatologist for treatment. Took several months to get into a Rheumatologist (all booked). Miserable in the mean time - not much sleep. Finally got into Dr (privacy) at the Clinic on 12/10/21. After a lengthy exam he diagnosed me with Polymyalgia Rheumatica and prescribed Prednisone to treat it. The Prednisone reduced the severity of the pain almost immediately (reduced pain to lower average 2 - 3). Continued to take two Tylenol PM and two Aspirin at bedtime to help with sleep.  Read that Aspirin maybe should not be taken with Prednisone so asked Dr and received note to not take it so stopped taking two Aspirin with Tylenol PM as of 12/22/21. Worried about long term effect of using Prednisone reading it has significant side effects (sugar diabetes, weight gain amongst others).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Sleep disorder
Clinical narrative: A little over 2 weeks after receiving the J&J vaccine I noticed sudden significant pain in both shoulders. The pain was a deep aching pain all around the shoulders (not one spot). Pain was different than I had ever experienced before was constant (24/7) worse first thing in AM then better after a shower. Pain ranged from 3 to 8. Over time the pain spread to collar bone/neck. Tried Advil and it had no affect. Starting trying all types of pain medicines and rubs. The only pain medication I used that had any significant effect was Aspirin. I was taking 2 Excedrin around 8:00 AM, 2 Aspirin around 2:00 PM then two Tylenol PM and two extra strength Aspirin around 10:00 PM when going to bed (to try and get some sleep). Las Lasted till normally about 2:00 AM then full pain back. Very difficult to get sleep even when med was working (still much pain)and normally sleep on side. Made an appointment at Orthopedic doctor for the shoulder pain. Dr did exam and ordered blood tests. Dr indicated it was likely shoulders and not neck. The blood tests showed non-specific inflammation and said he needed to refer me to Rheumatologist for treatment. Took several months to get into a Rheumatologist (all booked). Miserable in the mean time - not much sleep. Finally got into Dr (privacy) at the Clinic on 12/10/21. After a lengthy exam he diagnosed me with Polymyalgia Rheumatica and prescribed Prednisone to treat it. The Prednisone reduced the severity of the pain almost immediately (reduced pain to lower average 2 - 3). Continued to take two Tylenol PM and two Aspirin at bedtime to help with sleep.  Read that Aspirin maybe should not be taken with Prednisone so asked Dr and received note to not take it so stopped taking two Aspirin with Tylenol PM as of 12/22/21. Worried about long term effect of using Prednisone reading it has significant side effects (sugar diabetes, weight gain amongst others).
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting after 10 minutes, severe nausea throughout the next 12 hours.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Multiple sclerosis, Scan with contrast abnormal
Clinical narrative: Had my first shot in December 2020 and second shot January 2021. Now since 11/21/21 I have now been diagnosed with multiple sclerosis.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased
Clinical narrative: Rapid heartbeat, flutter of heartbeat/rhythm, out of rhythm, rapid and strong heart patterns.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Vaccine positive rechallenge
Clinical narrative: Mild pain around my heart.  Happened after second shot too. I have had pericarditis previously (early 2000's)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Metamorphopsia, Migraine
Clinical narrative: Headaches and migraines lasted for 2 weeks after second Pfizer Covid vaccine shot. Also kaleidoscope vision which I have never experienced before (happened 4 times within the 2 week period). Now 7 months later, still have kaleidoscope vision about twice a month.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Diarrhoea, Gingival bleeding, SARS-CoV-2 test negative
Clinical narrative: Day 5: Mild diarrhea getting progressively worse until day 7 with onset of severe incapacitating  vertigo, which prevented ability to get out of bed. Now at day 9, severe abdominal pain radiates to lower back with severe lower back pain. Unable to leave bedroom for the last 48 hours. Received a negative COVID-19 rapid test from spouse today (day 9). Unable to leave bedroom for treatment at doctor due to vertigo, diarrhea, abdominal and lower back pain. Also, large amounts of blood spit out on two occasions while brushing teeth (approximately 2 tablespoons). I am not sure where all the blood came from. May be a dental issue because it occurred during brushing but has never happened before.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Day 5: Mild diarrhea getting progressively worse until day 7 with onset of severe incapacitating  vertigo, which prevented ability to get out of bed. Now at day 9, severe abdominal pain radiates to lower back with severe lower back pain. Unable to leave bedroom for the last 48 hours. Received a negative COVID-19 rapid test from spouse today (day 9). Unable to leave bedroom for treatment at doctor due to vertigo, diarrhea, abdominal and lower back pain. Also, large amounts of blood spit out on two occasions while brushing teeth (approximately 2 tablespoons). I am not sure where all the blood came from. May be a dental issue because it occurred during brushing but has never happened before.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Paraesthesia
Clinical narrative: Tingling in Left Lower Extremity  x 2 days and now spread to R leg and both hands.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Breast induration, Breast pain, Chest pain
Clinical narrative: No treatments. Outcomes hair loss,  constant migraines, skin irritation and itching, no milk supply
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain of skin, Pruritus, Rash, Skin irritation
Clinical narrative: No treatments. Outcomes hair loss,  constant migraines, skin irritation and itching, no milk supply
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation, Swelling of eyelid
Clinical narrative: No treatments. Outcomes hair loss,  constant migraines, skin irritation and itching, no milk supply
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cardiac monitoring, Dyspnoea, Electrocardiogram
Clinical narrative: Heart palpitations, shortness of breath, body weakness, fatigue, all subsequently diagnosed as atrial fibrillation (afib).  I had no history of afib prior to getting the Moderna booster on 11/19/21. Currently in the process of trying to find a successful treatment with a Cardiologist.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: Heart palpitations, shortness of breath, body weakness, fatigue, all subsequently diagnosed as atrial fibrillation (afib).  I had no history of afib prior to getting the Moderna booster on 11/19/21. Currently in the process of trying to find a successful treatment with a Cardiologist.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Extreme headache lasting several days; slight soreness at injection site
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID FOR THE THIRD TIME; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid for the third time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid for the third time was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208289.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208236.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: CHILLS; FELT LIKE CRAP; FEVER; TIRED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, felt like crap, fever, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, tired, headache and felt like crap was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SUFFERING SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering severe reactions was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site paraesthesia, Injection site rash, Injection site reaction
Clinical narrative: FEELING WEAKNESS IN INJECTION ARM; TINGLING IN INJECTION ARM THAT GOES ALL THE WAY DOWN LEFT ARM; FEELS LIKE COULD SLEEP FOR DAYS THAT STARTED TO GET WORSE; BUMP UNDER SKIN ON ARM GOT INJECTION; LEFT ARM PAIN, EVERY DAY IT HAS PROGRESSED AND GOTTEN A LITTLE WORSE, VERY ARM SORE; PAIN AROUND INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 18-DEC-2021 12:12 for prophylactic vaccination. No concomitant medications were reported.  On 18-DEC-2021, the patient experienced headache. On 19-DEC-2021, the patient experienced left arm pain, every day it has progressed and gotten a little worse, very arm sore, and pain around injection site. On 20-DEC-2021, the patient experienced feels like could sleep for days that started to get worse, and bump under skin on arm got injection. On 22-DEC-2021, the patient experienced feeling weakness in injection arm, and tingling in injection arm that goes all the way down left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm pain, every day it has progressed and gotten a little worse, very arm sore, bump under skin on arm got injection, feeling weakness in injection arm, tingling in injection arm that goes all the way down left arm, headache, feels like could sleep for days that started to get worse, and pain around injection site. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: FEELING WEAKNESS IN INJECTION ARM; TINGLING IN INJECTION ARM THAT GOES ALL THE WAY DOWN LEFT ARM; FEELS LIKE COULD SLEEP FOR DAYS THAT STARTED TO GET WORSE; BUMP UNDER SKIN ON ARM GOT INJECTION; LEFT ARM PAIN, EVERY DAY IT HAS PROGRESSED AND GOTTEN A LITTLE WORSE, VERY ARM SORE; PAIN AROUND INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 18-DEC-2021 12:12 for prophylactic vaccination. No concomitant medications were reported.  On 18-DEC-2021, the patient experienced headache. On 19-DEC-2021, the patient experienced left arm pain, every day it has progressed and gotten a little worse, very arm sore, and pain around injection site. On 20-DEC-2021, the patient experienced feels like could sleep for days that started to get worse, and bump under skin on arm got injection. On 22-DEC-2021, the patient experienced feeling weakness in injection arm, and tingling in injection arm that goes all the way down left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm pain, every day it has progressed and gotten a little worse, very arm sore, bump under skin on arm got injection, feeling weakness in injection arm, tingling in injection arm that goes all the way down left arm, headache, feels like could sleep for days that started to get worse, and pain around injection site. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood potassium, Blood pressure measurement, Fall, Illness
Clinical narrative: Shaky; Fell out of bed; Weak; Got really sick after booster; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced ILLNESS (Got really sick after booster) (seriousness criterion hospitalization). On 10-Dec-2021, the patient experienced TREMOR (Shaky) (seriousness criterion hospitalization), FALL (Fell out of bed) (seriousness criterion hospitalization) and ASTHENIA (Weak) (seriousness criterion hospitalization). The patient was hospitalized from 10-Dec-2021 to 12-Dec-2021 due to ASTHENIA, FALL, ILLNESS and TREMOR. At the time of the report, TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood potassium: high (High) High. In December 2021, Blood pressure measurement: low (Low) Low BP.         At the hospital patient received IV Fluids.  Company comment:  This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-410982, MOD-2021-410964, MOD-2021-412276 (Patient Link).; Sender's Comments: This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaky; Fell out of bed; Weak; Got really sick after booster; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced ILLNESS (Got really sick after booster) (seriousness criterion hospitalization). On 10-Dec-2021, the patient experienced TREMOR (Shaky) (seriousness criterion hospitalization), FALL (Fell out of bed) (seriousness criterion hospitalization) and ASTHENIA (Weak) (seriousness criterion hospitalization). The patient was hospitalized from 10-Dec-2021 to 12-Dec-2021 due to ASTHENIA, FALL, ILLNESS and TREMOR. At the time of the report, TREMOR (Shaky), FALL (Fell out of bed), ASTHENIA (Weak) and ILLNESS (Got really sick after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood potassium: high (High) High. In December 2021, Blood pressure measurement: low (Low) Low BP.         At the hospital patient received IV Fluids.  Company comment:  This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-410982, MOD-2021-410964, MOD-2021-412276 (Patient Link).; Sender's Comments: This spontaneous case concerns an 80-year-old male patient, with no medical history provided, who experienced the serious (hospitalization) unexpected events of TREMOR, FALL, ASTHENIA and ILLNESS. The event occurred the 1 day after receiving a booster dose of mRNA-1273. The rechallenge is not applicable because the outcome of the events is unknown and no further dosing is expected. Patient was admitted to the hospital for 2 days, and relevant findings included increased blood potassium and low blood pressure. No final diagnosis was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the first shot). At the time of the report, VACCINATION COMPLICATION (side effects after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Has to schedule her root canal appointment/but has to also take antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics). At the time of the report, TOOTH DISORDER (Has to schedule her root canal appointment/but has to also take antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. Patient has stated that she scheduled to get her second dose of the Moderna vaccine on Friday 26Feb2021 and has to schedule her root canal appointment but has to also take antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report several side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event they experiencing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event they experiencing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event they experiencing). At the time of the report, VACCINATION COMPLICATION (adverse event they experiencing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vial sat out in room temperature for more than 24 hours and were not discarded as they should have been.  They inadvertently administered the expired vaccine to two patients\Vial was punctured 22 times; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F51A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Pharmacist stated that two Moderna vials were taken out of their refrigerator 30-Nov-2021 at 9:00 am and punctured. The vials sat out in room temperature for more than 24 hours and were not discarded as they should have been. They inadvertently administered the expired vaccine to two patients on 02-Dec-2021 at 9:30 am. He also stated vial was punctured 22 times. The vials impacted have been discarded. Date the vial was initially stored in the refrigerator was on 29-Nov-2021. The total amount of time the vial was exposed to room temperature over 24 hours.   This case was linked to US-MODERNATX, INC.-MOD-2021-404089 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes on 22-Dec-2021, Follow-up received on 22-Dec-2021 contains significant information, patient demographic details (race and ethnicity), and suspect details (dose and anatomical location) added. US-MODERNATX, INC.-MOD-2021-404089, Same reporter.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of URINARY RETENTION (urinary retention), PETECHIAE (a little bit of petechia lesions on his legs & hands), DYSPNOEA (shortness of breath), LYMPHADENOPATHY (cervical lymph node adenopathy in his neck) and MYALGIA (body aches) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 036A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (cervical lymph node adenopathy in his neck) and NAUSEA (nausea). On 04-Dec-2021, the patient experienced PYREXIA (mild fever / fever off & on). On 05-Dec-2021, the patient experienced URINARY RETENTION (urinary retention), PETECHIAE (a little bit of petechia lesions on his legs & hands), DYSPNOEA (shortness of breath), MYALGIA (body aches), FATIGUE (fatigue) and CHILLS (chills off & on). At the time of the report, URINARY RETENTION (urinary retention), PETECHIAE (a little bit of petechia lesions on his legs & hands), DYSPNOEA (shortness of breath), LYMPHADENOPATHY (cervical lymph node adenopathy in his neck), MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills off & on), PYREXIA (mild fever / fever off & on) and NAUSEA (nausea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2021-411004 (Patient Link).