chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Oral discomfort, Pain in extremity, Tongue discomfort
Clinical narrative: burning on the roof of the mouth; Burning of the tongue; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of burning mouth in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included glucose oxidase, lactoferrin, lactoperoxidase, lysozyme (Biotene).   In February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2021, 3 days after receiving Shingrix, the patient experienced burning mouth and burning tongue. In February 2021, the patient experienced pain in arm. On an unknown date, the outcome of the burning mouth and burning tongue were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the burning mouth, burning tongue and pain in arm to be related to Shingrix.  Additional details was reported as follows: The patient reported case for herself. The 1st dose of the Shingrix vaccine received two weeks before day of reporting and experiencing a little soreness in the arm, burning on the roof of the mouth, and burning of the tongue. She stated that the burning developed 3 to 4 days after the shot. She reported that it had got a little better, and had been on and off. She has checked with her dentist for oral thrush, and they confirmed that it was not oral thrush. She stated that nothing else has been changed, and that everything had stayed the same. The patient having to suck on mints and spray on Biotene to ease the burning. She also reported holding water in her mouth also helps. She had a set of bloodwork done that came out fine. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: VACCINE HAS GOTTEN RID OF THEIR BLADDER INCONTIENCE / HELPED WITH NERVE DAMAGE; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included nerve damage (previous nerve damage from shingles) and bladder incontinence.   In December 2020, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient wanted to provide positive feedback for Shingrix because the patient no longer experienced bladder incontinence and that previous never damage from shingles was going away. The reporter consented to follow up. This case had been linked with US2021AMR047706, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR047706:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: arm presented redness / at site of injection; swelling at site of injection; headaches that are very bad; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on an unknown date).   On 14th February 2021, the patient received the 2nd dose of Shingrix. On 14th February 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, headache and tiredness. On an unknown date, the outcome of the injection site erythema, injection site swelling, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, headache and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had her second dose of Shingrix and her arm presented redness and swelling at site of injection. She had been getting headaches that were very bad and she was feeling tired. The patient called to get recommendations regarding her symptoms. The consent for follow-up was not requested by involuntary omission of the agent.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction; whole body hives including soles of feet and scalp; This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were unknown.   It was unknown if the reporter considered the allergic reaction and hives to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination not applicable. The field representative received an email from the RN. Stated the following: Patient has prior history of allergic reaction to the prior shingles vaccine There were no additional details provided in the call. It was unknown if the reporter considered the allergic reaction and hives to be related to Shingles vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Feeling crappy / Feeling miserable; Can barely move; Headache; Feeling / achy; Feeling / nauseous; Her right arm hurts; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dental cleaning. Previously administered products included Shingrix (Patient received 1st dose of shingrix on an unknown date.).   On 15th February 2021 04:00, the patient received the 2nd dose of Shingrix (intramuscular). On 16th February 2021, 1 days after receiving Shingrix, the patient experienced feels awful, mobility decreased, headache, pain, nausea and pain in arm. On an unknown date, the outcome of the feels awful, mobility decreased, headache, pain, nausea and pain in arm were not recovered/not resolved.   The reporter considered the feels awful, mobility decreased, headache, pain, nausea and pain in arm to be possibly related to Shingrix.  Additional details provided as follow: The patient reported case for herself. The reporter was asking if it was okay if she went to her dental cleaning on ay of reporting. She said that this was type of dental cleaning was a deep gum dental cleaning. It was given every 5 years where they numb everything and go deep down under the gums. Because she had metal in her neck she was pretreated with antibiotics prior to today's dental appointment. The patient received the injection intramuscularly at the pharmacy on day before reporting in the right deltoid. Th patient did not have the lot number or expiration date but did provide her pharmacy's phone number. The patient's symptoms included, she could barely move, headache, feeling miserable, achy and nauseous. She also said her right arm hurts; the arm where she received the injection. These events did not resolved. The reporter does felt these events are related to the Shingrix because she said she never feels this way. (She said she did not remember the first Shingrix shot bothering her). The reporter requesting consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Feeling crappy / Feeling miserable; Can barely move; Headache; Feeling / achy; Feeling / nauseous; Her right arm hurts; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dental cleaning. Previously administered products included Shingrix (Patient received 1st dose of shingrix on an unknown date.).   On 15th February 2021 04:00, the patient received the 2nd dose of Shingrix (intramuscular). On 16th February 2021, 1 days after receiving Shingrix, the patient experienced feels awful, mobility decreased, headache, pain, nausea and pain in arm. On an unknown date, the outcome of the feels awful, mobility decreased, headache, pain, nausea and pain in arm were not recovered/not resolved.   The reporter considered the feels awful, mobility decreased, headache, pain, nausea and pain in arm to be possibly related to Shingrix.  Additional details provided as follow: The patient reported case for herself. The reporter was asking if it was okay if she went to her dental cleaning on ay of reporting. She said that this was type of dental cleaning was a deep gum dental cleaning. It was given every 5 years where they numb everything and go deep down under the gums. Because she had metal in her neck she was pretreated with antibiotics prior to today's dental appointment. The patient received the injection intramuscularly at the pharmacy on day before reporting in the right deltoid. Th patient did not have the lot number or expiration date but did provide her pharmacy's phone number. The patient's symptoms included, she could barely move, headache, feeling miserable, achy and nauseous. She also said her right arm hurts; the arm where she received the injection. These events did not resolved. The reporter does felt these events are related to the Shingrix because she said she never feels this way. (She said she did not remember the first Shingrix shot bothering her). The reporter requesting consent to follow up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain / really sore arm / uses his arm a lot because he does a lot of physical work; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis.   Concomitant products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta).   On 25th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient himself. The patient mentioned that, he was on Breo ellipta and he did not state that his condition had worsened or that he experienced any adverse event while using the Breo ellipta. The patient received 1st dose of Shingrix in his left arm and experienced left arm pain that lasted for 8 to 9 months. The patient had a really sore arm and because of the arm pain, he had never received the 2nd dose. The patient was claiming that, he uses his arm a lot for physical work and therefore, he elected not getting the 2nd dose. The reporter consented to follow up. The batch number was updated from 3MY56 to 3NY5G, as per the sales data sheet.  Note: The 2nd dose was not captured as suspect for 'incomplete course', as the patient didn't want to take the 2nd dose due to medical reasons.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itch at injection site / unresolved; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of shingrix on an unknown date).   On 17th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema. On 22nd February 2021, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient's husband. Age at vaccination was not reported. There was no adverse event related to the first dose. The patient experienced redness at the injection site. The patient also began to itch at the injection site, which began 5 days after the injection. The events were unresolved. The patient was seen by a physician, who did not know how to treat it. The formulation of Shingrix was not known The reporter did not consent to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Shivering; fever; Muscle pain in top of left arm; nausea; pain in the injection site / pain in his upper left arm; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 1st dose of Shingrix. In January 2021, 24 hrs after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea and muscle pain. On 29th January 2021, the patient experienced shivering and fever. On an unknown date, the outcome of the injection site pain, fatigue, shivering, nausea, muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, shivering, nausea, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced fever and shivering which started about 8 hours after the vaccination and resolved the next day. On 30th January 2021, the patient experienced pain in the injection site, pain in his upper left arm, tiredness, and nausea which resolved 3 to 4 days later. The patient was concerned if he would experience injection site pain when he gets his next Shingrix vaccination. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Shivering; fever; Muscle pain in top of left arm; nausea; pain in the injection site / pain in his upper left arm; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2021, the patient received the 1st dose of Shingrix. In January 2021, 24 hrs after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea and muscle pain. On 29th January 2021, the patient experienced shivering and fever. On an unknown date, the outcome of the injection site pain, fatigue, shivering, nausea, muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, shivering, nausea, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced fever and shivering which started about 8 hours after the vaccination and resolved the next day. On 30th January 2021, the patient experienced pain in the injection site, pain in his upper left arm, tiredness, and nausea which resolved 3 to 4 days later. The patient was concerned if he would experience injection site pain when he gets his next Shingrix vaccination. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Scab
Clinical narrative: Blisters / appeared near the injection site on her upper left arm / Still has a few on her stomach today / "chicken-poc" like blisters appear each day; Blisters that scab over; This case was reported by a consumer via call center representative and described the occurrence of blister in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2021, 2 days after receiving Shingrix, the patient experienced blister and scab. On 8th March 2021, the outcome of the scab was recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister and scab to be related to Shingrix.  Additional information provided as follows: Several days later vaccination, patient developed blisters that scab over appeared near the injection site on her upper left arm. The patient still had a few on her stomach on day of reporting. A few chickenpox like blisters appeared each day and scab over. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash erythematous, Skin burning sensation, Skin discolouration
Clinical narrative: red rash; red rash /  rash comes and goes; itching and burning in his left arm; burning in his left arm /  rash comes and goes and gets red and then light; rash comes and goes and gets red and then light; This case was reported by a consumer via call center representative and described the occurrence of rash in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2021, the patient received the 1st dose of Shingrix. On 26th February 2021, less than a day after receiving Shingrix, the patient experienced rash, erythema, pruritus, burning sensation and decoloration skin. On an unknown date, the outcome of the rash, erythema, pruritus, burning sensation and decoloration skin were unknown.   It was unknown if the reporter considered the rash, erythema, pruritus, burning sensation and decoloration skin to be related to Shingrix.  Additional details were provided as follows: The patient reporter case for himself. Right after receiving the Shingrix dose, patient experienced itching and burning in his left arm and a red rash right under where he received the vaccination. He claimed that the rash came and went and gets red and then light. He had burning and itching too. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Illness, Impaired work ability
Clinical narrative: slept a lot; she was feeling sick and took a half day; took half day off of work; sore arm / arm pain was the right arm (the side that was injected); chills; headache the whole time; cold; shaky; This case was reported by a other health professional via call center representative and described the occurrence of sleep excessive in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, chills, headache, cold and tremor. On 28th December 2020, the patient experienced sleep excessive, sickness and activities of daily living impaired. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the sleep excessive, pain in arm, chills, headache, cold, tremor and sickness were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the sleep excessive, sickness and activities of daily living impaired to be related to Shingrix. The reporter considered the pain in arm, chills, headache, cold and tremor to be related to Shingrix.   Additional details were received as follows: The case was reported by the patient for herself. The patient used to be a medical assistant. The patient received 1st dose of Shingrix in the right deltoid.  The patient had headache the whole time, chills a little and a sore arm. About 24 hours after the shot, she began to experience side effects, like cold and shaky which continued through the night and Monday.  She was worked on Monday morning and was feeling sick and taken a half day and on the same afternoon, the patient slept a lot.  For headache the patient taken Tylenol, headache did not resolve until Tuesday night.  The patient reported that all the events were resolved, even the arm pain, three days after (by Tuesday night).  She stated that the arm pain was the right arm (the side that was injected) but that there was no redness or swelling at the injection site. The patient did not had a physician. The reporter did not want to provide her email address and does not have a personal fax number.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nasopharyngitis, Tremor
Clinical narrative: slept a lot; she was feeling sick and took a half day; took half day off of work; sore arm / arm pain was the right arm (the side that was injected); chills; headache the whole time; cold; shaky; This case was reported by a other health professional via call center representative and described the occurrence of sleep excessive in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, chills, headache, cold and tremor. On 28th December 2020, the patient experienced sleep excessive, sickness and activities of daily living impaired. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the sleep excessive, pain in arm, chills, headache, cold, tremor and sickness were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the sleep excessive, sickness and activities of daily living impaired to be related to Shingrix. The reporter considered the pain in arm, chills, headache, cold and tremor to be related to Shingrix.   Additional details were received as follows: The case was reported by the patient for herself. The patient used to be a medical assistant. The patient received 1st dose of Shingrix in the right deltoid.  The patient had headache the whole time, chills a little and a sore arm. About 24 hours after the shot, she began to experience side effects, like cold and shaky which continued through the night and Monday.  She was worked on Monday morning and was feeling sick and taken a half day and on the same afternoon, the patient slept a lot.  For headache the patient taken Tylenol, headache did not resolve until Tuesday night.  The patient reported that all the events were resolved, even the arm pain, three days after (by Tuesday night).  She stated that the arm pain was the right arm (the side that was injected) but that there was no redness or swelling at the injection site. The patient did not had a physician. The reporter did not want to provide her email address and does not have a personal fax number.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: earliest appointment for second dose is 52 days after first dose; A spontaneous report was received from a consumer, who was also a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and the earliest appointment for second dose is 52 days after first dose (inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant product use was not reported.   On 27 JAN 2021  the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The patient reported that the earliest appointment for second dose is on 20 Mar 2021, 52 days after the first dose.  Action taken with mRNA-1273 in response to the events was not applicable.  The event of earliest appointment for second dose is 52 days after first dose was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported
Sex: F
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Flare-up of her colitis; A spontaneous report was received from a consumer who was a female patient that received Moderna's (mRNA-1273) Covid-19 vaccine and experienced flare-up of her colitis.  The patient's medical history included Colitis (type unspecified). No concomitant medications were reported.  On 03-Feb-2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of Covid-19 infection .   On an unknown date, the patient experienced a flare up of her Colitis.  Lab data was not provided.  Treatment for the event included Prednisone.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, flare up of her Colitis, was considered to be unknown.  The primary reporter believed that the adverse event was not related to the vaccine.; Reporter's Comments: Based on reporter's causality, the event is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinittus; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced tinittus.  The patient's medical history was not provided. Concomitant medications included atenolol, ramipril and simvastatin.  On 03 Feb 2021, prior to the onset of event, patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) on the left arm for the prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient experienced tinittus. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event tinittus was not recovered (still ongoing).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hepatic enzyme increased, Muscular weakness, Pyrexia, Urinary tract infection
Clinical narrative: Uti infection; Limp with no strength/ patient couldn't stand; Liver enzymes were elevated; Fever; Extreme weakness; A spontaneous case was received from the consumer concerning female patient of unknown age who received Moderna's  COVID-19 vaccine and experienced UTI infection/urinary tract infection, extreme weakness/asthenia, limp with no strength/ patient couldn't stand/muscular weakness, fever/pyrexia, liver enzymes were elevated/hepatic enzyme increased.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Atorvastatin, Esomeprazole magnesium, Clavex, amlodipine, Cetirizine, Tramadol, Gabapentin.  On 28 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number: 038K20A) at unknown injection site for the prophylaxis of COVID-19 infection.  On 28 Jan 2021 the patient experienced extreme weakness. She experienced severe symptoms like she couldn't stand, limp with no strength, fever, UTI infection. Treatment of the event included antibiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, UTI infection, extreme weakness, limp with no strength and patient couldn't stand, fever, liver enzymes were elevated was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Delirium, Headache, Insomnia, Weight decreased
Clinical narrative: Delirious thinking; So uncomfortable couldn't sleep; Delirious thinking, loss of appetite; Loss 5 lbs after the vaccination; Headache; A spontaneous report was received from a consumer concerning a 71-year-old,male patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced headache, couldn't sleep, delirious thinking , loss of appetite and loss of weight.   The patient's medical history included COVID-19 infection from 07 Jan 2021- 20 Jan 2021. No relevant concomitant medications were mentioned.  On 01 Feb 2021, the patient received mRNA-1273 (Batch number not provided)  in the left arm for prophylaxis of COVID-19 infection.   After the vaccination, side effects were 36 hours of headache, couldn't sleep, delirious thinking, loss of appetite for solid foods,only drank liquids, lost 5 lbs after the vaccination.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  Outcome of the events, headache, couldn't sleep, delirious thinking, loss of appetite and loss of weight, were considered as recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blindness, Burning sensation, Discomfort, Headache
Clinical narrative: arm pain; hurts to move her arm; coudn't even see; total discomfort; trembling eyes; insomnia; sensation of fire in her head; Nausea; terrible headache that stops when she rests; Numbness in pinky finger; A spontaneous report was received from a consumer who was a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced total discomfort, trembling eyes, couldn't even see, insomnia, sensation of fire in her head, arm pain, nausea, terrible headache that stops when she rests, numbness in pinky finger and it hurts to move her arm.  No past medical history was reported.   Concomitant medication use was not reported.   On 02-FEb-2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (Lot unknown)  intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient called to report that she had tons of reactions including: total discomfort, trembling eyes, she couldn't even see, insomnia, a sensation of fire in her head, arm pain, nausea, a terrible headache that stopped when she rested, numbness in pinky finger and it hurt to move her arm.  No Laboratory details provided.  Treatment information was not provided.  . Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, total discomfort, trembling eyes, couldn't even see, insomnia, sensation of fire in her head, arm pain, nausea, terrible headache that stops when she rests, numbness in pinky finger and it hurts to move her arm, were considered unknown.  .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Nausea, Vaccination site pain
Clinical narrative: arm pain; hurts to move her arm; coudn't even see; total discomfort; trembling eyes; insomnia; sensation of fire in her head; Nausea; terrible headache that stops when she rests; Numbness in pinky finger; A spontaneous report was received from a consumer who was a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced total discomfort, trembling eyes, couldn't even see, insomnia, sensation of fire in her head, arm pain, nausea, terrible headache that stops when she rests, numbness in pinky finger and it hurts to move her arm.  No past medical history was reported.   Concomitant medication use was not reported.   On 02-FEb-2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (Lot unknown)  intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient called to report that she had tons of reactions including: total discomfort, trembling eyes, she couldn't even see, insomnia, a sensation of fire in her head, arm pain, nausea, a terrible headache that stopped when she rested, numbness in pinky finger and it hurt to move her arm.  No Laboratory details provided.  Treatment information was not provided.  . Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, total discomfort, trembling eyes, couldn't even see, insomnia, sensation of fire in her head, arm pain, nausea, terrible headache that stops when she rests, numbness in pinky finger and it hurts to move her arm, were considered unknown.  .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Dissociation, Dreamy state, Feeling abnormal
Clinical narrative: Confusion; Mentally slow; Like I was in a dream and woke up yesterday but I remember everything; Delirium; Mental FOG; Detached from reality; A spontaneous case report was received from a physician concerning a 32 year old male patient, who received Moderna's Covid 19 vaccine and experienced events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly on 24 Dec 2021. On 21 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced confusion and mentally slow. He was sent home from work because he was not normal. He explained it as, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state. He went to the ER (emergency room). Relevant laboratory results included unspecified lab tests and results were negative. Treatment details was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state was considered resolved on 26 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: Confusion; Mentally slow; Like I was in a dream and woke up yesterday but I remember everything; Delirium; Mental FOG; Detached from reality; A spontaneous case report was received from a physician concerning a 32 year old male patient, who received Moderna's Covid 19 vaccine and experienced events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly on 24 Dec 2021. On 21 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced confusion and mentally slow. He was sent home from work because he was not normal. He explained it as, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state. He went to the ER (emergency room). Relevant laboratory results included unspecified lab tests and results were negative. Treatment details was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state was considered resolved on 26 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Gait inability, Headache
Clinical narrative: Afraid husband may found her on the floor; Hardly can walk; So weak; Dizziness; Diarrhea; Vomiting; Fever; Headache; A spontaneous report was received from a sixty-six-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the consumer experienced the events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was unknown.  The assessment for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Afraid husband may found her on the floor; Hardly can walk; So weak; Dizziness; Diarrhea; Vomiting; Fever; Headache; A spontaneous report was received from a sixty-six-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the consumer experienced the events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was unknown.  The assessment for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Diarrhea; Headache; Dizzy; No appetite; Nausea; Fatigue; A spontaneous report was received from a Consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, nausea, dizziness, diarrhea, decreased appetite and fatigue.  The patient's medical history was not provided. Concomitant medications reported cholesterol.  On 25-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, nausea, dizziness, diarrhea, decreased appetite and fatigue.  Treatment details included, Tylenol, Imodium.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Diarrhea; Headache; Dizzy; No appetite; Nausea; Fatigue; A spontaneous report was received from a Consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, nausea, dizziness, diarrhea, decreased appetite and fatigue.  The patient's medical history was not provided. Concomitant medications reported cholesterol.  On 25-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, nausea, dizziness, diarrhea, decreased appetite and fatigue.  Treatment details included, Tylenol, Imodium.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Electrocardiogram abnormal, Loss of consciousness
Clinical narrative: Passed out for 40 secs; Chills; Cardiac issues; A spontaneous report was received from a consumer who was also a 34-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced passed out for 40 secs/ loss of consciousness, chills, and cardiac issues/ cardiac disorder.  The patient's medical history included depression. Products known to have been used by the patient, within two weeks prior to the event, included quetiapine fumarate (Seroquel) since 2014.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 12 Jan 2021. On 10 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection.  On 10 Feb 2021, after receiving the second dose of the vaccine the patient, had experienced cardiac issues.  On 11 Feb 2021, the patient started experiencing chills and passed out for 40 seconds (secs). The patient had visited the emergency room (ER) and EKG (electrocardiogram) showed slight abnormality. She was given heart monitor for 14 days. She was scheduled for Stress test and Echo. She was on antipsychotic medications for seven years. She was curious whether the antipsychotic drugs caused the cardiac abnormalities in response to Covid-19 vaccine. Treatment information was not provided. The adverse event of passed out for 40 secs was assessed as medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events chills and cardiac issues was unknown. Outcome of the event passed out for 40 secs was recovered on 11 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Confusional state, Fatigue, Head injury
Clinical narrative: confused; extremely weak; cold and clammy; barely could move arm; banged head on cabinet; overwhelming nausea; lost consciousness; arm hurt a little bit/throbbing pain; Felt fatigued; A spontaneous report was received from a consumer, who was also a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt a little bit/throbbing pain, felt fatigued, confused, overwhelming nausea, lost consciousness, banged her head on the cabinet, extremely weak, cold and clammy and barely could move arm .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, the patient received the first of the two planned doses of mRNA-1273 (batch# 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On the night of 13 Feb 20212, the patient experienced arm hurt a little bit and she felt fatigued.  In the early morning of 14 Feb 2021, the patient went to the bathroom.  On her way to the bathroom,  she felt confused and had overwhelming nausea.  She lost consciousness and banged her head on the cabinet.  Within second, she regained consciousness but felt extremely weak.  She could not recall how she got back to her bed.  The patient said she was cold and clammy at that time and she never got back to sleep.  During the day on 14 Feb 2021, the patient felt a throbbing pain on the arm where she got the injection.  She was not sure whether that was due to the injection or due to her fall when she lost consciousness.  She could barely move the arm.  Then she took a nap in the afternoon and was able to recover from her lack of sleep that night.    Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was unknown (although her doctor advised her not to get the second dose given the reaction she had).  The outcome of the events was resolved on 15 Feb 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Additional information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded