chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site reaction, Pain, Throat irritation
Clinical narrative: scratchy throat; Vomited; Chills; Entire body, even fingers and toes, ached; Welt at injection site; face was bright red/breasts were cherry red; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on 21Sep2020 on the left arm at a single dose as a pneumonia shot. The patient had no medical history and there were no concomitant medications.  The patient was trying to get a list of ingredients before she even thinks about getting the COVID shot (confirmed that she has not received the COVID shot) because she had a severe reaction to the pneumonia shot. On an unspecified date in Sep2020, in the evening, it started with scratchy throat. The patient's granddaughter suffers from anaphylaxis and her reactions begin with a scratchy throat. The patient's daughter left Children's Benadryl at the patient's house in case her granddaughter had a reaction. So the patient took Children's Benadryl after throat was scratchy because that is all she had. On an unspecified date in Sep2020 (reported as 'Thursday') at 06:00 in the morning the patient vomited and had chills. Her entire body even fingers and toes ached. She looked in mirror, her face was bright red. Her breasts were cherry red. The patient had a hug welt on her left arm at the site of the injection. The patient called doctor and was advised no more shots. The outcome of the events were unknown. It was also reported that approximately six weeks later the patient got the Fluzone shot and had a similar reaction, but not quite as severe, the patient was bright red, had a welt, she kind of chilly and not her usual self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria, Vomiting
Clinical narrative: scratchy throat; Vomited; Chills; Entire body, even fingers and toes, ached; Welt at injection site; face was bright red/breasts were cherry red; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on 21Sep2020 on the left arm at a single dose as a pneumonia shot. The patient had no medical history and there were no concomitant medications.  The patient was trying to get a list of ingredients before she even thinks about getting the COVID shot (confirmed that she has not received the COVID shot) because she had a severe reaction to the pneumonia shot. On an unspecified date in Sep2020, in the evening, it started with scratchy throat. The patient's granddaughter suffers from anaphylaxis and her reactions begin with a scratchy throat. The patient's daughter left Children's Benadryl at the patient's house in case her granddaughter had a reaction. So the patient took Children's Benadryl after throat was scratchy because that is all she had. On an unspecified date in Sep2020 (reported as 'Thursday') at 06:00 in the morning the patient vomited and had chills. Her entire body even fingers and toes ached. She looked in mirror, her face was bright red. Her breasts were cherry red. The patient had a hug welt on her left arm at the site of the injection. The patient called doctor and was advised no more shots. The outcome of the events were unknown. It was also reported that approximately six weeks later the patient got the Fluzone shot and had a similar reaction, but not quite as severe, the patient was bright red, had a welt, she kind of chilly and not her usual self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse reporting for the mother. A 92-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation .  Medical history included dementia.   The patient's concomitant medications were not reported. In Oct2020, the patient received the flu vaccine. The patient was tested positive for covid  on 27Jan2021 with outcome of unknown. The patient was hospitalised because of the event on 29Jan2021. The patient got her first vaccine on 12Jan2021, she tested negative for COVID on 19Jan2021 but on 27Jan2021 she tested positive. The patient has been retested on 29Jan2021 and is still positive.   Information of lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID after 15 days) with BNT162b2 can not be completely excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left deltoid on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 26Jan2021. When he came home that day his left arm swelled up and had a knot at the injection site. States he went right out, clarifies he went to sleep for hours. The next day (27Jan2021) when he woke up, he rubbed the area and it was sore. Three days ago (30Jan2021), he started running out of breath, he would walk to the mailbox and have to stop since he was out of breath. He never had that happen before. He was not sure what it was or if something else going on. He would have no breath whatsoever if he gets up to walk. When he was sitting still he was ok. If he gets up to walk to the bathroom, he was out of breath by the time he gets to the bathroom. States he was not short of breath as long as he was not doing anything. States it was crazy though when he starts walking and he gets out of breath. This has never happened to him before. He does not know if it was the vaccine or something else. He saw the shortness of breath was one of the side effects. He wants to find out what he should do and if he should go to the hospital. Advised to contact hcp. He asks if he was supposed to go back for the second shot. He has an appointment with his doctor in the next two weeks for all the medications he takes. The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Haematuria, SARS-CoV-2 test
Clinical narrative: bladder infection/UTI/Antibiotics; blood in my urine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported similar events for two patients. This is the first of two reports.  A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization.  The patient has no medical history. The patient's concomitant medications were not reported. The patient reported that on 27Jan2021, exactly 2 weeks after the 1st dose of the vaccine, she came down with a UTI and bladder infection which caused her to have blood in her urine. This also happened to the patient's father who suffered the same thing 2 weeks after his first vaccine. Antibiotic was given as treatment for the patient. Lab data include nasal swab COVID test: negative on 18Jan2021. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same product and event, different patient
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: extremely sick; dizziness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration on the left deltoid on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was asthmatic diagnosed around 8 or 9 years old. Concomitant medication included albuterol [salbutamol] for asthma. On 29Jan2021, the patient had first dose of the COVID vaccine and ended up getting extremely sick. The patient was taken by ambulance to the hospital on the same day. As reported, "so I was in ambulance dying just put me on there, but I got 2 doses of the "Aefrom" and I ended up of another dose of "hawdapil." The patient still had a little bit of dizziness which was not bad and has improved. The doctor instructed the patient to report and find out if patient was going to be able to get the second dose because they were saying not to. The patient got the vaccine at an hospital, in a line. Outcome of the event "extremely sick" was unknown and of dizziness was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of the two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills. The clinical outcome of chills was unknown.   same reporter/drug, different patient
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: a sore arm for a day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm for a day on an unspecified date. Clinical outcome of the event was unknown.   Information related to lot/batch has been requested.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site rash, Lymphadenopathy, Pain, Rash erythematous
Clinical narrative: rash at injection site, redness, body aches, enlarge lymph nodes left arm pit. Large red  rash left side with dark scaring
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Scar, Skin discolouration
Clinical narrative: rash at injection site, redness, body aches, enlarge lymph nodes left arm pit. Large red  rash left side with dark scaring
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Pharyngeal swelling, Skin burning sensation, Urticaria
Clinical narrative: Arm burning, swelling of throat, facial numbness, dizziness, hives
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the pt was treated by healthcare providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses and damages in the future. The outcome of the events shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: After my first dose of Shingrix I became nauseous; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and became nauseous. The patient wanted to know was there any advice to minimize this side effect.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix. On 11th January 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved.   The reporter considered the influenza-like symptoms to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started developing flu-like symptoms after the shot and thought it prudent to get tested for coronavirus, flu and anything else they were offering that day no matter how trivial. The patient tested for the flu and COVID-19, and both results came back negative. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pain, Pain
Clinical narrative: allergic reaction; site where they injected me caused pain; my body had some aches; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female 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, injection site pain and general body pain. On an unknown date, the outcome of the allergic reaction, injection site pain and general body pain were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain and general body pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingle vaccination and the site where they injected her caused pain and her body had some aches, it was an allergic reaction to the vaccine. The reporter did not consent to follow-up to her and her prescribing healthcare professional.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Insomnia, Rash, Sleep disorder
Clinical narrative: rash over the chest, thighs, arms, and knee area; hives over the chest, thighs, arms, and knee area; being unable to sleep for the past 3 or 4 days due to the rash and hives; rash at the injection site; bruising at the injection site; This case was reported by a consumer and described the occurrence of injection site rash in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, 7 days after receiving Shingrix, the patient experienced rash and hives. In January 2021, the patient experienced injection site rash, injection site bruising and sleeplessness. The patient was treated with cortisone acetate and prednisone. On an unknown date, the outcome of the injection site rash, rash and hives were not recovered/not resolved and the outcome of the injection site bruising and sleeplessness were unknown.   It was unknown if the reporter considered the injection site rash, injection site bruising, rash, hives and sleeplessness to be related to Shingrix.  Additional details were provided as follows:  The patient experienced bruising and rash at the injection site within 24 hours of vaccination  The patient experienced rash and hives over the chest, thighs, arms, and knee area.  The patient was unable to sleep for the past 3 or 4 days before the date of reporting due to the rash and hives.  Cortisone and prednisone prescribed to treat the rash and hives was unsuccessful.  The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: rash over the chest, thighs, arms, and knee area; hives over the chest, thighs, arms, and knee area; being unable to sleep for the past 3 or 4 days due to the rash and hives; rash at the injection site; bruising at the injection site; This case was reported by a consumer and described the occurrence of injection site rash in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, 7 days after receiving Shingrix, the patient experienced rash and hives. In January 2021, the patient experienced injection site rash, injection site bruising and sleeplessness. The patient was treated with cortisone acetate and prednisone. On an unknown date, the outcome of the injection site rash, rash and hives were not recovered/not resolved and the outcome of the injection site bruising and sleeplessness were unknown.   It was unknown if the reporter considered the injection site rash, injection site bruising, rash, hives and sleeplessness to be related to Shingrix.  Additional details were provided as follows:  The patient experienced bruising and rash at the injection site within 24 hours of vaccination  The patient experienced rash and hives over the chest, thighs, arms, and knee area.  The patient was unable to sleep for the past 3 or 4 days before the date of reporting due to the rash and hives.  Cortisone and prednisone prescribed to treat the rash and hives was unsuccessful.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: muscle aches; fatigue; did not feel well; This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fatigue and feeling unwell. On an unknown date, the outcome of the muscle pain, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows:    The reporter was patient's brother.   It was reported that the patient did not feel well after the vaccine, for either 3 or 5 days.  The patient experienced fatigue and muscle aches, but there might have been other symptoms as well.  The patient was not sure if she would receive the 2nd dose.  The reporter spoke with patient about this about 2-3 weeks before the date of reporting.  The reporter did not have additional information, but would ask his sister to call to provide more information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm was sore at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of injection site pain (received flu vaccine on an unknown date, refer case US2021AMR013295).   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient The age at vaccination was not reported. The reporter did not have the lot/expiration date but did provide contact information for his pharmacy. The patient received Shingrix shot 1 in September 2020. The patient stated that his arm was sore at the injection site. For tolerance of 2nd dose refer case US2021AMR013283. This case is linked to the US2021AMR013295 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013283:Same reporter. US-GLAXOSMITHKLINE-US2021AMR013295:Same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Injection site swelling, Malaise
Clinical narrative: malaise; knot forming near the elbow, below the injection site; Limited ability to place her arm above her head / decreased mobility; swelling at injection site; arm is still painful; pain at injection site; Fatigue; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, injection site pain and fatigue. On 14th October 2020, the patient experienced injected limb mobility decreased, malaise and mass. On an unknown date, the outcome of the injected limb mobility decreased, mass and pain in arm were not recovered/not resolved and the outcome of the injection site swelling, malaise, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, malaise, mass, pain in arm, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and the patient reported pain at injection site, swelling at injection site, fatigue, and malaise. The patient reported that the next day, she experienced a knot forming near the elbow, below the injection site.   The patient reported that the arm was still painful and she had limited ability to place her arm above her head without the pain increasing. The soreness and the decreased mobility of the injected arm was still present, but all other events had resolved. The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain in extremity
Clinical narrative: malaise; knot forming near the elbow, below the injection site; Limited ability to place her arm above her head / decreased mobility; swelling at injection site; arm is still painful; pain at injection site; Fatigue; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, injection site pain and fatigue. On 14th October 2020, the patient experienced injected limb mobility decreased, malaise and mass. On an unknown date, the outcome of the injected limb mobility decreased, mass and pain in arm were not recovered/not resolved and the outcome of the injection site swelling, malaise, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, malaise, mass, pain in arm, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and the patient reported pain at injection site, swelling at injection site, fatigue, and malaise. The patient reported that the next day, she experienced a knot forming near the elbow, below the injection site.   The patient reported that the arm was still painful and she had limited ability to place her arm above her head without the pain increasing. The soreness and the decreased mobility of the injected arm was still present, but all other events had resolved. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a physician and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported via web form. The age at vaccination was not reported. The patient had sore arm that the patient related back to her second Shingrix vaccination which was given in Sept 2020. The patient denied any nodule or visible abnormality. The reporter did not agree nor denied follow-up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: FAINTED; vision impairment (blackout); DIZZINESS; spinning; NAUSEA; VOMITED; over heating; chills; FATIGUE; CHILLS; over heating; A spontaneous report was received from a consumer concerning a female 55 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, vision impairment (blackout), spinning, chills, fever, fatigue, nausea, dizziness, and vomited.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A), intramuscularly (IM) (site not provided), on 05 Jan 2021. On 02-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (lot #013M20A), IM (site not provided) for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient received their first Moderna vaccine. On 06 Jan 2021, patient experienced chills and overheating. On 02 Feb 2021 the patient received second dose of Moderna vaccine and experienced chills and fatigue on same day. On 03 Feb 2021, the patient experienced overheating, nausea and vomited, dizziness, spinning, vision impairment (blackout), and fainted. Treatment was not administered.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   Action taken with second dose of mRNA-1273 in response to the event was not provided The outcome of all events was unknown.; 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.  Further information has been requested. Chills, Pyrexia, nausea, vomiting and fatigue are listed events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vertigo, Visual impairment, Vomiting
Clinical narrative: FAINTED; vision impairment (blackout); DIZZINESS; spinning; NAUSEA; VOMITED; over heating; chills; FATIGUE; CHILLS; over heating; A spontaneous report was received from a consumer concerning a female 55 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, vision impairment (blackout), spinning, chills, fever, fatigue, nausea, dizziness, and vomited.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A), intramuscularly (IM) (site not provided), on 05 Jan 2021. On 02-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (lot #013M20A), IM (site not provided) for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient received their first Moderna vaccine. On 06 Jan 2021, patient experienced chills and overheating. On 02 Feb 2021 the patient received second dose of Moderna vaccine and experienced chills and fatigue on same day. On 03 Feb 2021, the patient experienced overheating, nausea and vomited, dizziness, spinning, vision impairment (blackout), and fainted. Treatment was not administered.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   Action taken with second dose of mRNA-1273 in response to the event was not provided The outcome of all events was unknown.; 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.  Further information has been requested. Chills, Pyrexia, nausea, vomiting and fatigue are listed events.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Covid-19 vaccine to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female, who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection at the age of 17-year-old.  Action taken with mRNA-1273 in response to the events was resolved.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of 17-year-old, female administered mRNA-1273 (lot # 026L20A) at inappropriate age (inappropriate age at vaccine administration). There were no associated adverse events with the event of inappropriate age at vaccine administration
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pneumonia, SARS-CoV-2 test
Clinical narrative: Pneumonia; A spontaneous report was received from a physician concerning a 78 years-old, male patient, who received Moderna's COVID-19 Vaccine and who experienced pneumonia.  The patient's medical history included chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis. Products known to have been used by the patient, within two weeks prior to the event, included umeclidinium bromide/ vilanterol trifenatate, irbesartan, amlodipine besilate, metoprolol, glipizide, metformin, omeprazole, magnesium, and omega 3.  The patient received their first of two planned doses of mRNA-1273 intramuscularly on 22 Jan 2021 for the prophylaxis of COVID-19 infection.   On 22 Jan 2021 within a few hours of first dose, the patient developed fever, chills, weakness, and productive cough. On 24 Jan 2021, the patient was admitted to hospital due to oxygen levels in the 60s with productive cough, yellow sputum, and short of breath. He was diagnosed with pneumonia. During hospitalization, the patient had two negative PCR COVID-19 tests.  Treatment information was not provided.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of event pneumonia  was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's medical history of COPD and pulmonary fibrosis may have been contributory.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Delirium, Feeling cold, Nausea
Clinical narrative: he has eaten almost nothing; Hot to the touch (Maybe had a fever); started shaking again; has neuropathy and felt extreme pain in his feet; A little bit of delirium; Shaking violently from chills and felt very, very cold/ Could not stop the shakes; has neuropathy and felt extreme pain in his feet; Nausea; A Spontaneous report was received from a consumer concerning her husband, a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced extreme pain in his feet (increased neuropathy), a little bit of delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, hot to the touch (maybe had a fever), started shaking again, and he has eaten almost nothing.  The patient's medical history included neuropathy. Concomitant medications included fish oil, blood thinner, blood pressure medication, atorvastatin, Lyrica and baby aspirin.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient started to experience side effects: nausea, shaking from chills, felt very cold and couldn't not stop the shakes. The patient has neuropathy and felt extreme pain in his feet which continued until 01 Feb 2021, when it got somewhat better.   On 02 Feb 2021, the patient was good at first but then started shaking again. During the night, the patient shook violently from chills again and he was hot to the touch (maybe he had a fever but we didn't have a thermometer). The patient also had increased neuropathy and nausea and had eaten almost nothing. He also experienced a little bit of delirium. The patient's wife gave him acetaminophen that seemed to bring down the chills.  Action taken with mRNA-1273 in response to the events was not reported.   The events of has neuropathy and felt extreme pain in his feet, shaking violently from chills and felt very, very cold/couldn't not stop the shakes, and started shaking again were recovering/resolving on 01 Feb 2021. The outcome of the events of a little bit of delirium, nausea, hot to touch (maybe had a fever), has neuropathy and felt extreme pain in his feet, increased neuropathy and he has eaten almost nothing  was considered unknown.; Reporter's Comments: This report concerns a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non-serious events of extreme pain in his feet (increased neuropathy), delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, fever, and he has eaten almost nothing. 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: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Pyrexia
Clinical narrative: he has eaten almost nothing; Hot to the touch (Maybe had a fever); started shaking again; has neuropathy and felt extreme pain in his feet; A little bit of delirium; Shaking violently from chills and felt very, very cold/ Could not stop the shakes; has neuropathy and felt extreme pain in his feet; Nausea; A Spontaneous report was received from a consumer concerning her husband, a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced extreme pain in his feet (increased neuropathy), a little bit of delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, hot to the touch (maybe had a fever), started shaking again, and he has eaten almost nothing.  The patient's medical history included neuropathy. Concomitant medications included fish oil, blood thinner, blood pressure medication, atorvastatin, Lyrica and baby aspirin.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient started to experience side effects: nausea, shaking from chills, felt very cold and couldn't not stop the shakes. The patient has neuropathy and felt extreme pain in his feet which continued until 01 Feb 2021, when it got somewhat better.   On 02 Feb 2021, the patient was good at first but then started shaking again. During the night, the patient shook violently from chills again and he was hot to the touch (maybe he had a fever but we didn't have a thermometer). The patient also had increased neuropathy and nausea and had eaten almost nothing. He also experienced a little bit of delirium. The patient's wife gave him acetaminophen that seemed to bring down the chills.  Action taken with mRNA-1273 in response to the events was not reported.   The events of has neuropathy and felt extreme pain in his feet, shaking violently from chills and felt very, very cold/couldn't not stop the shakes, and started shaking again were recovering/resolving on 01 Feb 2021. The outcome of the events of a little bit of delirium, nausea, hot to touch (maybe had a fever), has neuropathy and felt extreme pain in his feet, increased neuropathy and he has eaten almost nothing  was considered unknown.; Reporter's Comments: This report concerns a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non-serious events of extreme pain in his feet (increased neuropathy), delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, fever, and he has eaten almost nothing. 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: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage).  The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine.   On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided.  The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event,  pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Hyperhidrosis, Hypokinesia, Loss of consciousness
Clinical narrative: blacked out, passed out; could not move any part of the body; hard time breathing; sweating; A spontaneous report was received regarding a 73-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sweating, blacking out, passing out, inability to move any part of his body.  The patient's medical history was not provided. Concomitant medications were not provided.   On 01 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  The injection took place in his car in a drive-in vaccination location.  On 01 Feb 2021, approximately four minutes after the mRNA-1273 vaccine was given, the patient experienced sweating, blacking out, passing out, inability to move any part of his body.   The patient reports that when he woke up he was out of his car on the grass and the emergency crew was working on him. They had given him a shot of an Epi-Pen. He had a hard time breathing and could not move any part of his body. He was placed in a wheelchair and taken into the emergency room. There, an EKG was done which had normal results. He was released from the emergency room approximately two hours later.   Action taken with mRNA-1273 was not reported.  The outcome of the events, sweating, blacking out, passing out, inability to move any part of his body, was considered resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Patient with lyme disease received the second shot of the vaccine and ended at hospital; A spontaneous report was received from a consumer, concerning a male patient of unspecified age and, who received Moderna's COVID-19 vaccine (mRNA-1273) and where patient with lyme disease received the second shot of the vaccine and ended at hospital.  The patient's medical history included lyme disease.  Concomitant medications use was not provided  On an unknown date, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection.    The reporter stated that her physician advised her not to have the second shot of vaccine as on an unspecified date, other patient with lyme disease had ended up at hospital after the second shot of vaccine, Treatment of this event was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, patient with lyme disease received the second shot of the vaccine and ended at hospital was considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time as the reason for hospitalization is lacking.  Further information has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Intestinal obstruction, Nausea
Clinical narrative: Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation.    The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam.   On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report.  The second dose of mRNA-1273 was delayed in response to the events.   The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.