chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: mistakenly gave a 21 year old female a high dose flu shot; mistakenly gave a 21 year old female a high dose flu shot; Initial information received on 29-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (under the reference 00878105).  This case involves a 21 years old female patient whom mistakenly gave a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration and overdose (same day latency).  It was reported "I mistakenly gave a 21 year old female a high dose flu shot. Are there any contraindications to this or any complications that need to watched for?"  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There would be no information on the batch number for this case.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: This case involves a 15 years old male patient whom expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] single dose vial being administered (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); HPV VACCINE (HPV VACCINE) and INFLUENZA VACCINE (FLU) (lot number and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination. On 30-Nov-2021, the patient received a first dose of suspect ADACEL (0.5 ml, total, once, lot C5631AA and expiration date: 27-Nov-2021) via unknown route in the right deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported "Expired ADACEL single dose vial was administered to a patient. Caller stated that the product expired on 27-Nov-2021 and would like to know how to proceed?" No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: This case involves a 19-year-old female patient who vaccinated with one dosage form (once) of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (single use vial, strength: 0.5 mL, lot U6787AA, expiry date 08-Nov-2021) via intramuscular route in the left deltoid on 28-Nov-2021 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication reported no other vaccines. It was a case of actual medication error due to expired vaccine used (latency was on same day). It was reported "The caller reports an expired vaccine was administered to a patient, does it need to be repeated? Is this dose valid and when should the patient get the next dose?" At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: This case involves a 4 years old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as a concomitant vaccine. On 29-Nov-2021, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (Suspension for injection, total, lot number: not reported and expiration date: 02-Oct-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (Same day latency). It was reported "Caller reporting she received shipment in May and usually has a longer time until expiration, reporting she needs to 'always check the date' Caller with question on whether vaccine needs repeating." At time of reporting, no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Medication error
Clinical narrative: patient received two doses of FLUZONE QUADRIVALENT this year with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (under reference 00878749).  This case involves an 88 years old female patient who received two doses of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] this year (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines  The patient received 0.5 mL first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ696AA and expiration date: 30-Jun-2022) via intramuscular route in the left arm on 25-Oct-2021 and 0.5 mL second dose of same vaccine in the right arm on 19-Nov-2021 for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Medical Assistant reported that a patient received two doses of FLUZONE QUADRIVALENT this year. The caller would like to know if there are any adverse events to monitor for and how to proceed. The first dose was administered on 25OCT2021 and the second dose was administered on 19NOV2021. The caller reported that the patient has not reported any adverse side effects or adverse events."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy  after receiving FLUZONE QIV PFS with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Agency (Reference number- 00880415) and transmitted to Sanofi on 01-Dec-2021.  This case involves a 23-year-old female pregnant patient after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient medical history, past medical treatment, family history and concomitant medication were not provided. On 01-Dec-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [frequency: once, strength: standard, lot UT7336NA, expiry date: 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant after received FLUZONE QUADRIVALENT vaccine.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Syringe issue, Underdose
Clinical narrative: screwed the needle onto the end and there was a needle malfunction; only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub; vaccine administered at subcutaneous route/ no AE; Initial information regarding an unsolicited valid non serious case was received from pharmacist via Agency (Reference number- 00880523) and transmitted to Sanofi on 01-Dec-2021.  This case involves a 60-year-old female patient receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] who experienced screwed the needle onto the end and there was a needle malfunction (needle issue) and only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub (underdose) and vaccine administered at subcutaneous route (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [injection, strength: standard, frequency: once, lot UT7377JA, expiry date: 30-Jun-2022] via subcutaneous route in the left deltoid for prophylactic vaccination.  It was reported "Pharmacist states that she attempted to vaccinate a patient with FLUZONE QUADRIVALENT PFS. She attached a "Medical Needle Pro Edge Safety Device 25g x 1 inch needle" to the FLUZONE QUADRIVALENT PFS. The needle attached securely, however when the pharmacist attempted to administer the vaccine, only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub where the needle attaches to the syringe. The Pharmacist asks if she should reinject the patient or if the vaccine was valid."  This case is medication error due to Inappropriate route of vaccination and vaccine underdose (latency same day).  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G decreased, Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had the shingles 6 times since 2011 in 6 different places). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blood immunoglobulin g decreased. The patient was treated with intravenous fluid (nos) (Infusion). On an unknown date, the outcome of the vaccination failure, shingles and blood immunoglobulin g decreased were unknown. It was unknown if the reporter considered the vaccination failure, shingles and blood immunoglobulin g decreased to be related to Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had vaccine yearly and had the shingles 6 times since 2011 in 6 different places. The doctor had confirmed every time and given him/her medicine three times daily for 7 days, now he/she took a low dose of the shingles medication daily for a year to see if it would prevent them. The patient had low IGG (immunoglobulin G) and had 5-hour infusions monthly. The follow up would not be possible as no contact information was available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: fever; woke up nauseated; head hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a 11-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included MENINGOCOCCAL VACCINE for prophylaxis.   On 30th November 2021, the patient received Tdap Vaccine and MENINGOCOCCAL VACCINE. On 1st December 2021, 1 days after receiving Tdap Vaccine, the patient experienced headache. On 2nd December 2021, the patient experienced fever and nausea. On an unknown date, the outcome of the headache, fever and nausea were unknown.   It was unknown if the reporter considered the headache, fever and nausea to be related to Tdap Vaccine.  Additional details were reported as follows: The case was reported by the patient's mother. The patient received unspecified meningitis and Tdap vaccines.  The reporter was unsure if the meningitis was serotype B or serotype A, C, W and Y, due to limitation in company dictionary coded as WHO DD Dictionary.  Reporter did not have lot numbers or brand names of the products administered. On 1st December 2021, the patient's head hurt (headache). On 2nd December 2021, the patient woke up nauseated and had a fever.  No further information gathered. Reporter going to contact pediatric office to obtain the names of the vaccines administered. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 29th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th November 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. The patient received 1st dose of Shingrix and immediately had pain in his arm at the injection site. The pain resolved after an unknown amount of time. The reporter had nothing else to report. The reporter did not have batch number or expiration date information.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: was given menA (lyophilized component) with saline diluent; was given menA (lyophilized component) with saline diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA582A, expiry date 31st August 2022) for prophylaxis.   On 30th November 2021, the patient received Menveo (intramuscular) .5 ml. On 30th November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that the patient was given menA (lyophilized component) with saline diluent instead of with the correct menCYW component in the right deltoid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL AFTER 6 HOURS; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 07-MAR-2022) dose was not reported, administered on 03-DEC-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, the patient experienced administration of vaccine from punctured vial to the patient after 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine from punctured vial to the patient after 6 hours was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral coldness, Skin disorder
Clinical narrative: SKIN DISORDER; COLDNESS OF SKIN; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced skin disorder, and coldness of skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from coldness of skin, and had not recovered from skin disorder. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: heart palpitations 3 to 4 days after second dose; aches; tiredness; fever; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 29-Jan-2021. Previously administered products included for COVID-19: Proair and Flovent. Past adverse reactions to the above products included Product used for unknown indication with Flovent and Proair. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: heart palpitations 3 to 4 days after second dose; aches; tiredness; fever; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 29-Jan-2021. Previously administered products included for COVID-19: Proair and Flovent. Past adverse reactions to the above products included Product used for unknown indication with Flovent and Proair. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, PALPITATIONS (heart palpitations 3 to 4 days after second dose), PAIN (aches), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Gait disturbance, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: freezing to death, she was absolutely freezing; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it even hurt her to walk; during night her feet started cramping real bad.; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it was so bad she could not trust herself to drive.; this was way beyond chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.) and NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 004M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills) outcome was unknown.            No concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Tremor
Clinical narrative: freezing to death, she was absolutely freezing; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it even hurt her to walk; during night her feet started cramping real bad.; she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather; it was so bad she could not trust herself to drive.; this was way beyond chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.) and NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 004M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (freezing to death, she was absolutely freezing), TREMOR (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), GAIT DISTURBANCE (it even hurt her to walk), MUSCLE SPASMS (during night her feet started cramping real bad.), NASOPHARYNGITIS (she was being so cold, and the weather is hot where she lives, she felt like it was like below 0° weather), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it was so bad she could not trust herself to drive.) and CHILLS (this was way beyond chills) outcome was unknown.            No concomitant medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Erythema, Fatigue
Clinical narrative: redness; swelling; Pain in left armpit; tenderness in left armpit; swelling of the lymph nodes in the left armpit; Fatigue; headache; muscle pain; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit) and LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Migraine and Asthma (on asthma inhaler - not used in over a year). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, RIZATRIPTAN for Migraine.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient takes migraine medication more often than inhaler due to using the computer for work.  Patient reported that the second dose was the worst.   This case was linked to MOD-2021-405038, MOD-2021-405022 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: redness; swelling; Pain in left armpit; tenderness in left armpit; swelling of the lymph nodes in the left armpit; Fatigue; headache; muscle pain; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit) and LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Migraine and Asthma (on asthma inhaler - not used in over a year). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, RIZATRIPTAN for Migraine.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient takes migraine medication more often than inhaler due to using the computer for work.  Patient reported that the second dose was the worst.   This case was linked to MOD-2021-405038, MOD-2021-405022 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: redness; swelling; Pain in left armpit; tenderness in left armpit; swelling of the lymph nodes in the left armpit; Fatigue; headache; muscle pain; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit) and LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Migraine and Asthma (on asthma inhaler - not used in over a year). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, RIZATRIPTAN for Migraine.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient takes migraine medication more often than inhaler due to using the computer for work.  Patient reported that the second dose was the worst.   This case was linked to MOD-2021-405038, MOD-2021-405022 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: blisters on my arm; itching all over; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters on my arm) and PRURITUS (itching all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (blisters on my arm) and PRURITUS (itching all over). At the time of the report, BLISTER (blisters on my arm) and PRURITUS (itching all over) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. On December 2021, after the booster dose patient experienced itching all over and blisters on arm.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feel very sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel very sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel very sick). At the time of the report, MALAISE (Feel very sick) outcome was unknown.            Concomitant information was not provided.Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain lymph node after first shot; Swelling lymph node after first shot; Loss of appetite after first shot; Fatigue after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite after first shot), LYMPH NODE PAIN (Pain lymph node after first shot), FATIGUE (Fatigue after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced DECREASED APPETITE (Loss of appetite after first shot) and FATIGUE (Fatigue after first shot). On 02-Nov-2021, the patient experienced LYMPH NODE PAIN (Pain lymph node after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot). On 01-Nov-2021, DECREASED APPETITE (Loss of appetite after first shot) and FATIGUE (Fatigue after first shot) had resolved. On 04-Nov-2021, LYMPH NODE PAIN (Pain lymph node after first shot) and LYMPHADENOPATHY (Swelling lymph node after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-405144 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: The caller reports that her husband felt very tired after receiving each dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (The caller reports that her husband felt very tired after receiving each dose of the Moderna Covid-19 vaccine.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (The caller reports that her husband felt very tired after receiving each dose of the Moderna Covid-19 vaccine.). At the time of the report, FATIGUE (The caller reports that her husband felt very tired after receiving each dose of the Moderna Covid-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: is not sure if this because of nerve pain or shingles; last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (is not sure if this because of nerve pain or shingles), PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PYREXIA (fever). On 05-Dec-2021, the patient experienced PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain). On an unknown date, the patient experienced NEURALGIA (is not sure if this because of nerve pain or shingles). In November 2021, PYREXIA (fever) had resolved. On 06-Dec-2021, PAIN IN EXTREMITY (last 48 hours and 4 weeks after booster she is suddenly experiencing leg pain on left side interior leg pain every 2 hours intermittently/whole night she had pain but now she has no pain) had resolved. At the time of the report, NEURALGIA (is not sure if this because of nerve pain or shingles) outcome was unknown.            Concomitant medications details were not reported by the reporter. It was reported that patient was not sure if the pain because of nerve pain or shingles. As she had shingles after second dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-405235 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: ache all over; Chills; Head ache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache). At the time of the report, PAIN (ache all over), CHILLS (Chills) and HEADACHE (Head ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash that extended from the site of the vaccination to the back, chest and legs. Rash that extended from the site of the vaccination to the back, chest and legs. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.). At the time of the report, RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) and VACCINATION SITE RASH (Rash that extended from the site of the vaccination to the back, chest and legs.) outcome was unknown.            No medical history was provided by the reporter. Treatment information topic and oral antihistamines was provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:01 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 04-Nov-2021 at 11:01 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021 at 11:01 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, upon delivery of each vaccine order (021B21A: 02/2021 and 021B21A: 03/2021). The vaccines was placed into the freezer the same day they were delivered. The vial was removed from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patient did not appear for their vaccine. The vial was not kept in the refrigerator for more than a week, since all unused vials were utilized for the following patient.   On 04-NOV-2021 at 11:01 am, the patient received the expired additional dose of vaccine. The patient previously received the 2 doses of vaccine (name unspecified).  No concomitant medications were reported.   No treatment information was reported.   This case was linked to MOD-2021-399960 (Patient Link).