chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: Continual strain and pain in my left fore arm. between my elbow and wrist; Continual strain and pain in my left fore arm. between my elbow and wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0169) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: handled with medication; "Sulfa Drug Allergy" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; TOPIRAMATE; DULOXETINE; PRIMIDONE. Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6205, vaccine location: left arm), administration date: 23Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: MUSCLE STRAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Apr2021, outcome "not recovered" and all described as "Continual strain and pain in my left fore arm. between my elbow and wrist". Therapeutic measures were not taken as a result of muscle strain, pain in extremity.  Additional Information: Facility type vaccine was reported as other. The patient reported that, "continual strain and pain in my left fore arm. between my elbow and wrist. I sometimes can not even pick up a soda can or shuffle a deck of cards." No pain at the injection site. Started immediately after receiving the second vaccine and had not lessened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arachnoiditis, Balance disorder, Blood test, Clonus, Computerised tomogram
Clinical narrative: arachnoiditis; unable to walk; unable to urinate; This case was reported by a consumer via call center representative and described the occurrence of arachnoiditis in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced arachnoiditis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and unable to urinate (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the arachnoiditis, unable to walk and unable to urinate were recovered/resolved.   It was unknown if the reporter considered the arachnoiditis, unable to walk and unable to urinate to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. Within a week after receiving vaccine, the patient was hospitalized for 6 days.  The patient was unable to walk or urinate that's what sent him to the hospital.  He was diagnosed with arachnoiditis and given IV medications.  The healthcare processional recommended for him to not receive dose 2 of Shingrix. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Magnetic resonance imaging, Mobility decreased, Muscle twitching, Nerve injury
Clinical narrative: arachnoiditis; unable to walk; unable to urinate; This case was reported by a consumer via call center representative and described the occurrence of arachnoiditis in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced arachnoiditis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and unable to urinate (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the arachnoiditis, unable to walk and unable to urinate were recovered/resolved.   It was unknown if the reporter considered the arachnoiditis, unable to walk and unable to urinate to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. Within a week after receiving vaccine, the patient was hospitalized for 6 days.  The patient was unable to walk or urinate that's what sent him to the hospital.  He was diagnosed with arachnoiditis and given IV medications.  The healthcare processional recommended for him to not receive dose 2 of Shingrix. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urinary retention
Clinical narrative: arachnoiditis; unable to walk; unable to urinate; This case was reported by a consumer via call center representative and described the occurrence of arachnoiditis in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced arachnoiditis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and unable to urinate (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the arachnoiditis, unable to walk and unable to urinate were recovered/resolved.   It was unknown if the reporter considered the arachnoiditis, unable to walk and unable to urinate to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. Within a week after receiving vaccine, the patient was hospitalized for 6 days.  The patient was unable to walk or urinate that's what sent him to the hospital.  He was diagnosed with arachnoiditis and given IV medications.  The healthcare processional recommended for him to not receive dose 2 of Shingrix. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arachnoiditis, Gait inability, Urinary retention
Clinical narrative: arachnoiditis; unable to walk; unable to urinate; This case was reported by a consumer via call center representative and described the occurrence of arachnoiditis in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced arachnoiditis (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization) and unable to urinate (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the arachnoiditis, unable to walk and unable to urinate were recovered/resolved.   It was unknown if the reporter considered the arachnoiditis, unable to walk and unable to urinate to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. Within a week after receiving vaccine, the patient was hospitalized for 6 days.  The patient was unable to walk or urinate that's what sent him to the hospital.  He was diagnosed with arachnoiditis and given IV medications.  The healthcare processional recommended for him to not receive dose 2 of Shingrix. The reporter did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: was given a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number PM35L, expiry date 6th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019) and Shingrix (received 2nd dose in 2019).   On 15th December 2021, the patient received the 3rd dose of Shingrix (intramuscular) 50 µg. On 15th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient was given a 3rd dose of Shingrix in left deltoid, which led to extra dose administered. The previous doses received by the patient were undocumented in the patient records. The reporter did not consent to follow up.
Sex: F
Vaccine: MMR, MMR
Symptoms: Adverse reaction
Clinical narrative: No additional AE reported.; administered MMR II via the intramuscular route, not subcutaneously; This spontaneous report has received from a pharmacist refers to herself of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (0.5 milliliter, batch/lot # and expiration date were not reported) intramuscularly for prophylaxis (Incorrect route of product administration). No additional information was provided. No additional adverse event (AE) was reported. No product quality complaint (PQC) was reported.
Sex: F
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; administered MMR II via the intramuscular route, not subcutaneously; This spontaneous report has received from a pharmacist refers to herself of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (0.5 milliliter, batch/lot # and expiration date were not reported) intramuscularly for prophylaxis (Incorrect route of product administration). No additional information was provided. No additional adverse event (AE) was reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Insomnia, Pruritus, Rash
Clinical narrative: allergic reaction; itching at night, soles, hands, scalp to toes; This case was reported by a nurse and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022, the patient received the 1st dose of Shingrix. In January 2022, 2 days after receiving Shingrix, the patient experienced allergic reaction and pruritus. The patient was treated with STEROIDS NOS (STEROID (NOT SPECIFIED)), cetirizine hydrochloride (Zyrtec), famotidine (Pepcid) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and pruritus were not recovered/not resolved.   The reporter considered the allergic reaction and pruritus to be probably related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. About 2 days later, the patient noticed the soles of his/her feet and hands itching at night.  Over the next couple weeks, this was spread to different parts of his/her body. The patient literally itched from his/her scalp to toes, though not all at the same time and almost exclusively at night.  The patient saw his/her internist who said it was probably an allergic reaction to Shingrix and gave his/her a steroid shot and recommended Zyrtec, Pepcid, and Benadryl at night.  This had provided relief but the itching still flared up. The patient asked that, heard of this in other Shingrix recipient, If so, had any recommendations and asked if they recommended for the second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: allergic reaction; itching at night, soles, hands, scalp to toes; This case was reported by a nurse and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022, the patient received the 1st dose of Shingrix. In January 2022, 2 days after receiving Shingrix, the patient experienced allergic reaction and pruritus. The patient was treated with STEROIDS NOS (STEROID (NOT SPECIFIED)), cetirizine hydrochloride (Zyrtec), famotidine (Pepcid) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and pruritus were not recovered/not resolved.   The reporter considered the allergic reaction and pruritus to be probably related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. About 2 days later, the patient noticed the soles of his/her feet and hands itching at night.  Over the next couple weeks, this was spread to different parts of his/her body. The patient literally itched from his/her scalp to toes, though not all at the same time and almost exclusively at night.  The patient saw his/her internist who said it was probably an allergic reaction to Shingrix and gave his/her a steroid shot and recommended Zyrtec, Pepcid, and Benadryl at night.  This had provided relief but the itching still flared up. The patient asked that, heard of this in other Shingrix recipient, If so, had any recommendations and asked if they recommended for the second dose.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular autonomic function test, Electromyogram, Fall, Magnetic resonance imaging, Monoplegia
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Small fibre neuropathy, X-ray
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Electric shock sensation, Electromyogram, Feeling cold
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Magnetic resonance imaging head normal, Magnetic resonance imaging normal, Meralgia paraesthetica
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Neuropathy peripheral, Paraesthesia, Small fibre neuropathy, X-ray
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In November 2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in June or July 2021 with very minor burning in front of both thighs, symptoms seemed to peak in September (with all of symptoms listed above). In October symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, and burning on front of both thighs. Started Gabapentin in November, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: left foot pain; left foot pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: she's prediabetic; "hypertension" (unspecified if ongoing), notes: she has prehypertension; "headaches" (unspecified if ongoing), notes: since march, since last April of last year; "upper respiratory infection" (unspecified if ongoing); "depressed" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Past drug history included: Oxycodone for pain. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset Jan2021, outcome "not recovered" and all described as "left foot pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, muscle spasms.  Additional information: The patient stated she is a nursing assistant in a nursing home. Her first vaccine was in 17Jan2021. For the lot number the patient stated there was an E and that she can't make out the second letter. Stated E3247. She started having problems with left foot, first she was having pain in it, then she started getting frequent cramps in her foot. She stated it was the same time she received the vaccine, in Jan2021. The patient stated it goes away and comes back. On and off. At first, she ignored it since other people have side effects, but its temporary, and hers is not, its on and off. Not on a daily basis, maybe every two days. She was prediabetic, prehypertension, and taking care of Covid patients. Since Covid came in, diabetes and hypertension, headaches every day. She was on anti-depressants so depressed after what she's been through. The patient started taking Metformin. The patient stated, since covid, last year, March her blood pressure and diabetes elevated she had an upper respiratory infection since then and her blood pressure. During covid she has had terrible headaches since March, since last April of last year. She had an MRI. On different medications for pain, oxycodone and everything and it doesn't go away. The patient stated she stopped taking it. It's not helping. Don't go away. No additional vaccines administered. The event did not require a visit to emergency Room. No prior vaccinations (within 4 weeks). Family medical history relevant to AE(s) were none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Pain in extremity
Clinical narrative: left foot pain; left foot pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: she's prediabetic; "hypertension" (unspecified if ongoing), notes: she has prehypertension; "headaches" (unspecified if ongoing), notes: since march, since last April of last year; "upper respiratory infection" (unspecified if ongoing); "depressed" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Past drug history included: Oxycodone for pain. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset Jan2021, outcome "not recovered" and all described as "left foot pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, muscle spasms.  Additional information: The patient stated she is a nursing assistant in a nursing home. Her first vaccine was in 17Jan2021. For the lot number the patient stated there was an E and that she can't make out the second letter. Stated E3247. She started having problems with left foot, first she was having pain in it, then she started getting frequent cramps in her foot. She stated it was the same time she received the vaccine, in Jan2021. The patient stated it goes away and comes back. On and off. At first, she ignored it since other people have side effects, but its temporary, and hers is not, its on and off. Not on a daily basis, maybe every two days. She was prediabetic, prehypertension, and taking care of Covid patients. Since Covid came in, diabetes and hypertension, headaches every day. She was on anti-depressants so depressed after what she's been through. The patient started taking Metformin. The patient stated, since covid, last year, March her blood pressure and diabetes elevated she had an upper respiratory infection since then and her blood pressure. During covid she has had terrible headaches since March, since last April of last year. She had an MRI. On different medications for pain, oxycodone and everything and it doesn't go away. The patient stated she stopped taking it. It's not helping. Don't go away. No additional vaccines administered. The event did not require a visit to emergency Room. No prior vaccinations (within 4 weeks). Family medical history relevant to AE(s) were none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Dizziness, Headache
Clinical narrative: This spontaneous report received from a patient concerned a female patient, of unspecified age, received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch/lot# unknown), dose not reported, on Feb 18, 2022, at 10:30, for immunization. The patient's height, weight, medical history, concurrent conditions and concomitant medications not reported. On Feb 18, 2022, patient experienced chest pressure, pressure in left breast, pressure in left-side of clavicle, pressure in throat, dizziness, pressure in left armpit and chills. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from chest pressure, pressure in left breast, pressure in left armpit, pressure in left-side of clavicle, pressure in throat and dizziness. The outcome of chills: not reported. The batch/lot number requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Breast discomfort, Chest discomfort, Chills, Dizziness
Clinical narrative: This spontaneous report received from a patient concerned a female patient, of unspecified age, received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch/lot# unknown), dose not reported, on Feb 18, 2022, at 10:30, for immunization. The patient's height, weight, medical history, concurrent conditions and concomitant medications not reported. On Feb 18, 2022, patient experienced chest pressure, pressure in left breast, pressure in left-side of clavicle, pressure in throat, dizziness, pressure in left armpit and chills. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from chest pressure, pressure in left breast, pressure in left armpit, pressure in left-side of clavicle, pressure in throat and dizziness. The outcome of chills: not reported. The batch/lot number requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Oropharyngeal discomfort
Clinical narrative: This spontaneous report received from a patient concerned a female patient, of unspecified age, received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch/lot# unknown), dose not reported, on Feb 18, 2022, at 10:30, for immunization. The patient's height, weight, medical history, concurrent conditions and concomitant medications not reported. On Feb 18, 2022, patient experienced chest pressure, pressure in left breast, pressure in left-side of clavicle, pressure in throat, dizziness, pressure in left armpit and chills. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from chest pressure, pressure in left breast, pressure in left armpit, pressure in left-side of clavicle, pressure in throat and dizziness. The outcome of chills: not reported. The batch/lot number requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Pleurisy, Vaccination complication
Clinical narrative: Pain on the ribs area on the backside; Pain when coughing; Pain when sneezing; pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain; Sore arm; Even breathing hurt; Fatigue; Pleurisy; Patient was administered a double dose of the Moderna vaccine instead of a booster; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing) and PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Lot number - 1805018 and Expiry date - not written) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster). On 21-Feb-2022, the patient experienced PLEURISY (Pleurisy). On an unknown date, the patient experienced BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt) and FATIGUE (Fatigue). The patient was treated with PREDNISONE from February 2022 to February 2022 for Adverse event, at a dose of 40 milligram. At the time of the report, BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt), PLEURISY (Pleurisy) and FATIGUE (Fatigue) had not resolved and ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2022, Laboratory test: pleurisy pleurisy.         No concomitant medications were reported.  At the vaccination site the patient was told to receive a double dose of the Moderna COVID-19 vaccine before the booster so she did. At 3 am she had to go to the ER for the intense pain.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Back pain, Cough, Fatigue, Laboratory test
Clinical narrative: Pain on the ribs area on the backside; Pain when coughing; Pain when sneezing; pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain; Sore arm; Even breathing hurt; Fatigue; Pleurisy; Patient was administered a double dose of the Moderna vaccine instead of a booster; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing) and PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Lot number - 1805018 and Expiry date - not written) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster). On 21-Feb-2022, the patient experienced PLEURISY (Pleurisy). On an unknown date, the patient experienced BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt) and FATIGUE (Fatigue). The patient was treated with PREDNISONE from February 2022 to February 2022 for Adverse event, at a dose of 40 milligram. At the time of the report, BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt), PLEURISY (Pleurisy) and FATIGUE (Fatigue) had not resolved and ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2022, Laboratory test: pleurisy pleurisy.         No concomitant medications were reported.  At the vaccination site the patient was told to receive a double dose of the Moderna COVID-19 vaccine before the booster so she did. At 3 am she had to go to the ER for the intense pain.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pain, Pain in extremity, Painful respiration, Pleurisy
Clinical narrative: Pain on the ribs area on the backside; Pain when coughing; Pain when sneezing; pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain; Sore arm; Even breathing hurt; Fatigue; Pleurisy; Patient was administered a double dose of the Moderna vaccine instead of a booster; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing) and PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Lot number - 1805018 and Expiry date - not written) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster). On 21-Feb-2022, the patient experienced PLEURISY (Pleurisy). On an unknown date, the patient experienced BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt) and FATIGUE (Fatigue). The patient was treated with PREDNISONE from February 2022 to February 2022 for Adverse event, at a dose of 40 milligram. At the time of the report, BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt), PLEURISY (Pleurisy) and FATIGUE (Fatigue) had not resolved and ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2022, Laboratory test: pleurisy pleurisy.         No concomitant medications were reported.  At the vaccination site the patient was told to receive a double dose of the Moderna COVID-19 vaccine before the booster so she did. At 3 am she had to go to the ER for the intense pain.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: Pain on the ribs area on the backside; Pain when coughing; Pain when sneezing; pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain; Sore arm; Even breathing hurt; Fatigue; Pleurisy; Patient was administered a double dose of the Moderna vaccine instead of a booster; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing) and PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Lot number - 1805018 and Expiry date - not written) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 16-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster). On 21-Feb-2022, the patient experienced PLEURISY (Pleurisy). On an unknown date, the patient experienced BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt) and FATIGUE (Fatigue). The patient was treated with PREDNISONE from February 2022 to February 2022 for Adverse event, at a dose of 40 milligram. At the time of the report, BACK PAIN (Back pain), MUSCULOSKELETAL CHEST PAIN (Pain on the ribs area on the backside), COUGH (Pain when coughing), SNEEZING (Pain when sneezing), PAIN (pain when she coughed or sneezed, she would scream for the pain it was excruciating/intense pain), PAIN IN EXTREMITY (Sore arm), PAINFUL RESPIRATION (Even breathing hurt), PLEURISY (Pleurisy) and FATIGUE (Fatigue) had not resolved and ACCIDENTAL OVERDOSE (Patient was administered a double dose of the Moderna vaccine instead of a booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2022, Laboratory test: pleurisy pleurisy.         No concomitant medications were reported.  At the vaccination site the patient was told to receive a double dose of the Moderna COVID-19 vaccine before the booster so she did. At 3 am she had to go to the ER for the intense pain.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: diffuse urticaria 1 hour following vaccine administration
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Headache, Visual impairment
Clinical narrative: Vision changes and headaches began after vaccine. Diagnosed with temporal (giant cell) arteritis on 12/27/21.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Balance disorder, Dizziness, Headache
Clinical narrative: I received my booster shot on 1/20. I immediately started having an adverse reaction. Within hours I couldn't move my arm what so ever and I could feel debilitating pain radiating up the left side of my neck and down my finger tips. I couldn't move my neck to the left of my left wrist at all. I then began having nerve pain in my feet, severe headaches and dizziness, high fevers, excruciating joint pain, and vomiting.  For approximately one week after I felt off balance and dizzy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: I received my booster shot on 1/20. I immediately started having an adverse reaction. Within hours I couldn't move my arm what so ever and I could feel debilitating pain radiating up the left side of my neck and down my finger tips. I couldn't move my neck to the left of my left wrist at all. I then began having nerve pain in my feet, severe headaches and dizziness, high fevers, excruciating joint pain, and vomiting.  For approximately one week after I felt off balance and dizzy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Shivering and  fever of 96.0 degrees
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anion gap, Blood 25-hydroxycholecalciferol, Blood chloride increased, Blood creatine phosphokinase normal, Blood magnesium normal
Clinical narrative: Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Chest discomfort, Chest pain, Differential white blood cell count normal
Clinical narrative: Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Epstein-Barr virus antibody negative
Clinical narrative: Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count normal, Metabolic function test, Mononucleosis heterophile test negative, Palpitations
Clinical narrative: Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Shortness of breath, fatigue, pounding heart beat, chest pain, heaviness in chest - onset ~4 days after vaccine. Swelling in calves - onset ~10 days after vaccine. Given prednisone 20mg for 5 days, swelling in calves resolved and other symptoms improved, but still present as of 2/26/22.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Headache, Impaired work ability
Clinical narrative: Severe headache Severe fatigue Severe muscle pain Could barely get out of bed to use the toilet. No appetite. pushed fluids when awake. took Tramadol, which did not relieve any pain symptoms. Stomach pains on day 4 after eating food.   Returned to work on day 4, after I was forced to stay home an additional day to wait for a negative PCR COVID test, because my symptoms were "COVID".  Will need stronger pain meds for 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: Severe headache Severe fatigue Severe muscle pain Could barely get out of bed to use the toilet. No appetite. pushed fluids when awake. took Tramadol, which did not relieve any pain symptoms. Stomach pains on day 4 after eating food.   Returned to work on day 4, after I was forced to stay home an additional day to wait for a negative PCR COVID test, because my symptoms were "COVID".  Will need stronger pain meds for 2nd dose.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Menstrual disorder
Clinical narrative: menstrual disorder, serious allergic eczema
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram abdomen, Computerised tomogram thorax, Echocardiogram, Electrocardiogram
Clinical narrative: Pericarditis causing sinus tachycardia since onset of symptoms 12/24/21 and continuing.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Pericarditis, Sinus tachycardia
Clinical narrative: Pericarditis causing sinus tachycardia since onset of symptoms 12/24/21 and continuing.
Sex: M
Vaccine: UNK
Symptoms: Injection site induration, Pruritus, Rash
Clinical narrative: Rashes itching. Follow the same at home instructions for "food allergies" in September. Two doses of Benedryl in last 24 hours 5 ml. Slight harness at injection sight right hip. Not sure which one was on which side.  Does not seem bothered. No difficulty breathing. Will continue benedryl. Circled hard spot to see if larger or smaller by morning. Will return to Dr. If worsen. Last time was told it was his food Allergies sent home with benedryl. Will definitely follow up with the clinic over the weekend or on Monday if available. Or ER.  The paperwork says DTap - no details on specifics Hepatitis A - no details on specifics
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dyspepsia, Furuncle, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Severe continual heartburn for about a week IMMEDIATELY following the vaccine, tingling and numbness on the left side of my body (some in leg, lots in my arm, but largely in my face) that persisted on and off for several months. No weakness or pain or loss of mobility, just numbness and tingling. This was after my second dose, the first one did not seem to have side effects. I also had increased incidence of acne and boils for months afterward as well. None of these things (except a much milder version of the heartburn) were a problem for me before or since, and I have had no side effects aside from any vaccine before other than the usual soreness of injection site and tiredness. I have virtually no allergies that I know of, only an extremely mild rash from amoxicillin