chrisvoncsefalvay/vaers-outcomes huggingface dataset:
continious deltoid muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comments: The case was self reported by the patient. Several months after getting Shingrix vaccine, the patient had continuous deltoid muscle pain. The patient asked was this common. The patient stated there were no record of 1st dose where he/she get it and asked was there any way he/she could get them. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Flu-like like symptoms. Headache, chills, low grade fever, extreme fatigue, some queasiness. Symptoms have persisted for 10 days at this point and are no better.  Chills seem to be getting worse. Advil helps Headache and chills, but I can't take it every day without upsetting my stomach.
It was a flu shot. Left arm was sore the next day, pain traveled up the arm into the shoulder and neck.  Pain worsened, and now I have shooting pain when raising the arm and have difficulting sleeping or turning over in bed due to the pain.
Itching; Hives; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th July 2019, 2 days after receiving Shingrix, the patient experienced pruritus and hives. On 18th July 2019, the outcome of the pruritus and hives were recovered/resolved.   It was unknown if the reporter considered the pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The consumer on the line reported her husband woke up with hives on the underarm where he received the shot, a few hives on his body, and a whole bunch on his inner thighs and scrotum. The patient had itching on his palms, which woke him. The patient was travelling and initially thought maybe there were insects or bed bugs on the bed causing the itching. The patient went back to bed, the arm started clearing up and the itching on his palms as well, and when he got up there was no trace of anything. The reporter had no further information to provide for vaccine, lot number or expiry date was unknown. The responsible provider was unknown, it was the pharmacist on staff. The patient had no spleen. Consent provided to follow up with the physician.
Day after vaccine on 1/13 soreness of LA, dizzy, fatigue, by Saturday felt much better. On January 21 day 8 Left arm became swollen, hard and had a  burning sensation.  No treatment.
Diarrhea/stool incontinence (single sudden episode of watery stool)
pt recv vax 23MAY97 & mom called 28MAY97 states has red raised rash on lat side of lt side outer side;
Swelling; Redness; A spontaneous report was received from a healthcare professional concerning a 61-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling and redness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reported having a slight reaction from the vaccine she was administered a week ago. On 23 Dec 2020, she experienced swelling and redness. It was stated that "the median length for the site reaction for 2-3 days". Treatment was not provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events swelling and redness was unknown.; Reporter's Comments: This case concerns a 61 year-old, female patient, who experienced events of swelling and redness. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Right hand swelling with some right hand numbness that seemed to travel up the right arm, denied any respiratory complaints
Red bumpy rash at site of injection on R arm; More tired than usual; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm) and FATIGUE (More tired than usual) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included GABAPENTIN for Neuropathy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch) and FATIGUE (More tired than usual). On an unknown date, the patient experienced VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm) and FATIGUE (More tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient reported painful throbbing radiating down her right arm starting a couple hours after the shot on 10/4 and said it is still continuing on 10/8.   Suggested she go to the MD on Monday to get checked out.
numbness left face-immediate Numbness left arm- 1-2 days later No weakness/ No Bell's palsy identified Seen by Neurology (04/23/2021)-agrees vaccine reaction-gave her Decadron for a few days
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose, lot and expiry date unknown). On an unknown date the patient developed rash, redness and swelling after receiving ZOSTAVAX. The outcome of events was reported as not resolved. Follow-up information was received from the physician concerning the 53 year old female patient with no allergies and a history of chicken pox, who on 16-NOV-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# reported as 5006832) in her left arm. There was no concomitant medication. On an unknown date in November 2013 the patient experienced redness and swelling after receiving ZOSTAVAX (as previously reported). On 16-NOV-2013, 2 days after vaccination, the patient experienced red, hot and blistery rash only at injection site (multiple lesions) and painful arm. The maximum temperature was 99.6. The patient did not recent exposure to chicken pox or shingles. On an unknown date in November 2013, the patient recovered from the events. This is one of the several reports from the same source. Additional information is not expected.
Tenant received a booster dose of the Pfzer vaccine at current Assisted Living on 10/20/21 but had already received a booster dose by PCP Office on 09/27/21. No symptoms or adverse outcomes noted to receiving additional dose.
fainted; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient fainted when she got up to go the bathroom during the night after receiving the vaccine that day.  The reporter did not consent to follow-up. The reporter declined to provide any additional details. This case has been linked with case US2020009790, reported by same reporter.
When I woke up the next morning after receiving the vaccine, my entire body hurt. -Achy muscles  -Skin sensitivity -Excessive tiredness
Pt devel cystic areas @ the inject site of 1st & 2nd DTP; both injects were given in the quadriceps area; Had cyst like lesion p/3rd DTP MAY86; p/4th DTP in the gluteal area, devel sterile abscess that required surgical debridement;
Information has been received from a medical technologist concerning a 5 year old male with no allergies and no history of chickenpox or recent exposure to chickenpox or herpes zoster who on 12/10/98 was vaccinated in the right lateral thigh with a 0.5ml first dose of varicella virus vaccine (627870/1260H). It was noted that no rash occurred at the injection site or elsewhere within 42 days of the vaccination. In May, 2003, the pt was diagnosed with thoracic Ewing's Sarcoma. Therapies included Septra, nystatin and granulocyte colony stimulating factor. On 12/22/03 the pt completed chemotherapy for Ewing's sarcoma. Three days later, on the morning of 12/25/03, the pt developed a temp of 38.2 C, an itching rash, and multiple vesicles that were widespread over most of his body. It was reported that the pt was also lymphopenic with a WBC of 0.7 and a lymphocyte coutn of 8%. There were no other systemic reactions and the pt experienced no pain. On the same day the pt was seen and admitted to the hospital. Specimens from an abdominal and an arm vesicle were sent for Direct flurorescent antibody and a culture. The results were positive for VZV. No specimen was collected for PCR analysis and it was requested that a specimen for typing be obtained. No photos were taken. On 12/30/03 the pt was discharged from the hospital and was reported to be recovering. Subsequently, the pt recovered. No product quality complaint was involved. Info received on 1/6/04 contained the following adverse experience: Ewing's Sarcoma (May 2003). Additional info has been requested. On 1/29/04 it ws reported that the results of the VZV PCR noted that the patient had the wild type strain of the virus. No further information is available.
12 hours after injection I had severe chills and shaking. This lasted about 4 hours. Hot and cold chills.  My balance was also affected.  No fever, no vomiting.
No adverse event; BUD was reported as 12May2022 and vaccine was administered on 16-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12May2022 and vaccine was administered on 16-May-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12May2022 and vaccine was administered on 16-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12May2022 and vaccine was administered on 16-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12May2022 and vaccine was administered on 16-May-2022).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains additional no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
As with shots 1 and 2, I had a fever, chills, sore arm and body ache. Then the outer part of my upper arm swelled to twice its size and was red and painful on the upper arm for a week. The pain transferred to the left scapula, left part of the neck and left upper arm to the elbow. The arthritic-type pain has now lasted more than two weeks. Advil, Tylenol and a prescribed muscle relaxant do not cure the pain.
Progressive tingling in extremities and lower face/ mouth, random muscle contractions, progressive loss of motor skills over the course of a week, at the end of which patient could not fasten a button. Upon arrival to the ER, patient's extremities were cold, clammy, and colorless. Admitted to Medical Center as an inpatient (Dec. 3, 2006). Diagnosed with Guillain Barre Syndrome, and treated with three courses of plasmapheresis. While hospitalized, patient experienced mild tachycardia and hypotension. 90% recovery as of release from the hospital. One month later (approx. early Jan. 2007) mild relapse with tingling in extremities and moderate loss of motor skills, which subsided within a few days. 2 months after hospitalization (approx. mid-Feb. 2007) another mild relapse, mild tingling in extremities and moderate motor skill loss, again subsided within a few days time. About 3 months after hospitalization (approx. mid-March 2007) more severe relapse (currently unsubsided) with tingling in extremities, loss of motor skills, dizziness, collapsing spells, orthostatic hypotension, shaking/ quakes, clammy hands and feet. Diagnosed by a private neurologist as having vestibular nerve difficulties. Although improved, patient still experiences dizziness, quakes, occasional, uncontrolled single muscle twitches randomly throughout her body. Extremities, including random digits of the hand, occasionally become cold and clammy, which cannot be remedied with heat, but subside by themselves.  09/04/2007 Records received from CDC for DOS 12/3-8/2006.  Patient presented with 1 week hx of paresthesias in her arms and legs.  Symptoms began with runny nose and sore throat, then pt woke the next day with tingling in arms and fingertips.  The following day pt began having difficulty walking, motor weakness and gait imbalance.  Seen by PCP who was unable to elicit any reflexes. Pt presented to the ER with worsening sx, especially with fine motor control in the hands. Asymptomatic tachycardia noted throughout hospital stay likely due to autonomic instability.  Responded well to plasmapharesis. Discharge DX: Preventative (presumptive?) Guillain-Barre syndrome.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients with unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot number and expiration date unknown), (dose number, route, dose and anatomical location unspecified) for prophylaxis and VAQTA (lot number and expiration date unknown), (dose number, route, dose and anatomical location unspecified). Concomitant medications were not reported. It was reported that on an unknown date unspecified patients may have received improperly stored and VAQTA and GARDASIL, which were exposed to 31F for 15 hours. No adverse events were reported. Additional information has been requested.
Lose sense of smell after booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (Lose sense of smell after booster) 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 ANOSMIA (Lose sense of smell after booster). At the time of the report, ANOSMIA (Lose sense of smell after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest - Anosmia (reported as lose sense of smell). The event occurred after the patient had received the booster dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown and no additional details regarding the clinical course of the events was provided. The rechallenge is not applicable as the event occurred following booster dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest - Anosmia (reported as lose sense of smell). The event occurred after the patient had received the booster dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown and no additional details regarding the clinical course of the events was provided. The rechallenge is not applicable as the event occurred following booster dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Mom reports that approximately one and a half hours after receiving vaccines patient began to cry and cried for 7 hours inconsolably.
Both groins had sharp pain on 11/12/01, mostly gone in 3 hours. Visited doctor on 11/13/01. No other problems. Suspected shot reaction. On 11/13/01 at 17:30, both shoulders very sore; left arm at injection site, was stiff and couldn't move. It was gone in about 5 hours.
have gotten both of the vaccinations, I still get the shingles/suspected vaccination failure; still get the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles before vaccination).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 5-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had both of the shingle vaccinations and  still get the shingles and they were worse now than they were before the shots. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
On 10/23 patient developed difficulty breathing, cough, and fever. Patient's wife has had COVID for the past 5 days. He was seen in urgent care on 10/24 and tested positive for COVID. He was prescribed Lagevrio at his visit and took his first dose that today. Following the urgent care visit, patient developed weakness, confusion, and inability to stand which prompted his visit to the ED on 10/24. He was admitted 10/24 - 10/27 for COVID-19 infection, acute kidney injury, and hypokalemia. Patient did not require supplemental O2. Patient has received primary COVID vaccine series and one booster.
15 yo patient was seen for vaccine catch up schedule and due for 2nd dose of MMR and varicella.  The provider, recommended proquad which was given.  It was shortly after administration of the proquad that the clinic staff realized the patient was outside of the age range for proquad administration.   Mother of patient was notified of this error X3 days later, mother of patient reports that there were no adverse reactions to the Proquad administration
Beginning around 3 am, I began feeling chills and aches throughout my body.  In getting up around 7:30 am, I felt more intense aches, fever, and some dizziness.  Nausea set in around 12 pm.  After resting until about 5 pm, the symptoms began to subside though aches continued.
Initial unsolicited report received from a nurse on 09-Aug-2018. This case involves a six month old patient (gender not reported) who was vaccinated with a dose of PENTACEL (Batch number: C5545AA, expiration date: 06-Oct-2019, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that, the ACTHIB was reconstituted with sterile water and administered to a six month old child and the DTap-IPV portion was not administered. It was not known whether the patient had any 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 Directive 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. List of documents held by sender: none.
arms broke out in hives initially on the right where the injection was done then spread to the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. On 31-Jul-2021, VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given by the reporter.
Redness, swelling, pain, hardness at site, raised swollen painful to touch. Have tried ice pack, Motrin 800mg tid.