chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breast tenderness; Itching; Hives; Numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Trauma and Hives. Concurrent medical conditions included Bipolar disorder, Depression, Polycystic ovarian syndrome and Drug allergy (Cefidinir) since 02-Aug-2012. Concomitant products included ARIPIPRAZOLE (ABILIFY) from 18-Jun-2020 to an unknown date for Bipolar affective disorder, unspecified.    On 20-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 12:05 PM, the patient experienced BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 50 mg once; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 10 mg once and ACETAMINOPHEN (oral) 20-Jan-2021 for Adverse event following immunisation, at a dose of 650 mg once. At the time of the report, BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood pressure measurement (120-80 mmHg): 146/89 mmHg (High) Abnormal. On 20-Jan-2021, Body temperature (36.5-37.5): 36.6 (normal) degree Celsius. On 20-Jan-2021, Heart rate (70-99): 89 (normal) beats per minute. On 20-Jan-2021, Respiratory rate: 18 (normal) other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non Significant Follow-up Append On 21-Jun-2021: Major narrative update, corrections for suspect product, con.meds, treatment, med.history. Added lab data, updated Events and  Causality Assessment
Rash; redness on left chest and under his left breast.; Breast discharge; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of erythema in a 84-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30-MAY-2023, the patient received Shingles vaccine. In JUN-2023, 2 weeks after receiving Shingles vaccine, the patient experienced erythema (Verbatim: redness on left chest and under his left breast.). On an unknown date, the patient experienced breast discharge (Verbatim: Breast discharge) and rash (Verbatim: Rash).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the erythema and rash were not reported and the outcome of the breast discharge was resolved (duration 2 months).   It was unknown if the reporter considered the erythema, breast discharge and rash to be related to Shingles vaccine.     It was unknown if the company considered the erythema, breast discharge and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-OCT-2023 Patient advised he received the shingles vaccine and developed 2 weeks post vaccination some redness on left chest and under his left breast. When asked exact start date was unknown. Patient advised that he got an antiviral to counteract the symptoms of shingles 2 days after the rash appeared but no pain, when asked exact start date was unknown. Patient advised he has redness with slight discharge for 2 months, when asked exact start date was unknown and no further details were available.
Cellulitis at injection site in left deltoid 4" x 4" red swollen area.
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE, APPROXIMATELY AROUND 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 96 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5ml of the Janssen covid-19 vaccine as the initial dose, approximately around 0.3ml and off label use(dose series 2). As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5ml of the Janssen covid-19 vaccine as the initial dose, approximately around 0.3m and off label use was unknown.  This report was non-serious.  This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211209551, 20211210160, 20211210058, 20211209843, 20211210588, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209679, 20211209706, 20211209740, 20211209775, 20211209798, 20211209874, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Later during the night after the vaccine I developed a high fever, body aches for about 24hrs which caused me to sleep the next day.  2 weeks later I developed a bacteria infection in my right eye and possibly bronchitis so I went to the Urgent Care  and was treated with Z-Pack and steroids.  I feel alot better but I still have a little lingering cough.  This past Friday I woke up with a pain in the right side of my neck which got worse so I went to my PCP on Sat who diagnosed me with Carotidynia where he states my corotid artrery is inflammed and was prescribed an antiinflammitant Diclosenac with the intents of decreasing the inflammation.
sore arm; headache could not shake; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 10:00 (Lot number: EN6199) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time(24hr): 04:30 PM, Anatomical site of Location: Left upper arm, Batch/Lot number: E19267, Route Of administration: Intramuscular), administration date: 10Feb2021, when the patient was 58 years old, for Covid-19 immunisation, reaction(s): "had temp. of 103", "Sore arm", "very light headed likewise going to pass out". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache could not shake"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Vaccine Facility Type was Doctor's office/Urgent care for (1st shot) and Community facility for (2nd shot). Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Concomitant drugs were reported as none.   No follow-up attempts are possible. No further information is expected.
3/27 Awoke at 1 am with muscle ache & cramps in legs.  Shoulder was stiff., could not sleep due to pain.  Around 5 am 101 fever, body aches,  sick to stomach, migraine headache.    3/28 fever is gone , muscle pain gone, migraine more like a bad headache now..
Severe burning, searing pain in stomach, stabbing chest pains intermittently, 8/10 pain in major joints
Left arm at injection site became very sore, swollen, hot, red, hard, and spread as far as the elbow.  Started 8 days after the shot and lasted 4 days.
Tingling in index and second finger in left hand. Fells like fingers are asleep.
hives (diffuse) occurred 2hr post vax-no other clinical signs or sx devel hives easily controlled by DPH;
Narrative:  71yo male pt with PAST MEDICAL HISTORY: 1 dm has seen endocrine 2 h/o etoh abuse 3 h/o cocaine abuse 4 hypogonadism/ed 5 hyperlipidemia 6 tobacco abuse 7 cad s/p des placement to mid dx in 2012 8 increased psa/patient cancelled biopsy. Pt resided at rehab housing, previously homeless. Per agency records pt had received a J&J covid vaccine on 3/10/2021 but not from agency. No other info regarding source of vaccine given. Pt died on 10/8/2021. No information given regarding circumstances of pt's death. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
complaining of pleuritic shortness of breath found to have large pericardial effusion requiring pericardiocentesis and chest tube. Patient with no prior past medical history.
At 18:30, felt warm and was given Tylenol. At 19:00 was being put to bed by grandma as she was holding her, she stiffened up and eyes rolled back. Grandma called 911 and she started convulsing. Had 8-10 convulsions. Unconscious 10 minutes in ambulance.
Heart plantations started occurring, often keeping me awake until 2am. The palpitations also irregularly occurred during the day until mid-june (1 month).
pt recvd vax & w/in 1.5 hrs of vax devel about 25 vesicles;about 24 hrs later pt devel 15 vesicles;nurse stated that a MD felt pt's vesicles were not d/t vax;MD felt vesicles d/t flea bites
After vaccination, Patient reported dizziness. Quickly patient became unconscious and breathing stopped. Epipen was administered due to suspected allergic reaction. Soon after that patient came back to consciousness. Paramedics came and took patient to hospital for further evaluation. Patient was reported doing well later in the day.
I had the shingles vaccine on April 13, 2009. On Thursday I had a rash which got worse every day.  I went to see Dr. today.  He diagnosed shingles. I am now on acyclovir.
RETURNED TO MEDICAL OFFICE, SAID SAME DOCTOR TOLD TO GIVE IT TIME AND SEE PRIMARY. SITE WAS SWOLLEN, RED AND HOT. COULDN'T MOVE OR LIFT ARM- GREW WORSE DAILY. WAS INFECTED- GIVEN DOXYCYCLINE HYCLATE 100 MG. ON 7-10-20 BY MEDICAL OFFICE DOCTOR
I only had a sore arm with the first vaccination in March 2019. With this second shot in June (about 11 weeks later), I began experiencing fever, body ache, fatigue and intense headache beginning about 24 hours following the vaccination and continuing for 36 hours. Nausea lasted from hour 30-36. These symptoms subsided. On day three, I began noticing an intermittent stabbing pain deep in my left eyeball. Coincidentally, in June 2018 I had an outbreak of shingles (my second) beginning in my left ear and running down my face into my chin area. If the eye pain continues today and does not lessen, I will see my eye doctor.
Injection was given on the left arm. Patient noticed red raised rash on right arm forearm at 8:00 PM. It  appeared on stomach area near belly button, left upper thigh front and back in the shower he noticed the rest. And is now on the right leg.
Ear infection within a few days; amoxicillin did not clear up, needed a second antibiotic, 2 week dose of cefprozil
5 1/4in x 4 3/4in, red, warm, local reaction
Approximately 2 hours post vax the patient returned to the office with large hives and welts on her extremities and trunk and pruritus.
Information has been received from a medical assistant concerning a 35 year old white female, who abuses tobacco, who on 02-JAN-2007 was inadvertently vaccinated intramuscularly in the left deltoid with a pediatric 0.5 ml first dose of RECOMBIVAX HB (Lot# 652881/0105F). On 02-JAN-2007 the patient received a second pediatric 0.5 ml dose of RECOMBIVAX HB (Lot# 652881/0105F) There was no illness at the time of vaccination and no adverse events following prior vaccination. On 03-JAN-2007, at 8:30 p.m., the patient stated she went to the emergency room with dizziness, nausea, confusion and pruritus. The emergency department chart indicated that the patient had muscle soreness in both legs and felt shakey. It was reported that the history and presentation was consistent with an acute allergic dermatitis. The reporter noted that the reaction was due to a side affect of RECOMBIVAX HB. There was no evidence of upper airway stridor, loss of voice, or trouble swallowing prior to the exam. The symptoms were rated at the emergency department as merely annoying. No nasal congestion and no symptoms of conjunctivitis. The patient denied rash. There was no fever, chills, sweats, or chest pain. The primary diagnosis was an allergic reaction. Upon discharge the patient was instructed to arrange for a follow-up appointment in one day or immediately if the symptoms got worse. Subsequently the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Severe lower back pain radiating to lower extremities, weakness of lower extremities.  Symptoms gradually progressing since the day after receiving the above vaccination.
3RD DOSE MODERNA COVID VACCINE GIVEN 8/18/22, LOT # NOT AVAILABLE; pt in Regional Health System in from 7/21-8/29/22; positive COVID test 7/21/22; admitted with worsening SOB and anemia; developed bilateral pneumonia with pleural effusion; family opted for surgical evaluation for left lower lobe parapneumonic effusion vs empyema; 8/29/22 transferred to Medical Center on full BiPAP, hypotensive, with no response to external stimulus; respiratory acidosis and hyperkalemia; pt's  condition worsened; family opted to withdraw aggressive treatment; transitioned to DNR, comfort measures, and pt expired in the hospital
Spleen is quite enlarged, I was informed this is not normal reaction from the Pharmacist I talked to today, two days after vaccination day.  ALL my lymph glands/nodes are quite swollen throughout my body!! Temp of 100.4 at its highest yesterday (Sunday, April 11th)! I have not had my spleen enlarge since the 1990's!
I began experiencing symptoms of shingles within 48 hours of receiving my second dose of the Covid vaccine. I am 28 years old with no chronic health conditions and no prior history of shingles. As of 5/26/21 I was officially diagnosed with shingles by a medical doctor and was prescribed and have been taking Valtrex 1 gram oral tablets every 8 hours and have 20 tablets in total along with using Lidoderm 5% topical films 12 hours on 12 hours off. I am still experiencing symptoms and outbreaks of shingles and today is 5/28/21.
patient was given pfizer 1st dose vaccine at 3:35pm and at 4:40pm reported feeling hot/nausea/neck pain (stiffness).  BP 102/76 HR 81. Re took at 5:04 BP 96/62 HR 86. patient did report occasional anxiety but not with vaccines.  called EMT at her request.
Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA751A, expiry date 31st October 2024) for prophylaxis.   On 15th December 2022, the patient received Menveo. On 15th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The address of vaccination facility was not known by the healthcare professional. The reporter consented to follow-up. Additional supportive information: The patient only received the diluent of Menveo on the day of reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Reported Symptoms: FATIGUE; FEVER; HEADACHE; INJECTION SITE ERYTHEM; INJECTION SITE PAIN
Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-455416, MOD-2022-455428 (Patient Link).
COLD, TINGLY INDEX FINGER ON HAND OF OPPOSITE HAND (VACCINE GIVEN IN LEFT ARM, SYMPTOMS OCCURING IN RIGHT INDEX FINGER)
14 hours after the shot I started running a slight fever. 20 hours after the shot my fever was over 100 and I had bad chills. My fever topped out at 102.7 and it came with severe chills and body aches. My fever keeps fluctuating and the chills come and go.
Initial information received from a healthcare professional on 06 AUGUST 2013. This is a invalid case as individual patient identifiers were missing. Cluster of  several patients whose age, gender, medical history and concomitant medications were not reported,  had received a dose of ADACEL (lot number, dose number, route and site of vaccination were not reported) on unspecified date. On an unspecified date, several patients developed swollen painful days after receiving ADACEL. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: none
On 10/11/2021 I was diagnosed with a huge blood clot in my right leg.  The doctor prescribed blood thinners and referred me to my Oncologist who confirmed no cancer.  Although both doctors indicated that the blood clot was unrelated to the vaccine, I feel like it's important to report the information.
booster; having minor body aches and pains; minor injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, dose 1, single), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "having minor body aches and pains"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor injection site pain".  Additional information: It was reported that, the patient having minor body aches and pains along with minor injection site pain after administration of Pfizer Covid 19 booster. Stated that, the events took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
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. 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
On 01/12/2023 My daughter woke up at 06:30AM. By 07:00AM she was explaining that every time she would lift her leg to walk, the lower part of her stomach hurt. She seemed to be in a lot of pain. I had her lay down. I got in touch with her pediatrician who was concerned it may be appendicitis and advised we go to the emergency room. They did an ultrasound that was inconclusive. They tested her urine. They did an additional ultrasound where they located a cyst on her ovary. They also did blood tests. They performed a CT scan and put her on a saline solution IV. They did a third ultrasound after her bladder was full. They could not see the cyst on her ovary that time. They were also having trouble finding her appendix. They didn't allow her to eat until 06:00PM. They suggested we stay overnight. They mentioned giving her an MRI the next day. On the morning of 01/13/2023, they redrew blood and everything seemed normal. They sent her home advising that we follow up with her pediatrician. By 01/16/2023, the pain had subsided. They advised that she may experience this again.
two inch diameter red rash with itching, swelling, soreness, and pain at injection site
Arm still sore - approx one month. Tingling - scalp & extremities.
Developed asthmatic like symptoms about two weeks after the 2nd shot. This manifested itself by coughing, shortness of breath, wheezing and fatigue. These symptoms waxed and waned until on the day of her death, she passed out and fell. Shortly after getting to the ER (within 20 minutes), she went into cardiac arrest, was resuscitated but never regained consciousness.
9/10  pain in left wrist (opposite side of vaccination) for 10 hours. Ibuprophen minimally helpful. Resolved completely after 24 hours.  Fevers/chills/shakes for 12 hours.