chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cancelled second covid shot scheduled for 23feb2021; pain progressed to mid back; pain progressed to low back; Pain in her groin area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GROIN PAIN (Pain in her groin area), BACK PAIN (pain progressed to low back), BACK PAIN (pain progressed to mid back) and INTENTIONAL PRODUCT USE ISSUE (Cancelled second covid shot scheduled for 23feb2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042320A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Nov-2020 and Arrhythmia (NOS) (arrhythmias after having covid) from 15-Dec-2020 to 19-Feb-2021. Concurrent medical conditions included Drug allergy (blood pressure medications) and Drug allergy (aspirin). Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) and BIOTIN for Routine health maintenance.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced GROIN PAIN (Pain in her groin area). On 08-Feb-2021, the patient experienced BACK PAIN (pain progressed to low back). On 15-Feb-2021, the patient experienced BACK PAIN (pain progressed to mid back). On 19-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Cancelled second covid shot scheduled for 23feb2021). The patient was treated with METHYLPREDNISOLONE (METHYLPREDNISOLON [METHYLPREDNISOLONE]) at a dose of 1 dosage form and KETOROLAC TROMETHAMINE (TORADOL) at a dose of 1 dosage form. On 19-Feb-2021, INTENTIONAL PRODUCT USE ISSUE (Cancelled second covid shot scheduled for 23feb2021) had resolved. At the time of the report, GROIN PAIN (Pain in her groin area), BACK PAIN (pain progressed to low back) and BACK PAIN (pain progressed to mid back) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Other concomitant product included Mukta Vati for blood pressure.   On unknow date, Magnetic resonance imaging was performed and result was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: updated allergy, historical condition, concomitant medicationsadded one additional eventupdated events outcome from not recovered/resolved  to recovered/resolved,
Her friend got really really cold; couldn't quit shaking lasted 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "Her friend got really really cold"; TREMOR (non-serious), outcome "unknown", described as "couldn't quit shaking lasted 24 hours ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021219920 same reporter/drug/AE with different patient
Possible wrong reconstitution; dose was probably reconstituted about a week ago with the incorrect or extra component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2023, the patient received Arexvy. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Possible wrong reconstitution) and inappropriate dose of vaccine administered (Verbatim: dose was probably reconstituted about a week ago with the incorrect or extra component). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 15-NOV-2023 The reporter called into request information about the possibility of receiving a replacement of the diluent for Arexvy as a dose was probably reconstitute about a week ago from reporting day with the incorrect or extra component. Reporter did not have any information about the possible event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Reporter reported that the Arexvy dose was reconstituted with incorrect or extra component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Day 1 evening of, pain in the arm. Day 2 Next morning Pain in every joint from the waist up, Severe tiredness, and internal itching. Day 3 Severe pain in joints from waist up, Moderate tiredness, Severe itching only benadryl could stop, and Mild Rash. Day 4 Moderate joint pain from waist up. Severe internal itching only benadryl could stop and Increasing Rash. Day 5 Mild Joint pain, Severe itching only benadryl could stop and increasing rash. Day 6 Continued Severe itching and mild rash sought medical attention. Dr prescribed Medrol dose and mile joint pain went away, rash stopped and itching slowed down.
suspected vaccination failure; Shingles; Phantom Pain on head at night; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colorectal cancer (survivor with missing 36 lymph nodes) and shingles (experienced in February 2020). Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on unknown date in 2020, refer case US2021AMR019382). Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and phantom pain. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and phantom pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the phantom pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the spouse of the patient. The age at vaccination was not reported, however could be 58 or 59 years. The patient had shingles approximately every week since his second Shingrix vaccine. He also had phantom pain on his head at night. Valtrex was used as a treatment for shingles. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019382:same patient, 1st dose
Patient called and said she had swelling and a rash on the area where the shot was give.  She reported no fevers, swelling in other areas, vomiting or diarrhea.   I instructed her to apply a compress as well as NSAID for swelling.  I also told her to keep an eye on the rash, use benadryl but call her provider if it doesn't start to fade in a few days.
Right shoulder arthroscopic I & D with resection of necrotic bone performed 8/5/08.  Hx: patient c/o pain and swelling since 48 hrs after injection.  ER visit x 2.  9/26/08 Reviewed hospital medical records of 8/5-8/25/2008. FINAL DX: no d/c summary dictated yet.  H&P & consults states septic arthritis/osteomyelitis right humerus, secondary to IM injection. Records reveal patient experienced septic osteomyelitis of right shoulder s/p arthroscopic I&D with debridement.  Pain in right arm developed immediately s/p HPV vax 7/16.  Seen by PCP & tx w/pain med.  Pain persisted & developed low grade fever.  Seen in ER on 7/23, x-ray neg & d/c to home on pain meds.  Began to have swelling of right shoulder/arm, low grade fever, worsening pain & refusal to move arm.  Was pale & ill-appearing, sent home from school & taken to ER.  CT scan & x-ray revealed right humerus osteomyelitis.  Taken to OR for I&D with debridement to remove necrotic bone.  Tx w/IV antibiotics.  Did well initially then developed tacycardia & hypotension.  Tx w/fluid & transferrred to higher level of care ICU.  ID, ortho, neuro consults done.  Intubated until 8/15.  Initially did well post extubation then had altered mental status thought to be ICU psychosis.  Had repeat surgery x 2.
fever 99.7; nausea; stomach cramping; lower back pain; heart racing; dizziness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 09Apr2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and gluten. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included daily vitamins, fish oil, calcium, D, and probiotics from unknown dates for unknown indications. The patient previously received sulfamethoxazole, trimethoprim (BACTRIM) from an unknown date for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 on 19Mar2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2 on 09Apr2021 at 23:30 (also reported as about 8 hours post dose 2) the patient experienced fever 99.7, headache, nausea, stomach cramping, lower back pain and heart racing. At 36 hours post dose 2 symptoms started to reside. At 48 hours slight headache, heart racing, and dizziness remained. At 60 hours, heart racing and slight dizziness remained. The patient did not receive any treatment for the events. The outcomes of fever 99.7, headache, nausea, stomach cramping, and lower  back pain were recovered. The outcomes of dizziness and heart racing were unknown. It was also reported that since the vaccination the patient had not been diagnosed with COVID-19.   No follow-up attempts are needed. No further information is expected.
Patient described achy joints and stiffness, especially after going from sitting to standing.  It started about a day after the vaccine and is still happening (4 days after).  He said it is not usual for him but he feels ok otherwise.
Approximately 5 hours after the 2nd Pfizer Vaccine, my left knee started hurting and never stopped. I went to see a doctor on 06/14/2021 and asked to look at my knee. He did notice swelling and fluid. I have never had knee issues, no trauma. The pain started the day of the 2nd vaccine and never stopped.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 02-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered pneumonia, exacerbation of chronic obstructive pulmonary disease, and later was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Pneumonia, exacerbation of chronic obstructive pulmonary disease, and shingles were considered disabling. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
Couldn't move arm; Couldn't sleep in any position but her back; Arm was very sore; got the aching; Just below vaccine,got rash; muscles were hard; muscle swelled up; Red at the site of the vaccine; Joint pain; Muscle pain; Chills; Nausea/ready to throw up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm), INSOMNIA (Couldn't sleep in any position but her back), PAIN IN EXTREMITY (Arm was very sore), PAIN (got the aching) and VACCINATION SITE RASH (Just below vaccine,got rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm), INSOMNIA (Couldn't sleep in any position but her back), PAIN IN EXTREMITY (Arm was very sore), PAIN (got the aching), VACCINATION SITE RASH (Just below vaccine,got rash), VACCINATION SITE INDURATION (muscles were hard), VACCINATION SITE SWELLING (muscle swelled up), VACCINATION SITE ERYTHEMA (Red at the site of the vaccine), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea/ready to throw up). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm), VACCINATION SITE RASH (Just below vaccine,got rash), VACCINATION SITE INDURATION (muscles were hard), VACCINATION SITE SWELLING (muscle swelled up), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and CHILLS (Chills) was resolving and INSOMNIA (Couldn't sleep in any position but her back), PAIN IN EXTREMITY (Arm was very sore), PAIN (got the aching), VACCINATION SITE ERYTHEMA (Red at the site of the vaccine) and NAUSEA (Nausea/ready to throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Heart rate: 96 Checked in a sitting position for the first time. and 105 Checked for the second time..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication for the event Nausea included Ginger capsule.  Previously administered products included for Smallpox: SMALLPOX VACCINE (Had small pox vaccine when the patient was younger.).   This case was linked to MOD-2021-016218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Follow-up received on 18-Feb-2021 included addition of new events, lab report, treatment medication, and description of the events experienced after the first dose.
Patient stated that overnight after receiving the vaccine side effects began. She stated that she had shooting and stabbing pain in her chest and felt extremely week and fell on the floor. Patient also had a headache, fever, sweats, and could not sleep. She stated the side effects only lasted for about a day and then stopped.
Dizziness, Headache, Myalgia, NauseaVomiting, fatigue, chills Narrative:
Legal report of a male pt who experienced neurodevelopmental injuries coincident with Certiva. On an unreported date, the pt received Certiva vaccination. On an unreported date, the pt experienced severe neurodevelopmental injuries, which was considered medically significant. Pertinent laboratory tests, diagnostic procedures, medical history or concomitant medication information was not provided. The pt was a child.
Headache, CoughWheeze, Syncope, congestion, fatigue Narrative: 12/31 received vaccine. 1/2 onset of nasal congestion, fatigue, HA, runny nose. 1/3 onset of productive cough. 1/4-1/5 stayed home from work. 1/6  back to work with lingering mild headache. Other symptoms have resolved. Will test for COVID-19. 1/7 COVID-19 test is negative. Symptoms have otherwise  resolved.
Child started with redness to right thigh at around 10am 3/18/09.  Redness worse & area getting swollen leg looks more swollen.  Child seen at 8am on 3/19/09.  Mom also took child to ER 3/18/09 at 1800.  Pt treated with BENADRYL & CEPHALEXIN by Dr.
This initial spontaneous case, was received on 28-Nov-2017, from other health professional, concerning a 60-year-old adult male patient. On 24-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF34409, expiry date: Jun-2018), which was stored at a maximum temperature of 57.6 degrees F, about 5 hours (explicitly considered as incorrect product storage and drug administration error). The reporter assessed the event as non-serious.
Chills, Muscle contractions, Fever = 102.7 Patient on antibiotic for a sinus infection at time of injection
I had bad breath like a metallic breath on a Saturday May seventh 2022 at 3AM I woke with a sore throat, at 9AM a rapid Covid test was negative. 10 AM I called teladoc who gave me some OTC remedies which was salt water gargle, chloraseptic and cough drops at or around 1PM I felt malaise sluggishness and disorientation @ 2:22PM I was informed I had a close contact exposure. AT 3:30 PM took a PCR test final result was negative, At midnight I had tightness in my chest AND swelling in my eustachian tubes by three AM it had improved. By 2:30pm the following day symptoms were improving and by eight PM I felt nearly normal. By AM Monday May ninth 2022 I was energetic with clear head and throat almost completely better and PCR cam in negative.
I applied it on Sunday, April 4, that day my head hurt a lot, my arm and neck took me acetaminophen and it produced a lot of sleep I fell asleep from 11 am to 700 pm without waking up The next day my head hurt a lot, my arm and in general my body and so 4 days went by on the fourth day My general discomfort and headache decreased. On Saturday 10 the general malaise the headache a little fever and on Monday the symptoms worsened on Wednesday I can not hold it anymore and my legs began to swell more and to redden and my veins were began to sprout and I felt that I was burning, I requested a medical appointment and I have been disabled since that day and the symptoms yes
pt recv vax; 5 mins sz; tonic clonic x/ lt arm & rt leg "locked & bent"; abnormal EEG;
Sore arm, knot in arm that s still present. And needed surgery in shoulder after deterioration.
PATIENT REPORTED A RASH THAT STARTED 2 DAYS AFTER RECEIVING VACCINATION.
This spontaneous report was received from a registered nurse and refers to a two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2017, the patients were vaccinated with PROQUAD injection lot # M022402 with an expiration date 01-NOV-2017 and lot# M035690 with an expiration date 06-FEB-2018 for prophylaxis (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD experienced the temperature excursion of 7 degree Fahrenheit, reported also as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (and also as -14 degrees Celsius to -10 degrees Celsus) for 30 minutes. A digital data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012359: US-009507513-1703USA007869:
Arm started feeling sore around 8pm day of vaccine. At 4am I woke up shivering uncontrollably with a headache. Arm soreness was worse and was now affecting my whole right arm and not just injection site. Hurt to move right arm any at all and chest felt like an elephant was sitting on it. Fever at 6am was at 102.5 F. Treated pain and fever with Tylenol. Temp went down to 101.9 at next check. Continued running a fever all day, shifting from sweating to shivering and being cold. Was very tired and stayed in bed most of the day.  Temp was down to 100.5 when went to bed. Arm is still sore today and woke up covered in sweat. Temp was at 99.9. Still very tired but chest tightness has gone down.
Aching all over hours after. 2 weeks later achy pain right leg and knee with some swelling.  Achy joints Tylenol and 5mg Meloxicam started 2nd day. 2 weeks later Meloxicam q.d.  Right knee pain increased with walking. Better after 4 days on MeloxicM. Still some aches and soreness in right leg.
I felt aching on my entire upper left arm all the way to shoulder. Had a minor fever midnight which make sleeping difficult. Fever stopped on 4/10/ 21 evening. Ache stopped on 4/12/21.  I consumed 4 panadol pill in total, 2 on 4/9/21 midnight, 2 on 4/10/21 morning
Mom states child fine & playing on 3/29 until 3 p.m. when great grandmother told mom child couldn't walk; mom states she gave him tylenol becuse he felt hot but temp not taken; sympoms continued until Friday when child c/o anorexia and child still unable to walk; PHN observed child attempting to walk and dragging right thigh; no redness, edema, noted by inspection; Temp 97.7 F.  Referred to doctor 3/30 for further evaluation; mom stated she has noticed child limp before now. Returned to Doctor 4/7/06
Pt recvd 3 doses of Engerix-B vax & did not seroconvert; booster dose was administered; no tx was given;
Patient was under the authorized age group of 18 years old. Should have received a Pfizer dose instead of a Moderna dose for patient in this age group. This was discovered around the time when 2nd dose was due in series for patient. I discovered that the pharmacy intern incorrectly gave a Moderna shot to a 15 year old when only Pfizer is indicated. The data verified for the intern was done by an RPH. Parent was alerted and wanted Moderna, but pharmacist recommended Pfizer for patient's second dose as recommended by the CDC guidelines.
Localized swelling at vaccine site on left arm. Member had vaccine 6/21/2017. Small 4cm by 3 cm area mild swelling area is soft none tender to palpation. Skin temperature is normal.
6/5/16 Patient developed shoulder pain, knee discomfort/tightness. 6/15/16 Joint pains spread and arm and leg edema developed. Amlodipine stopped, HCTZ increased, then stopped. Furosemide started. 7/5/16 Rheum eval more labs. Knee fluid aspirated since then patient had also seen a hand specialist for carpal tunnel, infectious disease and renal specialists. Serum sickness is diagnosis. Not fully recovered yet but improving on steroids.
Patient was schedule to receive the Pfizer vaccine but received the Janssen vaccine instead. Patient waited the 15 min after vaccine was given and left the facility.