chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of brachial neuritis in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination include Salmonella Typhi Vi Capsular Polysaccharide vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; Smallpox Vaccine; manufacturer unspecified; unknown; unknown given on an unspecified dated. On 23 July 2012 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). On or about 11 August 2012, 19 days after vaccination with BOOSTRIX, the subject experienced brachial neuritis, injections site pain, pain, not eating, not sleeping, not thinking, deep muscle pain and nerve pain. The subject reported she "never had a bad reaction to any of the many immunizations I have received. Living overseas I had smallpox, typhus vaccine, etc.)." Nineteen days after receiving BOOSTRIX she suddenly developed excruciating stabbing, constant pain at the injections site (left arm), left shoulder, upper left back, neck, upper front chest and down the length of left arm. She described the pain as "the kind of pain that prevent you from eating, sleeping, thinking etc. Brachial neuritis fits the bill. I am not enduring the sixth day of unrelenting pain; my doctor has prescribed pain killer as there is no cure' for this condition. It feels like I am getting the shot over and over again at the actual injections site. I have never in my life experienced such intense pain. Pain is the main symptom, no rash, no swelling etc It is a deep muscular/nerve pain". At the time of reporting the events were unresolved.
Pentacel that only the diluent was used for the DTAP portion of the vaccine wih no AE; Patient administered  0.25 ml dose of Pentacel with no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 6-month-old and unknown gender patient for whom it was reported "pentacel that only the diluent was used for the dtap portion of the vaccine" [product preparation issue] and patient administered 0.25 ml dose of pentacel while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [incorrect dose administered].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a 0.25 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ528AA and expiry date: not reported] via an intramuscular route in the right thigh for prophylactic vaccination.  It was reported patient visit on 03-Sep-2021.   No other vaccines were reported.   It was a case of actual medication error due to incorrect dose administered and product preparation issue [Latency: on the same day].   It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives (trunk, arms, neck, legs mainly) on 11/26/2021 up until today. Severity variable, visited the dermatologist office and advised to take loratadine at least twice a day until hives resolve. Experiencing just dermatographia at this time. I take loratadine daily in the AM and will take it in the PM as well if I experience itching.
rash side effect; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash side effect). At the time of the report, RASH (rash side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Throbbing h/a, painful eyes & stiff neck a few hrs p/2nd pre-exposure dose; gradually subsided p/24 hrs;
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip) and ABSCESS (she thought it could have been an abcess or due to the vaccination) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pollen allergy and Sensitivity to weather change. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), MOBILITY DECREASED (she could barely lift her arm), ILLNESS (She got sick), ORAL HERPES (developed a herpes bump on her lip), LYMPHADENOPATHY (lymph nodes are still swollen) and MYALGIA (Pain under arm). On an unknown date, the patient experienced ABSCESS (she thought it could have been an abcess or due to the vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (she could barely lift her arm) had resolved. On 27-Apr-2021, ILLNESS (She got sick) and ORAL HERPES (developed a herpes bump on her lip) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling under arm/The arm was a bit swollen), ABSCESS (she thought it could have been an abcess or due to the vaccination) and LYMPHADENOPATHY (lymph nodes are still swollen) outcome was unknown and MYALGIA (Pain under arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.
Moderna COVID-19 Vaccine. 8 days after first shot I got redness, itching and swelling at and around injection site. Feels like a marble sized ball under the skin at injection site. This started 8 days after.
Unilateral left shoulder and arm pain, weakness, and anesthesia beginning 12 hours after vaccination, worst within 5 days, but still recovering from it.
Diffuse redness surrounding injection site. No other s+s. Returns to clinic 12/9/11 Large 3"x2" erythema and swelling localized to injection site.
Numbness on face 2-5 minutes after; heavy legs, mild headache, body aches and irritability 48 hours after.
UNSTABLE ANGINA ACUTE NON ST ELEVATION MI ACUTE MI 12/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
usually gets sick after the vaccines; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a female patient of an unknown age who usually gets sick after the vaccines after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, formulation, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event usually gets sick after the vaccines (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Seizure Like "episodes" Pain in calves Swelling in neck breathing trouble/Wheezing
Woke up in sweat; Pounding headache/ severe headache; Feeling super weak/ Too weak to get out of bed rest of day.; Dizzy; Started throwing up x3; Fell asleep and only woke up to intermediate alarms/ Was awake for a total of 2.5 hours before falling asleep again; Started feeling severely nauseous; Fatigued; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 14:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), diagnosed with ovarian cyst on 01Mar in an unknown year and gluten intolerance (allergy to gluten). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) daily for an unknown indication, from an unknown date and hydrocodone (MANUFACTURER UNKNOWN) on 01Mar2021 and 02Mar2021, for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 10Feb2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021 at 20:30, the patient started feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15. On 04Mar2021 at 07:15, the patient woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, fell asleep and only woke up to intermediate alarms the patient set for herself, was too weak to get out of bed rest of day and was awake for a total of 2.5 hours before falling asleep again at 18:30 and waking up at 06:15 on 05Mar2021. On 05Mar2021, the patient felt better than the previous day but still had a severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling severely nauseous and fatigued, fell asleep and slept through the night until 07:15, woke up in sweat, pounding headache, feeling super weak and dizzy, tried to get water but started throwing up 3 times, too weak to get out of the bed rest of the day, was awake for a total of 2.5 hours before falling asleep again and severe headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Per Neurology Notes the Client had fulminant progressive decline and hospitalization 3-4 weeks after the vaccine. The Client was  diagnosed with CIDP (chronic inflammatory demyelinating polyneuropathy)(primary encounter diagnosis) & AMSAN (acute motor and sensory axonal neuropathy) (a subtype of GBS)
Parents reported that approx 1week after vaccination patient developed a bump in left arm at site of DTaP vaccination.  They waited to see if would resolve and brought him for evaluation on 7/3/08 at which time he had a small subcutaneous nodule at site of injection with a central pin-point black spot.  Mildly tender to palpation.  No erythema, fevers, or signs of infection but does have mild hyperpigmentation at site.  5/27/08 he received DTaP & MMR in left arm.  However the reaction occurred only at the site of the DTaP injection.
Cellulitis, fever, headache, weakness, sore throat; TX: acetaminophen, ibuprofen, azithromycin
Patient received undiluted pfizer "orange" cap covid vaccine. Patient experienced no symptoms or adverse effects.
Site of injection red, warm swollen itchy.  Improving over the next 24 hours.  No treatment.
Received vaccine 2/12/15. Later developed N/V then diarrhea progressed to dizziness, incr. fluid loss over several hours w/ abd pain. Seen in E.R. for IV fluids - discharged home that day.
Severe localized reaction at the injection site. Redness and swelling extending out 3-4 inches out of the site. Pt. will contact her MD if necessary. Recommended APAP/Benadryl/ & cold compress.
PATIENT GOT MODERNA AS FIRST DOSE AND PFIZER AS THE SECOND DOSE
Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medications was reported.
First dose was given 1/5/21 and second dose given 1/21/21.  It was only 16 days apart.
Within 24 hours I developed chest pain about 2 inches to left of sternum. Within another 24 hours the pain shifted another 2 inches towards my left armpit. Pain can be slight to intense at times requiring me to sit down.  Within 24 hours I developed a painful bump in the trapezoid about halfway between neck and shoulder.  The bump has gone down now (day 10) but the pain continues. It?s relatively constant throughout the day but gets severe enough towards the evening to stop or minimize the use of my left arm. It seems to be activity related. The more I need to do that day, the worse it is in the evening. Pain in left arm has been as expected but continues at day 10. It is slowly subsiding and is minimal compared to the other two pain locations.
Vaccination @ 10:28 a.m.; pre-syncopal/paresthesias episode @ 10:43 a.m. Patient's vitals were monitored for an hour, ice packs on chest. Blood pressure monitored and blood sugar check. Patient was alert and stable prior to discharge. VAERS online reporting done as well, 02/23/2021 report number: 318851
Slight swelling of area around right eye, vision is not affected.  Left eye not affected.  Slight headache.
soreness; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, less than a day after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On 21st April 2019, the outcome of the pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The patient asked did the 2nd shot have the same side effect as the first shingix. The patient had shot on Saturday very sore and felt flu like symptom that evening of vaccination and was ok for the next day. The patient just wants to know about the 2nd shot was it the same as the first and was just The patient was curious, would received in 6 months. The patient did not gave permission to contact their physician.
Vaccine given 8/29/2017, patient still complains of arm/muscle pain near injection site-Left deltoid as of 10/14/2017.
10 inch in diameter circle of redness around the injection site of the vaccine; arm was sore with a 10 inch diameter of redness around the injection site of the vaccine; A spontaneous report was received from a consumer concerning 79 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with a 10 inch in diameter circle of redness around the injection site of the vaccine.   The patient's medical history was not reported.  Concomitant medications were reported as the patient took diabetic medication.  On 26 Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) via intramuscular in left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, same day of first dose of vaccination the patient experienced arm was sore with a 10-inch diameter of redness around the injection site of the vaccine.  On an unknown date in 2021, the patient experienced mild sore arm reaction, but redness has not gone away.  Laboratory test was not done.  Treatment information was not provided.  All the events occurred after first dose of vaccination.  The outcomes of the event remain unknown.  Action taken with mRNA-1273 in response to the events are unknown; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014617:
GENERALISED ACHING; FEVER; HEADACHE; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 18-JUN-2021, the subject experienced generalised aching. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced headache. On 18-JUN-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-JUN-2021, had not recovered from headache, and the outcome of generalised aching and muscle soreness was not reported. This report was non-serious.
Headache; Pain at injection site; Swollen injection site; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 30 -year-old male patient received his  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9626), via an unspecified route of administration (on the left arm) on 30Jan2021 16:15 (at the age of 30-years-old), single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included amlodipine;olmesartan, lorazepam. The patient experienced Headache,Pain at injection site, Swollen injection site, Fatigued, all on 31Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 Nasal Swab (reported as post vaccination). No treatment received for the adverse events. The outcome of the events was not recovered. Prior to vaccination, it is unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (date of test reported as 06Jan2021). The reporter assessed the events as non-serious.
Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began to feel a dull ache in the left breast. The pain grew sharper and deeper to the point where I could not lift my left arm, it was that painful making it hard to sleep. The next day the pain started diminishing. On the 3rd day after the vaccine, the pain had mostly resolved.
Patient reports severe headache and body aches. She also reports severe stomach upset and nausea, near vomiting. She is unable to eat due to the nausea. She has diabetes and since receiving the immunization her blood sugar has increased from normal range to between 200-300. This morning her fasting was elevated at 201. Increase has been resistant to multiple insulin doses and she is still unable to eat.
pt given vax & noted to have maculopap rash on forehead @ 1640 hrs given DPH for rash;
No adverse event. Wrong vaccine given. Pneumococcal 23 given instead of PREVNAR 13.
When the student nurse administered the vaccine to the client's left arm, the needle wasn't tightly screwed to the syringe, and most part of the vaccine spilled out. This ended up client didn't receive the full dose of vaccine.
This case was reported by a nurse via sales rep and described the occurrence of headache in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever, pain in arm and rash. On an unknown date, the outcome of the headache, fever and rash were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the headache, fever, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed splitting headache, fever (body temperature was recorded as 100.3 degree F). The patient's arm was still sore on day 3 and developed rash on breast.