chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. Concomitant products included doxazosin. On 4th June 2018, the patient received SHINGRIX .5 ml. On 5th June 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the general body pain was unknown and the outcome of the influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm were not recovered/not resolved. The reporter considered the general body pain, influenza-like symptoms, gastrointestinal symptom nos, rib pain, nausea, loss of energy and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received HIGH BLOOD PRESSURE MEDICATION as concomitant drug. The patient received Shingrix vaccine on left arm on 4th June 2018 at 14: 58. The pharmacist reported that the patient experienced side effects after receiving the SHINGRIX vaccine. The patient had body aches, loss of energy, flu like symptoms, an achy arm, rib pain, nausea with gastrointestinal symptoms. The pharmacist advised the patient to take regular Tylenol and she would follow-up with the patient on the day of reporting. The pharmacist spoke with the patient on the day of reporting and the patient was feeling better.
COUGHING, SHORTNESS OF BREATH,INSOMIA, DIZZINESS, DROWNSING
He began having severe pain in his left lumbar area, increased pain and radiation down his leg, severe excruiating knee pain requiring ER visit, this continued and got worse resulting in another ER visit, MRI unremarkable, pain continued down leg to left foot, then over right foot and lower leg and neck area.  After wight loss of 15 pounds, inability to ambulate and due to severity of pain he was admitted to the hospital.  Lab showed elevated ESR and CRP. Diagnosed with a polyarthitis/polyneuritis, treated with high dose steroids and pain meds.  He continues to have weakness and pain on left side but less severe than first four weeks post-vaccination. He walks slow with a limp.
(1) Severe headache, followed by -> eased after 9pm (2) nauseousness, then (3) weak knees with (4) hot flashes (5) rash-welts - starting at 3:30 11/17/2010 - large. Still as of 12:15 11/17/2010 - not as severe.
Patient received H1N1 vaccine on 10/19/09 while pregnant. Delivered 2/11/10 and infant was born deaf. Denies family H/O deafness.
Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022; Patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 04 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was on 11-Jan-2022 The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. No adverse event reported. No treatment drugs were reported
BILATERAL TINNITUS....TERRIBLE...my hearing is affected...Sounds like I'm talking out of a can...
Body aches, tiredness and headache around 7 hours after injection. Then chills shortly after and inability to sleep. Around 14 hours after injection chills passed. Fatigue and headache remained for around 32 hours after with headache finally passing after 36 hours.
Serious, full body rash, not itchy. Red measles-like bumps all over forearms and thighs. Did not have any skin reaction previous to the second COVID shot. Woke up the morning after shot with extensive rash.
6 days after vaccine developed itchy red rash left arm that spread to whole body lasted 2-3 days. Also developed dizziness/ vertigo/ headache that continued
I had a vasovagal reaction within minutes which caused me to faint, come to, and faint again several times.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was being administered first dose of menactra and second dose of Tdap.  Walked around after getting vaccines.  Then started to fall mom caught him.  Patient fainted for less than 10 seconds.  Remained flushed, pale, weak.  Nurse brought NP.  Ice packs applied, water given, vitals monitored and EMS activated.  EMS arrived patient still alert and oriented still weak and feeling dizzy.  Patient transported to ER via ambulance with mom.
Shortly after getting 1st Covid vaccine, pt began experiencing headache and rated headache as 8 out of 10 which eventually after Tylenol dose dropped to 6 out of 10. Pt states arm pain 7 out of 10 also with decreased range of motion. Pharmacist assessed where shot was given and stated shot area looked normal. Pt returned to work and worked the rest of the evening.
Vaccines given yesterday - today returned with red indurated areas on both thighs. Rx given for Keflex.
Mother reported child developed red, swollen, and warm area on left arm where shots were given.  First noticed 04/13/04 at 1800.
Headache, Fever, Chills, Achiness, A Rash that started to spread 2 days after vaccine and has spread to all of upper left arm and onto lower arm.
3-4 blisters under the tip of her tongue, blisters as little strawberry dots under the rim of her; felt a cut on her tongue 10-15 minutes after receiving the vaccine; her tongue was hurting; front and side of the tongue had stinging feeling; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (3-4 blisters under the tip of her tongue, blisters as little strawberry dots under the rim of her), ORAL CONTUSION (felt a cut on her tongue 10-15 minutes after receiving the vaccine), GLOSSODYNIA (her tongue was hurting) and TONGUE BITING (front and side of the tongue had stinging feeling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TONGUE BLISTERING (3-4 blisters under the tip of her tongue, blisters as little strawberry dots under the rim of her), ORAL CONTUSION (felt a cut on her tongue 10-15 minutes after receiving the vaccine), GLOSSODYNIA (her tongue was hurting) and TONGUE BITING (front and side of the tongue had stinging feeling). On 15-Feb-2021, TONGUE BLISTERING (3-4 blisters under the tip of her tongue, blisters as little strawberry dots under the rim of her), ORAL CONTUSION (felt a cut on her tongue 10-15 minutes after receiving the vaccine) and GLOSSODYNIA (her tongue was hurting) had resolved and TONGUE BITING (front and side of the tongue had stinging feeling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went out to her car 25 minutes after receiving the vaccine to smoke e-cigarette but did not smoke because her tongue was hurting, and did smoke later on. Concomitant medications were not provided. Treatment information was not reported.
pt recv vax 5/27/99 & c/o of rash on body arms & legs x 1wk;pt was examined by MD & dx w/varicella;
dizziness,nausea, elevated blood pressure in the 24 hours after the vaccine was given
next morning 11/21/2019 experiencing burning pain in shoulder and arm area, could not lift arm, could not rotate arm, could not sleep on arm as if rotator cup was out.  12/13/2019 back to clinic because pain was debilitating and to this day 1/21/2020 it still has pain (symptoms related to SIRVA), in which I researched my symptoms, the clinic said they never heard of SIRVA. 12/13/2019 Cortesone, Prendesone given by clinic for pain 1/2/2020 cyclobenzaprine given by clinic
Rash after AVA #1. Occurred 7 hours after receiving the vaccine, macular papular rash on back of injected arm, same side of trunk and thigh. Resolved with steroid cream. AVA series stopped. Will come to hospital for skin testing to the vaccine this month.
Janssen COVID-19 Vaccine EUA  Experienced strong muscular back pain, mostly lumbar but pain felt across entire back. Normal existing body pains also felt amplified.  Strong fatigue as if I had engaged in arduous physical activity but had not.   Took Advil PM night of vaccine and woke up feeling no pain but slight headache. Took excedrin extra strength in anticipation for headache escalating and felt no further pain until 4:30 pm the day after vaccine. Pain more intense, took 800mg of ibuprofen at 6pm and pain was alleviated by 8pm. Took Advil PM again night 2, and woke up with no pain again. Now 4:45pm of day 3 and not feeling pain but it could return when effects of Excedrin wear off.
Patient received vaccination 11/25. On 11/28, localized reaction with swelling, warmth, soreness at site. Swollen and sore supraclavicular lymph node on left side. Localized reaction at injection site resolved. Lymph node remains swollen.
arm pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. 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 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
feverish; feeling like I do not want to do anything; low grade fever 88-99; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included NIFEDIPINE, LISINOPRIL, FUROSEMIDE, COLECALCIFEROL (VITAMIN D 3), TURMERIC [CURCUMA LONGA RHIZOME], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and MOVE FREE ADVANCED for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BAYERS ASPIRIN) at a dose of UNK, bid. At the time of the report, PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99) was resolving. Not Provided      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.   additional concomitant medications include multi vitamin , calcium magnesium  zinc, fish oil.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA284722, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a four years old patient who received vaccine FLUZONE QUADRIVALENT that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect QUADRIVALENT INFLUENZA VACCINE (lot number U1997AA) via intramuscular route in the left deltoid. It was a case of actual medication error due to product storage error. 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.
6wk p/vax pt devel signs of cardiomyopathy thought to be of viral origin;
Onset papular rash (L) arm involving deltoid to forearm area 2 days following injection-compatible with H. Zoster
pt recvd vax; pt exp fatigue; nausea; arm itched & was swollen;
Caller received first dose of Pfizer-BioNTech COVID-19 Vaccine on 10FEB2021/tested positive COVID-19 on 18Feb2021; This is a spontaneous report received from a contactable consumer(patient) via medical information team. A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date not reported) via unspecified route of administration, in left arm on 10Feb2021 at 5:45 PM (at the age of 87 years), as a single dose for covid-19 immunization. The patient medical history reported as she has had Heart failure since she was a child and concomitant medications were not reported. There was no prior Vaccinations within 4 weeks. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional Vaccines administered on same date of the Pfizer Suspect. There was no AE(s) which require a visit to Emergency Room and physician office. On 18Feb2021, the patient tested positive for the COVID-19 Virus. She said she had no symptoms when she tested positive for the COVID-19 Virus. She asked if she should still get her second COVID-19 Vaccine, stating she was scheduled to receive her second COVID-19 Vaccine on 04Mar2021. She stated that her husband had COVID-19 Virus, clarifying her husband had passed. She reported that her COVID-19 Virus quarantine period ended on 28Feb2021(Yesterday). However, her doctor advised her not to take the vaccine and move it on a later date on April. She would like to know if she needs to move the schedule for her second dose. She had a COVID-19 Virus nasal swab test performed on 18Feb2021 at (Pharmacy). She said she had to wait 3 days to receive the COVID-19 Virus nasal swab test results from (Pharmacy). The Relevant Tests includes Positive COVID-19 Virus test. Outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Administered Menveo on L arm then administered Hep A in R arm. After the Hep A was given, patient started to feel dizzy and then fainted. She did not fall off exam table, I was able to catch her. She gained consciousness within seconds. The provider came into the room and examined her. BP was taken and patient was kept for an additional 30-45 mins in office for monitoring.
This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, in May 2017, the patient was in the office for a routine dose of PREVNAR 13 (strength, dose, Lot # and expiration date were not reported) for prophylaxis and inadvertently received the first dose of PNEUMOVAX 23 Lot # N003993 with an expiration date on 31-OCT-2018, intramuscularly (strength and dose were not reported) for prophylaxis instead of PREVNAR 13. However, there was no report of adverse effects. Additional information has been requested.
Abdominal rash beginning approximately 2 hours after vaccine administration. Severe sharp right shoulder pain beginning approximately 2 hours after injection, lasting 3 days, resulting in inability to move arm away from rib cage. Excessive fatigue despite rest that has continued into Day 6, and has not recovered from this at the time of this report. Patient has been unable to participate in daily life or attend work shifts.
Vaccine injected into L deltoid but none administered because frozen. On inspection the syringe looked like it contained over 0.2 mL but not opaque so a drop was squirted out to make 0.2 mL but when place in deltoid plunger wouldn't go down probably because frozen (likely expanded and why over 0.2 mL). Syringe was on an ice pack.
First dose more than 42 days ago. Yet to get second dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose more than 42 days ago. Yet to get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose more than 42 days ago. Yet to get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose more than 42 days ago. Yet to get second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.
pt called in and reported painfull arm w/ hard lump -size of golf ball over inject site, not seen
A day + a half later, patient developed a red, tender patch about 1 inch beneath the injection site the size of 1"x3". Patient said the area is just tender and red (not warm nor noticeably swollen).
Moderna COVID-19 Vaccine EUA Fever - kept at 102 degrees Farenheit with alternating ibuprophen and acetaminophen round the clock, chills, headache, fatigue, all-over excruciating body aches, joint pain, beginning 12 hours after shot and resolving 36 hours after shot
Arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arm  soreness) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (Arm  soreness). At the time of the report, ARTHRALGIA (Arm  soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Vaccine was administered in his shoulder and he read that it was supposed to be in his muscle.
Local pain at injection site laster about 4 days. Severe headache, fever of 102F, nausea, chills, body aches, cold sweats for 36 hours post injection. Still current multiple episodes of dizziness daily. Took tylenol for first 24hrs to reduce fever.