chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Patient reports chest as feeling tight, had difficulty swallowing and breathing about  a day after receiving first dose. She reports feeling like this for a few days, and if she had not gotten better at the time of phone call she would have gone to hospital. She was advised to reach out to her doctor and to go to ER if she experiences any more difficulty breathing.
Numbness and tingling both hands, arms, tingling to face below eyes to chin. Recurred 5/7 in arms; again on 5/9 to arms and face. To physician on 5/10, while experiencing no symptoms. On 5/11, tingling (crawling) to face and scalp. Temp today 99.8 orally.
INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced incorrect storage of drug. On 05-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509090.
4 days p/the vax was administered; pt had a tonic seizure; pt was hospitalized overnoc & recvd the following tests; CAT Scan, Brain scan, EKG, MRI;
Pharmacist is reporting that a patient received VARIVAX Intramuscular route instead of subcutaneous route.; This spontaneous report was received from a pharmacist referring to a 37-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-SEP-2020, the patient received an intramuscular dose instead of a subcutaneous one of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, lot number T012551 and expiration date 10-APR-2022 for prophylaxis.
Pt recvd Typhoid vax 09OCT90, & pt devel erythema w/heat @ inject site; This was dx as cellulitis & was successfully treated w/Dicloxacillin every 6 hrs for 1 wk;
The nurse gave the patient the 0.25mL dose when it should have been the 0.5mL dose.
It started with very bad fatigue. I than started with dizziness, numbness in the feet, joint pain, arm pain, the smell of cigarettes, ringing in the ears, low blood pressure, minimum movement in my left arm, blurred vision, heart palpitations,  and Iritis in my right eye. Currently under doctors care.
It was reported that a 37 year old female received Fluzone (U0872AB), IM in the right deltoid on 10/25/02. Approximately one week later, the pt developed a nodule at the injection site, no pain or redness present. The nodule subsided gradually over the next two weeks. No other symptoms reported. All the symptoms resolved. This case is closed.
Chief complaint of dryness of her tongue. Felt better after drinking Gatorade. Observed for 30 Min, no issues.
severe left shoulder pain and decreased mobility of left arm/shoulder. Started and 3AM 10/14/21 after receiving the injection 2:32PM on 10/13/2021 and has not yet improved. Pt is treating with ice and ibuprofen and has been advised to contact Dr.  if the symptoms do not start to improve or get worse.  Pt has not yet sought medical care but may if needed.
This non-serious medically confirmed health authority report (initial receipt 20-JAN-2015) concerns a male patient who had no medical history and no current illness and no medications at the time of vaccination. In 2013, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed left axilla lymph node tenderness, redness and swelling (two or three marble-sized nodes). Outcome was recovered. Linked to case 2015048755.
RUE with redness, warmth, and tenderness to the area below the deltoid and not at the site of the injection. Area measures approximately 15 cm x 4 cm. No fluctuance at the site or fluid drainage. BENADRYL, MOTRIN, cool/warm compresses at the site for treatment.
Chills throughout Thursday nite 3/4, Fever Friday AM 3/5 102.4F, slept most of day, Fever blisters occurred on top and bottom lips as well as blisters in roof of mouth. Fatigue.  Tylenol,  topical applications for blisters as well as salt water oral gargle several days.
Patient describes numbness, tingling and warm sensation down entire arm, injection site to wrist. Injection was IM and placement was correct
Experienced severe gout flareup  starting 3/31/21 and lasting a little over a week.  Prior to vaccination, I had not experienced a severe flareup of that duration for slightly over a year.
This spontaneous report as received from a pharmacist refers to an approximately 73 year old male patient. No current condition was reported. Pertinent medical history was reported as bilateral knee replacement surgery. No historical medication was reported. Approximately in 2013, as reported 1 year ago the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On 09-SEP-2014, the patient experienced difficulty in sleeping (disability) and severe shingles of the left face, mouth and ear. Approximately on 08-SEP-2014, a day before his shingles symptoms started patient received a root canal treatment. The patient was evaluated by physician on that date and was prescribed Gabapentin, acetaminophen, PERCOCET, and lidocaine mouth rinse. On 17-SEP-2014, the dose of Gabapentin was increased. The patient was having difficulty sleeping due to the pain of the shingles outbreak. The outcome of difficulty sleeping and severe shingles of the left face, mouth and ear was reported as not resolved. The outcome of root canal treatment was unknown. The causality was unknown. Sought medical attention was reported as Yes-office visit. No product quality complaint was reported. Additional information has been requested.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In June 2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown. Not Provided          No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Plaque psoriasis flare on legs was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.   Reporter did not allow further contact
The patient experienced no symptoms; a patient received an incomplete dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's current condition included reflux and vocal cord paralysis. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On 06-JUL-2020, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1676327, expiration date: 19-APR-2021, orally for prophylaxis. The patient's parent was concerned that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) might be too thin for the baby to ingest safely and requested that administration of the dose be stopped before it was complete. The patient experienced no symptoms.
I experienced what I have since learned is referred to as "Covid Arm": my arm became slightly swollen, warm, and red around the injection site, covering almost all of the outside of my upper arm. It looked like a giant mosquito bite, but it did not itch. I had some minor muscle soreness as well, but no other symptoms (no headache, no fever, etc.).
Patient passed out, fell, observed eyes rolling to back of head, patients arms were clenching, tremors observed throughout entire body. Episode lasted about 20-30 seconds.
Pt vaccinated 3/19/03, major take coalated 3/26/03, scab separated approx. 5 wks post vaccination (4/23/03). Site still irritated at time erythema, urticaria. Intermittent periods of skin "irritation" since then. On 5/17, following exam of site on 5/16, lesion became more erythematous, sore, and 24 hour period axillary lymphademopathy occurred. As of 5/19/03, she is back to normal.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # reported as N000238, expiration date 25-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. A Digital Data Logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
I lost my nerves in feet by compromising my immune system; I lost my nerves in feet by compromising my immune system; I lost my health; 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), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL NERVE INJURY (medically significant), IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "I lost my nerves in feet by compromising my immune system"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "I lost my health".  Additional information: The patient was super healthy and prancing for Triathlon. The patient took vaccines and lost health since and also lost his nerves in feet by compromising immune system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID vaccine breakthrough case. Pfizer 3/9/21 EN6208, 3/30/21 EW0150, and 9/29/21 301359A
No peritherapeutic pain. Ecchymosis at injection site onset within 24 h, resolved after 18 days. Myalgia at injection site onset within 24 h and continuing to the present (30 days later): tolerable but non negligible upon exertion.
7 days after vaccine administration she developed redness/rash , swelling and itching around the vaccine site. She took antihistamines for itching after onset on 1/21/21,  and has since been using topical hydrocortisone cream. Symptoms have decreased day by day but not completely resolved as of 1/27/21.
Reddened, warm area to upper right arm approximately 4 inches across; not painful, no drainage. Tylenol, Advil, cold compresses.
Information has been received from a pharmacist referring to 3 newborns (numbered 110, 111 and 112). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. On course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5./0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event reported, However patient was below age approved for 18 years or older on vaccine. Followed up with patient's guardians did not report any events
Dizziness; Anxiety; Panic attack; Autoimmune disease, that exacerbated; I immediately had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, Autoimmune disorder and Allergy NOS (Allergens). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness), ANXIETY (Anxiety), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Vertigo, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; IBUPROFEN at a dose of 200 milligram three times a day and PARACETAMOL (TYLENOL) at a dose of 1000 milligram. At the time of the report, DIZZINESS (Dizziness), PANIC ATTACK (Panic attack), CONDITION AGGRAVATED (Autoimmune disease, that exacerbated) and NAUSEA (I immediately had nausea) outcome was unknown and ANXIETY (Anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-209616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 and contains no significant information. patient reported I'm feeling better and it took 2 months and a lot of green tea with anti inflammatories.
Diarrhea; Stomach distress; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-331183 (Patient Link).
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment given to patient.
Rash began on back Tues. 7/22/03 and on Sat. 7/26/03 by 4PM spread to face, then to limbs, trunk. Fever, not measured Thurs night, also fussy. Treated for acute Otitis Media Friday with amoxicillin. Sunday, 7/27/03 at 5AM seen in ER. Dr did not think rash was due to amoxicillin. Rash apparent today-raised, red, merged on face, limbs, torso. Appears to be alert and no distress.
PATIENT SEEN FOR WELL CHILD VISIT ON 12-29-2008, RECEIVED VARICELLA, HEPATITIS A, AND FLU VACCINES.  PARENT CALLED ON 12-30-2008 WITH POSSIBLE REACTION TOLD TO COME IN, APPOINTMENT MADE FOR SAME DAY.  PATIENT SEEN BY DR DIAGNOSED AS VACCINE REACTION GIVEN PRESCRIPTION FOR ATARAX AND COOL COMPRESSES, IF WORSENS TO RETURN TO CLINIC.
When called a couple of days later, she reported no adverse reaction other than the sore arm as she was informed she would most likely experience from  a tetanus immunization.  This was given for a cat bite she had received the prior day.  The nurse was concerned regarding infection
suspected vaccination failure; had it; 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This spontaneous report was received from a pharmacist regarding a 47 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneous injection, (lot number not reported). No concomitant medications were reported. Subsequently the patient received ZOSTAVAX and broke out with shingles within 2 months. No treatment information was reported. The outcome of the event was unknown. This case is linked to 1209USA008748(same reporter link). Additional information has been requested.
Headache, Myalgia, Diarrhea, NauseaVomiting, fatigue Narrative:
Pt received the influenza vaccine 2005-2006 - Fluvirin - 0.5 ml IM at 12:10 11/3/05. At 13:30, she felt dizzy, spots in vision, itchiness - to nose, throat, chest, facial redness, and SOB. She received 25mg diphenhydramine.  At 17:00 pt complained of weakness, dizziness. She receive fluid and felt much better.
patient received mixture of the powder of the pentacel with the liquid of the quadracel, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 months old patient received a 0.5 ml third dose of mixture of the powder of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AD, expiry date: 04-Apr-2021) with the liquid of the QUADRACEL, via an intramuscular route in the left thigh on 29-Apr-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient did not experienced 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 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.
Given in upper arm. Redness, swelling to elbow, pain and fever of 100.8.
1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd Adverse Event 4/16/2021 Left posterior knee pain, pain is still present but pain level has decreased, no treatment 3rd Adverse Event 4/16/2021 Left supraclavicular tender and enlarged lymph node for 2 days, no longer tender but lymph node is currently slightly enlarged, no treatment.
At bedtime, generally lightheaded for 5 minutes, shivering about 2 minutes before sudden fainting that lasted no more than 1/2 minute. Thirst, weakness, and continued shivering lasting 25 minutes while drinking water and 5 oz of Gatorade. More comfortable as symptoms subsided and slept comfortably.