chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 41-year-old female who presents for evaluation of left arm injection site. Patient reports she got a hepatitis A vaccination injection in her proximal left upper extremity on 10/8/18. Patient states she first noticed erythema at the injection site about a week after the injection was given. Patient states 2 weeks after the injection was given, the area drained pus. Patient states that the lesion drained pus and blood for about 1 month. Patient states she was prescribed ciprofloxacin and minocycline on 1/3/19. Patient states she is not able to tolerate the ciprofloxacin secondary to dizziness. Rates pain 1/10 most of the time. Denies fever, sweats, chills. I&D performed, cultures obtained, wet-to-dry dressing BID.
Tingling in fingertips, chills, generalized body or rapidly worsening  itching.
Large Local Reaction developing on left deltoid 2-4 days after vaccine with swelling per mom reported as "softball size."  Treated with Tylenol / Ibuprofen and warm compresses. Visit recommended for formal evaluation, but declined.
Room started spinning like vertigo; Unsteady and very dizzy; Unsteady and very dizzy; Fell; he was extremely tired for both COVID-19 Vaccines; Arm was a little sore after the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. The patient's concomitant medications were not reported. Past drug history included: Meclizine for Vertigo, reaction(s): "didn't feel it was helping him", notes: Patient took Meclizine for Vertigo, but didn't feel it was helping him so he stopped taking it. Vaccination history included: Bnt162b2 (Might have had first injection on 02Feb2021 at 2:30PM), administration date: 02Feb2021, when the patient was 74 years old, for Covid-19 immunisation, reaction(s): "Arm was really, really, severely sore the first time", "he was extremely tired for both COVID-19 Vaccines". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was a little sore after the second dose"; VERTIGO (non-serious), outcome "unknown", described as "Room started spinning like vertigo"; BALANCE DISORDER (non-serious), DIZZINESS POSTURAL (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Unsteady and very dizzy"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "Fell"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "he was extremely tired for both COVID-19 Vaccines". The events "room started spinning like vertigo", "unsteady and very dizzy" and "unsteady and very dizzy" were evaluated at the physician office visit.  Additional information: It was reported that patient had severe things after the second COVID-19 Vaccine. Arm was a little sore after the second dose. The room started spinning like vertigo. Patient was unsteady and very dizzy. Had to go to doctor's office. Reporter stated the patient was unsteady and he fell. Has never had this before. Patient received second COVID-19 Vaccine on 02Mar2021 around noon. Patient was deathly afraid of the COVID Virus. Patient knows people who had been sick with COVID. was kind of scared and hearing what was going on. Reporter stated that patient was extremely tired for both COVID-19 Vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
skin blister; eye blister; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included umeclidinium bromide, vilanterol trifenatate (Anoro) inhalation powder for product used for unknown indication.   On an unknown date, the patient received Shingrix and Anoro at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Anoro, the patient experienced blister and eye disorder. On an unknown date, the outcome of the blister and eye disorder were unknown.   It was unknown if the reporter considered the blister and eye disorder to be related to Shingrix and Anoro.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked whether skin or eye blister resulted from receiving the shingles vaccine. No other information was reported.
pt recv vax 10FEB97 & 22MAY97 pt devel a gen rash that consisted of more than 50 lesions on face, chest, back, & legs;
Mom called office with complaints of developed rash (3 spots) left shoulder, right shoulder and left lower leg-was seen in office same day and dx with erythema multiform. No rash evident prior to immunizations.
pt recvd vax on 4APR95 in mid afternoon; DTP area bled sm amount p/needle withdrawn; pt cried for approx 10 mins p/vax; mom advised to given APAP; t105 from 6PM til 6AM next day;
Patient stated that her lips were tingling and her face flushed immediately following administration.  Diphenhydramine was given by mouth and she was monitored. No other symptoms occurred.
I received my shot at approximately 8:40 a.m. I had pain at the injection site immediately, but it wasn?t super severe pain. At approximately 3:30 p.m. that same day of the shot that I received, I started experiencing flu like symptoms such as severe aches throughout my body and hot flashes. My body was also significantly shaking as I would randomly become very cold and achy when I wasn?t having hot flashes. I also had a severe headache. Slight pain on the injection site, but not horrible. The day after the shot, I feel weak and nauseous.
noted several red bumps like bug bites, slightly itchy and swollen. chest, right side,
Ordered ADACEL SINGLE DOSE VIALS but received ADACEL PRE-FILLED SYRINGES with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00860023) and transmitted to Sanofi on 16-Nov-2021.  This case involves an unknown age female patient who ordered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] single dose vials [0.5 mL (total)] but received ADACEL pre-filled syringes (lot number and expiry date not reported) on an unknown date for prophylactic vaccination (product dispensing error).  It was a case of potential medication error due to product dispensing error (latency was on same day).  It was reported "caller ordered ADACEL SINGLE DOSE VIALS but received ADACEL PRE-FILLED SYRINGES; caller would like to know if she can use VanishPoint needles on pre-filled syringes."  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.
This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 14-JUN-2017, the patient was vaccinated with an improperly storage dose of VARIVAX (dose and route were not reported) lot number M045204, expiration date 11-NOV-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius (-9.5 degrees Celsius) in a time frame of 327 hours in total (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000679, 1707USA000680, 1707USA000681, 1707USA000682). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682.
woke up on saturday with slight abdominal ache, below navel, and sporatic sharp pains like gas. this lasted all day but stayed not too unbearable and the sharp pains subsided.  The next day my lower abdomen felt like my intestines were inflamed, sore to the touch and any movement hurt like I was bruised.  There was no diarrhea, no constipation , no flatulence. I am a vegan and eat basicly the same foods all the time and have no issues with my digestion, ever.  The only thing different was that I had my booster. It has gotten a little less sore daily and today I feel pretty good but still have tenderness if I push on that area or if I pull my muscles in tight.  Just thought it was odd, and worry about getting another booster because it wasn't pleasant
Chest, neck, shoulder, and jaw pain on the left side. Left side of the face felt numb. Left arm felt heavy and tingly.  Short of breath.   Took a full strength aspirin at 2PM on the 2nd of September. it alleviated symptoms but had massive anxiety to the point of being unable to hold my arms still enough to do dishes. Symptoms returned in the evening, took another full aspirin at 9PM. Went to ER at 2PM on the 3rd of September. Took a aspirin at 6AM on the 4th and the 5th of September. Symptoms went away after for the most part on the 6th of September.
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid 19 on unspecified date of 2021 (Friday) and is due for the second dose of the Pfizer Covid 19 vaccine 19Apr2021. Patient enquired whether she could take the second dose on the 19. The patient underwent lab tests and procedures which included Covid 19 found to be positive on unspecified date of 2021(Friday). The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
She came into the pharmacy on 3/13/23 and stated that her arm is now gray after her covid booster.  She said that the day of the vaccine, her skin turned gray-ish in pallor from the top of her shoulder down to her wrist.  She said her arm was sore that day.  She stated that it feels like she has arthritis in her shoulder and pointed to the area of her arm near her armpit on the front of her left arm.   She denied numbness, tingling, or pain.  She also stated that her left hand is warmer than her right hand.  She said her arm is less gray now than it was before,  but is still gray compared to her other arm.  I was not able to assess her arm, but the part of her wrist visible on her left arm was not noticeably different than her right arm.
This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M042322 expiration date 21-FEB-2018 and lot # N002913 expiration date 23-FEB-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010531.
Lingering shortness of breath; Weight gain; lingering shortness of breath for two weeks and described it as severe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine) and Drug allergy (Demerol). Concomitant products included PRAVASTATIN, EZETIMIBE (ZETIA) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe). At the time of the report, DYSPNOEA (Lingering shortness of breath), WEIGHT INCREASED (Weight gain) and DYSPNOEA (lingering shortness of breath for two weeks and described it as severe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The Patient did not inform her primary health care provider about her symptoms but she had consulted a cardiologist prior to her first dose.  The patient second dose is scheduled on 11Apr2021
pt recv vax 25JAN99 & APAP given that PM for fever;26JAn99 1030AM sz taken to ER;seen by own MD 27JAN99;exam negative for ear infect etc;28JAN99 no further sz;a little sleepy according to mom;
Approximately 1 day after my vaccine I experienced the following symptoms: Rash all over my arm, Swollen lymph nodes under my left arm, Body aches (overall lasted for 9 days). I went to the doctor for consultation and was prescribed to take ibuprofen for treatment and eventually helped remove the rash and my body aches.
It was reported that a 2 month old male pt received Tripedia, IPOL and ActHib on 7/28/99. That same day the pt experienced drowsiness and paleness.
PATIENT REPORTS NUMBNESS IN FACE WITH MILD IMPROVEMENT OVER 3 DAYS.
No adverse effects reported; patient was administered a dose of MMRII which was improperly stored; Information has been received from a healthcare worker/medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  On 02-MAY-2019, the patient was administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R031680, expiration date 01-NOV-2020 and therapy type: rHA (recombinant Human albumin, data logger); route of administration was not reported) for prophylaxis, which was improperly stored (product storage error). No adverse events were reported. There was no previous temperature excursion. No product quality complaint (PQC) was involved.  Lot number R031680 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
Patient received Moderna COVID vaccine on 2/20/21 (lot # 012M20A), 3/19/21 (lot # 045A21A), 2/15/22 (lot # 045L12A), and 4/13/22 (lot # 002M21A). On 9/5/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure due to COVID19 infection. As of today (9/8/22), patient is still admitted in the med/surg unit.
Cold chills, fatigue, headache 4pm on 3/11 until about 10 am. I feel fine this morning. 3/12
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 7/28/2021 for unknown duration.
Stomach started hurting; Stomach felt bloated; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several weeks after receiving Shingrix, the patient experienced stomach pain and abdominal bloating. On an unknown date, the outcome of the stomach pain and abdominal bloating were recovered/resolved.   It was unknown if the reporter considered the stomach pain and abdominal bloating to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR073540   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient was stating that, a few weeks after getting his Shingrix vaccine, his stomach started hurting and felt bloated. He said that lasted about a month and then went away.  The reporter didn't have any information in regards to lot number or expiration of the vaccine. The reporter did not consent to follow-up. No health care professional for follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022073189.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073540:Same reporter
Client received 0.5 ml of Typhim Vi in the Right thigh 05/07/19. Client is 15 months old. Minimum age for Typhim Vi is 2 years. Notified mother of child that dose was given in error as this vaccine is not licensed for children under age 2 years. Mother reports that client had no adverse reactions to the vaccine.
After receiving the vaccine my skin breaks out in hives all over my body when anything touches me including air. This started about 2 weeks after the vaccine and only affects my skin. I have never had allergic reactions in my skin in the past and I have not been exposed to any new environmental factors in the past six months other than the vaccine that was delivered intradermal.
After giving vaccine, injection site enlarged immediately. Appeared bruised.  Patient remained in pharmacy 15 minutes for follow-up.  Patient had flu shots in past history with no adverse reaction.  Injection site appeared to shrink slightly. Told patient to take Benadryl and to put ice on site. Told patient to follow-up with MD if problem persists or worsens.
Pt recv vax on 1/5/99; on 1/5/99 pt exp two seizures x 3-5 sec, fever (99.4)
pt received first dose of Pfizer COVID vaccine  and approximately 10 minutes later became pale and diaphoretic. He complained of nausea and feeling lightheaded. He was given two orange juices and 500cc normal saline administered . He was given 2cc(10mg) of ephedrine IV per Dr. Routine vital sign monitoring and an EKG were performed. The patient and his mohter declined EMS transport and decided to go to Hospital. He was seen there and dismissed to home that same day.
Patient received a pediatric dose of Pfizer vaccine, however, she was 15 years old at time of vaccination. She should have received an adult formulation dose of Pfizer vaccine.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) 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 reported as unknown. Vaccine was expired on 24-Oct-2021.  The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT ADMINISTRATION ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  No treatment medication details was provided.  patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which was colder than they should had been  The patients who were administered the vaccine that underwent temperature excursion