chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR. Concurrent medical conditions included esophageal reflux, microtia and ventricular septal defect. Relevant medical history included: "bilateral microtia with absent ear, EAC small muscular VSD, esophageal reflux". The reporter was unable to clarify the medical history details. Concurrent vaccination included HIB (non-gsk); Sanofi; unknown given on 13 May 2010. Concurrent medications included AXID and PREVACID. On 13 May 2010 at 16:20 the subject received 2nd dose of PEDIARIX (.5 ml, unknown route, left thigh). On 13 May 2010 the subject received 2nd dose of PREVNAR (unknown route, right thigh). Less than one week after vaccination with PEDIARIX and PREVNAR (either 13 May 2010 or 14 May 2010), the subject experienced injection site redness, swelling injection site and fever (rectal temperature of 102.2 degrees Fahrenheit). The subject was treated with warm compress and TYLENOL. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with PEDIARIX and PREVNAR.
anaphylactic reaction; Initial information was received on 05-Aug-2020 regarding an unsolicited valid serious case (via GMIPROD) from the pharmacist.  This case involves a female patient (age was not reported) who experienced anaphylactic reaction, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient received Adacel vaccine on an unknown date of 2006 with batch number C2454AA for prophylactic vaccination and no adverse event was reported post vaccination.  The patient's medical history, past medical treatment and family history were not provided.  At time of reporting, the patient's allergy was under investigation at allergy clinic.  The patient's concomitant medication was not reported.  In May-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6539AA and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.; Sender's Comments: This case concerns a female patient of unknown age who presented with anaphylactic reaction after vaccination with ADACEL. The time to onset is unknown. Also the patient received same vaccine in the past and had no adverse event post vaccination.  Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
pt c/o of chest pressure @ 1510. chief called at 1514. ems/911 arrived at 1527.  pt axox3. no loc. @ 1514 bp 130/70. hr 79 RR 18. o2 96% RA.  pt assessed and observed for 15 min for reaction.  EMS did EKG in ambulance. pt signed out AMA. drove off in personal vehicle.
Erythema, swelling, tenderness (4" in diameter) of left arm at site of injection.
chicken pox lesions appeared 9mos p/vax given;had 20 lesions, no fever or other sx present
Patient presented to the ED on 1/27/22 with complaints of 3 weeks of fatigue, headache, abdominal pain, and decreased appetite. He tested positive for COVID on 1/27/22.
Superficial cutaneous hives; resolved with Benadryl, no recurrences.
Lethargy Fever of 103.4 Numbness and tingling to elbows and fingertips on the left side (with good capillary refill), and numbness and tingling from the forearm down to fingertips on right arm (with good capillary refill)
Patient had 1st Gardasil vaccine administered on 8/20/07 -  called 8/22/07 c/o rash over entire body with itching - taking Benadryl with some relief. To see PCP today at 2:45pm.
nausea, diarrhea, vomit x 1, low grade fever 10 days after vaccine given
booster; prickly skin; headache; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; SKIN DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "prickly skin"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; DIARRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "diarrhea".   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
No adverse outcomes at this time. Patient was vaccinated with a 3rd dose of Moderna per Show me Vax. Patient stated that this was her first dose.  Pt arrived to today for a COVID vaccine. Pt states that this will be her first Covid vaccine. In good faith. pt was vaccinated with the Moderna at this time. When this nurse went to enter the vaccine information into SMV it appeared that pt had 2 doses of Moderna from in February and March 2021. When asked about this, the pt denied ever being vaccinated with any COVID vaccine and stated that "It had to be my daughter. She has done this in the past and she does it because she does not have insurance." She stated that her daughters name is which is very similar to her own name and birthday. This nurse called and they stated that they do not have a copy of the pts ID but did have signed consents. Consents were faxed to my office. The signatures were small and grainy, but appear alike. Pt continues to deny being vaccinated in the past. health department and was instructed to enter the dose given and write a note about what occurred in which this nurse did.
1. COULD NOT STAND UP 8 HRS LATER 2. 4/29/21 COULD NOT TALK RIGHT, LEFT ARM ERATIC, CHILLS, BOWEL & BLADDER ISSUES , WENT TO ER 3. 5/22/21 LIGHT HEADED ,DIZZY  ,CHILLS BOWEL & BLADDER WENT TO ER  4 . 5/22 /21 TO 8/17/21 ON AND OFF LIGHT HEADED AND DIZZY BOWEL & BLADDER ISSEUES EARLY NOT BAD NO MORE JUST LIGHT EFFECTS NOW AND THEN
Guillain-Barré syndrome - left arm (vaccine given to right arm) Slight loss of sensitivity in left leg.  Occured around 2 weeks after vaccine.
I developed a rash under my left arm on Feb.1,2021. By Feb. 3, it had spread to under my right arm, my trunk, back and inner thigh area. The rash exhibited a classic pine tree pattern with an initial herald patch under the left arm. The rash is consistent with a diagnosis of Pityriasis Rosea. Over the last 5 days, the rash has begun to fade on the trunk and back and the herald patch has disappeared during the laast 24 hours. A low level if itching has been treated with 25 mg. of Benadryl taken at bedtime.
got my first shot 4/29. is it too late now to get second?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got my first shot 4/29. is it too late now to get second?) 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 29-Apr-2021, 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 (got my first shot 4/29. is it too late now to get second?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got my first shot 4/29. is it too late now to get second?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided by the reporter. Treatment information was not provided.
now feeling much better; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 3 days ago and was now feeling much better. The patient enquired was it safe to have an intense gym workout today or do the patient need rest following the vaccine for a specific period. The patient enquired about exercise after Shingrix vaccine. The pharmacist had replied that there was nothing specific in the prescription information regarding exercise restrictions, beacause patient care was individualized, a healthcare provider should always be consulted to evaluate your health and provide guidance to you based on your medical history. The reporter did not provided the details and asked if he/she can resume exercise today and stated that he/she could contact doctor.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since February 2017, the patients were vaccinated with the improperly stored (-14 degrees Celsius to -10 degrees Celsius for 153 hours and 39 minutes) doses of VARIVAX (lot # M047662, for prophylaxis; dose, route of administration and expiration date were not reported) reconstituted with the properly stored sterile diluent (dose, route of administration and expiration date were not reported). No adverse effects and previous excursion were reported. The call was made because of data logger. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001227:
8 days after first vaccination site immediately below injection area in right arm became itchy, swollen, red and tender.  Redness has been spreading.
Woke up this morning with body aches and chills.  Didn't sleep good last night because of arm and shoulder pain.  Nausious and diarrhea.
Received TYLENOL at home. Pt. received MENACTRA on R deltoid on 5/1/09. About 30 hours later on 5/2/09; mother noticed redness, induration pain and swelling about 4" below the injection site. When seen in the office on 5/4/09; there was an area of erythema with heat point of tenderness around a 2 mm papule which was about 4" below the injection site. Mild induration still present. Erythema spread all around that papule.
Patient experienced tightness to the left arm, felt the need to take deeper breaths, chest heaviness, nasal stuffiness, bilateral hands tight and swollen, redness/blotchiness to bilateral upper extremities, itchy skin, nausea.
temperature excursion for punctured IPOL, fridge has been dipping to 35 F occasionally and product reached 35 F lowest temperature reached 33.98 F (1.1 C) with no reported adverse event; IPOL has been administered post excursion with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient and reporter reported temperature excursion for punctured IPV (VERO) [IPOL], fridge has been dipping to 35 f occasionally and product reached 35 f lowest temperature reached 33.98 f (1.1 c) with no reported adverse event and IPOL has been administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Immunisation; influenza vaccine live reassort 3V (Flumist) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.  Caller reported that punctured IPV (VERO) was exposed to temperature excursion, fridge has been dipping to 35 f occasionally and product reached 35 f lowest temperature reached 33.98 f (1.1 c) with no reported adverse event (product storage error) (unknown latency).  On 12-Oct-2023, the patient was administered a standard dose 4 of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot W1A191M, expiry date- 16-FEB-2025 ) via intramuscular route in the left thigh for Immunization post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller stated that their fridge has been dipping to 35 F occasionally. The caller was unsure how often or how long the product reached 35 F. She said the temperature would come right back up. However, on 11OCT2023, the lowest temperature reached 33.98 F (1.1 C). The caller was unsure how long the product was out of range.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
Severe Headache ("Felt like someone hit me with a bat in the head"; water/tylenol given; sent to ED - given Toradol; later: chills; resolved per follow-up call prior day.
Swollen axillary lymph nodes in each arm, fatigue, arthralgias, fever, chills. Resolved after 5 days.
Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Severe, Additional Details: Brief loss of consciousness
"got the 2 shots and still got COVID"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("got the 2 shots and still got COVID") 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 COVID-19 ("got the 2 shots and still got COVID"). At the time of the report, COVID-19 ("got the 2 shots and still got COVID") outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: This case concerns a patient with unknown age and gender, no relevant medical history, who experienced the non-serious event of special interest of COVID-19. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.
No adverse event; 35 patients received a 0.25 ml (25 mcg) dose as booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml (25 mcg) dose as booster) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 microgram. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml (25 mcg) dose as booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml (25 mcg) dose as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml (25 mcg) dose as booster).    No concomitant product use was reported.   Patient administered booster dose.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
About 20 minutes after receiving the injection I experienced a pounding heart, warmth in my upper body and tingling around my lips and a feeling that something was not right. I was driving home at the time and immediately turned around and drove myself to the ER.
Tired, sore arm, rapid heartbeat, swollen lymph node (left armpit)
Information has been received from a Licensed Vocational Nurse (L.V.N.) who reported that, on multiple unspecified dates, multiple unspecified patients were administered improperly stored ROTATEQ (lot # L020861, expired date 25-JAN-2017, dose and route not reported). No adverse effect was reported. The vaccines were at temperature 33 F for 74 hours. There was no previous temperature excursion. This is one of the several reports with the same reporter. Additional information has been requested.
Pt. received PNEUMOVAX & FLUVIRIN on 9.22.11, wife reports pt.'s arm hurt, felt lightheaded, fainted twice & had 2 seizures 2 days after vaccination. Pt. was never taken to hospital or Doctor.
pt presented to ER 24 hrs post vax; sx of irritability & t40.5C; started on APAP & Rochephin;
emergency appendectomy; This is a spontaneous report from a contactable pharmacist received from medical information team and Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jun2021 and "underwent emergency appendectomy (which was not related to the vaccine as per reporter) so the patient missed his schedule for the second dose of the vaccine". Reporter wanted to know if the patient can still get the second dose of the vaccine. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is no reasonable possibility of causal association between the event Appendix disorder and the suspect product BNT162B2 .The case will be reassessed if additional information becomes available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 21:00 as dose 4 (booster), single at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive 6 days after finished paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Information was received from a third party claims management company who represented a pharmacy. A female of unknown age received PNEUMOVAX 23 (Lot # L012215, Exp. 13JAN2017) on 05-OCT-2015 and shortly after developed a rash at the injection site. The pharmacy quarantined the vial. The outcome of the rash at the injection site was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In February 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-FEB-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient left home after 15 min and was feeling fine. A couple of hours later she felt chills, pain at site and high fever according to sister she had 106.
Patient received first does of pfizer and second dose of moderna, patient checked that his first dose was moderna on the cdc check list. on his vaccination card it said first does of moderna but on vaccine site it shows first dose  was pfizer.  patient had no adverse reaction or signs or symptoms while he was on site. no treatment was given.