chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case is part of a cluster of three children who received DAPTACEL (lot number C3718AA) and each developed vaccination site and/or localized reactions. Initial report received on 27 April 2011 from a health professional. A 15 month old female patient, with no known allergies and no concomitant medications, received a fourth intramuscular dose of DAPTACEL (lot number C3718AA) at an unknown site and a fourth left deltoid intramuscular injection of ACT-HIB (lot number UH318AA, which corresponds to sanofi pasteur SA lot number G1103-1) on 25 April 2011. The patient had no illness at the time of vaccination. On 26 April 2011, the patient had swelling and firmness at the vaccine site (arm unknown). The patient's recovery status was unknown. Follow-up information was received from a health care professional on 27 May 2011. The patient's outcome was reported as recovered (date not reported). The events for the other two children are captured in cases 2011-02509 and 2011-02508. Documents held by sender: none.
acquired an extreme allergic reaction with red puffiness around my eyes; acquired an extreme allergic reaction with red puffiness around my eyes; 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 NOS), 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: DRUG HYPERSENSITIVITY (non-serious), PERIORBITAL SWELLING (non-serious), outcome "unknown" and all described as "acquired an extreme allergic reaction with red puffiness around my eyes".  Additional information: the patient had acquired an extreme allergic reaction with red puffiness around eyes after receiving the Pfizer vaccine series and COVID 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223992 same patient/reporter; different dose/AE;
This case was reported by a physician and described the occurrence of nodule injection site in a 10-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included eczema. Concurrent vaccination included ACTHIB (Sanofi) and PREVNAR (Wyeth Labs) both given on 1 December 2010. There were no concurrent medications. On 1 December 2010 at 17:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh. On 1 December 2010, immediately after vaccination with PEDIARIX, the subject developed a nodule at the injection site and a rash on the skin. The parents of the subject sought medical attention after the nodule persisted for one week. At the time of reporting the events were improved. The physician considered the nodule probably related to vaccination with PEDIARIX and stated that since the subject has a history of eczema, she was not certain that the rash was related to PEDIARIX although she said it was possible.
NERVE PAIN; COULD NOT LIFT ARM; ARM ACHED; DIZZINESS/FAINTING, NAUSEA.
Information has been received from a physician concerning an approximately 13 month old male who in early October 2004, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of MMR. The physician reported that the patient was thought to be well and without any known underlying condition. It had since been determined that the patient had a primary immune deficiency that could not be classified easily and that he had an antiviral T-cell function that was defective clinically. Three weeks after vaccination, the patient began to have chicken pox lesions appear followed by protracted diarrhea and profound malnutrition. The patient was treated as an outpatient with oral acyclovir and was not getting better. The patient was then admitted to a hospital and was not getting any better. The patient was then transferred to another hospital on 12/8/04 where he was treated with IV acyclovir and for 10 days prior to the report, foscarnet. The patient was reported to have hypogammaglobulinemia with leukopenia. He had a normal mitogen response. At the time of the report, the patient remained hospitalized. Although he was improving, through out the sixth week post vaccination course he has had new crops of chicken pox and was not healing normally from the lesions. At the time of the report, the patient had had lesions of chicken pox for four weeks and the reporter believed this was a case of antiviral induced resistance from acyclovir. The physician noted that he had specimens that tested positive for varicella zoster virus on 12/8/04 and that he though that the strain was the Oka strain that had a mutated gene. The physician also had specimens from the second reoccurrence of the chicken pox. The physician indicated an interest in sequencing the thymidine kinase gene to determine if a mutation exists or if there had been a reversion to the WTV. A product quality complaint was not involved. Additional information has been requested. Per follow up report received on 06/14/2005:  Patient still has not recovered. 10/5/06 Received Death Certificate which reveals COD as measles inclusion body encephalitis & immunodeficiency/ss
Infanrix given as 4th DTap 3 months after last Pediarix; Infanrix given as 4th DTap 3 months after last Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 12-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received first dose on 30th March 2022), Pediarix (received second dose on 16th August 2022) and Pediarix (received third dose on 20th October 2022).   On 27th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 27th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: Coordinator mentioned a 12-month-old patient was administered Infanrix as a 4th dose in a DTap series. Coordinator mentioned the patient had Pediarix Then at the patient's 12 month well baby checkup received the Infanrix on 27th January 2023 as an early 4th Dtap dose. No additional details provided. Did not consent to follow-up. Additional supportive information: the patient received 4th dose of DTap vaccine, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration
Extreme stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 02Feb2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccine. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) and experienced drug allergy. On 27Feb2021 at 10:00, the patient experienced extreme stomach pain. 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 event extreme stomach pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
she had severe tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she had severe tinnitus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 007J212A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2022, the patient experienced TINNITUS (she had severe tinnitus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TINNITUS (she had severe tinnitus) was resolving.            No concomitant medications were reported.  It was reported that patient had severe tinnitus after twenty eight hours on 27-Feb-2022. She states that she has tinnitus generally, but it's mild. She took Benadryl to sleep and she was feeling better on 28-Feb-2022.
after 11 days i couldn't move my hand and painful . the redness and hardness and itchiness. started to spread for the last four four days
pt recvd vax in lt arm & lt arm became swollen & red dx lt arm infected; rx w/ATB IV
pt exp exposure to varicella in MAY95 & mom vax 13JUN95 & 14JUN95 mom devel a pink rash & area around the inj site was red & sore (WAES95080243);11JUL95 pt devel a mild case of chickenpox w/50 lesions located on face & neck;no temp;
This spontaneous report as received from a nurse refers to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-MAR-2018 the 3 month old patient was vaccinated with a dose of M-M-R II (drug administered to patient of inappropriate age) (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneously for prophylaxis. No adverse events were reported. There was no product quality compliant reported.
Report redness and itchy at the injection along with swelling of the left supraclavicular lymph nodes.  Treatment-none. Outcome- itchiness resolved, redness improved-mild and lymph node swelling is improving.  Does not interfere with ADL.
CLT reported, not observed.  CLT received Booster 1 on 11/11/2021 Moderna. Three hours after vaccination client experienced intermittent dizziness for three-four hours and then it was gone. Clt did not report it to Provider and did not seek any treatment.
After MENACTRA facial angioedema - 8/19/14 lip swelling. Arm swelling and itching - 8/13/14. Arm swelling - local reaction 8-5-14.
I began having symptoms of intense pms approximately 12 days after 1st shot. I had the pms symptoms for 8 days and then had very heavy bleeding for 7 days . It was much more painful and much heavier than normal. After my 2nd dose I had even heavier periods that have been so painful. The bleeding is so heavy and so painful that I can?t leave my couch for the first 3 days of my period now.
Initially onset of tingling and numbness in thumb, 2nd, and 3rd fingers on day of vaccination. Shoulder aching within 24 hours of vaccination. Intermittent arm and finger numbness and tingling along with shoulder aching has progressively worsened over 10 days. In addition has had onset of axillary aching within the past three days. All symptoms significantly worse over the past 24 hours.
bacterial meningitis; paralysis; he ended up in a coma.; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced paralysis after getting the first dose of the vaccine, then was later diagnosed with bacterial meningitis. The patient said his doctors said it was a possibility that it was linked to the vaccine because it was the only thing he did differently that day. Symptoms came on quickly and he ended up in a coma. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Initially my toes were numb on both feet, and within a day quickly progressing to weakness and heaviness in legs and then numbness in fingertips.
At 12:54 pm 40 year old female patient stated she felt left side face numbness. Vital signs, b/p: 149/90, p: 113, o2: 96%, R: 20. Monitored and patient did not complain and further symptoms, but per unit manager to call emergency services to get transferred to hospital for evaluation.
Pt came into the pharmacy. Arm was red and swollen, but pt reports symptoms are improving. Counseled pt to use ice/ibuprofen/tylenol if needed.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with eighth report of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 19-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 18-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore, no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. The narrative was amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative was corrected.
16MAR93 10AM pt recvd DTP & on 18MAR93 9AM pt devel reddened area 7x10cm hot to touch; mom brough pt in;
Weakness of her left side that has gotten progressively worse.  Left facial droop, salivating, and trouble eating.  Not able to stand due to weakness.
ARM SWOLLEN, RED AND HOT TO THE TOUCH. PATIENT TRIED TYLENOL AND COLD COMPRESS WITH MINIMAL RELIEF, ADVISED TO TAKE ANTIHISTAMINE AND CALL PCP IF DOESNT IMPROVE
weakness; arm soreness; body aches; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Concomitant medications were not reported.Treatment information included ibuprofen.
Patient called and reported an 8 out of 10 pain scale that night and she was sick in her stomach, no sense of tingling at all but when asked where the vaccine was administered she measured three fingers from her the top of her shoulder and stated the immunization was given much higher than that. This event is likely due to the administration of the vaccine however it is not possible to tell for sure. The patients physicians office was notified and the patient was instructed to contact her doctor as well for follow up to ensure no permanent lasting injury was sustained. She stated the day of reporting that the pain was at 4-5 and had subsided tremendously.
3RD DOSE MODERNA COVID VACCINE GIVEN 11/17/21, #012F21A; 4TH DOSE MODERNA COVID VACCINE GIVEN 8/19/22, #060AA2A; pt resides in Healthcare and Rehab Center; pt had a positive COVID test in facility on 8/31/22 and passed away on the same day in the facility
achy deltoids for a day or so; This is a spontaneous report from contactable consumer. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients.  A female patient (reporter's wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EL8982) via an unspecified route of administration on 18Jan2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EM9809) via an unspecified route of administration on 08Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced achy deltoids for a day or so, otherwise no adverse reactions after receiving both doses of the Pfizer COVID-19 vaccine on 18Jan and 08Feb2021 (Batches EL8982 and EM9809, respectively). The events were non-serious. The clinical outcome of the events were not reported.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283957 Same reporter/drug/event, different patient
Strange taste of smell after first dose of vaccine; Strange taste of smell after first dose of vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), dose 1 via an unspecified route of administration on an unspecified date as dose 1,single for covid-19 immunisation. The patient's medical history included covid-19 two months prior to the vaccine administration. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced strange taste of smell after first dose of vaccine. The patient underwent lab tests and procedures which included covid-19 which was positive on an unknown date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
02/07/22 presents to Birth Center Triage for " 38w3d " "blood tinged discharge and some contractions". "No pertinent past medical history"
Patient vaccinated as indicated above and tested positive for COVID-19 on 8/27/21.
intense dizziness; fatigue; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 12:00 (Lot number: EN6206) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies". The following information was reported: DIZZINESS (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "intense dizziness"; FATIGUE (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "fatigue"; PAIN (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "body aches". The events "intense dizziness", "fatigue" and "body aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, fatigue, pain.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The patient took other medications in two weeks which included men's multivitamin and probiotic. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. Intense dizziness was experienced for first 3 weeks after vaccination while fatigue and body aches were first 5 days after vaccination.  No follow-up attempts are possible. No further information is expected.
Fever, red, hot swollen arm at injection site. Genital Herpes outbreak within 1 week of vaccination (generally patient has 1-2 outbreaks in a 5 year period).
Varicella rash in left arm/chest/buttocks/legs 48 hrs after vaccine. Fever >100 lesions TX: anti-itch baths and calamine lotion
Slightly raised rash that was morbilliform, diffuse  on anterior chest first then back, then right flank. Only on trunk no appendicular issues. Some of this dermatogrqohic in the scalp and base of neck. When scratching in office, there was a post auticular rash. In office there was flank rash and truncal issues too was increasingly dermatograohic
Headache, Myalgia, Fever, NauseaVomiting, cold, chills Narrative: