chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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. On or about 06-NOV-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term 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-SEP-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash, which was diagnosed as herpes zosters. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. 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.
administering vaccine punctured skin of left upper arm with needle, noted syringe did not contain any of the required dose of Pfizer vaccine and withdrew needle without engaging plunger. then administered confirmed dose of Pfizer vaccine in left deltoid. No adverse effects noted following dose administration.
First, it became difficult to swallow.  Then my eyes became puffy and oozed whitish pus.  A cough started.  Next vomiting.
Red swollen site -lasted 3 days White spotted rash under skin on left arm only.  -lasted less than 24 hours Rash was itchy burning and painful- lasted less than 24 hours  Low grade fever
Large, localized reaction at injection site characterized by erythema, warmth, and pruritus involving the left upper arm, which became apparent within 4 days of the vaccine.
23JUL97 t101 ax;24JUL97 throat sore, white patch blister;PCN ordered given x 24hr;not better noticed blisters on inner buccal area;no more fever;sores disappear;
Immunizations were given about 1pm on 4-30-03. Mother states that about 7:30 that night a rash started behind her ears and progressed to the back, belly button, and then face. She was also coughing and mother made an ER visit. Denied trouble breating. Mother states that they gave pt a shot to counteract the reaction and the doctor stated that what happens on the outside usually happens on the inside so patient was given Tagamet and Benadryl.  Sent home with Benadryl 1 1/2 tsp Q 4-6 hours and to return if worse.  Pt followed up with her primary doctor on 7-1-03 and was told she had generalized reactions from either MMR or DTaP and pt should not receive any more of either of these vaccines.
Patient dev deep quadricep abscess requiring surgical I&D on 5/12/07. Seen for presumed (R) quad granuloma 4/21/07 and surg. consult 4/9/07. 6/4/08-records received for DOS 4/9-5/22/07-On 5/11/07-Incision and drainage of right thigh abscess, culture negative. C/O infection site granuloma that developed into muscle abscess in right thigh. Firm mass on right anterior thigh occurred in March 07 several weeks after a vaccination on that side. No fever no pain.
very bad neck-ache / electrical shocks / inside her head and neck area; headache/up the back of the neck to the top of her head/electrical shocks / inside her head and neck area; electrical shocks; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose in November 2020, for tolerance refer case US2021102746).   On 17th April 2021, the patient received the 2nd dose of Shingrix. On 18th April 2021, 1 days after receiving Shingrix, the patient experienced neck pain, headache and electric shock. On 21st April 2021, the outcome of the electric shock was recovered/resolved. On 25th April 2021, the outcome of the neck pain and headache were recovered/resolved.   It was unknown if the reporter considered the neck pain, headache and electric shock to be related to Shingrix.  Additional details were reported as follows: The patient reported for herself. The patient received Shingrix vaccine in the left arm and had very bad neck-ache, a headache that went up the back of the neck to the top of her head and electrical shocks that could feel inside her head and neck area. The patient reported the electrical shocks lessened each day and were gone by Wednesday and neck pain and headache diminished each day and was completely gone by Sunday. The patient did not consent to follow up and did not give permission to contact HCP (health care professional).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102746:Same reporter
Large swelling and very painful inside arm above elbow pit. Slight Fever. Headache. Pain got worse and after advice of helpline decided to go to Emergency Room.
Pain, stiffness, severe chills and rigor, HA, vomiting, joint pain - severe flu-like symptoms without fever - pt states similar to Interferon shots.
very painful / got bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   The reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient stated he/she received shingles vaccine and it was very painful . The patient got bad with the vaccine. The follow up would not possible as no contact details was available. For tolerance of second dose refer linked case US2021AMR249896, reported by the same reporter, for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249896:Same reporter, 2nd dose
This spontaneous report was received from a nurse regarding a currently 12-month-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX injection (lot # R011806 and expiration date: 23-APR-2018) (dose and route were unknown) for prophylaxis following a temperature excursion (product storage error). There were no adverse effects (no adverse event) reported. The temperature and timeframe excursion were at or above 15-degree Fahrenheit to 46-degree Fahrenheit (-9 degree Celsius to 8-degree Celsius) (19.3 Fahrenheit) for 40 minutes. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1812USA001527.
More prominent,severe flu like reactions; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt date: 03-Feb-2023. Reporter's Comment: The pharmacist for a retail pharmacy chain mentioned that she would get reports about a cluster of patients who had more severe flu like reaction after getting vaccinated with Shingrix.  She wondered if it was specific to a certain lot because the reports always seem to come in clusters. She did not have any details but said she would keep track in the future and report specifics in the future. The reporter said there was a cluster of patients, in probing her she said she thought it was 2-4 patients who reported more severe flu like reactions (more severe than she normally heard from patients). The reporter did not have specific patients to share, but she knew that all the patients were older than 50 years of age (approved age for Shingrix), but she did not have specifics ages. The reporter did not consent to follow up. Additional Supportive Information: The case is linked with case US2023AMR018990, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR018990:Same reporter.
Delayed immune response; This is a literature report. A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), intramuscular (Batch/Lot number: unknown) as right deltoid region for tetanus immunisation. Relevant medical history included: "acne vulgaris" (ongoing). Concomitant medication(s) included: DOXYCYCLINE taken for acne; SPIRONOLACTONE taken for acne; DAPSONE taken for acne. Vaccination history included: Bnt162b2 (dose 1, intramuscular injection into the left deltoid region), administration date: Dec2020, for Covid 19 immunisation, reaction(s): "Fall/wound"; Bnt162b2 (dose 1, intramuscular injection into the left deltoid region), administration date: Dec2020, for COVID-19 immunisation, reaction(s): "Fall/wound". The following information was reported: THERAPEUTIC RESPONSE DELAYED (medically significant), outcome "recovered", described as "Delayed immune response". The patient underwent the following laboratory tests and procedures: immune complex assay: protective post-vaccination antibody levels, notes: immunoassay for tetanus; protective post-vaccination antibody levels, notes: immunoassay for diphtheria; sars-cov-2 antibody test: it was positive for antibodies to the spike (s1), notes: protein of the SARS-CoV-2 virus. repeat serological testing was done using this assay at day 57 after the completion her COVID-19 vaccination series; significant for negative igm and negative igg to, notes: the Spike (S1) protein of the SARS-CoV-2 virus. (Sensitivity 100%, Specificity 100%); sars-cov-2 test: negative, notes: Additional serological testing.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events THERAPEUTIC RESPONSE DELAYED and the vaccine (BNT162B2 )cannot be excluded "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.",Linked Report(s) : US-PFIZER INC-202101883226 same article/drug/patient;different event
Left side of face paralysis began 2/25/17. Diagnosed with Bell's palsy. Treated with oral steroids and antivirals (Acyclovir and Prednisone).
We were informed by PCP; after leaving the health dept pt told her aunt her back hurt and felt funny; aunt found red rash that was warm to touch on pt's back. Went to see PCP and was given Benadryl on 8/31/04 I called the home and was told the rash was gone and pt is fine.
got COVID; got COVID; This is a spontaneous report from a contactable pharmacist.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. on an unspecified date of 2021 the patient experienced that he got covid.The patient got his first does in Feb and then got COVID and was hospitalized and treated with Remdesivir. The patient did receive his second dose last week. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: got positive on an unspecified date of 2021. Therapeutic measures were taken as Remdesivir  as a result of got covid. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like vaccination date and COVID infection date needed for a full meaningful medical assessment
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L025738, expiry date: 14-AUG-2017 (dose-0.5ml, strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of influenza symptoms in a male subject aged between 40 and 49 years old who was vaccinated with Flu vaccine (manufacturer unspecified). On an unspecified date in September 2011 the subject received a dose of Flu vaccine (details unknown). On 19 September 2011, less than one week after vaccination with Flu vaccine, the subject experienced "full blown" influenza symptoms. The healthcare professional reported that the subject almost went to the emergency. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Flu vaccine. The healthcare professional reported two subject's who experienced adverse events following vaccination with Flu vaccine. This is case 2 of 2 (see case ID A0945847A for details of the other reports).
TOOK VIVOTIF AFTER PLACING IT IN THE FREEZER; A spontaneous case report was received from a nurse on 12-Sep-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201909-000734 (PVX2019-2370; male) and PVX201909-000735 (PVX2019-2371; female) were created and cross-linked in the database.  This case report (PVX2019-2371) described an elderly female consumer (over 65-year-old) who "took Vivotif after placing it in the freezer" (PT: Product storage error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif, which was kept in the freezer for 12 hours at unknown temperature. The remaining doses were kept in the refrigerator. The dosage dates remained unknown.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.; Sender's Comments:  US-PaxVax Berna GmbH-PVX201909-000734:
This spontaneous report has been received from an administrator and refers to a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2017, the patient was vaccinated with ROTATEQ orally, 1 dose, lot # N003984, expiration date 19-NOV-2018 or lot # M044397, expiration date 20-JUN-2018. The specific lot number of vaccine administered to the patient was unknown by reporter. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at or above 32 degrees Fahrenheit (F) up to 35 F (35.4F) for 45 minutes. Digital data logger was involved. There were no previous excursions reported.
My left ear started  popping up. Went to my primary doctor and prescribed  ear droops. This problem continue  after treatment. My hearing abilities  decreased due a this  adverse effect.
About 2 hours after receiving the 2nd of 2 SHINGRIX shots, the patient experienced excruciating, debilitating pain at the injection site, radiating down the entire arm. The 2nd shot was given 60 days after the first shot. Patient declined medical treatment. Patient's daughter, a nurse, gave the patient 800mg of ibuprofen. Another 800mg dose was given 8 hours later. The pharmacy was notified the next day. Pharmacist was told that the patient was sleeping. Pharmacist strongly suggested that patient's spouse call their PCP. Upon followup several hours later, pharmacist was notified that patient was doing much better and was awaiting a callback from the PCP.
Within a few days of the first vaccine I noticed I was developing tinnitus.It quickly became painful an debilitating. I called my Primary and asked for an audiology referral. On April 8th I had my audiology appt. She ran tests and referred me for hearing aids.  The second vaccine was received on 04/27/2021. My symptoms didn't change.
Onset - fever, chills, body ache 4 hours after injection. Symptoms escalated Sunday to weakness, dizzy, headache. Treated with ALEVE; went to work on Monday and returned home with severe body aches, fever and fatigue.
Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past when fever went up extremely quick. I did not measure my body temperature because I immediately ran under the blanket. Icy-cold hands and feet, even after my body temperature seemed to stabilize. I fell asleep but not a restful sleep. I woke up after 2.5 to 3 hours with the feeling that it was morning, but in fact it was between 2am and 3 am. At that point I felt the worst part had gone, I felt weak and with muscle aches but I could drink water and go back to bed. I did not have a restful sleep all night and I woke up may times. By the morning I was tired but no fever.
anxiety, c/o "weird sensation like liquid on lips" patient later reported to assessing nurse that the mouth symptoms may have been related to hand sanitizer Narrative:
10/7/05 Rash described as 'little red spots' on trunk, stomach and back as well as thighs and calves of both legs. Rash began day after 1st oral typhoid pill pt reports rash resolved soon after completing 1 week course of oral typhoid. Pt reports taking benadryl to relieve symptoms. Mild shortness of breath was decribed.
This spontaneous report as received from two health professional (N.P. (nurse practitioner) and R.N.P (registered nurse practitioner)) refer to a 21 years old female patient. The registered nurse practitioner stated patient received doses of HPV vaccine;the nurse practitioner stated the vaccine was unspecified between GARDASIL or CERVARIX. The registered nurse practitioner reported that the patient received first dose of in July 2012, second dose in November 2012 and third dose in December 2012. The registered nurse practitioner and the nurse practitioner stated an additional dose was administered today, 11-MAR-2013, 0.5 ml, intramuscular. N.P. stated not all doses administered in OB/GYN office; office had another section for pediatrics where earlier doses may have been administered. No adverse effect reported. Additional information has been requested.
Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, cold sweats, and throat swelling sensation. Patient's temperature was low at 95.8 to 96.2.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
sore arm; 63 days since first shot without having second shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (sore arm) and PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot).            This case was linked to US-MODERNATX, INC.-MOD-2021-117989 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117989:Wife case
Macular, red, slightly itchy rash on both arms. Temp 98, BP 118.70, pulse 68. Rash gone 3 days p/MD gave Kenalog IM & Tavist.
Patient got a booster dose from vial punctured more than 12 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021 at 9:29 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021 at 9:29 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before). On 09-Dec-2021 at 9:29 AM, EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications Included medications for Diabetes. No treatment Information was provided by the reporter.  Reporter stated that on 07-Dec-2021 the vial was initially stored in the refrigerator and on 08-Dec-2021 at 11:40 AM, the vial was first punctured and stored in refrigerator. The vial did not undergo any temperature excursions.