chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 1/2 wks pain in rt shoulder joint; shooting pain over shoulder blade @ time of vax; bruised feeling on deltoid p/vax 3-4 days;
Dose administered from a vial punctured greater than 20 times; Dose administered from a vial punctured greater than 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No Treatment medications reported.
Patient describes two days post vaccine had pain on left foot, then both feet. Reports primary care doctor noted loss of reflexes in legs. Pain progressed to involve both calves.  EMG on 10/26/2016 and on 5/25/2017 both show axonal polyneuropathy.
I started having muscle pain, sore back, then moved into upper respiratory issues like sneezing, congestion, cough. Then I picked up the sore throat. On the 9th we went to urgent care and was told we had a cold. The next morning we tested positive with COVID-19. I took LAGEVRIO 200mg capsules. It's been working and I feel better everyday. My voice is a bit raspy right now.
Initial information received on 15 May 2008 from a literature article.  The following case report information is verbatim from the literature article.  "We present a patient who developed an immediate systemic anaphylactic reaction to the inactivated FLUZONE."  "A 37-year-old male returned to the immunization clinic complaining of a warm sensation over his entire body 15 minutes after receiving a 0.5-ml intramuscular injection of FLUZONE; Aventis Pasteur.  He also experienced face tingling and redness, pruritis, postnasal drip, and lip numbness.  He had a localized cutaneous reaction at his right deltoid injection site.  He denied chest tightness, shortness of breath, and wheezing.  Based on his symptoms, he was given 10 mg of cetirizine and observed.  Over the next 15 minutes he developed lip swelling, worsening facial flushing, and heartburn with audible belching.  He was then treated with 0.3 ml of epinephrine intramuscularly and 150 mg of ranitidine orally.  His symptoms resolved over the next 30 minutes."  "His past medical history was significant for a 4x4 cm right arm localized reaction to FLUZONE (unknown manufacturer) given four years prior that occurred within 15 minutes.  He had received other immunizations in the past without any adverse effects.  He denied food allergies including eggs and gelatin."  "The FLUZONE vaccine that our patient received contained hemagglutinin representative of the three relevant influenza strains.  It was prepared from influenza viruses propagated in chicken eggs.  It also contained 0.5% gelatin (0.025 mg) which acts as a stabilizer and the preservative thimerosal, a mercury derivative at 25 micrograms of mercury per dose."  "As part of his evaluation, the patient returned to the clinic on a separate day for skin prick testing.  He was skin tested to FLUZONE, native egg (white, yolk, and whole) and gelatin (Jell-O sugared gelatin, Kraft Foods).  His skin testing response to FLUZONE was positive (3 x 4 mm wheal and 5 x 7 mm flare), gelatin was positive (3 x 4 mm wheal and 5 x 5 mm flare) and egg was negative (egg white: 0 x 0 mm wheal and 4 x 4 mm flare; egg whole: 2 x 2 mm wheal and 3 x 3 mm flare, and egg yolk: 2 x 2 mm wheal and 4 x 4 mm flare).  His histamine-positive control was 4 x 5 mm wheal and 26 x 30 mm flare, and the diluent negative control was 0 x 0 mm wheal and 0 x 0 mm flare.  Results of concomitant gelatin skin tests on 2 control subjects (clinic staff) were negative (0 x 0 mm wheal and 0 x 0 flare).  Immunocap specific IgE testing to egg (white, whole, and yolk) and gelatin were negative (<0.35 kU/l).  IgE immunoblots were performed with 2 cord blood serums and the patient's serum at a 1:20 dilution against 20 micrograms of the FLUZONE.  The patient's IgE immunoblot showed a protein band at 100 kDa which is similar to the molecular weight of gelatin protein, a 68 kDa protein which is similar to the molecular weight of hemagglutinin protein from FLUZONE, and a 45-kDa protein band that is similar to the molecular weight of ovalbumin protein from chicken embryo/egg.  These IgE immunoblot bands were not found on the 2 cord blood non-atopic serum specimens."
Cellulitis on left deltoid where Tdap was given.  Area hot, red. swollen.  Smaller area of redness with heat on right deltoid where Menactra was given.
This spontaneous report was received from a nurse practitioner concerning a 20 year old patient of an unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On unknown dates, the patient was vaccinated for the first and second dose of the GARDASIL (strength, dose, route, lot# and expiration date) for prophylaxis. After that, on 26-MAR-2016, the patient received the third dose of the human papillomavirus series with GARDASIL 9 (strength, dose and route were unknown) lot# L019297, expiration date 18-AUG-2017, for prophylaxis. No adverse event effect was reported. No product quality complaint was involved. Additional information has been requested.
Right arm, where gardasil immunization was given, developed red rash on upper and lower arm. Still there and slightly worse after 10 days. First noticed at day 2.
Red at injection sites after injections. Evening of injections whole body itching, felt pain and burning at same time on back of left arm. Home from school on 2/17/16, back of arm very large hard and welled. Discussed concerns with Health Officer who advised to go to PCP and take Benadryl around the clock for 24 hours.
Pt recvd 1st Engerix-B vax 26MAR91 & devel mild joint pain, h/a & lethargy for the first day; 26APR91 given 2nd dose of Engerix-B & devel joint pain, h/a, & lethargy x 2 days;
six minutes after receiving vaccine patient complained of feeling as if his throat was closing up. Pt appeared pale and clammy. Vital signs BP 150/100, Heart rate 142, PO2 99.  2 doses of EPI given, EMS called. Pt was transported to Hospital.
received 4 doses of DTaP before the age of 2 years, with no reported adevrse event; Initial information received from on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2  years old patient who received 4 doses of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTaP) before the age of 2 years, with no reported adevrse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported in unknown administration site for immunization.  It was reported that the patient had received 4 doses of DTaP before the age of 2 years, with no reported adevrse event (inappropriate schedule of product administration) (unknown latency)   Action taken : not applicable.  Outcome: unknown   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.; Sender's Comments:  01188572:
Urticarial rash of right thigh, persisted for about 24 hours.
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 18-JAN-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX injection (expiration date 24-DEC-2016; dose, site and route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Stress; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STRESS (Stress). At the time of the report, STRESS (Stress) had not resolved.            Concomitant medication was unknown.  On an unknown date, the patient experienced very stressed. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  Treatment medication was unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt related the following about 4 hrs p/recvd vax; had difficulty swallowing; ha da red ring around inject-site of Td; seen by MD gave some DPH w/in 24 hrs felt fine & red ring was gone;
Infant developed rash, hive-like lesions, on face & trunk 2-3hrs p/receiving vax; Lesions appeared when child cried & was warm; Lesions resolved when child peaceful; Mom denies fever; Scenerio was repetative & continues;
The patient  is a 56 y.o. female with a past medical history of DM2, asthma, HTN, chronic pain, systemic lupus erythematous, and fibromyalgia who presents to the BHL ED with a complaint of shortness of breath, cough, and fever that started 4 days prior to admission. She has associated mild chest pain with inspiration and a headache; otherwise, she denies any associated N/V/D, lost of taste or smell.   She tested positive  for Covid at the clinic  ,12/8/2021.The patient received 2 doses of Covid vaccines and was due for her booster.  She will be admitted to hospital medicine for treatment of symptoms.
Employee has had a sore, stiff left arm and neck since administration of the Influenza vaccine since November 5, 2015.
A spontaneous report was received from a consumer concerning a female patient (height: 61.0 inches; weight: 80.0 pounds). Patient would get sick three times a year during spring, summer and winter. Patient received nasal FLUMIST (intranasal) in 2011 and 2012 and nasal FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient would get the flu. The patient stated that since taking the FLUMIST, her daughter would get a cold once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration. The outcome of the events of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) was unknown. The company physician assessed the events of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) to be non-serious. Corrected report on 08-Nov-2016: Suspect product FLUMIST was added. Dosing regimen was corrected. Associated case ID was added. Narrative updated.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:07 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.17. Concomitant products were not provided. Batch 031L20A on 14-Feb-2021 under gone Excursion time was 09 AM, 10 AM, 11 AM and 2 PM temperature was 32,32,32 and 37 respectively, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
3-12-21 redness and progressively gotten worse. Took tylenol and was icing compresses Recommended  antihistamine, to ice 10mins on/10mins off, and to draw a line around the affected area to monitor changes; caller verbalized understanding.
Patient given MMRV instead of MMR vaccine, so was given an extra dose of varicella.  Mom has been contacted to check on patient and advised of error, have not heard back from her as of this filing.
Vaccine caused a change in menstrual cycle.  My cycle started early (10 days after vaccine) and lasted 18 days - up until I received the next dose of the vaccine.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-JUL-2013, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
With in six hours after vax, marked pain occured in arm injected and pt wrist became painful and swollen on awakening, followed by left wrist hours later. Both wrists were increasingly swollen, red, tender, malaise increase persisted for > 2 months, pt had known RA for > 30 years that had been under complete remission for > 15 years prior to present event.
pt recv vax & several hr post vax on the day of vax pt exp severe abd pain;pt will be evaluated by MD; sx cont;
fainted after the administration; Information has been received from a field representative, referring to a female teenage patient between the age of 11-12 years old. The patient's concomitant medication and drug reactions/allergies were unknown. The patient had no pertinent medical history.  On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTap), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as unspecified meningitis vaccine) and final dose of unidentified Merck hpv vaccine (name, strength, dose detail, route of administration, lot number and expiration date of all suspect drugs were not reported) for routine vaccination.  On the same date after the administration, the patient fainted. It was unknown whether any lab diagnostics or studies were performed or not. The patient did not seek medical attention. It was reported that the vaccines were not discontinued. The outcome of faint was reported as recovered after resting on the exam table. The causality assessment was not provided.  Upon internal review, the patient fainted was considered as medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA003067:
every time i take something to drink i have to use the bathroom immediately; feels sick as a dog; barely can walk; body aches; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Medical History Information not Reported.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches). At the time of the report, BOWEL MOVEMENT IRREGULARITY (every time i take something to drink i have to use the bathroom immediately), VACCINATION COMPLICATION (feels sick as a dog), GAIT DISTURBANCE (barely can walk) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.
Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Bilateral intermittent tinnitus / ranges from low hum to high screech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6205) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: to PN; "Topical adhesive allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; ESCITALOPRAM; TEMAZEPAM; VALSARTAN; VITAMIN C; VITAMIN D NOS. Past drug history included: Claritin, reaction(s): "Drug allergy"; Bactrim ds, reaction(s): "Drug allergy". The following information was reported: TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Bilateral intermittent tinnitus / ranges from low hum to high screech". It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that three days after vaccination the event was experienced.  No follow-up attempts are possible. No further information is expected.
UVEITIS IN THE RIGHT EYE TATTOOS WERE EXTREMELY INFECTED, THAT THEY WERE OPEN WOUNDS DIAGNOSISED WITH AUTO-IMMUNE DISEASE (SARCOIDOSIS) LOST HEARING IN BOTH EARS - APRIL 2022
The day after I got my vaccine, I started getting an itch. On scratching the itch, I  get hives like bumps. This comes and goes on various parts of the body. It is 12 days since I got my short and the itch and hives are continuing. It is irritating, otherwise I am fine.  The vaccine was administered at Health Department.
Within 5 hrs of vaccination I had confusion severe... and distant ion .. temp 102.6 .. chills .. generalized pain severe
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (strength reported as 5mcg/0.5ml, lot # M031574, expiration date 11-NOV-2018; dose and route of administration were not reported) for prophylaxis. The vaccine was improperly stored in the temperature from 47 Fahrenheit (F) to 77F for a few times, 5 hours in total. No adverse effects were reported. The call was made because of the data logger. Follow up information has been received from the registered nurse on 20-JUN-2017 referring to one of two patients who was vaccinated with improperly stored RECOMBIVAX HB on 17-JUN-2017. The vaccine was improperly stored in the temperature from 47 F to 77F for 1 hour and 30 minutes (previously reported as 5 hours total). There was no (previously reported as yes) previous temperature excursion. Sender's Comments: US-009507513-1703USA010484.
Pt recvd 3 doses Engerix-B vax; 2 wks p/3rd dose (JUN91) exp nervousness & trembling, tingling & numbness in hands & feet; face sensitive & nose sensitive to air; twitching in legs, hotness & extreme fatigue; poss conduction problems;
WE MISTAKENLY ADMINSTERED DOSE 2 AT DAY 14 INSTEAD OF 21\.
Left arm swollen from injection site down about 3". Red and warm to touch. Benadryl and ibuprofen recommended. Apply cool compresses.
pt recvd vax & fainted; pt had hematoma on his left, lateral side of head;