chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nursing home reported that patient needed second dose of Moderna Covid vaccine. Vaccine card indicated the patient had previously had 1 dose on 5/28/2021. Vaccine was administered 7/2/2021. Upon looking in system, it is reported that patient had previously received 2 covid vaccines. 1 dose given by a Pharmacy on 3/26/2021 and 1 dose given by a different Pharmacy on 5/28/2021. 3rd dose administered by another Pharmacy on 7/2/2021.  Patient is not experiencing any adverse effects at this time.  Nursing home alerted and will monitor patient for any adverse events.
Patient has a red, itchy, 50mm induration of posterior portion of upper left arm. No treatment necessary.
I woke Sunday at 5AM after shot on Saturday at 1 PM   with really bad headache. took 2 Ibuprofen . went back to bed. Was able to sleep. Woke about 8:30 AM and felt I needed to check my temperature. It was 99.9 and I have run about 97.6 normally  for several yrs now.  My left arm where shot was given was swollen about size of a walnut, with a red  rectangle which lasted through Tuesday. Arm still somewhat swollen on  Wednesday-today.  I didn't feel rea well  Sunday thru Tuesday.  Arm still bit swollen on Wednesday ,  redness is gone .
Intractable back pain; Couldnt walk; Stiffness; Herniated disk l4/l5; this vaccine caused swelling; This is a spontaneous report from a contactable consumer (patient)    A 47-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (at the age of 47) on 21May2021 17:00 (Batch/Lot Number: EW0176) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to PNC, allopurinol (ELEVIL), cymbalta. No other vaccine was received in four weeks. Concomitant medications were received but not specified. The patient experienced intractable back pain on 21May2021 19:00, couldnt walk on 21May2021 19:00, stiffness on 25May2021, herniated disk l4/l5 on 21May2021 19:00, this vaccine caused swelling on 21May2021 19:00. The patient was hospitalized for 3 days for intractable back pain and couldnt walk. Patient received unspecified treatment. No Covid prior vaccination, or Covid tested post vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: no underlying issues, herniated disk l4/l5 also a fracture of her hip.  The events outcome was not recovered.
It started when I was driving home that day. My whole face went numb on the left down my shoulder and my arm. Then the headache started, Blur vision, Headache that I thought it was due to my vision so I wen to see Dr. and She put me in Antibiotics and that didn't do anything. I went back and again more Antibiotics and nothing and finally on the third appointment she said she didn't know. Everything lasted from March till June 2021. I suddenly woke up one morning and everything was gone.
Patient reported reoccurrence of shingles symptoms including headache, pain, rash and fatigue. Symptoms begin the morning after the vaccine was administered and resolved within 3 days.
feel sluggish; tiredness/tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired). At the time of the report, SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
had both shingles shot, I have shingles now / suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both shingles shot and had shingles now. It was painful, but his or her physician said that the shots kept him or her from being worse. The patient was glad that he or she got both shots. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Rash on stomach, low-grade temp, fussy over 2 days. No treatment other than TYLENOL.
Patient presented to the ED and was subsequently hospitalized for alcohol withdrawal syndrome with seizure, Wernicke's encephalopathy within 6 weeks of receiving COVID vaccination.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had eight temperature excursions: 64 hours, 488 hours, 40 hours, 72 hours, 56 hours, 112 hours, 976 hours and 328 hours. The lowest recorded temperature was 29 F (-1.66666667 Celsius) while the highest recorded temperature was 48 F (8.888888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
No additional adverse events reported; expired MMR-II was in advertently administered to twins; This spontaneous report has been received from a medical assistant, concerning a twin patient of an unknown gender and age. The patient's medical history, drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.   On 07-SEP-2022, patient was inadvertently vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (dose, formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot number T029549 which had been verified to be valid, expiration date reported as 01-SEP-2022 but validated as 10-SEP-2022, conflicting information), as prophylaxis (Expired product administered). In addition, a sterile diluent (lot Number U001953, which has been verified to be valid, expiration date reported and validated as 18-JAN-2023) was used to reconstitute the vaccine (medication dilution). No additional adverse events were provided.; Sender's Comments:  US-009507513-2209USA003388:
Left arm was sore and swollen later that day after the shot (3/25/2021).  Swelling has not gone down and is now worse and I have been diagnosed with lymphoedema in my left arm. On 4/5/2021 i woke up with severe fever blisters all along my upper lips. Called my dr on 4/8/2021 and they called in a prescription of Valacyclovir 1mg.  Took 2 doses of prescription and about 3 weeks for my lips to clear up and they are still red and tender. Went in on 4/22 to get my second dose of the covid shot but after talking to my dr about what had occurred and showing her my arm and lips I decided to postpone the injection. Call back and request an appoint for her to look at my arm on 6/1/2021 because the swelling in my arm is getting worse.
Employee complained of having weakness to her extremities, feeling of numbness. No acute change in condition noted, employee alert, oriented, verbally responsive. Employee appeared anxious. Taken to TTA where employee was seen by doctor, 911 was called. Employee was assessed by 911 paramedics and eventually taken to hospital. All through the process employee remained alert, awake, oriented, with no acute change in condition. Vitals were taken.
Bruising and purpura to bilateral upper extremities. PTT elevated. Platelet count normal.
Fatigue, Headache, Muscle pain, joint pain, Nausea  for two days.   Stayed home and rested.
Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips
Patient approached the pharmacy counter 9/22/23 after receiving vaccination from 9/20/22  with redness at the injection area , told her not sure if its a rash or cellulitis. Patient decided to go to urgent care and was diagnosed with cellulitis.
Urticarial, itchy rash at injection site, did not spread. No respiratory symptoms.
Redness and itchiness around injection site, extending 4x4 inches. Hard and puffy at site of injection. Administered on the 8th of February, with reactions occurring at 16th of February.
Chills Headache Lethargy 2 p.m. to 9 p.m.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not reported. On 01-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 144, and 360 hours, with the lowest recorded temperature of 33, and 34 degrees Fahrenheit (0.55, and 1.11 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of shoulder pain in a adult unk patient who received FLUARIX. On 4th September 2014, the patient received FLUARIX (unknown). On an unknown date, less than a year after receiving FLUARIX, the patient experienced shoulder pain, pain in arm, back pain, neck pain and stiffness. On an unknown date, the outcome of the shoulder pain, pain in arm, back pain, neck pain and stiffness were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, back pain, neck pain and stiffness to be related to FLUARIX. Additional information received: This case was one of the 8 cases reported after vaccination with FLUARIX (see case US2014GSK005295).
Rash, erythematous on hand with vesicular heads, different ages, scattered throughout.
Still have pain in my arm at the point where the vaccine was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Still have pain in my arm at the point where the vaccine was given". The event "still have pain in my arm at the point where the vaccine was given" required physician office visit.  Additional information: The patient was vaccinated two doses in 2021. She still had pain in her arm at the point where the vaccine was given. When she went to the doctor, they did not know why and there was no solution.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 5 days post vax pt experienced an urticarial rash from head to toe. Pt was treated with Benadryl with some relief.
Diarrhea; Sleepy; Hungry; He was irritable; Light weight chills; Nausea; Live hangover; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover) and IRRITABILITY (He was irritable) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HANGOVER (Live hangover). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), IRRITABILITY (He was irritable), CHILLS (Light weight chills) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover), CHILLS (Light weight chills) and NAUSEA (Nausea) outcome was unknown and IRRITABILITY (He was irritable) had resolved.            Concomitant product use was not provided.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-160354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 contains details on: Events( weight chills and diarrhea were added as events). He received 2nd shot on 08 Apr 2021.
Patient an 18yo female date of birth: 02/11/2003, presenting for a 2nd dose of Pfizer COVID vaccine. Client stated that on 4/14/2021 she received her 1st dose of Pfizer COVID vaccine (Lot: EW0162 expiration date: 08/31/2021). She reported that one day status post vaccine she felt the left side of her neck lymph nodes swelling. She denied any other symptoms such as shortness of breath, headache, chest pain, dizziness, rash, swelling of mouth, face, tongue or throat. She stated the lymph are still slightly swollen. She denied allergies to foods, drugs, environment, denied any underlying medical conditions and reported positive for autoimmune neutropenia when an infant which resolved before her 2nd birthday.
Information has been received from an unspecified source concerning a child who on an unspecified date was vaccinated with a dose of pediatric RECOMBIVAX HB in hospital at discharge. Within 16 hours the patient developed dyspnea (shortness of breath) and convulsions. It was unknown if the patient sought medical attention. At the time of reporting, the status of the patient was unknown. Upon internal review, convulsions was considered to be an other important medical event. Additional information has been requested.
pt recv vax & stated I'm having trouble breathing, my lips are numb my fingers are tingling;11:30AM nurse did physical assessment;P76, RR14, shallow resp & cold hands;11:31AM nurse administered; epi & told to dial 911;
Soon after he received the first dose of vaccine, his tongue and mouth became swollen and he could hardly talk. Then his Parkinson's symptoms became exacerbated.  Extra Sinemet did not help. The next day he became suicidal, took more benzodiazepines, went for a walk, got dizzy, and disoriented. He lay down. Was not found for 6 hours. He woke up in intensive care unit. In ICU, he arrested.  He was hospitalized for 3 weeks and eventually recovered. (11 days acute hospital, 10 days rehab hospital)
Seizure, 52 hours, after receiving Prevnar and Hepatitis No 3. No prior problems with immunizations.
cusion on paternal side, has/had lymph node enlargement after vaccine booster in Jan2022, size going down; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization complete; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "cusion on paternal side, has/had lymph node enlargement after vaccine booster in Jan2022, size going down".  Family Medical history relevant to AE (s): Cousin on paternal side, age 66 has/had lymph node enlargement after vaccine booster in Jan2022, size going down.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Daptacel was inadvertently administered to an 11 years old, no AE; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who was inadvertently administered 0.5 ml booster dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5818AA and Exp. Date 21-Oct-2019 via intramuscular route in the right deltoid, on 20-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to  inappropriate age at vaccine administration.  No reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  List of documents held by sender: none.
Since vaccination, severe pain on the injection area increased to the whole arm and persisted for months. unable to use vaccinated arm due to pain.
Information has been received from a lawyer concerning a female who on an unspecified date, was vaccinated with 1 dose of MMRII. Subsequently, the pt developed reflex sympathetic dystrophy (RSD). It was reported, that the RSD was "in relation to the injection procedure, not to the vaccine". Upon internal review, reflex sympathetic dystrophy was determined to be an "Other Important Medical Event". Additional information has been requested.
Patient contacted office as she received a Flublok on 10/4/23 administered by APRN.  Patient feels the vaccine was given too high, she did have some pain with injection but presumed it was normal. She then has continued to have pain and issues with motion. She has had advil and steroids without resolution. She is working with her PCP to see arm specialist.
No additional AE reported; vaccine was administered after the expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 15-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, ot number S025610, expiration date 18-AUG-2021 (route of administration not provided) for prophylaxis (expired product administered). No adverse event was reported.
I have small lymphocytic lymphoma, have had slow, indolent course for 4.5 years.  After vaccination my blood levels crashed, as you can see in the lab results below.  *please note, I had the vaccine and the following blood tests in another area.  (I have since moved back home.) My doctor there is a different Dr.
I have developed a rash and have itched severely.  Visited an urgent care and was told it was poison ivy or something similar.  Was given a steroid shot, oral steroid, and a steroid cream but the rash and itching remain.
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "a-fib" (unspecified if ongoing); "Known allergies: water pills" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (18Oct2022) Negative, notes: testing negative; (24Oct2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day after injection experienced fever (101 deg), full body aches, chills, fatigue for approximately 24 hours
3-11-21 C/O RASH TO BOTH LEGS & ABD SINCE 9:30AM. NO SOB OR DYSPNEA. 1:42PM BENADRYL 50MG GIVEN PO.  STATES SHE WILL SPEND THE REST OF THE WORK DAY SITTING DOWN AND HUSBAND WILL DRIVE HER HOME. 3-15-21 10:46AM:  STATES SHE DID GO TO ER X2, FACILITY ADMITTED HER FOR VASCULITIS X1DAY. 'THOUGHT IT MAY BE A DELAYED VACCINE REACTION.'  RASH ON LEGS, ABD & NOW FOREARMS IS NOW 'PURPLE'. HAD LOTS OF JOINT PAIN ALSO.  SHE WAS GIVEN SOLUMEDRAL AND PREDNISONE AND IS FEELING BETTER NOW, WILL RETURN TO WORK TOMORROW.
Hepatitis B vaccine given on 01/07/2022 expired on 01/06/22.
1st dose: soreness in upper right arm for 3-4 days, worst after sleeping/not moving 2nd dose: starting 7 hours post-vaccination - pain in joint, full body muscle aches, lethargy, headache; starting 24 hours later: fever spiked (100) - resolved within approximately 3-4 hours; remaining symptoms resolved at almost exactly 36 hours from when they started
severe itching of back lt calf; urticaria on back & lt calf; evening of 5APR93; waited till next morning for f/u w/MD:
3hr p/vax lungs felt congested;4hr tongue began to swell;given DPH w/in 1hr problems subsided;