chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received TWINRIX (batch number dk23d, expiry date 8th February 2021) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (TWINRIX Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd February 2022, the patient received TWINRIX and TWINRIX Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving TWINRIX and TWINRIX Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Nurse reported that, a female patient was administrated with an expired dose of TWINRIX, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Tiredness. Soreness at injection site. Mild to moderate flu-like symptoms. 101F fever. Treated with rest, liquids, and 500mg acetaminophen. Symptoms lasted 36 hours.
I was asking the doctor for medicine, because I had a cold I could not shake. I was told to take to a COVID-19 test first. It was negative. The next day I was sick with fever and fatigue and congestion in the head and face. I was having cold like symptoms and prescribed PAXLOVID. I had and experimental CART-T five years ago to treat my Lymphoma. One of the side effects is that I have a compromised immune system. After taking the PAXLOVID, it was the second time I took it, I had COVID-19 in July. This time around I did not rebound. The symptoms stayed the same. My doctor prescribed and IV-IG treatment the next week, three days later, I felt 100% better. The medicine it helped but the congestion in head and chest was very much present. I was coughing so much my abdomen muscles started to hurt. The PAXLOVID keeps the symptoms at a minimum.
Information has been received from a 66 year old male patient reporting on himself with seasonal allergy and pain and history of severe back and neck pain who on 03-JAN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) in his left arm (dose, route and lot # not provided). Concomitant therapy included OXYCONTIN and LIPITOR. On approximately 10-JAN-2012 "one week to 10 days later", the patient experienced severe itching of the ears, back, left hip, and crotch on his right side. The itching had gotten progressively worse and worse and the patient stated now event his eyes were itching. The patient stated the itching was worse at night and was usually preceded by tingling. The patient indicated he had been to several health care providers, including Allergist, Neurologist and Dermatologist, and had had numerous tests and labs taken. Laboratory tests included blood labs, thyroid test, Lyme test, CT angiogram, vitamin deficiency test and neurological activity test; results were not provided. The patient was treated with BENADRYL 25 mg and ALLEGRA 180 mg. At the time of the report, the patient had not recovered from the events. The patient stated he had upcoming test schedule: lipid test, CPK test SED rate. Follow-up information from the consumer revealed that since getting the ZOSTAVAX (Merck) his ears continued to itch so badly that he heard a high pitched noise. Additional information has been requested.
After receiving flu vaccine, experienced moderate to severe aching pain at site, (R) shoulder. Difficulty lifting arm, increased pain when resting on (R) shoulder. Symptoms have been ongoing since time of flu shot.
shortness of breath, dizzy, sore throat, muscle aches, dry mouth, muscle spasms, fever (100.8)  extremely tired, headache
p/v24hr, swelling of arm in area of inj;p/72hr more swelling, extending to w;/in 2 inches of elbow & w/in 2 inches of shoulder;
Pt received 3 vaccines. While crying immediately after the last one, he had what resembled a "breath-holding spell". He turned grey and became apneic and bradycardic. He  required CPR for resuscitation.
1/20 vaccination About 2 weeks later, I started getting up in the mornings with my hands hurting. I was doing water aerobics and stopped. I called the doctor and explained having pain in my hands. I have been using different ointments for the pain.  *blood work scheduled with f/up with PCM 4/30  Hot flash experienced 2-3 days after vaccination.
Upon reconsitution of the Pfizer vaccine 0.9ml of NSS used instead of 1.8ml, 0.3ml of the reconstituted solution pulled up for administration.  Double dose administered.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 23-JAN-2016, the patient was treated at a physician's office for a persistent vesicular rash, which was which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of 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.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Swollen lymph nodes in left armpit area for approximately two days. Post swelling there was a sharp pain in shoulder:rotator cuff that affected range of motion. Initially, pain was triggered periodically with specific movements. Currently, the pain is almost constant and affected by a multitude of shoulder movements
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
Information has been received from a physician concerning a 10-week-old male born prematurely who on 12-MAR-2007 was vaccinated PO with the first dose of Rotateq (Lot #656188/1238F). Concomitant vaccination administered on that day included the first IM dose in the left thigh of Pediarix (Lot #AC21B084BA), the first IM dose in the right thigh of PedvaxHib (Lot #654397/1014F) and the first IM dose in the right thigh of Prevnar (130867207). There was no illness at the time of vaccination. The physician reported that on 27-MAR-2007, the patient developed diarrhea. On 02-APR-2007, the patient presented to the physician's office with continued diarrhea. On 04-APR-2007, the developed dehydration and was hospitalized that same day. Stool cultures and blood cultures were both negative. On 08-APR-2007, the patient was discharged from the hospital. At the time of this report, the patient's diarrhea and dehydration persisted. The physician also considered the diarrhea and dehydration other important medical events since they required a GI referral. Additional information has been requested.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported 2 cases for different patients. This is the 1st of 2 reports. A male patient of unspecified age and race/ethnicity received TRUMENBA (NDC# 0005-0100-01), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site/ pain in the arm in Jun2017 with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, but pain came back.
About 40 minutes post vax, the pt developed shaking chills and suspected that she was running a fever. She noticed pain in her left arm and also the left side of the neck as well as a headache. She developed numbness or tingling in the left arm. There was not shortness of breath and no chest pain. she had not had any of this previously. She was seen at an ER and her treatment included an IV of normal saline, IV SoluMedrol, Benadryl, Zantac as well as Tylenol. She was afebrile by the time she left the ER. MD states this was an adverse reaction to Lyme vaccine.
Information has been received from a nurse practitioner concerning a 31 year old female student with depression and no drug reaction or allergy who at 15:37 on 26-SEP-2008 was vaccinated with the first dose of MMR II (lot # 656668/1307U), SQ, 0.5ml in the right arm, MENACTRA (U2731AA), 0.5ml, IM in the right deltoid and ADACEL (C2766AA), 0.5ml, IM in the left deltoid. Concomitant therapy included olanzapine and citalopram-antidepressants. On 07-OCT-2008 (previously reported on 08-OCT-2008) the patient reported that she had a headache and took aspirin, On 09-OCT-2008 the patient reported that she awoke with a generalized itchy maculopapular rash on her arms, legs, and trunk of body. The patient was seen and was given ZYRTEC and ATARAX. The patient recovered in a few days. The patient did not do any lab diagnostics. Follow up information received from the nurse practitioner stated that the patient needed medical treatment for the rash and headache and did not have a life-threatening illness. It was reported that the patient was vaccinated with a second dose of MMR II (date not reported) and  the patient had no problems. The nurse practitioner reported that the patient's reaction probably had nothing to do with the first dose of MMR II. No further information is available.
I had rotator surgery on the right shoulder 10 years ago with no issues since. Since the shot my entire right arm is experiencing issues. Began with slight stiffness in the upper arm muscle. Then I began to experience pain with the thumb joint being stiff and it has moved to my shoulder and a larger area of the  upper arm. No longer able to lift with out assistance or severe pain. Wrist is also experiencing slight pain and stiffness. Some days my neck on that side feels tight. I did not experience this with first shot. First shot was strange feelings that ran from the site of injection on my left arm to the left side of my head and ear.  Manufacturer was Pfizer
Whooping cough vaccine. My daughter is pregnant. First the area got extremely sore to touch around 2 inches wide and 6 inches long. Over 2 day it got really red over the same area. Called the doctor six day later and he told me to use benadryl 2 X a day and sent itch cream to the pharmacy. The redness continued to move down my arm to just above my elbow and continues to itch and bright red this is the 8 day since the shot.
retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that:  "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea.  No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit.   Further information needed, further information expected.
Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.) 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 ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.). At the time of the report, ILLNESS (Friend who felt sick after her first dose of the Moderna Covid-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Extreme debilitating continuous pain in right arm (extending from neck to wrist) after pneumonia shot. This lasted 3 days with 4 more days of moderate pain at site of shot
Numbness and tingling in extremities; loss of feeling sensation to hands; this continued for a period of approx. 20 minutes
pt recv vax & devel an inj site rxn characterized by redness, swelling & pain;
experiencing itchiness on head, and skin becomes itchy and irritated when touched; experiencing itchiness on head, and skin becomes itchy and irritated when touched; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H321B, 041C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched) had not resolved.            No concomitant medications was reported.    This case was linked to MOD-2021-404946 (Patient Link).
Chest rash, itchiness, injection site swelling. Patient described symptoms exacerbating her fibromyalgia, increase neck pain, joint pain, stiffness.
Phone call received by public health on 3/29/21 to report adverse reaction to vaccination given on 3/26/21.  States after observation time at  public health clinic, she went home and later felt like her tongue was swelling, but had no difficulty breathing.  She did call her MD, but did not go in to the clinic as she has anxiety, also stated she did feel ill later and for a couple of days. States her MD clinic told her she is allergic to this vaccine and  not to have the 2nd dose.
clonic sz, apneic 1 min, nauseated w/in 20 minutes of dose whle MD was treating laceration of forehead;
blood pressure kept going up and down\she could not get her blood pressure under control; Fever at injection site (right arm); muscle aches in  neck; Sharp pains in legs; pain in stomach; had blurred vision; she had floaters; headache; she had a fever where the vaccine was given (at injection site); body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 044A01A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation in March 2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 experienced BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) (seriousness criterion hospitalization), VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to BLOOD PRESSURE FLUCTUATION. At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) had not resolved and VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment for the event included blood pressure medication and eye drops.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My lungs have been producing flehm and occasionally shortness of breathe so I went to see my pulmonologist and I had a cat scan on my lungs. I was prescribed albuterol and Flonase.
improperly stored; no adverse effect; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and allergies were unknown. On 22-AUG-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, frequency, route was not reported) lot# R033343 expiration date 03-AUG-2020 or lot# S012244 expiration date: 09-FEB-2021, for prophylaxis (product storage error). The vaccine underwent temperature excursion of 0.0 degree Celsius, for 23 hours 30 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved. Previously no temperature excursion was reported. The call was due to digital data logger.
Patient received her first Moderna dose on 3/18/21 and was scheduled for her second dose on 4/15/21. Patient showed up on 4/6/21 for a nutrition appointment and came up to the vaccine clinic and said she had been added as an add-on for the vaccine for that day. She was vaccinated for her vaccine 1.5 weeks early.
A few weeks after first dose CFS/ME symptoms  (extreme fatigue, brain fog, pain) were exacerbated. A few weeks after 2nd dose I became recliner/bed  bound, brain fog,  and unable to speak more than few sentences at a time due to throat pain (symptoms I had when I first got sick in the 1990a). The severe sx remained unchanged for 21/2 months. In last 11/2 month there is improvement in being able to get out of recliner/bed but it is still difficult to talk. unknown if this worsening of sx will be permanent but they are extremely slow to improve.
I was given the Flu injection in my left arm on 11/3/19.   Immediately following I made a comment about the way it had felt and the "different" type of pain.  The response from the nurse was; "Ooh, that was a little far back wasn't it"  I tried to shake off the odd feeling.  It increasingly got worse over the next few days till I could no longer lift my arm and I had tingling in my hand.  The pain increase to an unbearable level resulting in a visit to urgent care.  I was given an injection of a steroid along with oral medications.  This only helped a small amount.  I have since seen several doctors and therapist. I have a weak arm and hand, decreased range of motion, with varying levels of pain at all times day and night. I am now facing surgery to repair the damage that has been caused by this vaccine.
Stomach upset within 3 hours. Additional side effects within 12 hours: muscle aches, pain at site of injection, headache, chills, fatigue, weakness. All symptoms resolved with 36 hours of the vaccination.
Pt got Spikevax 1 day after the BUD 11/19/2023 . Vaccine was not expired. No adverse event was reported