chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got an antibody test  and it came back negative; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 19Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received second dose for injection, lot number: EM9810), intramuscular, administered in Arm Left on 25Feb2021 13:00 (at the age of 79 years old) at a single dose for covid-19 immunisation. The patient had a vaccine in a hospital. Medical history included restless leg syndrome, sleep apnea, congestive heart failure, diabetes diagnosed in 2015, incontinence, pulmonologist diagnosed mid-esophageal GERD on unspecified date in 2020 (9 months ago and prescribed breathing treatments when she has wheezing), and shingles (after unspecified shingles vaccine). Concomitant medication included albuterol [salbutamol] for wheezing, heart medicines and all kinds of mediations. The patient previously took hepatitis A and B vaccine for immunization and experienced negative antibodies so she was given a booster; and first dose of bnt162b2 (lot number: EL9265) on 02Feb2021 (at the age of 78 years old) injected in left arm in the muscle at a single dose for covid-19 immunisation. The patient had no additional vaccines administered on the same date of the  vaccine. The patient had no prior vaccination within four weeks. It was reported that the patient got an antibody test (SARS COVID 19 IGG test) on 18Mar2021 and it came back negative. She wanted to travel to India this fall and is concerned she has not developed antibodies and wonders if she should get a booster. The patient had no other problems. The patient mentioned it was medically significant because if she does not build any antibodies, she could get shingles again. That is her concern and she would love to go to India. She does not think it is related to the vaccine. She thinks it is her. She thinks she just does not build antibodies. Outcome of the event was unknown.   Relatedness of drug to reaction(s)/event(s) Reaction assessed: SARS COVID 19 IGG test came back negative   Source of assessment: Primary Source Reporter   Method of assessment: Global Introspection Drug result: Unknown; Sender's Comments: Based on available information a contributory role of bnt162b2 SARS-CoV-2 antibody test negative  cannot be excluded.  case will be reassessed if additional information is received.
I developed what I though was a rash across my abdomen. It looked a bit like a web across my skin, with purplish coloring to the web. I noticed it appear pretty quickly and was concerned and went to my doctor the same day. He explained this is a mild vascular response to the body mounting an immune response, and not actually a rash. He assured me it would pass and there was nothing to be worried about. It was gone by the next day.
A medical assistant reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided.  On 27-APR-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) with lot number T002845 and expiration date 23-JAN-2022 (both verified as valid) for prophylaxis (dose, vaccination scheme, route and anatomical location of administration were not reported). Varicella virus vaccine live (oka/merck) (VARIVAX)  was improperly stored at a temperature of -14 degrees Celsius for a time frame of 35 hours and 43 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2106USA001746: US-009507513-2106USA001761: US-009507513-2106USA001914: US-009507513-2106USA001941: US-009507513-2106USA001959:
CLIENT HAD INITIAL SERIES OF 1 JANSSEN COVID VACCINE 3/6/2021; BOOSTER MODERNA GIVEN 11/3/2021; PROVIDED ADDITIONAL BOOSTER PFIZER DOSE TODAY 4/15/2022; CLIENT NOT IMMUNOCOMPROMISED OR OVER AGE 50 YRS THEREFORE DID NOT MEET ADDITINAL DOSE CRITERIA ; NO SIDE EFFECTS  AND RELEASED TO HER OWN CARE.
My daughter has sever pain in left arm accompanied with a raised red rash with a bruise right below where the shot was given. The raised rash and bride is about 3 inches wide and 4 inches long. She?s complained about the pain. She also is very tired, irritable and had a low fever.
The patient just fainted after the vaccine was given. The patient remain lethargic and weak. The patient face was pale and she was experiencing dizziness whenever she tries to get up. The
Sm. red bumps developed on neck 2 days ago and spread today to upper arms, abdomen & back with a few on face. Afebrile - child playful. Acting as she normally does.
MD & 2 staff members recvd 3 doses of Engerix-B & were nonresponders;
CONTACT NOTE: Patient and spouse on campus today for scheduled covid vaccine. Spouse is also  caregiver.   1442- this RN responded to alert from Front desk identifying the patient  and the report of his wife whom had brought him to the lobby for help as he  had had a "Focal seizure". Unknown baseline moving forward- evident patient  totaly dependent, unknown speech baseline. Right hand and bilateral legs  contacted.  This RN donning PPE as per above walked onto lobby scene with Wife controlling  patient's home wheelchair of which he was secured into with a gait belt.  Per wife "He had his covid shot about 3 hours ago, he has a history of seizures" Patient unresponsive to name or sternal rub, radial pulse present, thready, even  chest rise, eyes open, equal bilateral pupils.   This RN wheeled patient to hallway also responding to the FD  message, Team Nurses  involved in patient's care.  This RN attempting to illicit response, some grimace to sternal rub.  1443  74/40 BP HR: 56 SPO2 87% RA- eyes open and reactive to light. Oxygen 4L applied.  1444- Patient responsive to sternal rub, follows commands to blink when he hears  his name consistent with the assessment command "blink if you can hear me". 90/57 HR: 80 SPO2 100% 4 L NC 1450- able to grip with left hand, right hand contracted and with pulse oximetry  applied. Respirations continue even and unlabored, saturations satisfactory, no  verbal response, blinks at will, appears to be gaining lucidity.   Decreased to 2L NC, moving head freely. 1500 86/56 78hr 1 L NC 99% with good non-verbal response, pupils contracting  bilaterally equally in harmony, remains non-verbal.  Able to grip and release RN fingers, move head freely, blink at command.  Patient transferred to Gurney and transported.  OF Note:  EMS on standby for all of assessment from ~1445 forward. SBAR provided with  known history, presentation, and known Dx on file.  Wife/Caregiver to go with patient via ambulance, patient wheelchair stored, name on chair. All personal belongings : yellow cap, black bag, given to  wife.   Wife informed staff will follow up post discharge,understands to  notify via call  to staff of discharge from Hospital Facility: Hospital.  OUTPATIENT MEDS: DRUG LIST As of May 21, 2021 This object does not handle Complex Pharmacy Orders. --------------------------------------------- ASPIRIN 81MG CHEW TAB GALANTAMINE HYDROBROMIDE 8MG TAB HYDROPHILIC (EQV AQUAPHOR) TOP OINT METOPROLOL TARTRATE 25MG TAB MULTIVITS W/MINERALS TAB/CAP (NO VIT K) OMEPRAZOLE 20MG EC CAP SERTRALINE HCL 100MG TAB TAMSULOSIN HCL 0.4MG CAP
Pt had mild tinniuts and vertigo before vaccine which then became disabling; it is slowly resolving 6 months later; his wife had milder, but similar sx after vaccine as well
Patient received the second dose in the Shingrix series on 11/19/19 and on 11/28/19 noticed a spider-bite like rash in a cluster on her upper torso. On 11/30/19, she and her husband (who also has a VAERS submitted because a similar occurrence happened to him) felt symptoms were bad enough to make a trip to an urgent care. They went to a walk in clinic and both received prescriptions for antiviral medication as they were both diagnosed with shingles.
After 5 minutes of receiving the vaccine the patient c/o having numbness from the site of injection up her neck and face. Neuro assessment WNL, Vital signs WNL. Patient left clinic after 30 minutes of observation, denied need to go to ER for further workup.
This spontaneous report was received from a nurse refers to a unknown number of patients (gender and age unknown). On an unknown date, the patients were vaccinated with M-M-R II injection. It was reported that on unknown date, the patients may have been vaccinated with M-M-R II stored as high as 50F for up to 19 hours. No adverse effect reported. Additional information has been requested. This is one of several reports from the same source.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 840 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
HYPOTENSION 6/1/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)  HYPOTENSION 6/1/2021 HEMOPTYSIS  HYPOTENSION 6/1/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
pain in the arm; started losing hair, but now it is falling out in clumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and ALOPECIA (started losing hair, but now it is falling out in clumps) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and ALOPECIA (started losing hair, but now it is falling out in clumps). On 12-Feb-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, ALOPECIA (started losing hair, but now it is falling out in clumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
12 days after patient was tested positive with covid 19/she had COVID 19; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient said she got the first dose of the vaccine last 17Dec2020. 12 days after patient was tested positive with covid 19/she had COVID 19 on 29Dec2020. patient also added she was scheduled to get the second dose of the vaccine last 07Jan2021 but was not able to get it. The doctors are not sure if she can get it at any point. She would like to know if she needs to wait 3 months so they can check her antibodies and then get it or not. Another doctor said when she does start, she should get first dose again and then a second. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse concerning a 11 year old male with no medical history of drug allergies who on 17-JUN-2008 was vaccinated with the second dose of  VARIVAX (Oka/Merck) in the left arm (lot # 660337/098X). There was no illness at the time of vaccination. On 19-JUN-2008, the patient experienced injection site complaints and erythema of left arm. The injection site reactions were reported as heat and swelling. Swelling and erythema of left arm measuring 4.5 x 5.0. Area was warm to the touch. The patient was observed and used cold compress and TYLENOL for comfort. At the time of the report the children recovered on unspecified dates. There was no product quality complaint involved. Additional information is not expected.
* After Shot Lots Of Energy  * Got Shot At 11:30 am At 9:00pm Arm Started Hurting Real  bad *  Layed  Down Got Real Bad Chills   * My Whole Body Is Aching * Had Slight Headache *  Temperture  101.3  *  Finally  Went To Sleep *  Woke Back Up Chills Are Back Body Still Sore *Sweating Really Bad *Got Up Finally And Stayed Up 08:30am * Stomach Was Feeling Nausea  Went Away Fter few Hours *Back To Normal 100% 04:00pm
Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and LNPSF100MCG) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (He has lung cancer and goes to Chemotherapy twice a month.) since an unknown date. Concurrent medical conditions included Lung cancer. Concomitant products included INSULIN and METFORMIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up information included patient demographics, historical condition, second dose suspect drug details, event information was updated.
pt recv vax 27APR95 late PM; 24 hr later hives started on forearm; DPH was started; hives appeared & disappeared in different parts of the body on & off x 3 days; tight cough began @ same time & persisted;
Information has been received from a Licensed Vocational Nurse (L.V.N.) referring to a patient of unknown age and unknown gender. History medication and drug allergies were not reported. On 18-MAY-2015 the patient was vaccinated with a dose of incorrect storage RECOMBIVAX HB (dose, strength and route were not reported) (lot# K017721, expire date 27-AUG-2016). Concomitant drug was not reported. At the time of reporting, no adverse effects were reported and it was unspecified if the patient sought any medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to two patients of unknown age and gender. On an unknown date, the patients missed doses of VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. Product quality complained was reported for cracked vials and dislodged flip cap on the VARIVAX (Merck) vials. Additional information has been requested.
Information has been received from a consumer concerning her 7 month old son with a history of jaundice at birth and no known drug reactions/allergies who in November 2007 (exact date not reported), was vaccinated (route and site not reported) with a PedvaxHIB (manufacturer unknown). Mother thought the vaccine her son received was recalled but was unsure if he received PedvaxHIB (lot# not reported). The mother could not specify which vaccine her son had received. Concomitant therapy included acetaminophen (TYLENOL). In November 2007 (exact date not reported), post vaccination, the patient developed a fever, vomiting and cough. The patient was admitted into the hospital 3 days after. It was concluded that the patient had bronchitis. The mother reported that the patient was still vomiting but thought it might be from teething and that he still had a cough. The mother also reported that the patient had loose stool. The patient did receive unspecified medical attention. No diagnostic labs tests were performed. Additional information has been requested. 6/2/08-records received for DOS 11/19-11/20/07-DC DX: bronchiolitis. Presented to ED with C/O cough and cough times 2 days, trouble breathing since yesterday worse today. Poor feeding all day. Lungs diminished breath sounds, wheezes upon inspiration upon expiration. Respirations rapid labored intercostal retractions accessory muscle use. Body temperature increased.
Day after shot...achy, day after that ...achy, weakness, muscle aches, headache.  This continued, especially the weakness and muscle aches and chills for 10 days.  Then I began to have diarrhea, stomach ache and of course, continuation of weakness.  Basically, I feel pretty crappy and have not gotten back to my normal self before the 2nd shot.  I have no temp, no sore throat, no cough.  It is hard to do anything although I did accompany my wife grocery shopping but sat in the car part of the time.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 1st February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st February 2019, 12 hrs after receiving SHINGRIX, the patient experienced headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain. On an unknown date, the outcome of the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain were recovered/resolved. It was unknown if the reporter considered the headache, joint pain, chills, sweating, upset stomach, insomnia, appetite absent and muscle pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that within 12 hours of the injection, the patient experienced headache, joint pain, chills, sweating, stomach upset, could not sleep, could not eat and muscle aches. All the symptoms were lasted about 2 days and resolved. The reporter declined consent for follow up.
rash at injection site; puffy injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
24 hours after vax, injected arm painful, swollen, immobile. Nausea/vomitting. All lasted 14 hours, then normal vaccine pain.
muscle pain; tiredness; headache; shivering; low grade fever; redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (experienced pain, swelling and redness at the injection site, see case US2019GSK203632).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 6th November 2019, less than a day after receiving Shingrix, the patient experienced localized erythema, local swelling, tiredness, headache, shivering and low grade fever. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever were unknown.   It was unknown if the reporter considered the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized reaction and was little red and swollen. The patient also experienced muscle pain in her back and legs, tiredness, headache, shivering, and low grade fever. The patient said that  there was no severe flu like reaction. The patient consented to follow up.
At 07:00 pm she reports feeling arm pain. 10:00 am she reports itches to the armpits, breast, groin, and back with hives. She took Benadryl 25 mg  PO  at 02:00 am  and was not able to fall asleep. She took an additional dose of Benadryl 25 mg PO at 03:00 am with some relief noted.  She states she has body aches and still doesn't feel well. N o other medical  problems at this time.
Headache; neck pain; pain in eyers ears, arms, in the back of the legs, calves,feet and the whole body; feel sick; fever; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/lot number: E100151) dose 1, Via an unspecified route of administration, administered in right arm on 07Apr2021 at 12:30 AM as a single dose (at the age of 38 year) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, ferrous fumarate (VITRON C). Past drug included Sulfa Bactrim and Metoclopramide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination include Centrun Woman, Vitron C. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Apr2021 at 23:30, the patient experienced headache, neck pain, pain in eyers ears, arms, in the back of the legs, calves, feet and the whole body, feel sick, fever. Since the vaccination, the patient had not been tested for COVID-19. Patient felt sick and fever on the same date. The patient reported that she had reactions to the vaccine during the night. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Initial report received from a healthcare professional on 10 April 2013. A female patient (age not specified), had received an intramuscular dose of ADACEL vaccine (batch number: U4612AA, dose number and site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's medical history, health during pregnancy, risk factors and concomitant mediations were not reported. The patient's date of last menstrual period was 10 July 2012 and the estimated delivery date was 27 April 2013. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.