chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     There was no parental vaccine exposure.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.). At the time of the report, COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported patient tested positive for covid and has gone to doctor to get medication. Patient had all her Moderna vaccines.  Treatment medications were not reported.   Reporter did not allow further contact
Headache and general low energy following vaccination. Unable to focus on work for the afternoon.  Day 1 after vaccination: Experienced violent rigors while in bed at 00:00 (14 hours post-vaccination). By 03:00 temp of 101.8, rigors had passed but slept poorly. Headache, fatigue, and low-grade fever persisted the day following vaccination, could not work.  + Tachycardia, +lymphadenopathy R armpit. Ibuprofen and tylenol for symptom relief.  **** CONCERNING EVENT **** Day 2 after vaccination --- No more fever. Ongoing intermittent mild tachycardia especially when walking or moving. By 11:30AM noticed chest heaviness and difficulty getting a full deep breath. Not "pain." Administered valium 1mg from existing Rx at 2pm but did not notice any significant change in symptoms. This chest heaviness persisted as a prominent symptom through day until nearly 6pm. Gradually faded after that, with lingering stiff R side neck stiffness/occipital soreness and arm soreness after 8pm that night.   Day 3 after vaccination no ongoing chest heaviness. Still some mild tachycardia with activity. +Lymphadenopathy R armpit. Continued R neck stiffness and occipital soreness, very faint headache at times, especially with eye movement.  Day 4 after vaccination - feel relatively "baseline" with mild R neck soreness.  No headache or lymphadenopathy now.
FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON  LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm  for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received Moderna vaccinations in Jan/Feb, then received Pfizer booster in August (8/18/21); admitted 11/2/2021 with new myocarditis, also dx with RSV; unclear etiology. Probably viral. Presentation with RSV positive culture ?RSV myocarditis in adults is rare.
Within one hour of MMR, Varivax and PPD, pt experienced puffy eyes, splotches in face and on scrotum which resolved within 12 hrs and did not recur. Pt had animal crackers before reaction but after shots but on subsequent ? crackers, no reaction occurred. PPD also given 12/27/02.
Left thigh swollen to knee with erythema and warmth. Diameter of thigh 2 1/2 cm larger than right. At knee 2cm larger diameter than right.
I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However, by Feb 21  noticed swelling under my armpit on the left side as well as somewhat swollen nodes in the left side of my neck. The swelling under my arm became worse over the next two days. When I raised my left arm I felt considerable pain. Over the next 2 days I also had swelling in my left forearm near bend in my elbow. I also had a rash the size of a patch above the injection site.  I looked this issue up online and found reports that approximately 16% of women who had received the 2nd Covid shot experienced swelling under the armpit. I contacted my doctor by e mail .  I switched from taking tylelnol to advil.  All side effects are gone except there is still a little swelling in armpit.  I contacted my Doctor and will see her on March 15th if the swelling is not gone.
Per pt. is unable to lift arm beyond shoulder level due to pain. Mobility is mostly available at elbow joint. Pt will visit MD for examination.
Redness; Pain at the injection site; Arm soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), ERYTHEMA (Redness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dizziness. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache). On 06-Feb-2021, the patient experienced ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 02-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that her symptoms cleared up after a few days. She had her second dose of vaccine with no adverse events.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included event outcome and second dose information.
Patient was seated in chair in front of pharmacy. He started to seize and his head was against the wall. 911 was called. As RPH stepped out for the patient he came out the the seizure and tried to stand up. RPH told him to remain seated and wait for EMS to arrive. No history of seizure was reported on Vaccine Administration Record before administration. When questioned patient said it has happened previously when he tried to get a tattoo. EMS evaluated patient and his vitals were okay. After about 30 minutes the patient left the pharmacy.
No adverse Event; Got vaccinated aft er BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got vaccinated aft er BUD) and NO ADVERSE EVENT (No adverse Event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got vaccinated aft er BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got vaccinated aft er BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Got vaccinated aft er BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
She received her annual flu vaccine 12/2/14. She had a little knot at the injection site (L) deltoid for a couple of days and then it went down but then it came back. It has persisted since that time she had similar bumps on her arm in the past but they've always gone away in few days. Not this one. Since she has a previous history of Lipoma, an ultrasound of the deltoid has been order to confirm that the lesion is indeed hematoma.
This spontaneous report as received from a medical assistant refers to a 38 years old female patient with allergic rhinitis. On 20-MAR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J013345 exp date 11-JAN-2015) dose 1, .5ml, intramuscular in the left arm. Concomitant therapies included ZYRTEC and FLONASE. Medical assistant does not think the patient has received PNEUMOVAX in the past. In March 2014 the patient experienced flu-like symptoms and soreness of the left arm. The outcome of flu-like symptoms and soreness of the left arm was reported as recovering. The patient sought medical assistance at the office on 24-MAR-2014, none labs were performed and the patient was treated with acetaminophen/hydrocodone tablet. Additional information has been requested.
Data Quality Team contacted clinic staff at local Family Health Center informing staff that upon review of COVID-19 vaccine data. It was found that this child had documentation in their local records indicating that the child had received an adult Pfizer purple cap COVID-19 vaccine on 12/07/2021. Clinic staff was unaware of this incident until the Data Quality Team brought it to staffs attention on 12/19/2022.
Same day post vax, the pt started itching on her eczema spots and a few small hives. Pt was treated with Benadryl.
soreness at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced soreness at injection site after receiving 1st dose of vaccine. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020107123.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107123:same reporter
Pt came to ER c/o recent dx of corona virus with worsening SOB, low sats in upper 70's.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
3 hours after 2nd dose almost fainted when exercising.  4 hours after injection started to feel achey,  headache,  and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
2MIN AFTER DOSE DIZZY, VERY CONFUSED,  SLIGHT CHEST PRESSURE,  30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED  IN A FOG.  VERY CONGESTED , SNEEZING, ITCHY EYES,  STUFFY EARS,  VERY CONFUSED.  STRANGE FEELING INSIDE MY BODY - TINGLING .  FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES.  NAUSAUES.  6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
syncope occurred about 10 minutes after dose.  Patient recovered over about 5 minutes and was ok after about 15.  No further issues.
Injection site was a little warm to the touch; A little bit of redness at the injection site on her son's left thigh; This is a spontaneous report from a contactable nurse. A 7-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. DJ7719, Expiration date: 20Aug2022, NDC number: 0005-1971-01) at 0.5 ml, single dose, in the left thigh (left vastus lateralis) and hib vaccine conj (tet tox) (HIBERIX, Lot. KP24R, Expiration date: 24Oct2021) in the left thigh (left vastus lateralis); both on 15Oct2020, for immunization. Relevant medical history and concomitant medications were none. On an unspecified date, in Oct2020, the patient's mother stated there was a little bit of redness at the injection site on her son's left thigh, and the injection site was a little warm to the touch, but nothing else. Clinical outcome of the events was unknown at time of this report.  It was reported that on 29Oct2020, patient was inadvertently re-administered the pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) and hib vaccine conj (tet tox) (HIBERIX) again. Patient was also administered diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) on 29Oct2020.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L003774 and L013063 with expiration dater 04-FEB-2017 and 14-APR-2017, respectively (route was not provided). On an unknown date, there was an incorrect product storage as the unspecified number of patients received the improperly (Oka/Merck) VARIVAX. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown.  This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 12 month old male patient with ear infection. Drug Reactions/Allergies were not reported. On 27-MAR-2013 the patient was vaccinated with a dose of (merck) PROQUAD (lot # H020134, expiration date 07-MAY-2014), 0.5 ml, subcutaneously. Concomitant therapies included amoxicillin started on 27-MAR-2013. The healthcare worker reported that the patient developed a measles like rash following vaccination with (merck) PROQUAD on 27-MAR-2013. The measles like rash developed yesterday (07-APR-2013) on the face, neck and upper chest and this morning (08-APR-2013) the measles like rash has spread to the arms, abdomen and back. Patient sought medical attention. No treatment was given for adverse event. Patient's outcome was unknown. Additional information is not expected.
12/22 7 pm, severe leg cramps; 12/23 7 am: diarrhea, abdominal pain. noon: nausea requiring medication; 5 pm, shaking chills, normal temperature. 9 pm: bloody diarrhea, and what looked more like sloughing nonpigmented tissue rather than stool, continued abdominal pain. Woke with diarrhea and pain 1 am. This morning, frequent stool and moderate abdominal pain.  No chills.   Recovered from diverticulitis around 12/3, scheduled for colonoscopy 1/6/21 and probably colectomy 1/8/2021.
31MAY91 mom reported vomiting, listlessness & T of 102 w/APAP following DPT given that day.Referred to MD or ER stat.3JUN91 PC to mom-went to ER 31MAY91 stayed 3 hrs.HR-172.Returned to ER 1JUN91, pt's HR-142.MD thought due to DPT.
the adverse effect is there is a ball of something in the left part of my neck.  It wasn't there yesterday.
Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigue and no appetite. She developed a cough, loss of taste/smell, and then nausea/vomiting. She tested positive for Covid-19 on the 11th. She hasn't been able to hold down meds for the last week. She is having intermittent chest pains which she attributes to not being able to take her cardiac meds. Was started on supplemental oxygen and admitted to hospital. Is still admitted at time of writing.
This spontaneous report as received from a medical assistant refers to a 62 year old female patient. On 27-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J006242, expiry date 03-AUG-2014. On an unknown date in SEP-2013, the patient experienced injection site reaction that she described as soreness in her arm and warm to touch and soreness in her arm and warm to touch. The outcome of the events were reported as recovering, the patient was scheduled for a follow up appointment. This is one of the 3 reports received from the same reporter. Additional information has been requested.
Body aches, nausea, slight chills - lasted 12 hours.  Then totally fine and normal. Treatment - tried to sleep, but didn't sleep well.
VACCINE NOT EFFECTIVE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed along with the additional information received from central complaint vigilance on 30-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was at very high risk and got COVID-19 infection. It was also reported that, the vaccine was not effective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and vaccine not effective was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000187891. The suspected RA has been confirmed to be not voided (meet criteria) in investigation result. based on the evaluation/investigation performed.; Sender's Comments: V0-20210801047-Covid-19 vaccine ad26.cov2.s -VACCINE NOT EFFECTIVE .This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt recvd 1st dose of vax 5OCT92 & 6OCT92 pt devel hives, itching, facial redness w/blotching & periorbital puffiness; pt presented to ER & tx w/DPH & Pred w/good results;
Flu shots do not work; Initial information received on 20-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) whom INFLUENZA VACCINE shots do not work (drug ineffective).  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, a flu shots do not work on patient (drug ineffective, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Flu shots do NOT work! I know this personally from patients I have cared for and co-workers who have had this shot and still get the flu!"  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Patient got a 3rd dose although she did not fall under the current guideline for moderna,  We did not have an attestation form on file. She had no ill effects from the vaccine and wanted a booster.
Difficulty breathing and swelling of lips. She used her inhaler and took Benadryl 50mg PO.
A nurse reported that a resident of a long-term care facility received a dose of flu shield in November 2001. In January 2002, the pt developed a "severe" respiratory infection characterized by congestion and fever. A rapid antigen test was negative for influenza A. The resident recovered. No further info was available at the date of this report.
Narrative: Patient reported myalgia with chills, nausea after 1st vaccine which resolved in 3-4 days
Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no taste or smell.
Redness and sensitivity at local injection site, persisting > 4 months after flu shot. Per patient, had tried applying ice pack on arm. Also took Aspirin for pain.
Initial report received from a health care professional on 02 June 2010. A 6-month-old infant, with no reported medical history, received an injection (route and site not provided) on 02 December 2009 of ACTHIB, sanofi pasteur SA lot number D0395-1 and sanofi pasteur Inc. lot number UF673AA, an injection of PEDIARIX (lot number GSKAC21B187AA) and PREVNAR (lot number D1920) and turned blue in bed the same day the patient had the immunization. The event was not reported at the time. The patient's mother reported the event at the infants 12 month visit and refused all immunizations for the patient due to this event. Documents held by sender: None.