chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore at the injection site) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
headache; soreness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (soreness in the arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
breaks out in a sweat; Runny nose; headache; fatigue; shortness of breath; stomach issues; diarrhea; stomach feels like it's burning; my ears have been hurting; congestion; sore throat; A spontaneous report was received from a healthcare professional for a 37-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and developed fatigue, shortness of breath (dyspnoea), stomach issues (abdominal discomfort), diarrhea (diarrhoea), burning feeling in the stomach (dyspepsia), ear pain, headache, congestion (nasal congestion), runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and breaking out in a sweat while doing the dishes (hyperhidrosis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, one day after receiving the vaccine, the patient reported fatigue, shortness of breath, stomach issues, diarrhea, stomach feels like it's burning, ears have been hurting, headache, congestion, runny nose and sore throat. The patient reported exposure to COVID-19 as she was caring for someone who had tested positive.  They were awaiting COVID test results.    On 31 Dec 2020, the patient reported breaking out in a sweat and has shortness of breath even doing the dishes. They reported that sore throat was not as bad.  Treatment for the events included ibuprofen, omeprazole and bismuth salicylate.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events,  fatigue, shortness of breath, stomach issues, diarrhea, burning feeling in the stomach, ear pain, headache, congestion, runny nose, and  breaking out in a sweat while doing the dishes were considered not recovered/not resolved.   The outcome for the event, sore throat, was considered recovering/resolving.; Reporter's Comments: This case concerns a 37-year-old female who had NS events of unexpected dyspnea, abdominal discomfort, dyspepsia, diarrhea, nasal congestion, rhinorrhea, oropharyngeal pain, ear pain, hyperhidrosis and expected headache and fatigue.  Event onset occurred Day 1 after the first dose of mRNA-1273. Treated with ibuprofen, omeprazole. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
GREEN STOOLS; This spontaneous case (PVX2019-897) was received from a nurse on 16-Apr-2019. It describes a female consumer who had green stools, after the administration of Vaxchora (lot no: 7000012 and expiry date: Jun 2019) for an unknown indication.   Case report: The consumer took the first dose of Vaxchora on 09-Apr-2019 and after 3 to 4 days, she had green stools. She stated that it was partly a dark organic green, and there were also parts of brighter green towards the ends of the stool. Stools were softer than her normal bowel movements. She did not have diarrhea, cramping, chills, fever or headache. There were no changes in her diet. On 22-Apr-2019, an additional information was received with the outcome of event.  The consumer's past medical condition included mitral valve prolapse and mild seasonal allergies. She did not have any history of gastrointestinal illness.  The consumer's past medication included Hepatitis A and B vaccine which was taken a week before (Apr 2019), Measles, mumps, and rubella (MMR) vaccine on 05-Apr-2019, and tetanus vaccine on 29-Mar-2019.  Action taken with Vaxchora was unknown.  The consumer had recovered from the event green stools.; Sender's Comments: Company's Comment : In this case a female consumer passed green stools following administration of first dose of Vaxchora. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vaxchora is assessed as possible . Also, there is concomitant intake of multiple vaccines which could have contributed to the event.
9/29/11 - Fever 103 degrees, vomiting. Cellulitis - right arm.
Two seizures next day after receiving DTaP. Pt was hospitalized to rule out sepsis, it was ruled out as well as possible physical abuse.
Hep B #1: 11/28/18; Hep B #2: 12/28/18; Gave Hep B #3 on 3/4/19 too close to #2. Used Agency  assessment tool which stated accelerated date was 2/22/18 and recommended date was 2/28/18 and Checked Minimum interval chart from CDC and failed to read footnote #11 on Hep B 3#. Instead looked at minimum interval to #3 and saw 8 weeks, therefore gave dose #3. Immunization coordinator reported the assessment glitch to the Agency staff, and inquired of CDC staff recommendation for next vaccine which it was recommended to give a 4th dose on or after April 29, 2019. Client did not have any adverse reactions and was not upset.
Patient presented to emergency department on 9/22/2021  for sudden onset bilateral lower extremity weakness and paralysis. Patient reports she received her first dose of the Covid vaccination about 2 weeks prior to admission.  After that, she started to note bilateral lower extremity cramping which she thought was due to low potassium and did not have any pain.  She states it was not particularly bothersome otherwise.  The morning of admission, 9/22/21 she woke up feeling her usual self and was able to go around and through her normal routine, but after she sat down later in the morning on a chair, she felt like her legs became completely flaccid and she could not move them.    An initial MRI of the lumbar and thoracic spine showed multiple areas of stenosis but no acute findings.  On evaluation by neurosurgical specialists, patient had flaccid paralysis in both lower extremities at about the T12 level with decreased rectal tone. Patient was soon after evaluated by neurology specialists where Guillain-Barre syndrome was felt to be likely diagnosis and patient was started on IVIG.  A spinal tap was also performed which was potentially suggestive of bacterial meningitis despite patient showing no systemic symptoms suggestive of meningitis. Patient was started on empiric antibiotics, however further testing was negative and antibiotics were discontinued at the guidance of Infectious Disease specialists.  A repeat MRI on 9/26/21 of TSpine showed Transverse Myelitis of T10-L1.  Neurology consultation again weighed in and recommended high dose steroids and continuing IVIG. Patient ultimately completed course of both of these, will minimal improvement in symptoms. Patient was discharged to inpatient rehabilitation facility on 10/4/2021, and at the time of discharge remained without all sensation from bilateral knees down,  decreased sensation from hips down to knees and no mobility in bilateral lower extremities.  Patient improved in their functional status throughout rehabilitation stay however remained with lower extremity paralysis.  Patient continued to improve and was deemed stable to discharge to skilled nursing facility on 10/27/21.
Information has been received from a registered pharmacist (from a completed questionnaire) concerning his a 64 year old father with no known drug reactions or allergies and Barrett's oesophagus and hypertension who on 08-JUN-2012, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 mL, subcutaneously in the arm (lot number 672606/1655AA, expiration date 21-JAN-2013). Concomitant therapy included NORVASC, NEXIUM, ZANTAC, LIPITOR and TOPROL. The patient was not recently exposured to chickenpox or shingles. On 09-JUN-2012 (also reported as 11-JUN-2012), the patient experienced two lesions with a hard, itchy, red rash and painful area next to his left nipple (breast) the size of a "thumbnail". The second spot was an inch below the first and it was the size of a "pinky nail", but did not itch as much. A rash did not occur at the site of injection post-vaccination. There was no treatment given for adverse events. At the time of the report the patient recovered. No laboratory tests were performed. The patient sought medical attention via phone. Follow-up information has been received from an other professional refers to his dad, a 64 year old male patient. On 09-JUN-2012 the patient experienced adverse event after receiving ZOSTAVAX. On 12-JUN-2012 the patient had recovered. Additional information is not expected.
EXTREME EMOTIONAL REACTION, HIGH ANXIETY, HALLUCINATIONS, HIGH PANIC, MEMORY FLASHES OF PAST, EXTREME AND CLEAR RECALL OF PAST ACTIVITY, FEAR, LOSS OF CONTROL....
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in November 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Case Narrative: Based on additional information received on 01 February 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 21-Dec-2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular first dose of Fluzone HD (batch number: UI460AA, expiry date: 05-MAY-2016) in right deltoid on 14-Dec-2015. Previous medications included seasonal standard Flu vaccine (unspecified date) and never had a reaction, experinced reaction (swelling from her shoulder to her neck which lasted about 2 week) after tetanus vaccine several years ago on unspecified dates. Illness at time of vaccination was reported not reported and medical conditions of patient included history of fibromyalgia. Concomitant medications were not reported. On 15-Dec-2015, at about 1:30 am one day after vaccination, the patient woke up and could not move head off pillow and could not move her right side. Which lasted for 40 minutes and then she was able to move her right side and turn and get up but was stiff throughout her whole body. The patient also experienced sweating and her nightclothes and bedding was wet. On an unspecified date after vaccination the patient experienced events flare up of fibromyalgia, sore and tiredness and did not feel good for all week and felt nauseaous. She felt her head was too big for her neck and difficult to hold head up. On an unspecified day after vaccination the patient also experienced red knot size of thumb and forefinger together. The patient did not visit physician. No Laboratory investigations were reported. Corrective treatments were not reported. It was reported that on an unspecified day the event red knot size of thumb and forefinger and mobility decreased was resolved. The outcomes of all other events were reported as not recovered. Follow up information received from pharmacist on 01 February 2016. Batch number and expiry date of Fluzone HD was updated as UI427AA and 28 March 2016. On an unknown date, following the vaccination the patient had experienced tender to touch at vaccination site. The patient did not receive any corrective treatment. It was reported that, the knot was on the underside of arm and not on the where the patient received a shot. On an unknown date, the patient recovered from the tender to touch. Documents held by sender: none.
Arm soreness, facial flushing immediately following injection. Pt later became short of breath with mid sternal pain.
tiny pin point of blood in his arm after the administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, ), for Covid-19 immunization, reaction(s): "tiny pin point of blood in his arm after the administration"; Bnt162b2 (Dose 2, Single), for Covid-19 immunization, reaction(s): "iny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "tiny pin point of blood in his arm after the administration". Additional Information: Reporter stated that for the first four doses, he did not have any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number.
Patient had a flu shot on 11/29/06. Patient returned to clinic on 12/1/06 with a hard lump on left upper arm. Patient had a local reaction.
Hospitalization: 9/7/22 ADMIT, 9/9/22 DISCHARGE. Presentation to the ED: SYNCOPE & FALL.  COVID-19 + date: 9/7/22. Treatment: ROCEPHIN.  Discharge to: HOME.
I FORGOT TO DILUTE THE VACCINE AND ADMINISTERED  0.3ML OF PFIZER VACCINE WITHOUT DILUTING
Patient called the clinic on August 17, 2022 and complained of intense pain at the left deltoid region. LROM. No redness, swelling, itching, red streaks noted by patient. Patient sought additional care on August 20, 2022 via urgent care. X-rays taken. Patient then was seen by her primary care provider on August 22nd.
I had a breakthrough Covid case, I was freezing constant chills nausea, lethargy, I was prescribed PAXLOVID.
Normal labor and delivery on 10/18/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Provider discharge summary "The patient is a very poor historian but reports to me that he felt bad while at dialysis. He reports a cough and fever. He states he lives with his wife who is sick with COVID 19. He has received his vaccination. He report he is on oxygen at home.   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  These were his acute medical issues addressed this hospitalization:   COVID pneumonia with hypoxia - required O2 support via nasal cannula.  Mainly admitted for significant weakness.   - Antibiotics completed after some concern for bacterial pneumonia. - O2 removed 1/4. Doing well on RA so far. - diagnosed 12/20/21. - Vaccinated x 2 (Pfizer). - Decadron received 12/21 to 1/5/22. - out of severe resp restrictions.   ESRD-  nephrology following for HD. Dialysis x 11 years. Currently dialysis via L forearm AVF.           - will resume his MWF dialysis schedule at dialysis unit.   HLD- continue with statin   Hx of COPD- home meds. Not exacerbating.   HTN- home meds   Hx of PH- monitor.   Hx of CAD with pacemaker in place- monitor    Hx of GERD- continue with meds.    He remains quite debilitated. Therapies recommend SNF placement. Accepted at nursing home. DC in stable condition to nursing home 1/6/22."
Erythema and induration left deltoid with pruritis. Temp 99.6.
Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021; Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) and PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) and PRODUCT STORAGE ERROR (Patient received vaccine on 20-Jan-2022 past the BUD (beyond use date) of 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that all the vials of the product were placed in the refrigerator upon the receipt on 02-Oct-2021, hence the reported BUD was 01-Nov-2021. expiration reported as 19-Mar-2022.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up received. Updated report type as spontaneous valid case, added product storage error event and updated narrative.
Pt was administered IPV, DTaP, Hib/HepB, and PCV7 on 7/20/05 at around 3:00 p.m.  Pt was given Tylenol at the clinic and every 4-6 hrs at home.  At around 6:00 a.m., pt was noted to feel warm.  At 7:00 a.m. she was noted to have a temp of 102 and over the next hour she became "listless, grey, and limp."  She was brought the the Ped E.R. at around 7:045 a.m.  Parents deny any previous symptomology or sick contacts.  At the E.R. her vitals were: BP 85/57, p 130, rr 32, t 37.6.  Physical exam was unremarkable.  A blood Cx was drawn and noted to be neg after 24 hrs.  WBC 18.3, Hct 30.8, plts 328.  The family refused both a lumbar puncture and urethral catheterization for UA and urine cx.  Pt was given Ceftriaxone 100 mg/kg IV.  Upon d/c her temp was noted to be 38.5, and she was given Tylenol 15 mg/kg.    During a follow-up clinic visit on 7/21 the parents reported that she had remained afebrile, and asymptomatic.  Her vitals were T 98.4 F, HR 150, RR 36 and her physical exam was unremarkable.
This person got the Janssen covid vaccine at pharmacy.     She reports had headaches and stroke like symptoms. Was treated at local Hospital/ED. Patient voiced concerns of possible reaction to vaccine.
Patient had syncope in observation area post vaccination. He developed increased heart rate and blood pressure which resolved in 20 minutes. His vitals were monitored by EMTs at the site, blood sugar and pulse ox were normal. Patient was monitored after episode and released without administering any medications.
2/19/21- Patient presented with shortness of breath  that appears to be chronic, but potentially worse (this was 5 days after 2nd Covid vaccine). Lab tests showed thrombocytopenia (unknown if this is new or old) as well as mild transaminitis (again, not known if new) 3/23/21- Patient presented with a stroke involving the R frontal and parietal lobe. Echo normal at that time 4/22/21- presented to urgent care again and was found to have elevated troponin (without associated chest pain or EKG changes). Echo was normal, but cardiac MRI showed evidence of myocarditis
About 10 minutes after getting the Pfizer vaccine my Jaw started hurting and lips tingling,  then my face starting getting numb. After I woke up this morning my face is still numb.