chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date the patient received an incorrect 0.5ml dose of ZOSTAVAX (route and lot# unknown) due to a product quality complaint (PQC). No adverse reactions were reported. Additional information has been requested.
Information has been received from a physician concerning a 12 week old male with gastrooesophageal reflux, a history of bronchiolitis and no reported illness at the time of vaccination who on 27-FEB-2008 at 15:50 was vaccinated IM with the first dose of ROTATEQ (lot # 659682/1733U). On 11-MAR-2008 the patient began with vomiting and watery and profuse diarrhea, general malaise and crying with poor response to treatment (unspecified) the patient was hospitalized. On approximately 11-MAR-2008 the patient had a white blood cell count of 6.9, hemoglobin of 10.4, hematocrit of 30.4, platelets of 425,000, stool was positive for rotavirus, positive culture for Respiratory Syncytial Virus (RSV). It was reported that the patient was alert, active and afebrile while in the hospital. The patient was discharged from the hospital on 23-MAR-2008 with a guarded prognosis, in good condition on a regular diet, no activity restrictions and on albuterol (dose, route unspecified). The discharge diagnosis were bronchiolitis, RSV, acute gastroenteritis, rotavirus positive and anemia. The outcome was reported as recovered resolved. The physician felt that the hospitalization was prolonged (12 days). Additional information has been requested.
This spontaneous report as received from a company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. Dose and frequency were not provided. On an unknown date the patient experienced stomach pain, nervousness and symptoms similar to lyme disease. The outcome of symptoms similar to lyme disease, nervousness and stomach pain was unknown. The action taken regarding GARDASIL was reported as discontinued and not reintroduced. The reporter relatedness was unknown. Additional information has been requested.
Pt became lightheaded, diaphoretic after injection. Attempted to walk but fell to floor. No loss of consciousness. BP 104/72. Epinephrine .55cc given. Pt waited in office. Approximately 1/2 hours. Felt fine when she left with mother BP 106/68. No adverse reaction at site. Pt did report a feeling of "pins and needles' in arm that injection was given in for approximately 2 minutes.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 03-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008602 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008607 1209USA008608 1209USA008609 1209USA008611 1209USA008612 1209USA008613 1209USA008614. Additional information has been requested.
leg cramping; swelling at injection site; itching at the injection site; red at the injection site; injection site hardness; A spontaneous report was received from a healthcare professional (an emergency medical technician) who was also a 55-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced leg cramping (muscle spasms), swelling at injection site, injection site itching, injection site redness, and injection site hardness (injection site induration).   The patient's medical history was not provided. Concomitant medications included prazosin, lamotrigin, bupropion, metoprolol, propylthiouracil, hydroxyzine, cyanocobalamin, adreset, and oxicell.  On 24 Dec 2020, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient experienced itching, hardness, swelling, and redness at the injection site. The redness was initially the size of a 50-cent coin, then doubled in size to the diameter of a coffee cup. The patient also reported experiencing leg cramping (date not provided).   Treatment for the events included a hot compress and diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events of itching and swelling at injection site and leg cramping were unknown.  The event of redness at the injection site was resolving.  The event of hardness at the injection site was not resolved at the time of this report.; Reporter'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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054857:CROSS LINKED WITH 1 CASE
experienced stomach pain on 4/20/21 at 11AM, urine was purple colored, possibly with blood one time in the afternoon around 2PM.  Continued to experience intermittent stomach pain and difficulty with bowel movements for the next month, along with intermittent dull back pain.  Received second does of Moderna on 5/12, lot number 021C21A.  On 5/24 around 9PM, a stone about the size of a grain of rice was passed while urinating.  Pain in the stomach and back have not recurred since.
Extreme soreness of whole muscle at injection site, intense red flushing of both cheeks on face, fatigue, whole body muscle weakness and joint stiffness/achiness
chronic hypoxia respiratory failure; Unresponsive; A spontaneous report was received from Pfizer concerning a 51-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had developed hypoxia a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 07 Jan 2021, around 6:00 pm, the patient became increasingly hypoxic. He was transported to the hospital for acute on chronic hypoxia respiratory failure. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Jan 2021 at 11:25pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
pressure on the left side of her chest; sore muscles; headache; injection site pain with first dose; body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST DISCOMFORT (pressure on the left side of her chest), MYALGIA (sore muscles), HEADACHE (headache), INJECTION SITE PAIN (injection site pain with first dose) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure on the left side of her chest), MYALGIA (sore muscles), HEADACHE (headache), INJECTION SITE PAIN (injection site pain with first dose) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (pressure on the left side of her chest), MYALGIA (sore muscles), HEADACHE (headache), INJECTION SITE PAIN (injection site pain with first dose) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-114316 (Patient Link).
Patient reports she could not walk for 3 days. All of her muscles were very weak and heavy. She had to use a walker or cane over the last week and a half. Patient reports that 5 years ago she had more mild flu-like symptoms and was bed ridden for 4 days. Patient denies any respiratory component.
This case was reported by a healthcare professional and described the occurence of muscle weakness in a 34-year-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent medical conditions included allergy to Percocet, allergy to Ultracet and migraine. Previous vaccination included Engerix B given on 26 March 2007 without any adverse events. Concurrent vaccinations included Tetanus vaccine, Allegra, Zomig, Rhinocort, Effexor XR and Topamax. On 26 April 2007 the subject received a 2nd dose of Engerix B at 1.0 ml in the right arm. During the injection the subject experienced a muscle spasm and was referred to a neurologist who prescribed prednisone. After two weeks, the subject reported that her hand turned blue, she developed muscle weakness, cramping, pain and numbness. On exam, the subject did not demonstrate any weakness is grip, swelling, or discoloration. The subject reported worsening symptoms and was hospitalized twice for progressive symptoms. The healthcare professional considered the events were disabling. The hand discoloration resolved.
107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82.  The outcome was recovering.  Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A week later I started to get an allergy reaction in my skin, for other reasons of nasal allergy they prescribed me medrol and zytromax and even then the skin allergy did not go away. The allergy is in the left hand, left forearm and right hand. It is a rash with hives that group, which remain red and do not seem to heal. Much itching and discomfort. I have already been 7 days and they do not heal if not that it continues to spread.
parents made an online appointment with the wrong date of birth 11/6/2008, so her record showed she was 12 years old and she got the adult pfizer when in fact she should have gotten pediatric.
Patient received vaccine on 2/7/13 and on 2/8/13, the patient calls the nurse reporting that the vaccine injection caused swelling with pain (10/10) and that he had problem moving his arm. He went to urgent care clinic on 2/8/13 where the nurse triaged the situation. Plan of care was alternating warm and cold compress 20 minutes every 2 hours, naproxen for pain control, VICODIN as instruction, and monitor right arm. If the pain and swelling worsen, then go to nearest ER. Follow up with the patient on 2/11/13.
pt recv flu & pneumococcal vax combined & given in one inj;sl soreness @ site;
has had more of a soreness reaction to the pneumonia shot; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (Solution for injection in pre-filled syringe, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient previously took flu shot. The patient had more of a soreness reaction to the pneumonia shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed. No further information expected.
Body shaking hard 1st evening, arm swollen up got hard in area around vaccination. Profuse sweating soaked sheets 1st night. Pt felt "poisoned" severe head pain "deep inhead" missed a week's work. Muscle contraction.
Provider hospital summary "Per HPI, Patient is poor historian.  Only complaint has been a rasping in his throat and a cough productive of clear sputum for the past week or two.    Per chart review, was covered in fresh and dried stool with excorations on buttocks and upper thighs and surrounding skin erythema when he arrived in Emergency Department.  EMS reported oxygen saturation of 88% on room air.  Was admitted to the hospital 11/8/2021 when he presented with transient dysarthria; declined MRI of brain at that time.    Has had 2 COVID vaccines but not a booster. Has intentionally lost about 5 lbs in the past months.   Denies recent fever, chills, marked fatigue, sore throat, chest discomfort, shortness of breath, abdominal discomfort, nausea, vomiting, diarrhea, constipation, black or bloody bowel movements, pain with urination, lightheadedness, falls, need to use assistive devices to ambulate.     1. Sepsis: suspect secondary to COVID-19 URI. Pt initially febrile to 102.6F, leukocytosis 42, lactate 8.1. Fever, lactic acidosis resolved.    2. Acute respiratory failure: due to COVID-19. Noted to be saturating at 88% on RA upon arrival however desaturated early AM 11/26 now requiring NIPPV support at max setting.  CTA on admission negative for PE, diffuse ground glass opacity. Possibly developed severe aspiration PNA. Discussed with daughter, explained of patient's grave prognosis in setting of underlying dementia-elected to change code status to DNR/DNI comfort care at this time. Patient kept on BIPAP along with broad spectrum abx, however BP and HR continued to decline. Patient pronounced dead on 11/27/2021 at 11:30 AM.    3. Hyponatremia: suspect due to dehydration   4. Rhabdomyolysis: CPK 8000 on admission. Patient was seen by EMS 2-3 days ago after being found on floor for unknown length of time, though no medical attention sought at that time.    5. Acute renal insufficiency   6. Acute metabolic encephalopathy/FTT: patient had a GLF early this year and cognition has been slowing down. APS case apparently opened.   7. CLL: reportedly not following with oncologist. Relative leukocytosis compared to baseline.    8. CAD: s/p CABG   9. MDD - Cymbalta    10. Acute on chronic thrombocytopenia"
This is a spontaneous report from a contactable nurse calling from physician's office who reported for a patient. This is second of the two reports from the same reporter. This 4-weeks old female patient received PREVNAR 13 (Lot# G75073) on 17Oct2013 in left thigh, at 0.5ml single. The patient had no relevant medical history. Relevant concomitant medication included HIB on 15Oct2013 at single dose on left thigh, DTAP vaccine on 15Oct2013 at single dose on right thigh, Polio on 15Oct2013 at single dose on left arm and rotavirus vaccine on 15Oct2013 at single dose orally. It was reported that on 17Oct2013 while on PREVNAR 13 the patients leg was red, tender and swollen. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report. Follow-up (10Dec2013): New information received from a contactable nurse includes: addition of the event inappropriate age at vaccine administration. Follow-up attempts completed. No further information expected.
Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.    Reporter did not allow further contact
FLU-LIKE SYMPTOMS; MUSCLE SPASMS; ARM NUMBNESS; SHARP NECK PAIN; SHARP SPINE PAIN; EAR PRESSURE; FEVER; HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and nut allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination to the Left Arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, muscle spasms, arm numbness, sharp neck pain, sharp spine pain, ear pressure, fever, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, fever, muscle spasms, arm numbness, hives, sharp neck pain, sharp spine pain and ear pressure was not reported. This report was non-serious.
My son got extremely sick a day after the shot.  With a very high fever.   Uncomfortable, screaming, not sleeping, not eating.   Then one week later his right leg went limp and he could not walk.    This lasted for about a 24  hours.
Headache, Myalgia, rash on arm, more diffuse and less itchy than before. used steroid ointment (topicort 0.25%) Narrative:  Other Relevant History:
Initial and follow-up information has been received from a registered nurse for the manufacturing registry of GARDASIL concerning a 20 year old female with bipolar disorder, depression, anxiety, polycystic ovaries and thalassaemia minor who on 28-FEB-2007 was vaccinated with first dose of GARDASIL (Lot #656049/0187U, expiration date 29-SEP-2009).  There was no concomitant medication (client told the nurse she was not taking any medications at the time).  Prior to vaccination on 28-FEB-2007, urine pregnancy test was performed and was negative.  Client presented to the office of 23-MAR-2007 and urine pregnancy test performed was positive for pregnancy.  The patient's last menstrual period was 28-JAN-2007.  Estimated date of delivery was 04-Nov-2007.  Follow-up information indicated that the patient had a miscarriage at approximately 9 weeks gestation on an unspecified date.  It was reported that the pregnancy was a spontaneous triplet pregnancy.  There were three empty gestational sacs.  No fetal heart tones were ever detected and there was no further progression of development.  It was reported that the gestational sac sizes were about three to four weeks of development.  At the time of the report the patient was pregnant again (WAES# 0806USA00961).  The outcome of the patient was unknown.  Upon internal review the miscarriage was considered to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.
RASH APPEARED ON FACE/SCALP APPROX 1-2 MINUTES AFTER INJECTIONS. RASH SPREAD TO BOTH ARMS. INJECTION SITE WHERE PEDIARIX WAS GIVEN WAS REALLY RED.
First shot: arm hurt a little bit; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "First shot: arm hurt a little bit". Additional Information: The patient had first shot a couple of weeks ago. He was ok, but his arm hurt a little bit and he was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336056 same patient/drug, different event (2nd dose)
severe fever, chills ,body ache , head ache  all night took Tylenol a every 4 hr  all night and the next day. the 2nd day day feel much better and  able to go back to work.
Patient reports feeling dizziness, sweating at the time of JANSSEN vaccine administration. Paramedics are notified and take his vitals they are within normal limits.