chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee received Booster dose of Pfizer covid vaccine on 01/25/22 at about 1:30 pm and then at about 6:00 pm she began having severe pain to her right arm  which is the injection site,  swollen and painful right lymph node,  itching all over her body,  severe headache and painful tongue with small bumps on it.  At the time of these symptoms as per employee she took Benadryl and Tylenol. Today (1/31/22) employee still has mild pain and swelling to her right arm as well as slight itching.
This is a spontaneous report from a contactable Physician. A 65-years-old patient (Weight: 140 lb., Height: 59 in) of an unspecified ethnicity and gender received PREVNAR 13 (lot S43277, Exp date Sep2018), intramuscular in left arm on 03Nov2017 11:00 at 0.5 ml single dose for immunization at Physician office. Medical history included ongoing hypothyroidism. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 75 mcg daily for hypothyroid and FLUZONE on 27Oct2017 for immunization with no adverse effect. No additional vaccines were administered on same date of pneumococcal 13-val conj vac (dipht crm197 protein). On 03Nov2017 at 17:00, about 6hrs after injection, the patient experienced local injection reaction described as large area of intense skin reaction with erythema and local tenderness, very large and painful. The patient was evaluated at physician office and recovered on 06Dec2017.
Stiff neck following H1N1 vaccine, persisted for 3 mos. despite use of Rx muscle relaxant, heat pad, neck massager; then had knee surgery with unexpected complications I had no risk factors for blood clot, blood thinners, autoimmune reaction, now Rheumatoid Arthritis. Question if H1N1 vaccine contributed to this.
Initially: Tired, took nap Second Day: Muscle pain on both side of lower back.  Triggered when bending lower back.  Lasted ~4 days, got better on 3 through 5 days. After 8 days, in evening I noticed red spots  (~1.5" circular) on right side of chest and near neck on shoulder.  Also maller spots below shoulder on front.  I have photo showing red areas.  Rash on not on side of body (left) where vaccine was administered. Rash is on right side of body.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 24-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Pain; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications was  provided by the reporter. No concomitant medications was reported by the reporter.
It has been more than 35 days after first dose and has not received the second dose; Got COVID-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced COVID-19 (Got COVID-19 after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE at an unspecified dose and frequency. At the time of the report, COVID-19 (Got COVID-19 after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has been more than 35 days after first dose and has not received the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.         He was told not to get the second dose for 90 days after having COVID. Now he is about to get the second dose. No concomitant medications were mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: document received and contains no new information.
INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness. This report was non-serious.
Patient came in wanting second dose, she received first dose from us 2/7/22 after giving her 2nd dose she asked if we could give her updated card with all her shots and updated name.  pt received 2 shots 4/26/21 and 5/24/21 under another name.  She was not a resident at that time and has since became a resident and changed her name.  Pt feels fine she has just received 4 doses and only indicated for 3
The patient is a 86 y.o. male patient of MD with history of CAD, hypertension, hyperlipidemia, COPD, hypothyroidism, CAD, myocardial infarction, prostate cancer s/p resection and RT, and squamous cell cancer of the left calf. who presented to the Hospital with shortness of breath.   Sepsis due to Viral and bacterial pneumonia Acute Hypoxic Respiratory Failure, due to COVID 19 Pneumonia and Superimposed Bacterial Pneumonia COPD Exacerbation Desaturated to the 70s on room air. Afebrile, tachypneic and with leukocytosis on admission. Now all improving. Lactate WNL. Required 5L NC on admission, weaned to 3L today Recently started on Augmentin for possible CAP Positive COVID test  3/2/23 CXR interstitial and alveolar opacities about the mid and lower lung zones. Superimposed multilobar pneumonia in the distribution of the right middle lobe and lower lobes as well as lingula is difficult to exclude Procalcitonin elevated so likely superimposed bacterial infection present Continue Unasyn IV Dexamethasone ordered, Symptoms started 10-14 days prior to admission, no Remdesivir ordered CRP improving Albuterol PRN On trelegy at home, continued as Spiriva and Symbicort here May require prolonged wean off supplemental O2 given severity of COPD in last PFT's. Discharged home on home oxygen, requiring 4L via NC during exertion and 2L NC at rest. Discussed following up with PCP and Pulmonologist Course of Dexamethasone and Augmentin (previously prescribed and at home) prescribed on discharge to complete treatment   Hyponatremia, mild AKI- resolved Sodium 127 on admission, improved to 130, now 126 again Cr initially 1.34, now down to normal.  Suspect due to poor PO intake initially. Mmild edema noted on 3/4, Lasix 20 mg given, Na remains 126. Will start salt tablets.  Check Osm u/p CoUrinary Tract Infection, ruled out Urinary Retention s/p Suprapubic catheter History of Prostate cancer UA suggestive of infection Urine culture with no growth No specific urinary symptoms, but SPC in place Unasyn for CAP as above anyways, but culture confirmed no UTI   CAD Hypertension Hyperlipidemia Currently no chest pain Continue home aspirin, atorvastatin, and diltiazem   Chronic normocytic anemia Due ot chronic disease, Hb ~10-11 since January No signs of bleeding. Monitor   Hypothyroidism Continue home levothyroxine   Depression/Anxiety Continue home amitriptyline ntinue to monitor
He got the covid vaccine (2nd dose) on 3/10/21. He should not be given the Boostrix 14 Days after that. Patient call CDC & they said monitoring
Swollen lymph nodes in upper right chest near collarbone; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 26Mar2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex virus (HSV) and latex allergy. Concomitant medications included lysine (MANUFACTURER UNKNOWN) and women's multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00 the patient experienced swollen lymph nodes in upper right chest near collarbone. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph nodes in upper right chest near collarbone was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
24 hours after DTaP/Hib given. Developed fever for 8 days. Diagnosis with acute otitis media bilateral 7 days within vaccine given.
strong heart pain that woke her up at 4 AM; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (strong heart pain that woke her up at 4 AM) and PYREXIA (Fever) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On 02-Apr-2021, the patient experienced CHEST PAIN (strong heart pain that woke her up at 4 AM). On 03-Apr-2021, CHEST PAIN (strong heart pain that woke her up at 4 AM) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a licensed practical nurse concerning a 12 year old male patient who on 09-SEP-2009 was vaccinated with his second dose of VARIVAX (Merck) (Lot number was not provided).  On 10-SEP-2009 the patient was seen in the office with an injection site reaction that was 3cm by 3cm.  The area was red and warm.  No fever or open lesions.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included belimumab (Benlysta).   On 4th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix and an unknown time after starting Benlysta, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's husband had his Shingrix booster the day before reporting in afternoon.  This morning he had muscle pain.   The correction performed as per action item reply: The concomitant products included belimumab (Benlysta) was deleted.
Tdap given 5-7-07 -  student states after being out and about on 5-12-07, in th evening she began to have difficulty breathing. Mom took to ER. Dr said was allergic reaction but no specific source diagnosed. Student given steroids by Dr and sent home - Prednisone and Benadryl (went to ER on 5/13/07)
feb 12 at 1500 was given the Moderna vaccine .   On the 16th developed a headache , muscle aches , and nausea.   Symptoms have improved today with no treatment.   Patient states had similar symptoms 6 months ago.  Patient was given the Pneumonia and Shingles   vaccine on the same day.   Persistent symptoms see PMD.
pt recvd vax; pt devel hives & eczema; pt had suspected scabies; pt devel hives again & was seen in ER;
This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 2nd dose of SHINGRIX. On 20th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain, muscle pain, back pain, shoulder pain and headache. On an unknown date, the outcome of the pain, muscle pain and back pain were not recovered/not resolved and the outcome of the shoulder pain and headache were unknown. It was unknown if the reporter considered the pain, muscle pain, back pain, shoulder pain and headache to be related to SHINGRIX. Additional details were provided as follows:  The age at vaccination was not reported. On the same day of vaccination, the patient started experiencing achy, muscle ache in her back, shoulder and head.
After shots and done waiting in office - WCL d/c. While in parking lot she felt dizzy and facing pale so father brought her back to office. Looking pale with HR 79 strong no distress alert warm to touch pink nail bed - observation done with fully recovered.
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    The case contains the information regarding patient 11th of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:case
HIGH FEVER; RUNNY NOSE; GIVEN TYLENOL; RED CHEEKS
A few days after the vaccination in her left arm, her right forearm started swelling and it was tingling & sore.  There was apparently no reason for the swelling - the NP said she didn't know the cause but to take an anti-inflammatory.  In a few days the strange swelling went away.
Sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles 2 years ago and it was so painfull) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient also reported that had shingles 2 years ago and it was so painful and nothing works it had to run it's course. The patient got the shingles vaccine and got a little sick but still worth getting it. The patient mentioned that took vaccine and don't regret it. The contact details was not reported hence follow-up not possible. For second dose refer linked case US2021AMR195128, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195128:same reporter,same patient
Within 30 minutes of administration of DAPTACEL (the only vaccine given) became itchy all over, runny nose and short dry paroxysmal cough. She responded to rapid administration of BENADRYL 12.5 mg and Albuterol through inhaler with INSPIREASE and nasal saline flush within 15 ' - These were repeated prophylactically 4 hrs later.
THUMPING IN LEFT EAR; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced thumping in left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thumping in left ear. This report was non-serious.
Weird taste in her tongue, swelling and scratchiness in posterior throat and coughing; history of multiple episodes of anaphylaxis; ROS negative except as noted; given Benadryl and improved; patient slept and awoke feeling well.  Sent home and advised to follow up as needed.
Swelling of throat, became unable to swallow. Fever - 100 degrees F - symptoms started 8 pm. 9/18/13. ER gave dexamethasone inj. TYLENOL, ibuprofen, ranitidine Rxs upon discharge: Hydroxyzine HCL 25 mg, prednisone 20 mg, ibuprofen, ranitidine.
Tested positive after taking vaccine; A spontaneous report was received from a 47-year-old female patient who is also a healthcare professional who experienced testing positive after taking vaccine with the use of mRNA-1273.   Medical history included being Immunocompromised and Multiple Sclerosis. There were no concomitant medications used by the patient.    On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Batch # 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient had a positive COVID-19 test with a Rapid lab kit.  The second test was positive as well. Additionally, the patient did a third test using PCR on 31 Dec 2021. On 05 Jan 2021, the patient still had not received results as her sample had been lost. She was administered another test on 06 Jan 2021 and results were still pending. On 08 Jan 2021, the patient was advised her PCR test was negative. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event, tested positive for the vaccine, was not provided.  The outcome for the event, tested positive for the vaccine, was recovered/resolved.; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of positive COVID-19 test with a Rapid lab kit is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of producing a positive test result.
Pt became fretful, lost appetite, low grade fever; Father observed respiratory arrest, on 3rd day Sunday & met MD @ ER, recovered;
A report has been received from a Physician concerning an adult, female subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced arm muscle pain. The outcome of arm muscle pain is unknown. The report was considered to be non-serious.
Stuffy nose, fever, chills, shaking, migraine - Lasted 3-5 days