chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 21 August 2010 from a literature citation: A healthy 18-year-old female patient who had not been known to be taking any prescription medications, had received an injection of MENOMUNE A/C/Y/W-1 (lot number, route and site of administration not reported) on 21 August 2003 and ten days later, she developed a rash beginning around her ankles. Over the next week, the rash spread to her legs, thighs, buttocks and arms. A urinalysis confirmed the presence of blood and protein. On 04 September 2003, a skin biopsy was performed with results consistent with HSP (Henoch-Schonlein Purpura). Prednisone 40 mg was prescribed and tapered over three weeks, and rash resolved. On 08 September 2003, the patient began to notice migrating polyarthralgias of the ankles, knees, elbows and wrists. On 16 September 2003, she developed a second similar rash and experienced a few episodes of abdominal discomfort and nausea and one episode of emesis. On 03 October 2003, she was admitted to the hospital for a renal biopsy. On admission, her physical examination results were abnormal. She had pitting edema of the lower extremities which was greater than or equal to 1, and a nonblanching nonpruritic, maculopapular rash on her arms and legs bilaterally. No vesicles or crusting were noted. Laboratory findings upon admission revealed hemoglobin level of 13.0 g/dL, white blood cell count of 14000.4 cells per uL, platelet count of 288000 cells per uL, prothrombin time of 11.7 seconds, an international normalized ratio (INR) of 1.2, partial thromboplastin time of 24 seconds, and a creatinine level of 1.0 mg/dL; a 24-hour urine test revealed protein excretion of nearly 7g. Results from the renal biopsy revealed glomeruli with mild to moderate segmental mesangial proliferative changes, and occasional glomeruli showed segmental endocapillary proliferation. No tubulitis was seen, and there was no interstitial fibrosis or tubular atrophy. Intratubular red blood cell casts were seen. Immunofluorescent studies showed segmental glomerular mesangial staining for C3 (moderate), properdin (trace) and IgA (trace). The biopsy results were considered diagnostic for HSP. Subsequent to the hospitalization, the patient's HSP had gone into remission, but recurred one year later. Two years later, the patient was still receiving low-dose alternate day prednisone. Outcome was not reported. Documents held by sender: None.
sore arm; painful stiff neck; painful stiff neck; chills; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Jan2021, the patient experienced sore arm, painful stiff neck, and chills. Patient could not lift arm above shoulder height or turn head. At the time of report, still have some neck pain but better than yesterday. Patient was able to turn head today. No chills and arm was still sore. The outcome of the event sore arm was not recovered, painful stiff neck was recovering and recovered from the event chills.  No follow-up attempts are possible; information about batch number cannot be obtained.
Five days after my second vaccine, at about 8 am, I developed fairly diffuse abdominal pain, and retching.  I left work and went home.  This lasted for about 3 to 4 hours, then let up, but then developed about 45 minutes of profound rigors, which then let up, then my temperature (had been normal) went up to less than 102 F.  For the next six days I continued to run fever, never higher than 103, chills, and some migrating abdominal pain, no diarrhea, normal stools, constipated if anything.  Stayed home from work obviously.  On Sunday, and Monday am, still running fevers, my pain seemed to settle into my right lower quadrant.      My wife, a family physician, helped arrange a CT scan Abdomen and Pelvis, as we were concerned about appendicitis, maybe an abscess.  The scan revealed normal appendix, but several lesions in the right side of the liver thought highly suspicious for "metastatic disease."  MRI recommended, and had this Wednesday that week, and it confirmed the lesions, with characteristics suspicious for metastatic tumors.  By Monday afternoon, my fever abated, and I felt much better.  Able to return to work.  The abdominal discomfort was improved, maybe due to constipation.  Friday of that week, I was able to get to see my primary provider, who is in Omaha, NE to review the situation, and we agreed a liver biopsy was needed.       A week later, Friday, Jan. 29, I had CT guided liver biopsy at  hospital in Omaha. 16 cores taken, and no malignancy found, but significant inflammatory cells, especially lymphocytes.  Meanwhile I have felt fine.  Decided to do a follow up MRI of liver, which was done Friday, April 2, and all the areas have resolved.    There is an entity called "Inflammatory pseudotumors" of the liver, and my condition fits with this.  It is very rare.     A consideration would be whether it would be possible to stain the biopsy to see if the lymphocytes carry antibodies to the corona virus.
15 minutes after injection patient reported feeling lightheaded and nervous. Patient denies chest pain, difficulty breathings, itchiness or pain. Patient was evaluated by EMS at 11:19 am Blood Pressure 168/95 at 11:29 am Blood pressure 148/92 O2sat 100% Patient is drinking water and feeling better. 11:35 am Patient reports her symptoms have resolved, and wishes to leave.  Patient was advised to follow up with her PCP or to ED if symptoms return.
GARDASIL 9 vaccination was administered into my right arm and now months later the pain that once was mild grew over time to now being severe and unbearable.
Child on apnea monitor since birth. Born 1 month premature. Parents awakened by monitor going off. I am unsure of # of episodes throughout night. Parents have not yet returned call.  Full ER report will be faxed, which includes all treatment, etc. 4/20/06 Received ER medical records which reveal patient arrived in full arrest w/blood around nares & was unable to be resuscitated. 5/25/06 Received autopsy report which reveal COD as SIDS with cosleeping in child with history of sleep apnea & mild chronic bronchitis/ss
Patient stated she did not feel well after receiving vaccines then passed out. Was only out a few seconds and came to. Patient was dizzy and pale. Orange juice and ice pop given no other treatment need, Dr. was in to see patient after the event.
sick for a day and a half; This is a spontaneous report from contactable consumer (patient's mother) reported that a male patient of unspecified age received the BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was sick for a day and a half and had his shot a long time ago. Outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist via other company refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported).        On an unknown date, 15-20 days after onset of therapy, the patient experienced itching rash. The outcome of the event and the relatedness between the event and M-M-R II were not reported.       Additional information is not expected as there were no healthcare professional contact details provided.
Pt experienced headache, blurry vision, "muffled sounds,"  flushing/sweating & experienced dizziness. Juice was given, mom stated this happens for all shots, crackers given, pt lay down & rested. Provider cleared pt, pt stable & released from vaccination site
Chills, muscle and joint pain, headache, dizziness/fainted, headache, light nausea
This initial spontaneous report was received from the father of a three year old female patient. The patient was taking no concomitant medication and had no pertinent medical history or allergies. On 03-APR-2017, the patient was administered "routine" VARIVAX, "0.5 dose" (route and lot # not provided). On 15-NOV-2017, the patient was diagnosed with shingles. The father stated she "got shingles from varicella vaccine". She currently has shingles on half her body. She was seen in the Emergency Room (ER) on an unspecified date and released. Unspecified labs/diagnostics were done described as "studied to see what was wrong with her". She was prescribed acyclovir "five times a day" and ibuprofen "whenever she cries". The patient was still experiencing pain at the time of the report. The outcome of the event was not recovered. Causality assessment was related. The father stated he wants to sue the company for giving his daughter shingles. Additional information has been requested.
She missed the date for her 2nd dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd dose.) 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 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd dose.). On 27-Jul-2021, PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Came in 4 days later with red warm indurated area extended to under axilla. Seen by MD Rx'd with ibuprofen and advised to use wet compresses.
Redness/swelling, blisters, rash & itching started occurring day after vaccine adm. and progressed. 11/18/12 Pt told to take BENADRYL and to see MD if symptoms did not resolve. No resolution pt going to MD 11/20/12.
Patient already had pfizer shot in the July. He told us he wasn't vaccinated and wanted the moderna shot. When we tried to bill moderna, it rejected and said he had pfizer shot already. He did not disclose this information and said he wasn't vaccinated yet to 3 pharmacy staff including the pharmacy district manager.
Information has been received from a medical assistant referring to a 32 year old patient of unknown gender. On 03-JUN-2015 the medical assistant inadvertently removed the pediatric instead of the adult formulations of VAQTA (strength reported as 25/0.5, unit not reported) and RECOMIBVAX HB (strength reported as 5/0.5 microgram/ml) from the refrigerator. Subsequently on the same day, the patient was vaccinated with the pediatric dose of VAQTA and RECOMBIVAX HB (dose, lot # and route were not reported) (accidental underdose). No adverse events were reported. Additional information has been requested.
My salad tasted like metallic; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received Shingrix. On 18th November 2022, 3 days after receiving Shingrix, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was not recovered/not resolved.   It was unknown if the reporter considered the taste metallic to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the vaccine on Tuesday and today on the day of reporting he/she had salad which had tasted like a metallic. The patient had metallic taste. The reporter requested consent to follow-up.
Patient's "7" in 67 looked like a "3"  accidentally administered regular dose instead of High Dose flu vaccine
vaccination site reaction: It is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of; Fever; This is a spontaneous report from a contactable pharmacist.   A 32-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot # CD0412, Expiry Date Jan2022. NDC # 0005197102) intramuscular at 0.5 ml, single at left arm on 05Feb2020 for immunisation.  Medical history included ongoing Non-familial hypogammaglobulinaemia.  There were no concomitant medications.  The patient received PREVNAR 13 with the indication of non-familial hypogammaglobulinaemia on 05Feb202. On Thursday, 06Feb2020, morning the patient began running a fever of 100 or better.  She has been treating it with Tylenol and it will help a little bit. She has also had an injection site reaction in Feb2020: it is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of like hives. The reporter assessed the events as non serious. The patient underwent lab tests and procedures which included: body temperature: 100 or more  on 06Feb2020. The outcome of fever, injection site reaction, it is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of like hives was not recovered.
High fever, vomiting, lethargic. Going on 12 days. Last shot round it lasted a month.
On November 27, 2017 the day following the vaccine, woke up with a rash on arm. Called the pharmacy and was advised it would get a little red where the injection was. On November 28, 2017 called primary care physician and was instructed to get an MRI immediately. While walking to get the MRI, the ankle swelled up and starting turning black and blue. Admitted to Medical Center on November 29, 2017 and discharged on December 22, 2017. Returned back to the hospital on December 29, 2017 and was admitted again until January 8, 2018.
Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023; Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023; This spontaneous safety report, with reference number 02340148 (Interaction # 02340145), was received by the partner on 21-FEB-2023 and forwarded on 23-FEB-2023, from a physician.  Due to the nature of the event, the causality between the events "Patient who was previously administered PENTACEL on 03/15/2022, on 06/09/2022, and on 01/10/2022 was administered VAXELIS via VAXELIS Prefilled Syringe at 15 Months on 02/20/2023" and Vaxelis was not applicable.  No further information is expected given that the reporter did not give consent for further follow-up communication.
Chills, fever, Red rash on entire face, chest , arms and back. The rash appeared 2 days after (05/14)  to present day (05/16). I was given Methylprednisolone to stop my body?s reaction to the shot.
Late afternoon 10-07-14 - early flu-like symptoms. 10-08-14 not feeling well. Aching, no energy. 10-09-14 fever - over 100 degrees - aches, pains, headache. 10-10-14, Fever, aches, pains worse. Go to emergency - 9:30 pm. Had heart display irregular rhythm. Admitted to hospital for test. Ran fever in hospital. 10-12-14 released from hospital.
Information has been received from a physician concerning a female who was vaccinated with the first dose GARDASIL (lot# not provided). Per the reporter, after receiving the first dose of GARDASIL the patient experienced dizziness. The patient sought unspecified medical attention. No further information was provided. Additional information is not expected.
Patient received undiluted dose of Pfizer, 150mcg. This was dose 2 in series. Phone call to patient on 10/29, patient reported more discomfort in her arm than with the first dose, potential swelling to arm,  feels warm/red to patient, but denies fevers. Also noted nausea and headache. Had taken ibuprofen 400mg, encouraged to take acetaminophen 1000mg and Ibuprofen 800mg every 8 hours until symptoms resolve. On 10/30, patient continued to deny fevers, reported feeling much better, and that swelling to arm had improved.
Patient reportedly had  shortness of breath, hives, diarrhea, nausea, vomiting approximately 4 hours after receiving vaccine. Symptoms resolved with Benadryl.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 15-AUG-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # K010523, expiry date: 25-FEB-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
classic neurophathy; warm on the bottom of feet; face tingling; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th February 2019, refer case US2019AMR161883 ). Concurrent medical conditions included bone spur.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), localized feeling of warmth and tingling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the neuropathy and tingling were unknown and the outcome of the localized feeling of warmth was not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, localized feeling of warmth and tingling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose 2 of Shingrix and that months later he started to feel warm on the bottoms of his feet and it feels like, classic neuropathy to him. He states he sought medical care and his physician told him it was bone spurs and not related to Shingrix, but patient felt it was incorrect.  The patient stated that 3 weeks ago he experienced like his face was started tingling as well. The reporter consented to follow up.
Pain lt shoulder, lt elbow and lt forearm after 2nd injection on 7/11/2002. Saw MD at MEA Clinic and told I have arthritis in shoulder.
Covid arm in both arms; Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm in both arms) and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm in both arms) and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.). At the time of the report, VACCINATION SITE REACTION (Covid arm in both arms) outcome was unknown and VACCINATION SITE PAIN (Second arm stings 3x daily. Rub it lightly and it goes away. Feels like being stung by a mosquito.) had not resolved.      No concomitant medication was provided.  The patient had received second shot 8 months ago. While reading FAQ L.3 (Clinical Trial side effects), the patient reported that the patient had most side effects all of those except for the nausea.  The patient's second arm stings 3 times daily. The patient rubs it lightly and it goes away. The patient felt like being stung by a mosquito and felt irritating. The stinging was less in first arm.  No treatment medication was provided.   This case was linked to MOD-2022-512065 (Patient Link).
Intense itching of feet and hands approximately 33 hours after dosing.  Also experienced fever, chills and a sore throat after approximately 4 hours of dosing.
COVID positive 1/14/22. Presented to ER on 1/14/22. Received dexamethasone, ceftriaxone and doxycycline. Small PE developed. Taper dexamethasone, Levaquin 500 mg for 5 days and eliquis for 6 months at least. Discharged on 1/17/22. Presented to ED again on 1/19/22. Last hospital course, he was confused upon admission.  This time he is awake, alert, and coherent.  He went home, was taking his medications including Eliquis as he was diagnosed with pulmonary emboli during his last hospital course.  He was on his 5 L, which he is usually on chronically, and he has  measuring his pulse ox, found to be low.  He came to the emergency room.  He  has now been placed on OptiFlow with 60% FiO2 on 40 L flow rate.  He is in no  obvious distress.  Chest x-ray does show worsening pneumonia, however, repeat  CT angio at this time.  Patient is agreeable to hospitalization at this time.   He is in no obvious distress. Admitted on 1/19/22. Received remdesivir. Discharged again on 1/28/22.
Parent called on 12/4/12 to report child had rash on face and other parts of her body (left message for nurse).  No further information received.  Three attempts to contact parent for further information/follow-up were unsuccessful.
Within 15 minutes after receiving vaccine, pt sxs included nausea, dizziness, HA, feeling anxious, shaky, SOB, sweating, shallow rapid breathing, SOB tumors, BP 130/100, 160/104, P-120 R 20-22. Transported to ED by EMTs.
Systemic: Flushed / Sweating-Severe, Additional Details: Pt asked "is this supposed to make me hot" a few minutes after the vaccine was given. I said, no and asked if she was ok. She said yes, but that she was really hot. I got a fan for her and had her sit infront of the fan for the rest of the 15 min. After 15 min, she said she was fine and felt fine to leave. I told her she could stay as long as she wanted to/needed to; but she said that wasn't necessary and she felt fine, and she left.