chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 4 month old male patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA010964: US-009507513-1807USA006807: US-009507513-1807USA006808: US-009507513-1807USA006809.
Respiratory Arrest. Transported to the ER - when resuscitation efforts failed. Hx of TEF, GERD - Probably an aspiration event. 11/9/05 Received medical records from ER which revealed patient arrived in full arrest & was unable to be resuscitated. 4.20/06 Received Death Certificate which revealed COD as apnea and respiratory failure.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown date (reported as a long time ago), the patient was vaccinated with VARIVAX injection (dose, route of administration, lot # and expiration date were not reported) and PROQUAD injection (dose, route of administration, lot # and expiration date were not reported). Sterile diluent (manufacturer unknown) was used to reconstitute the vaccine. No symptoms were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1707USA005223.
Approximately 15 hours (7:00 am) post vaccine, experienced mild headache.  Took 600 mg Ibuprofen.  Approximately 5 hours later (noon), I experienced increasing headache, generalized body aches, and chills.  Rest and alternating Tylenol and Ibuprofen.  As of now, February 13, mild headache only.
w/in 2-3 hrs devel h/a nausea, vomiting, chills, fever;
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mastocytosis" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Bactrum, reaction(s): "Known allergies: Bactrum". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: I started taking Paxlovid on Day 3 of symptoms; (15Aug2022) Negative, notes: I tested negative on Day 10; (16Aug2022) Positive, notes: On Day 11 I tested positive; (17Aug2022) Positive, notes: Today is Day 12 and I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID 19 Treatment started at 08Aug2022 and stopped at 12Aug2022.I have a cough and congestion again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via field employee refers to a patient of unknown demographics. Concurrent conditions and pertinent medical history were unknown. On an unknown date the patient was vaccinated with GARDASIL (dosing details unknown). It was reported that the patient fainted after receiving GARDASIL. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
After second dose of Covid my left deltoid became enlarged.  Not really swollen but enlarged and has never gone done since receiving the vaccine.  This  wasn't noticed until April .   No pain or redness, sometimes get a sharp pain in back but not consistent.
Information has been received from a physician concerning a 13 month old female who on 24 Oct 2006 at 13:40 pm was vaccinated subcutaneously in the right arm with a first dose of Proquad (lot# 655141/0833F). Subsequently, the patient experienced "chickenpox at site of injection." It was unspecified if medical attention was sought. No further information was reported. Additional information has been requested.
Information has been received from a physician, via a company representative, concerning a 16 year old female patient who on 25-OCT-2007 was vaccinated IM with the first dose, 0.5  ml, of GARDASIL vaccine (yeast) (lot # not provided). The patient fainted following the vaccination, and was taken to the emergency room. The outcome of the event was unknown. No further information was available.
Brain fog; Feels like a broken rib on her left side; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.    This case was linked to MOD-2021-055108 (Patient Link).
Pt received influenza vaccine on 11/12/2003.  On 11/24/2003, patient developed idiopathic thrombocytopenic purpura with a platelet count of 3,000.
Blurry vision in both eyes, inflammation of both eyes, light sensitivity of both eye, unstable vision of both eye, lessen vision of both eyes.  Use lotemax ointment on both eyes lids for two weeks at bedtime and every Monday, Wednesday and Friday at bedtime after the two weeks
Began to experience substantial swelling at the injection site and the skin was very hot to the touch.  The arm became very painful to move and I could hardly raise it.  On 9/17/11 it continued to swell and It seemed like the area that was swollen was hardened.  At some point during the afternoon, a circular rash began to develop around the injection site and extending down the arm a bit.
Injection site became hard, swollen and painful into right breast under right arm and across right shoulder blade. Treatment included Aleve 500mg, ice and rest.
This is a spontaneous report from a contactable Other-HCP (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 31 years), as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date was not reported), via an unspecified route of administration, Arm Left, on 30Dec2020 (age at vaccination: 31 years), as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. Past drug event included genetically tested to diazepam allergy. The patient had 4 children and last born in May2020. She was not nursing when vaccinated. Concomitant medications included L-methylfolate, vitamin B complex, cyanocobalamin (B12), and lamotrigine (LAMOT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that she started with a few hives on her elbows at the end of Jan2021, then her entire body was covered in large hives (red, warm, raised, itchy) almost every day. She spoke with NP and tried oral steroids, and multiple antihistamines with no relief. She stopped all meds and supplements. She spoke with immunologist and started on multiple antihistamines daily. She had no relief and at times worsened and started on xolair injections. Xolair was the only medication that has helped. There were still hives but not every day and not head to toe like they were. She also has to take antihistamines. When she didn't, she break out in more hives. She has taken multiple pictures to document. Since Jan2021, she was struggled with abnormal menstrual cycles, gut issues, severe brain fog, edema, angioedema, along with the hives. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events which included mult. meds, stopped all current meds, and Xolair. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of angioedema cannot be 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.
Patient was fully vaccinated with J&J on 4/8/21.  Has had cough, congestion, runny nose for the past 6 days as well as fever. Patient has been admitted with COVID since 12/8/21
12/13/2021, aches, chills, fever, weakness in legs, all COVID type symptoms, lasted 4 days.
After vax given, pt became pale,diaphoretic,diff breathing,upset stomach,rapid pulse,low bp 60/38. Pt given .3mg epi/50mg (im) Benadryl. pt unable to swallow,give inject solumedrol per MD. Pt began to get puffiness in eyelids and below chin
Pt with petechiae rash x 10 days. NO fever only rash. Same day I sent him for labs STAT and critical results and was sent again to ER for admission that night. Later during hospitalization patient had diagnosis Idiopathic severe Aplastic Anemia by Dr and sent to Hospital for consultation and evaluation of a possible allogenic hematopoietic stem cell transplant (HCT).
Information has been received from a NP concerning a 36 month old male with "no allergies" who on 06/07/01 was vaccinated SC in the left thigh with a first dose of 0.5mL (Lot # 637672/1610K) and "had break through chickenpox". There was no concomitant medication. The pt presented to the nurse practitioner with a "rash", described as a mild case of varicella. There were no lab studies performed. It was noted that no treatment or hospitalization was needed. It was also noted that the child was exposed to chickenpox at day care. Unspecified medical attention was sought. It was also noted that symptoms resolved and the pt had recovered. The reporter also mentioned another pt who experienced a similar reaction with varicella virus vaccine live (Lot # 624781/0056H) (WAES # 0308USA01465).  No further information is expected.
severe upper abdominal pain (esophagus). it was painful to breathe. a cold shiver throughout my entire body when i exhaled. vomiting .. i could not hold down water. went to urgent care and they referred me to the hospital ER.  they could not find anything wrong.
Two days after vaccination, patient experience shortness of breath, chest pain and a sensation of heat in the upper left arm area. The chest pains and shortness of breath occasionally still occurs.
Information has been received from a physician concerning a female who in 2008, "within the past year", was vaccinated with a dose of GARDASIL (lot # not reported). Immediately after vaccination the patient passed out, hit her head and broke a tooth. Patient sought medical attention via an office visit. On an unspecified date the patient recovered. No further information is available.
felt foggy; flu like symptoms; fever of 102.3; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt foggy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever of 102.3) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (felt foggy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (fever of 102.3). On 20-Apr-2021, FEELING ABNORMAL (felt foggy) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PYREXIA (fever of 102.3) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 102.3 (High) 102.3.         No concomitant medications information was reported. No treatment medications were provided.
Wide spread rash which started at injection site. 9-24-12 - Followed up with pt. rash is resolving today with BENADRYL and hydrocortisone cream.
The patient was to get the Moderna Bivalent. Instead the Moderna Pediatric age 6-11 was administered
73 year old patient taking Adacel with no reported adverse event; Initial information was received on 24-May-2021 regarding an unsolicited valid non-serious case received from a consumer or other non-professional.  This case involves a 73 year old (unknown gender) patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).   It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medications were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration. (latency same day)  It was unknown if there were laboratory data/results available.   At the time of report, no adverse event was reported.  It was unknown if the patient experienced any additional symptoms/events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Pain, redness, swelling & fever to (R) delt. Pt scheduled follow up 01/13/12 - no showed unable to reach by phone - letter mailed 1/16/12.
Information has been received from a Doctor of Pharmacy concerning a 40 year old (also reported as 44 year old) female with diabetes who on 11-APR-2009 (also reported as 13-APR-2009) was vaccinated with a dose of PNEUMOVAX 0.5 ml, IV instead of subcutaneous or intramuscular. Concomitant therapy included methylprednisolone, docusate Na, LOVENOX, FLONASE, MUCINEX, LEVEMIR, ATROVENT, CLARITIN, GLUCOPHAGE, PRILOSEC and BRETHINE. The patient was being treated for pneumonia. The physician reported that on the same day of vaccination, the patient was complaining of burning in the arm and numbness in her back. The patient was bradycardic and at the time of reporting was tachycardic. Unknown if any laboratory tests were performed. The patient was receiving ice packs at the IV site and was being monitored. As of 11-APR-2009, it was unknown if the patient was going to continue to receive PNUEMOVAX, as per pharmacist the patient was "doing ok". It was reported by pharmacist that the patient's heart rate initially went down, but at the time of reporting was "doing ok". No further information is available.
15 min p/inject pt felt throat feeling tight; felt wt on chest was sent to ER for observation given DPH dx hyperventilation
Rash/hives. Dermatologist prescribed cream. The rash occurred today again 02/23/2022 severely.
No additional AE's; Patient was administered the 1st ROTATEQ dose after 15 weeks of age by Nurse per physician's order; This spontaneous report was received from a nurse, concerning a 4-month-old male patient. No information about the patient's concurrent conditions, drug allergies, concomitant therapies or medical history was provided.  On 14-JUN-2021, after 15 weeks of age, the patient was vaccinated by nurse per physician's order with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1707572, and expiration date 11-MAR-2022, which were verified to be valid) for prophylaxis (vaccination scheme frequency was not reported) (product administered to patient of inappropriate age). No additional adverse event (AE).
Vaccinated 1/12/2021. Left arm became sore next day, and continues through today. Reported as normal course of arm pain which became much more intense on 1/22/2021. Large red, raised rash, warm to touch present. Spreading noticed over next several days. As of today, 1/26/2021, patient reports rash has decreased, is no longer warm to touch. Pain is still present, but less intense than previously.
Pfizer Bivalent given inadvertently the patient had not had initial Monovalent vaccine.  No adverse reaction occurred.
This patient came back Saturday 08.16.2015 saying her arm still feels warm and she did have a big red rash too. She said she had fever the first few days. Her rash was not blistering or anything, its slightly raised.
Days 1, 2 and 3 muscular arm pain,   Pain subsided days 4, 5, 6 and 7 mild stiffness and ache which I had prior to the shot so I would call it ack to normal.    Day 8 and  9(current) pain kept me up at night, can hardly move my arm.  Taking Tylenol.
18Mar05 at 1400 Pt received sm pox at 1405 pt had tightness in the chest and shortness of breath. Dr examined the pt , we administered at 3. Epi SC and 25mg Benadryl IM. Pt was transported to ER.
felt awful for several days; shingles / suspected vaccination failure; In June I had shingles/she has had a cse of shingles every month since June 2023; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, the patient received the 1st dose of Shingrix. In JUN-2023, between 3 and 5 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: In June I had shingles/she has had a cse of shingles every month since June 2023). On an unknown date, the patient experienced feels awful (Verbatim: felt awful for several days).     The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the feels awful was resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feels awful to be related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the company considered the feels awful to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-AUG-2023 and 21-AUG-2023 The patient self-reported this case. The patient noted that when she received her second Shingrix vaccine, she had a robust response and felt awful for several days. In June 2023, the patient had shingles and was treated with Valacyclovir HCI 1 gram, 3 times a day for 7 days. In July 2023 had Shingles again, about 3 weeks after finishing above treatment. Doctor stated to take same treatment for 2 full weeks. The patient finished that and about 10 days later in August, the patient had Shingles again. Now doctor wants her to take above treatment for 3 months. The patient thought this was an adverse reaction to the Shingles vaccine, Shingrix. The reporter wants GSK to follow-up with her healthcare professional since she had a case of shingles every month since June 2023. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Medical history, current conditions and drug allergies were not reported. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX single dose, lot # K007988, expiration date 03-SEP-2015) subcutaneous in the right arm. No concomitant medication was reported. On an unspecified date in October 2014, the patient developed redness, warmth, swelling, and tenderness at the injection site. The patient sought for pharmacist attention. The outcome of redness, warmth, swelling, and tenderness at the injection site was not reported. The relatedness between the ZOSTAVAX and the events was not provided. Additional information is not expected because there was no consent to further contact.
severe chills, headache, low grade fever, joint pain, nausea and vomiting, and injection site soreness Onset was within <5 hours of injection and lasted 60 hours. Took Tylenol for fever which helped control that symptom.  It was like hospitalized COVIC all over again. Reluctant to receive 2nd dose if I have this same adverse reaction.  I had donated my COVID convalescent plasma that morning for the 4th occasion but I was told it would not interfere with the vaccine.