chrisvoncsefalvay/vaers-outcomes huggingface dataset:
29ARP92 3 to 4 hrs p/recvd 1st dose of Engerix-B devel chills, fever, shakes & arm weakness; no tx given but pt did see a MD concerning the events;
3" red, itchy lump 1st day post vax;1" red, itchy lump 2nd day post vax;cont w/soreness @ inj site 1JUN98;
FAINTING REACTION SYNCOPE - PATEINT REPORTS OF PREVIOUS HISTORY OF FAINTING REACTION TO NEEDLE PRICKS IN THE PAST. PATIENT WAS STABLE ABD MONITORED FOR MORE THAN 30 MINUTS
pt recv vax 8JAN98 & 2 days post vax pt devel a rash characterized by several red dots over upper chest, measuring 0.5cm;6hr later the rash generalized & some hives devel;both eyelids became swollen;pt was seen by MD & tx w/DPH;
This is a spontaneous report from a contactable consumer reporting for daughter. A 18-years-old female patient received first dose of TRUMENBA, via an unspecified route of administration on 21Aug2017 at single dose for preventative measure. Patient had no medical history. There were no concomitant medications. The patient experienced chills, fever, fainted, felt clammy, general malaise/not feeling well, all on early morning of 22Aug2017 and received treatment of TYLENOL. Outcome of events was recovered.
Chills, Nausea, Fatigue, Skin-Red Patch Near Injection Site.
no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) 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. 066H21A) for COVID-19 prophylaxis.     HCP did not describe Medical History or Condition.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 3rd out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case
Night of vaccine, injection site was red, swollen with a lump at the site. Hives on arm and legs. 3/16 person became nauseated, had a horrible headache and a temp of 102 F
Moderna COVID?19 Vaccine EUA -at approximately 2:30pm arm soreness began and lasted until 1pm on 1/3 -at approximately 9:30pm a fever of 101.2 occurred, sweats, chills, extreme fatigue began and lasted until approximately 10am on 1/2
Information has been received from a registered nurse concerning an approximate 7-year-old patient who on 18-JUN-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008 the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
For the last 16+ months, I have had a significant change in both Taste and Smell.  There are many things I can not smell, more that have a distorted smell and with every food item that has a distorted smell, I also have a distorted tasted.  This was all reported to CDC (with followup via telephone interview).  Over the last 4 months or so, the condition had improved somewhat, although certainly not gone. After my recent Covid booster, the taste and smell issues have once again worsened. The negative, nauseating, distorted smells are worse and the taste of a very long list of food (same foods for last 16 months) has also become worse.  I am concerned the vaccine has caused this issue to reoccur/worsen.
Fainted/nausea/decreased BP - Trendelenberg used. Unable to get a B/P but pt was alert. B/P after 10 min was 100/58 (normal per pt)
The patient's left arm was erythematous and indurated. The axilla was also erythematous and indurated along with the left side of torso.
Initial and follow-up information has been received from a 16 year old female consumer with head lice and no previous pregnancies, who on 08-APR-2008, was vaccinated with a third dose of GARDASIL vaccine (Lot # 659964/1978U) and later found out that she was pregnant.  Concomitant therapy included DOCUSATE SODIUM + minerals (unspecified) (+) OMEGA-3 marine triglycerides (+) succinic acid (+) vitamins (unspecified) (PRIMACARE)).  At the time of the report the patient was 6 months gestation.  The patient's estimated conception date was approximately 21-NOV-2007, last menstrual period was approximately 30-NOV-2007 and her estimated delivery date was 14-AUG-2008.  The patient sought unspecified medical attention.  Blood work was taken and the results were not reported.  On 24-APR-2008 an ultrasound was performed for an anomaly screening/dating and the results were were within limits.  It was reported that it was too late to perform a Maternal Serum Alpha-Fetoprotein Screening (MSAFF).  At the time of the report, the outcome of the patient was unknown.  Additional information was received from the physician's office stating that the patient delivered a normal infant without congenital anomalies.  Additional information was received from a registered nurse concerning the patient who on 14-AUG-2008 (weeks from LMP: 40+) delivered a female normal infant without congenital abnormalities and complications or abnormalities.  The infant weight: 7#  7 oz.  length: 21".  "Apgar scores: 8/10, and 9/10", head circumference : 34cm.  It was reported that the patient presented late entrant to care at 25 weeks.  In May 2008, the patient was diagnosed with with head lice.  In "mid-May" 2008, the patient was treated with RID.  The patient experienced maternal fever during labor/delivery.  The patient was GBS (+) and was treated with antibiotics in labor.  Additional information has been requested. 04/07/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Additional information has been received from the nurse who informed that the patient's baby had "no problems" and was healthy and normal. No further information is available.
I was positive for Covid 19 I was tired and had a headache; I had body aches that lasted couple of day.
Mother reported arm Lt red, swollen, painful. T 102 degrees. Taken to urgent care 3/23/03. Reported to vaccine administered center 3/25/03. When asked again stated Rt arm involved T up to 104 degrees 3/27/03. Tx Advil, Benadryl, antibiotic.
On 12/27/2021 I started having scratchy throat. I did a test that day that was negative. The next day I had congestion, coughing, and sore throat and did another test that was negative. I felt worse on the 29th and I did another test and that was positive. I contacted my PCP to let them know I was Positive and they just recommended self-treating home-care. I had moderate symptoms for a week and did not require any medical care. After I recovered from COVID-19, I did continue to have fatigue and chest pain. I also saw my ENT for sinus issue and dizziness. Prescribed and Antibiotic for sinus infection and Prednisone.
Woke up itching and had hives all over her face and arms. They go away and come back all over her body.
injection site a little swollen; itchiness at injection; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site a little swollen), INJECTION SITE PRURITUS (itchiness at injection) and INJECTION SITE ERYTHEMA (redness at injection site) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site a little swollen), INJECTION SITE PRURITUS (itchiness at injection) and INJECTION SITE ERYTHEMA (redness at injection site).   outcome was unknown and not Provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received vaccines at 1 PM - Mother noticed a rash on face, abdomen, back, face, swelling of lips, rhinorrhea - No SOB about 12 hours later; Tx with one dose of BENADRYL - sx resolved.
Sever headache off and on for 3 days so far chills sweat,  sever fatigue  x 2 days Injection site pain to the point of not moving arm
minor soreness; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; cold sores; muscle soreness; joint pain; fever, 101.5°F, very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness) and ARTHRALGIA (joint pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (minor soreness), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (minor soreness) had not resolved and LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), ORAL HERPES (cold sores), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5°f (High) 101.5°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Rheumatologist recommended to stop taking biologicals when getting the vaccine.   This case was linked to MOD-2021-390480, MOD-2021-390502 (Patient Link).
Pain at injection site; Redness at injection site; Swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:15 (Lot number: EN6203) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; CENTRUM WOMEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Pain at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Redness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Swelling at injection site". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling. Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19. The patient had no reported allergies to medications, food, or other products. The events were considered as non-serious by the reporter. No follow-up attempts are possible. No further information is expected.
Four days after second dose I started do you have a shooting pain in the back of my neck and head. Four days after the consistent pain started I developed a rash on my neck and was diagnosed with shingles. The rash spread on the left side of my body following the dermatome line up to my scalp.
Shingles in right thigh 3 months after Varivax in same thigh.
7 days after my first shot I started to develop a localized rash near the injection site. It grew over three days and then subsided shortly thereafter.
w/in 1hr of vax upper thigh swelled, reddened, got very warm & became extremely tender all concentric about the DTPH site;sx resolved w/in 24hr;
Maybe I reported this wrong? I was all ready to go get the new booster but got covid instead. S/sx: chest congestion, cough, phlegm, fatigue, headache, sore throat. Recovered from covid, then symptoms got worse again and I had a relapse with positive covid test (after negative covid tests). First had s/sx 9/12/2022, reached a peak on 9/15/22, all symptoms gone except fatigue on 9/18/22. Extreme fatigue continued through 9/24/22.   Relapse started around 10/5/22. I tested positive on 10/8/22. S/sx besides fatigue gone as of 10/10/22. Fatigue continues to this day (10/18/2022).
Case of pregnancy follow-up received from a healthcare professional on 29 September 2010 under the reference numbers 10-0624 and P10-0065. A 29-year-old female patient, with no reported illness at time of vaccination, had received her dose of ADACEL, batch number C3476AA, on 20 September 2010. On an unspecified date post-vaccination, the patient experienced redness of skin at the injection site. The patient's date of last menstrual period was 27 August 2010. The estimated date of delivery was 05 June 2011. The outcome was unknown. Follow-up information was received 24 January 2011 from a health care professional who reported that this patient was no longer a patient at their office. The patient transferred her care November 2010. No further information was provided at the time of the report. Documents held by sender: none.
only received the liquid portion; only received the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter stated that, they found an extra powder portion of Menveo so they know a patient only received the liquid portion of the vaccine. The reporter stated that, they have been able to narrow it down to four potential patients based on the lot number, but they could not tell which patient only received a partial dose.  No additional information was provided on the call, but reporter consented to follow up from safety. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, they found an extra powder portion of Menveo so they know a patient only received the liquid portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a physician concerning a female baby who "this week", on approximately 27-JUN-2011, was vaccinated orally with the third dose of ROTATEQ (Lot number not provided). It was reported that "other vaccines might have been administered". "This week", on approximately 27-JUN-2011, the patient threw up after receiving ROTATEQ. The patient vomited in the waiting room immediately following administration and vomited again the same day after returning home. No lab diagnostics studies performed. The patient sought unspecified medical attention. She was on therapy and the event improved. On an unspecified date, the patient recovered. Additional information has been requested.
Noted feeling very tired almost flu like symptoms that evening and next day looked red and angry...still puffy on day 3..she states she is ok but wants glaxo to know.
When the patient reported to the Emergency Department on 01/27/2019 at 0030, she reported that about a week ago she received the flu vaccine in her left shoulder. However, over the previous week she developed erythema, tenderness, and swelling in her left shoulder. She denied fever, dizziness, nausea, vomiting, change in appetite, sore throat, runny nose, abdominal pain, constipation, diarrhea, other joint pain, or other rash. In the emergency department, she had WBC 7.2, creatinine 1.09, CK 242, myoglobin 61.9.  CRP 0.6. CT scan of the left shoulder did not show any signs of osteomyelitis or fluid collections or concerns for abscess. Blood cultures were collected and she was started on vancomycin and piperacillin/tazobactam. Patient was instructed to keep her arm elevated. The next day (01/28/2019) the erythema was spreading distally, but appeared better proximally.  Piperacillin/tazobactam was discontinued. Patient was discharged from the hospital on 1/30/2019 with prescriptions for doxycycline 100mg PO BID and Cephalexin 500 mg PO Q6H for 3 days. Total antibiotic course was 7 days. At the time of this report, blood cultures were no growth at 4 days.
feel that I now have a mild case of shingles on the right side of my stomach; Slight rash that itches a lot; This case was reported by a consumer via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles couple of years before reporting date).   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were unknown.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had a mild case of shingles on the right side of my stomach and slight itchy rash after vaccination. The patient asked is side effect of getting shot.
No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002283:
He states that he had taken NSAID medication around that time for tendonitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TENDONITIS (non-serious), outcome "unknown", described as "He states that he had taken NSAID medication around that time for tendonitis". Therapeutic measures were taken as a result of tendonitis.  Additional information: previously had both doses of the Pfizer covid vaccine. He states that he had taken NSAID medication around that time for tendonitis and that he had recently heard on the radio that the use of NSAIDs could have effects with the vaccine. Caller is requesting any information on the use of NSAIDs with the Pfizer covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Missed the 2nd Shingrix dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient missed the 2nd Shingrix dose till the time of reporting which led to incomplete course of vaccination, also asked do he/she need to start over. No contact details were available.
Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative:  employee was told to follow up with his physician and get tested for covid