chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital in the reported that a 56 year-old male (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 31-Mar-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a registered nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Farhenhit and maximum 5.7 degree Farhenhit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Reporter details updated, Vaccine start date and Dose number of the vaccine.
Sore throat, lump in neck, pain in neck, pain in arm, lump and redness around injection site.  Body aches, headache, weakness, fatigue.
Patient was vaccinated on 02-27-2012 without incident or complaints. Reported to the nurse at 7:30 AM for meds. On 03/2/2012 patient complained of "rash, itching and behavior changes". Nurse stated she did not observe any S/S. Health department received letter from the patient on 03/08/2012 with patient's complaint and follow-up began then from HD staff.
Pt reported sweating & nausea. BP 101/74; HR 93; RR 24.  30 min post vaccination. Pt feeling much better. Advised pt to get rest, rehydrate & what to do in case of emergency. Released in stable condition
pt recv vax & approx a yr p/vax pt exp breakthrough chickenpox described as sporadic w/less than 50 lesions;tx w/Zovirax;
This spontaneous report as received from a medical assistant 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 18-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Initial case retrieved from the scientific literature on 06 January 2012. Verbatim from abstract: "Subacute thyroiditis (SAT) is an extremely rare complication of influenza vaccination. Several infectious agents have been related with SAT. It is also well known the association between HLA-B35 and the development of SAT. We described a case of subacute thyroiditis and dyserythropoesis occurring shortly after administration of an influenza vaccine in a 55-year-old man with history of diabetes and psoriasis, family history of autoimmunity without clinical evidence of acute viral infection prior to the onset of symptoms. We propose that, the events occurring in the patient may be explained as result of complex interactions between the individual genetic background and environmental exposure to infectious agent that generated a pro-inflammatory status, where the vaccine was the trigger for the subsequent alterations in thyroid and bone marrow. These findings highlight the importance of immunogenetic factors involved in response to vaccination that is the central theme in the growing field of 'vaccinomics'." Documents held by sender: None.
Fever & Seizure records received 5/3/07-notes received DX Febrile Seizure same day as vaccines. Temp 103.6 in ER. Shaking, eyes rolled questionable cyanosis
PT IS ON 4TH WEEK OF XELJANZ. SHE HAD HER 1ST MODERNA COVID VACCINE 12 DAYS AGO. PT STATES THAT EVERY JOINT IN BODY ACHES. THE SEVERE PAIN SEEMS TO ROTATE AROUND JOINTS - CURRENTLY HER RIGHT HAND IS WEAK & PAINFUL THAT SHE CAN'T PICK UP OBJECTS. HER RIGHT SHOULDER/ELBOW, WHOLE ARM IS SEVERE PAIN. SHE HAS HEADACHES. SHE IS EXHAUSTED & GOES TO BED ABOUT 7:30PM. IT'S HARD TO FALL ASLEEP & THEN HARD TO GET OUT OF BED SINCE SHE CAN'T LIFT HERSELF UP (HAS TO ROLL OUT OF BED). SHE IS A GOLFER & TRIED TO GOLF THE OTHER WEEK. SHE TOOK 2 ALEVE AT START & BY THE BACK 9 HOLES HAD TO TAKE AT LEAST 2 MORE. SHE IS TAKING ABOUT 6 ALEVE TABLETS IN A 12 HOUR PERIOD RIGHT NOW TO HELP ALLEVIATE THE PAIN. SHE STATES SHE WAS NEVER IN THIS SEVERE PAIN BEFORE XELJANZ OR COVID VACCINE. PT CAN'T PINPOINT WHEN THE SEVERE PAIN STARTED - PRIOR TO OR AFTER COVID VACCINE. PROVIDED CONSULTATION AND ADVISED PT TO F/U WITH MD TOMORROW MORNING.
The patient developed symptoms suggesting peripheral neuropathy ~2 days after vaccine administration. Burning/stinging sensations and paresthesias in arms, hands, legs, and feet were noted. The patient noted arthropathy-like symptoms in the proximal, medial, and distal interphalangeal joints of both hands, which persisted for 3 days before resolving spontaneously. Mild joint swelling was noted. No erythema was noted. The patient experienced increased symptoms of burning/stinging and muscle weakness in the groin and legs (bilaterally) following a presumed muscle overuse injury on 12/26/21 (no specific event noted), which have persisted despite bed rest and which intensify with mild activity. Peripheral neuropathy has persisted but does not appear to be increasing in severity, with the exception of symptoms related to the presumed overuse injury.
23 weeks pregnant and got vaccinated; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated) 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 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated). On 16-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product given by reporter. No treatment product given by reporter. The health care worker wrote same lot number of Moderna vaccine in my vaccination passport. The patient was worried that they did not administer the correct vaccine. This incident gives so much worry to the patient.
having sharp pains on the left side of my head on my skull; swollen lymph nodes in my throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "recovered" (15Apr2021), described as "swollen lymph nodes in my throat"; HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "having sharp pains on the left side of my head on my skull".  Additional Information: Caller received her 1st Pfizer vaccine dose on 13Apr2021 Then on 14Apr2021 she states "swollen lymph nodes in my  throat that  lasted for one day and then went away. Today, 15Apr2021, I am having sharp pains on the left side of my head on my skull. Caller received her vaccine dose in  her left arm. Caller states  that "Tylenol not helping." How long will this last and no one told us how we are supposed to treat this pain. "Response received that spoke to caller from the attached documents.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tdap on Monday 11-30-09. Fever 101.5 2 days later and off and on for a few days. Began having more than usual seizures then, gradually getting worse, culminating in status 10 days later on 12/10/09. Went to local ER, transferred to PICU at hospital. Stayed in at hospital 3 days. Seizure meds adjusted. No specific infection identified. Remained "off" with more seizures than usual for another 10 days or so. Finally back to baseline by 12/25/09. "Has not been this bad for the past 12 years" per mom. She was wondering if could be related to Tdap. I wasn't sure, but agreed with her that we should let you know especially in light of research on children with mitochondrial disorders and adverse reactions to vaccines.
Initial information received on 10 September 2007 from a health care professional.  A 15-year-old male patient, who had nasal congestion at the time of vaccination and a history of sinus infections, had received a first dose injection of Menactra, lot number U2375BA, 09 August 2007.  Route and site of administration were not provided.  The subject had been treated with Cefzil on 23 July 2007 for ten days and was started on Augmentin on the day of vaccination.  In the "first week of September", a nasal culture was completed secondary to a history of sinus infections, which showed an unknown strain of Neisseria meningitidis.  "No other symptoms reported."  The subject was treated with Levaquin.  Other medical intervention was noted as "none".  Recovery status was not reported.
Shingles episode; puffy rash; puffy rash across the bridge of my nose and arching up to my right eyebrow and it is itchy; puffy rash across; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced shingles, rash, pruritus and puffy skin. On an unknown date, the outcome of the shingles, rash, pruritus and puffy skin were unknown.   It was unknown if the reporter considered the shingles, rash, pruritus and puffy skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix shot series, the last one about 5 days ago. The patient getting a puffy rash across the bridge of my nose and arching up to my right eyebrow and it is itchy.  The patient asked it possible for the vaccine to trigger a Shingles episode.
Redness and inflammation at injection site. Large area of the arm and it was given 1 week ago at this point.
Pt is 11 years and 11 month old, he was given the Pfizer Bivalent Vaccine for 12 years old. No side effects or reaction reported> Patient was able to leave the pharmacy with no issue. Left a voice message on mother's phone to call back for follow up
This spontaneous report as received from a licensed nurse practitioner, refers to herself: a 59 year old female patient. Patient had no pertinent medical history or drug reactions/allergies. On 25-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) in the left arm for prophylaxis which was recommended by physician. After receiving ZOSTAVAX (exact date in 2013 not provided) the patient experienced a "local reaction" and cellulitis at the injection site that got progressively worse. The nurse stated the injection site reaction progressed to a 3 inch welt that was hard underneath, red and warm to the touch. The nurse stated she felt feverish, had achy joints and 'just felt crappy overall'. ZOSTAVAX was administered to the back of the left arm by an unspecified health department worker. The nurse stated the ZOSTAVAX was pre-drawn into a plastic syringe that may have been left out for more than 30 minutes. ON 03-JUL-2013 the nurse stated she felt much better, however there was still a 1.5 inch area at the injection site that was red and discolored. The nurse also stated that 10 unspecified "co-workers" had the exact same reaction after receiving the pre-drawn syringes of ZOSTAVAX on 25-JUN-2013 (see case 1307USA009035). Additional information has been requested.
3/20/15 11 PM-Migraine headache, lightheadedness, nausea, vomiting. 3/21/15 AM-sore muscles, lightheadedness, nausea, diarrhea; PM-sore muscles, migraine, neck pain, nausea.
No adverse event; HCP called to report PROQUAD had been administered to a 37-year-old female. Patient hasn't reported signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC.; This spontaneous report was received from a pharmacist refers to a 37-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-JUL-2014 the patient was vaccinated with an improperly stored (oka/MERCK) VARIVAX, subcutaneous, 0.5 ml, (lot number and expiration date not reported). No adverse effects reported. This is one of two reports from the same reporter (1407USA007856). Additional information has been requested.
she started having Flu-like symptoms: sore throat and runny nose without fever; she started having Flu-like symptoms: sore throat and runny nose without fever; Flu like symptoms; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "she started having Flu-like symptoms: sore throat and runny nose without fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arthralgia/ joint pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Arthralgia/ joint pain".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200967151 same reporter/drug/AE, different patient;
Patient reports having a grand mal seizure 24 hours after administration of flu vaccine. No treatment, consulted neurologist on day of seizure.
pollen allergy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). This consumer reported similar events for two patients (son and self). This is the first of two report.  A 70 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pollen allergies started yesterday 19Apr2021, and his son's pollen allergy symptoms started on 18Apr2021. It only happened when smelling pollen from flowers. They do not have this allergy before and was only developed after taking the vaccine. He also mentioned that his wife has taken the vaccine but there was no allergy. Second doses are scheduled for 30Apr2021. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021448825 same reporter, drug, event, different patient
Patient had a cough prior to getting the vaccine.  24 hours after the vaccine he had a fever (highest was 101.3) and his cough worsened (he was unable to sleep).  He also slept for most of the day.  Patient is medically complex, so the coughing is worrisome.
1st booster shot on 26Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-590863 (Patient Link).
pt recv vax 14JUL95 & on 26JAN98 pt devel skin lesions, fever & itching;2 days post onset pt recovered from fever 7 1 days post onset, pt recovered from itching;13FEB98;pt recovered from skin lesions;
Patient states that she "Didn't feel right" after few hours after the shot. Woke up next day with a swollen arm, painful to the touch.
flu shot given 29OCT93 in lt deltoid; awakened 30OCT93 w/stiffness in neck on lt side; no temp or other sx; duration approx 6 days;
knocked me sideways; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (knocked me sideways) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (knocked me sideways). At the time of the report, IMMUNISATION REACTION (knocked me sideways) outcome was unknown. Concomitant drugs were not reported. The patient just had fourth jab as it was six months since patient had booster. Patient had Pfizer again after Moderna booster. Treatment details were not given. Reporter did not allow further contact
He reported that there was no pain at the time of injection, then felt a lot of pain at 4 pm, then could barely move his arm by 6 pm, by 9 pm he could not move his shoulder at all and was in extreme pain if bumped. He lost strength in his arm and hand and could not even get his shirt on and had to have his wife help him dress. Some function has returned to his hand but he is still having trouble with the strength.
2021 Pfizer COVID19 Vaccinations - Jan 25, Feb 15 & booster on Oct 20 Adverse Events afterward: Heart palpitations while in bed:  Mar 3, Oct 14, Nov 2, 14, 25, Dec 7 Nov 10 - was rejected for blood donation because blood pressure was 178/102.  (I donate frequently and have never been rejected due to HBP.  Made a doctor appointment for the next day.) After multiple doctor visits 11/21 thru 1/22, I have been diagnosed w/high blood pressure and AFib.  I am now on 5 heart medications, as follows:  Hydrochlorothiazide 12.5mg, Amlodipine 5mg, Metoprolol 25mg, Flecainide 50mg, Eliquis 5mg.