chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tachycardia up to 130; tightness in chest ,  discomfort in chest; low pulse ox of 94; out of breath; fever of 101.2; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia up to 130), CHEST DISCOMFORT (tightness in chest ,  discomfort in chest), OXYGEN SATURATION ABNORMAL (low pulse ox of 94), DYSPNOEA (out of breath) and PYREXIA (fever of 101.2) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthmatic. Concomitant products included INHALER for Asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (tachycardia up to 130), CHEST DISCOMFORT (tightness in chest ,  discomfort in chest), OXYGEN SATURATION ABNORMAL (low pulse ox of 94), DYSPNOEA (out of breath), PYREXIA (fever of 101.2), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, TACHYCARDIA (tachycardia up to 130) and OXYGEN SATURATION ABNORMAL (low pulse ox of 94) had resolved and CHEST DISCOMFORT (tightness in chest ,  discomfort in chest), DYSPNOEA (out of breath), PYREXIA (fever of 101.2), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: 130 (High) tachycardia up to 130. On 04-Feb-2021, Oxygen saturation: 94 Low. On 04-Feb-2021, Pyrexia: 101.2 High.     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 treatment information was provided., patient reported feeling like using inhaler because she is asthmatic, but it is unknown if she used it.
death Narrative: Patient received COVID vaccine #1 on 2/4/21. On 3/1/21, it was reported to the facility that patient had passed away on 2/24/21. No notes on file with respect to what happened around the time of his passing. No autopsy results available. 20 days from time of vaccine to date of death.
back spasms; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an specified date in Feb2021, patient stated she had back spasms and when picking up methylprednisolone, pharmacist indicate had vaccine. Also, took Advair but would not be alive without it. Scheduled 24Feb2021 for second dose.  Mentioned husband also takes Advair. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), MONTELUKAST SODIUM (SINGULAIR), PYRIDOSTIGMINE BROMIDE (MESTINON), MIRABEGRON, TAMSULOSIN HCL and UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 101.7degree F. On 24-Feb-2021, Pyrexia: 103.9degree F. On 26-Feb-2021, Pyrexia: fluctuated from 97.9 to 99.8 degrees F. On 27-Feb-2021, Pyrexia: 97.5 - 99.6 degrees F. On 28-Feb-2021, Pyrexia: 97.3 - 99.7 degrees F 28Feb2021 to 1Mar2021, his temperature range was 98.1 to 100.4 degrees F. Between Mar1 to Mar2, his temperature range was 104.4 - 103.8 degrees F.. On an unknown date, Pyrexia:.         Treatment information also included cold compresses on head  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   This case was linked to MOD21-042365, MOD-2021-031515 (Patient Link).
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 17Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Otherwise excellent health. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Jan2022, outcome "recovered"; COVID-19 (medically significant) with onset Jun2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Negative, notes: Tested negative 4 days upon completion of Paxlovid; (Jul2023) Positive, notes: positive again 2 days later; (Jul2023) Positive, notes: since testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 26Jun2023 and stop date 01Jul2023. Tested negative 4 days upon completion of Paxlovid. Then positive again 2 days later. Today is day 6 since testing positive and was feeling more sick each day. Mild symptoms, but going in the wrong direction. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250571 same reporter/patient, different drug/event;
Itching all over with raised red spots that were warm to the touch.   Vomiting followed before bedtime and next day.  Was out of work 3 days.
As per patient, arm soreness started next day. Which developed into weakness/soreness from hand to shoulder. Patient was unable to pick arm up above head.  History obtained by pt and ED f/u  Patient has not f/u w/ our office.
ADMINISTRATION ERROR:  Someone pulled a box of 10 viles of Moderna vaccine on 12/29/22 and put into the refrigerator and is good for 30 days.  He got the vaccine on 2/10/23, and should not have been used past 1/29/22 but was administered.  He has not had any reaction from the vaccine, they have contacted him more than one tile.    They did call Moderna and they are going to Email them back to see if he needs to be re-vaccinated.
The day after the J&J vaccine I experienced the typical headaches, backache and sore arm which I was told to expect.  My headaches, backache and arm pain lasted approx  4 weeks.  I took advil/tylenol daily for weeks due to the discomfort.  My arm pain continues to persist three months after the vaccine.  I also developed swollen lymph nodes along my collar bones 3 months after the vaccine.  It is on the same side as my vaccine.  I have went from being 100% healthy and feeling great to constant arm pain,  occasional arm numbness, swollen lymph nodes (which I have never had in my life) and generally feeling  unlike my self.   I reached out to my Dr. and am awaiting bloodwork results.  I have three ultrasounds scheduled as well as 2 cat scans.  They are looking for blood clots and trying to figure out the pain at the injection site as well as swollen lymph nodes on the vaccine side.  In closing, I feel something is very wrong as my symptoms persist and multiply.
On 11/21/2000 the pt received the first dose of Lymerix. Subsequently she was found to be pregnant. The date of her last menstrual period was 10/21/2000, the date of the positive pregnancy test was 11/28/2000 and the estimated delivery date is 07/30/2001. As of 11/30/2000 the outcome of the pregnancy is ongoing. The follow-up states that on 10/13/2000, the vaccinee had an appendectomy and a ruptured ovarian cyst. On 09/14/2001, the vaccine provider stated,"We have no reports on the outcome of her possible pregnancy."
achy and chills starting at 7:30 pm and felt better the following evening around 7:30pm
fever; body aches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 19:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 23Dec2020 and experienced arm sore. After the second dose, patient experienced fever and body aches. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
It was nausea, vomiting, light sensitivity (migraine symptoms), pounding on the base of my skull. It hurt to open my eyes. I took my rescue medication Ubrelvy 100 mg at onset of migraine, it didn't work. I took another one two hours later. I sat in the shower trying to relieve the pressure. It took about 48 hours for it actually go away. It was lingering though. I could go about my day to day but there was this constant pressure in my head. That went on for about a week. I work with my physicians and he confirmed it was a migraine. Rest was what helped.
Patient is a 41 y.o. male on no AC/AP with no pmhx reported presents 1/31 PM initially to Hospital for acute onset 10/10 headache refractory to 800mg motrin which started in occipital region then spread to whole head and neck, nausea and vomiting x 3. Symptoms started around 5pm when he was on a conference call and reports he got bad news so was stressed out. Denies any recent trauma.    Pt received toradol 30mg, dexamethasone 10mg, benadryl 25mg and reglan 10mg at hospital prior to transfer. CT showed diffuse SAH and CTA showed no signs of obvious aneurysms. He then received 1g IV keppra and was started on Cardene for BP goal <140. He was transferred to NICU for further monitoring.    While in the NICU, his exam and imaging remained stable. He underwent CTA which was unrevealing, and DSA which showed evidence of vasculopathy. BPs came down to <160 and he came off of cardene, did not require additional meds.  He was transferred to the floor. Upon transfer, he had another thunderclap HA, accompanied by HTN to the 200s systolic, tachycardia to the 120s, diaphoresis, and blotchy macular rash over the anterior shoulders. Imaging was negative for vasospasm or recurrent bleed, and it was felt that patient's presentation was most c/w RCVS. Trigger felt either 2/2 caffeine intake (patient reported drinking 60 oz coffee daily) vs. Sympathetic discharge syndrome such as pheochromocytoma or carcinoid syndrome. LP was performed, which revealed no nucleated cells and protein elevated in proportion to blood, which confirmed the diagnosis of RCVS. Studies were sent off to diagnose carcinoid syndrome and pheo. Patient was started on nimodipine/gabapentin with standing tylenol and PRN oxycodone for breakthrough pain. Within days, the HAs had markedly decreased in intensity. He was taken off of keppra after 1 week with stable exam and no e/o seizures.  He was briefly switched from nimodipine to verapamil but switched back prior to discharge. He was discharged with outpatient followup.
Information has been received from a 66 year old male with hypertension who on 13-AUG-2008 was vaccinated with ZOSTAVAX (Oka/Merck).  The lot # is not provided.  Concomitant therapy included losartan potassium (MSD) and doxazosin mesylate.  On 14-AUG-2008 the patient experienced dehydration, extreme vertigo and runaway high blood pressure and was hospitalized for 2 days from 24-SEP-2008 to 26-SEP-2008.  Subsequently, the patient recovered.  Additional information is not expected.  12/1/08 MR received for DOS 8/24-27/2008 with D/C DX:  Benign Postural Vertigo.  Hypercalcemia-resolved. Leukocytosis-resolved. HTN. BPH. Pt presented to ER with 4 day hx of vertigo worsened by positional changes, nausea and vomiting. One episode of chills, no fever. Likely viral. Tx with Antivert and diazepam with some resolution, not complete.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by WV National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from WV National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Patient tolerated vaccines well, appropriately spaced on arm, arm wiped with alcohol pad prior to administration. Next day he woke up with a HA, was lethargic, had a fever of 101 by the afternoon, and his arm was sore. Noticed the back of his arm (where PPSV23 was given) was red and warm to the touch. Next day, felt more lethargic and erythema spread to almost the entire underside of his arm. He saw a nurse at his recovery center who marked the outline of the inflamed area. 3 days after administration, area continued to increase in size and patient went to ED where he was told he had cellulitis and given a prescription for SMX/TMP 800/160mg po BID for 5 days. Patient reports arm was completely back to normal within 3-4 days after ED visit. Doing well 14 days later.
Injection site swelling; Injection site redness; Fever; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee on behalf of her aunt. The age at vaccination was not reported.  It was reported that when the patient got the Shingrix vaccine she had the injection site swell and turn red for several days after the shot. The patient also ran a fever and the injection site was sore to the touch for a number of days afterwards. The patient said that none of her friends who also got the vaccine had the same reaction. She said they were both listed as side effects (unknown which two events) from the shots so she was not sure if she needed to report it or not so  erred on the side of caution and reported the incident. This case has been linked with the case US2019AMR134680, reported by same reporter for same patient (2nd dose).
In the firs night, pain on the location of shot and fever were experienced. On the second day,  I experienced serious muscle sores all over with fatigue and fever around 99 F. On the third day, the fatigue and fever got woes around 100. On the fife day. the fever remained around 100 F. On the night, I experienced numbness on my fingers and toes with ice-cold feeling. I felt so tired and stay in bed all day. On the sixth day,  temperature reached 102 F. I felt muscle sore around my rib. My legs cramped too. On the seventh  day, finally temperature started drop to around 98.5 F and feeling better.
Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart; Bruise is slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore). At the time of the report, CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Major increase in pain during menstrual cycle, increase in amount of discarded tissue during menstrual cycle.
Immediately after 1st vaccine injection, arm was sore at injection site but resolved fully within 3 days. On around day 9, arm began to feel like something was pinching internally. The pain grew from only feeling it when I moved my arm a certain way, to now being painful at all times. On day 14 post injection, my arm has began to be extremely sensitive to sunscreen, lotion, etc.
ASTHMA; HEART PROBLEM; SICK; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced asthma, heart problem, and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, heart problem and sick was not reported. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases
High fever (fever was greater than or equal to 102 degrees); This non-serious spontaneous safety report, with reference number 2022SA294152 was received by a partner on 19-JUL-2022 and forwarded to Agency on 24-AUG-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".  No further information is expected.  NON SIGNIFICANT FOLLOW UP INFORMATION was forwarded to the agency by the partner with reference number: 2022SA354686 on 26-AUG-2022. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "High fever (fever was greater than or equal to 102 degrees)".   Further information is expected.  For reference purposes, this case is linked to MCM-003947 (same reporter).
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown demographics. The patients concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were vaccinated with unspecified improperly stored doses of RECOMBIVAX HB lot# K010535 and expiration date 27-AUG-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. This is one of several cases from the same reporter. Follow up information has been received on 20-OCt-2015, a phone call was placed to the reporting licensed practical nurse who reported that she would have to research the request made for patients identifiers, lot number and expiration date and dates of vaccination. Additional information has been requested. Narrative has been updated.
The patient received a pediatric Pfizer Covid vaccine, but she is only 4 years old, which is under the approved age. The parents falsified the child's date of birth during check in and on the paperwork. They called the pharmacy the next day (4/21/22) to apologize and let us know that she was actually under age. There were no adverse effects reported during the time of the vaccine, at the time of the phone call on 4/21/22 or at the time of the follow up call on 4/25/22.
pt recv vax 14JUN96 & 12JUL96 pt exp altered mental status & was hosp;13JUL96 given med;14JUL96 pt devel 10 chicken pox lesions, which appeared briefly;WBC count from cerebrospinal fluid was 16;FA test undeterminable because too few cells;
Presyncopal episode in office. After arriving home had temp of 102 degrees, chills, aches.
First pains in right eye appeared on 11/23.  Rash first appeared on 11/26.  Visit to Urgent Care on 11/28 with diagnosis of shingles.  Nausea 11/28/2021 - 11/30/2021.  Eye doctor on 11/29));  followup eye doctor visits on 12/6, 12/13, and 12/23.   11/29 shingles starting to scab; 12/3 scabs were starting to fall off, by 12/17 the shingles scabs were mostly all healed up.  Emergency Room on 12/4/2021.  for abdominal pain but CAT scans of abdomen, chest, and head found nothing other than constipation and a small amount of fluid outside the left lung which was attributed to the fact that she was laying on her left side most of the day and night; was not admitted to hospital and left after diagnostics were done and one bag IV fluids was given.  12/11 started having postherpetic neuralgia with severe intermittent flares of pain that were so overwhelming as to compel crying out in overwhelm, neuralgia continues but the severity is reduced by the Gabapetin being taken.
Morning of July 9, 2021 ~3:00AM experienced pain on right side along ribs. Pain increased while breathing in. Sought medical treatment at urgent care facility 7/9/21 ~10:00 AM.  Imaging done on site revealed multiple subsegmental pulmonary emboli without acute cor pulmonale.