chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection  (which is very rare on me), and was treated with antibiotics.   With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
Patient woke on 1/3/2021 weak having uncontroled bowels and off and on confusion.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Skin sensitivity(left side from knee down to top of foot) joint pain(osteoarthritis flare up)06/01/2021Cortisone injection, More migraines than normal(Morphine), acute running nose. All are ongoing
brachial plexus neuropathy LUE (pain deltoid muscle, tingling fingers, dec ability to lift arm;
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% normal saline, preservative free. Consulted FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised. Outreach team contacted impacted patient and offered to speak with a physician to discuss.
Pt vaccinated with DTP/HIB developed high temp, & irritability within 12 hrs of shot.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old patient received BNT162b2 (BNT162B2 NOS), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". Clinical courses: the patient now has COVID. The patient has lost sense of smell and taste. Very tired. The patient need a booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis.  On 15th November 2018, the patient received SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 16th November 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. About 3 weeks before the time of reporting, the patient received SHINGRIX and Flu vaccine on the same day. The fever was lasted on and off for several days. The patient required emergency room visit. The physician had other questions concerning about the SHINGRIX, so the physician was warm transferred to medical information for further information. The reporter did not give consent to follow-up.
1st dose- left arm pain and left clavicle area, two days 2nd dose- right arm.  Hot painful rash on arm at injection site.  Mimicking cellulitis.  Day two, felt very cold unable to warm up despite adding several layers.  Arm reaction lasted 7 days.
Ataxia, vomiting, nasal pain , generalized weakness and tremor, left head tilt starting 3 hours after immunization and lasting approx. 12 hours. pt. was hospitalized. CT head negative and neurology quite concerned. Was scheduled for MRI but symptoms completely resolved by AM (I was the hospital attending staff). Likely a reaction to the attenuated virus itself.? if primary MD has already reported this reaction? 12/2/08 Reviewed hospital medical records of 11/7-11/8/2008. FINAL DX: possibly vaccine-related ataxia & vomiting. Records reveal patient experienced abnormal behavior after nap on day of vaccination w/left head tilt, left side weakness, falling to left side, nose pain, runny nose & vomiting.  Recent sick contacts in daycare.  Seen in Urgent Care & sent for admission.  Neuro consult done & found to be WNL.  D/C to home w/PCP f/u.
Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022; Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date) and PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna COVID-19 was adminsitered beyond the beyond use date) and PRODUCT STORAGE ERROR (Lot 083J21A put in the fridge on 07-Feb-2022 and was administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursion.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-584673 (Patient Link).
On the evening of 5-16-2022, I started having a sore throat, a headache, fatigue, dry cough, low grade fever (not above 100.0) and head congestion. I took a home Covid test on 5-17 and it was positive. I called my doctor on the same day and went to have a follow up Covid test at Hospital and it was also positive. I asked my doctor for the monoclonal infusion. I had the infusion at 10AM today. I am still not feeling well.  I am reporting my breakthru case of Covid.
Elevated Temperature of 102.0; Ataxia, unable to support self with legs and very shaky, New onset of confusion
Clinical Summary Patient is a 83 y.o. male with a history of Crohn's Disease, HTN who presented to the HCF 7/11/22 with acute on chronic back pain without trauma. CT L-spine with mild to moderate DDD without significant spinal canal stenosis, mild bilateral neural foraminal narrowing. Transferred to HCF Observation 7/12/2022 for PT/OT evaluation. COVID+ with ongoing cough for 3 weeks PTA. Hospitalization was complicated by new onset fevers and dysphagia. PEG placed 7/22/22. Prolonged stay for SNF placement.   1. Acute on Chronic Back Pain: with increased difficulty ambulating, ambulates with cane at baseline. No trauma/injury. CT L-spine with mild to moderate DDD without significant spinal canal stenosis, mild bilateral neural foraminal narrowing. Pain control. PT/OT followed. 2. COVID-19 infection: vaccinated x2, boosted x1. COVID+ 7/12/22 with dry cough x3 weeks PTA. Acute onset generalized weakness and then new fevers 7/15/22. No significant hypoxia noted. CRP >200, ferritin 900s. No indication for steroids yet but will continue to monitor. Not a candidate for remdesivir or MAB per ID. ID followed given ongoing symptoms but new onset fevers, Covid CT value consistent with infectious levels and IgG positive. ID stated not a mab infusion candidate.  3. Fever: Noted multiple times 7/15/22. ?Persistent Covid infection but unusual that it would just be occurring now after having cough for 3 weeks. Possible superimposed bacterial PNA that might not be apparent by CXR due to recent dehydration. Full infectious work up with CXR, urine antigens, blood cultures, sputum culture, repeat UA, lactate, MRSA probe and procal mostly unremarkable. CRP significantly elevated at 204 with normal ESRD. Respiratory PCR panel +Covid but nothing else. Immunocompromised which complicates picture. Azathioprine held. Empiric Rocephin/Azithro added 7/15/22 with no recurrence of fever thereafter. Completed 7 day course of rocephin 7/21/22. ID followed. Resume imuran as outpatient week of 8/1/22.  4. Generalized weakness: Likely due to Covid-19 and possibly other superimposed infection being work up as above. PT/OT followed 5. Dysphagia: Ongoing cough, worse with any intake. Failed MBS 7/14/22, SLP recommended NPO and tube feeds started through NG 7/16/22. Failed repeat MBS 7/21/22 and SLP recommended NPO except ice chips. Palliative care followed. PEG placed 7/22/22.  6. Acute Metabolic Encephalopathy: with progressive confusion since hospitalization. No new focal neuro deficits. Oriented x3 7/19/22.  7. Vasovagal Syncope: Witnessed, on bedside commode while having BM 7/13/22. BP 68/30. Improved after IVF. No recurrence.  8. Crohn's Disease: Continued home Imuran initially but then discontinued in the setting of active fevers/infection. Defer resuming Humira to primary GI as outpatient.  9. HTN: Adjusted home norvasc, ARB, initiated Coreg.  10. Abnormal CT: noted L spine with multilevel DDD, L3-L4, L4-L5 without significant spinal canal stenosis. Noted bilateral non obstructive nephrolithiasis.  11. Abnormal Sputum Culture: sputum culture showed moderate yeast 7/16/22. Abnormal sputum culture is clinically undetermined
first dose 05Feb2019, not received second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th February 2019).   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 Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The nurse reported that the patient received first dose of Shingrix and the patient had not received second dose.  The first dose was administered at a different facility and reporter did not have the lot number or expiration date information. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination. The case has been linked with case US2022064035 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064035:Same reporter
Vaccine was diluted with sterile water instead of the recommended normal saline.  No adverse events have been reported.
Stomach Ache, chills, very tired, diaharra, nausea, could not eat much, dizzy
A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a ten-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Aug-2010, the patient received FLUMIST. On 15-Feb-2011, a rapid flu test performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Dizziness and Vertigo Start morning after 2nd injection.  Severe dizziness after transiting from sitting to standing position for several day's after 2nd injection.  Vertigo still persists at night when shifting positions in the bed or when attempting to sit or stand from a horizontal position.   Dizziness and vertigo effects diminish during the day and seem to have subsided by evening.    Only to recur after sometime laying down.
Became jittery, looked very pale, was nauseous and gagging, seemed disoriented. HR mildly low (55-60) but good cap refill, normal O2 sat, normal BP. Lasted about 5 minutes, then became hungry.  Returned to baseline after eating a banana and felt completely normal afterward.
Feel ear clogged; Elevated blood pressure; Numbness on the left side; Headache; This spontaneous case was received on 18-Sep-2023 from a non-healthcare professional (patient's wife) (reference number SEQW23-02379) and concerned a 60-years-old male patient.   The patient's medical history and concomitant medications were not reported.  On 08-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, 'since that day', the patient started to feel ear clogged, headache, elevated blood pressure and numbness on the left side.  The outcome of the events was unknown.  This case was assessed as non-serious.  Company comment: A 60-year-old male patient complained of ear discomfort, hypertension, hypoaesthesia and headache, on the same date, after the vaccination with Flucelvax Quadrivalent. Medical history, concomitant medication and relevant diagnostic findings were not provided. Based on suggestive temporal relationship, causality for all reported events is assessed as possibly related.; Sender's Comments: A 60-year-old male patient complained of ear discomfort, hypertension, hypoaesthesia and headache, on the same date, after the vaccination with Flucelvax Quadrivalent. Medical history, concomitant medication and relevant diagnostic findings were not provided. Based on suggestive temporal relationship, causality for all reported events is assessed as possibly related.
This case was reported by a consumer via patient support programs and described the occurrence of difficulty breathing in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a day after receiving BOOSTRIX, the patient experienced difficulty breathing, light headedness, feeling drunk and difficulty in standing. On an unknown date, the outcome of the difficulty breathing, light headedness, feeling drunk and difficulty in standing were unknown. It was unknown if the reporter considered the difficulty breathing, light headedness, feeling drunk and difficulty in standing to be related to BOOSTRIX. Additional details were provided as follows: This case was received from nurse via the vaccine patient assistance program. The age at vaccination was not reported. It was reported, that the reporter directed to the patient to dial 911. The caller stated that, her mother just had been administered BOOSTRIX and it was totally out of it. She stated when asked if she was responsive that she was, but that she was like drunk, she was dizzy, lightheaded, could not stand and was having difficulty breathing.
pt recv vax 19NOV97 9AM & started 20NOV97 w/painful lt shoulder-swollen & red;limited ROM d/t pain;took APAP for fever-no other tx;also nausea;body felt numb;poss immune rxn;
Pt became tachycardic following vaccination (Hr=140's). Pt monitored by medics and med provider for 45 minute but pt's HR remained 115-120's. Pt refused ambulance transport to hospital . AMA form signed by pt after medical provider explained risks.
Information was received from a pharmacist concerning a 42 year old female patient who on an unknown date, was vaccinated with GARDASIL 9 (lot number, expiration date, dosage, and route of administration not provided). No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. No side effects to report. No further information to report. Additional information has been requested.
developed raised striatians to abdomen and left and right flank area on 12/18/20 at 12 am, no treatment, resolved on 12/20/20 at 12 am.
Have started falling and unstable. Went to doctor and referred me to PT. Pt has referred me to ENT. I am concerned the vaccine has started some kind of autoimmune process where autoantibodies are attacking vestibular nerve.
Vaccine (PREVNAR 13) administered in (R) deltoid on 10/20/15. Following day, temp 99.8, fatigue, pain at injection site. Red, itchy rash below injection site 10/25/15.
pt exp flu-like sx coincident w/administration of flu inj; these sx began approx 1 to 2 days p/vax;
Swollen red rash about 2 inches in diameter.  Was not hot and did not itch.
About an hour post vax pt broke out with hives all over, in mouth also. Mother took pt to private MD where she was treated with oral Benadryl. Mother was advised to give Benadryl q6h. Pt also had an increased temperature to 103. Pt was fine the next AM. Private MD felt it was "probably vaccine related."
Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. Swollen lymph nodes in armpits and under jaw.   Bed rest, sleep, daytime/nighttime cold medicine, liquids.
Nausea Vomiting, Dizziness Sever headache, Server sweating so much she had to change her cloths multiple times and left wet marks on chairs, had to change sheets.
migrating myalgias and arthralgias, belching and abdominal pain, vomiting
R arm red and swollen noticed about 8pm 8/5/03. Saw Dr. 8/6/03. Given Zithromax -cellulitis? Talked to mother 8/7/03 child has no complaints of pain. Redness is gone, no knot and swelling is almost gone.
Awoke to left arm twiching at the site of the injection, left hand and left foot had severe tingling or numbness, twiching in brain in central area of brain.  Twiching in brain more noticeable and severe when eyes closed and has continued to increase in frequency to about at least once an hour lasting approx. 15 seconds.  Tingling in hands and feet also include right side of body as week went on and only occurs after sleeping for approx. 3 hours or more.  Week 3 was the start of slight cold insensitivity in hands, twitching in brain continues, numbness in hands and feet occurs approx. every other night and only during sleep.
urticarial rash about 5 hr p/vax; tx DPH & steroid;
exactly 11 hours after vaccination experienced chills, aches, pains, extreme headache, it continued throughout the night and all day Monday and was somewhat alleviated by taking extra strength Tylenol every 6 hours.  By Tuesday I was only marginally improved and developed a heaviness in the base of the throat/top of the chest area with coughing. The pressure/heaviness has improved a little as has the coughing but they both still persist. It has been exactly one week since the booster shot. I have reported all symptoms to my primary care physician and pharmacist. If things don't improve in a few more days my doctor wants me to come in for an examination.
Emergency room visit and subsequent Hospitalization x 3days for severe vertigo, nausea, and vomiting. Transferred to rehab hospital for therapy to treat vertigo.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 01-DEC-2015, the patient was vaccinated with dose of ZOSTAVAX vial 194500 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Pfizer instead of Moderna for 2nd dose. Pt's 1st dose of Moderna was administered through health department on 4/29/21 and 1st dose did not show in the patient's chart. The error was discovered right after administration while completing documentation.
pt recv vax & felt lightheaded for a few seconds;pt has an allergy to tetracycline & has no prior hx of rxn to flu vax;pt recovered;
I started a running a low grade fever anywhere from 99 to 100.6 throughout the next two weeks. I had 10 pm, my swelling on my arm and rash was back - (I had an 8inch circle  (immediately it was that size)- raised, red skin, itchy and warm to the touch). I had a low grade fever. My body temperature is typically 96. I had flu-like symptoms; tired, lethargic; migraine - chronic ongoing; upset stomach; body aches. Not feeling good. I didn't have pain in my arm. But my whole body was just tired and achy. This went on for two weeks. The rash on my arm was only there for the first week. I took Benadryl - ( I didn't take it when I had to work - and took it mostly just h ad night for the week I had the rash) and a topical cream (steroid two times a day for the week I had the rash) for the itching. Three ibuprofen three times a day for the body aches and I took this for the full two weeks.
I do not know if any of this was realted to the H1N1 vaccination, but thought I would let you know-in case you ever have any other reports, similar. I received the nasal mist vaccination on Fri- and on Monday had a simple knee surgery, requiring general anesthesia. I have had general anesthesia several times during surgeries and have never had a problem. Apparently while in the recovery room I started convulsing and was transported to a trauma center, I had non-stop uncontrollable seizures for 2.5 hours and seizures for a total of 7 hours. They could not figure out why this happened. I've never had this type of reaction or had a seizure in my life. Im a healthy person on no medications. 11/18/2009 ED record for 11/2/2009. Patient with seizure activity which was immediately S/P OP orthopedic knee surgery. required intubation and IV Versed and Ativan with resolution of s/s.