chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing, fast heart rate, weakness, wheezing, sudden onset of frequent coughing... these symptoms lasted in their full severity for 30 mins. After 30 mins they began to lessen, until ~ 1 hour after the onset of symptoms the patient felt safe to lay down and try to go to sleep. The following morning (~ 13 hours after shot had been administered).
I started itching on my back real bad. Benadryl did not help. It was red. I tried it for some days without success with Benadryl so I went to healthcare facility and they gave me Prednisone and something else that I don't remember and in about 2 days it was almost clear.
Shot area never healed - oozing & scab, oozing again. Told I was reacting to shot. Insisted to see Dermo doc - biopsy was cancer & 5 years later lump removed.
ACUTE DVT OF RIGHT POPLITEAL VEIN 2/17/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Severe chills after vaccine (1.5 hrs) lasting 8 hrs. Fever of 102.5 degrees F that would not resolve, next morning at 99.6.
Headache fever , temp 102 at 3 AM and hallucinations, red raised rash surrounding injection site, on 1/30  night sweats, sore throat
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart.   Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
Sever outbreak of shingles left side of face, left ear including inner left ear hindering hearing in that ear, scalp, upper back near neck
Incorrect solution used; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Incorrect solution used) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 GSK Field staff reported an adverse event that was reported to him. The reporter stated that while preparing a dose for administration, the provider used sterile solution instead of the adjuvant provided. The dose was administered to a patient.  No further information was available. The reporter consented to follow up. The patient had Shingrix reconstituted with sterile solution instead of the adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Next day, she had really bad body aches.; She also had fatigue next day.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; She slept for 23.5 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040021A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), BUSPIRONE HYDROCHLORIDE (BUSPAR) and FLUOXETINE for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HYPERSOMNIA (She slept for 23.5 hours). On 23-Aug-2021, the patient experienced PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.). On 24-Aug-2021, the patient experienced PAIN (Next day, she had really bad body aches.) and FATIGUE (She also had fatigue next day.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Blood pressure medicine.  Patient had body aches. She also had fatigue. She slept for 23.5 hours and at the day of reporting she felt better.
Pain in arm and shoulder lasting from date of vaccination to present; diminished range of motion in shoulder; throbbing pain throughout the day. 3+ weeks and counting. Unable to use arm without pain.
Patient reported two days post injection a lump, redness and hot to the touch at the site of injection
This spontaneous report was received from a pharmacist refers to a 70 year old female patient. On 15-AUG-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, (with lot number J016257 and expiry date 20-FEB-2015) (dosing regimen unspecified) for prevention of shingles. No concomitant medication was reported. On 15-AUG-2014, the patient experienced inflammation and soreness in the middle of her rash and itchiness. The patient did not receive treatment for the events but sought medical attention. VZV packet was offered to the patient (details unspecified) and she was not pregnant while vaccination. The outcome of all the events was not resolved. The causality of the events was unknown for ZOSTAVAX. A product quality complaint (PQC) was not involved. This is one of several reports from same reporter. Additional information has been requested.
Pt given Varivax vaccine and around 8 or 9 days later developed disseminated papular rash that is pruritic. Low grade fever around 100*101 F.
Received ZOSTAVAX vaccine 2-22-12 at pharmacy. Wife called pharmacy 2-24-12 and reported a 5 inch blister at vaccine site, which she thought was shingles.
Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, back aches, legs and feet ached.  Hurt the balls of my feet when I walked.  My eyes felt like they had sand paper in them.  I did not run a fever but my  body felt like I had. I had Flu B January of 2018,  my syptoms after Janssen Shot were as severe as Flu B, but the duration was not as long! Approximately 24 hrs after injection I starting experiencing a headache, along with neck and shoulder aches.  And I experienced fatigue for 3 days after injection along with the headache and neck, shoulder and back ache. On the fourth day  following the injection I only feel tired.  Aches, pains and headache are gone.
Hives on chest, slight tingling up right neck and right ear lobe.  Resolved within 4 hours
pain & swelling @ inject site w/muscle aches; p/2nd dose on 30NOV92 devel generalized  itching, swelling of eye area bilaterally & hives for 24 hrs;
High fever over 103F, chills, and body ache: took DAYQUIL and NIGHTQUIL 4x over two days.
1.5 erythema no warmth, slight tender area in right deltoid with small papular outer lesion within.
She got her vaccines, the next day she could not even get up . She was fatigued, her bones were hurting, the pain was excruciating, didn't do much that day.  She did not want to eat or do anything.  She then got into bed.  The next day she was a little bit better, a little hoarse.  She woke up with itching.  She went to her dermatologist who prescribed a cream, which he said that it looked like she had an AE reaction to the vaccine.  She was given prednisone for this, Triamcinolone cream for the itching as well.  She has been using it but it does not seem to be getting any better, and in fact feels like it's getting worse.  Her dermatologist.  She has an APT on 10/16/23 for a return FU.  She also likes swimming and wants to know if the chlorine would be good for her.  Her left side is the one that is affected with the blisters, redness.  On the right side she has just a few dots.  It went from her face, to her neck, her whole arm has blisters on the inside of the arm following where the injection was given.
Covid Booster on 02/16/2022 approx 15 mins after started having SOB/chest pain/palpation. Later that day sharp stabbing pain from arm to right armpit area. Still having same symptoms that has not improved.  Patient received her booster on Feb 16th. A short time after receiving injection she began having symptoms are reported above. Employee did not report to work on Feb 17th and 18th due to symptoms. On Feb 21st, she entered a verge and reported of continued symptoms to nurse manager.  Notes: 2/21/2022-1312- EE called and reported that she was having a reaction from the Covid booster she received 6 days ago.  She reports SOB, fever, heart palpitations, pain at site, redness at site and swelling at site.  This nurse asked if she had been covid tested.  EE reports 3 negative covid tests that she took at home.  This nurse explained that we cannot accept a home test and that we would need to know that she was negative for covid before we could set her up to be seen.  EE did not agree that she needed to be tested but agreed to be transferred to hotline.  This nurse explained to her that if the test is negative we can get her a appointment at Work care and if her test is positive then we would go through the covid positive process then she can be seen after completion of a isolation period.  EE will call Employee Health once she receives her covid results.  EE then transferred to covid hotline.  LPN 2/21/2022-1517- Email from Dr. asking someone to call her regarding testing.  This nurse called her and Dr. asked why Patient was sent for testing.  This nurse explained that her symptoms of SOB and fever that she reported was the reasoning for her to tested.  Dr. stated that Patient did not report fever she reported fatigue and that she reported SOB with heart palpitations only.  This nurse explained that based off of Patient's symptoms on the call earlier she had reported fever, SOB, heart palpitations, pain, redness and swelling at injection site.  Dr. reported that Patient had 3 negative home test and this was a vaccine reaction.  This nurse explained that we do not accept home test and in order for Patient to be seen we needed her to be tested based off of her symptoms.  This nurse stated that if the hotline did not feel testing was recommended Patient could call Employee Health back and get guidance at that time.  Dr. stated Patient was covid tested.  LPN 2/21/2022-1530- Patient called and reported her negative test and would like to get her Work Care appointment scheduled.  This nurse explained she would get the appointment scheduled and let Patient know when it is.  LPN   2/21/2022-1538- This nurse spoke with staff at Work Care and she scheduled EE for 10am on 2/22/2022 with staff.   LPN 2/21/2022-1542- LVM for EE regarding appointment.  LPN
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003724, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain. On 21st December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, his wife experienced soreness after her second dose of SHINGRIX, but it went away in a couple of days and was not extreme. No further details were provided.
15min p/vax while on route home, pt exp dizziness, flushing, sweating & feeling funny;sx still present 4hr later;advised to call MD;sent to ER for eval;tx w/DPH & steroid;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA injection, 50/1.0 U/ml (lot # M018767, 01-FEB-2018) (dosing regimen and frequency unknown) intramuscularly in left arm for prophylaxis (expired product administered). No adverse events were reported. There was no product quality compliant reported. This case is linked to case number 1804USA008643 via same reporter link. Sender's Comments: US-009507513-1804USA008643.
Adult patient received a pediatric dose of Engerix-B; Adult patient received a pediatric dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: The reporter consented to follow up.  Additional Supportive Information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
patient was given only the DTaP-IPV portion and ActHIB separately, No AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a four-month-old female patient who was administered with the Dtap-IPV portion and Act-HIB with 0.4% sodium chloride separately of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 15-Oct-2020 , the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [lot UJ163AAA, U6395AA and expiration date: 15-Oct-2020 and  24-Apr-2021] via intramuscular route in left leg (Dtap-IPV) and in the right leg (Act-HIB) for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Inconsolable crying which persisted for greater than 14 hrs; called MD advised to give warm baths, hot compresses & APAP every 4 hrs; resolved by 21MAY92;
Red, swelling on 10/16/14 in left arm. Pain on day it was received and continues. Dr thinks it is a staph infection. BACTRIM DS-2 rounds maybe 3 rounds. Fluconazole for yeast due to being on antibiotics.
complains of nausea that started in the beginning of February of 2021 after Getting COVID-19 vaccine.  After 3-4 weeks, started having dizziness.  Then, started having headache. Nausea starts off first thing in the morning after getting up and then becomes associated with headache and dizziness.
heart condition; This is a spontaneous report from a contactable consumer (patient). A female patient with age of 75 (unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL), apixaban (ELIQUIS), lisinopril, metoprolol, ascorbic acid; betacarotene; chromium picolinate; lycopene; mecobalamin; pyridoxine; retinol acetate; riboflavin; thiamine; tocopheryl acetate; vitamin b12 nos; xantofyl; zinc sulfate (OPTIVITE), clopidogrel bisulfate (PLAVIX), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]).  Patient stated she had a heart condition and had caner. Caller asked if she can use antipyretics before or after vaccination? Caller stated her daughter told her that paracetamol makes the vaccine less effective.  Information on the lot/batch number has been requested.
Symptoms -  EE reports beginning on Saturday PM she felt fatigued and HA.  Sunday and Monday worsening HA and fatigue.  EE report she called off of work Monday and Tuesday and RTW on Wedneday.  EE reports complete resolution of symptoms today.  Last day of work and shift - ? at work today Home remedies? -   rest and tylenol Any improvement? ? yes, resolution of symptoms Recommendation? EE encouraged to continue to monitor her symptoms and to follow the guidelines outlined in the  Workplace Policy.  EE denied COVID-19 exposure without proper PPE and denied travel.  EE verbalized back understanding and denied further questions at this time.
Started with very loud buzzing of ears that lasted approx 24 hrs. then developed migraine headache. 24 hours after vaccine extreme fatigue and twitching of nerves in face. Especially around eyes. Tearing of eyes and increased trigeminal neuralgia pain which continues.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
11/14/21 presents to ED for "chest pain x 4 days". PMHx "DM2 and atrial fibrilliation"
This case was reported by a nurse via sales rep and described the occurrence of injection site reaction in a adult male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient had mild local reaction at injection site and was concerned if this was beacause of the latex or product.
12-24 hours after vaccine started with severe headache, nausea, and vomiting. Large local reaction to site (redness/swelling/tenderness) and fever up to 102. (left deltoid)
I started feeling really tired and had a headache right after vx. Seemed to subside but then it came back really strong around 6/11/2022. I had a 102 fever with diarrhea and vomiting. One of my feet became so swollen that I could barely walk. I did a couple of at home COVID tests, and they were all negative. I still wasn't feeling well so I went to a lab for official testing and the test came back negative too. I saw 2 NP's at my regular Dr's office and they suspected I might have had COVID at some point, but they didn't do any further testing.