chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 2/4/99; 15 min post vax pt exp red vax site; tx=Benadryl & cream
Abdominal Pain Severe, Sweating Heavily, Shooting Pains Up Back,  Severe Diarrhea (Watery,Shooting out of me),  Severe Nasea,, Weakness, Fatigue, Could not stand up,  Dizzy,, Spins, Close to Fainting, Never Vomitted,  Called Ambulance Went to Emergency, Let me go After about 6 Hours .Next 5 days after incident, I was still Extremely Weak,  Fatigued,  Slept A lot,  Ate Minimal Amount of Very Bland Food,  Still had Severe Pain in Stomach,  Touch my Stomach and it Really Hurt, Swelling Around Shot Area Was now a Hard Knot Sensititve to Touch.
pt c/o pain in lt arm on 18JUN97;one day p/vax appeared in clinic today w/sowllen upper arm (shot site) & shoulder area;area around vax w/blister lesions, redness @ site;
Narrative:  PT WAS VACCINATED IN A TIMELY MANNER 12/30/20, 1/20/21 AND PROVIDED BOOSTER 10/7/21 OF PFIZER MRNA VACCINE. PT CAME TO ED WITH COMPLAINTS OF WEAKNESS AFTER FALLING. PATIENT TESTED POSITIVE FOR COVID. HE WAS ADMITTED FOR WEAKNESS. PATIENT WAS TREATED, RECOVERED, AND DISCHARGED AFTER SHORT HOSPITAL STAY.
Patient complaining of heart palpitations that started 24 hours after the administration of the vaccine. Patient still having palpitations today, patient states that the intensity of the palpitations have decreased since they first started on 3/2/2021. Patient also complained of shortness of breath that started first at rest and then the patient noticed that when going up the stairs she felt really out of breath that she had to lay down and rest. Patient also had two episodes of dizziness on 3/4/2021.
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the  clinic  at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
Tinnitus/ after the dose of the product the secondary noise got loud as well\secondary sound has gotten better but the primary sound got significantly worse; This is a spontaneous report from a contactable consumer. A 70 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included tinnitus (since 20 years). Concomitant medications were not reported. After the first shot tinnitus got significantly worse pretty lost, secondary sound has gotten better but the primary sound got significantly worse. The patient stated that her question was she was due for her second COVID shot the next day, and she was in a quandary because she had tinnitus for 20 years, and after her first shot, her primary noise got loud, and she had a secondary noise as well that is normally not loud but after the dose of the product the secondary noise got loud as well. Caller stated that her primary noise was crickets, and her secondary was a fan, and it sounded like an industrial fan like an airplane over her house, it was that loud. Caller stated that the fan noise had diminished, and she only hears it lightly now, but the crickets have stayed. Caller was wondering about recommendations for the second dose as her appointment was next day. The outcome of the event was unknown.
Many red, itchy swellings/ bumps mostly on left groin but some on right groin.  Some new bumps further down legs a few days later.  I sent Dr photos of the bumps.
Pt stated the next day after getting her covid vaccine he gave herself a COPAXONE injection and then started getting flushing, shortness of breath that increased into shakes/convulsions and a fever that would spike and then fall and then spike again.  It went on for a few hours until she finally vomited and then started to get better until it just stopped.
Client was given Moderna Booster dose instead of the Moderna Bivalent Booster dose. No reactions noted.
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
Parent nor patient communicated H1N1 already administered elsewhere (dr office). Patient 11 y.o. and only 1 dose required.
dull ache in arm from injection site to wrist in arm, per pt, "golf ball" size lump in arm at injection site
Patient had a COVID-19 vaccine on 10/27/2023 at Pharmacy. The next day he was confused,  febrile, admitted to the hospital. Ultimately diagnosed with HSV encephalitis.  May or may not be related but wanted to file VAERS
Information has been received from a 68 year old female who on 26-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided) and a dose of influenza virus vaccine (unspecified) in the same arm. On 26-JAN-2010 the patient experienced warmness in her arm as well as swelling. The patient sought medical attention and was on therapy. On 01-FEB-2010, the patient had recovered. Additional information has been requested.
Muscle pain/weakness, nausea, increased pain at injection site. Refused E.R. visit per spouse.
Post Menopausal bleeding from date of injection to present (over 3 weeks); migraine; body aches; lethargy
Vaccinee rec'd three doses Engerix-B (Deltoid) & did not have titers when checked three months p/the third dose.
SEVERE HEADACHE; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 27 year old. 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: 1808978, expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced inability to sleep. On 02-APR-2021, the subject experienced severe headache.  Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of inability to sleep was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol.
Woke up crying, chills (shaky), achy, and with fever of 103.9F
Developed dry cough which progressed to intermittent dry/productive cough with yellow sputum, intermittent wheezing with deep breaths.
Received a TDAP at employee health on 7/21/11 developed with fever 5 hours after vaccine of 103-104, chills, fatigue, headache, nausea and shakiness.
Client's arm started swelling at the injection site, the night of the injection. Swelling grew worse each day with heat and redness spreading down the arm. Day 3-client had fever of 103 degrees and was lethargic. Mom took client to ER where diagnosis of cellulitis and staph infection was made. Client put on antibiotics. I spoke with mom on 11/16/17 and she stated client was better and swelling was almost gone.
One hour after the vaccinations patient developed swelling of the lower eye lids.  Seen at hosp. peds ER.  Treated with P.O Benadryl & sent home on Benadryl & prednisone p.o.  No general symptoms.
parents made an online covid 19 vaccine appointment and filled out an electronic consent form with a DOB   came in on 04/21/2021 to get her first dose and we administered her with Moderna covid vaccine. When she returned on 05/19/2021 to get her second dose, she filled out another paper consent form  with her real DOB . That's when we realized we administered Moderna covid vaccine to a 17 year old . No adverse events to report.
pt recvd vax & several days p/dose 2 exp stomach pain & cramps; outcome: still has cramps; dose 1 given 7AY93;
on 3/16/2021   lost feeling in both legs and was unable to stand - vital signs were normal - doctor's exam at 12:30 was unremarkable - this was 18 days post injection #1 on 4/04/2021   lost feeling in both legs again, was unable to stand, B/P was 220/122,  posturing on left side, disoriented - week preceding  was marked by uncharacteristic disorientation and anxiety and complaints of pain to light touch on skin, -  week following was characteristic of recovery from mild stroke - now mental status is returning to normal, overall strength decreased - this was 16 days post injection #2
25OCT96PM sore arm, insomnia;26OCT & 27OCT96 gen joint aches, frequent stools, frequent urination, tinnitus, visual disturbances;28OCT96 emotional high, sweating;29OCT96 hypoglycemia sx, tachycardia, erythema multiforme;cloudy vision;
COVID breakthrough. Presented to hospital on 8/30 for unrelated reason and tested positive for COVID on 8/30/22. Patient had fever of 100.8 on presentation to the hospital.
pt recvd vax 14JUL94 & approx 2 days later, devel a fever ranging from 100.7-102; 18JUL PM, eyes moving w/quick jerking movements, body twitching; 19JUL AM seen in ER; hospitalized; CBC indicated viral infect; dx viral encephalitis
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of  unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 5 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Fever, swollen glands, cough, runny nose starting 6/20 - 6/23 Itchy rash starting 6/22
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M026874 expiry date 19-JUL-2017; dose and route were not reported). The doses were stored under temperature of 14F for 7 days and there was no data logger involved. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
epigastric pain sharp in stomach for 12 hrs; duration cramps for 30 seconds; therapy initiated; discontinued 4th capsule;
shingles; inappropriate schedule of vaccine administered; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a an approximately 59-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 06-OCT-2009, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for prophylaxis. On an unspecified date in 2012, the pt suffered shingles, including any and all of its sequelae as a result of her receipt of zoster vaccine live (ZOSTAVAX). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment monitoring and/or medications. As a result, the pt required and/or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/or hospital care, attention, and services. She incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Her direct medical losses and costs included physician care, monitoring, and treatment. She incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was considered to be not recovered. The lawyer considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered the event of shingles to be disabling.
This is a spontaneous report obtained from a contactable nurse through a sales representative. This nurse reported about two different children. This is the second of two reports. A female child of an unspecified age and ethnicity received on 02JUL2015 at 11:29, TRUMENBA; (Lot J29203; Ex 30JUN2016) 0.5 ml at single dose, IM (intramuscularly), on the right UOQ in upper leg. Relevant medical history and concomitant medications were unknown. On an 02JUL2015, the patient experienced extreme pain. Clinical outcome of the event was recovered on 06JUL2015. Follow-up (11AUG2015): New information received from the same contactable nurse includes: product data, reaction data and outcome.
Shingrix vaccine which triggered Shingles Outbreak; shingles; vesicles on her hands and knees/ Vesicles appeared around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included immunosuppressants nos (Immunosuppressive Therapy (Nos)).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vesicles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and vesicles were recovered/resolved.   The reporter considered the vaccination failure, shingles and vesicles to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Jul-2022 and 11-Jul-2022 Reporter's Comments:  The patient reported that she received her Shingrix vaccine which triggered a Shingles Outbreak. Patient was certain that this was an outbreak of shingles as she had experienced it previously.  Vesicles appeared around the injection site, on her hands, and knees.  The patient was successfully treated with a ten days course of Valtrex.  The reporter reported that, also patient was on immunosuppressive therapy. The reporter consented to follow up. No further details provided on web form. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
patient was given a 5th dose of Pentacel, no AE; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old patient of an unknown gender who received a fourth and fifth doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number, expiry date, dose, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to extra dose administered. It was reported that the interval between the 4th and 5th administrations was 12 weeks and 3 days.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
PT HAD IMMEDIATE DIZZINESS POST VACCINATION AND WARM SENSATION AT INJECTION SITE; PT WAS ASKED TO REMAIN SEATED AND GIVEN COLD COMPRESS FOR INJECTIOIN SITE, FOLLOWED AT AT  645PM ON 3/16/22 - STATED THAT SHE WAS JUST ACTUALLY AFRAID OF NEEDLES  AND OTHERWISE DOING OK
On 05/15/2003: Quarter sized lump and bruise on upper left arm.
A Covid vaccine initial series  was scheduled with the first dose to be given on October 15th, 2022.  Instead of the initial Pediatric Pfizer Covid vaccine, a bivalent pediatric Pfizer vaccine was administered.  The error was discovered on November 5th when the patient returned for the second dose 3 weeks later.  The parent was notified.  No further vaccines were given until the patient's physician approves.  No negative outcome was reported at the time of discovery.
LPN mixed menveo with sterile water; LPN mixed menveo with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 25-SEP-2023, the patient received Menveo. On 25-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: LPN mixed menveo with sterile water) and inappropriate dose of vaccine administered (Verbatim: LPN mixed menveo with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 27 Sep 2023 Nurse reported an LPN mixed menveo with sterile water and gave to patient instead of mixing the gray cap diluent.  The reporter asked if the patient need another injection and how long would she have to wait? The reporter did not consent to follow-up. The nurse mixed menveo with sterile water and gave to patient instead of mixing the gray cap diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a elderly male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The reporter stated that the patient called about 3 days post-vaccination and reported that his vaccinated arm was red, painful, and swollen. He came back into the pharmacy 5 days post vaccination to show it to her and she also spoke to the patient's doctor who was not concerned. The events did not affect his activities of daily living. The symptoms lasted about 7 or 8 days. The reporter could be contacted.
According to staff....Recipient received the above vaccination and went to sit for 30 minutes.  He had already explained to the staff that he had had previous reactions to bee stings that required epinephrine so the nurse practitioner had  instructed him that he was to wait for 30 minutes vs the usual 15 minutes.  It is unclear exactly how many minutes into the post-vaccination period passed before he began to report numbness around his lips.  The nurse practitioner then indicated he began a "rash" on the back of his neck.  The recipient reported that this was feeling very much like his previous allergic reactions.  They took his BP and it was reported to be around 180/100 at that time.   He did not report feeling SOB but reported his throat felt like it had in previous allergic reactions.  Recipient remained alert and oriented the entire time.  It was decided by the two nurse practitioners on site that he be given the epinephrine and Benadryl IM.  His BP remained elevated and then, following the epinephrine, he became very shaky and a bit foggy. 911 was then notified for further assistance from the EMT's and possible evaluation at the local hospital which was about 5 minutes away.  Paramedics evaluated the recipient and agreed that evaluation at the hospital would be warranted.  He never lost consciousness or required oxygen or other assistance. He was able to place himself on the gurney and was speaking with his wife (that was present)as he was taken out the door.  The transfer was done out of an abundance of caution. We do not know if the hospital kept him following the incident.