chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took the vaccine on Friday (10/27) evening, went to home, had dinner, watching a movie and went to sleep. Next day morning when I got up, there was a strong pain on my lower back. I couldn't even walk easily or stand-up properly for almost the entire day. I called the Facility Advice Nurse and they suggested me to take Ibuprofen, cold pack and gave me an appointment to check with the doctor on Monday morning. I took couple of Ibuprofens on Saturday and the cold pack. It gradually got better on Sunday & Monday. But, I still continue to have the mild pain on my back.
Patient inadvertently given two flu shot vaccines at this encounter Of note flu vaccine it was initially given by MA at the beginning of the encounter which was ordered appropriately.  Tomorrow had documented in the EMR that the shot was given.  At the end of the encounter I noted that pt. was due for 11-year-old vaccines and asked dad to come back into the room so that he can also receive those 3 vaccines.  Orders placed for three 11-year-old vaccines Tdap Menveo HPV in the EMR.  Asked to administer the remaining vaccines because other MA was not available.  On the blue sheet patient was unaware that other MA already had given the flu shot at this point, and administered all 4 vaccines to the child.  Per her report, she had administered the flu shot, and 1 other shot in 1 arm.  The dad at that point had asked her which shots she was giving because he had already received a flu vaccine but at that point the other extra dose was already given.  She then continued to give the 2 other vaccines in the other arm.  When he was brought to my attention that this mistake happen, I discussed with dad in detail with an apology that the child was given extra dose of the flu vaccine.  I noted that we were going to look into studies investigating possible side effects and adverse reactions, and that we would notify our practice manager in regards to this error so that system changes could be made.  I noted to dad that most likely will have a little bit of fever and some myalgia but I would call back with more details.  Dad expressed understanding and much thanks and did not have any further questions.  I also offered to call the family each day this week to check in to make sure child is okay.  15 minutes after the encounter, after research done called mom on the home phone number listed in the chart.  Discussed with mom- study found in VAERS study with excess doses given-influenza was one of the top vaccines.  Most common side effects were fever, and pain at injection site and erythema in the injection site and headache.  Also reported another study which in excess of 10 times the amount of flu vaccine and was given with most side effects that were very similar in profile.  Again emphasized our apology that this happen and also reemphasized that we would try to take system wide efforts to try to prevent this at our practice.  Offered to again call the family this week, mom said that that was not necessary and that she will call our clinic if she noticed that the child had any adverse reactions more than just the normal fever pain at the site and myalgia.  Mom was very understanding over the phone and noted that she was a nurse and she said that mistakes happen.  I expressed thanks and asked for further questions which she denied.  Will make report to VA ERS  Will make risk report and will notify her practice manager of the situation
About 2 min p/inject pt became extremely irritable & legs were blotchy mottled appearance w/sheets of purpish skin;
i don't know if this lot is correct, because I can barely read what she wrote... My cycle is only 14 days long now. I get a full period every 2 weeks, and because of it, I have developed anemia. My cycle will not go back to normal. My last normal cycle was December 5th. then on December 9th i was vaccinated. my next period came 2 weeks later, and I have continued to have periods every 2 weeks. the gynecologist tested via ultra sound, and I am still ovulating. These are true periods, not some type of spotting or breakthrough bleeding. She doesn't know why it's happening for any reason beyond the vaccine. My last physical was in October. I was not anemic at that time. Please help.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was 50 years or older. In 2018, the patient had one dose of SHINGRIX two to three months before the reporting date and immediately she started to have pain in the arm that was injected and it had been painful ever since. The patient did not plan to get a second dose of SHINGRIX.
Initially did well after HPV9 vaccine was given. Approx. 3 1/2 wks later - redness and visible "lump" to area arm pain and stiffness. Denies bruising. Has improved over past 4 days.
Patient vaccinated with Pediatric Covid vaccine at 1344.  At 1346, she received her flu shot and reports she immediately felt dizzy. RN was notified at 1358 and patient assessed. Patient reported she briefly felt short of breath ans needed to take her mask off and that subsided. She at that time said her stomach was hurting and she felt like she needed to throw up and she was very tired. She remained alert and oriented but was unable to sit up. Her face was pale. She was given an apple juice box and she slumped over leaning on her dad so she stayed in the seat. We were able to get her to the gurney until MD Stat team came. Doctor responded to the call and assessed the patient. Her HR (77) BP (98/52 (90)) and Sat was 100. Her color returned and she was more talkative and stated she was no longer nauseated or tired. The dotor determined she was ok and she left on her own accompanied by her father
Narrative:  Timing error, 2nd COVID vaccine (Moderna) dose given too soon 22 days after first dose.
Excruciating pain in feet; Pain in ankles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of foot pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of neuralgia (1st dose received on an unknown date, refer linked case US2023AMR067520).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced foot pain (Verbatim: Excruciating pain in feet) and pain ankle (Verbatim: Pain in ankles). The outcome of the foot pain and pain ankle were not resolved.   It was unknown if the reporter considered the foot pain and pain ankle to be related to Shingles vaccine.     It was unknown if the company considered the foot pain and pain ankle to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067520   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced excruciating pain in just his or her feet and sometimes in ankles. The patient stated that he or she just want it to go away. Follow-up would not possible as no contact details were available; Sender's Comments:  US-GSK-US2023AMR067520:Same patient
Rash on left deltoid at injection site that developed approximately 2 weeks after administration.  Rash is collection of about 8-10 raised flesh colored papules of 1-2mm in diameter.  Not painful or itchy.  Patient is not bothered by the rash. Skin surrounding the rash is normal.  No vesicles, blistering or crusting.
Erythematous rash on neck, trunk groin, buttocks and Left antecubital region.
Tested Positive for Covid-19 on 3/29/21. Symptoms of congestion and runny nose. Tested for NCAA surveillance for student-athletes.
Patient was given MENACTRA & GARDASIL in the L upper arm.  Within 10 seconds she passed out for about 5 seconds. She complained of dizziness & headache when she woke up.
Fever to 101F on 9/01, then erythema to injection site (left anterior thigh) on 9/02. Pt presented to Emergency Department 9/02 & was initiated on a cellulitis protocol (cefazolin 1g IV q 8 hrs) & given ibuprofen 600mg po prn. Pt remains in Emergency Department receiving treatment at this time.
Soreness at injection site, achey, hurting joints, headache, stomachache, fatigue
Pt developed dizziness and near syncope shortly after injection. He reports a history of vasovagal reactions with injections in the past. BP 78/60 and then improved to 102/68. HR improved from 40-58 after several minutes. Over the course of 15-20 minutes, symptoms resolved and pt fully recovered.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 11-AUG-2015 the patient was vaccinated with a dose of expired ZOSTAVAX (dose, lot# and route were unknown, expiration date 20-MAR-2015) (Expired product administered). No concomitant therapy information was provided. Unspecified product quality issue (PQC) was involved. No adverse events were reported. Additional information has been requested.
4/21 daytime - nausea, vomiting, diarrhea, fever & neck pain.  4/21 10:29PM At hospital ED - febrile, appearing septic & hypotensive & had tachycardia.  4/21 11:34 PM Intubated.  4/22 12:36AM Pronounced dead.
Within four hours of having the vaccine I became very tired. I started getting a splitting headache, which is very abnormal for me, as I do not have headaches. I then began to shake and feel general illness. My body became weak and I was extremely tired. I went to bed very early, around 8:00 pm and had a fever of 100. My normal body temperature is 96.7. This is when it got bad. I started having fever dreams and convulsing. I would convulse and wake up but couldn?t communicate to my husband. I was unable to communicate at all. Then I would start to either hallucinate or slip back into fever dreams. I would convulse and feel my head hurt badly. Then my eyes started hurting from the pressure of the convulsions. This went on until around 1:00 am, and I could not communicate to my husband still. It was like I was paralyzed. My head hurt very badly. Around 1:00 am, I was able to use my arm to smack my husband awake. I was not able to communicate to him well. He took my temperature, and I had a fever of 104.1. He got ice packs and put them all over my body to help cool me down. I was delirious at this point and couldn?t speak or think properly. It took about two hours to cool my body down with ice packs and cold water. We called urgent cares for help, but no one could help us. We were afraid to go into the hospital because we could not afford the copay. Around 5:00 am  my fever was down to 100 and my husband helped me up to use the restroom. I could not walk well and was unable to walk without assistance. My head still hurt very badly and I feel very weak and dizzy. After a while, I was able to sleep.  I had a fever going between 100-101 for three days after the vaccine and all three days I was very weak, unable to walk well, my head hurt, and I was dizzy. It took a full week for me to return to a normal temperature. It took about two weeks before I started to feel normal again. I now will suffer occasional headaches, which has never been normal for me.
Fatigue since an hour after injection, muscle pain since an hour after injection, site soreness sense 30 min after injection, chills for 45 minutes starting an hour after injection, and nausea for 45 minutes starting an hour after injection
Started with itching and slight fever on Friday night, fever has been on and off for 3 days, itching continues, slight worsening in cough.
The caller's arm was sore after the first dose; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Feb2021 11:00 (Lot number: EN6202) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer survivor" (unspecified if ongoing), notes: Verbatim: cancer survivor; "slipped discs" (unspecified if ongoing), notes: The caller has 3 slipped discs in her back.; "radical hysterectomy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN taken for pain. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The caller's arm was sore after the first dose". Additional Information: The patient's lymph nodes were not taken out, radical hysterectomy, year 6 on that. The patient's arm was sore after the first dose. The patient has no history of all previous immunization and has no additional vaccines administered on same date of the COVID-19 vaccine. The adverse events did not require a visit to emergency room nor physician office visit. The patient has no family medical history relevant to the adverse events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021319777 same patient, same drug, different event, different dose of vaccine.
Diarrhea started same day vaccine was given with nausea/vomiting and stomach pains. Diarrhea was still present on 4/16/21
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Negative; (06Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered Tdap, Meningococcal, and HPV. Pt became teary after HPV injection and within 5 minutes stated her head hurt, became pale.  Sat her down, cool rag to forehead, took vitals (106/60, P92, R12, T97.6)Had pt stay in area for 20 minutes.  States she is fine before leaving the clinic.
On 09/13/00 the pt received his first dose of Lymerix, inadvertently. Pt was supposed to receive Prevnar vax. Four days post vax the pt experienced a fever greater than 102 degrees, as reported by the family. As of 09/18/00, the outcome of the event is unresolved. The follow up states on 9/13/00, the child received an injection of LYMErix, instead of an injection of Prevnar. On that date, he also received injections of Acel-Imune, ActHIB, and IPOL. Number of previous doses of these vaccines was not reported. On 9/18/00, five days post immunization, the child developed fever to 103 deg F. He was seen by the physician, who noted a nonspecific macular rash and a red pharynx. On 9/20/00, seven days post-immunization, the child had a fever of 101 deg F., decreased eating and fussiness. He was again seen by the physician, who noted multiple small vesicle and ulcers in the oropharynx. The physician stated that the events were "consistent with Coxsackie virus. Doubt vaccine reaction." All symptoms resolved "in two to three" with no sequelae.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. Since an unspecified date in 2015 the patients were vaccinated with doses of ROTATEQ (lot # K024700 with expiration date of 30-JUL-2016, oral; strength, dosage and frequency unspecified) which were improperly stored (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I developed seropositive rheumatoid arthritis in August 2021, diagnosed by Rheumatologist in August 2021.  Taking meds Prednisone, Embrel, and Methotrexate for treatment of RA now.  No family history of RA,  I don't know if this is related to the vaccine or not but no family hx autoimmune disease.
This is a spontaneous report received 02-NOV-2016 from a nurse via a telephone call. The nurse reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 (lot # M023169, expiration 13-JUN-2018 or PEDVAXHIB (lot # M025192, expiration 21-MAR-2019) on multiple unspecified dates. No adverse effects were reported. The nurse also reported GARDASIL 9 (lot # M023169, expiration 13-JUN-2018) and PEDVAXHIB (lot # M025192, expiration 21-MAR-2019) excursion information: temperature 47.50 F for 4 minutes and temperature 33.60 F for 5 minutes. There was no previous temperature excursion. The phone call was not a result of a data logger. Additionally, the nurse reported that an unspecified patient was vaccinated with an unspecified vaccine on an unspecified date and experienced an unspecified adverse reaction. No further information was provided. Additional information was requested.
1358 60 y/o female received 1st Covid vaccine and was sitting in observation room for 30 minutes.  At the 30 minute mark pt stated  that she felt dizzy when she tried to stand up.  Brought Pt to backroom for evaluation she stated that her tongue felt thick and her lips felt numb.  Vitals BP 136/75 P 74 Temp 99.3 .  Pt was evaluated by Dr and he determined that she needed to be observed.  1412 Asked pt how she was feeling "Right eye feels funny like pressure and her throat was tight.  At this time Dr determined that pt needed Epi Pen. 1413 Epi Pen administered to right thigh EMS was called. Vitals BP 174/86 P 75 R 22.  Denied difficulty breathing.  Pt became very emotional and stated she was scared. Reassured pt she was going to be fine and provided additional blankets for her chills.  1419 EMS took over her care
local react of large swollen, hot area from shoulder to elbow; tx w/ice & DPH, PRN; As of 5AUG93, recovery status unk;
Confusion, memory loss, muscle pain-whole body on going  4 weeks after second dose-shingles onset
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 17:00 as dose 1, single (Lot number: EN6204), in left arm, on 27Mar2021 at 17:00 as dose 2, single (Lot number: ER8727), in left arm and on 23Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "knonw allergies: phenergan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative; (14May2022) Negative; (17May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received other medication in 2 weeks. COVID 19 Treatment: Paxlovid, treatment start date: 08May2022 and stop date: 13May2022. Started 08May, did fine was feeling great. 13May tested negative, 14May tested negative. That night started coughing, got very hoarse but still felt ok otherwise. On 15May called Dr and got more benzonate 200 mg. But felt fine otherwise. Still occasional cough and runny nose and hoarse. On Tues 17May in the evening on top of everything her throat started hurting. Took another test and it was positive in less than a min.  No follow-up attempts are possible. No further information is expected.
Received an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 2sx5d, expiry date 24-FEB-2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose). The outcome of the expired vaccine used was 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-MAR-2023 The nurse reported that a patient received an expired dose of Havrix which led to expired vaccine used. The reporter did not consent to follow up.
Information has been received from a certified medical assistant concerning a patient who on 07-SEP-2010 was vaccinated with ZOSTAVAX (Merck) (Lot# 665516/1271Y, dose/frequency, route unspecified). The patient was inadvertently administered ZOSTAVAX (Merck) instead of VARIVAX (Merck). No adverse effects reported. Follow up information reported that the medical assistant stated that the patient was administered ZOSTAVAX (Merck) instead of VARIVAX (Merck) due to a medical error and not product confusion, and refused to give the patient's name or DOB. Additional information is not expected.
Injection site tenderness. Wrong drug administered.  From initial information received on 6/7/05 from a health care professional, it was reported that a patient, no specifics provided, received the wrong product and had a possible reaction of local area soreness. The patient was administered a dose of TRIPEDIA vaccine instead of TD ADS ADULT on an unspecified date. Reportedly the reaction of soreness was only temporary. The patient's recovery status was not reported. It was reported that thirty-six adult outpatients received Tripedia instead of TD ADS ADULT however, there was only one report
High-pitched cry, body stiffening in intermittent episodes over several hours.  Arms held out over front or overhead.  Recovered following day, no fever.
Per PHONE report only, not seen in office: Reports onset of generalized hives on extremities, back, and neck, hand and facial swelling, shortness of breath, and HA that developed 3 days after first dose of vaccine. No hx of allergies in the past. No recent change in diet. Pt had been prescribed oral birth control the same day as her vaccine; however, she states she had not yet started taking it at time of symptom onset. No other medications reported. She took an OTC antihistamine, which has helped to improve symptoms. Continues to have HA, rash, and some swelling but has improved since starting antihistamine.