chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bexsero instead of Engerix-B; one month old received Bexsero; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-month-old male patient who received Men B NVS (Bexsero) (batch number KL472, expiry date 30th September 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 31-AUG-2022 Reporter's Comment: The nurse reported that, a one month old baby received a Bexsero vaccine instead of Engerix-B. The permission to store personal information in Medical Information database declined. The follow up permission was denied. Additional Supportive Information: The patient received Bexsero vaccine instead of Engerix-B at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
After the first 24 hrs, arm was sore for 48 hours, score of a 7
pt recvd vax & exp f w/ t 103; pt stopped breathing & taken to ER;
Lump at injection site; Redness at injection site about two inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site about two inches) and VACCINATION SITE MASS (Lump at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site about two inches). On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site). On 17-Feb-2021, VACCINATION SITE ERYTHEMA (Redness at injection site about two inches) had resolved. At the time of the report, VACCINATION SITE MASS (Lump at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.
I received the J J vaccine because of the Government mandated vaccination, after 10 day I woke up to go to work at 5:00 am  falling flat on my face out of bed unable to talk, and paralyzed from my head to my feet ,calling emergency 911 taken to hospital scared I was dying my life has been Hell ever since
Dry mouth; Thirst; Morning nausea/Evening nausea; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), THIRST (Thirst) and NAUSEA (Morning nausea/Evening nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), THIRST (Thirst) and NAUSEA (Morning nausea/Evening nausea). At the time of the report, DRY MOUTH (Dry mouth), THIRST (Thirst) and NAUSEA (Morning nausea/Evening nausea) had not resolved.            No concomitant medications were mentioned.  The patient reported receiving the vaccine 5 days ago, exact date unknown.  No treatment details were reported.
This child's entire lateral / anterior surface of the left thigh red, warm, and swollen.
headache, sinus congestion, sore throat, productive cough, body aches starting on 9/16/21. Seen in clinic on 9/17/21, tested negative for COVID at that time. Seen again on 9/21/21, tested positive for COVID. Husband tested positive on 9/15/21
Approximately 2 minutes after immunization subject complained of feeling faint, nauseous, need to defecate, hot, dizzy, sweaty, "felt weird", breathing fast but not labored. Treated with ice to face, head-down position, took off shirt, ice water to sip. No hives, No respiratory distress. Ambulance arrived and spoke to patient. Finger stick blood sugar done - results 52 mg/dl. Ambulance staff suggested something sugary to eat. Subject had a glass of pop, candy bar, and peanut butter and jelly sandwich. Subject refused transport to ER because he felt better. Rested in easy chair until 1 pm; felt recovered and returned to work. At 3pm, still tired. By5pm, all symptoms resolved.
Mildly lightheaded after injection, was seated and recovered before leaving pharmacy.  Called 3 days after injection with site reaction, and counseled that it would resolve within a few days, and patient called 6/28/2011 that symptoms were improving.
Information has been received from a registered nurse (RN) concerning a 6-month-old female patient who on 10-JUL-2006 was vaccinated by mouth with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653915/0389F).  Concomitant vaccinations administered on that same day included the third IM dose in the left thigh of PEDIARIX (Lot #AC21B065AA), the third IM dose in the right thigh of ACTHIB (Lot #UE793AA) and the third dose in the right thigh of PREVNAR (Lot #B08658C). It was unknown if medical attention was sought and no adverse events were reported. On 07-AUG-2006, the patient was vaccinated with the second dose of ROTATEQ (Lot # 653915/0389F). Additional information is not expected.
p/vax pt began vomiting & devel extreme h/a;pt then blacked-out & fell down the stairs of home;had extreme h/a & mult black-outs & dizziness;see black spots & have suddenly began wetting the bed;military claims none of this from shot. Annual FU received states still has severe unexplained headaches.
Patient got injection at 3:12 PM on 12/26/15.  She said the injection site was sore but no other adverse symptoms before she went to bed.  When she woke up at 9 AM on 12/27/2015, the injection site wss red and warm.  Her whole arm was swollen and normal temperature.  She said occasionally she would feel a pain pass thru her arm.  Possibly a pinched nerve.
Patient felt throat was tingling, gave her a 50mg dose of benadryl and changed her monitoring time from 15 minutes to 30 minutes.  She felt that it was getting worse so we called EMS to take her to Hospital.
Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .
Patient received vaccine on 8/29/17 and started experiencing symptoms on 8/30/17. She feels dizzy and is having blurred vision.
severe chills, sweating, body aches/pains, head ache, fever,  shaking. lasting 48 hrs. Then body aches/pain, head ache, flu like symptoms over nest 72 hours.
Doctor thought it might have been spinal stenosis but she was not officially diagnosed; Trouble walking; This case was reported by a pharmacist via call center representative and described the occurrence of spinal stenosis in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix .5 ml. On 3rd July 2019, 1 days after receiving Shingrix, the patient experienced spinal stenosis and walking difficulty. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the spinal stenosis was unknown and the outcome of the walking difficulty was recovered/resolved.   It was unknown if the reporter considered the spinal stenosis and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The patient had trouble walking the day after receiving the vaccine. It lasted a while and her doctor thought it might have been spinal stenosis but she was not officially diagnosed with that condition. She was treated with steroids and the symptom has resolved. The reporter consented to follow up.
Headache, Metalic taste, Monitored for 30mins. 17:32 Headache better, instructed to F/U with PCP if symptom returns or worsen, state understanding left for home.
Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA000474: US-009507513-1707USA004998: US-009507513-1708USA000472: US-009507513-1708USA000473:
MMR administered SQ in left upper thigh on 1/25/05. On 1/27/05 mom reported 3 x 2 inch area of local redness around injection site with mild tenderness.  Red, raised, warm; no limping, no fever, no specific cmplaints from child.  advised continued monitoring, Tylenol for discomfort, and compresses to leg.  On 1/28/05 erythema at injection site was measured at 10 cm diamters, raised, red, slightly warm, and slightly tender.  Afebrile.  Office Fu on Monday 1/31/05 revealed a mildly indurated, non-tender area on left upper thigh, no longer red around original injection site.  Marked areas from 1/27 and 1/28/05 were measured at 6 cm and 9 cm diameter respectively.  Pt was afebrile, without rash, joint pain, and was otherwise happy and asymptomatic.
This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first and the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). However, on 19-APR-2017, as the third dose of the series, the patient received GARDASIL (lot number M014929) for prophylaxis (dose, route of administration and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Hives all over body, very large and raised. Benadryl worked somewhat. Zyrtec (20mg) stopped the reaction almost totally. However, after about a week or so, they reoccurred just as severely as at first. Took Tylenol when I felt warm, along with the Zyrtec and that also worked for a few days. After a massage today, large areas of hives broke out on my thighs and neck.
He got his vaccine, he started with weight loss.  He went to see the doctor due to this, and does not remember this.  He continued to loose weight and continued to see his doctor and they ran a lot of tests to determine why he is loosing weight.  He lost weight, would gain it back and then would loose again.  He weighed 140#, and is now down to 105#, and cannot find out a reason why.  He subsequently had the other two vaccines without any change in the condition.  It seemed that with each vaccine his weight would continue to decline.    Said to contact the doctor for information on dates and tests.    2nd vaccine on 3/19/21: Pfizer, lot #EN6205.  3rd vaccine on 12/30/21, LOT#FH8020.    He is scared, does to what to do and does not know if this is going to cost him his life.
After the vaccination, I had a bit of soreness in my arm, but I didn't experience anything out of the ordinary. About 10 days later, I noticed an unusual pain in my left hip. I tried stretching, but it got worse. It continued to get worse over the next few days. I couldn't walk from the parking lot and my building, which was about 3/4 of a mile, without stopping. That's not normal for me. I already had a regular doctor's appointment scheduled. During my appointment, I mentioned it to my doctor. My doctor didn't think much of it and said to wait to see if it goes away. It lasted for another five to seven days. I was on the verge of calling the doctor again, but it went away suddenly. It lasted two to three weeks total, but it hasn't come back since then.
Noticed rash on torso, upper legs, like little pimples. A bit itchy lasted for 5 days. Completely gone by 3/24. On 3/22 noticed swelling on knees, by the 3/23 swelling was on joints through out body, especially on right hand and index finger. On 3/24 doctor at urgent care diagnosed it as serums sickness and recommended Benadryl and Ibuprofen as needed. As expected pt felt better on 3-4 days feels 95% better.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 14-APR-2015, the patient was inadvertently vaccinated with an expired first dose of M-M-R II (lot # J004210 exp date 12-APR-2015) subcutaneously. No adverse effect was reported. Additional information has been requested.
Patient states that a few hours after she received the shot, she noticed a bump on her arm. As the night went on, it continued to get worse and ended up swelling from her shoulder to elbow. Patient called her primary doctor who called in an antibiotic for her thinking that it could have been an infection starting. Patient contacting pharmacy the next morning to explain what had happened, but stated that she was on her way to urgent care to actually have a doctor look at the arm, being it's the weekend and her primary doctor did not actually see her. Patient stopped into the store after the urgent care visit and was told by md at urgent care to purchase over the counter cetirizine and take that for a few days along with icing the area.
My son was sent home from daycare Thursday 01/07/21  with  a rectal temp of 103.7. Administered Tylenol 5mL and Motrin 5mL once home. Pt had decreased appetite and increased fussiness. Lungs were auscultated clear, and no nasal secretions present. His symptoms subsided on Saturday afternoon 01/09/2021 and no longer required Tylenol/Motrin for comfort or to decrease fever. None of the other children or workers at daycare have any symptoms or fevers since.
fever & vomiting 1 wk p/receiving 3 doses of vax; dx as pericarditis; 10JUL92 phone f/u w/plasma center indicater tiem of vax was greater than 1.5 mo a/onset of sx;
Missed dose; This is a spontaneous report from a contactable consumer (mother). This consumer (mother) reported similar event for 2 patients (twins). This is 2nd of 2 reports. A 19-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on Aug2018 at a single dose for an immunization. Medical history included none. Concomitant medication was not reported. The reporter stated that they were on the 2 dose schedule with meningococcal group b rlp2086. First dose was in Aug2018 and their second was supposed to be in Jan2019, so her doctor recommended one thing and pharmacy recommended another so she called first. The second dose was supposed to be 6 months after the first one but the second one was a missed dose now. They forgot about it. She went to see doctor and doctor recommended in getting the second dose, but the pharmacy recommended something different to administer it. The doctor recommended going ahead and getting the second dose but the pharmacy recommended to start the cycle over again. So she called and got an answer. They did live in the dorm, and lived in it in Jan2019 when the missed dose occurred.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019265453 same reporter/drug/event, different patients
Patient received 4 doses of Pfizer covid vaccine. 4th dose was administered 21 days from 3rd dose because patient reported to us that his 3rd dose was his first dose.  No adverse reactions reported from patient. Discovered when patient asked for vaccine records to be printed.
Ileocecal intussusception.  8/18/2008 MR received for DOS 08/1-2/2008 with D/C DX:  Acute Ileocolic Intussusception, s/p air contrast enema reduction. Pt presented to ER following an episode of bright red blood per rectum as well as alternating fussiness and lethargy. Air contrast enema dx and reduced the IS. Pt had a couple mucusy stool post-procedure but otherwise did well with progressive po.
ENCEPHALITIS STATUS EPILEPTICUI 60 Day follow up states seizures, death. On October 25,2002, pt died as a result of complications of his seizures Discharge Summary received on 9/23/2002 states viral infection, Hepatomegaly, anemia, and thrombocytosis.
This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization at the physician office. The patient's medical history and concomitant medications were not reported. The patient had some pain, redness, and swelling at the injections site on an unspecified date. The outcome of the events, pain, redness, and swelling at the injection site, was unknown. Information on batch number has been requested.
Cashier reported to the pharmacist that a patient in the post-vaccination waiting area looked red and sweaty prompting the pharmacist to check on the patient.  This was approximately 5 minutes after the patient had received his vaccine.  The patient had his eyes closed and reported feeling hot and tingly.  Patient exhibited no signs of rash or respiratory reaction. Patient was given a cold pack for his neck and recovered after a few minutes.  During a follow-up call the next day, the patient reported he had fainted at some point when his eyes were closed.  After leaving the pharmacy, the patient went home and took a nap.  The patient reported no further or lasting effects.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FAITED AFTER VACCINE ADMIN, HIT HEAD IN PHARMACY, TAKEN BY AMBULANCE TO EMERGENCY ROOM
VACCINES INADVERTENTLY ADMINISTERED TO THIS PATIENT WHEN IT SHOULD HAVE BEEN GIVEN TO SIBLING
Information has been received from a nurse concerning an unknown number of female patients who were vaccinated with the second dose of Gardasil and experienced pain and burning at the injection site. There was no specific information about the patients. There were no adverse experiences reported after receiving the first dose. Medical attention was sought. No further information is available.
Pt developed chills, fever which broke in 24 hours, sever muscle aches which lasted about 24 hours then developed combination of cold sores and canker sores. pt was prescribed Valacyclovir 1 gram, qty 4, SIG: take 2 tablets every 12 hours for 2 doses
The Patient is experiencing twitching in the mouth twitch on the left, started Sunday night, the jaw twitch started Thursday 7th of October. He has experienced a shoulder twitch on the right shoulder once on the 5th at 3 AM. He has twitching left knee on the 5th at 2 AM and then again on the 5th 230 AM
Large lump about the size of a ping pong ball at the injection site. Hot to the touch, painful and very itchy.
No adverse event; Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medications were reported.  Patient received Moderna bivalent booster dose.  No treatment medications were reported.
pt recv vax 10JUN97 on 12JUN97 awoken w/t103, chills;APAP given by PM was feeling better;temp dec only had inc temp x 1 day;
Itch; Warm to touch; Soreness and ache; COVID arm rash; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 09-Apr-2021, the patient experienced PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired). At the time of the report, PRURITUS (Itch), SKIN WARM (Warm to touch), PAIN (Soreness and ache), VACCINATION SITE RASH (COVID arm rash) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the COVID arm rash included cortisone cream.
Woke up this morning with a large red circle around the injection site approximately the size of a tea cup saucer with warmth and slight amount of swelling noted.  Nurse advising to contact PCP for further treatment.
Myalgia, Arthralgia, NauseaVomiting, Injection site pain Narrative:  Other Relevant History:
1. Tendonitis of the left achilles.  Began 29 hours after injection -- 5pm on Saturday, January 30th. 2. Nausea and vomiting: Began 40 hours after injection -- 3am on Sunday, January 31st.