chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; adult doses given to 2 children; adult doses given to 2 children; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 12-Aug-2022, the patient experienced OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children).    No concomitant medication information provided. The nurse stated that the two children received 100 mcg from a Moderna vial with a red cap. No treatment information provided.
Rash started approximately 12 hours after immunization and increased over next 24 hours, punctate, blanching, erythema rash on chest, papules on erythematous on back, no vesicles, annular line of erythema round injection sites, no viral symptoms.
Patient states he has had excessive bruising and inflammation in the leg since getting shot. He has had problems with circulation before but notes that it had not gotten as bad as it has within the last couple of months. Pt traveled out of the country after receiving shot and states that he noticed bruising on his legs and experienced severe inflammation of the legs around 2 weeks after receiving shots (around 3/30/21), noting that at one point they almost "looked purple". Since returning pt states inflammation has not been as severe but bruising continues  and he is now noticing it on his arms as well. Patient has gone to see cardiovascular specialist who sent him to get a circulation test (pt not sure name of exam) on 6/24/21. He has an appointment to review results on 7/8/21.
Patient stated he has a severe phobia to needles and immunizations.   Moments after receiving the vaccine he started shaking and reported blacking out (it resembled a seizure).  Patient stated this has happened to him before after receiving vaccines.  He sat down in chair for 30 minutes and drank some water and reported feeling much better after that.  He did not want any medical attention after the incident and did not want any prior to leaving.
Pt reports receiving influenza and pneumococcal vaccines on 10/16/01. Beginning on 10/18/01, a light rash developed over ankles and feet. By 10/19/01, the rash was raised, red on ankles, feet, stomach and chest. No pustules or open lesions. He reports that he has generalized pruritus but no pain. He was encouraged to see his PCP for dx.
Grapefruit size swelling on left thigh. Treatment: take Benadryl, call for more swelling/fever.
Third dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number XY22F, expiry date 27-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th July 2019) and Shingrix (received 2nd dose on 9th September 2019).   On 13-MAR-2023, the patient received the 3rd dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Third dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter reported that the patient was inadvertently administered a third dose of Shingrix. The reporter consented to follow up. The patient was inadvertently administered a third dose of Shingrix, which led to extra dose administered.
Pt received the HPV quadrivalent vaccine. Lot#J013777.  Exp date: 11Aug2016. Pt had a vasovagal episode afterwards.
extreme confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (extreme confusion) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (extreme confusion). At the time of the report, CONFUSIONAL STATE (extreme confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Late in afternoon following receiving flu shot, child's left upper arm became red and swollen, worsened by following day (shoulder to just above elbow) - significant local reaction - ice pack and NSAIDs.
sore muscle at injection site; exhaustion; lethargy; general ache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 17:00, as a single dose for COVID-19 immunisation. Medical history included genital herpes and depression. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included LEXAPRO and VALTREX, all for an unspecified indication. The patient was allergic to neomycin and bacitracin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 06:00, the patient experienced very sore muscles at injection site "Cant lift arm past my shoulders", generalized aches, lethargy and exhausted. The patient did not receive any treatment for the reported events. The clinical outcome of the events generalized aches, lethargy, exhausted, injection site pain was not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes in armpit on arm of shot, fatigue, chills, fever, nausea, migraine, swollen arm at site of injection,
Rash duration for 3 days. Less than 50 pox. No fever, no meds given.
Rapidly climbing temperature, shivering, injection site tenderness.  Started Tylenol and cold packs to reduce fever.  Highest temperature was 103.8 degrees. For 36 hours could not get temperature below 100.
Large Area below injection site swollen for a week Rash extending down from injection site Extreme depression for a week
This solicited report was received from a consumer (reported as "neighbor") via market research agency regarding a 12 year old female subject enrolled in a market research program. The subject's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date (reported March) the subject was vaccinated with HPV vaccine dose 3 in the arm (route and lot details unknown) (manufacturer unknown). Around 01-MAR-2016 the subject started having leg pain with heat. From an unknown date in June 2016 (reported as now) the patient has no leg muscle strength and could not walk. All these events occurred after the last dose of vaccine. On an unknown date unspecified lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to HPV vaccine (manufacturer unknown). The reporter considered "could not walk" as disabling. Additional information has been requested.
Information has been received from a physician concerning a 7 or 8 year old male who was vaccinated with a varicella virus vaccine live. Subsequently the patient experienced chicken pox. He had lesions on the trunk, chest and above the eye brow. The patient was seen by a physician. No product quality complaint was involved. No further information was provided. Additional information has been requested.
pt recv vax 25SEP97 & 10OCT97 pt mom noted pt devel five lesions on chest, then ultimately approx 15 lesions;
Long lasting headache ~20 hrs after and 100.4 fever ~27 hrs later
This spontaneous report was received from a consumer who refers on his 70 year old grandmother. On an unknown dates the patient received two doses of pneumonia vaccine (manufacturer unknown) (dose, route, site of administration and lot # not reported) in two months and she did not have any side effects. Additional information is not expected.
Coughing; This is a spontaneous report received from contactable consumer (patient). A female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had her second shot yesterday (20Apr2021), of the Pfizer shot and today (21Apr2021) she had started coughing. She stated it was from time to time, not all the time. The outcome of the evet was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Started with itching at approx 01:00PM, continued with some itching then noticed whelps over entire body at 04:30PM. Injection site very red and whelped. Went to ER and received DECADRON 4mg IM at 06:15PM and was having tightness in chest and throat at that time.
Around 3 am on 2/3 2021 this employee started having chills and her right arm ached.  She got out of bed at 6 am and had achyness all over with headache and a temp of 101.  She was slightly nauseaous but this resolved on eating a cracker.  She took Ibuprofen at 6am and slept for 2 more hours and woke up hot.  It took her 7 hours to get over these symptoms.
This spontaneous report as received from a certified nurse practitioner, refers to two patients of unknown age and gender. The nurse practitioner reported that the patients received their first dose of RECOMBIVAX HB on an unspecified date in October 2012 and would be receiving their second dose on an unspecified date in the near future. No adverse effects were reported. Additional information has been requested.
Pt developed a sudden onset of right-sided facial numbness and right arm and right leg weakness.  Came to the emergency department was found to have a stroke and given tPA with resolution of symptoms
Information has been received from a certified medical assistant (CMA), concerning a 17 year old female patient, who on approximately 12-MAY-2007 ("two months ago") was vaccinated with the first dose of Gardasil with no reactions, and on 12-JUL-2007 was vaccinated IM in the right deltoid, with the second dose of Gardasil (Lot #658100/0525U). Concomitant therapy included vaccinations in the left arm with Menactra and Vaqta. On 12-JUL-2007, after receiving the vaccination with Gardasil, the patient fainted. No further details were provided, and it was unknown if the patient had recovered. The CMA reported that an 18 year old female patient experienced a similar episode after vaccination with Gardasil (lot #655503/0012U) (WAES #0706USA04707). Additional information has been requested.
2 day history of bumps on legs and arms, itchy, using Calamine lotion and antibiotic cream at home. Added BENADRYL for itching.
Pt came to ER with complaints of rash on right deltoid, hands itching, swollen rt arm. Pt had received 3 vaccinations at clinic on 7/24/17--HPV, meningococcal, and tetanus. I don't know any more details about the names of the vaccines that what is listed here. Clinic should have this information, as well is it should be listed in the vaccines database, which I do not have access to.
1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain was more if the head is shaken or if I jump. This pain disappeared on 27th March. 2. On March 26th both the feet are swollen , left foot more than the right. I still feel slight numbness in the feet today on March 28th. 3. On March 27th , around noon, a blood clott showed up on my left palm , it caused intense pain in the arm for 10 minutes before starting to subside itself. I felt a lump in my palm , it was visible in dark color ,about 1 cm in size. I still feel it in my palm today on 28th March.
"Staff member was receiving her first dose today. Staff member reported to fell sweaty, lightheaded, tongue felt tingling. Vaccine Staff took staff member back to vestibule, to have staff member to lay down.   Vital signs: 1535 HR 94 B/P 108/72  SpO2 100 1540 HR 92 B/P 109/72 SpO2 100 1550 HR 77 B/P 97/63 SpO2 100  Staff member reported feeling better after sitting for 5 min. Monitored staff member for about 20 min.  "
Product storage error; Bexsero instead of Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   On 08-AUG-2023, the patient received Bexsero. On 08-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Menquadfi). On an unknown date, the patient experienced product storage error (Verbatim: Product storage error). The outcome of the wrong vaccine administered and product storage error were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 08-Aug-2023 The healthcare professional called to inform that a prefilled syringe was activated (needle attached) on 25th July 2023 and such dose was administered until 08th August 2023 to a patient, which led to product storage error. The caller stated that such patient should had received Menquadfi instead of Bexsero, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Since it is normal for a vaccine site to be warm, red and sore I didn't pay any attention to it. After a few weeks I noticed that my left arm (where I got the H1N1 vaccine) was still sore, hot and red and was not getting any better. The right arm where I got the seasonal flu vaccine was fine. When I was able to, I went to the occupational health office at work the end of December (I think 12/28). I was given 650mg of Motrin to take 3x a day. It didn't help. I went back a week later and was started on a Medrol pack 1/9/10. All the symptoms went away, but a few days after stopping the Medrol they all came back. I took a picture to show the blotchy red on 1/19. I was started on a second Medrol pack 1/23. A CBC was drawn and I was told the results were all normal. The redness went away but then I got an upper respiratory infection. Now the soreness and warmth are always there but the redness only periodically appears. On 3/19/10 I noticed my arm was getting increasingly more painful and red I took a picture. In the morning my arm felt even worse than the day before so I looked at it and the redness had spread an was more blotchy. I took another picture. The entire deltoid is very sore and painful and is several degrees warmer than my other arm. The best way I can describe it is like a cross between a bad sunburn, wicked bruise, and a badly sprained ankle.
Patient felt faint and dizzy with headache after vaccine given.  Patient monitored, symptoms resolved without issue
Localized redness, swelling: hot left upper thigh 9 cm x 7.5 cm. Cool compresses & MOTRIN care.
Large red area away in inner arm about an inch from injection. Painful and very hot to the the touch. Started to spread and seen Dr.
Left arm pain and chest pain. Went to ED, had a cardiac work up which was all negative. Significant left arm pain continuing.
THROBBING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-APR-2021, the subject experienced throbbing headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from throbbing headache. This report was non-serious.
Received Janssen COVID vaccine on 3/19/2021 around 8 am. Was in ER on 3/20/21 around 3 pm.  Was found to have acute occlusive deep venous thrombosis of the left popliteal vein, peroneal veins and one of the paired left posterior tibialis veins proximally.
Patient complained of red swollen, hot arm after her PNEUMOVAX 23 shot. I recommended to apply ice, take BENADRYL and try anti-inflammatory. Pt. went to ER where they gave BENADRYL and applied ice and gave anti-inflammatory.
Significant swelling on upper arm, neck and shoulder stiffness and pain from injection site up into my ear. Shooting pain in my ear for several days, turning to a dull ache for several more. Chronic fatigue that had been improving saw a massive regression for at least 2 months.
This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patient were vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one the three reports received from the same reporter. Additional information is not expected.
Left arm pain in shoulder radiating into neck. Has had body aches, stomach feeling sore, fever to 101. Also having headache.
Pt received 2 doses of Engerix-B post needle stick injury experienced low grade fever (99 degreesF), severe progressive pain in back of neck & back, slight drowsiness. Seen in ER Dx w/Aseptic Meningitis; No treatment given; fever, fatigue
My husband sent a text to me at 1340 : "I think I had a bit of a reaction to the flu shot. Within minutes the back of my throat felt weird, swollen. It isn't getting worse so I guess I won't worry about it." I wrote back to go back into the clinic thinking he was at his PCP. However, he was at a Flu clinic set up for today at the university where he teaches. The nurses from clinic did not have an Epi Pen or Benedryl. My husband refused an ambulance. They monitored him for over 20 minutes. I called at 1407, he was talking and laughing with them. Said swelling was going down. His PCP was notified. RNs at the site suggested he take Benedryl at home. Was notified by RNs at site and his PCP by phone to pull over if difficulty breathing starts and call 911. He seems to be ok at this time.
I experienced multiple adverse side effects: 1 pressure in my head 2 strong headache 3 pain in my left arm 4 numbness in my left arm 5 very low blood pressure 86/61 6 extreme weakness 6 today is the second day that I have to call in sick
Left leg pain started about 4/16/21. Reports evaluated by nurse practitioner at the medical office of primary care provider on 4/23/21. Ultrasound ordered a hospital and diagnosed with a blood clot in the left leg on 4/23/2021. Placed on a "blood thinner" to take orally BID for one month then once daily for undetermined duration. States MD is not considering the vaccination as the reason for the blood clot because of the duration of time between when the vaccine was given and the onset of the blood clot. When asked, pt reports a platelet count was done.
No Additional AE; HCP calling to report AE for patient that received expired dose of PROQUAD.; This spontaneous report was received from a medical assistant, referring to 4-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 07-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection rHA (single dose, lot #W007747, expiration date 04-SEP-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event (AE). No product product quality complaint (PQC). (Expired dose administered, No adverse event).
Pt received Pfizer-BioNTech COVID-19 Vaccine EUA at approximately 4:00 pm and sat down in post-vac area. Pt began to complain of shortness of breath and "chest pressure."  Pt stated that "it feels the same as when I get penicillin."  Pt has no rashes/hives, no facial or oral swelling, denies any itchiness, and has clear lung sounds bilaterally.  Pt was given a bottle of water to sip during assessment and stated that the water helped her feel better. After approximately 10 minutes Pt stated that her symptoms had resolved and wished to go home. Pt was advised to seek medical assistance if her symptoms returned or worsened. Pt verbalized understanding and left clinic without incident.
8 days after vaccine- Red swelling at injection site, enlarged lymph nodes in left axilla, same side as injection.
Two days after vaccination, I felt a little bit headache after I woke up. It was getting worse at noon. Then I took one pill of advil and  felt better after that.
Information has been received from a RN concerning a 56 year old female employee with no known drug allergies who on 06/16/03 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 642720/0172M). There was no concomitant medication. On 06/17/03 the pt developed pruritus, redness and swelling at the injection site. Subsequently, one to two days later, the pt's symptoms resolved. Additional information has been requested.
Patient's date of birth reported as  and was only 11 at time of vaccination.  Vaccine given approx. 2 months before 12th birthday.  No adverse reaction reported.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
Patient had fever 24 hours after vaccine. Then 2 and 3 days later had facial swelling and blotchy redness around both eyes, worse around right eye. Pt. also suffered general malaise during this time. All resolved uneventfully without any outside intervention. (Patient's brother had the same symptoms recently after receiving his kindergarten shots at another facility).
Treatment went swimmingly, how my body reacted to it though because of my chronic pain was not great. chills and tingling constantly for 24 hours, pains shooting from the areas I've been diagnosed to my head, to my hands and fingers, and the rest of my body. Because of the additional pain, more exhaustion, so I need more sleep.
Patient reported a rash down the right arm and thigh that is  clearing. Patient also reports having a continuous headache since vaccine administration. She has tried otc medications with no relief. Patient was advised to go to the Emergency Room for further care related to this reaction.