chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was hospitalized with disseminated zoster infection complicated by VZV encephalitis, left upper extremity and motor neuropathy. The infection started 3 weeks after the vaccine was given.  Patient experienced about one week of neck, upper back and left arm pain followed by vesicular rash (C5-C6 and T1 distribution) and left upper extremity weakness. Weakness was focal to the left upper extremity, particularly the deltoid with hyporeflexia in the triceps and brachioradialis on the left (2+ throughout elsewhere). Patient was treated with IV acyclovir for a two week course. His rash and mental status have improved. He continues to have left upper extremity weakness, which seems to be slowly improving.
Patient went to medical office, where they stated her the back of her right arm is red, swollen and looks like cellulitis. I will report it to VAERS but I also advised the triage nurse to advise patient to seek urgent care. Nurse verbalized understanding.
incorrect vaccine administered.Boostrix was  erroneously given instead  of Engerix
Initial unsolicited report received from a Physician on 10 December 2015. This case involves a 13-year-old female patient who was vaccinated with a dose of HEPATITIS B VACCINE (batch number U5304AA, expiry date was not reported) intramuscularly in left deltoid on 03 November 2015. Illness at time of vaccination was reported as none at time of vaccination but had had a "virus" 2 weeks prior to vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies. Patient had no other vaccinations within 4 weeks of vaccinations. On 1 December 2015, 28 days following the vaccination patient experienced symptoms of ascending paralysis and later diagnosed as Guillain Barre Syndrome. Patient required emergency room (ER)/doctor visit. On an unspecified date, patient was hospitalized. Laboratory investigation corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none. Follow up information received from Physician on 17 February 2016. It was reported that, the patient was recovering from the events. No additional information provided. Sender's Comments: Follow up received on 17-FEB-2016, dose not changes the assessment. Guillain Barre Syndrome is unlisted with the INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. As patient had medical history of viral infection that could be a causative factor for the event. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
8 days after covid vaccination with no other reactions I had itchy, raised, hot, hard, red injection site
sore arm; nausea; was hardly able to eat and was feeling off; was hardly able to eat and was feeling off; severe vertigo; vomit; worst symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0173), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 16:00 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to Pineapple from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) taken for an unspecified indication, start and stop date were not reported. On 08May2021 04:00 consumer reported initial side effects were sore arm, and nausea. By Friday evening I was hardly able to eat and was feeling off. I woke up in the middle of the night out of sorts and the room was spinning. This subsided after a few hours, but then by Saturday at midnight/1am, I was experiencing severe vertigo and began to vomit. This took until Wednesday of the next week to subside entirely, but Saturday being the worst symptoms. They gradually improved everyday thereafter with use of dramamine, zofran, and valium at the ER (Saturday 08 May), then dramamine the following days as needed. The patient received treatment with Zofran, Meclazine, and Valium. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWD150 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Apr2021 at 13:15, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 13:15, as a single dose for COVID-19 immunization and it was in his left arm and he experienced a pain like somebody has punched him, it went away but then it returned. Prior Vaccination (4 weeks prior) the patient did not receive any vaccine. The last vaccine he received was for shingles and that was a 2-part vaccine but it was too away at least a couple of months before receiving the vaccine. The patient's medical history included blood pressure and blood cholesterol. Concomitant medications included atorvastatin calcium (the tablet was 20mg and he only took half so that would be 10 mg and that was my cholesterol) and lisinopril. The patient reported that on an unspecified date, he experienced a pain like somebody had punched him, it went away but then it returned; continues to be sore. He had got limited motion and being able to reach back with it; the pain was almost constant and its beginning to worry. When paraphrased, the patient stated, he wanna report that, it happened because that arm was fine, he had no problem with that with his left arm on and he expected soreness to go away and it started getting the limited motion and really pain really increases anytime he moved it towards his back. The patient stated, he had an appointment with his doctor, and they required him to have a lab work done and he was looking at his report, the lab was on 21Apr2021. The patient stated, he saw his doctor about a week later and he told him about it, and he said when he had his injection his arm was very sore and felt like its gonna fall off. He said just continue to stay active and that's what he had done but it's been over a month now and it's not getting better. It felt worst. He was having a hard time sleeping. He got his lab report, and he was sure they could pass you on to where you need to got its a bog facility. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:16 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20.01.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-April-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-April-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
About twenty minutes after the injection, I was walking to the transit and my legs felt a little bit numb (but not tingly) I thought maybe it was nerves. About 25 minutes after the injection, I was concerned (possibly too anxious) and I decided to return to the site. I crossed the bridge and sat down at the bridge gate. The personnel there called an EMT, and about 15 minutes later the EMT came to talk to me and take my blood pressure and pulse Oxygen. Blood pressure was 137 - 87. Pulse Ox was 100%. By that time I had calmed down the sensation in my legs had eased. Approximately 2 hours after the injection I began to feel soreness in my joints (and this did not pre-occupy me, since I knew that feeling the beginning of aches and pains a couple hours after injection is normal). It is now 6 hours and 32 minutes after the injection, and I am feeling ok. It was quite probably anxiety on my end. The folks in city were very nice to me at the pedestrian bridge gate. I have noted talking the EMT below as health professional visit, I also plan to go see Dr. prior to the 2nd shot.
pt recv vax 10SEP97 & noted 50% hair loss p/dose 2 of vax;October throughout December 1997 pt had been to attending physician;they could not discover a reason for the 50% hair loss;
Ulcerative colitis flare,severe flare; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flare,severe flare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that patient has had a severe flare of his ulcerative colitis that his gastroenterologist has not been able to control the symptoms. Ulcerative colitis flare was due to the vaccine.   No concomitant medications were reported. No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I received 3 vaccinations.  A flu,pneumonia,tetanus.  ALL while I was sick with Bronchitis. Around 10pm that night, I had a huge rash that looked like the united states on my arm.  I was sick with a fever of 101.  I went to bed.  It took me 2 weeks to get better.  A month later I developed pain in my wrists (Early Rheumatoid arthritis symptoms).  a month after that I became pregnant and the disease went into remission.  I still had wrist pain.  AFter my daughter was born, I woke up one morning and could not move.  I started crying.  I was totally unfunctional.  IT was the most horrible experience of my life.  these shots have taken away my life, my joy and everything that gave me pleasure.  I live everyday in PAIN.  24 hours a day, 7 days a week.  I am disabled.  I am on social security disability.  I have a 16month old to take care of.  this has been horrible on me.  My hands hardly work.  I finally had one evening that wasn't so painful to sit down here and do this.  I tried previously many times, but got knocked offline.  I feel like my life is over.  I cannot work anymore.  I am being treated and will continue to be treated for this disease.  I was healthy until I got these shots. I appologize if the date is not right that I got these shots.  I cannot remember things anymore.  My memory is really bad.  I used to have to write down when I fed my baby so I would not feed her too soon.  I am sorry.I do not remember which arm either.  I hope you get my records to find that information out.  I do apologize.
skin became flushed, warm & dry, dizziness, BP 160/80, resp became labored 24/min & inc 30/min;fainted; Epi given;BP 180/110;P60, R36 shallow resp 2nd dose Epi given;irratic breathing
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Painful L gluteal and L thigh vesicles. Patient had a prior episode of shingles in 2018. Treated with Valtrex 1g TID for 10 days with complete resolution of the vesicles after completing the regimen, but remains with pain.
Patient reported receiving medical treatment for bacterial colitis (on 12-14-12 pt received Rx for Clindamycin 300mg 1 three times daily).
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 13 years. It was also confirmed that on 02-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1708USA001768: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739.
10/11/99:recieved vaccine and noticed two blisters overlying posterior left deltoid on 10/12/99, 1 cm each. 10/13/99:vessicle burst weeping clear fluid.
PT CALLED INTO CLINIC ON 2/15/2006 STATING THAT SHE WAS FEELING BAD AND WAS WEAK.
?Moderna COVID-19 Vaccine Bright red solid large circle around injection site showed up 9 days later. About 4x6". Itchy, swollen and red too. Lots and lots of body aches and very tired since vaccine.
This spontaneous report was received from a health professional (nurse) refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On 15-MAY-2015 the patient was inadvertently administered with an expired dose of PNEUMOVAX23 (lot # J004387, expiry date: 04-JAN-2015) .5ml, intramuscular. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
all the basic side effects to include difficulty breathing; cold, one nostril clogged; one nostril clogged; lots of pressure in my head; eyes hurt; nipples became hard andpainful to the touch; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), mixed connective tissue disease (MCTD), allergy, asthma and covid-19 in Nov2020.Concomitant medications included RA, MCTD, Allergy, Asthma medications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient previously received fluticasone(MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 17:00, the patient experienced all the basic side effects to include difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch, the side effects she was experiencing from the vaccine was defiantly on the same level as Covid-19 side effects. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events difficulty breathing (cold, one nostril clogged), lots of pressure in head, eyes hurt, nipples became hard and painful to the touch were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Muscle pains in left arm, shoulder and neck; Headache; Shoulder pain; Neck pain; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG207), via an unspecified route of administration in the left arm on 11Mar2021 at 18:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and shellfish allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received aspirin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced muscle pains in left arm, shoulder and neck and headache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events muscle pains in left arm, shoulder and neck and headache. The clinical outcomes of the events muscle pain, headache, shoulder pain and neck pain were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Seroma of right breast (severe generalized swelling of right breast only, no redness) that lasted approximately one month and then self-resolved.  I have a history of breast implants that were placed in December 2013 without any issue.
On September 21 around 5:00 pm I noticed a knot at the injection site that was itchy and hot to touch went to bed got up September 22 at 8:30 and had a another bump much larger that was itchy and its hot to touch and has my muscle sore.
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip.  Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.