chrisvoncsefalvay/vaers-outcomes huggingface dataset:
F/U with family MD on 4/7/03 Dx'd muscle soreness d/t coughing from bronchitis. Prescribed add'l antibiotics. PT's statement: "I received a smallpox vax on 2/26/03. At the time of the vax I had been having a chronic cough for a few wks along w/occasional head congestion. I had not had any fever or other significant SXs and assumed I was just having some sinus drainage. A wk after the smallpox vax I had increased coughing, sore throat, body aches, and a low-grade fever that lasted for a couple days. The cough, especially at night, continued off and on along w/some head congestion. I used over the counter sinus and anti-histamine medications to treat the SXs. 3/22/03 I went on vacation to [other states]. In the middle of a gold game on 3/23, I developed chest pains and shortness of breath that lasted for approx an hour. That evening I developed a 102.8 temp, chills alternating w/sweats, increased coughing and severe body aches that lasted into the next day. I went to an ER that morning (3/24). My chest x-ray was essentially normal and the MD Dx'd bronchitis, sinusitis, and a bilateral ear infection and put me on Lavaquon 500 mg once/day for 6 days and a cough syrup. W/in 36 hrs the fever was gone, the cough was decreased and I was feeling better. I finished the antibiotic medication 3/29 and 2 days later I started back w/increased coughing, especially at night, and increased head congestion. I am not taking any over the counter medications at this time. I still have noticed brief episodes of chest pain and occasional shortness of breath off and on since the original episode on 3/23. I have a Hx of recent elevated blood pressure over the past year and am taking Lisinopril once per day. My blood pressure has been w/in normal ranges since taking the blood pressure med. I felt my SXs were probably due to the bronchitis/sinusitis. When the info came out regarding the cardiac SXs following the smallpox vax I was not sure if I should be concerned regarding the chest pains and shortness of breath related to the vax. Since those SXs did not start until 3-4 wks after the vax I did not know if it was likely to be related or not. I discussed this w/the nurse and she suggested I submit a written description [report].
17-yr old received the 1st dose of the Moderna Covid-19 vaccine (Lot #030A21A) on 3/11/21 against current vaccine age regulations and FDA emergency authorized use  (for individuals over the age of 18) ; arrived at facility for scheduled 2nd dose 4/9/21; no adverse symptoms / reactions were reported by parent / dad post 1st vaccination at this time.
Patient stated that the morning after receiving the immunization she woke up feeling "like she lost her mind". She felt foggy and disoriented, and needed assistance standing and walking. The next morning she felt fine.
Patient was very nervous and his muscles were very tight as he was receiving the vaccination, about a minute after receiving the vaccine the patient had a grand mal (full body) seizure for about 10 seconds. Patient also had leopard like spots appear on his neck at this time. After the seizure ended the patient was completely fine and did not seem to have any prolonged reaction. A follow up 6 days later confirmed the patient is fine and has not experienced any further side effects.
patient received a pediatric booster, rather than a 12+ booster dose. Parent present at visit. Attempted to call parent to obtain medical history, medications, ect. unable to reach
had generalized urticaria 30min p/vax;treated w/ Epinephrine, Benadryl, Solumedrol; all sx resolved; watched in hosp overnight, w/no recurrence
Cellulitis of the leg; This is a spontaneous report from a contactable physician. A 38-year-old male patient received first dose of BNT162B2 (Lot/batch number and expiry date was not reported), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing eczema (Topical steroids), deep vein thrombosis (DVT) since 10 years ago and stopped 6months after treatment, Fasciotomy for compartmental syndrome s/p gunshot wound (Stop date: After surgery) and ongoing Allergies (PRN medication), all on an unknown dates. Patient has history of gunshot wound subsequent compartment syndrome of DVTs status post treatment 10 years ago of the left lower extremity. Family medical history of gunshot wound of compartment syndrome DVT on this side following. Patient had cellulitis of the leg 1 month prior to "11Feb". The patient experienced cellulitis of the leg on 11Feb2021. The outcome of the event was recovered on an unknown date. The physician reported that the patient provided information regarding the reported adverse event with the use of the product. The physician considered that the Pfizer vaccine had no causal effect to the adverse event.  The following information on the lot/batch number has been requested.; Sender's Comments: Based on information provided, the event cellulitis is an inter-current condition, thus unrelated to the suspect drug.
This spontaneous report has been received from the medical assistant refers to 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On 01-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot # N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
constantly throwing up starting 8PM 5/26/99;can't keep anything down gave ginger ale saltine crackers p/laid down for a few mint;this AM threw that up too;reporter does not think this is a rxn from vax but wanted to make sure;seen by MD
On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Bright red face) and FEELING HOT (Hot face/hot ears). On 09-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid-19 arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 12-Mar-2021, VACCINATION SITE REACTION (Covid-19 arm) had resolved. At the time of the report, ERYTHEMA (Bright red face) outcome was unknown and FEELING HOT (Hot face/hot ears) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
L arm pain, swelling, tenderness, redness at site of shingles vaccine.  No fever but sensed chills. Tylenol and icing trialed on 11/4 but no relief.  4x10cm well demarcated erythematous area with induration, tenderness and with central 1x4cm firmer area suggestive of fluid collection/hematoma or seroma noted at visit to office on 11/5/14.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-MAR_2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 48 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit, the second lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit, the third lasting for 24 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit, the fourth lasting for 24 hours, with the highest recorded temperature of 46.6 degrees, the fifth lasting for 48 hours, with the highest temperature of 46.8 degrees, the sixth lasting for 96 hours, with the highest recorded of 47.2 degrees Fahrenheit, the seventh lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit, the eighth lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit and the ninth lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain, redness, swelling, rash and knot at injection site, 102.6 fever, tiredness, muscle pain, chills, nausea and headache.  The arm pain, swelling and rash took 7 days to resolve.  All other symptoms resolved 24-48 hours later with NSAID pain reliever.
Menveo not reconstituted; received dose not reconstituted.; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The reporter reported that, Menveo was given without being reconstituted.  They did not know which patient at this time received the dose that was not reconstituted. The reporter agreed to follow up from GlaxoSmithKline. Additional Supportive Information: The reporter reported that, Menveo was given without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Loss of hearing in both ears. Reported to primary care physician first and was treated with an ear cleaning and an antibiotic. Did not improve, and was checked again with worsening hearing loss. Was referred immediately to ENT and was given a 10-day cortisone medication.  This did not help, so was given three injections into the eardrum, once weekly for three weeks.  The hearing improved slightly, but has never been the same as before the vaccination event.  She has been to Hearing Center several times for hearing test, plus another hearing aide center, plus another ENT to see if she was a candidate for a cochlear implant.  All, with no resolution of this problem so far.  We are now in the process of purchasing a new hearing aide due to the drastic loss of hearing since the vaccination.  The cost of the new hearing aide is $6000.
pt recv vax 24APR99 & 26APR99 p/school red, swollen (welt), staring to touch it;runny nose, no temp 3" long x 1";taken to MD 4" x 2 1/2" wide wasn't as raised;put on atarax & prelone;site of redness & swelling was rt w/site of inj lt;
I received my  second Shingrix vaccine.  One day after receiving it, I had flu like symptoms, a fever of 100.5 aches, chills  fatigue and my arm was tender and swollen at the injection site.  The fever went away the next day (2 days after vaccine) and I felt  OK - not great 3 days after the vaccine.
Patient died of Sudden Infant Death Syndrome the day after receiving DTaP, IPV, HIB, PCV7 and Rotateq.  6/13/08 Autopsy report states COD as SIDS. Report also states slight pulmonary edema & petechial hemorrhages on thymus gland, pericardium of heart & pleurae of lungs.  Patient had been placed down for nap on his left side in adult bed at daycare provider.  Patient found face down & unresponsive approx 45-50 min later.  CPR was started & EMS called. PMH: NSVD, no complications.  Upper respiratory congestion frequently since birth & seen for cold s/s by PCP on 3/3.  Otitis media 2/1 & had mild wheezing.   Sibling w/recent cold symptoms.  Had to be picked up early from daycare x2 the week before death due to vomiting.
immunization was given on 9/21/20 - pt reported within hours area around immunization became bloody, and red, raw irritated. Area appeared to be in the same area  as the inject-safe barrier used. Patient showed pharmacy pictures today on 9/29/20 of bandage/arm. pt reported area fully healed.
non stop runny nose; worst headache of my life; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (non stop runny nose), HEADACHE (worst headache of my life) and CHILLS (Chills) in a 68-year-old patient of an unknown 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 RHINORRHOEA (non stop runny nose), HEADACHE (worst headache of my life) and CHILLS (Chills). At the time of the report, RHINORRHOEA (non stop runny nose), HEADACHE (worst headache of my life) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. Upon internal review on 04-Aug-2021, the age was corrected to 68 years.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Occipital neuralgia on same side as vaccine administered; muscle pain entire body; fever; joint pain; fatigue
Right arm is itchy at injection site, and circular rash has developed at injection site. Arm is also stiff and there is discomfort when raising arm above head.
Initial solicited report received on 02 March 2017 and follow up information received on 07 March 2017 from an investigator in a trial. A 22-year-old male subject with no significant medical history reported. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 06 January 2016. On 18 January 2016, 12 days after vaccination the subject was diagnosed with I21.3 ST-elevation (stemi) myocardial infarction of unspecified site, I30.9 acute pericarditis, unspecified and I31.9 disease of pericardium, unspecified. The lab data included 18 January 2016 within 30 days post vaccination, the Troponin I was 0.69 ng/ml (abnormal), ECG was abnormal, Echocardiogram was normal while MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a 22-year-old male who developed acute pericarditis, unspecified and ST segment elevation myocardial infarction with favorable temporal association post vaccination with ACAM2000. Pericarditis and myocardial infarctions are listed adverse events that may occur following vaccination with live vaccinia virus smallpox vaccine. Based on data available, role of study vaccine can not be ruled out.
Near syncope, tachycardia with palpitations, nausea, dizziness, shakiness, pallor, fever
Female patient with 12 years of age had a cutaneous reaction in both arms after fifteen minutes of observation. Presented itching in the punctured area.
Adacel, menquadfi administered to patient after temperature excursion at 31.5° Fahrenheit for 2 hours 45 minutes due to potential mechanical issue with the refrigerator with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jun-2023, the patient received a dose of 0.5 ml suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (suspension for injection) and Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) (lot number; strength; expiry date unknown) after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (Poor quality product administered) (latency: same day). Information regarding batch number was requested in the case.   It was reported, "Adacel, Daptacel, IPOL, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis. Product activated/prepared? NO Due to a human error: NO and Does extended stability data cover the excursion: NO These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient awoke on 8/11 with a quarter sized red area on the back side of the upper portion of his right arm where the vaccine had been subcutaneously administered. Over the course of the day he developed fever and body aches; especially his low back. By the end of the day the red area was 3 inches by 3 inches and swollen. He was taking Tylenol 500mg for his discomfort. On 8/12 at 3 PM he came back to the clinic and the red area was warm, hard and 4 inches by 4 inches. On 8/13 called patient at 12:30 PM and he said the fever and aches were gone, but his arm was more swollen. Advised him to see a doctor before the weekend. Called client on Sat. afternoon and he said the doctor told him he just had to wait until it cleared up on its own. He said he had red spots from his elbow to shoulder. He was advised to alternate Tylenol with Motrin and use cool packs to decrease the swelling.
Left arm became immobile on the evening after the 8/14 vaccination. Very painful if I tried to move it with my right arm. Was unable to sleep that night due to discomfort. This morning, 8/16 I finally can raise my left arm, but still with some pain.
arm sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer via a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that, got the first dose of the Covid19 vaccine today 24Feb2021. She said that on an unspecified date her arm sore and asked if she can take Ibuprofen, Tylenol, or Advil. The outcome for the event was unknown.  Follow-up attempts are completed. No further information is expected.
pt administered flu shot instead of covid booster - could have been avoided had I asked an open ended question as to which vaccine pt was receiving.  what happened is pt states she approached the tech at drop off requesting a covid booster - rx tech states she didn't hear her clearly and asked did you say flu shot, pt said yes.  when I walked out to greet the patient I said in part of my spiel "I have a fluzone hd shot here for you today, do you have any questions?".  Pt said no.  I administered the fluzone hd then patient handed me her covid card asking me to fill it in.  I told her I gave her a flu shot.  She was understanding and said that mistakes do happen and was more upset that it was going to make her sick.  she states previously the flu shot gave her pneumonia and another time it resulted in her being hospitalized and she states her doctor doesn't want her getting flu shots or pneumonia shots because the flu shots make her so sick.  I apologized profusely and said that I as well as the company take errors like this very seriously and that we would be filing a report and looking in to how to prevent an error like this from happening again in the future.  I told her I should have asked her what shot she was expecting that way we could have prevented this altogether. I told her I'd add a comment to her file stating no flu shots and no pneumonia shots. I told her from then on I would use open-ended questions.  She told me to not feel too bad about it and I said but I do, I went into pharmacy to help people and now I did the exact opposite of  helping you.  She assured me that she wasn't upset and not too worried about it. I told her I would follow up with her on friday to see how she is feeling.  I left a message with her doctor's office with the receptionist as to what happened and she said she would inform the doctor.  submitting a vaers report as well
No other AE.; an expired dose of PROQUAD that was administered; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 04-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot # T028297, expiry date 16-FEB-2022 (route of administration and vaccination site were not reported) for prophylaxis. No adverse event was reported.
approx 3" diameter reddened, warm, swollen firm area @ inj site rt deltoid devel p/25FEB98;pt seen for re-check of thumb injury 28FEB98;afeb on 28FEB98, T98.6 tympanic
A Physician reports that after vaccinations in June 1999, his pt had flecks of blood in his stools. On week post immunization his stools became mucousy. Three weeks post immunization, his stools were completely mucous. The pt became irritable and crampy before passing each stool. The child was entirely breast fed. The Dr instructed the the mother to begin feeding the child with Nutramigen, but no change in stools occurred. Slimy stools persisted as of 07/19/1999. The Dr diagnosed possible colitis.
In September I had the worse Flu of my life, I headaches sore body and the worse headache of my life.
Rash on trunk, chest, and back extending to groin 5 days after vaccine followed by significant swelling and mild redness around injection site 8 days after vaccine