chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 7 months too early. Patient turns 12 on 12/28/2021.
approx 1NOV92 devel achiness & sore throat which progressed to fever of 100 or higher, chills, chest congestion w/productive cough, sinus infection, w/yellow-green sinus drainage; tx w/PCN; 16NOV sinus infect dx;
Patient received two Fluad vaccinations on same day. No adverse reactions at time of vaccination. Called for follow-up but have not received call back from patient at this time.
got the first dose of moderna after being a part of manufacturer trial; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna after being a part of manufacturer) in a male patient of an unknown age 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 INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna after being a part of manufacturer trial). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (got the first dose of moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: follow up was received on 08-JUN-2021 contains updated information about patient Demographics and dose information; Sender's Comments: This report refers to a case of Interchange of vaccine productsfor m RNA-1273, lot # unknown with no associated AEs.
Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and tightness starting in left neck. Itching in the eyes.. Benadryl 50 mg po taken and pepcid 40 mg po taken at home. To emergency room within 1 hour after the vaccine due to tightening and swelling in the neck. They gave me Solumedrol  IM and po zyrtec and observed me for awhile. Tightening in the neck eased up and I went home. By bedtime I turned pastey white color, no rash. In the morning I broke out in another rash on my face and neck. Rash resolved by the second day.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Info has been received from an LPN concerning a female child with drug hypersensitivity "all mycins", including neomycin, epinephrine and lidocaine, who was vaccinated with a dose of MMRII. There was no concomitant medication. Subsequently, the pt developed injection site swelling. Unspecified medical attention was sought. No relevant diagnostic test/lab data reported. Subsequently, the pt recovered from the injection site swelling. Additional info has been requested.
On February 18, 2023, I started coughing. Later that evening, I had a 99.9-degree fever. I woke up the next morning with a headache, and I was still coughing. I had a low-grade fever that evening as well. I went to be early and slept through the night. I took a COVID-19 test on February 20, 2023. The result was positive. I spoke to the COVID-19 nurse. I told her what my symptoms were, and she called in a prescription of PAXLOVID. I started PAXLOVID the next day. The only symptom I really had left by then was a cough. By Wednesday, I felt fine, but I had a lingering cough for about three weeks. It all felt like head congestion. I tested negative for COVID-19 about two and a half weeks later.
Pt exp lt thigh, knee et lt scrotum very swollen, red, hot et raised; had 3 hrs of continuous crying-not relieved by APAP; t103.6 R eve of immun, lowered to 101 w/APAP;
24 hours after DTAP administrat pte came to office with 6 cm erythema and induration at vaccine site.
Slept for 15 hours a day; Extreme fatigue; A1C is 8.4/HAC1 were at 8.4 post-vaccination; This is a spontaneous report from a contactable consumer (nurse). This consumer reported for 89-year-old female patient (reporters godmother).  A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19May2021 (at the age of 89-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Reported stated that patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine 19May2021. The reporter stated that patient HAC1 were at 8.4 (2021) post-vaccination and she has been experiencing extreme fatigue on an unknown date on 2021. She described her godmother as 'active' and explained 'she works out, attends her physical therapies, and swims'. Reporter asked for the efficacy of a single dose of the Pfizer-BioNTech COVID-19 vaccine. Reporter again stated, she had extreme fatigue, her A1C is 8.4 and she doesn't have side effects listed. She slept for 15 hours a day (2021). She was scheduled for her next injection on Wednesday and they were concerned about the second injection. They didn't know if they could postpone it and if they did, does it affect the effectiveness. She wants to know the percentage of coverage after the first injection and how long she can wait. The events were reported as non-serious. The patient underwent lab tests and procedures which included A1C: 8.4 on 2021. The outcome of events were unknown.  Information on Lot/Batch number has been requested.
Patient developed redness/rash at the site of injection the day after she got the vaccine. She complained of pain and itching in the area. She did not mention using any medications to treat these adverse effects but said that things have gradually improved over the past few days (got vaccine on 6/1, adverse events began on 6/2, and came to show me the redness/rash on 6/7). She said that at first both the itching and the pain were severe but now it doesn't itch or hurt as much anymore
Less that a week after pt had the shots and she started having strokes and seizures. Has gotten worse. Due to severe milk allergy, pediatrician asked that we not get the MMR shot at the time pt was supposed to receive it. Finally at or around 18 months of age, MD directed us to go ahead and get the shot.   About 1-2 weeks after getting the MMR shot, pt started falling down when she tried to walk. Pt seemed to be almost paralyzed from the hips down through the thighs. The child would scream and cry with pain when parent would even try to change her diaper or dress her. Every time parent placed her on her feet to walk "since she was walking/running" she would fall to her face or backwards. She would cry. This went on for almost 2 months. Pt underwent so many horrible medical test ordered by pediatrician and also by hospital since we took pt there several times due to the extreme pain she had from this MMR shot and the affect it had on her body. Finally after many test which gave no answers we searched out another MD. We were referred to MD who examine pt and her medical records and came to me with a diagnoses.  MD told me(parent) that pt had an adverse reaction to the MMR shot. He did not ask us to report this to VAERS nor did he tell us there was any type of reporting system for adverse reactions with immunizations. Had I known, I would of reported this and I really don't think I would of allowed  pt to receive any more vaccinations. But MD's really played down the situation and told me and my mother who was present when the diagnosis was made "that this was a very common occurrence. That the MMR and this reaction my child had was just a common occurrence." I can't believe that at this point if it were so it would be published right? MD continued to treat pt as her pediatrician from the age of about 20 months to 7 in Oct 26, 2001. On Oct 26, 2001, MD administered 2 shots. 1. A flu shot. 2. A chicken pox shot. 3. Zithromax for ear infection. Pt used Zithromax a lot during her childhood since she had a lot of allerg. Discharge Summary received on 7/29/2003 states seizure. Medical Record received on 8/06/2003 states rash and cold symptoms.
Vaccination adverse reaction; rash in th face; Sore arm; swelling face; eyelids red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), SWELLING FACE (swelling face), SWELLING OF EYELID (eyelids red and swollen), VACCINATION COMPLICATION (Vaccination adverse reaction) and RASH (rash in th face) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), SWELLING FACE (swelling face), SWELLING OF EYELID (eyelids red and swollen) and RASH (rash in th face). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm), SWELLING OF EYELID (eyelids red and swollen) and RASH (rash in th face) had not resolved and SWELLING FACE (swelling face) and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up On 25-May-2021: Non Significant follow up
Vertigo, dizziness, prolonged dizziness and vertigo still taking place to present time 01/06/2022
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced near syncopal episode (stressed she did not actually pass out) on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Patient states sore muscles, started the next day and it really hurt two days after the shot. He states pain into his shoulder and neck on left side. He states hard to lay down and sleep. He states ibuprofen helps a little and the pain is going away slowly.
VERTIGO; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date in MAY-2021, the patient was previously treated with covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown), 1 in total, dose was not reported (dose series 1) for prophylactic vaccination. Following vaccination with covid-19 vaccine , the patient tasted a metal taste in mouth and patient arm was a bit sore (dose series 1). On an unspecified date in AUG-2021, the patient suddenly began having vertigo (dose series 1).   The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown), 1 in total, dose was not reported (dose series 2), administered on 01-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 05-NOV-2021, following vaccination with booster (dose series 2) of covid-19 vaccine, the patient experienced recurrence of vertigo (dose series 2). As per the report, patient stated that the vertigo started to get worse again on 05-NOV-2021 and 06-NOV-2021 and patient also stated that she "feels like I did when I first got it back in AUG-2021" (dose series 1).  The action taken with covid-19 vaccine as not applicable.  The outcome of vertigo  was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211118821.
This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 85-year-old female patient who received SHINGRIX for prophylaxis.  On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 18th June 2018, 2 days after receiving SHINGRIX, the patient experienced injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site inflammation and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient left voicemail and reported that experienced inflammation and redness just beneath the injection site that is about 2 to 4 inches in size and was very red. Upon callback to the patient on 19th June 2018, the patient reported that she applied ice pack to the area and that it was improving. The patient stated that she was late for appointment and unable to answer further questions for the report. The patient filed limited report and demographics for pharmacy and physician were not obtained before caller ended the call.
an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA123826, 2019SA124197, 2019SA124199 and 2019SA124200 (same reporter).  This case involves a 5 years old male patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the right thigh on 04-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event was occurred.   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 Directive and Module VI of the Practices. 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.  Documents held by sender: none.
This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL Single-Dose (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
The client received the COVID vaccine (Pfizer dose 1, lot # EW0167, expiration date 5/6/2021) at 1430. At 1500, she reported a "pinching" sensation in her left chest, which didn't get worse or better upon inspiration or expiration. The pinching sensation was intermittent and didn't radiate. RN and EMT responded at this time. She denied any shortness of breath or changes in vision, and had no visible flushing, diaphoresis, or swelling. The client was sitting in her chair in the observation area, in no apparent distress. At 1505, the client's vital signs were as follows: blood pressure 144/100, heart rate 82, respiratory rate 12, and O2 96%. Lung sounds were clear to auscultation bilaterally. The client stated her blood pressure is "usually high" but wasn't sure of her exact baseline. The client stated that she hadn't eaten or drank anything yet that day. She was offered water at that time, which she accepted. The client stated she has a history of fibromyalgia, migraines, and obesity, and she takes duloxetine, gabapentin, and vitamins. She has allergies to keflex and ben-gay. The client was alert and oriented. She denied any need to lie down and stated her symptoms were improving. At 1510, the client's vital signs were as follows: blood pressure 140/98, heart rate 78, respiratory rate 12, and O2 98%. She was offered benadryl, which she declined. The client stated that her symptoms had resolved at that time and she wanted to go home. Client advised of recommended 30 minute wait time and educated regarding emergency management, AMR activation, v-safe, and primary care follow up. The client stood up without any dizziness and ambulated to her car with a steady gait, where she was driven home by her husband.
Eyes swollen; Lips swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen). At the time of the report, EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-APR-2021 does not contain any new information.
Beginning 6 hours after, extreme fatigue, brain fog, weakness, arm pain at injection site, loss of appetite, nausea, mild sporadic chest pains, loss of breath once.  Felt all this for 24 hours.  Arm pain, chest pains, loss of breath decreased after 24 hours.  Brain fog, weakness, fatigue started to decrease after 48 hours.   I am still having fatigue, weakness and GI issues like loss of appetite, nausea and going to the bathroom frequently.  I want to hold off on my 2nd shot for several weeks.
PATIENT BECAME PALE, FAINTED, SEIZED AND VOMITED 4 TIMES. PATIENT'S COLOR RETURNED, GAVE JUICE AND OBSERVED UNTIL ABLE TO LEAVE.
Approximately 48 hours after injections with Tdap and varicella vaccines, area of immunization reportedly became red, inflamed, hot to touch and tense. Ibuprofen has been administered for treatment. Sxs. reducing after 3 days.
Patient began having redness and swelling at injection site the night of her vaccine, 10/2/18, She then had facial swelling and redness the next day which continues to get worse. Her throat also has visible swelling. She was taken to the ED for treatment.
FeveR > 100.4 - > 48 hRs Headache - > 48 hRs
Fatigue swelling of face  Shortness of breath Cough Joint pain Headache Chest pain dizziness
had the shingle vaccine / Dealing with them now/ Suspected vaccination failure; shingles worse; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient was dealing with them at the time of reporting and was absolutely miserable. They were worse since had the vaccine than they were before the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Neck pain began day after injection on 5/6/2021. Neck pain became more severe throughout the day and through the night. I could barely move my head side to side or up and down as the pain became worse.  On 5/7/2021 my neck pain became the most severe. By the morning of 5/8/2021 the pain began to decrease, however it didn't completely go away. On 5/7 and 5/8 I have been extremely tired.
Pt was injected with BOOSTRIX and within a few seconds of administration fell unconscious (father was right next to her sitting down and caught her). Pt remained unconscious for about 1 minute then regained consciousness. Then stayed conscious for a while then they lost consciousness again for a shorter duration one or two more times. 911 was called and upon arrival the vitals they took were low blood pressure and low heart rate. Pt was taken to hospital on stretcher for further evaluation. Pt said they generally felt alright when asked but did appear pale.
9/11/08 VACCINE GIVEN.  9/18/08 RASH BEGAN ON LEGS.  FEVER 99-100 DEGREES. 9/19/08 SEEN AT FACILITY RASH FAIRLY DENSE OVER ABDOMEN, FINE MACULAR, PINK, ALSO HAS RASH ON FACE MORE PATCH ERYTHEMA, SPOTTY WITH FINE MACULAR RASH.  LEFT TM WITH ERYTHEMA.  WILL BE TREATED WITH ZITHROMAX 100G/TSP-5 DAY REGIMEN.
This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-AUG-2015, 09-NOV-2015 and on 09-MAY-2016, the patient was vaccinated with doses of GARDASIL 9 (lot # L007560, lot # L048237, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
about 1900hrs (5 hrs p/shot) devel t104 ax, exp 3-4 hrs of crying/screaming; no other s&s; tx w/APAP; next day all was okay;
Site soreness 7pm  3/8 duration 10  days Metallic taste 7am 3/9 duration 24 hrs Total loss of appetite 7am 3/9  duration 24 hours Total body joint aches  3:00pm 3/9  duration 18 hours  Vomiting/diarrhea 8am 3/10 duration 2 hours Severe chills/mild body aches 2pm 3/10 duration 3 hours Fatigue 3/10 2pm 24 hours Severe left shoulder joint pain, redness, heat, swelling 3/11 duration  10 days Stye in left eye lower lid 3/14  duration 6 days