chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the ZOSTAVAX immunization and afterwards started to experience a large and painful swollen rash in the area. Four days later she went to her physician... the MD told her that the vaccine had been administered too low and that is what probably caused the reaction (vaccine was administered SUBQ above the elbow by a pharmacist). Patient is currently in pain and says she is being treated with antibiotics and prednisone. She says that her MD who is an expert (but did not administer the vaccine) said that he has never seen anything like it and that it is very unusual that she would experience such a reaction or infection from the vaccine and that it is due to administration error. Patient denies any allergies. I am reporting this because the patient is seeking monetary compensation from Walgreens. I have not seen the rash to examine its characteristics.
Covid-like symptoms - deep cough, runny nose.  Treatment: none  Diagnosis: Cough  Outcome: treat symptoms
LUE numbness and weakness which lasted ~3 weeks post-vaccine, improving slowly over time.  Had malaise and lymphadenopathy, R axilla. Normal reflexes, sensory exam, very mild weakness, LUE on 11/08/2021. Relates that her BP has been higher at home (150/90, regularly 120+/80), also high in office 173/90
Diarrhea 5-8 times per day for over 2 weeks. This started immediatley folling her 6 month well visit appointment. She also has diarrhea several times during the night. Sometimes she appears to not be as active and happy as she was. I called the doctor and they said this is normal but if it still continues for another week to call back for testing.
Patient was under the age eligible for vaccination at the time she received the vaccine. Patient and guardian thought and consented for vaccine because they thought it would be ok because patient was almost 16 and eligible.
Patient experienced red coloring to skin from top of right arm to about 2 inches below elbow. Patient experienced itching and the skin is hot to the touch. Elbow and arm is swollen and elbow aches. This was patient 2nd vaccination.
Severe arm pain; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 38-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 on an unknown date (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included that the patient was diagnosed with COVID-19 on an unknown date. Concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the unspecified vaccine within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced severe arm pain, fever and fatigue. The clinical outcome of the events of severe arm pain, fever and fatigue was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I began to have runny nose, watery eye, a slight and a raspy voice. I was tired easier during the day than normal for a few days. I called a nurse to see if they could provide the therapeutic medication Paxlovid which the called in for me. I began to feel better immediately after taking. My symptoms only lasted about 48 hours. I began taking the medication on the evening of the 29th.
After my son took the vaccine, he started to have fever. Normally he would have fever, and a rash that would come on his face. Normally takes about 3 days to go away after the vaccine. The fever would go away, after I give him tylenol, but it kept coming back. I kept giving it to him. He started getting weaker, and being stuffy. Especially at night time, the fever will get so high. I started giving him motrin, and it would not go away. I called the doctor and his fever was 103 and they told me to bring him in. I did and then they took him to the hospital, ran tests to see if had pneumonia. They took him for a 24 hour observation, but he wasnt improving. He stayed in the hospital in the acute ward. They said it was rsv, then cavasocky, then pneumonia, then they would treat him for those. He was placed on the ventilator. He went through all of that. Now that we have relocated to another state, his doctor stated that he will not give him the vaccine due to his reaction to the live vaccination. He can get other vaccinations, but not the live one. Now I am thinking its something they dont want to tell me, if the vaccination has anything to do with my sons reaction in 2018. Stayed
Patient described pain at the injection site radiating to elbow and wrist when pressure is applied down on arm (i.e. bracing to get out of chair). Patient described pain happening immediately and still present 6 days after injection.
Severe rigors 1 am - 2am. Wife wanted to bring me to hospital. Feverish, but temperature not taken.  Subsequent muscle aches, sweating/chills, headache to degree couldn't get to work for first time in many years. Very surprised by severity.
nausea, vomiting, fever, diarrhea approx 1 hr p/vax;
Painful body aches (much worse than the flu), tiredness, temperature fluctuation. All peaked at around 12-24 hours post vaccine and have gradually subsided since.
radiating shoulder pain; swelling at the injection site; experiencing pain and swelling at the injection site / pain having been a 10 at times; rash; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix. On 26th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, rash and injection site swelling. In December 2020, the patient experienced shoulder pain. On an unknown date, the outcome of the injection site pain, injection site swelling and shoulder pain were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the injection site pain, rash, injection site swelling and shoulder pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of the Shingrix vaccine in left deltoid and the same day, the patient experienced pain and swelling at the injection site and rash. The rash resolved after approximately 1 week and pain and swelling were ongoing, with pain had been a 10 at times. Less than a month after receiving Shingrix, the patient experienced radiating shoulder pain, that had been occurring for approximately 2 months. The patient reported that the pain, swelling, and radiating shoulder pain had all progressed since their onset. The reporter did not consent to follow-up.
Initial report received from Non-Health Care Professional on 24 April 2012. A 42-year-old female patient, whose medical history and concomitant medications were not reported, had received dose of FLUZONE HD vaccine (lot number and site of administration- not reported) in December 2011. The patient reported that she had a knot in her arm where the injection was given, the arm was still sore (soreness had been got worse and down below to the elbow). The patient also had continuous cough. The physician suggested that the events were related to the flu shot. The outcome of the events was reported as not recovered. Documents held by sender: none.
This spontaneous report was received from healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored  GARDASIL which were exposed to 1.0 C for 5 hours, (Dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint 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.
pt recv vax AUG97 & in 1997 pt devel varicella w/approx 1 to 10 lesions;
feeling unwell; chills; throwing up food a couple of times; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling unwell, chills, throwing up food a couple of times in Feb2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.
headache; soreness in the arm; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (soreness in the arm) and HYPERSENSITIVITY (hypersensitivity reaction) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine  (Dose 3, batch lot no 8FF2590) on 27-Oct-2021, Pfizer vaccine  (Dose 4, batch lot no FM0658) on 22-Mar-2022, Pfizer vaccine  (Dose 5, batch lot no GH9694) on 12-Sep-2022, Pfizer vaccine  (Dose 6, batch lot no GJ3268) in April 2023, RSV VACCINE on 05-Sep-2023 and Influenza on 05-Sep-2023. Past adverse reactions to the above products included Headache with Pfizer vaccine , Pfizer vaccine , Pfizer vaccine  and Pfizer vaccine ; and No adverse event with Influenza and RSV VACCINE.    On 16-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (soreness in the arm) and HYPERSENSITIVITY (hypersensitivity reaction). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (soreness in the arm) had resolved and HYPERSENSITIVITY (hypersensitivity reaction) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 15Jan2021, patient received first Moderna dose (lot number 041L20A). On 12Feb2021, patient received second Moderna dose (lot number 030D20A). Patient received the injection from a 1-inch needle instead of a 1.5-inch needle. Patient read that for his weight he was supposed to receive the vaccine from a 1.5-inch needle to prevent this from becoming a subcutaneous injection. Stated that there may be the potential for an additional dose in the future to manage the dosing administration error.  Treatment medications were not reported.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills, tingling on feed to mid calf Narrative:   Other Relevant History:
must be something I'm allergic to; breathing problems/severe respiratory problems; get very ill every; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included asthma and allergy (allergic to lot of stuff).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergy, difficulty breathing and unwell. On an unknown date, the outcome of the allergy, difficulty breathing and unwell were unknown.   It was unknown if the reporter considered the allergy, difficulty breathing and unwell to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that some sf the patients were intolerant to some vaccines. The patient gets very ill every time she had Flu vaccine so stopped having them and stated they were not suitable for everyone. The patient received couple of Flu vaccines. The patient was asthmatic and got breathing problems (severe respiratory problems) after vaccination and stated it must be something she was allergic to. The reporter reported that her brothers were given Penicillin in hospital and it nearly finished them off and both had allergic reaction. The reporter stated that it was great if the vaccines work but one should not assume that vaccines were right for everyone.
This spontaneous report as received from a physician refers to a 5 years old male patient with no pertinent medical history or drug allergies. The patient was vaccinated with a dose of PROQUAD (merck) (lot number reported as "H015642", exp 06-JAN-2014) on an unspecified date. No other co-suspects were reported. Concomitant medications included: FLUMIST received on the same visit along with PROQUAD (merck). Physician reported that patient passed out after receiving PROQUAD (merck) on an unspecified date. Patient passed out for a few seconds and regained consciousness right away after a few seconds. Patient was observed in the office and sent home. No treatment information was given for the adverse event. At the time of the report, the patient's outcome was unknown. No lab diagnostic studies performed. The relatedness for the adverse event was unknown for PROQUAD (Merck). On internal review, pass out was determined to be an other important medical event. Additional information is not expected.
Extremely cold (fingers and toes became numb), aching bones/joints, itchy skin, hives, headache, fever, extreme sweating, sore throat, hoarse voice, sore throat, runny/stuffy nose, eye pain, fatigue,  nausea, lack of appetite, confusion, feeling like my body was moving in slow motion
I (the patient) experienced severe symptoms about 10 hours after receiving the vaccine. The serious symptoms lasted for 24 hours after receiving the vaccine: Serious Symptoms: -Intense Chills/Hot flashes -Rapid heart rate (90bpm) -Difficulty breathing -Joint and muscle pain -Headache -Nausea/Diarhea -Dizziness -Unable to sleep  Moderate symptoms lasted for 48hrs after receiving the vaccine: -headache -Muscle and Joint pain -Chills
I had left lower extremity pain and edema. I had these symptoms for about 5 days. I went to the hospital. I went got and ultrasound and had a DVT.
Nerve pain in back/arm/neck, loss of bladder control (twice), headache, brain fog, vertigo, dizziness, balance problems, weakness in leg muscles, fatigue
seizures; diagnosed with Cavernoma Disorder; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant) and cavernoma. On an unknown date, the outcome of the seizure and cavernoma were unknown.   It was unknown if the reporter considered the seizure and cavernoma to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 53 or 54 years. The patient received vaccine in right deltoid. On an unknown date after receiving the Shingrix vaccine the patient began to experience seizures and was diagnosed with cavernoma disorder. The reporter consented to follow up.
Severe itching on vaccinated are, chest , stomach and back. Rashes and hives, Burning skin, Sneezing, over active sinuses, Nausea, swelling in neck glands and ear glands, facial swelling at mouth and eyes, tightness in chest and difficulty breathing. The symptoms got worse each day and I went to Urgent Care on the 6 th day when the swelling started. I was given a Steroid shot and a prescription for Predizone for 10 days. The shot helped within a hour or two but the symptoms are still there but not as severe. All these symptoms have happened to me before when I have accidentally injested Gluten or Wheat. Is there Wheat in the fillers?  I am very nervous about having the 2nd shot !!!!!!!
Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.  About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
Initial information received on 22-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven month age patient (gender unknown) who experienced inadvertently gave 2 doses, one week apart to 7 mos old, no adverse event, while he/she received vaccine [PENTACEL]. The patient's past medical history, medical treatment, vaccination and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. Patient received two doses of vaccine inadvertently one week apart. Final diagnosis was inadvertently gave 2 doses, one week apart to 7 mos old, no adverse event. The patient outcome is reported as Not Applicable for inadvertently gave 2 doses, one week apart to 7 mos old, no adverse 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 Directive  and Module VI of the Good Pharmacovigilance 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.
pt received pediatric dose (0.5 ml) of Hepatitis A vaccine instead of adult dose (1 ml) during program no negative outcomes
Information has been received from a registered nurse concerning a 25 year old female assistant director of admissions, who on 19-JUN-2007 was vaccinated with a second dose of Gardasil. On 20-JUN-2007 the patient reported that she woke up with a rash on her back with no itch. At the time of the report, the rash still persisted. Additional information has been requested.
I had a severe headache for 4 days and have had breathing problems for the last 6 months. I can not take a deep breath without coughing. Early symptoms were relieved by Tylenol Extra Strength and  breathing symptoms are relieved by Robitussin DM cough medicine.
About 5 minutes after I got the shot, I felt as though someone poured warm liquid starting at my head to toes, I also began to tingle. My mouth got hot and tingly. Elevated Blood pressure, and felt like I was going to pass out. I was laid down, and was very clammy. The really severe tingling and hot feeling passed in about 3-5 minutes, but it lasted for about 1.5 hours in a much more mild fashion.
fever, shaking, headache, spine pain, neck, body aches, throwing up, chills    Please note the date spacing between dose 1 and 2  Date and time of vaccination: (list both if they received both shots):   04/04/2021 @930 04/16/2021 @1030
Swelling of throat and neck, shortness of breath, light headed, took antihistamine and monitored for several hours.
At approx 10-13 min throat pain/tingling.  Given zyryec. Resolved around an hour.  Day 2 left arm localized at site approx 5-6cm redness/raised/warm.
Soreness initially, but since vaccination has had multiple outbreaks of Herpes, not recorded before.
Initial information received on 13-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 11 months old female patient who received a 0.5ml dose of ACTHIB batch number: UI860AA and expiration date: 07-Sep-2019 via unknown route in the left thigh on 13-Feb-2019 and (for diluent batch number: U5964AA and expiration date: 09-Jan-2019). The patients past vaccination(s) included PENTACEL in SEP-2018. The patients past medical history, medical treatment(s) and family history were not provided. Concomitant vaccinations included PREVNAR. It was an actual medication error due to expired product administered. A expired diluent was reconstituted with ACT-HIB and administered to an 11 month old patient. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-JAN-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 12-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
rash on face,arms & trunk,hot,flushed;started feeling hot,face & ears turned red then redness gradually moved down neck,arms,& trunk;denies diff breathing,or any other sx;dec in sx w/in 1hr;
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient received a dose of GARDASIL (lot#, dose frequency and route not provided). The physician reported that he had a patient who on an unknown date had a rash on their arm for 6 months after receiving the vaccine. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not provided. Additional information has been requested.
Headache,  achy joints and shortness of breath which has been constant and possibly getting worse.  Am unable to run as normal.