chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 12 hours after shot, severe pain from elbow to neck (no redness or swelling), fever (100F0101F), vomiting, deep muscle pain in legs (back of calves, back of thighs), some lower back pain, at one point pain around ribs and hurt to breathe (that stopped within 30 minutes) and headache. Family history (paternal) of rheumatoid arthritis.
On 4/5/01 large local reaction that got worse. Was seen by ER doctor and given RX for Keflex to treat cellulitis.
Slight fever, excessive stiffness and soreness in the local area of shot (right arm tricep). Pain and stiffness unlike any other immunization.
patient was administered with expired Pentacel with no reported adverse event; Initial information received from on 19-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old female patient where patient was administered with expired diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine for Prophylactic vaccination.  On 19-Sep-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ737AAA and expiration date- 18-Sep-2023) via intramuscular route in the left thigh (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was unknown on an unknown date 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 Directive 2001/83/EC 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.
covid vaccine breakthrough case  dose 1  3/11/21  Pfizer  EN6207 dose 2  4/1/21  Pfizer  EW0150 dose 3  12/3/21  Moderna  060H21A dose 4  4/14/22  Moderna  027L21A
TDAP (L) arm 10/1/2010 - first noted sx. 1 week later ? red swollen hot bumpy itchy area at injection site - larger than 1 1/2 inches (size at OV 10/13/2010) used lotion on it - received Pred Pak - hydroxyzine 10/13/2010.
Patient developed (L) shoulder pain 2 days following vaccine administration worsening 2 weeks following administration with reduced range of motion.
Pt c/o medicine stinging when injected 31May90. Stinging lasted for about 10 min. & "for about 1 wk the spot of inject hurt for a short time
Could not sleep. Felt like on Ten cups of coffee. Could not think well Did not sleep for 24 hours Extreme fatigue  By 3rd day felt well
Drooling, dysarthria, fever to 103 x 3 days, right facial droop with resolution of everything except the dysarthria.
she gets COVID again; she gets COVID again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she gets COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: she gets COVID again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201054880 Same reporter/drug/patient, different dose/AE;
A report was received from a health care professional on 09/23/2002, concerning a female patient in her 40's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading thoughout the entire arm. On 09/23 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health care professional is concerned that the event may have been associated with this particular batch.
This spontaneous report was received from a current 72 year old male patient with sulfa allergy and post herpetic neuralgia pain after got shingles approximately in 2006 (approximately 7-8 years ago). About one year and three months ago, approximately in November 2012, the patient was vaccinated with a dose of ZOSTAVAX (total dose, route, lot number and expiration date not provided). The patient had no any co-suspect therapy or concomitant medications. It was reported that after receiving the ZOSTAVAX, his preexisting post-hermetic neuralgia pain, which manifested itself in his right hip, radiating to his right buttocks, right back and right leg cleared up almost immediately (within 3-5 days or receiving the ZOSTAVAX). 7-8 years ago when he was diagnosed with the shingles, the patient was prescribed VALTREX for two weeks during the acute stage of the disease and prescribed 1/2 of the VALTREX daily as prophylaxis. The patient stated that his post-herpetic neuralgia pain continued to be so sad despite taking the VALTREX, that he discontinued taking it about two years ago, at which time he visited a pain clinic for the post-herpetic neuralgia pain. The patient reported that he refused to take any pain medication. The patient stated that although the injection site of the ZOSTAVAX itched a little (approximately in November 2012), his post-herpetic neuralgia pain subsided. The patient noted that this discomfort was completely gone despite his pain had been so bad that his physician suggested a pain clinic. The patient also reported that he was now (approximately in February 2014) beginning to feel a bit discomfort in this area again, like a little bundle of sore nerves. At the time of the report, the patient's injection site itchy outcome was unknown, and patient had not recovered from a discomfort in the area like a little bundle of sore nerves. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Enlarged spleen; Burning in her chest; Severe stomach pains; A spontaneous report was received from a consumer concerning for his wife, a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning in her chest/Chest pain, severe stomach pains/Abdominal pain upper, enlarged spleen/Splenomegaly.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29Jan2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events burning in her chest, severe stomach pains after her first shot, Physician said she has an enlarged spleen. Treatment information was not provided. The event severe stomach pains was considered as medically significant by reporter.   Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, burning in her chest, severe stomach pains, enlarged spleen was unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Red rash with swelling and itching at site of injection but also on inside of arm down to middle of forearm.
chest x-ray presented like a lung infection; Vomited once; Fever of 100-103.5 for 12 days; Extreme nausea throughout; Swollen lymph nodes in neck; Cough; heart murmur; blood tested high inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 12:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bee venom" (unspecified if ongoing), notes: Known allergies: Bee venom. Family history included: "Family history of vaccine reactions" (unspecified if ongoing), notes: Family history of vaccine reactions. There were no concomitant medications. no other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. The following information was reported: PNEUMONIA (medically significant) with onset 22Nov2021 19:00, outcome "recovering", described as "chest x-ray presented like a lung infection"; VOMITING (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Vomited once"; PYREXIA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Fever of 100-103.5 for 12 days"; NAUSEA (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Extreme nausea throughout"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Swollen lymph nodes in neck"; COUGH (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "Cough"; CARDIAC MURMUR (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "heart murmur"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 22Nov2021 19:00, outcome "recovering", described as "blood tested high inflammatory markers". The events "chest x-ray presented like a lung infection", "vomited once", "fever of 100-103.5 for 12 days", "extreme nausea throughout", "swollen lymph nodes in neck", "cough", "heart murmur" and "blood tested high inflammatory markers" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (22Nov2021) presented like a lung infection; electrocardiogram: (22Nov2021) unknown results; inflammatory marker test: (22Nov2021) high inflammatory markers, notes: blood tested high inflammatory markers; pyrexia: (22Nov2021) 100-103.5; sars-cov-2 test: (30Nov2021) negative. Therapeutic measures were taken as a result of pneumonia, vomiting, pyrexia, nausea, lymphadenopathy, cough, cardiac murmur, inflammatory marker increased included Motrin.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: ~~~
I have had tinnitus since the day after the vaccine. It is constant 24-7 at roughly a 5-7 volume. I have not found anything that makes it go away. I went to an ENT who essentially told me there was nothing he could do.
Diarrhea; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's wife) reported for husband. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 31May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 10May2021 as 1st dose, single dose for COVID-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea. Although reporter knew that diarrhea was a part of side effects of vaccine and she was wondering how long it can, how long he can experience this one. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse practitioner refers to an 18 year old female patient who was postpartum. The patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0214AE during verification process, exp. date 13-OCT-2014) on 16-JUL-2012. Concomitant medications included prenatal vitamins (unspecified). On 16-JUL-2012 the patient experienced tonic-clonic movement and syncope after receiving her dose (the syncope and tonic-clonic movement lasted 30 seconds). Patient did not receive any treatment for adverse event. The outcome of syncope and tonic-clonic movement was reported as recovered/resolved in the office (on 16-JUL-2012). Additional information has been requested.
I am writing to inform you of a very painful reaction I had when I received the first of my two Shingles vaccination.  As soon as the pharmacist put it in, I about jumped off my chair which has never happened when receiving shots.  About and hour and a half later, my arm started to have sharp pain that seemed to extend from my fingers to the middle back of my neck.  I was in terrible pain for about 24 hours, moderate pain for another 24 and then started to recover.
booster; redness; swelling in arm from shoulder to elbow; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. This is one of two reports. This report is for female patient:  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Done: 1st), for COVID-19 immunization; Bnt162b2 (Done: 2nd), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ERYTHEMA (non-serious), outcome "unknown", described as "redness "; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in arm from shoulder to elbow ".  Additional information: Reporter stated that "I have seen two women and one man over 65 years, who got redness and swelling in their arm from shoulder to elbow a few days after getting the Pfizer booster shot." Reporter was asking information about side effects for recipients 56 years and older for the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I received my Moderna for COVID-19 on 02/02/2021. On 02/06/2021, in the morning I had numbness and tingling on my left hand and palm. My arm was very sore and  it was extremely painful. I also had fever of 99.2. My arm numbness and tingling is still going on that hasn't resolved and I've been seeing a doctor for it. I had an MRI on 03/10/2021 and I had an EMG on 03/22/2021, It confirmed that I had a nerve damage. On 06/08/2021 I went to a Neurologist who told me I had Brachial Plexopathy which was caused by the vaccine. My doctor followed up for few months. On 11/11/2021 she did another EMG it showed her the same nerve damage that was there. I am still dealing with it now and it hasn't resolved yet.
Unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) (batch number 3JK5K, expiry date 11th September 2022) for prophylaxis.   On 14th September 2020, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adverse event. The action taken with Shingrix was unknown. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). The patient had ingested Shnigrix vial Kit 0.5 ml by intramuscular route on 19 August 2020.
Pt developed gastrointestinal distress including constipation and diarrhea lasting 5 days. Increased eczema and lethargy
Myalgia, Arthralgia, Fever, NauseaVomiting, chills Narrative: Fever, chills, myalgia, arthralgia, nausea
By the end of the same day my daughter experienced negative reaction to her vaccines. She was extremely tired and lethargic. She had a fever and was twitchy for 2 days. Complete loss of appetite and a rash.
Breakthrough case admission after 2 vaccines Moderna 2/22/21 lot# 023M20A;  Moderna 3/22/21 lot# 047A21A;
lightheaded, lethargic, diaphoretic, low blood pressure 86/46, P 65, O2 98%. 8:27am IV o left arm. 8:35 Hospital
2nd dose of Moderna vaccine administered <25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
pain in shoulder for a month with no improvement. loss of range of mobility.  Patient reported to MD for follow up and came to pharmacy to fill medication and VAERS was created.
breaking out in hives.  It started at my scalp, than my neck, and continues on my back, chest, ankles, and rear end
After a day, I had very dark circle at the site of injection, about the size of a nickel. A few days later I had severe shoulder pain that lasted until today (at this point it's very nearly gone). I also had some joint-issues that have also resolved in the last few days.
headache; fever; chills; very unusual markings on legs; This is a spontaneous report from non-contactable consumer (patient himself) via Pfizer sponsored program.  A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccine, the patient had experienced normal side effects such as headache, fever and chills. But the last week or so he had very unusual markings on legs. Lines on legs go up and down and they come and go. Never took any medication. Even HCP doesn't knew where marks came from but suggested covid vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
I had some arm pain  the day of and few a few days afterwards at the site of injection. Around the 19th, I would come home from working 6 hours a day and I would feel very tired and head would feel fuzzy. At first, I thought I had thought I had forgotten to take pills that day but that wasn't the case. I took a nap after work. That proceeded for that whole week. During the week, one of my co-workers had been diagnosed with COVID. I was running a low grade fever - got up to 100 as max but usually 99, soreness and extremely heavy feeling for arms and head; fatigue. I had a little loss of appetite. I just wanted to sleep. I tried to come back to work, but about a week after feeling like this I went to Dr. - Prednisone and antibiotics. Prednisone helped a bit but within a few days of finishing the round, I was back to horrible fatigue level. I wanted to sleep 18 hours and had no energy. It was a lot of sleeping. Ended up going back to doctor and he had a CT scan done. He saw something in sinus area but not my brain. ENT doctor: decided to do allergy testing. Sleep study coming up soon to possibly to see if it my sleep. I have been doing OTC CBD - it is water based. It is one of the stronger liquid based CBDs and I have been taking about .75 mg once a day. It is the only thing that is giving me energy. I have tried acupuncture with not huge results. I am getting back with my doctor about it possibly being Fibromyalgia. I realized that the heavy feeling I am feeling in my body is just pain. My concern is that my COVID shot triggered Fibromyalgia - My  mom was diagnosed with that in the past and had it. I have had times in the past before  with some very mild, minor body pain (when I get sick it hits me harder) and times of low energy (when I'm sick it seems it hits me). With my energy Presently, I have to think about what I am going to do on one day - to make sure if I have enough energy for the next day with what I'm doing - have to budget my energy. It feels like I'm on a planet with extra gravity. Ibuprofen or Tylenol for the pain sometimes. My doctor did a lot of bloodwork - three blood draws. The only thing that came back as abnormal: Very basic inflammation - Yes, I have a moderate level of inflammation. I am not premenopausal; B12 levels were fine; iron levels were fine; white blood cells were fine; my platelets were fine. I tried to go down on my CBD with what I'm taking. I missed work yesterday because of it. Slept 8 hours at night and then from 8-1 during the day and then another hour that evening. I got the second vaccine 5/7/2021 - around 1:00PM - right arm. I had to be wheeled in to get that vaccine because I was so weak.
This patient received an expired vaccination. It had been taken out of the fridge on 4/28/21 so it should've been used by 5/28/21. The expiration on the bottle was 11/09/21. This patient experienced body aches, fatigue, and chills.
Symptoms started 11/6/21 or 11/10/21.  Symptoms include: Patient has been experiencing pain in her left arm since she got her Moderna booster shot. She also experiences numbness in her left hand and fingers. She is currently traveling and has been to the hospital twice for the symptoms, but her pain has not gotten any better.  Spoke with patient directly she went back to the urgent care the did an ultrasound that was normal but did put her on a short course of prednisone which has reduce the swelling.  She states that extra-strength Tylenol is helpful.  She is reassured unlikely that there is a series event.  May take several more weeks before she is feeling better.  She can take 1-2 extra-strength Tylenol 3 times a day as needed.  She verbalized understanding.