chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given covid vaccine at approximately 8:15pm. About 5 minutes later, patient was sitting outside with mother when the mother started calling the patients name saying that he just had a seizure or it looked like he was convulsing. I ran out to check on the patient whom at the time was back to alertness and conscious. He was slowly breathing but fully alert and slightly leaning on the chair next to him while holding onto his mom. Technician was told to call 911 at that time as well . About 2-3 minutes later as I turned to grab the phone the patient started to shake again for about 5 to 10 seconds and went back to full alertness. At this point I was checking the patient breathing & pulse while following the instructions of the operator on the phone. After which the paramedics arrived and took over to work up the patient.
Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.
Patient received first dose Pfizer and left waiting room ~10 min after vaccination, although instructed to stay for 15 min. He said his ears were ringing while in the waiting room, but he did not remember leaving the room. Other customers said he collapsed while exiting the waiting room, got up and stumbled across the aisle and collapsed again on the floor, hitting his head on the floor. He bled quite a bit and BP was 114/67 on lying position. He was conscious when I checked on him. No other sx reported besides ringing ears. Store employee gave him some water and he took a sip, I stopped him and instructed NPO. Paramedic arrived while I was checking BP. Paramedic said they will take him to the Hospital.
Adverse events did not occur until after second shot. Common side effects occurred - fever, headache, lethargy, flu-like symptoms etc. Reason for Doctor visit was due to new chest pain, chest tightening sensations.
Sores or ulcers in the mouth. So painful it's hard to eat and drink somewhat. Able to breath ok though. Saw a Doctor and they thought it was a virus maybe but it happened so close after his shot. Symptoms started on a Monday and as of Friday evening he is still having bumps appear in the mouth and under tongue.
p/vax pt noticed swelling & redness;mom became concerned took child to ER that noc because redness persisted;lt leg had moderate swelling from knee up & redness all up thigh back of thigh;warm to touch;
Patient reports pain in arm and is waking up at night. After discussing with doctor, he believes a nerve may have been impacted by the vaccine.
Very little reaction; Queasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Very little reaction) and NAUSEA (Queasy stomach) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G204) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in December 2020.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Very little reaction) and NAUSEA (Queasy stomach). At the time of the report, ADVERSE REACTION (Very little reaction) and NAUSEA (Queasy stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-098344, US-MODERNATX, INC.-MOD-2021-029709, US-MODERNATX, INC.-MOD-2021-029709 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR attached-NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098344:cross linked - appears to be the case assigned for the 2nd vaccine US-MODERNATX, INC.-MOD-2021-029709:Cross linked US-MODERNATX, INC.-MOD-2021-029709:cross linked
VARIVAX administered left thigh 10/1/08 - To office 10/3/08 with large redness area at site. Lot#0770X
Have severe body aches, fever, fatigue, no energy. About 17 hours till I was able to get out of bed. I had COVID 19 in December and had identical symptoms.
3 doses of menquadfi were administered to patients post-excursion with no reported adverse event; 3 doses of menquadfi were administered to patients post-excursion with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited non-valid  non-serious case received via other health professional.  This case involves 3 doses of menquadfi were administered to unspecified patients post-excursion with vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength: unknown) at dose of 3 DF (Dosage Formulation) at dose number 3 (lot U7633AA, Expiry date: 25-Apr-2025)  via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious 3 doses of menquadfi were administered to patients post-excursion with no reported adverse event (poor quality product administered) (product storage error) (same day latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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.
I experienced a breakthrough case of COVID-19, my sister was sick at first and thought it was a sinus infection or a cold and she tested negative so then after visiting her for the weekend 03/10-03/12, I felt the symptoms Monday (03/13/2023) night. I didn't worry about testing because she had tested negative, but then she ended up testing positive and I got tested and was positive as well. I experienced body aches, coughing, congestion, headache and sore throat.
inject 1200 by 1900 n/v, h/a, no fever, body aches esp joints, diarrhea; lasted until next AM; h/a the next day by 3rd day sx gone;
This spontaneous report as received from a pharmacist, who was also the mother of the patient, refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with GARDASIL 9 (route and site of administration, lot # and expiry date were not reported) for prophylaxis and received all 3 doses in total. All of the doses were not agitated in the vial prior to administration and were all clear in appearance (the prescribing information states that the product should be a white cloudy color after agitation). No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000279.
Woke up from a nap with chest pain that radiated around to the back.   Heart rate was 120 and dizzy when standing.  ER determined it was not a heart attack, but asked that I follow up with family doctor. Followed up with family doctor - orders for heart monitor and stress echo
Pt was given 0.1 mL intradermal however wheal was not produced. Pt was given 0.1 ML intradermal again which produced wheal. Pt left in no distress
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 11:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.09 for dose administered on 03-Nov-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion with temperature 35 degrees Fahrenheit from 10:00 AM to 11:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. 6 vial was moved to clinic, Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
The day after at 1 am exp chills, low grade fever, nausea, headache and fatigue. After Tylenol after 24 hrs the symptoms was better. I was able to to return to work.
she is now recovering from a Covid-19 infection; she is now recovering from a Covid-19 infection; This is a spontaneous report received from a contactable consumer (patient) via  Team. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: WAQ5525), via an unspecified route of administration on arm left on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient did the first shot on 17Mar2021, she just got the Covid after she got the vaccine in 2021. Caller adds that she has the second shot of the vaccine scheduled on 14Apr2021. Caller's doctor said to do the vaccine on 14Apr2021, but she was afraid that something will happen to her body. She states she was now recovering from a COVID-19 infection and was due for her second dose on 14Apr2021. The outcome of the events was reported as recovering.
Thought was going to die with first shot; Feeling paralyzed and laid in bed for 3 days; About 7-8 hours her arm was killing; Lot of her previous pain from the accident had come back; Unusual reaction; Every bone and muscle in her body was hurting; Headache; Every bone and muscle in her body was hurting; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Thought was going to die with first shot) and PARALYSIS (Feeling paralyzed and laid in bed for 3 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident automobile. Concomitant products included ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and MELATONIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Thought was going to die with first shot) (seriousness criterion medically significant), PARALYSIS (Feeling paralyzed and laid in bed for 3 days) (seriousness criterion medically significant), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting). At the time of the report, NEAR DEATH EXPERIENCE (Thought was going to die with first shot), PARALYSIS (Feeling paralyzed and laid in bed for 3 days), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.  Company Comment: 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.   This case was linked to MOD-2021-099253 (Patient Link).; 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.
C/O allergic reaction wheezing, stridor, red rash noted upon arrival to ER. Pt was treated with IV Benadryl, Pepcid, and Decadron. Then treated with Epi SQ and Depo Medrol IM. Pt was given consent from here and she answered no on consent as to allergic to any medicine or food. Seen in ER 1-11-07.
Patient reported that 2-3 minutes after vaccination, he felt his heart racing. He reports he checked his apple watch and saw his HR go up to 113. He reports his HR is normally in the 50s/60s.   Tachycardia
Day 2-4 had dyareah (liquid) Day 6-present (day 7)- alergic reaction:  Itching from deep deep inside, hives (bad)
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and inflammation. On an unknown date, the outcome of the injection site erythema and inflammation were unknown. It was unknown if the reporter considered the injection site erythema and inflammation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient was experiencing redness at the injection site about 3 by 4 inches in size. The patient was very patient. Because he was very insistent and he probably was a bit repetitive and he wanted to be certain that it was reasonable to not have a reaction for two to three days. The patient did not show up for three days and it was inflamed now and it was not for three days. So patient was very persistent and he was very patient and understanding. The reporter consented to follow up.
Right side of body has severe muscular pain, neuropathy, tingling, burning, stabbing sensations.  Naseau, diarrhea, headache. Right arm, hand, trunk, rib cage, hip, leg, foot pain and tingling.  Mild fever and right side head, neck and throat tight.
pt has sore injection site 3 months after shot.  sholder movemoent is fine.
Tested positive for Covid on 11/4/21.  mild cold symptoms, mostly very tired
Headache mild-moderate  Fever 101deg Fatigue Sore arm Took Tylenol, drank fluids, rested
This spontaneous report as received from a 68 years old female patient with medical of diabetes. On an unknown date in May 2012 also reported as on an unspecified date about 2 years ago, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: not provided) (lot #, exp. date: unknown) for the prevention of shingles. On an unknown date in May 2013 also reported as on an unspecified date about one year ago, the patient developed bladder infection and shingles after receiving ZOSTAVAX. On an unknown date, the patient developed also genital herpes after receiving the ZOSTAVAX. The patient sought medical attendance. She has been using DERMOPLAST (dosage, frequency and manufacturer: unspecified) to relieve her pain and itch and it was working great. The patient did not undergo any diagnostic studies. The shingles rash was on her "butt" at the time of the report. The outcome of developed shingles was reported as not recovered/not resolved. The outcome of developed a bladder infection and developed genital herpes was not reported. This report is linked with MARRS # 1406USA001041 (Same Patient Link). Additional information has been requested.
No additional AE; Improperly Stored / Administered V ARlV AX; This spontaneous report was received from a physician and refers to a child patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 25-OCT-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot#U010395 was verified to be valid, expiration date: 01-APR-2023) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccine was exposed was -1.4 degrees of Celsius (C) and the time frame was reported as 1 hour and 30 minutes. Also reported as -15 C for 1 hour 30 minutes. Lowest temperature was -1.4C at about 2:15 pm and went up since then by about -2C to -15C by 3:30 pm. Freezer was not shut properly. No previous temperature excursion was reported. It was unknown if digital data logger was involved. No adverse reaction were reported.
In the middle of the night after second innoculation  found myself on the floor next to my bed. I have no idea how I got there and was not aware of who I has or how I got there.  I don't remember how I got to the floor and didn't remember falling out of  bed.  The next morning my right hip was very sore, so I concluded I had been unconcious ancd fell out of bed I'm reporting this on the hope  that cases ofothers who had similar cases can help me understand.  I believe my case is unusual and severe,  I live alone and I could have been fatally injured
At approx. 10 pm 9/22/10 pt's eyes rolled back in head, hands clenched and pulled arms to chest, then shaking began for approx 30 seconds. Went to ER. Fever of 101.4 at time labs and CXR done mom refused spinal.
Redness, swelling, pain at site with lingering symptoms since 3/12/13 when injection given.
So the first day or two I felt like I had been hit by a bus. Everything hurt, all my joints, extreme fatigue and pain in my muscles. I felt somewhat feverish and it hurt to move. I stayed in bed and took some pain medication the nurse recommended and just hydrated as much as possible, 2 liters of Pedialyte. After the 2nd day the symptoms receded a bit, the thing that didn't was this pain and weakness almost inflammation and stiffness in my hands. I couldn't easily grip things in my hands without being in extreme pain. I couldn't hold a mug, a pen, barely tie my shoelaces. This lasted for well over a week, in extreme pain. It has gone down, my fingers don't hurt anymore but I still feel stiffness and fatigue in my pointer and thumbs going down to my wrist in both hands. Opening jars, writing, scrolling through phone is very difficult. I called my doctor several times to get advice after this was continuing and they recommended ice or heat and take ibuprofen this was leading up to the holidays. They said get in touch post holidays if still an issues and I will since it's still an issue. it's primarily running along the side of my hands where my point finger and going down my wrist.
on a ladder pulling wire, turned wrong and popped his shoulder; on a ladder pulling wire, turned wrong and popped his shoulder and neck; Sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder), NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder), NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache). On 12-Apr-2021, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (headache) had resolved. At the time of the report, LIMB INJURY (on a ladder pulling wire, turned wrong and popped his shoulder) and NECK INJURY (on a ladder pulling wire, turned wrong and popped his shoulder and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient's granddaughter visited one week prior to 12-Arp-2021 and the granddaughter tested positive for Covid-19.  The patient did not take a Covid-19 test.  The patient was taking steroids, unknown dose and frequency for shoulder and neck injury.
Fatigue staring 24 hours after vaccination and lasting 48 hours. Headache 72 hours after vaccination.  Sweats and chills, cough, nausea and vomiting all  72 hours after vaccination.
Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscularly. The patient had a shooting pain that went down her arm, back up around her head and down her other arm and into her legs. It also affected her sight and hearing. The patient did not mention this to her physician until she came back for her second dose. The physician did not administer the second dose. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from the licensed practical nurse concerning the 18 year old female patient with no illness at the time of vaccination who on 27-JUL-2009 at 2:35 pm was vaccinated with a first IM dose of GARDASIL (Lot # 0702X) into her left deltoid. It was reported that there was no adverse event. It was also reported that when the patient visited the doctor's office on August 2009 she was OK. Additional information is not expected.