chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 minutes status post vaccination while sitting in the observation area the patient indicated to the RN nurse observer that she "felt her face was flushed". Pt was seen and evaluated by NP, a redness was observed on patients bilateral cheeks and forehead. Pt was negative for chest pain, SOB, Facial Swelling, or N/V. There was no rash noted vital signs were taken, Patient was treated with 50mg of oral diphenhydramine, EMS was activated, pt was able to ambulate out of the vaccination center under the care of EMS and was transfered to the Hospital for further evaluation.
sore injection site left arm.; Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm.) and EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 014F21A, 031B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.). On 26-Mar-2022, the patient experienced VACCINATION SITE PAIN (sore injection site left arm.). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm.) and EXTRA DOSE ADMINISTERED (Patient received his second Moderna Covid-19 booster dose 2 days before a second booster dose was approved.) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-526778, MOD-2022-526820, MOD-2022-526822 (Patient Link).
2 insect looking bites on buttocks; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (2 insect looking bites on buttocks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METHOTREXATE, FOLIC ACID, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and TRIAMCINOLONE for an unknown indication.    On 04-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 ARTHROPOD BITE (2 insect looking bites on buttocks). At the time of the report, ARTHROPOD BITE (2 insect looking bites on buttocks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medications were Benadryl Gel and triamcinolone cream.  No treatment medication was provided Patient stated that she had 2 insect looking bites on the back of her buttocks that went away after taking an antihistamine. Patient stated that she completed the form but don't know how to return it via email. Patient printed it out and copied it if you can send an actual address to mail it.   This case was linked to MOD-2021-254162 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Non significant follow up received and does not contain any new information
Narrative: Patient developed lightheadedness after 1st dose of Pfizer covid vaccine. No intervention or management needed.
Patient received Ofizer vaccine. Was sitting in the waiting area stating he felt dizzy. After about 8 minutes he felt nauseated and threw up
Patient reported to pharmacy 3 days after vaccines were given with a large, red, painful rash on his upper arm. (Left).
Had 2 differents vaccines and had 3 mild cases/suspected vaccination failure; 3 mild cases; Could not sit because of location on spine; Felt like severe fiberglass rubbed deeped into my skin; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 differents vaccines and had 3 mild cases/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 3 mild cases), mobility decreased (Verbatim: Could not sit because of location on spine) and pain (Verbatim: Felt like severe fiberglass rubbed deeped into my skin). The outcome of the vaccination failure was unknown and the outcome of the shingles, mobility decreased and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, mobility decreased and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, mobility decreased and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient have had three mild cases of shingles and would go without eating if I had to, in order to afford the vaccine not covered by his/her insurance. The patient received two different shingles vaccine and his/her first reaction was it felt like severe fiberglass rubbed deep into his/her skin but got worse. The patient could not sit because of location on spine and had to lay on his/her stomach. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
fever 100-101 forabout 6 -12hr overall body aches, chills, intermittent for 18 hr headache 24 hr sore left arm 18 hr
Information has been received from a consumer concerning her 11 year old granddaughter, who in September 2009 was vaccinated with the first dose of GARDASIL (lot # not reported). Subsequently, after she received the vaccine, the patient began to feel dizzy and nauseous. The patient recovered on the same day. The patient sought unspecified medical attention. Follow up information has been received from a consumer who reported that her granddaughter in approximately in October 2009 received her second dose of GARDASIL (lot # not reported). No adverse effects were reported. No further information is available.
09:45 Stiff neck; approximately 10:15 tightness in throat; 10:30 tightness in chest; 10:45 pressure/weight on chest making it a little difficult to breathe. 1st reported to nurse at 11:00; recheck at 1:00. Manufacturer notified 1:45; doctor notified 2:00. Ambulance 2:20 to ER.
pt recvd vax; 5-6 wks(ongoing) muscle fatigue,primarily shoulder gridle & calves along w/ diffuse fasciculations except for polyclonal inc of gamma globulin protein fraction; esr 12;exam by internist & neurologist neg;
two blood clots in his leg; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 08Feb2021 (Lot Number: EM9810, unknown expiration) and second dose on 02Mar2021 (Lot Number: ENU202, unknown expiration; pending clarification), both received at the age of 57 years old via unspecified route of administration as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter called to report that the patient had a Pfizer vaccine, received second COVID vaccine on 02Mar2021, and couples of weeks ago, a week longer that the patient was diagnosed with two blood clots in his leg. The patient got both of COVID-19 vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT CAME TO  THE PHARMACY ON 11/16/2021-COMPLAINING ABOUT THE REDNESS OF THE ARM, MILD SWELLING AND PAIN-RECOMMENDED PT TO TAKE BENADRYL AND PATIENT TOOK BENADRYL,, FOLLOWED UP WITH PT ON 11/17 AND 11/18-PT RECOVERED COMPLETELY ON 11/18/2021
3 day after vaccine had fever 100-101 degree F, irritability. Maculo papular rash.
Had both vaccines/got both illnesses anyways/Suspected vaccination failure; got both illnesses anyways; got both illnesses anyways; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated works about as well as the COVID vaccine.  The patient had both vaccines, got both illnesses anyways.  The patient stated that it was all a scam. It was unknown if the reporter considered the shingles and covid-19 to be related to COVID VACCINE.    Additional Supportive Information:This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming the targeted event were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. In worst approach, the case was kept valid for events Suspected vaccination failure, shingles and covid-19 considering that the patient was reporting about target disease.
Information has been received regarding a case in litigation from a lawyer and the spouse of a 71 year old deceased male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider at a hospital for the long-term prevention of shingles and zoster-related conditions. On or about 13-DEC-2016, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider at a hospital. On or about 03-JAN-2017, the patient was treated by a physician at the hospital for the following injury resulting from his use of ZOSTAVAX: Shingles. The outcome of the shingles was unknown. The patient died on 11-DEC-2017. The cause of death was not reported. It is unknown if an autopsy was performed. There are claimed damages as a result of: injury to themselves, injury to the person represented, wrongful death, survivorship action, loss of consortium, loss of services, and economic losses. Upon internal review, death was determined to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: Death.
Chills, headache, loss of appetite and loss of energy, and feeling like I am overly hot.  Symptoms started within a few hours of having received the shot and have continued through today, 8 February 2021.  Taking Advil seems to help somewhat but I still have no appetite and no energy.
patient said she's been experiencing fever and has a knot on her arm. she has been taking tylenol and advil
I had a running nose, stuffy head, dry throat, unproductive cough, and headache. I tested positive for COVID-19 at home. I talked to my doctor, and she prescribed me fluticasone and azithromycin. I still have a stuffy nose and a little cough.
My entire right hand and fingertips became very cold as soon as the vaccine was administered. This was less than 1 minute. The vaccine was administered in my left arm. Since then I have been experiencing intermittent very cold hands (entire hands and fingers) as well as my feet (all in the right extremities.
Vaccine given in same arm and same location arm feels weak.; Arm tingling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within two weeks. On 13Apr2021 at 06:00, 8 days after vaccination, the patient had experienced weak arm and tingling as if it was sleeping in the same location in same arm of vaccine given. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events weak arm and tingling was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sinus headache for 8 days. Severe brain fog. Would forget names of things. Would have to stop talking mid sentence because I could not remember what I was talking about. Felt unsafe driving because I could not focus. Nausea.
Nervous break down; Agitated; Nervousness; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep). At the time of the report, MENTAL DISORDER (Nervous break down), AGITATION (Agitated), NERVOUSNESS (Nervousness) and INSOMNIA (Couldn't sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information reported.   Reporter did not allow further contact
ANXIETY/SLEEP ISSUES; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced anxiety/sleep issues. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety/sleep issues. This report was non-serious.
I had blood in my urine and then it went away. Then, my back started hurting and I thought I had a kidney stone. I went to the Emergency Room to verify, and they told me that I have 3 kidney stones. I was prescribed Cephalexin, Tamsulosin, and Ibuprofen. I have to follow up as soon as my doctor calls me with the appointment.
patient reported headache and dizziness that started the day after vaccination and persisted for 4-5 days after the vaccination with some episodes of pre-syncope
Information has been received from a certified medical assistant regarding a 23 year old female patient with no drug reactions or allergies. The patient's medical history was unknown. Two years ago, in 2011, the patient was vaccinated with the first two doses of GARDASIL (dose, route and lot number were not provided). Concomitant medication included norgestimate. Now, the patient was at office inquiring if she can receive her third dose. The patient stated she developed swelling around the injection site after she received her second dose. The patient did not receive treatment for the adverse event. Subsequently, the patient recovered. Additional information has been requested.
I feel not so good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received Shingrix. On 10th October 2020, 1 days after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt not so good.
EMS arrived, pt signed to not be given or taken by squad.  Redness resolved, no noted resp distress & remained at clinic for approx 25 more mins. Pt felt well & wanted to drive home. Follow up call 15 mins after pt leaving (stated he was fine to drive & spouse was at home). Pt feeling well & at home without difficulty. Reminded pt again of side effects & when to call 911.
On 10/31/18, Patient received his second round of infant vaccines. A few hours after vaccines, he became extremely fuzzy and would not nurse, eat, or take a nap. Around 5 pm, I noticed he was turning red and hot, and realized he had a fever growing. I first recorded his fever at 102.3 degrees. I gave patient a lukewarm bath to try to decreased his fever. That did not help and instead his fever increased to 104.9 degrees, within an hour or so. He was beyond inconsolable and very irritable. There was swelling and redness at the injection site on both of his thighs, and his head and body were extremely hot. I immediately rushed him to Hospital. We stayed overnight in observation and until he was stable and his fever had gone down. He had diarrhea that lasted over a week, which made him very lethargic and dehydrated. He also developed a minor rash on his upper torso area. His babbling decreased, and at age two, he is experiencing a severe speech delay, as well as behavioral problems.
pt recv vax not following lights or objects, lethargic, screaming @ noc; eyes had bug eyed look;devel stopped & reversed, head seemed to swell, hurts himself;does not walk or talk;pt in wheel chair;mom feels pertussis encephalopathy;
We had that the patient received one booster dose (3rd dose) in our system and they stated and again verified before administration that they were going to be receiving their second booster (4th dose). The patient has not reported any adverse events, but later stated it was actually his 3rd booster (5th dose) after administration.
High fever initially observed at 101 F and trending up to 103.8 F by the end of the day.  Significant lymph node swelling the following day with a mild fever.  No fever the third day, and reduced lymph node swelling.
pt devel vomiting the day p/vax, then also devel diarrhea;pt had decreased activity & decreased oral intake;17APR99 pt was hosp for IV hydration;
FEVER AFTER IMMUNIZATION-FIND ERYTHEMATOUS RASH 4 DAYS AFTER IMMUNIZATION
11/8/07 Heat, redness 3x5 area right arm at site of zoster vaccine.  Pain started 11/8/07.  Saw private physician - given Rx of doxycycline 100mg BID x14 days.  Dx: cellulitis.
The shot itself wasn't abnormal it was sore like normal. A month later I got a cold that lasted for a week then it cleared for two days. Then I started feeling sick cough, headache mainly the cough. Everyday it got worse harder to breath Jan 10 I lost the ability to bear weight. I took a few test they all came back negative. I went to my doctor, and she checked my lungs they were clear, and I went home. Jan 31 my dr. sent me for a chest x-ray and it showed I had a enlarged heart. I then went to a HCF they did a echocardiogram the assist kept making faces and told me I was very symptomatic. They did transfer me to the ER department. They gave me two IV and then send me by ambulance with lights to another facility where they did surgery inserted a needle pulling fluid off the heart. Then I was in cardiac ICU I was there until the 20th which is when I was discharged. Two weeks later I went to see the Cardiologist and he said everything was fine. The medication they put me on for my heart has created even more issues and now I have to see another dr. about that.
Pt was administered Engerix-B vax on 22AUG91, reacted w/nausea, vomiting, diarrhea, h/a & fever; On 29SEP91 same patient was given Recombivax, reacted w/nausea w/in 1-2 hrs;
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial information received on 16 October 2007 from a health care professional. An elderly, (age not specified), male patient had received an injection of influenza vaccine, manufacturer unknown, lot number unknown, and route and site of administration not provided; on an unspecified date in 2006. On hour post-vaccination, the patient developed generalized hives and since then has had chronic urticaria. The event required a doctor visit. Treatment included multiple unspecified antihistamines. Pre-existing medical history included a possible allergy to FluMist. It was unknown whether the patient was taking FluMist at the time of vaccination. Illness at the time of vaccination was unknown. At the time of this report, the patient had not recovered.
After getting home 2 hours after 2nd dose, felt a little woozy all of a sudden and had slight chills and mild headache.  Lay down for 2-hour nap.  Felt much better after my nap.  Went out for a walk and had no further side effects.