chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right upper thigh swollen, red and hot around injection site about 10 cm x 7 cm. Seen in ER 7/30 treated with Keflex. Recheck 7/31 with reduced redness. Phone follow-up 8/1 - much improved.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 76-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date June 2019) for prophylaxis. On 27th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 12 days after receiving SHINGRIX, the patient experienced generalized pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was unchanged. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided  as follows: The patient received SHINGRIX on an left deltoid. The pharmacist states patient experienced itching all over the body. The patient took Benadryl and it was not helped her till the time of reporting. No further information was provided by the pharmacist.
Patient received vaccine 3/14/23 at 1530. Per provider visit note 3/15/23 -  She passed out this morning.  She woke up, felt a little sick/nauseous.  Then dizzy/nauseous and passed out.  Mom witnessed the episode.  Mom caught her, did not hit her head.  Had a HA this morning.  Has a hx of migraines.  No cold sx.  No ST.  No V/D.  Eating and sleeping fine.  Has eaten today.  Denied FHx of cardiac issues.  Denied CP/SOB.  Sx slightly improved.  Had men B #2 yesterday.  Left arm feels sore.
48 hours after vaccination child became febrile. Temps ranging from 99-102 for 5 days with no other symptoms. Father spoke with Dr office over phone. No OV or treatment.
PROQUAD. Pt waited 15 minutes. When I went to check injection site, pt had a welt and redness near injection area.
5/7/21: Woke up with Extreme Exhaustion, Fever and Nausea - stayed home, took tylenol for fever, did minor activities and slept as necessary 5/8/21: Fever gone.  Exhaustion and nausea still present but less severe 5/10/21: Exhaustion still present but less severe 5/15/21 @~8:30 am EST: Notice 5 red areas on inner upper right arm area.  No pain or swelling  Went to Hospital ER for evaluation. 5/15/21 @~10:30 am EST: ER diagnosed blood clot in upper right arm. Was put on blood thinners (Eliquis) that day and was told to continue for about one month and follow up with primary care physician. 5/19/21: Saw primary care physician to review Hospital data (History: Patient had a provoked blood clot (i.e. due to "bad" blood draw for donation) in Summer 2019 in the upper left arm. Was on blood thinners for 3 months - clot gone after that. Didn't continue taking blood thinners due to good medical health history and no personal history of blood clots or family blood clot issues).  As of this report submittal, still on blood thinners.
She was experiencing headaches, joint pain, and fever; She was experiencing headaches, joint pain, and fever; She was experiencing headaches, joint pain, and fever; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient of an unspecified age received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was experiencing headaches, joint pain, and fever on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Suspected vaccination failure; Got the shingles / very mild case; They still hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself or herself. The age at vaccination was not reported. The patient reporter that, he or she got the shingles a few years after receiving the Shingles shot very mild case but they still hurt. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Administered Expired Vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine to a patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039C21A) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine to a patient). On 29-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported
death N17.9 - AKI (acute kidney injury) (CMS/HCC)
Patient was given 5-11 year old pfizer covid vaccine vial (10mcg/mL) diluted with 2.2 mL sodium chloride. Spoke with guardian, patient does not currently have any side effects or issues reported.
1st shot on 3/23/21; had period on 3/28/21 (first one in five months so thought it odd since assumed was menopausal); 2nd shot on 4/14/21; had period on 4/21/21 (again thought was menopausal so found this very disconcerting. Also, this second period was much more heavy and lasted longer than the one previous month). I didn?t assume the periods were related to the COVID shots until I saw an article about other women reporting same.  Just wanted to share this in case it turns out to be related to COVID vaccination.  Will wait to see if I have another period in May, since no more shots.
Symptoms include pain/decreased range of motion to right arm 1-2 days after receiving Flu vaccine. Pain was present every day until seen by PCP on 12/6/22, pain was mild-moderate from 11/15/22-11/28/22. Pain/decreased ROM became more moderate-severe after the week of 11/28/22. Severity of decreased range of motion-cannot lift arm above shoulder height or perform activities of daily living such as brushing hair, etc that involve right arm.  Pain is dull, aching pain with/without movement. When arm is lifted above shoulder height, pain is sharp. Pain makes it difficult to sleep on affected right side.  Seen by PCP Dr.  on 12/6/22.  Was prescribed medication and scheduled for MRI on 12/15/22. Referral sent for physical therapy.
Information has been received from a physician who reported he had four doses of varicella virus vaccine live, but did not seroconvert. On 03/29/2001, the pt was vaccinate with fifth dose varicella vaccine that expired on 03/29/2001. Unspecified medical attention was sought. Additional info has been requested.
Four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine; Four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported In the last few days, reporter have had four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Also, reporter aware of two other cases in vaccinated patients who are being seen by colleagues. This may be sampling issue, but it was running contrary to the conventional wisdom that most of the cases are in unvaccinated people. Last patient out of four was a 68-year-old man who had a syncopal episode. His only symptoms were severe muscle aches and a headache. He also appears to have spread it to his wife and adult daughter who are also all fully vaccinated. They had the same symptoms. The entire family had their Pfizer vaccinations in March, and all three are positive. Are others seeing this. Are we missing more of these vaccinated cases because we no longer routinely test vaccinated people who are not having typical presentation.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of drug ineffective and COVID-19 and the suspect product of BNT162B2 cannot be completely ruled out.
less than a  week after the vaccine I had difficulty speaking, like I forgot some words at the same time that my head was lightweight and felt a pressure, it went away after some minutes and I decided not to give it importance I had a second episode on 3/25/2022, I couldn't see from half of my right eye, and I felt a little dizzy, I ate something , thinking that maybe I was weak for not eating, later I was talking and I forgot a word, that was there , but I couldn't say it, I change subject and it happened again and again in each frase I was saying, I couldn't finish any frase, and started to try to explain words with the meaning of the word, and sounded a little weird, so I apologized and changed subject again, but every frase was like that, until I was able to say short frases and decided not to talk any more, later I went back to normal, but my head was very pressured, like my brain was shrinking, I went to sleep, worried the it would be worst next day, but it went away, but now I have this pressure on my head constantly
Her blood pressure was very elevated.  EMS was called and taken to the hospital. She had COVID many months prior.
Approximately three hours after receiving the vaccine I became nauseated. I had been sitting with my legs extended, as I attempted get up from the chair I experienced a severe cramp to my left anterior leg and my knee was locked. After several minutes I was able to stand and the cramp subsided and my knee was no longer locked. As I began walking I became extremely hot and sweaty and felt light headed. I then fainted. No injury, with my husband's help and the wall I eased to the floor. After approximately 30 seconds I was able to get up and walk an additional eight feet to my bed. I still felt nauseated, hot and sweaty for 10 minutes longer. This sequence of events lasted about 15 minutes. I then felt fatigued and slept for 45 minutes. When I woke up I felt fine.
COVID Arm which began on day 2 and worsened over the next 3 days.  As of today 11/15/21 I am still waiting for it to resolve.  Also had body aches, fatigue, and mild headache which did end.
I received my 5th booster shot on 09/23/2022. My COVID-19 Infection symptoms started on 11/27/2022 in the morning around 8:00AM. I had body aches, sore throat, congestions, and slight cough. On Sunday I called my doctor she prescribed me with PAXLOVID for 5 days. I took over the counter ADVIL, TYLENOL, MUCINEX and ZYRTEC as per needed. I tested negative on day 5. On day 7th tested positive for COVID-19 infection again this time I repeated the same over the counter medications. On 12/23/2022 I felt bad. I had low grade fever and I was vomiting. I tested negative for COVID-19  since I didn't test for Flu I wasn't sure what this was.
Severe body aches way worse than flu. Felt like hot coals burning into my joints  Chest pain Fever Chills Headache
Felt faint and started vomiting immediately after receiving vaccine, vomited several times, felt better after approximately 10-15 minutes.
Acute ischemic Optic Neuropathy (eye stroke) right eye. Loss is peripheral vision.
I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body aches; Chills; This is a spontaneous report from a contactable nurse reporting for self.  A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot#  EK923, via an unspecified route of administration on 05Jan2021 08:45 as a single dose (dose 1), left arm (age at vaccination: 36 years old), for COVID-19 immunization.  The patient was not pregnant at the time of vaccination. There was no other vaccine administered in the 4 weeks prior to the COVID vaccine. Medical history included multiple sclerosis and hypothyroidism . The patient was receiving unspecified concomitant medications ("10 meds").The patient previously took copaxone and experienced drug allergy.  The patient reported having a sore arm, but also had been having a low-grade fever. The highest it had been was 99.5. The patient also had body aches and chills. These symptoms started couple hours after the injection (on 05Jan2021) and have been with the patient since then. The events were reported as non-serious. There was no hospitalization or treatment received for the events. The outcome of the events sore arm, low grade fever, body aches, and chills was not recovered. The patient had not been COVID-19 tested post vaccination.
Severe headache which was immediate. chills & fever for 3 days, tremors lasted an hour or two day of vaccine, body aches a day, brain fog example trouble concentrating, forgetfulness hard to focus still have but is improving. I called my Doctor and was prescribed a Migraine medication which seems to helping greatly. Missed two days of work due to fever and headache.
Red hard itchy bump, about the size of a 50 cent piece,  at site of injection. Only on second dose.
Redness and swelling on upper arm, warm/cold compresses, some pain, no changes at time of reporting. Has no deficit in range of motion. Pain not as bad when distracted (swim team).  Will monitor site and add TYLENOL/MOTRIN as needed for pain. Parent will phone back after weekend to report on progress, or phone as needed.
Severe joint pain in elbows, knees, and shoulders. Hands are becoming numb has difficulty in gripping or making a fist. Shaking in hands began today. Elbows painful to touch. Injection site unremarkable.
swollen left armpit; swollen left FOREARM; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 10:45 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER0732, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 02Feb2021, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 05Jan2022, outcome "recovered", described as "swollen left armpit"; OEDEMA PERIPHERAL (non-serious) with onset 05Jan2022, outcome "not recovered", described as "swollen left FOREARM". The events "swollen left armpit" and "swollen left forearm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, oedema peripheral. Additional information  No other vaccine in four weeks, No Other vaccine in two weeks. No covid prior vaccination. The swollen armpit subsided, the left forearm has not even after 40 days since the covid booster.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US010648 is an initial spontaneous report received from a nurse on 22 May 2014 with a follow up report received on 19 Jun 2014. This report refers to a 13-year-old female patient. She received only the powder component of MENVEO (batch number: A12102) mixed with sterile diluent instead of MenCYW-135 liquid component, intramuscularly into left deltoid, on 17 Apr 2014 at 10:58 am. The reporter believed that the sterile diluent was normal saline but she was not sure. Reporter insisted that the patient did not experience any adverse event following this medication error. Follow up reported on 19 Jun 2014: Updated patient demographics (height and weight), vaccination details (left deltoid at 10:58 am) and changed batch number (M12102 to A12102).
Moderate-severe pain in her large leg muscles; moderate pain in arm at injection site for a few days; This is a spontaneous report from a non-contactable nurse (patient) received via a Pfizer sales representative.  A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 and experienced moderate pain at injection site and fatigue. In Jan2021, the patient experienced moderate-severe pain in her large leg muscles for at least 24 hours and moderate pain in arm at injection site for a few days.  The patient outcome of the events was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
Patient given TDaP 6-29-17 pain in RD that day and has continuing pain as of 7-6-17. Advised to alternate hot and cold compress. Move her arm in a circular motion. Rx MEDROL dosepak.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient around 65 years old. The patients medical history and concurrent conditions included diabetes mellitus, wheelchair user, disability, allergy to TYLENOL, sulfonamide and cephalosporin. On 22-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, lot number and expiration date were not provided). Concomitant therapies were not provided. The patient stated that in April 2016, her unspecified arm was swollen and she had unspecified injection site pain. Additionally the patient experienced, injection site swelling, injection site erythema and injection site irritation. No treatment was given for the adverse events, the case did not involve cancer or overdose. The outcome of injection site pain, injection site swelling, injection site erythema, injection site irritation and peripheral swelling was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Severe lower abdominal pain and weakness for about 6-7 hours a day after vaccine administration.
I had the flu shot 11-7-07 at around 11:00 am. At around 11:00 pm. I woke up itching all over. By 4:00 a.m. 11-8-07 I had hives all over. I went to the emergency room and was treated. I also had chills. This lasted through Friday evening. 11-9-07
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 23/40 which was not suggestive of malingering (<6). The patient was diagnosed with severe mircosmia (5th percentile). The PEA (phenyl ethyl alcohol) test scores were -6.38 left, -5.50 right and -6.00 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
This spontaneous report was received from a physician assistant and refers to a patient of 13 or 14 year old of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In August 2017 (reported as "about 14 months ago, when the patient was 12 years old"), the patient received the first dose of GARDASIL 9. On 23-OCT-2018, the patient was in the office to receive the second dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) (inappropriate schedule of drug administration). No adverse effects reported.