chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within an hour of receiving vax, pt's right arm, from injection site to elbow and 2" above injection site, became red, swollen, painful (could not lift arm) and warm. After 2 hours, pt noted to have a pink line running from armpit down to elbow. Pt was seen on 11/3/01 and given an injection of Cephalosporin and a prescription for antibiotics. She was instructed to follow up with her MD if condition worsened. On 11/5/01, the swelling and redness improved, but pt had a knot at the injection site and it was still tender to touch. Pt had a previous dose of the pneumonia 23 vax in 1994 with no reaction reported.
Rapid fluttering heartbeat over course of 3 months. Attacks increased in frequencey and intensity as time went on.
head hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts a lot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head hurts a lot). At the time of the report, HEADACHE (head hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Information has been received from a registered nurse concerning a 67 year old male with high cholesterol, asthma, chronic rhinitis and hypertension who on 19-DEC-2006, was vaccinated SC with a second 0.5 ml dose of Pneumovax 23 (lot# 655499/0988F). Concomitant therapy included ADVAIR, BENICAR, COMBIVENT, NEXIUM, montelukast sodium, cough, cold and flu therapies (unspecified) and an unspecified cholesterol medication. The next day, the patient's arm was very red and swollen and his temperature was 102F. He was seen in Urgent Care and was diagnosed with cellulitis at the injection site and allergic reaction. The patient was treated with doxycycline and prednisone. At the time of this report, the patient's outcome was unknown. It was noted that the patient received his first dose in May 2004. No product quality complaint was involved. Additional information has been requested.
6-8 weeks after immunization, I developed poly myalgia. Never had issue with muscles and joints before this.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: SHE REPORTED EYE FLASHES AND EYE FLOATINGS ON 12/20/2021 VIA PHONE. SHE HAD AN APPOINTMENT WITH MD ON 12/20/21.
Severe brain fog/mental fatigue for an extended period of time following Pfizer Covid shot (severe several weeks, extended several months). Inability to process complex though or focus, brain moving slowly, mental fatigue. Couldn?t effectively do my job. Also noted alcohol had a negative effect, with hangovers increased 4x. After 13 days, I notice that coffee is causing the issue to amplify. I quit my daily coffee and immediately noticed an improvement. After 3 days of caffeine withdrawals, I finally felt better. So essentially, the combination of the vaccine symptoms and caffeine caused extended brain fog.   Feeling better, I got the second shot. Had a typical real bad reaction with fever etc., but no extended brain fog like previous, only a little loopiness immediately after. However, 1-2 weeks later after I think all is well, I get some brain fog/mental fatigue returning with the use of alcohol and caffeine, reactions that would not be typical with mild usage. I quit coffee/caffeine again to stop the symptoms. After 2 weeks, alcohol did not have a negative effect, but caffeine continued to, so I stayed off. At this point, I started a Vitamin D supplement since my doctor noted I was low.   2 months after the initial shot, I try coffee again, and it slows my brain down quite a bit. So it?s quite an extended issue at this time. At 3 months, I saw a neurologist, who recommended trying different and smaller amounts of caffeine. Trying tea, the issues remained. But trying Coke, it felt like normal caffeine, but had me wired. After this, I was able to slowly increase from extremely small coffee/caffeine amounts without feeling brain fog, and this is where I?m at today.   My Doctor and I have a more detailed summary of issues if that would be useful.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:07 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 28.72 for dose administered on 13-Feb-2021 and 28.82 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34,37 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-April-2021. Product moved to clinic on 20-Mar-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I had a migraine that came on instantly. I had no warning. The migraine lasted for two days. This happened during the observation period.
BLEEDING AT INJECTION SITE (BLOOD ON BANDAID) BRUISING AND THE SHOT HURT
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "bee stings" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I had tested negative the day before; Positive, notes: I started taking Paxlovid on Day 1 after testing positive for Covid; Negative, notes: Tested negative on day 7; Positive, notes: However on Day 9 I developed symptoms and felt sick again and tested positive. I continued to be sick and test positive for a full week. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient started taking Paxlovid on Day 1 after testing positive for Covid. She had tested negative the day before, but was experiencing a sore throat, cough, and runny nose. After starting Paxlovid, she started feeling better by day 2 or 3. She completed the 5 days treatment and tested negative on day 7. However, on Day 9 she developed symptoms and felt sick again and tested positive. She called my doctor for a second round of paxlovid and he said it was not necessary. She continued to be sick and test positive for a full week. She believed the 5 days treatment was not sufficient to fully rid the virus from her body. If she had to do it again, she would not take paxlovid unless she was offered a 10 days dose.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
mom brought pt to hlth unit on 26MAY @1PM;mom said pt just started shaking now but had fever & cried all noc; t102.2 now pt is shaking as w/chills; chest congested;referred to MD;given APAP;seen by MD 26MAY put on ATB;MD said had red throat
Patient states that she had a little soreness after the vaccination for a few days, but then it went away. However, 7 days after vaccination (07/09) the patient states that at night her arm was very painful that she cried and took some ibuprofen. Patient states that it still hurts today (07/10). Patient is going to take some ibuprofen for a couple days and then if not relieved will go to an urgent care. Patient states no redness or swelling.
First night: Restless sleep, bad dreams, very sore arm.  Second night: Sore arm, achy joints, slight headache. Third night: Sore arm, night sweats, very sore hip.  (low energy all days)
Redness and itching started 10/6/15. Now, c/o redness, pain, warmth itching. Reaction two fingers below (L) shoulder to about 2 fingers above elbow. Low grade fever at visit (99.2) cetirizine, clobetasol propionate, and prednisone prescribed.
Approximately one month post vax, the vaccinee developed diabetes insipidus and a tumor on his pituitary gland. The vaccinee is receiving replacement therapy for his pituitary tumor.
Received immunizations in this office on 5/31/06. She was noted to have an otitis media withoutfever. Mother called the office on 6/1/06 and talked to the nurse because she was running a fever and not acting quite right. She was given standard instruction for post immunization. During the night she became febrile and started having respiratory difficulties with her pulse ox dropping into the 80's. Mother drove her to the emergency room. In route the child became apneic. By the time she arrived she was asytolic. Rescussitation was unsuccessful. She had a temperature of 107 when she arrived in the ER.This patient had fever and cardiovascular colapse within 48 hours of immunization. I feel this was a major immunization reaction. 7/18/06 Received medical records from ER which reveal patient developed respiratory distress & failure.  PMH: tracheomalacia, developmental delay, chronic respiratory deficitis & congenital heart defects.  Had trach & PEG in place & was on home O2. Developed decreased LOC prior to hospitalization with cyanosis despite O2.  Found to be febrile at 107, apneic & asystolic in ER & resuscitation was unsuccessful. 7/31/06 Received medical records from PCP which did not add new info. 8/9/06 Received Death Certificate which stated COD as pneumonia with dehydration with tracheomalacia as underlying cause./ss
08/24/18- received flu vaccination. 08/27/18-08/30/18 symptoms of severe pain on my scalp behind my right ear. Right neck pain into right clavicle, pain to back of right scapula. 08/31/18- woke up with complete right sided facial paralysis- went in to see my doctor- dx with Bell's Palsy 09/11/18- developed mild right ear pain- dx with Ramsey Hunt Syndrome. 09/18/18- follow-up appointment- Right ear pain more severe- face is still paralyzed. 09/19/19- developed zit-like rash behind right ear and a few bumps on right side of neck. Ear pain severe at this point. Prescribed pain meds and nerve medications. Present- still having right ear pain and facial paralysis.
My arm is hard and feels like I have a knot in my arm.  The area where I got the injection is warm
Pt had near syncople episode at the front desk while mom was checking out. Color was pale, remained awake. BP 88/58 awake, alert and walked out of office 15 min after episode.
I received my second Pfizer COVID-19 booster on 4/21/2022. On 12/11/2022, my husband tested positive at home, whereas I tested negative. We then went together to an urgent clinic, where I was retested. The clinical test was also negative, but I could tell that I was getting some of the early symptoms of COVID-19, particularly a scratchy throat. Even though I tested negative, the NP told me that my symptoms indicated that I was following on my husband's heels. I was then advised to take another test in 24 or 48 hours. I did this, and I tested positive. I took the advice that the NP gave my husband, which was to self-isolate, take cough drops, take ibuprofen for fever, and gargle with salt water. Besides the scratchy throat, I also experienced intermittent fevers, fatigue, coughing, and loss of taste and smell. I felt better within 7 days after the onset. I tested myself every other day during this period. It wasn't until 12/21/2022 that I tested negative. At the time of this writing, I feel fine for the most part, though my energy isn't as high as it was prior to the COVID-19. I am also still dealing with the loss of taste and smell.
3 hrs p/vax pt woke from a nap; was lying on back for diaper change when became progressively pale over a 1-2 min period; eyes were not focusing on voice, pt was very dusky, gray circumorally, buccally gray/blue; fingers & toes white, limp
prickly rash on chest; 8 little dots that went away/it was red dots; itching/scratching in her head; sore arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Right arm on 06Mar2021 11:30 (at the age of 69 year old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. About 1.5 years ago, patient had a reaction; rash to Keflex, which was given to treat her sinus infection. After received the vaccine on 06Mar2021, on the next day, on 07Mar2021, she had a sore arm and that went away on the day after. Eight days later, on 14Mar2021, she was itchy, which lasted for 2 days. On 16Mar2021 she got a prickly rash on her chest. Also there were 8 little dots that went away in a couple days and she had scratching in her head everyday. The rash was treated with Neosporin because it was red dots, not like that, got red around the surrounding area.  Patient stated that, it was not a severe reaction, but minor.  At the time of report, the rash was fading, just sometimes feeling itchy, not all the time. She has itchy spots and the sensation of itchy. The patient's second dose is scheduled for 27Mar2021 and she is asking if it is ok for her to get the second. No relevant lab tests were done. The outcome of the event pain in arm was recovered, and of pruritus was not recovered and of other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Recurrent miscarriage, blighted ovum, 2 since vaccination. No previous history of miscarriage before this point and 2 previous live births.
Pt states woke up around 2am with extreme chills and stiffness having trouble moving and soreness in arms, shoulders, and neck.  She stated she had taken her temperature and was around 101.9.  She called today, 11/23/20, around 2pm and reported these events.  She states that she still has these symptoms and that her hands are swollen.  She had contacted her PCP and spoke to her about it.  She reports taking 1 Tylenol 325mg every 3 to 6 hours around the clock to try and help with fever. She states she can not take NSAIDS d/t CHF.  She states still running a fever and soreness, but has slightly improved since began Saturday night.  She states PCP told her to continue Tylenol and to seek medical attention if symptoms are not getting better or worsen in 1 to 2 days.
Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored ZOSTAVAX 19400 PFU (lot # L039095/expiry date 08-JAN-2017, lot # was reported as L046929/expiry date 17-FEB-2017, lot # was reported as L046295/expiry date 17-FEB-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch 74G79, expiry date 16th August 2019). On an unknown, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician believed that there was a quality issue with this lot because three patients that were administered the KINRIX vaccine and experienced a severe local injection site reaction. The physician would retain the product for return to GlaxoSmithKline for investigation. The physician was requesting that GlaxoSmithKline put a hold on this lot until investigation was completed. The physician was requesting investigation results. No credit was arranged. The physician refused to provide details and will fax the adverse event information to the safety department. The physician would also email photos to the quality department. The physician already reported the adverse events details to VAERS. This case has been linked with US2017175116 and US2017175119 as reported by same reporter for same event.
Initial unsolicited report received from nurse on 28-Aug-2018. This case involves a 25 patients who was vaccinated with a dose of vaccines MENACTRA (Batch number: U5948AB, U5848AA, U5986AA and U6015AA) (expiration date : 03-Jul-2019, 11-Mar-2019, 24-Aug-2019 and 06-Oct-2019), with a dose of QUADRACEL (Batch number: C5325BA and expiration date: 14-Nov-2019), with a dose of PENTACEL (Batch number: C5432AB and C5463AA) (expiration date: 29-Oct-2018 and 26-Feb-2019) with a dose of ADACEL (Batch number: U5850AA and C5546BA (expiration date: 17-JAN-2020 and 21-NOV-2020) (route and site of administration was not reported), ACT-HIB, TENIVAC, DAPTACEL and IPOL. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Shoulder pain at injection site. Patient noticed worsening two weeks after injection. Has been chronic, not resolving.
All of last night felt body aches; Arms are sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 11-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 PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore). At the time of the report, PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) outcome was unknown.        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.
After vaccines received, patient became pale, diaphoretic, clammy, and fainted.  Placed flat and legs elevated, cool compress applied to forehead for 15 minutes.
not sure if he got a full dose; syringe hit the bone; This case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered and wrong technique in product usage process. On an unknown date, the outcome of the incomplete dose administered and wrong technique in product usage process were unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The patient reported that he was not sure if he got a full dose of his first dose of Shingrix. The patient stated that he went to get his first dose last Friday 8th July 2022 and when the given the dose, the syringe hit the bone and full dose was not administered. The adverse event filed with very limited information. The reporter did not consent to follow-up. Additional supportive information: When the dose was given to the patient, the syringe hit the bone and full dose was not administered, which led to incomplete dose administered and wrong technique in product usage process.
5/09/2019-99.8 FEVER AND ACHY ALL OVER, STOMACH ACH --STARTED LAST NIGHT , BEEN TAKING APAP Q4HRS STILL DOES NOT FEEL GOOD.---5/10/2019-SORENESS STILL AND A RED RECTANGLE NEAR THE SHOT ABOUT 3 INCHES AWAY. 5/12-SYMPTOMS ALL RESOLVED