chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 4NOV95 & 5NOV95 pt devel a baseball-sized welt @ the inj site which persisted as of 77NOV95;6NOV95 pt devel hand swelling on the rt hand which has lessened somewhat but does persist;no further details known as of the date rpt
Headache Reports "Feeling hot, then cold", "Pressure headache 3-4/10 frontal area, body aches, excessive tiredness. On 1/20/21 employee reports that he feels much better. Education and guidance provided. Narrative:
Tested positive to covid 19 on 08/02/21; Tested positive to covid 19 on 08/02/21; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient experienced tested positive to covid-19. The patient underwent lab tests and procedures which included covid-19: positive on 30Jul2021.   Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID 19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records deviation investigations and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207 fill lot EN5340 and the formulated drug product lot EN5328.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of complaint investigation: The scope of this investigation included the reported finished goods lot EN6207 fill lot EN5340 and the bulk formulated drug product EN5328. Acceptable review of related documentation including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Document Review Summary: DEVIATIONS: Complete (Acceptable): There was one deviation investigation initiated related to in scope lots. QAR 5637107 The purpose of this investigation was to identify the root cause for exceeding the Time Out of Refrigeration limit of 46 hours during the production of the Covid 19 vaccine. Outcome for the event covid-19 was unknown. No follow-up attempts are needed. No further information is expected.
I was on my menstrual cycle and then a few hours after getting the vaccine it had just stopped. I had a severe headache that didn't go away for over a week and a half. I seeked medical care. I developed night sweats and heart complications. My GYN said my hormones were whacked. I had to be put on hormone therapy. I did a B12 shot to reduce it. My sense of smell reduced for about a half a day. I felt extremely fatigued to the point to where I couldn't do anything. I was in pain everywhere. Things that hurt before in the past started hurting again. I had loose stools. I still have issues with hormones and being able to absorb B vitamins. I can't take oral B Vitamin because my body is not absorbing it. My PCP put me on a bunch of enzymes and amino acids. I am being treated as if I was poisoned. I have been advised not to take the second covid shot because of the MRNA and my reaction to the first shot. I have nerve tingling issues and brain fog. I am now in the process of dealing with disability.
Lungs lost a lot of capacity which I was able to gauge by my swimming as well as being easily out of breath which is not normal
pt exp chills on evening of 26OCT93; next AM noted edema of axilla on arm used for inject along w/gradually inc vertigo & vomiting; seen by MD; had aching of entire body & was very tired, felt crummy x 2-3 wks;
No additional adverse event reported; Temperature excursion/ VARIVAX was administered to a patient; This spontaneous report as received from an office manager to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-FEB-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 time dose, lot # T022315, expiration date 30-JUN-2022 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of 5.5 degrees Celsius for 21 hours. There was no previous temperature excursion. Digital data logger was not involved. There was no adverse event reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005929:
Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: heavy menstrual flow for 2 periods after her 2nd vaccine, ears feel blocked, lump in chest, chest pain
Pt mother c/o soreness on R arm after vaccination . Pt mother states that Pt c/o redness at injection site of varicella vaccine larger than a quarter but smaller than a half dollar piece, some soreness at injection site.  Pt denies fever, rash, seizure, weakness, behavior changes, difficulty breathing, hoarseness, wheezing, hives, paleness, weakness, Tachycardia, dizziness. Offered appointment, pt mother has the VIS for Chickenpox States that red spot is not firm. States that she will continue to monitor vaccine spot and will call if she becomes concerned.
Fainted approximately 19 hours after vaccination for an unknown amount of time.   Horrendous arm pain.  Have been using Tylenol for pain.  Could not move arm and could not touch injection site area without severe pain.  Pain has lessened with use of Tylenol.
Acute Optic neuritis bilaterally, initial symptoms started 24 hours after injection, became severe a week after injection (lost sight in left eye). I was admitted to the hospital 1/19/21 and given 1000mg of Prednisone daily from 19th to the 22nd.
Redness, swelling and tenderness on arm. Significant swelling prompted appointment in Urgent Care.
Immediate sore arm at injection site that worsened over next 20 hours.  Peaking at night.  This reaction subsided the following day.   Fatigue and back aches the next evening on day 2.  Fatigue ongoing now still on day 4.
Pt. had trouble swallowing about 20 minutes after ZOSTAVAX. Contacted Dr, gave epinephrine pen injection one time in outer thigh. Pt. relieved and could swallow easily after one minute. No redness at inj. site - maybe developed - bumps felt.
blood clots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Additional information: What makes the Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines? I don't know much about the other vaccines except that Johnson & Johnsons wasn't good and my mom develop blood clots after reviewing hers. She used Pfizer I believe.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax c/o lt arm hurting & feeling heavy;pain increased;felt a lot of pain;took APAP;pt exp generalized aching & lt arm numbness;went to bed;awakened 6Am next morning w/no sx;
Information has been received from a Registered Nurse and medical records concerning a 14 year old female (65.5 inches, 114 pounds) with no known allergies who on 24-JUN-2011 was vaccinated with a first dose of GARDASIL (lot #666948/0886Z) intramuscularly in the left arm. On the same date, the patient was also vaccinated with a second dose of VARIVAX (Merck) (lot #669277/1697Z) in the right arm. After being vaccinated, while still in the physician's office, the patient experienced weakness, fainted and complained of visual loss. Her pulse was thready, her blood pressure was 60/40, she was pale with blue lips. Oxygen was administered, juice was given to the patient as well as candy. After fifteen minutes, the patient was still weak. She was sent to the Emergency Room via ambulance. On arrival the patient's vital signs were temperature 96.9, pulse 55, respirations 14, blood pressure 113/96 and oxygen saturation level 96%. The patient was treated for chief complaint of near syncope with a 0.9% sodium chloride infusion. The patient's electrocardiogram was normal. The patient's chemistry values were within normal limits, with the exception of elevated chloride 109 mmol/L, and complete blood count was within normal limits. The patient had improved, blood pressure was 98/52 and pulse oximetry 99%. The patient was discharged home with diagnosis of vasovagal syncope. At the time of report, the patient had recovered. Upon internal review, visual loss was determined to be an other important medical event. All available medical records will be provided upon request. Additional information has been requested.
7x10cm area of erythema w/2x3cm area of induration centrally
The next day I woke up very tired, mild headache, muscle pains, weak, shivering. The following morning however I woke up with an extremely severe migraine in my front left temple, it was the worst head pain I've ever experienced that I can remember. For the next 2+ days, all I could do was mostly sleep, I was so debilitated from the head pain.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # reported as "L008355" with expiration date on "09-SEP-2016"), (route and doses were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 hours after vaccines given, patient developed hives, coughing, high fever (temperature not taken), inconsolable screaming. Symptoms lasted, in varying degrees, for about 30 hours. Mom informed the provider 8/3/06 at which time Benadryl 6.25mg q6 hours was prescribed. Thereafter, patient started improving. By the time of evaluation by provider 8/4/06, patient's behavior was normal. He had 1-inch localized reactions around all injection sites except around the IPV site.
Shingrix series there are multiple lesions in a new spot; multiple genital herpes lesions in new; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included genital herpes (had 40 year history of genital herpes outbreaks consistently in 2 spots just one at a time.). Previously administered products included Shingrix (1st dose received on an unknown date).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced skin lesion and genital herpes. On an unknown date, the outcome of the skin lesion and genital herpes were unknown.   It was unknown if the reporter considered the skin lesion and genital herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had  40 year history of genital herpes outbreaks consistently in 2 spots just one at a time. The reporter stated that, after vaaccination with shingrix series, the patient edxperienced multiple lesions in a new spot that has never had lesions before. The reporter did not consent to follow up.
Woke with stabbing left ear pain a week after shot, intermittent, lasting a few seconds at a time and it dissipated when I got up. It happened again the next morning as well. I had this after the second shot, only it was more severe and would come and go throughout the day. That time, stabbing ear pain came and went over several weeks and finally went away altogether until I got the third shot.
Pt given booster dose of Pfizer Covid vaccine  for his 1st dose.  No reaction while pt waited in office for 15 minutes. No reaction reported to provider when parent was contacted in the evening.
pt c/o lightheadedness, dizzy, nausea. pt was seated, vitals taken, vitals wnl, after 15 minutes, s/s subsided, pt d/c home. vtals: BP 150/70, P 68, O2 97%, RR 20, T 98.4.
temperature this morning of right under 100 degrees; A spontaneous report was received from a consumer concerning a 79 year old male patient. Call was made by patient's wife. Concern was that the patient was having a raised temperature of just under 100 degrees but had since went away.   The patient's medical history includes Covid-19 infection in November 2020. No other medical history was provided. Concomitant product use was not provided.   Patient's wife reports that both she and her husband who tested positive for Covid-19 on 22 Nov 2020. Reporter stated they managed the symptoms at home for two weeks with the help of their health care provider. Reporter stated that they both received negative tests two weeks after convalescing.  Two to three days prior to the patient receiving the vaccine, he tested negative again.. Patient received one of two planned doses of mRNA1273 on 6Jan2021, for prophylaxis of Covid-19 infection, and the next morning had a body temperature of just under 100 degrees, which had since gone away. Called to inquire if he should have waited 90 days past infection to receive vaccine.   Action taken for mRNA-1273 in response to the events was not reported.   The outcome of this event was not provided.  The reporter did not provide causality for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pyrexia, a causal relationship cannot be excluded. Pyrexia is a listed event in all including CCDS.
sore arm, w/shooting pain up & down arm-pt has tired ice & advil-pain has dec but pain has cont
78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source.  PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery.
About 3 minutes after receiving the vaccine while the patient was waiting the recommended 15 minutes post-vaccination, the patient begain to experience symptoms of faintness. She tapped on our window to alert us but almost immediately began to fall out of her chair. Another patient being vaccinated at the time was able to catch the patient and support her head to keep it from hitting the ground. The patient was still alert, responsive, and in a sitting position on the ground when I reached her moments later. The patient shortly collapsed all the way to the ground; we were still able to support her head. We called 911. I rolled the patient to her back. I was able to find a pulse and was able to see the patient's chest rising with breaths. The patient still responded to verbal cues nodding that she could hear me. I removed her face covering to help ventilation. I checked the patient's blood pressure and it was within normal range. Within about 3 minutes the patient was considerably more alert. She asked for some water which we provided. Shortly thereafter she was able to stand with our assistance and return to her chair. EMS arrived and conducted an evaluation; they determined that she did not need to be transported to the hospital. The patient rested in her chair for approximately 15 minutes longer before departing.
Swelling to right thigh where injection (DTaP) was administered. Had redness to area also.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with incorrectly stored (33.1 F for 90 minutes) doses of VAQTA (lot # M032492, expiration date 02-MAR-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath, wheeziness, and coughing  .     February, 2, 2021
Small hard nodule appeared where vaccine was administered. Nodule slowly grew in size over time, appearing with redness and warmth. The nodule raised the skin at the site and was very painful to touch. Gynecology consult was sought 12/12/2016, and was told it could be some necrosis due to vaccine spill/vaccine technique with removal of needle. Site continued to worsen and became more painful. PCP consult was sought on 12/23/2016 for a second opinion. PCP determined the site was abscessed, but did not warrant antibiotic therapy yet as PCP believes this is a potential reaction to a preservative in the vaccine or a reaction in general. Site continued to worsen over the weekend and redness grew a few inches in diameter. Consult #2 with PCP on 12/28/2016, where an antibiotic was initiated. Site has not improved significantly since then and PCP follow-up #3 is scheduled for week of Jan 1, 2016.
right now she feels depressed; This is a spontaneous report from a Pfizer-sponsored program. A contactable 92-year-old female consumer reported for herself.  A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 19Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history includes Depression and concomitant medications include clonazepam 0.5 mg from an unspecified date and ongoing. On 20Mar2021, 1 day after the vaccination, the patient experienced depressed mood. The caller wanted to know weather she can administer clonazepam. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Patient was given vaccine and as soon as needle was taken out she become unconscious, white, sweating, she rolled her eyes and started seizing. EMS was then called and patient was put safely on the floor until EMS got there
1:30 PM developed a dry cough. Metal taste in mouth. Throat felt tightening and voice bacame hoarse. She could only whisper. At 3PM she reported her eyes became swollen hurting and sclera red with white pus draing from eyes. She had an increased headache at top of skull. Temperature noted of 101 at 4pm. Face flushed at that point. Patient reported chills at that time. She was advised by her MD to take Sudafed orally 2 nasal decongestant as per MD. Warm compresses on eyes. In the am when she woke up she called in sick. Her eyes continued to drain untill 2 pm on 10/18/2011. 10/19/2011 patient notes she is feeling improved, however her eyes are still looking reddened and glassy. Mild non productive cough continues.
Patient states 3-5 minutes after receiving vaccine her throat felt itchy. Patient then drank about 4 oz of water. States throat remained itchy for approximately 4 more minutes and then itching resolved. I looked at patient's throat at 15 minutes. No redness or swelling present and no more complaint of itching.
Patient started having tingling effect in her mouth, lips, ear, nose, under the eyes and at sinuses after 20 minutes of the receiving the vaccine. she consulted PCP and they recommended to take BENADRYL, which helped with her numbness but after four days still she had numbness.
Patient was given a Varivax in addition to a Pro Quad which contained Varicella; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2589271-1. The original narrative from the sender is as follows:  Patient was given a Varivax in addition to a Pro Quad which contained Varicella.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient was given a Varivax in addition to a Pro Quad which contained Varicella".  No further information is expected.  Based on the available information, the events were not related to Vaxelis but to other vaccines. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
left upper arm, 6.5 cm diameter erythems, mildly warm to touch, also small area 2cm, induration in the central portion
Extreme leg weakness with falls beginning the evening of vaccination date.  Inability to walk around house without walker and assistance, sleepiness, loss of appetite
PATIENT STATES SHE HAS LEFT SHOULDER PAIN AND LIMITED MOTION TO SHOULDER
Large lump on arm.  Lasted for 6 weeks (quarter size).  Fever (102 for first 2 days), joint hurt for 4 weeks (all joints hurt).  Reported on 06/19/2003.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient received a dose of ZOSTAVAX at a unspecified pharmacies and developed a "baseball size knot" at the injection site at an unspecified time. The patient was unable to move the arm. The outcome of events was unknown. Lot number 000444 is an invalid lot number for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.