chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn; This is a spontaneous report from a Pfizer-sponsored program.  A 49-year-old female patient reported that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), intramuscular in righ arm ton 09Mar2021 (at the age of 49-years-old) at single dose for covid-19 immunisation. The subject had a history of cholesterol (she mentions she takes a cholesterol medication as well but she doesn't have it with her at the time), fibromyalgia, blood pressure and muscle relaxant.  Relevant concomitant medications included naproxen for fibromyalgia, lisinopril for blood pressure and methocarbamol for muscle relaxant therapy.  The first day after the vaccine, the patient felt nothing, except heartburn. She clarifies further she felt fine the first day, completely fine.  The next day, she noticed on her arm, not in the place where they put the vaccine (injection site), but lower down the arm, near her hands, there was a big circle where her vein was.  patient may have mentioned the color green,  but could not clarify these details further after multiple attempts. She confirmed that 2 days later, this disappeared.  The patient also reported that her nose bled as well and felt dizzy and her heart was racing.  The reported events were palpitations with unknown outcome, skin discolouration on 10Mar2021 with outcome of recovered, epistaxis on 12Mar2021 with unknown outcome, dizziness on 12Mar2021 with unknown outcome and dyspepsia on 09Mar2021 with unknown outcome.
Pt reports today that within a few hours of receiving PREVNAR her whole body ached cold chills, not sure if she had a fever, and scratchy throat. No local reaction noted by nurse.
Complaint of shortness of breath, difficulty breathing, cough, chills, elevated temperature/fever, sore/scratchy throat, and headache.
Mom and child returned on 12/6/01 with left leg immunization site red and swollen in approx. 2" diameter. The child grabbed the syringe when 1st immunization was being injected and pulled it out. Had to re-inject to finish dose. The child did not touch the needle. It is too soon to tell if the pt has recovered.
pt recvd vax and devel Raynaud's synd w/ deterioration of fingertips;pt felt that exp was related to vax;
Headache and stiff neck, 1 day after vaccine and swelling at injection site with redness and tenderness 11cm X 19cm, to elbow. No missed duty.
Febrile seizure with a fever of 103. Admitted to ER 10 days after shot 8-21-06. Given IV and blood and urine sampled
Redness on upper arm that itched and was a large patch. Showed up a week after the shot. Had only a sore arm for two days after receiving the shot then the redness and itching started the following Wednesday. By Saturday Feb. 6 the redness was diminishing and the itching was less.
Right arm /shoulder pain and burning sensation,, she was given oral Benadryl and her symptoms resolved after treatment.
Below injection site, skin became erythematous, painful, edematous with increased warmth.
sore injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got his/her Shingles vaccine and a very sore arm ( injection site) but not as painful as getting shingles. The patient was thankful to his/her doctor recommended this to him/her yesterday at his/her physical.  The follow up would not possible as no contact details were available.
first dose of the Pfizer COVID-19 vaccine on 21Jan2021 However, she tested positive for COVID-19 on 01Feb2021; This is a spontaneous report from a contactable other Healthcare professional. This 31-years-old female female other Healthcare professional(patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of admin-istration on 21Jan2021 03:00 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization.The patient's medical history  and concomitant medications were not reported.  She stated that she had the first round of the vaccine on 21Jan2021 and then she tested positive for COVID 01Feb2021. She is due to get her second dose tomorrow. She already has the appointment sched-uled for tomorrow and wants to know if it is safe for her to get. She read online that she should wait 90 days; somewhere else online she read to wait for 2 weeks. She contacted her PCP and the PCP does not know. The PCP directed the reporter to call us to get our opinion. She tried to do her own research online, but got no where. Caller also added, her testing positive from COVID, she does not believe it is from the vaccine. The patient underwent lab tests and procedures which in-cluded s COVIDars-cov-2 test: positive on 01Feb2021.  The outcome of the event was unknown
Site: Pain at Injection Site-Severe, Additional Details: Patient reports severe pain when lifting his arm level with his shoulder.  He went to urgent care and is now having to follow up with a physical therapist.  It has been 15 days since his administration.  He reports that the vaccine was given very high on his arm.
reconstituted with a liquid other than the supplied AS01B adjuvant.; reconstituted with a liquid other than the supplied AS01B adjuvant.; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that another colleague administered to a patient 1st dose of Shingrix which was reconstituted with a liquid other than the supplied AS01B adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
the patient had developed an unspecified rash on both arms after the administration of PROQUAD on the same day; inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a nurse refers to a 5 year old female patient. The patient's concurrent condition was not reported. The patient did not have any concomitant medications or pertinent medical history or drug reactions or allergies. On 01-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R003294, expiration date: 31-JUL-2019, therapy type: recombinant human albumin (rha), in the left arm/deltoid (strength and route of administration was not reported) for prophylaxis (expired product administered). A sterile diluent was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number: S018820, expiration date: 24-SEP-2019. On 01-AUG-2019, on the same day after the administration of the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), the patient had developed an unspecified rash on both arms. The outcome of rash was reported as not recovered. The reporter's causality assessment between the suspect products and rash was not reported. No treatment was given for treating rash. No lab diagnostics or studies were performed. No product quality complaints were involved. There were no intervention to prevent serious criteria.
The patient was admiited on 1/1/22 and expired on 1/15/22 from acute hypoxic respiratory failure. She had a past medical history of left lower lobectomy, previous pneumothorax with trapped lung, adenocarcinoma of left lung on keytruda and chrons disease. She was hypoxic on arrival from EMS with pulse ox of 72%. She had a CTA PE obtained that shows a complete left pneumothorax and a trapped left lung. A hospital was contacted on request by the patient for a transfer. Although they were unable to take the transfer they were able to confirm that her two previous CT chest images one in October and one in August. Her tropnins continued to increase and she was started on a heparin gtts. Although thoracic surgery recommended a chest tube she refused to have it placed. Her RVP was positive for covid which was consistent with the ground glass atypical pneumonia scene in the right lung fields. She reports that she was vaccinated but that she recently started on immunotherapy for her chron's disease. She was admitted to ICU. Over the course of her stay she waxed and waned. She was downgraded out of ICU however she had an episode of abrupt hypoxia that resulted in loss of pulses. Multiple rounds of ACLS were done however patient was not able to achieve spontaneous circulation again and expired.
pt was taken to pediatrician 2MAY & was found to have ear infection & bronchitis; began running fever of 103 on 4MAY94 & called clinic 5MAY;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2012, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
first Shingrix over a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient's sister. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked that she could still get her 2nd dose or should she start over. The follow-up could not be possible as no contact details were available.
Case number PHEH2014US000800 is a combined initial and follow up spontaneous report received from a pharmacist on 07 JAN 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A) intramuscularly on 07 JAN 2014. No adverse event was reported following this medication error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 JAN 2014, it was identified that the  BPI labeling of the event "inappropriate age at vaccine administration " was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) Lasted 2 1/2 days
Pt has macular rash, >50, no crusting, no vesicles, started about 2 weeks after vaccine dose #1, worsening, reported 6/23/03.
Narrative: 66yo pt died during inpatient hospice care on 6/10/2021. Death caused by Amyotrophic Lateral Sclerosis per MD death note. Pt had received covid vaccinations on 2/25/2021 & 4/7/2021. Death appears unrelated to vaccinations.
Mother says child developed swelling the day after his shot was given. Given on 4/26/07. Swelling and redness from knee to groin. Child had difficulty walking until today.
Narrative:  98 y/o male received first dose of COVID-19 vaccine (Moderna) on 1/7/2021. Was in facility at the time, expired 1/17/2021.
I started to feel a numbness on my tongue immediately following the administration of the vaccine. The numbness also extended to the side of my head and the left side of my body which was where I had the vaccine administered. I remained at the location for 30 minutes but did not feel any better. The nurse checked my blood pressure as she indicated that I did not look well and it was around 180/90. The EMT's were called and an EKG was given. I was monitored at the location for an additional hour and then allowed to leave as I declined to be taken to the hospital. The symptoms lasted for about 12 to 24 hours then subsided completely.
3 days after administration of vaccine, redness, swelling, mild itchiness, size 55ml x 40ml, warm to touch progressing next day.
5days after the shot had raised rashes right below the injected site and itchy. 2 days later the raised area has flattened but the rash site got bigger and less itchy.
she feels that possibly the vaccine was administered incorrectly, "Wrong Route of Administration"; had a worser AE with the second dose with sore arm; possible fever; sweating; tiredness; body aches; shivering; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in August 2020, refer case US2020AMR249123).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. In December 2020, the patient experienced pain in arm, fever, sweating, tiredness, general body pain and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, sweating, tiredness, general body pain, shivering and wrong route of administration were unknown.   It was unknown if the reporter considered the pain in arm, fever, sweating, tiredness, general body pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the second dose of the Shingrix vaccine in her left arm and she felt that possibly the vaccine was administered incorrectly, wrong route of administration. The patient stated she had a worse adverse with the second dose with sore arm, shivering, body aches, tiredness, sweating and possible fever. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215496:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020AMR249184:same reporter US-GLAXOSMITHKLINE-US2020AMR249123:same patient (1st dose)
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches over whole body/ localized around rib cage; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9810) via an unspecified route of administration at left arm on 03Feb2021 17:45 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure, COPD, and allergies to Penicillin, various blood pressure meds. Concomitant medications included ongoing atenolol (TENORMIN) for high blood pressure, ongoing ergocalciferol (VIT D), ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing Multi Vitamin (unspecified). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231, the second letter need to read) via an unspecified route of administration at right arm on 13Jan2021 17:50 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was not prior vaccination. On 04Feb2021 02:00, the patient experienced hot flash (Seriousness criteria: Not Serious). She had headache on 04Feb2021 in middle of night and severe body aches (Seriousness criteria: Not Serious) on 04Feb2021. Next day severe body aches over whole body then by end of day pain was localized around rib cage. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test COVID-19 post vaccination. No therapeutic measures were taken as a result of the events. The outcome of the event hot flash was recovered on 04Feb2021; headache and "severe body aches over whole body/ localized around rib cage" were recovered on 05Feb2021.  Follow-up attempts are completed. No further information is expected.
across her abdomen is a rash- red and itchy; across her abdomen is a rash- red and itchy/red splotches; a slight headache; fever; chills; fatigue,tired; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207; expiry date: 31Jul2021) via an unspecified route of administration on 24Mar2021 (age at vaccination 70 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and the patient experienced soreness around the area of the arm, that was kind of rough. On 24Mar2021, at night of vaccination, the patient experienced a slight headache, fever, chills, fatigue, tired. On 26Mar2021, the patient experienced across her abdomen was a rash- red and itchy/ red splotches. The patient stated that on Wednesday, 24Mar2021, she got her last dose of the Pfizer vaccine and next day morning, she might have had it yesterday but she did not notice it yesterday, this morning she noticed red splotches across her stomach and it is a little itchy, she did not scratch but it is a little itchy. She put Benadryl cream (Lot number: LLCT288CTZ/1 and expiry date: Sep2022) on it for the itching, she can look under the light and see if it was still there, she says yes it was still ongoing. She said it has persisted about the same since this morning. The outcome of the event across her abdomen was a rash- red and itchy/ red splotches was reported as not recovered and the outcome of rest of the events was unknown.  No follow-up attempts are needed. No further information is expected.
pt recv vax 31JAN97;pt exp back pain, stomach aches, cold, cough & inc LFT's on the same day;pt was seen in ER;no tx was reported but further vax was discontinued;
Headache; fatigue; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male 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 03Apr2021 at 09:45(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:00, the patient experienced headache, fatigue and mild fever. The patient received tylenol at home as treatment of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache, fatigue and mild fever was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer refers to a female patient of unknown age, reporting on herself. On an unknown date the patient was vaccinated with ZOSTAVAX injection, 1 shot (lot # and exp date unspecified) (dose unspecified), right arm. The consumer stated that on an unknown date she experienced pain in her right arm at the ZOSTAVAX injection site and received the flu shot in the same arm within a couple of weeks of receiving ZOSTAVAX vaccination. At the time of the report the outcome of pain in right arm at the ZOSTAVAX injection site was unknown. It was unknown if the patient sought medical attention. There was no treatment given for the pain in right arm. Additional information is not expected.