chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 42-year-old female who received the pediatric orange top vaccination; they had a tech administer the children Pfizer COVID vaccine to an adult, they gave the full 1 mL dose; This is a spontaneous report received from a contactable other healthcare professional from medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 02Mar2022 (Lot number: FK5127) at the age of 42 years as dose 1, 1 ml single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: A 42-year-old female received the orange top vaccination on 02Mar2022. They had a tech administer the wrong Pfizer COVID vaccine to an adult, they gave the full 1 mL dose. The reporter stated that the patient was not experiencing any side effects (as of report date). The reporter needed guidance on what to do. For the seriousness, the reporter mentioned that she was between the 2rd and 3rd options, medically significant and life-threatening, just because she didn't know, but maybe it is more the 2nd one, medically significant.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002797.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown". The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Moderate to severe pain on shoulder, not in the joint, with much difficulty using arm for about 2 hours. Pain decreased with ice and Naproxen 220mg. At 6PM area tender without use of arm and mildly sore when I raise my arm. Full range of motion.
Patient received PNEUMOVAX in right deltoid 10/31/14. Reported painful administration and extreme soreness in muscle persistent for 5 or more days. Patient cannot use right arm without severe pain, and had trouble lifting arm at all. Left arm unaffected by FLUVIRIN.
Initially mild sore arm that progressed to very sore and persisted for several days. Also noticeable fatigue and nausea which lasted about 12 hours from onset (around 24 hours after injection).
Pt. c/o dizziness and pain in L arm near injection site and radiating to fingers, lasting less than 10 minutes. Pt. stated felt better and returned to class.
muscle soreness; feeling ill; This case was reported by a physician via sales rep and described the occurrence of muscle soreness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle soreness and feeling unwell. On an unknown date, the outcome of the muscle soreness and feeling unwell were unknown.   It was unknown if the reporter considered the muscle soreness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. The patient felt ill and had muscle soreness. The reporter agreed for the follow up. For tolerance of 2nd dose of Shingrix refer case US2019AMR097813.
Suspected vaccination failure; Small outbreaks; Painful; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingrix and the Zoster vaccine and the patient still get small but painful outbreaks. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Zoster vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory test confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around November 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
Information has been received from a nurse practitioner concerning a female who was vaccinated with 0.5 ml of the first dose of Gardasil. Within 24 hours after receiving the vaccine, the patient experienced rapid fluttering of the heart, which she described as a sort of "heart murmur". Subsequently, the patient recovered from rapid fluttering of the heart. No further information is available.
PATIENT STATES THAT SHE HAS REDNESS THAT HAS GONE DOWN TO HER ELBOW AND REQUIRED MEDICAL ATTENTION. THE DOCTOR STATED THAT SHE HAD CELLULITIS DUE TO THE INJECTION AND PLACED THE PATIENT ON CLINDAMYCIN.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck), subcutaneous. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) which underwent defrost cycling temperatures (higher than recommended). No adverse effects reported. Additional information has been requested.
no previous history of covid and was fully vaccinated being very sick due to the variant; no previous history of covid and was fully vaccinated being very sick due to the variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the variant, and was in the hospital. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095250 Same reporter/event/drug, different patient;US-PFIZER INC-202101094644 Same reporter/event/drug, different patient
aware of tachycardia with pulse rate of 130 and regular.   This lasted 3 hours and then gradually decreased to normal pulse rate over the next 6 hours
Per patient arm is really red and swollen real big. One day post injection. Treatment: apply ice and take BENADRYL after he gets back home.
Information has been received from a health professional concerning a 11 year old male pt who on 01Nov1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 08Apr04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: pt was unconscious/unresponsive for several minutes.  EMS services contacted.  After approximately 5-10 minutes pt responded sufficiently enough to provide information to EMS crew.  After examination and EMS consult with ER physician, pt refused treatment and left on own accord.
Prickly sensation right side of face-lasted 45min-1 hour.  Started after vaccine given-while waiting 20min after vaccine given.
102.6 fever; headache; body ache treated with tylenol fever went down to 100.9 with Tylenol and broke at 3:30 pm (approx 12 hours after onset)
Patient has a vaccine in our urgent care, she attempted 2 days later to schedule another vaccine.  Upon further investigation patient has scheduled herself and received 8 covid vaccines between 9/20/21 and 10/12/21.  Patient has had multiple doses of Pfizer and Moderna and 1 dose of Johnson and Johnson.  She received a dose of Moderna and J&J in the same day through local pharmacies.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use) on 27-Feb-2021 and Eczema. Concomitant products included LEVOTHYROXINE from 29-Jan-2021 to an unknown date for Thyroid disorder NOS.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Feb-2021 and the estimated date of delivery was 13-Nov-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications was provided by the reporter.  Past pregnancy: Live full term birth on 17-Nov-2019   Reporter did not allow further contact
We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with unvaccinated group. This case refers to one child (for other children please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1720 and MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
SHIVERING AND CHILLS; FEVER FOR 2 HOURS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced shivering and chills. On MAR-2021, the subject experienced fever for 2 hours. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever for 2 hours, shivering and chills and headache was not reported. This report was non-serious.
ACUTE RESPIRATORY FAILURE 12/29/2022 ASCITES ACUTE RESPIRATORY FAILURE 12/29/2022 LIVER MASS
Second day after vaccine shot I experienced extreme fatigue and pain. Third day I broke out in hives all over. Today I?m still in hives and have a pink eye.
Information has been received from a nurse practitioner concerning a 15 yr old female who on 22Jan06 was vaccinated with hep A virus vaccine inactivated, 0.5mL once. There was no concomitant medication. On 14Jan06 the pt experienced elevated liver enzymes after vaccination with hep A virus vaccine inactivated. She was vaccinated to go on a church mission trip. The nurse practitioner suspected the pt had a salmonella infection as well as hep A. The nurse practitioner also stated the pt was really sick. Medical attention was sought. The pt was reported as not recovered. Follow up was received from the nurse practitioner on 20Mar06 concerning this 16 yr white female who on 16Feb06 was evaluated for fever, vomiting, and diarrhea. On lab tests performed for these symptoms it was noted that the pt had slightly elevated liver functions (ALT 72 IU/L, AST 58 IU/L, bilirubin total 1.2 mg/dL, bilirubin direct 0.48mg/dL), negative hep A IgM, reactive hep A antibodies, and stool culture positive for salmonella. Follow up labs were not required. On an unspecified date, the pt recovered from the events. Additional information is not expected.
3-4 days p/vax exp swelling & migratory joint discomfort;;chief c/o migratory joint pains;migratory arthritis/palindromic arthritis;pain & stiffness;arthralgia & myalgia;neck stiffness & pain;pain raising arm & bending finger;ankle swelling
The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibuprofen was taken and symptoms lessened over 6 hours, they resolved by 01/10/2021.  Patient developed severe nausea the morning after vaccination (this also occurred after the first dose), and patient vomited several times with severe retching for 30 minutes. No medication was taken and symptoms subsided after 6 hours.
Allergic reaction in the left arm with slight swelling and redness pt advice to take TYLENOL or Ibuprofen OTC. DR PRESCRIBED antibiotic AUGMENTIN.
Diagnosed with Varicella on 09/17/2005.  Received Varivax on 08/10/1999.
Fatigue, nausea, fever 101.6, dizziness. Left work feeling as above. resolved temperature with Tylenol. Following morning, work up and felt better for about an hour, then felt weak and room began to go black and ears began to ring.  I never lost consciousness and called MD right away.  They have yet to attribute any of my symptoms to this vaccination, however no other blood or urine tests have provided other causes. As of the date of this entry I will be following up with the prescriber again, as I continue to feel fatigued and feverish and foggy (as if I were 102 degrees), yet I have no detectable temperature at this time.
PATIENT STATED HER LEFT HAND WAS TINGLY AND THE FOLLOWING MORNING HER FINGER TIPS WERE WHITE AND NUMB FOR A SHORT PERIOD OF TIME; PATIENT MENTIONED THIS WHEN SHE CAME TO GET HER 2ND DOSE FOR THE VACCINE
This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # K010215, expiry date 05-MAY-2017, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of five reports received from the same reporter. Additional information has been requested.
Woke up with pain under left ribs and down my left side. Pain became worse throughout the day. On day 2, still experiencing pain under the ribs on the left side and pain has now moved into my back. Nausea. I experienced pain for 2 more days.
left side of face swollen, could be swelling down underneath neck, it's not bad, but noticeable; left side face itching; could tell mouth was swollen, left side of mouth would pull; itching under chin and around the bone; This is a spontaneous report from a contactable consumer (patient). A 74 years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL3249, Expiration date: unknown) via intramuscular route of administration in left arm on 26Jan2021 11:00 2ND DOSE, SINGLE for COVID-19 immunisation (age at vaccination was 74 years). The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0142 or EL0140, Expiration date: unknown) via unspecified route of administration on 05Jan2021 single dose for COVID-19 immunisation. patient medical history included high blood pressure, remembers getting stung by wasp years ago and the same thing happened to her arm and at that time the doctor suggested for her to get an EpiPen and she got one, but never had to use it, getting stung by wasp years ago and the same thing happened to her arm and at that time the doctor suggested for her to get an EpiPen and she got one, but never had to use it. Patient's concomitant medication was not reported. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 the patient experienced itching under chin and around the bone at 19:30, left side face itching, could tell mouth was swollen at 11:30pm, left side of mouth would pull. On 28Jan2021 at 11:30pm patient experienced left side of face swollen, could be swelling down underneath neck, it's not bad, but noticeable (all events were ongoing). The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected
1/17/2021 after vaccination felt fatigued and body ache.  During the night  vaccination site and left axilla painful. 1/18/2021 - around 2:00 p.m. left arm became red, swollen and hot to touch from left elbow up into the left neck.  Took a hot shower that evening and took Tylenol and Benedryl 12.5 mg  with some relief obtained.  1/19/2021 - Pain in left arm improved and was sore with  itching off and on during the day.  The neck pain was gone.  Took BC powder and benedryl again in the evening.  1/20/2021 pain  and redness/swelling decreasing.  1/21/2021 - swelling more localized to the injection site, pink in color, warmer to touch in the center of the injection site area and less warm further out of the circle.
DTaP given in left deltoid 8/25/03. Today she present back to clinic with redness, warmth and swelling of left upper arm. Mother is instructed to use ice packs, Children's Ibuprofen PRN until swelling is gone. Referred to MD.
After the injection Friday she immediately complained of pain which worsened as the day went on. By the evening her arm was mildly swollen, warm, and markedly tender. In the morning she was a bit worse and this worsened somewhat during the day, with erythema, warmth, tenderness, and edema. She has exhibited no systemic signs and besides not being able to move her arm has been in good spirits. The same thing happened last year, but did not extend past her elbow. It is more severe this year.
Arm pain, fever, chills, nausea, headache, body aches. Lasted about 12 hours, except for arm pain which continues.
Swelling and pain at injection site (R arm), stomach upset, fevers, chills. Treated with Ciprofloxacin and prednisone.
4 days p/vax local, pruritic;rxn @ inj site lt deltoid, crusty w/4-7 vesicles;no sx of cellulitis;rash has not changed since onset;