chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A bad headache; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm  on 1Apr2021 at 08:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) , fexofenadine hydrochloride (ALLEGRA) ,H2-Blockers (MANUFACTURER UNKNOWN) all 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 01Apr2021 at 12:00 the patient experienced a bad headache. The event did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event a bad headache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
The first period  after the second vaccine was extra heavy and prolonged.; Had some spotting; no period for six weeks; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received an unknown dose dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 27Apr2021 at 15:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. On an unknown date in Apr2021, the first period after the second vaccine was extra heavy and prolonged. The patient had some spotting and then no period for six weeks. The patient was on regular spot for entire life and believe that the vaccine affected the period. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "the first period after the second vaccine was extra heavy and prolonged", "had some spotting" and no period for six weeks was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received Pfizer for his initial COVID-19 vaccination. When he came for his second, he was given Moderna in error.
while administering shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17th February 2024) for prophylaxis.   On 5th January 2023, the patient received Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The pharmacist reported that, while administering Shignrix to a patient half way through the patient moved and only received 3 quarters of half of the dose and the rest splashed on pharmacist face and eyes. The reporter consented to follow up. Additional Supportive Information: The patient did not receive recommended dose volume of the Shingrix, which led to accidental underdose. This case had been linked with US2023001210, reported by the same reporter.; Sender's Comments:  US-GSK-US2023001210:same reporter - pharmacist case
Pt was at daycare and had a 4 minute febrile seizure.  Fever of 102.2.
The injection site turned pink within 15 minutes of the administration of the vaccine.  It felt slightly warm to the touch.  She did not complain of any dizziness, lightheadedness, or breathing difficulties.  I recommended she take some Benadryl to control the possible allergic reaction.  I advised her to monitor the site for any changes, and to contact her physician or ER if her condition worsened.
first dose/ on 8th September 2020./second dose/not given at the time of the call.; This case was reported by a pharmacist via call center representative 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 (1st dose received on 8th September 2020).   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 as follows: The age at vaccination was not applicable. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The second dose was not given at the time of the call. No further details were reported. The HCP did not consent nor declined follow-up. No further details on the vaccine or patient were available at the time of the call.
Child has fever to 105 with vomiting & anorexia. Treated for fever, Resolved in 24 hours.
This is a 93y.o. female with type 2 diabetes mellitus, hypertension, sleep apnea, and atrial fibrillation who presents with body aches and back pain. She had sustained a fall recently with multiple injuries and believed her current pain was related to this event. She was seen in the ED on 11/4/21 and had negative trauma work-up and discharged home with Tylenol and a lidocaine patch. She did have an incidental finding of a right ovarian cyst at that time. Since her discharge, she's also been having intermittent abdominal pain. She denies any known fever or known exposures. She is fully vaccinated against COVID-19 since 4/14/21, but has not received a booster. She denies any further falls. No nausea, vomiting, diarrhea, chest pain, shortness of breath, or cough.   On arrival to the ED, BP was 127/58 and she was afebrile. HR 68, RR 18. SpO2 initially 97% on room air and 2 liters of supplemental oxygen later applied. Labs notable for potassium 5.7, creatinine 1.12, WBC 10.0. Chest x-ray negative for acute process. COVID-19 positive. The patient was admitted for further evaluation and management.
MMR was expired. Notify parent will given next dose 28 days after the expired dose.
rash on the abdomen and chest; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash on the abdomen and chest) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 24-Jun-2022 and Moderna COVID-19 Vaccine on 29-Jul-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 02-Jan-2023 at 5:03 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on the abdomen and chest). At the time of the report, RASH (rash on the abdomen and chest) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The parent reported a rash on the abdomen and chest starting 4 hours after the vaccine administration.  Concomitant medication was not provided. Treatment medication information was not provided by the reporter.
No adverse event reported by pt.  Likely erroneous dose on menveo containing two liquid components administered from this box, unable to determine which pt received the probably erroneous dose.  All patients to be re-vaccinated to ensure appropriate immunity.
Around June 1st insidious onset of generalized joint pain and swelling associated with stiffness. A week after joint pain developed tender nodules that began on her shins then became generalized. Patient was diagnosed with E. nodusum.  Had extensive work up done for etiology, none identified. By 8/2/21 symptoms had essentially resolved and patient was feeling much better.
she was supposed to get the second dose but HCP didn't administered it yet; Tested positive for COVID-19; A spontaneous report  was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid-19/ SARS-CoV-2 test positive, she was supposed to get the second dose but HCP didn't administered it yet/ missed dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events tested positive for covid-19, she was supposed to get the second dose but HCP didn't administered it yet.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, tested positive for covid-19 was unknown, The outcome of event, she was supposed to get the second dose but HCP didn't administered it yet was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt called nurse on 10-5-12, states has a small orange sized injection site rash, slightly swollen. No itching, pain, fever/chills. Rash and diarrhea.
Tested positive with Covid19 after being vaccinated with Pfizer EUA 03/23/2021-05/05/2021
Approx 1 mo post/vax #2, told the Dr the symptoms with the 1st injection. I had a more severe reaction of pain in ankles & knees & I have continued problems. Additional information received indicates diagnosis of polyneuropathy of feet and legs.
Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: After receiving vaccine, pt stated that she wanted to wait awhile before standing up. As I was reentering the pharmacy, I heard a crash and pt had fallen to the floor. An elderly woman, presumably her mother, said, "You fainted." Apparently she was unconsciousness for only a moment. She remained on the floor for a few minutes, then sat in a chair and sipped water, then vomited. After about 20 minutes they walked out together.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started experiencing numbness, tingling, and hand cramps minutes after receiving his pfizer vaccine. We sat him down in the chair and had him relax. I called EMS shortly after and they arrived quickly. They worked him up and concluded that he was having a panic attack related to being give the vaccine. Patient states that he wasnt anxious about it previous to administration nor did he seem anxious as well. He was calmed down by the EMS personnel and then was able to walk out of the store
fever, body aches on day of vaccine, then 3/15 came to clinic for chemo, post chemo symptoms included heavy tongue, tight throat, fingers twitching, eye twitch,
Patient received vaccine 8-13-2017. Patient came in to pick up KEFLEX (antibiotic) to prevent infection. Patient reported a red swollen red. Rash from deltoid to elbow.
Information has been received from a registered nurse concerning a 45 year old female with sulfa and DEMEROL allergies who on 29-MAY-2009 was vaccinated with the first dose of RECOMBIVAX HB (Thimerosal Free) (lot # 663315/1446X). Secondary suspect therapy included MMR II (lot # 663164/1583X). Concomitant therapy included VICODIN, SEROQUEL and fentanyl. The patient had a rash "now" in June 2009. The nurse stated the patient was stating "the rash looks like measles" and was "on her face". The nurse also stated the patient reported have a fever of 101F. The patient sought medical attention by calling physician's office. The patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning a 45 year old female patient smoker since age 21 who at 10:00 on 29-MAY-2009 was vaccinated IM in right deltoid with the first dose of RECOMBIVAX HB. Secondary suspect therapy included the first dose of MMR II given subcutaneously in left deltoid at 10:00 on 29-MAY-2009. In the morning of 15-JUN-2009, per patient, she awoke with fever of 101F and total body rash. She described rash as mottled and not raised. The rash was very itchy. The patient saw her own physician and was placed on MEDROL DOSEPAK. The patient had her second mantoux skin test (lot # C33036 AA) intradermal injection in right forearm at 10:00 on 29-MAY-2009 (first one on 19-MAY-2009). The patient's primary care physician drew titer on 18-JUN-2009. No results forwarded at that time. The physician told the patient she was immune to MMR II. The patient had recovered on 22-JUN-2009. The adverse events were considered to be an other important medical events by the registered nurse. Additional information is not expected.
This case was reported by a nurse via call center representative and described the occurrence of tendon disorder ni a 23-year-old female patient who received FLUARIX quadrivalent (batch number DX4SN, expiry date 30th May 2016). Concomitant products included birth control. On 7th October 2015, the patient received the 1st dose of FLUARIX quadrivalent (intramuscular) .5 ml. On 7th October 2015, several hours after receiving FLUARIX quadrivalent, the patient experienced tendon disorder, injection site pain and injected limb mobility decreased. The patient was treated with ibuprofen, ice pack (NOS) and NAPROSYN. On an unknown date, the outcome of the tendon disorder, injection site pain and injected limb mobility decreased were recovering/resolving. The reporter considered the tendon disorder, injection site pain and injected limb mobility decreased to be related to FLUARIX quadrivalent. Additional details were as follows: On 7th October 2015, at 16:01 pm, the patient received the 1st dose of FLUARIX quadrivalent in her left deltoid. On 7th October 2015, same evening, several hours after vaccination, the patient began experiencing severe pain at the injection site with limited range of motion. The healthcare professional reported that there was no redness or warmth at the injection site. On 19th October 2015, the patient came to the office to visit the doctor and she had continued to have limited movement to her left arm so was treated with the ibuprofen and an ice pack. On 2nd November 2015, the patient again returned to the office and the doctor felt that the issues were due to a reaction from the flu vaccine. She was diagnosed as having an irritated tendon in her left deltoid (injection site) and was prescribed NAPROSYN 500 mg one tab twice daily with food for 5 days. The patient did not receive any vaccines within 4 weeks after receiving the FLUARIX quadrivalent vaccine. An outbound call was made to verify the information. The reporter did not wish to provide the name of the administrator or the physician responsible.
Pt had 4 ordered vaccines, then c/o dizziness and then passed out in the exam table. Dr. aware. Pt monitored BP remained stable and was last documented as 130/87 prior to being D/C'd by Dr to go home w/mother. Syncopal episode lasted approximately 5 seconds.
I developed at least two swollen lymph nodes in my armpit area in the same arm as where I got the shot. It was painful if I pressed on the area and tender if left alone. It lasted for 4 days and then the nodes shrunk and the pain subsided. I did not do any special treatment.
On the morning of the 02/03/2021 (7:00 am) I noticed a red swelling around the injection site. It was hot  and itchy. On the morning of the 02/04/21, (7:00 am) I noticed that the red area had increased in size, not itchy but still warm. Messaged my Primary Care Physician at around 9:00 am and waiting for response.
About 12 hours after vaccination: fever (101 F), shaking chills, muscle aches. All resolved within 12 hours after onset.
Sore arm, after shot and still sore 3 months later.  Described as muscle cramps in his arm, especially at night.  He also has a little scab from the injection site and it has not healed and keeps scabbing over and over.
Childe has history of asthma and inadvertently received FluMist vaccine on 10/26/06 during a school based immunization. No immediate adverse effects. Child did develop Upper Respiratory symptoms about 11/11/2006. Did not require physician visit or school absence. Treated with Albuterol inhaler.
08/28/2002 Local redness and swelling. No fever. No other s/s. MD exam child on 08/29/2002 and states it is only a local reaction and not an allergic reaction. Mother gave Benadryl. 09/03/2002 swelling and redness gone the next day
My normal palpitations is 30 in an hour but I started having over 200 in an hour following the vaccination.
a 58 year old patient was administered Fluzone Quadrivalent High Dose by a staff / No AE; a 58 years old patient was administered Fluzone Quadrivalent High Dose by a staff due to not paying attention/ No AE; Initial information regarding this unsolicited valid non-serious case received from the nurse via Medical Information (Reference number- 00370461) on 24-Nov-2020.  This case involves a 58-year-old male patient who received a 0.7 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT (batch number and expiry date not reported) via an intramuscular route in an unknown administration site on 11-NOV-2020.    Medical history, past medical treatment, vaccination details and family history were not provided.  No other concomitant vaccines given.   It was a case of an actual medication error case due to inappropriate age at vaccine administration and it was a case of overdose (latency same day).    At the time of reporting, no adverse event was reported.    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.    There will be no information on the batch number for this case.
Information has been received from a 43 year old female with sulfa, penicillin and erythromycin allergies and asthma, allergic rhinitis and depression who on 04-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included cetirizine hydrochloride, LEXAPRO and ESTRACE. On 05-NOV-2010 "about 25 hours later" the patient began to have back pain which spreaded to the sternum. She had pain in the arm, armpit and chest. Also, she had neck stiffness. A 6 inch by 5 inch area of induration developed at the injection site. The skin was red, painful and hot in that area. She also developed malaise, nausea, headache and loss of appetite. At the time of report, the patient was recovering. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. It was reported that these adverse effects had kept her in bed and in her house for 4 days. They were considered to be disabling. Additional information has been requested.
This is a spontaneous report from a Pfizer sponsored program from a contactable physician. A 79-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies: prevnar on an unspecified date with outcome of unknown.
Just a sore throat that first evening along with aches and pains and chills. Got a Fever about three days later (on about day four). Sore throat and coughing. I had a video DR visit on January 4th. January 5, - COVID test - positive. Bedrest and quarantine. Had symptoms about 10 days.
No other information provided; VARlVAX was expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 04-AUG-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021924, expiration date 15-JUL-2021; strength, route of administration and anatomical site of vaccination were not reported) for prophylaxis (expired product administered). No other information provided.
Syncope and passing out;admitted and received potassium chloried 40 mEq tablet, for hypokalemia and DVT prophylaxsis with subcutaneous heparin. Was discharged after admission for overnight (from 01/07/21 to 01/08/21. Admitted for electrolyte abnormality. Of note, patient had one other syncope event a long time ago from a blood draw.
Adolescent was registered as 16 years old per birthdate, however when parent completed paper registration form, she wrote another date as the birthdate.  Adolescent was vaccinated before birthdate discrepancy was discovered.  Parent did sign for vaccination this date.  Birthday was confirmed in immunization records.