chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year-old received 1st dose Moderna COVID-19 vaccine; denied to give 2nd dose since patient is 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old received 1st dose Moderna COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (denied to give 2nd dose since patient is 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old received 1st dose Moderna COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (denied to give 2nd dose since patient is 17 years old). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year-old received 1st dose Moderna COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (denied to give 2nd dose since patient is 17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided
she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot; States the arm soreness and swelling and redness started about 2 days after the 1st shot; States the arm soreness and swelling and redness started about 2 days after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder NOS (she has autoimmune problems and anything foreign gets super angry ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot). At the time of the report, PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient received the Moderna vaccine, and her arm was sore. The arm soreness and swelling and redness started about 2 days after the 1st shot and the symptoms lasted for about three weeks and was completely resolved. She had a cough from a cold she got from her 6 years old son and stated that the cough she has begun 2 weeks ago and was ongoing and better.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Small outbreak of a rash on the child's Right Thigh at vaccination site, side of face (left), both arms towards the wrist, on upper chest and lower back.
Case number PHEH2012US025103 is an initial spontaneous report received from a pharmacist on 11 Dec 2012 with follow-up received on 20 Jan 2013. The report refers to an 11-year-old male patient. The patient's vaccination history included vaccination with MENVEO and was well tolerated. He was vaccinated only with MenCYW-135 component of MENVEO 0.5 ml (batch number: M10051, expiration date: Jan 2013) intramuscularly on left arm on 11 Dec 2012. Upon follow-up, parent information of incomplete vaccination and recommended repeat dose. No adverse events were reported. No further information was available. Follow-up received from a pharmacist on 20 Jan 2013. Therapy details, vaccination history and narrative updated.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 10th of 11 reports.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available,Linked Report(s) : PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
High pitched shrill cry for 15 minutes that began 3 hours after immunizations. Had fussiness and irritability on 01/04/2005 evening. Tylenol given every 4 hours.
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, possible autoimmune disease, activities of daily living impaired, stiffness, debilitating knee pain, debilitating back pain, headaches, nausea, memory loss and possible neurological problems. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX on 15 May 1999. On the same day, 15 May 1999, she developed flu-like symptoms, fatigue and joint aches and pains. In approximately 2001 she developed asthma and allergies. She also reported gynecological complaints. All events were attributed to LYMERIX by the subject. The case was assessed to be medically significant by GSK based on follow up. Treatment included Syndisc injections and anti-inflammatories. With the exception of flu-like symptoms and fatigue, the events were unresolved at the time of this report.
Now has ileo-ileo intussusception. Home today or tomorrow. Dx Abd U/S.
On 06/03/2023 a approximately 15:01 the donor was pale in color, sweating and reports feeling lightheaded/dizzy and feeling of faint. Ice Pack was applied to the back of the donor's neck and Propel water given. Donor began to pink up and report that he is feeling better at 1505, skin dry to touch. Donor reported he felt faint upon during his previous tetanus immunization (1st dose).  Donor leaves facility with a steady gait and in stable condition at 1513.
The pt experienced a temp late in the afternoon (low grade). That evening it was up to 103. The pt then experienced a seizure for 1 minutes. Was taken to the ER by ambulance. Treated with Pedialyte, Tylenol and Rocephin.
patient was given 2 doses of FLUZONE HD QIV 3 weeks apart with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who was given 2 doses of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] 3 weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included elasomeran (Spikevax) for Prophylactic vaccination.  Patient received one dose 3 weeks ago, then On 19-Oct-2023, the patient again received a standard dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown formulation) at a dose of 0.7 mL total (lot U8130DA, expiry date- 30-JUN-2024) via intramuscular route in the right arm for Immunization.  On 19-OCT-2023 the patient was given 2 doses of fluzone hd qiv 3 weeks apart with no reported adverse event (extra dose administered) (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Pharmacist called in asking for safety data and recommendations for FLUZONE HD QIV following its administration to a patient 3 weeks apart; patient did not remember that she already received one dose 3 weeks ago, and had another dose today 19Oct2023. Treatment: None   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
1. Legs pain.  2.  Some time weaken of lower limbs.  3.  Some time numbness of lower limbs.  4.  Shoulder  pain once in a while.  5.  Body ache-  3 weeks after #2 gardasil.  2/10/09 Received PCP medical records of 2/6/09. FINAL DX: none provided Records reveal patient experienced body aches, weakness & leg pain with intermittent leg numbness since 6/08 w/20# wt gain.  Exam WNL.
After 2 dose 5/2021 my skin was on fire was in bed for 3 days could not move to touch my skin hurt my legs hurt the most  sometimes I can barely walk my feet started swelling I have been to the ER because my feet kept swelling initial visit in Sept 2021 I had them look at my legs because I had little black and blue marks like someone was pinching me urgent care where they said Edema DVT I am going to the ER today for X-rays I can't take constant pain not being able to walk and having to go to sleep with my legs being elevated
pt presents with complaint of mi pain and itchiness on site. RN noted area:  redness, warm, raised and little tender to touch vital signs are stable vaccine was administered subcutaneously errouneously by RN.
No other AE; an expired dose of PROQUAD was inadvertently administered; This spontaneous report was received from an office manager regarding a 4-year-old patient whose gender was not specified. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies was provided.  On 04-AUG-2021, the patient was inadvertently administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot number S017246 has been verified to be valid, expiration date reported and validated as 01-DEC-2020) (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) for prophylaxis (expired product administered). The reporter was inquiring if the administered dose was a supported valid dose. No other adverse events (AE) were reported.
ache; I had fever chills; She herself experience the sore arm after taking the first dose; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after taking the first dose leading to pain in extremity on 08Aug2021 with outcome of unknown, she had fever chills causing pyrexia on 30Aug2021 with outcome of unknown and body ache on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this. The patient took Tylenol and was concerned about side effect with vaccine regimen.  The lot number for BNT162b2 was not provided and will be requested during follow up.
I initially felt the chemicals hitting my body. I went home feeling kind of weird. That night I went to bed with chills. I was shaking from the cold. I had to use a heating blanket and more blankets to stop shaking.  I finally calmed down and slept. For the next 36 hours, other then using the bathroom, I slept. Hot sweats, cold sweats....misery. I am no weak. I have not eaten in 36 hours, let alone taken any medication. My body is in shock.   It has now been 46 hours since the shot.
No adverse event; she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. .     On 08-Mar-2023, 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 08-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (she went to clinic to get 2nd dose of vaccine and was told her that she's received the booster, not the primary dose of vaccine).    No concomitant medications were reported.  It was reported that the patient went to Pharmacy for 1st dose of primary vaccine and received the booster dose. Patient was tired and weak after first dose, she was informed that the booster and the vaccine were same. Patient was offered with a second dose of the booster to complete the vaccine. Patient wanted to know if it was okay to receive a second bivalent dose in order to complete the vaccination series.  No treatment details were reported.   This case was linked to MOD-2023-719731 (Patient Link).
Fever 101.5, chills, burning sensation over whole body.  Basically a 12 hour reaction. Arm was very sore for 3 days
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose and route of administration not reported). The nurse stated that the patient may had also received VARIVAX (Merck) previously as well but she was unsure. Concomitant medications were not reported. On an unknown date, the patient was diagnosed with breast cancer. The patient currently takes tamoxifen for Breast Cancer (also reported as for a previous history of breast cancer). On an unknown date, the patient had MMR titers drawn after receiving the M-M-R II and the result of the titers for MMR were negative (antibody test negative). The outcome of breast cancer and antibody test negative was unknown. The relatedness of the events, breast cancer and antibody test negative to M-M-R II and VARIVAX (Merck) was not provided. Upon internal review, Breast cancer was determined to be medically significant. Additional information has been requested.
Extreme pain in arm, unable to raise arm above shoulder, lasted over period of multiple weeks. Also reported numbness and tingling in hand.
This spontaneous report as received from a nurse refers to a 9 months 5 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This case was reported by a healthcare professional and described the occurrence of influenza type a in a 20-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  The subject's medical history included diabetes.  Concurrent medications included Insulin.  On 15 November 2007 at 10:45 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 11 February 2008, 88 days after vaccination with Flulaval, the subject experienced high fever, cough and achiness.  On 13 February 2008, the subject tested positive for influenza A antigen and she experienced a vaccination failure.  This case was assessed as medically serious by GSK.  The subject was treated with oseltamivir phosphate (Tamiflu).  At the time of reporting the events were unresolved.  The nurse stated that she felt the causality for Flulaval causing the adverse event is unknown.
I got it on Thursday and on Friday afternoon I started feeling really tired and achy.  By 8 at night on Friday night I was running a temp of 102 and it fluctuated around 100-102 until Monday morning at 2, it was 98.6 at that time.  I had the shivers the whole time on and off and took Tylenol when I could and kept hydrated as much as I could.  I shook so much it threw out my back.  Anyway I had a similar reaction when I got the second shot way back at the beginning of the year.
Starting the night of the vaccine the patient started to feels chills, then the next morning she had a fever of 101 degrees which lasted for a day.  She also is experiencing a rash at the injection site and swelling under her eyes that still persists from the day after the vaccine to now 3 days later.
FATIGUE, CHILLS, MUSCLE ACHE, PAIN INJ SITE Narrative:
Information has been received from a health professional concerning an approximately 9 year old patient who was was vaccinated with a dose of VARIVAX (lot #, route and site of administration not reported). On approximately 27-MAY-2008 the patient developed 5-10 lesions. At the time of the reporting, the patient's outcome was unknown. This is one of several reports for the same source. No further information is available.
Pt to ED 11/13 for cough and AMS. Pt COVID+ 11/13, not candidate for remdesivir as pt not hypoxic. 11/15  denies any dizziness, weakness, or pain. 11/16 pt a&ox4, on room air. 11/17 pt discharged.
Patient presented to clinic for COVID vaccine. Patient signed consent form and denied receiving previous COVID vaccine. Patient provided a name and when searched this name in system found no results. Patient given 1st dose of Moderna COVID vaccine. No adverse reaction noted or reported by patient. On further review found an entry in system under the name Nickname. All other info such as DOB and address match. Information in system for "Nickname" showed that he received 2 doses of Pfizer COVID vaccine and 1 dose of Janssen COVID vaccine prior to receiving Moderna on 8/24/21. Called the facilities that administered the previous doses to verify and patient did receive all the listed vaccines. Patient not given second dose of Moderna. No adverse reactions have been reported by patient.
This spontaneous report as received from a medical assistant/practice manager refers to multiple patients of unknown demographics. Reporter stated that improperly stored doses of M-M-R II (Lot # L032182, expiry date: 25-AUG-2017/ Lot # L026553, expiry date: 16-JUL-2017/ Lot # reported as L041456, expiry date: 22-OCT-2017) were administered to the patients on unspecified dates. No adverse effects were reported. The outcome was unknown. Temperature and time frame was 65F for 65 hours. Data logger was involved. There were no previous excursions. Back in range: Yes. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.