chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/13/2014 - pt calls to report bruising at injection site and soreness - advised to ice and call back with update.  5/20/2014 - bruising and swelling gone. C/o muscle pain heat and ice not helping. Rx for MEDROL dose packs sent to pharm. 6/20/2014 - pt calls to report continuing muscle/arm pain MEDROL ineffective. Pt advise of need to be seen for eval. appt schl'd for 06/13/2014. 6/13/2014 - pt seen in office.
Muscle pains in right arm, both of my sides, right above the breast lining; Body ache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date, patient experienced side effects like the muscle pains in right arm, both of sides, right on the sides, right above the breast lining, sometimes get it in the back, in the back it comes and goes but this was higher on the sides and had the body aches. Patient was just wondering what is the length of time of recovery or how would it go. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant concerning a 15 month old male patient who on 30-NOV-2009, was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (route and lot number not reported). The medical assistant reported no adverse effect. Additional information has been requested.
Saturday after shot: felt fine afterwards; no soreness in arm, no other effects.  Sunday after shot: started feeling lightheaded/dizzy in the evening; headache Monday -- Friday: fatigue, muscle ache, lots of congestion (nose/lungs) and deep bronchial cough, intermittent headache, intermittent low grade fever -- unable to work. Saturday-today after shot: still  fatigue but better; congestion better as well--still congested but cough is relieved (saline nasal rinse helped a lot); no headache; no fever
pt devel an inj site rxn characterized by redness, induration (4cm wide), & pain w/arm movement following vax;
Gastroenteritis; This is a spontaneous report from a contactable Physician.  A 41-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on 01Jul2021 (age at the time of vaccination was 40-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, the patient experienced Gastroenteritis. The patient received BENTYL PPN as a treatment medication for adverse event. The patient underwent lab tests and medical procedures on 17Sep2021 which included Lactose tolerance which showed result as Negative. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & exp chills & sweats; dizziness, nausea, stomach cramps, diarrhea & cough;
45 min after administration: mild numbness in left arm and left hand. Same arm as injection side. Spread to both feet and right hand over next 3 weeks. Three and a half weeks later, I still have this effect.
This spontaneous report was received from an office manager concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-RII (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. It was reported that M-M-RII was reconstituted with properly sterile diluent (MERCK). The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA009964: US-009507513-1709USA010092.
Patient received Moderna vaccination and he is currently 17 years which has not been approved yet for his age. I did call back this morning to follow up with patient but I let a VM to callback for update on how he is feeling.
Runny nose, Sinus pressure, and Weakness. On 10/05/2022 tested positive.  I did a tele health on the same day Paxlovid for 5 days. On 10/06/2022 I started taking the medication.  I tested negative on 10/12/2022.
Information regarding Flu Mist was received from a healthcare professional regarding her 8 year old son who experienced accidental exposure and developed a fever and dry cough. The mother, a pharmacist, reported that she administered the Flumist to patients in November, 2003. Two days later, she developed a cough. Three days after she developed a cough, her son developed fever and a dry cough. The fever resolved after 1 day the cough lasted several days. The mother reported that her 4 year old son also developed fever and cough at the same time. Neither the sons nor his mother received Flumist. Related cases: See HQWYE46008DEC03 and HQWYE460208DEC03. No additional info was available at the time of this report.
Swelling and pain in my armpit on the same side as the vaccine dose was given. Swelling at injection site worse over time (this is just for your information as the concern is the armpit swelling/pain). The armpit swelling/pain was not experienced during the first or second vaccine dose.
Sweating/was diaphoretic/experienced diaphoresis; felt was going to faint, Extreme lightheadedness; slightly nauseated feeling; This case was reported by a consumer via interactive digital media and described the occurrence of hyperhidrosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, 14 hrs after receiving Shingles vaccine, the patient experienced hyperhidrosis, felt faint and nausea. On an unknown date, the outcome of the hyperhidrosis, felt faint and nausea were unknown.   It was unknown if the reporter considered the hyperhidrosis, felt faint and nausea to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had received Shingles vaccine on 10th October 2022 at approximately 11:30 am and at 02:00 am this morning (on reporting day) 14 hours later of vaccination woke and was diaphoretic/sweating, slightly nauseated and felt as though he/she was going to faint after going to the bathroom. The reporter had asked if this combination of symptomatic reactions were common or not. Additional supportive information: Follow-up would not possible as no contact details were available.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter called to report they gave 26 doses after the 30-day use by date. It was reported that the vial was initially stored in the refrigerator on 14 Jan 2022. The dates of vaccine administration were 14 Feb 2022, 15 Feb 2022, 16 Feb 2022, 18 Feb 2022, 21 Feb 2022.  No treatment medications were reported.
The patient came to show that her arm is swollen with a big red patch and warm to touch after getting 3 different vaccines in one arm. She said she never had a reaction to vaccine before. She is also calling her MD just to be on the safe side.
7/1/2023 @ 2;25 AM  Mom contacted Nurse Triage Call Line for concerns of fever up to 102.0 F, vomiting x 5, increasing crying, fretfulness.  Nurse advised: If no improvement to call back. In the meantime monitor, give Tylenol. 7/1/2023 @ 6:51 PM  Mom called Nurse Triage Call Line reporting pt. continues to have fever, (unmeasured), vomited 5 more times and is "screaming bloody murder." Kicking and pulling legs up. Advised to Hospital. Ultra Sound results: non obstructive bowel gas pattern. Due to severe symptoms of intussusception , sent to Hospital. for further eval. U/S repreated. and was negative for intussusception. Sent home on observance.
Swollen lymph nodes in arm pit, very sore to touch. Have used ice, heat, Advil and/or Tylenol. Does not relieve pain. Cannot sleep on side or lay arm down fully on side.
they had administered an expired vaccine to a patient, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 27 months old male patient administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection  (strength, dose: unknown) (lot: UJ662AA, Expiry date: 04-May-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Medical assistant called to report that they had administered an expired vaccine to a patient."  Action taken with Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
Client was 15 years old at time of vaccination. Consent was completed and signed by guardian with age listed as 16 years old. Birthdate was not verified by staff prior to injection.
Can you take for pain from the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Can you take for pain from the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Can you take for pain from the shot). At the time of the report, VACCINATION SITE PAIN (Can you take for pain from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
10/21/99 hives 11/15/99. Seen MD 11/18/99 & seen Dermatologist 12/2/99. Has stopped all lotions & creams. Denies change in detergents, soaps, new meds. No changes. Continues to have hives.
Approximately 10 minutes after receiving the vaccine, I became extremely dizzy, nauseous, my lips went numb, shortness of breath, weakness, slow reaction times, the inability to operate at my normal speed in thought and action, and I became very lethargic.  I received the vaccine during a shift at work, and I was unable to complete the shift at my normal efficiency or concentration. To my coworkers, I described the feeling as being intoxicated, but not slurring my words. This feeling decreased enough by 9pm where I felt safe to drive home, but it was not completely gone until  approximately 11pm.
16OCT98 rt arm (pneumovax arm) red, warm to touch & painful;measures 5"x5" localized redness 2" below shoulder & into inner aspect full ROM arm & fingers;+ capillary return;BP 122/70 radial pulse 88reg;T96.8 oral;
Soreness on her R arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on her R arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021 at 12:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021 at 12:38 PM, the patient experienced VACCINATION SITE PAIN (Soreness on her R arm). At the time of the report, VACCINATION SITE PAIN (Soreness on her R arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Per vaccinator,  while attempting to administer vaccination, needle separated from syringe and the vaccine sprayed out. Less than half of the dose was received by the patient. A replacement vaccine dose was administered.   Syringe/needle
herpes; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   The reporter considered the herpes virus infection to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Shingles vaccine gave the patient herpes.
Patient and I made an appointment at the Pharmacy to receive her Pfizer Covid-19 vaccination. Patient has not been vaccinated for Covid-19 before and signed up to get the first of the primary shots. When he finished administering the shot, I asked him to schedule the 2nd dose. He looked at me weird and said there wasn?t one and then he realized the error. He gave her the Bivalent Booster shot instead of the Pfizer original one. SHE HAS NOT BEEN PREVIOUSLY VACCINATED! There was no checking of vaccine cards or anything (she doesn?t have one anyway/never vaccinated). He then said he needed to call the CDC and Pfizer right away to find out how to proceed. He also mentioned to me that the boxes look similar between the primary vaccine and the booster one - his mistake Ugh. My daughter had to get the Covid-19 vaccine for her class at school, and this better not prevent that. Also, I am worried about if my daughter will have a reaction to a booster that was given without getting the Covid-19 primary series or vaccinations. He said the CDC and Pfizer told him she is fully vaccinated with only getting the Bivalent booster, but that there were not studies on reactions with only getting the booster. He also mentioned he sent a report to VAERS as well. I need answers as to the reason that you must be vaccinated previously before getting boosters and if this will affect my daughter, patient as far as health, vaccine cards, etc.
The purpose of this email is to recount the events surrounding patient: Patient is a 15y/o girl, who arrived at the building during the hour of 3:30-4:30pm, accompanied by her mother and sister. She received 0.5ml of FLUZONE vial (lot#UH476AB) to her Left Deltoid as documented by LVN. It was LVN who had administered the injection. Patient voiced no complaints after the injection, and her mother stated that her family receives flu shots every year. Patient returned to the building prior to the 5pm closing time. Patient had reported feeling "dizzy" and experiencing her "heart racing." RN evaluated her in her vehicle and reported patient had a pulse rate of 70/min. RN also administered nasal ammonia which resulted in no change in patient's condition. Patient was also given fluids to drink which had no effect on her presenting complaints. I contacted Assistant Manager, and I was advised to send patient to the Emergency department for further evaluation. As instructed I passed that advisement along to patient's mother. I obtained patient medical record and spoke to the Emergency Department to inform her that patient was en route. The above is an accurate account of the events surrounding patient's flu shot administration to the best of my recollection. If you have any further questions you can contact me. Thank you for allowing me the opportunity to be of assistance in this matter.
like welts / like hives on her skin; specially when she was in the sun she had this itchy rashes; her jaw was very sore on the left side; it was actually hard to chew/ sometimes it's still extremely painful to chew; started having weird rashes, mostly in her arms; months after she could still feel pain on the injection site; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER and RASH in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA, RASH PRURITIC, PAIN IN JAW, MASTICATION DISORDER, RASH, VACCINATION SITE PAIN, and FATIGUE outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-328497, MOD-2021-328467 (Patient Link).
Red spot at injection site that lasted for days until second injection, nurse looked at it and said it looked ok.  Red spot started to bleed and went to doctor, listed above, and received antibiotic to take 10 days and tube is ointment for spot.
Pt. reports the next day after the shot he was having difficulties standing and walking and required assistance for most of the day.  Questionable palpitations as he was concerned it "affected his heart" but no chest pain or diaphoresis. No SOB.   Pt. had a similar rxn to the first shot on 3/5/21 and had gone to the ER where CXR, EKG, base labs, vitals were all normal.
Employee report that on Saturday November 4, 2023 at mid day {noon}  she stared with at headache and to this date has had it for 3 consecutive day, drowsiness,  nasal congestion/rhinitis and having itchiness on face and scalp area. On Sunday November 5, she broke out in a rash to face and scalp. Took Tylenol 500 mg and Ibuprofen 8000mg  with out relief for headache. She has not done anything for rash.  Employee did not seek any type of medical care over the weekend at urgent care or ER.
Pt received vaccine from Pfizer on 6/14/21 and came in at 3 weeks for her second dose, but MODERNA was given by mistake. Pt 30 minutes after the vaccine was given she felt fine.
8 or 9 days after the first injection there was a red circular area around the injection site about 2 inches in diameter. It didn't itch or hurt and it was gone 2 days later.
Change in monthly menstruation cycle. Periods are occurring more frequent, less than 28 days apart. This is not normal for my cycle.
HYPOTENSION PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
08/30/22 presents to ED for "rectal bleeding". PMHx of "hypertension, diverticulosis, colon polyps, GI bleeding"
A few weeks after my second vaccine I did start to notice that my back was hurting and ignored it. It continued to get worse and worse and then went to urgent care on 3-15-2021, after noticing a rash on my back they stated that I have come down with shingles. The rash spread all across my abdomen and chest as well as my back. They gave me an antiviral to help combat the symptoms. The prescription did help, however my skin felt raw for over a month. As of now it is completely gone and symptoms are no longer there.
Fever (101 degree temp), body aches, splitting headache, nausea- onset 10 hours after vaccine x14 hours. Of most concern is the development of periorbital edema, erythmatous, pruritic eyes bilaterally, onset 24 hours after receiving vaccine- with slow, progressive development over the course of 2 days until medical treatment was sought.
HPV vaccine given patient passed out about 5 min after vaccination administration. She also mention she was having lots of headaches, shakiness and was feeling dizzy.
Patient was unresponsive in her dorm room and 911 was called.  EMS responded and found her blood sugar in the 20s. She was given an amp of D50 and her blood sugar did improve to 178 prior to arrival.   Patient awake and alert on arrival. She states that she has been having issues with hypoglycemia in the early morning hours since November. Patient denies any changes in her diet that may be contributing to increased hypoglycemic episodes.
Per patient he had a previous herpes outbreak 25 years ago.  States that it has been dormant for over twenty years.  Less than 48 hours after vaccine he has a significant genital herpetic outbreak.  Prescribed Valtrex 1 gram tablet: Take 1 tablet (oral) 3 times per day for 7 days; Total Qty: 21 (Twenty One) tablet.     Advised to follow up at our clinic or his Doctor if symptoms do not start to improve over the next day or two or if he has any new or worsening symptoms.