chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAINFUL AND SORE ARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced painful and sore arm. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful and sore arm. This report was non-serious.
It was reported that a female patient (3 of 4) was vaccinated with Fluzone SV 2001-2002 vaccine, lot number U0682AA on 10/16/01. Reportedly the patient developed a local reaction of redness and swelling at the injection site. Patient was evaluated by a physician and no therapy was prescribed. This case is linked with reports U200101061, U200101278 and U200101280.
Narrative:  72 y/o with bladder CA received first dose of Moderna COVID-19 vaccine 1/13. Pt had multiple hospitalizations as he was found unconscious during dialysis and found to have pneumonia and then had bloody discharge. Pt fell from wheelchair and had head laceration and recurrent pneumonia. On 3/15, pt's O2 was very low. Pt was placed on hospice care at outside hospital 3/16 and expired 3/20.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-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 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023. Treatment medication was not reported.  This case is for 6th patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
mom states pt had no problems until about 1030AM broke out in whelps; no breathing problems; called MD;
Admit for suspected COVID infection, presenting with SOB, CP, cough, N, V, D; exposed to ill daughter. Fully vaccinated. Did not require targeted treatmetn for COVID, minimal need for O2 therapy. Treated for dehydration and AKI. Improved and discharged home.
Bloody nose x 2, blood blisters inside mouth including tongue, cheek, and lip. These symptoms showed up on 04/23/21. Went to the dentist on 04/24/21 due to having tooth extraction on 03/18/21. Dentist confirmed that had healed completely and recommended getting blood work done. Went to Urgent Care had blood drawn, report showed ZERO platelets. I was sent to ER where they ran a blood test again, platelets were ONE. 2 bags of platelets were infused, that brought platelets to 5.  I was then admitted to the hospital and four hours later platelets were down to 2. They infused another 2 bags of platelets. Blood test showed platelets at 10.  Four hours later the platelets were down to 4. On 04/25/21 I was diagnosed with ITP and was given an infusion of IVIG, on 04/26/21 my platelets were up to 16. They infused another IVIG on 04/26/21 and on 04/27/21 platelets were at 41. I was discharged on 04/27/21. Went to clinic on 04/29/21 and platelets were at 130.
Upon arrival into clinic room patient visibly anxious with tears, mother reports she does not like shots. Patient reassured and brought into administration room after all vaccines prepared, seated during vaccination, 2 nurses assisted with vaccinating, patient screamed throughout administration and promptly after last vaccine given patient pale and syncopal, lowered to floor upon which she reopened her eyes, legs elevated while supine, mother in room with patient. Patient denies any SOB or symptoms in throat/tongue, no urticaria or anaphylaxis present.  Patient transferred to chair and given sips of water, mother reports patient did not eat today yet, given some snacks and she reported feeling better, color back to baseline. Continued to monitor patient in office, reported feeling better and was discharged after 30 minutes.
This retrospective pregnancy case was reported in a literature article and described the occurrence of ectopic kidney in a infant. The mother received Flu Seasonal QIV Dresden. The infant was exposed to Flu Seasonal QIV Dresden during the second trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with ectopic kidney. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of ectopic kidney was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the ectopic kidney may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of ectopic kidney in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (IIV) (manufacturer unknown) during the second trimester of pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero during the second trimester of pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient had ectopic kidney. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between ectopic kidney and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
When giving the immunization the pharmacist noticed that a large quantity of the medication ran down the patients arm. Patient did not get the full amount of the vaccine. There was no way of knowing how much the patient received and how much ran down the patients arm. The pharmacist then gave the immunization again.
patient received a vaccine which was wrong storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine which was wrong storage and handling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient received remdesivir in November .  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-significant follow-up
Information has been received from a 67 year old female consumer with myelodysplastic syndrome and no known drug reactions/allergies, who on 12-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included PROCRIT, GLUCOPHAGE, SYNTHROID, PROTONIX and clonazepam. The consumer reported that on 12-APR-2011, within 5 or 10 minutes of receiving the dose of PNEUMOVAX 23, she had severe reaction. She had severe flushing of her face, and also her face was red and hot. The consumer also said that she experience weakness and inability to walk or stand. She could not hold a cup of water that she was given. The patient stated that she got the shot in her hip and said that she had severe pain in her back, on the same side as the injection was given. The patient also experienced a severe headache. The patient also reported that she developed black circles under her eyes. The patient sought unspecified medical attention. The patient was given cortisone shot to help her with the reaction. No labs diagnostic tests were performed. It was reported that after an hour or two the patient was able to drive herself home. At the time of the report, the patient still had some redness in her face and she thought she might had a dull headache, but none of the other symptoms. Follow up information indicated that on 13-APR-2011 (previously reported as 12-APR-2011) the patient was vaccinated with a dose of PNEUMOVAX 23 (lot umber not provided) and after she received the vaccine her eyes sunked in, turned black and she had a pain in her right arm. It was reported that the patient did not seek medical attention. No treatment was given for the adverse events. No lab diagnostic test were performed. The patient was reported as not recovered. Additional information has been requested.
Costochrondritis. inflammation of cartilage in chest. Skeletal muscular issue. Stabbing pain in chest and pressure started Friday  the day of my 2nd dose of mederna.
Patient received Moderna vaccine for 1st dose on 3/17/2021. When she returned on 4/14/21 for her 2nd dose, she received the Pfizer vaccine.  No known symptoms or side effects at this time
This Pt was permitted to create an acct, make an appt in TVRS prior to this clinic date and get the vaccine before the  system stopped due to the age. It was not caught until check out when Pt 2nd shot appt was being made. They showed up on the list of people WITH scheduled appts in TVRS and were NOT added to TVRS at the time of the clinic.
This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot #: L025737, expiration date on 28-JUL-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
Initial onset of high pitched ringing tinnitus (went away after a few minutes), followed by muffled hearing in left ear. The muffled hearing eased up after around 2 hours, but since the initial Aug 8th onset until now (Sep 5), I've been experiencing sporadic tinnitus attacks, as well as a fullness in my ears that rarely ease up. Not usually muffled hearing, but feeling of pressure and stuffiness that can seems to move from one ear to the other. After around 2 weeks after the initial onset, the intensity of the discomfort lessened somewhat, but all the described symptoms still occur frequently. GP at an after hours clinic did not find any issues with ear canal or ear drum in preliminary screening. Currently waiting for ENT appointment.
THE PATIENT RECIEVED JANSSEN ON 08/18/2021 AND RECIEVED ANOTHER DOSE OF JANSSEN ON 08/31/2021
Patient reported having "a bad taste in mouth", which started about 1/2 hr after her first dose and lasted "no more than an hour".  She said more than 24 hr later, she had chills. Additionally, a sore arm started in the evening and lasted a couple of days. The chills and sore arm are typical side effects, but VAERs report submitted due to report of "bad taste in mouth", which is unusual. She said her daughter and niece reported the same reaction after vaccination. She was advised to have them report this via their vaccination site if not done so already.
Patient was given the booster dose of Moderna on 04/13/2022, the vaccine expired on 04/06/2022. No adverse reactions during the  required 15 minute waiting period after the immunization was given.
This is a spontaneous report from a contactable consumer reporting for herself. This 76-years-old female patient of unknown race/ethnicity received in Mar2018 a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. After vaccination, in Apr2018, patient experiences skin rashes. Outcome was unknown. Information on the batch number has been requested.
Information has been received from a licensed practical nurse concerning a 13 week old male patient who on 03-JUL-2008 was vaccinated orally with a first "one pouch" dose of ROTATEQ vaccine live (human-bovine). There were no adverse effects reported. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Follow-up information and vaccination administration records has been received from a licensed practical nurse concerning this 13 week old male infant who on 03-JUL-2008 was vaccinated orally with a 2ml dose of ROTATEQ vaccine live (human-bovine) (expiration date 11-SEP-2009). Concomitant vaccinations on the same day included a first  0.5ml dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot # AC14B046A) (expiration date 27-APR-2009) IM in the left thigh at 12:00 pm, a first 0.5cc dose of poliovirus virus vaccine inactivated (Vero) (IPOL) (lot # A0492) (expiration date 09-JUN-2009) SQ in the left thigh at 12:00 pm, a second 0.5cc dose of hepatitis B vaccine, recomb (MSD) (lot # 657607/1372U) IM in the right thigh at 12:00 pm and a first 0.5cc dose of PREVNAR vaccine (CRM197) (lot # C65931) IM in the right thigh. There was no illness at the time of vaccination or any adverse events following prior vaccinations. It was reported that the patient was seen as a new patient and noted to behind on his immunizations. The physician felt the patient could benefit from the ROTATEQ vaccine live (human-bovine) per his mother request. There was no adverse event reported. At the time of the report the patient's status was unknown. Additional information is not expected.
5 PM Few seconds after GARDASIL was injected to (L) deltoid IM, patient developed nausea, palpitation, to drowsiness, pyrexia followed. Developed pallor, diaphoresis to pre-syncopal attack. Tachy, stimulation applied; patient then reported nausea and subsequently vomited. After this pallor resolved and regained full consciousness. T 99, BP 100/70. Fully recovered, stood up, walked and discharged. Duration 15 minutes.
Patient received DTaP #4 in right thigh IM and flu vaccine in left thigh IM on 11/6/02. Local reaction vs. celulitis due to DTaP. Presented to office 11/8/02 with complaints of 2.5 inch diameter redness and swelling at injection site right thigh.
I first had a typical reaction to the vaccine, including soreness at site, fatigue, aches, and chills. On the fourth day after the shot, I developed shingles on my left side (the same side as where I received the vaccine). It began on the left side of my scalp and progressed down my forehead and to my left eye. My left eye also became very swollen, to the point of being shut.   I am 12 days post vaccine now, and I still have shingles and my eye is still very swollen. I have been seen at both the ER and urgent care. I am currently taking Valtrex, oral steroids, and have antibiotic ointment for my eye as well as steroid eye drops.
Vaginal bleeding similar to a period that lasted 2-3 days.  I am post menopausal. I have not had a period in at least 5 years.  The exact thing happened after the second vaccination.
Case number PHEH2013US010210 is an initial spontaneous report received from a physician on 02 May 2013. This report refers to a 19-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with second dose of pre-exposure series of RABAVERT (batch number: 500011A) intramuscularly on 25 Apr 2013. On the same date, she developed eczema on her right elbow. The next morning she had swelling of tongue. It was reported that the third dose was due on May 2013 and was not administered at the time of call. The outcome of the events was not reported.
My arm is still sore from the injection site; My nose is been running; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3249) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL; TOPROL XL. Vaccination history included: Bnt162b2 (First Dose, Lot no: EL1283, Intramuscularly, Left side.), administration date: 14Jan2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "My arm is still sore from the injection site"; RHINORRHOEA (non-serious) with onset Feb2021, outcome "not recovered", described as "My nose is been running". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Dull aching pain started evening after flu shot in left arm. Continued for a week then started to subside in second week. Patient noticed weakness in his arm while lifting weights. Pain continued on and off while at rest for several more weeks. Now pain mainly gone but had dull ache last night 12/9/13 again. No previous adverse reaction to a flu shot.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (strength, lot#, expiration date, dose and route were unknown) which was improperly stored. No adverse events were reported. Additional information has been requested.
Covid Vaccine: First: 3/11/21 (lot # EN6203 - LD) Second dose: 4/1/21 (lot # EN6208 -LD)  Patient received her second dose vaccine on Thursday 4/1.  On Friday 4/2 she started to develop sore arm and lightheaded sensation.  When she checked her blood pressure, her systolic was in the 80s.  Patient was presented to ED for checkup.
Per patient report via e-mail on 8/6/2018 at 7pm, a potential allergic reaction occurred the night of vaccination. Patient reports face broke out in hives and a bad fever was experienced. Her arm is still sore on Monday after getting the shot on 8/3/18, Fever is gone on 8/6/18, but face is still very splotchy. Client reports did not seek health care for this concern "because I'm stubborn". She reports that her face doesn't hurt or itch, but "looks terrible". Client is not sure what to call this "rash" as she doesn't believe it to be hives. She describes them as "tiny mosquito bites or acne everywhere, but its just color, There is no actual bump. Just splotches of color everywhere and has spread to legs as of 8/7/18 at 3:15pm. At this time client reports that they are not able to be felt and are not causing pain.  As of 8/15/18, per an email to Public Health Nurse, client reports that splotches on face stopped spreading and faded a "few days ago".
Patient received three 3 doses of the covid vaccine first on on 01/13/2021 second on 01/30/2021 third on 02/27/2021  This event was just discovered today on 3/5/2021.
Moderna administered 02/01/21.  Patient expired 02/10/2020 unexpectedly
Rash with induration; evaluated by MD and was given Benadryl and told not to get vaccine again.
fever - up to 100.4 - ibuprofen - lasted 8 hours headache - lasted 8 hours nausea - lasted 3 hours joint aches - lasted 8 hours injection site pain (more than minor) - lasted 8 hours
Patient with actual rash, no fever, lasted for 1 -2 wks. Treated with Benadryl and Aveeno baths.
5 days after receiving the vaccine, I noticed neck swelling( lump) in front of my neck, not sure if it is related but showed up all of a sudden.Was not there the day before. Had a neck/thyroid US shows bilateral cervical lymph nodes. Nodule  on the isthmus 1.9 cms in height moderately suspicious. Will need an FNA
3 days after receiving vaccine, patient broke out in an itchy bumpy rash along his chest, stomach, neck, and back. After a few days it seemed to resolve, then came back. He reported it to me today (2 weeks after immunization) and still had visible bumps on his neck. His wife had the same reaction.
cough, slight headache, slight congestion in the head, slightly whoozie head, slight chill.  Symptoms have subsided over four days but continue to linger.
EXPIRATION DATE WAS TRANSPOSED FROM 6/17/2021 TO 7/17/2021 IN EMR, VACCINE WAS GIVEN AFTER EXPIRATION DATE.
10 min after: shot rush of blood back to site  of injection, 11min after: wanting to cough, next morning: passing out on bathroom floor
myocarditis. initially thought to be non-stemi MI but coronary angiogram did not show severe stenosis. Patient had chest pain, elevated troponin