chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of three patients received expired FLUMIST was received from a health professional concerning an 18-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 29-Nov-2010. On 28-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and report causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported for the this patient.
1/17/12 Lying next to mom sleeping. She noticed rhythmic movement. Looked at him and his eyes were open, staring and he was shaking rhythmically all over. Lasted about 1 min, then he cried a little and went back to sleep. Temp 98. Intermittent jerking thru the night but not rhythmic.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
PATIENT REPORTED HIGH FEVER FOR A COUPLE DAYS, UNABLE TO GET OUT OF BED, CAN NOT MOVE ARMS OR SHOULDERS FEELING BETTER AFTER 48 HOURS BUT STILL HAS FEVER; MD TOLD HER TO DRINK FLUID AND TAKE TYLENOL; AREMS AND SHOULDERS ARE STARTING TO FEEL BETTER AT 48 HOURS
Experienced soreness in the left arm (injection site), chills/shivers, headache, joint pain/soreness, and general fatigue (mental haziness).
3/19/09 Started with rash neck + chest 3/20 face, arm leg c/o itching - approx 45
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil.  Subsequently, almost immediately after receiving the vaccination, the patient became very lightheaded.  The patient did not seek medical attention.  The patient recovered within five minute after the vaccine was administered.  No product quality complaint was involved.  Additional information has been requested.
Child became extremely fussy, stomach was tensing up (believed to be stomach cramps), upset stomach (lots of indigestion could be heard), appetite slightly depressed.
This spontaneous report as received from a other reporter, as part of marketing research program titled as "HCC Tracker ZOSTAVAX" conducted by MSW Research regarding a 51 year old female patient. There was no information on medical history. On unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, product lot #, expiry date not reported). There was no information on concomitant therapy reported. On an unknown date the patient reported that its a live virus, very dangerous for me. There was no information on diagnostic tests carried out to diagnose adverse event. The outcome of the event and causality was unknown. Additional information has been requested.
Injection site is very warm; Injection sire is more red; Arm more sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm more sore), VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm more sore). On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm more sore), VACCINATION SITE WARMTH (Injection site is very warm) and VACCINATION SITE ERYTHEMA (Injection sire is more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Approximately 10 days after receiving the first dose of the COVID vaccine, I began having worsening joint pain in my hands, shoulders, knees and ankles. I also experienced whole-body stiffness throughout the day. My hands swelled and turned red, white or sometimes blue. The symptoms worsened after receiving my second dose. At that point, I saw a rheumatoid specialist who diagnosed me with early mixed connective tissue disease (MCTD) and placed me on hydroxychloroquine and prednisone.
Rcvd Vax 12/28/99, during visit on 1/2/00, pt developed non-erythematous papular rash covering thighs.  Nodule felt at site of injection, rash surrounded area and extended up thighs to buttocks and groin area.  Baby had fever.
Severe headache, jaw spasms,  stiff neck & spine. It felt like my spine was on fire. Lasted x 9 days - gradually diminishing by day 9.
"pt ran a fever 100-101 & had a rash for 4 days, 10 days p/vax immun;"
Reaction 07/15/2021, 02:00. I started to feel dizzy and lightheaded. Over the next few days, I felt it was messing with my brain. I couldn't even do anything simple like even watch TV. I felt off also like the things that were happening on TV were real. I felt like I was off balance and the sensors were completely off like normal. Shadows throw me off when I was walking outside. Whereas a normal day I wouldn't be bothered by tress moving I felt like the ground was shifting. 07/29/2021, I noticed lumps and then made a appointment and I was told that it was normal and referred to a website to see how common it was. The lumps have gone away but I occasionally get breast pain. I haven't received any more vaccines.
Cellulitis to left arm. Running temperature started evening after vaccine. Started on Ax on 3-20-09.
Cramping; Diarrhea; Nausea; This spontaneous report was received from a physician via company representative referring to a male patient of an unknown age.  The information regarding patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was unknown.  On 20-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiry date, anatomical location, route of administration were unspecified) for prophylaxis. On the same day, the patient later experienced nausea, diarrhea and cramping afterwards. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Vaccine given 09/10/03, sent to ER 09/11/03 for left arm swelling at injection site and was given Keflex. On 09/12/03 she was seen at Val-Ped with erythema and pain to the left deltoid at that time she was given Rocephin IM (1mg). 9/13/03 the patient was sent to the ER for redness, increased tenderness and warmth. Follow up call 9/16/03, swelling is gone, no fever. Patient is better.
Chills; Body ache; Sore arm; This is a spontaneous report from a contactable pharmacist (patient) who reported events after first and second dose of the vaccine. This case is for events after the second dose.  A 31-year-old Female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810), via an unspecified route of administration, in Right arm on 24Feb2021 (at 31 years) at single dose for covid-19 immunisation . Patient had known allergy to Cantaloupe. Concomitant medications included multivitamin; ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc (AIRBORNE) and ibuprofen (ADVIL) for 2 days between doses. Previously on 03Feb2021 at 16:30 (at 30 years) patient receive first dose of the vaccine (lot EL9262) in Right arm for covid-19 immunisation and experienced sore arm for 2-3 days. On 24Feb2021 the patient experienced chills starting 12 hours after dose and lasting until about 28 hours after; body aches starting 16 hours after dose and lasting until about 28 hours after and sore arm for 2-3 days. No treatment given. The outcome of the events was recovered in Feb2021. No follow up attempts are possible; information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219538 same patient/vaccine, different dose/event.
No adverse effects reported; patient was vaccinated with an improperly stored M-M-R II; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis B virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified) and meningococcal ACYW conj vaccine (carrier unspecified).  On 27-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # R028382, expiration date 10-MAR-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The temperature was exposed to a temperature of 13.13 degree Celsius since 23-MAY-2019 to 02-OCT-2019 as recorded by a digital data logger was involved. There were no previous temperature excursions, however, on an unknown date the vaccine had a temperature excursion with a highest temperature above 9 degree Celsius (58.96 degree Celsius) for 8299 and 45 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012359: US-009507513-1910USA012355: US-009507513-1910USA012352: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012358: US-009507513-1910USA012351: US-009507513-1910USA012350: US-009507513-1910USA012353:
described a painful, silver dollar-sized blister popping up on his left calf approximately one week after his second COVID-19 vaccine. Then a second blister appeared on the right calf within a few days. He went to his primary care provider and they treated it but did not make a connection to the vaccine. It wasn't until a couple weeks later when his (adult) son got his second COVID-19 vaccine and had the exact same large blister appear on one of his calves that they made the connection to the vaccine. Obviously a genetic component here that someone needs to look at.
always get the light sniffles and a very low grade fever after I get one; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved a female patient of an unknown age who always get the light sniffles and a very low-grade fever (Pyrexia), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that patient always get the light sniffles and a very low-grade fever (Pyrexia) after receiving the suspect vaccine.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of pyrexia.  There will be no information available on the batch number for this case.
Pt. recieved 2nd dose COVID vaccine on 2 Feb and was admitted to Hospital on 3 Feb with Chest pain; DKA (diabetic ketoacidoses); Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus; Hyperglycemia.  He was discharged on 5 Feb.  His home course is unknown
Day after injection, pt felt numbness in right thumb which lasted 2 days and then subsided.
Redness of left deltoid injection site after receiving (TIV flu) vaccine 11/26/12. Redness did not begin until 11/27/12.
Abcess like reaction, right gluteal at site of administration 10 cm x 7 cm with deep induration, also malaise, fever, weakness, arthralgias.
Tinnitus.  Was mild/ very intermittent, now nearly continuous, much more significant.
BODY ACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2022) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches. This report was non-serious.
Pt recvd vax & devel pain @ inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered a High Dose influenza meant for 65 and over to this 58 year old.  10-03-2022  Client reports on adverse effects.
Patient requested Pfizer bivalent (confusion during data entry, tech believed to confirm moderna bivalent verbally), patient was given Moderna bivalent and patient asked if it was Pfizer after vaccine was already administered.  No adverse reaction reported at this time
has had a temperature of 102.5; body aches; shivering; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male consumer received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation/Lot number: Unknown, Expiry Date: Unknown), via unknown route of administration on left shoulder area  (Deltoid Left) on an 27Jan2021 at 15:30 as a SINGLE DOSE for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to the first administration date of the suspect vaccine. The patient was not administered with additional vaccines on same date of the Pfizer Suspect. The patient did not experience any adverse event following prior vaccination. The patient did not have any history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On 27Jan2021, the patient experienced shivering, body aches and temperature of 102.5. He stated that yesterday he got the vaccine and had a temperature of 102.5, body aches, and shivering. The patient received Tylenol his temperature goes down to 100.0 but not lower. This started late last night. The patient was taking the Tylenol every 5 hours and a pain pill Ultracet but the temperature did not decrease below 100. Outcome of the events were not recovered.  Information on lot/batch has been requested.
Patient given Pfizer monovalent (12+) vaccine instead of Pfizer Bivalent (12+) vaccine.
Patient seen in the office 11/12/2020 with adverse reaction. Patient noted to have macular, erythematous rash on right deltoid, tender to palpation at injection site, no fevers
3 days after the vaccine developed dermographic urticaria which has persisted daily for 9 months.
mom stated noticed rash on body & arms about 5:15PM; does not know what time broke out; no resp distress; recommended seeing family MD or going to ER; pt is taking Keflex @ this time;
reporting vaccine error...pt received first dose 9-7-2019 and another dose 10/29/2021 not separated by 10 year recommendation ...no adverse reaction noted
Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior right chin, increased hearing issues in right ear since time of vaccine.
Vaccine administered at 1:30PM.Patient started developing symptoms at 1:50PM. patient complaint of hot flash flush feeling and diarrhea . Notified doctor, he assessed patient. per provider advised to monitor patient for another 30 Minutes.  Notified provider okay for patient to go home if symptoms persist or worsen go to nearest emergency room patient verbalized understanding and agreed
This case was reported by an other manufacturer via a sales representative and described the occurrence of fainting in a subject of unspecified age and gender who was vaccinated with TWINRIX for prophylaxis. Other vaccinations that the subject received was GARDASIL. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). Within hours of vaccination with TWINRIX, the subject experienced fainting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the fainting was unspecified. It was also reported that four hours after the subject received TWINRIX, the subject came back in and received GARDASIL.
(L) arm deltoid area redness, visible swelling, increased warm, tenderness to palpation. Tx: ALEVE, cool compresses.
Client came in to have tb test read on 7/22/10 at around 09:00 am.  Client also received Tdap in her left deltoid and, Twinrix in her right deltoid. C/O arm very sore and warm to the touch, swollen, no reddness observed, painfull when moving arm.  Also since administration on 7/19/10 client claimed severe fatigue and stated she slept almost the whole time since getting the vaccines.  Also c/o body aches all over.
Vaccine administered on 4/23/09. Immediate bruising noted 1/2 dollar size. Bruising dissipated over weekend but Pt developed site of erythema, raised, warm to touch at site of injection. Negative for hives, dyspnea, rash.
53 expired doses of booster dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FH8027) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (53 expired doses of booster dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  Number of doses,vials 2 vials from the same lot provided. Doses were administered  out on 2 different dates: 30Nov2021 and 3Dec2021. Date the vial was initially stored in the refrigerator 29Oct2021
Pt recvd Engerix-B & 24 hrs p/dose had chills, 100 degree fever, nausea, abdominal cramps, h/a that last 5 days;
Vaccine error: 5-11 year dose given to this 3 year old. No adverse event shortly after. Informed mother to watch for increase in side effects.
patients who may have been vaccinated with imporoperlu stored vaccines; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The reporter stated that at his/her office recently discovered that fridge temperature were out of range. The reporter asked what excursions were permitted. The reporter wanted to know if the vaccines still effective. The Lowest temperature was 26F. It was first known excursion, Might had been up to 3 months. The fridge temps were pocketed. Some spots were 26 F, Some were 40F.  The reporter wanted to know if there was recommendations for patients who might have been vaccinated with improperly stored vaccines. The number of patients who received the vaccines and the demographics and lot and expiry dates, HCP stated it was unknown at the time of reporting. The reporter consented to follow up via email.
Fever, chills, dizziness, bruise @ the injection site, raised red lump below injection site
Excessive bleeding & cramps, even though it was Day 3 of period. 3 tampons & 3 pads each hour for several hrs. In 2 1/2 days, I've used 55 Super tampons & 33 large pads. This caused fatigue, low BP 98/48, 103/56, 106/53, dizziness, and onset of sleep w/ painful wake cycles. I used no pain meds, just grape molasses mixed with tahini as well as plain yogurt, salt & water mix to replenish electrolytes. 3rd day: the flow is down to 1 tampon + 1 pad / hour. Cramps increased.
Was sick, achy, head ache, fatigued after 1st shot for 24 hours. WOrse, fever , achy, headache, fatigue for 36 hours after second dose.
Did not get the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose three years ago).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The patient did not get the second dose. The patient indicated that he intended on getting the second dose as soon as possible. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for first dose of Shingrix.
Experienced tingling in tongue and increased mucus.  PHN administered 50 mg Benadryl PO.  Patient left in stable condition.