chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX-B (GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 16 February 2007, the subject received 3rd dose of Engerix-B. At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 16 February 2007, a hepatitis B surface antibody titer was negative. The pharmacist considered the event was probably related to vaccination with Engerix-B.
Redness and swelling at injection site; swelling of right arm, hand including fingers, induration and tenderness at injection site, started when patient woke up this AM; given instructions to ice, Atarax PRN itching and Amoxicillin if redness starts spreading and/or fever develops.
Left Arm Pain Fever sweating chills Dizzy Fainted in bathroom. Dehydrated Called 911. At 530am in morning Wanted me to go to hospital said I was feeling better they said to rest and follow up with your doctor which I did 930am that morning took ADVIL and TYLENOL.
Pt received MMR and DTaP on 7/22/03. MMR in right lateral arm; DTaP in left lateral arm. Mom reports pt started getting erythema, swelling and warmth around DTaP site 2-3 hours after injection. Progressed to whole upper arm. Seen 7/24/03 - started on Benadryl and Prednisone.
Initially the back of my neck was itching. My face burned, my forehead , neck, and shoulders was visually burned. After that any food I ate the burned came back. If I am near sunlight the burns come back same place every time.
pt was vomiting, near syncope, tremors, laid pt down and put her in trending burg, pt responded well BP was 112/62 911 was called. pt recovered and was able to verbalize how she was feeling and was transported to ER for further evaluation.
Diarrhea, Heaviness in Chest, Rash, Wheezing
States local pain and, she felt very tired that day (attributed it to blood draw that happened the same day_. Next day, anterior axillary area became swollen and painful. Moving the arm hurts, because it manipulates the area. Taking OTC medication (she thinks ibuprofen) which does help with the pain. Wearing her back pack over the left side only right now
chills to where body was shaking, headache, tiredness, hard to get out of bed, just not feeling well . This lasted a day, feel better today
PATIENT RECEIVED A SUBCUTANEOUS INJECTION TO HER LEFT ARM. NO ADVERSE EVENTS OCCURRED. PT WAS UNABLE TO RECEIVE AN INTRADERMAL INJECTION, THEREFORE VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.
PFIZER COVID VACCINE #3 GIVEN 6/22/21, LOT # UNKNOWN; 3/20/22 pt unresponsive at SNF; EMS called; intubated; CT head showed intraparenchmal brain bleed; neurosurgeon did not suggest surgical intervention; CXR showed stable persistent pneumonitis from recent COVID infection (had a positive test 2/20/22); pt eventually transitioned to comfort care and was palliatively extubated; he passed away in the hospital
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Depersonalization, visual snow, anxiety, brain fog, dizziness, objects she looks at jump and move around (including words when she's reading), occasional weakness in legs to the point where they give out, damage to short term memory, learning difficulties (and she's a straight A student), insomnia, and tingling in hands, feet, and legs. Oh, and extreme thirst.
When the shot was administered they were using a 1in needle instead of 1 1/2 inch needle. The next day it was red and swollen. It looked like the vaccine had moved from the middle of my arm to the right. The  whole area was red, warm to touch and as big as a baseball. Four weeks later I still had this, and went to the Dr. and gave me Keflex. My arm still hurts from the vaccine, there is still a lump there and painful to the touch.
Headache, blurred vision, fatigue, freezing chills with no fever.  Symptoms lasted about 36 hours
Initial information was received from a medical assistant concerning an approximately 15 months old male patient without pertinent medical history or drug reactions/allergies, who on 01-NOV-2012, the patient was vaccinated with a dose of VARIVAX (merck) (lot H011913 exp date 14-JUN-2014) (dose, route and indication were not reported). Suspect vaccine included a dose of M-M-R II (lot 0644AE exp date 27-MAR-2014) (dose, route and indication were not reported), Hib conj vaccine (tet toxoid). Concomitant medications included HAVRIX and PREVNAR 13. PENTACEL (dose, route, indication and lot number were not reported) and FLUZONE (route, dose, indication and lot number were not reported, all of them on the same date. On 09-NOV-2012 the patient developed chicken pox and measles. The patient had two different types of rashes vesicular primarily on the arms but also all over the body and a maculopapular rash primarily on the face, but also all over the body. The patient was treated with TYLENOL. At the time of report, the patient was recovering from the events. No laboratory test was performed. It was reported that the patient sought medical attention by contacting the office. This is one of several reports form the same source. Additional information has been requested.
2 days after reciving her seasonal influenza and bivalent booster she started with pain in her right arm side she got the COVID shot and which progressed to leg pain and weakness bilaterally in the thighs.  Patient was seen in the ED on Sunday given pain medications and was sent home.  On Monday she saw her primary Dr. and talked about the pain in her arm and thighs and he felt that it was possibly an immune reaction.  Later in that day as she was walking in her house her legs "buckled" and she fell down.  Today she was in the bathroom and had a hard time arising from the toilet due to weakness in her lower extremities.  Patient moved to a chair after this to rest and when she tried to get up she fell again.  She is complaining of severe pain in her knees and lower extremities with inability to walk well as she is unsure when her legs will give out again.  She denies any fever chills body aches.  No nausea vomiting or diarrhea.  No palpitations or chest pain prior to her falling.  She denies any shortness of breath or focal weakness.  Today when she fell she fell with her left leg trapped beneath her causing pain in that leg where she has had a replacement.  Patient is denied any dizziness associated with all of her falls.
PT COMPLAINED OF BAD PAIN IN LEFT ARM NEAR SHOULDER AND DOWN TO ELBOW. HE WAS GIVEN THE SHOT AROUND 6PM. PT DID NOT EVEN FEEL IT. THERE ALSO WAS NOT ANY BLOOD FROM THE INJECTION AND HE IS ON BLOOD THINNERS. HE LEFT THE PHARMACY PERFECTLY FINE. CALLED ME SATURDAY 9AM AND SAID FROM 9PM THE PREVIOUS NIGHT HE HAD PAIN IN HIS SHOULDER AND HAD DIFFICULTY SLEEPING.
Information has been received from a physician concerning three females who were vaccinated with a dose of GARDASIL on an unspecified date. The patient did not have HPV before receiving GARDASIL. After receiving GARDASIL, the patient had positive results of HPV. At the time of report, the outcome was unknown. The patient sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Within 24 hours postvax, pt developed an injection site reaction characterized by redness and swelling.  The pt was treated with Advil and application of moist heat and recovered within 4 days.
dose was given on day 14 at patient request b/c he was moving, employee who scheduled did not confirm date of prior dose and proceeded to schedule. vaccinator did not confirm date of prior dose to ensure it was within the acceptable time frame. it was 3 days too early.
Pt recvd 3 doses of Engerix-B, 3rd dose given 31MAY90 & it was determined that pt did not convert to a protective surface antibody level;
This spontaneous report as received from a licensed practical nurse refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse and described the occurrence of expired vaccine used in a 4-year-old male patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014).  On 4th December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
I have experienced moderate to severe fatigue since receiving the injection. I missed one day of work as a result. I have experienced some improvement since Day 0 (day of injection). I am submitting this form on Day 12 and still experiencing moderate fatigue.
Information has been received from an office manager via a company representative referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 24-JUN-2014, 04-NOV-2014 and 02-JAN-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (strength, dose, route, lot# and expiration date unknown) separately. The 3rd dose was too early. No adverse effects reported. Additional information has been requested.
2 hours after receiving the vaccine I had a nosebleed on the left side of my nose.
Possible cellulitis; Sore in arm; Swelled up ,when touched it; I had heat in it; Red,when touched it; Arm is sore to shoulder; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in arm/pain in extremity, red and swelled up when touched in it/erythema and swelling, had heat in it/feeling hot, possible cellulitis and arm was sore to shoulder/arthralgia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, approximately 10 days prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient complained sore arm radiating to shoulder, which was red, swollen and warm  and could be cellulitis.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. No follow up is possible.; Sender's Comments:
Dont know if this was an adverse reactions but I was contacted by vsafe and asked to report a health event since my last vaccine. I was diagnosed with sleep apnea in May  after having symptoms of weak body, lack of sleep and physical fatigue to the point its affecting my ability to perform daily chores/avtivities
24 hours after second dose started to get lower back pain that then turned in to numbness and tingling from hip to toes on both legs. Extreme leg weakness.
No signs/symptoms of adverse effects from administered vaccine have been reported; VARIVAX was administered after TE; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information regarding patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 23-OCT-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis after temperature excursion (product storage error). No signs or symptoms of adverse effects from administered vaccine were reported.
Beginning around 8:00 pm I felt prickly all over my body.  Not severe, but uncomfortable.  I believe I also developed a minor rash.  I took benadryl that night and slept fine.  I felt the same way on 3/23/21 and took benedryl again.  It seemed better 3/24/21 but came back on 3/25/21 and has  continued today 3/27/21.  After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day.  And ibuprofen and pepcid.  I only have taken the benadryl.  She advised not getting the second shot.
Info has been received from a consumer concerning a client who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the client developed hives. Additional info has been requested.
1:05 PM Five minutes after injection complained of lightheadedness, slight numb feeling left arm. Reseolved after sitting for 20 minutes (Opened outside door to increased air in room). After 20 minutes pt wanted leave, RN walked outside. Pt states she is going to PCP for complaint of hip pain which she had prior to immunization. At 2 PM at increased numbness in left arm, white lips, swollen lips. Given O2, EKG by physician. No epinephrine given by MD. Resolved on own. Pt also had lobster salad for lunch 1/2 prior to immunization. Never had a problem before. Advised to never have flu vaccine. Telephone call on 12/19/2001, pt feeling much better.
Upon trying to return unused vaccine vials to another store we realized that it was only good 30 days from the deep freeze.  We got the vaccine on 06-02-2022 and vaccinated on 08-02-2022. We thought that it was good until 10-30-2022 according to the mfg website when kept in the fridge. We created a report to Moderna and requested batch testing to see if we should revaccinate. Waiting for a reply.
SKIN FEELS WET (WHEN GETS IN BED, GOTTEN WORSE); HANDS HYPERSENSITIVE TO COLD AND HOT (LIKE WHEN WASHES, ALMOST LIKE DAGGERS); STRANGE AND UNCOMFORTABLE (NOT LIFE THREATENING); LEG, BACK, ARMS, FEET ARE SENSITIVE (WHEN WALKS, IF WALKS BAREFOOT FEETS ARE SENSITIVE TO TEMPERATURE)/ EXTREMITIES SENSITIVE; ODD SENSATION ON SKIN (LIKE A MENTHOL COOLING SENSATION)/SKIN FEELS COLD(WHEN GETS IN BED, GOTTEN WORSE); WARM SENSATION ON LEGS,THIGHS TO CALVES, AND SPREAD TO BACK AND ARMS (NOT ALL HAPPEN AT THE SAME TIME AND FEELS EXTREMELY SENSITIVE WHEN TOUCHES LIKE HER GRANITE COUNTERTOP); This spontaneous report received from a patient concerned a 57 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, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced odd sensation on skin (like a menthol cooling sensation) /skin feels cold (when gets in bed, gotten worse). On SEP-2021, the patient experienced warm sensation on legs, thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop). On an unspecified date, the patient experienced skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening), and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature) / extremities sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the odd sensation on skin (like a menthol cooling sensation)/skin feels cold(when gets in bed, gotten worse), warm sensation on legs,thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop), skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening) and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature)/ extremities sensitive was not reported. This report was non-serious.
Pt had a red and hot patch of skin from immunization (upper deltoid) to her elbow. Lasted 2-3 day. No itching or pain.
received her first / vaccine on September, 26, 2019 / never got her second dose; about 10 minutes after receiving her vaccine / arm began itching and lasted a while; arm was bruised from her injection site down to her elbow and it lasted for days; arm was swollen; felt tired on the day of her vaccination; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 26th September 2019, 10 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site bruising, injection site swelling and tiredness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site itching and injection site bruising were recovered/resolved and the outcome of the injection site swelling, tiredness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and about 10 minutes after receiving vaccine her arm began itching and lasted a while.  The patient also stated that her arm was bruised from her injection site down to her elbow and it lasted for days, arm was swollen and patient felt tired on the day of her vaccination. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that she never got her second dose. No additional information provided by the patient. The reporter consent to follow up.
Severe tinnitus.  I had very mild occasional tinnitus before the vaccine. But after the vaccine. it's been constant 24/7 and very loud.
Sensitivity of vision to blue light and outside light. Headaches resulted from sensitivity to light. Lasted 1-3 days. Wore reading glasses with blue light protection and took rest from screens. Anxiety increased during this time for 1-3 days.
Patient present to ED stating that the right side of his mouth was not moving right when he woke up at 06:00 am that morning (3.10.21).  Physician documented patient had trouble fully opening his right eye. Patient reported right upper dental for for several days prior to presentation. Diagnosed by physician with Bell's Palsy.
No symptoms; administered an expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported. On 06-DEC-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/milliliter, lot # R031045, expiration date: 18-NOV-2019 via intramuscular route for prophylaxis (dose number, anatomical location was not reported) (expired product administered). The patient experienced no symptoms (no adverse events). No product quality complaint was involved.
pt recvd vax & 1-2 minutes later fainted w/facial twitching;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: unspecified allergy (had allergies, Itchy eyes runs and runny nose from allergies, did not know what she was allergic to and took a medication in evenings for it). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination.  Non-company suspect vaccine included: mrNA-1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination as a booster dose. No concomitant medications were reported.  On 12-JAN-2022, the patient had cold like symptoms and stuffy nose and the patient had positive Covid 19 test (rapid test) on same day (suspected clinical vaccination failure and suspected covid-19 infection) (dose number in series 1).  Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority; Sender's Comments: V0:20220121036-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient arm swell up  that night and patient thought he can just wait and the swelling will die down, but he called the pharmacy today (anout 14 days after) saying that his arm is still swollen and it starts hurting
drowsiness & slurred speech started p/pt left the clinic;pt called from home;sx started half hr p/vax;slowly improving & completely resolved p/2hr;
About 2-3 weeks after my first covid booster shot, I started to get itchy pretty much all over my body- legs, back, upper chest and scalp. At first I thought it was related to skin dryness due to winter weather, but then I realized that taking a Claritin would help reduce itchiness for about 24 hours so I figured it was probably related to the vaccine. After the 24 hours, the itchiness would start back up again. Occasionally I would also get hives or raised bumps after itching. This lasted for around 2 months. I?ve never really experienced anything like it previously.
On 4/14/21, patient awoke with a severe headache and nausea and vomiting.  She does not have a  history of headaches.  Some photophobia.  Patient is treated with diphenhydramine, prochlorperazine and IV fluids.