chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of blackout in a female patient who received SHINGRIX for prophylaxis. In April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, 1 day after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), feeling unwell, fall, laceration of head and influenza-like symptoms. On an unknown date, the outcome of the blackout, feeling unwell, fall, laceration of head and influenza-like symptoms were unknown. It was unknown if the reporter considered the blackout, feeling unwell, fall, laceration of head and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient's age was between 50 and 52 years. The patient did not feel well after 2nd dose of SHINGRIX and called to ask if they had given her the same vaccine as last time. The next morning, the patient blacked out, fell, cut head and ended up in the emergency room. Flu like symptoms, etc. This occurrence took place about 3 to 3 and a half weeks ago, from the date of reporting but the reporter was informed at the morning of reporting date. The reporter did not agree to follow up from GlaxoSmithKline.
Moderna Bivalent Booster 11am, Aleve 220mg at 12pm, Aleve 220mg 10pm (bedtime).  Woke up crying at 2:35am, severe joint pain in majority of limb joints - ankles, knees, hips, shoulders, elbows, wrists, fingers.  Took Aleve 220mg 2:45am monday (because of the severe pain), Keterolac 10mg at 4:15am, Tylenol 1000mg (2x500mg) 7am (lessened pain 9-10 and I slept some), Tylenol 1000mg at 11am, slept a bit from 12:30-1:30ish, Tylenol 1000mg at 3pm, intermittent sleep between 4 and 6, Tylenol 1000mg at 6pm (joint pain lessened but increasing, and headache).  I have had kidney stones and this pain was so intense and long lasting (16 hours with three brief reprieves) that it competed for space on my most painful conditions list.
Pfizer-BioNTech COVID-19 Vaccine EUA  I woke up with a sizable lump on my right collarbone.  Last night my lump could be ?cupped? with my hand and I felt pressure in the right side of my chest. The pressure is so uncomfortable at times though that I can feel it in my chest and the back of my head.
About 13 mins post vaccine, patient suddenly slid off bench to the floor approximately 2 feet. Awoke spontaneously, Small cry, no bumps/ lumps on head or cuts/bruises that is visible. Alert and oriented to self place and month. Upper strength grips equal bilateral. Able to follow commands. HR 54, BP 80/40 resp 20 o2sat 97 and temp 98.2. Recheck after at 09:30 bp 98:58 hr 70 resp 20. Assist to set up offered apple juice and conversing appropriately with the staffs. At 09:42 HR 93 sat at 98%z 09:45 mom arrived to pick up the patient. Reported that patient had the same issue several times in the past 3.
Patient received PREVNAR on 2/5/19. Starting that night, patient got chills and joint pain that has now since disappeared. She reports the redness at the injection site has spread and saw her doctor today 2/8/19, who advised her to apply ice and take ADVIL and to monitor the redness.
Initial symptoms (Thursday evening): nausea, headache; tired Next day (Friday): arm ache getting worse though out the day; very tired Friday night: severe arm pain; very sharp sciatic pain at 4am Saturday morning: severe arm pain; rash around arm shot site ( three places - size of a nickel); felt exhausted Saturday evening; pain in arm is lessening; rash is growing (3" by 1"); sciatic pain Sunday afternoon: sharp sciatic pain  Monday morning; rash is fading; severe sciatic pain; 7 episodes in 1 hr; 2 more episodes in late morning
Congestion?s, Swelling of face, tightness of chest, difficulty swallowing, burning sensation of ears
Red in thigh - area shot given (L) thigh. 4 vesicles on red base.
It started with an itch in my hands and arms, after 30 to 45 min I got a rash in the chest area, and itchiness in the legs. I took a 25mg benadryl.
at around 12 hours post injection, presented with fever (over 100, exact value unknown), headaches and chills. Symptoms worsened over the next hour or so with severe chills). Symptoms subsided enough to allow for rest after 3-4 hours. Woke up with mild fever and no chills. Took acetaminophen and was mostly back to normal about 24 hours post injection. Some fatigue persisted for another 24 hours.
My left arm injection site has never stopped hurting.  It occasionally itches.  It is sore in the muscle.
Mother states the pt woke up one day post vax with red raised area on top of the leg around the vax site, was also red, hot to the touch. Pt was given Atarax in ER on 5/26/01.
My hands will start falling in sleeping; my finger, index finger is numb, my hands is whole numb; I have numbness it won't go away; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Sep2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient regrets getting Pfizer shot, it was giving side effect right now. The patient got it on Friday 03Sep2021 and now the patient's hands would start falling in sleeping, the patient's finger, index finger was numb, the patient's hands was whole numb. The patient had numbness it won't go away. The patient wanted to know if the patient had to get the second shot because the second shot was due on 24Sep2021. The patient asked whether to go and get second one and get more side effects. The outcome of the event was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
R09.02 HYPOXIA 1/12/2022 DYSPNEA R09.02 HYPOXIA 1/12/2022 PLEURAL EFFUSION R09.02 HYPOXIA 1/12/2022 CANCER METASTATIC TO PERITONEUM
2/7/2023 I had congestion, fatigue, coughing fits and I went to bed and stayed there which is unusual for me. I stayed in bed for three days. I took generic Flu and Nighttime Multi Symptom Relief.  I took an At Home COVID Test which was negative on 2/8/23.
Warm shooting pain from pelvic down to right leg, came and went for 2 months and then it went away. Insomnia: a few minutes into sleep and then jerky body movement comes and wakes me up, and then not being able (very difficult) to fall asleep. Sometimes, this repeats many times during the time I try to sleep causing me hardly get any sleep. 3 months and still going.
R arm induration  3.5x5.0 and17x9 cm erythema
Deep intense pain at injection site at moment of shot, spreading through arm and shoulder. Pain has continued for 6 weeks since shot and continues today. Doctor prescribed anti inflammatory on 11/5/13, which has helped only slightly.
On 9th day after vaccination, positive generalized rash on torso, upper arm, and back. No complaints of fever, chills or tender axilla. Exam on 14th day, rash is diffuse and dried except for 1 lesion on left shoulder. No axillary adenopathy; tenderness. Lesion about 8-12mm with erythema; no vesicles. Slight flakiness to site. Only on chest, back and upper arm. No on mucous membranes or hands.
I have numbness in my leg; I started feeling the numbness even more; I have been tired; This is a spontaneous report from a contactable consumer(patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0217; NDC number, UPC number and expiry date were reported as unknown) via intramuscularly on 16Jun2021 at 18:45 in left arm as a single dose for Covid-19 immunization. Medical history included latex allergy from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); losartan (LOSARTAN) and carvedilol (CARVEDILOL) all taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, Formulation: Solution for injection lot number: EW0187) via intramuscularly on 26May2021 at 13:00 in left arm for COVID-19 immunization. The patient did not receive any prior vaccination within 4 weeks. After the second dose the patient she started feeling numbness (today) 17Jun2021 (at 04:00) at work and even more and started feeling the numbness even more its just kind of in her way. The patient was tired after she received the vaccine. She wanted to know where she can report the side effects as she had read about the symptoms of the vaccine which she didn't came across. The patient reported her brother received both the doses of vaccine and he was fine. He did not experience anything. Investigation assessment was not reported. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
This case was received from a health professional on 20 June 2007.  Two infants with no reported medical history received ActHib (lot number UE957MB).  Following vaccination, they both developed anorexia; the events had not yet resolved.  This reporter also noted that two patients experienced bowel movements after each feeding following vaccination with ActHib; this information is captured in case number 2007-02264.  Additional information regarding a patient with decreased PO intake following vaccination with ActHib can be found in case number 2007-02275.
Patient had her shot that day around 10:30 am as part of her yearly physical. She took it fine in the moment with no complaints or pain. We left the office and went to get lunch around 11:15. Patient ate her lunch, but said her stomach felt queezy. By the time we arrived home in the car she mentioned her head was suddenly hurting. As we were preparing to go back to school that day from her appointment, we stopped home to get some advil for her head first. By the time we got inside our home - around 11:45 - patient said she felt as though she had the worst headache of her life. She tried to lie down - but said her head hurt too badly. I immediately called the pediatrician's office where we had just been to report this problem and to ask for advice. By this time patient was grabbing at her head whining and then shrieking. Soon after that she was in the bathroom throwing up violently and crying. This was so loud the nurse on the phone could hear it and asked me if that was patient in the background throwing up and crying. I answered, yes. The pediatricians nurse told me to get her to the ER and she would have her doctor call me as soon as possible which she later did.  Patient threw up repeatedly on the way in the car. Once we got to the ER - we were processed in the hospital ER. Once we were shown to a bed, a nurse and doc examined her and deemed this event to be a migraine. She was given oral fluids and ibuprofen. These doctors explored the idea of giving her a brain scan to rule out injury. They did not do the scan. I wish they had.   Patient has never, ever had a migraine for any reason in her life.   It is my strong belief as a parent there is a correlation between this drug and her sudden headache. And it really was scary. She will have to have a second dose and I dont think we should do it.
pt came in to get 2nd dose pfizer 9-14-21;Ran CAIRS & pt already got pfizer dose 1 on 4-15-21 & dose 2 on 5-6-21 at a healthcare agency. Pfizer dose given on 8-8-21 at savon 0598 was 3rd dose. Pt consent form on 8-8-21 = pt said never received covid19
Intense burning pain from injection site shoulder joint - > elbow. Lasted x 4 days also reported malaise/dizziness.
1SEP98 pt recv vax & 22SEP98 reports lt arm soreness  @ inj site;also reports soreness in both knees & wrists which attributes to lifting computer;monitors earlier this week;swelling @  site of inj;
Pt recv vax on 10/16/98; approx 1 hr post vax pt exp fainting
WITHIN 2 HOURS OF THE SHOT FELT PAIN IN BOTH LEGS . NEXT DAY SEVERE HEADACHE AND LEG PAIN , LARGE RED AREA AT SHOT . FEELING BETTER 2ND DAY  , REDNESS STILL ON ARM .
Intermittent feelings of pressure in the head. No pain, but an uncomfortable pressure that reminded me of the feeling I had after getting a concussion in 2014. Also, on a routine check up on 5/7/2021, my blood pressure was abnormally high at 186/100. The reading from my previous check up was 118/70. This was alarming. Before I left my appointment, the reading came down to 136/77, which is still very high for me. I have read other accounts online of people experiencing temporary increases in pressure following the covid-19 vaccine and wanted to report in case I too may have been experiencing this as a side effect. It has since began to normalize, with my most recent reading being 125/77 today, May 19th 2021. The strange pressure in my head is also presenting less frequently but has not completely dissipated.
Saturday November 20th and half of Sunday November 21st I experienced achiness, chills, arm soreness that went from my elbow up to my shoulder and from my shoulder over to the middle of my collarbone around my neck area,and fatigue. The afternoon of November 21st I started to feel better and only the fatigue  and arm / collarbone soreness remained. Monday November 22nd at approximately 10:00 p.m. at night I started to have the chills again and went to bed. I woke up around midnight with uncontrollable shaking, chills, chest pressure, confusion, disorientation, achiness. I had my husband take me to emergency room. They did a urinalysis, ekg, blood work, and CT scan. I was just charged seven hours later around 8:00 a.m. on Tuesday November 23rd. The emergency room doctor determined that it was a reaction to the moderna covid booster. I went home and the chills, fatigue, arm and collarbone soreness continued until Thursday November 25th. At that point the fatigue remained and lasted through Saturday November 27th.
pt recvd vax;16jul95 devel pain, swelling & tenderness at inject site; to md; site was noted to be indurated & purulent; placed on atb & referred to dermatologist;
Received 4 years shots on 1-28-04, DTaP, IPV, MMR on 1-30-04. Dad noticed entire leg being swollen and red. It was warm to touch. Motrin as needed pain.
Stated 2 hours following 1st dose of oral Typhoid began itching all over. Skin felt tingling. No visible rash, itching lasted all day. 95% better on Sunday (next day).
Sore arm, headache, nausea, muscle aches, 99.9 fever.
extreme arm pain starting the evening of shot and lasting 10 days later (still hurts). Shoulder ok to rotate. Pt said I shouldn't have put it in muscle ( I told her that's where it's supposed to go). Pt had tight fitting shirt on that I told her to push up farther than she initially had it up. Told patient to see md if doesn't get better
Pt feel pain, hot, itchy, Rash on  her Chest. Pt checked with  Dr and Dr confirmed it is not  cellulitis Pt dont need any med  or treament
24-48hr p/vax pt noted the onset of arthralgia (poly joint) & morbilliform rash bilat forearms extending over  thigh to trunk & legs;tender joints, poly fingers, wrist;erythematous maculopapular (morbilliform) rash;t102;
Developed 2 ulcers in roof of mouth 2/16/03.  Developed rash on right cheek with dark swollen area on 2/20/03.  Developed 2 pustules on face resembling a pimple on 2/24/03.
double heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves an 18 year old adult patient (gender: unknown) who experienced double heart attack while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (strength, formulation, frequency: unknown) produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.Information on the batch number was requested.  On an unknown date the patient developed a serious event, double heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It goes on and on, and on.. it's happening everywhere and is NOT normal!! Event: 18 years old has double heart attack and is fighting for his life. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (life-threatening) double heart attack.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (double heart attack).  At time of reporting, the outcome was Unknown for the event double heart attack.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns 18 years old adult patient who experienced double heart attack, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
REDNESS AROUND INJECTION SITE THAT IS BIG AND ROUND ABOUT 1-2 INCHES IN DIAMETER. THIS HAS LASTED 2 DAYS. TOLD PATIENT IT SHOULD GO AWAY WITHIN 1-2 DAYS AND IF NOT TO SEEK MEDICAL ATTENTION.
developed severe flare of Behcet's disease, widespread genital ulcers. Had not had prior outbreak since age 14
This spontaneous case, initially received from pharmacist (reporting on himself) on 01-Nov-2018, concerns a male patient of unspecified age. On 01-Nov-2018, during administration of FLUAD (TIV) (batch number: 250783), when the needle was put into the luer locking device which was secure, luer locking device on the barrel back sprayed on the reporter and the medicine was sprayed out. The needle on the luer lock and the luer piece came off. It was not a bad luer lock, but it just popped off the luer lock. The syringe was damaged near the luer lock. There were no signs of leakage. No adverse events were reported. This case: 201805410 is cross-linked to the case: 201805151 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034866. The reporter assessed this case as non-serious.
Patient received Pfizer covid vaccine on 1/8/21. She started with a rash 3 days later on 1/11/21. she was evaluated in clinic on 1/12. Rash was erythematous, papular rash to bilateral arms and abdomen. she had been taking Claritin and Benadryl which were not helpful. she reported severe itching. she denied any edema or difficulty breathing or swallowing. she was treated with a Medrol dose pak.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.15. No concomitant medications were reported.  Batch number 022M20A administered on 17-Feb-2021 underwent temperature excursion with temperature of 22 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 11-Feb-2021 and beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Fever, aches & pains - arm hurt so bad - had to get pain patches & pills. Developed a cough and still have it!
Got the shot Saturday patients arm was hurting Saturday and the people at shot clinic told the patient to take Tylenol for pain, Sunday the patient was extremely tired and clammy told the daughter his joints and body was hurting so badly. Sunday the patient woke up with allergy symptoms so patient was waiting it out to see dr until his appointment. The patient finally woke up on 3-31-21 around 5 am and the patient had cold chills and clammy the patient put on his robe then told his wife that he was too hot shortly after. The wife was leaving for work at 6am and the patient was curled around toilet stating he felt nauseous, wife left for work around 6am and then she stated about 15-20 minutes later the husband called her asking her to come back home she stated he sounded very short of breath and just not right, she turned around and got home around 645am and found her husband pale and in his recliner with his mouth open and unresponsive. The wife called 911 and she stated the told her pull him into floor and EMS arrived as soon as she got in the floor to start CPR.
Patient seen in office for c/o blood in stool with mucus 8 days after vaccine administered. Lab confirmed one positive hemoccult on 9-13-12. No medications ordered.
Red. Warm. And itchy 10 days out.   Less so than day after but more than day 2 after.
THE PATIENT DEVELOPED NAUSEA AND DIZZINESS ON THE SAME DAY THE VACCINE WAS ADMINISTERED, SHE DID NOT USE ANYTHING TO TREAT THE SYMPTOMS, WHICH LASTED 3 DAYS.
Extreme sweating through the night. Woke up just about every hour on the hour sweating. No noticeable  fever just sweating. Soreness  at injection site but no more than to be expected.
Hard lump developed beneath the injection site and I have never had that happen with a vaccine before.   Both the lump and injection site are red, warm, and painful.  Two days after the injection the rash size is growing larger and the pain has not decreased in intensity.