chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine I had headaches. Then I had sensitivity and nausea when I was close to my period. One day I couldn't work because they were so severe. I also had drainage and dizziness. I took migraine medication, but they didn't work. The headaches are so severe. I have an upcoming appointment scheduled for a MRI.
Right upper arm pain radiating to right shoulder and neck area. Unable to lift Right arm more than 45 degrees away from right side of body. Unrelieved with OTC pain medication.
didn't feel right; I didn't know who I was; low temperature; This case was reported by a consumer via sales rep and described the occurrence of feeling abnormal in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2021, the patient received the 1st dose of Shingrix. On 20th July 2021, 8 days after receiving Shingrix, the patient experienced body temperature decreased. On 21st July 2021, the patient experienced feeling abnormal (serious criteria hospitalization) and disorientation (serious criteria hospitalization). On an unknown date, the outcome of the feeling abnormal and disorientation were unknown and the outcome of the body temperature decreased was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, disorientation and body temperature decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2022 Reporter's Comment: The case was reported by the patient. After the first injection, the patient ran low temperature and went away, next day, she didn't feel right, following went into hospital. The patient went into hospital on 21st July 2021 and released on 24th July 2021. The patient didn't know that who she was. 9 days after receiving Shingrix,the patient experienced feeling abnormal, disorientation.  All testing in hospital was negative.  The only conclusion was the shingles vaccine with her doctor agreeing.  The patient got the second dose with no reaction. The reporter agreed to follow up.
face was nice and swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-042422-10642 (Agency).  A 44-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), (Batch/Lot number: unknown); botulinum toxin type a (BOTOX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Patient had Pfizer Covid-19 vaccines on Aug2021 and Sep2021), administration date: Aug2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "face was nice and swollen".  Additional information: The clinical course was reported as on an unknown date at the end of Dec2021 or the beginning of Jan2022, the consumer was injected with 2 vials of sculptra-1 vial on each side of the face- into the marionette lines, under the eyes, and upper cheeks The lot number and expiration are unknown to the consumer. The consumer reported that the injecting HCP stated she would not need any more treatments after the initial one, because the sagging of her skin was not that bad. The consumer additionally reported that the HCP stated that maybe she would need another treatment after 3 months. The consumer stated she did not go for a 3rd treatment because she was fasting and was going to go after fasting. The consumer additionally stated that after the first treatment, her face was nice and swollen, and she thought, this was going to work. The consumer stated after that, she never saw anything, and did not want to go for a third treatment if it was not working. Appointment with HCP is scheduled on an unknown date in May2022. Additionally, the consumer was treated with botox in the eyebrow, at the same time she was treated with sculptra, at the end of Dec2021 or the beginning of Jan2022. She had Pfizer Covid-19 vaccines on: Aug2021 and Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received Pfizer vaccines on 03/04/2021 and 03/25/2021. Pt presented to the ED with complaints of cough, congestion, and generalized fatigue. Pt was found to be COVID positive and diagnosed with  COVID-19 pneumonitis. Pt was hypoxic requiring 5L of oxygen. Pt began experiencing agonal breathing and was a DNR/DNI status. Pt died on 11/24/2021
Immediately following injection infant went into resp. arrest, followed by cardiac arrest. CPR started immediately by nurse et Dr. Ambulance called. Infant was intubated and transferred to ER. Was admitted.
08/16/18 Client developed severe headache about 9:00 pm followed by nausea/chills/fever (101F) and backache about 11:30 pm. On 08/17/18 about 5:00 pm she took 1 OTC BENADRYL which helped lessened the symptoms some but they still continued until 08/18/18 around noon when she started feeling much better. On 08/19/18 only her left arm was sore with some tingling. On 08/20/18 night about 9:00 pm she developed another headache but not as severe as one on 08/16/18. Today (08/21/2018) she woke up with fever/redness/tingling in her left arm so she took another BENADRYL around 11:00 am and that has helped some with these symptoms.
Within minutes of innoculation, site area became extremely itchy. I brought this to the attention of the medics in the 15-minute observation room, and they immediately took me to an exam room where I was attentively cared for by several nurses, medics, and healthcare staff. I was given liquid Benedryl as my arm began to rash around the site. Within about five minutes of being in the exam room, my tongue began to feel like it was swelling in the back of my mouth, it soon began to feel swollen through the whole tongue, and it became increasingly difficult to swallow. Upon notifying the nurse nearby, I was immediately given an EpiPen injection. I do not know what may vitals were as everything happened very quickly, but I was told that my face, neck, and chest became rashy quickly, but subsided after several minutes from the EpiPen, at which time I was given more liquid Benadryl. Once stable, I was taken to the emergency room for monitoring for two hours. I felt better quite quickly after arriving in the emergency room, but the itching persisted through the evening. After 15 hours of sleep, I awoke to only a sore arm and thigh from each injection site.
Face flush for 6 hours; This is a spontaneous report from a non-contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration at the age of 67 years on 25Jan2021 11:30 at single dose in the left arm for COVID-19 immunization. Medical history included mild hypertension. The patient had no allergies to medications, food, or other products. Prior vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included rosuvastatin, losartan and hctz. The patient experienced face flush (non-serious) for 6 hours on 25Jan2021 11:45. There was no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
4 days post flu vax c/o cough, sore throat, muscle aches, h/a, then 8 days post shot pt seen in ER c/o abd pain & SOB, nausea, vomiting; pt given meds;
2 days after immunization pt developed red, indurated area at injection site.  This enlarged to size 18 x 12 cm of erythema & 10 cm of induration.
Numbness around mouth, severe cramps 9/10, headache 9/10, lymph nodes in arm pit- enlarged  to the size of a 1/2 of a golf ball. Lymph nodes in following locations were tender- axillary, cervical, thoracic duct, elbow creases and inguinal. No fever or chills
Patient stated that 1/2 hour after the vaccine, she developed severe shoulder joint pain that traveled to her elbow and wrist within an hour.
consumer reports that pt was vaxed 23OCT; 3 hrs later pt vomited, became cold, clammy & non-responsive; required hospitalization for 3 days; discharged 26OCT; re-admitted 29OCT for 2 days w/similar episode; 2NOV still not usual self;
Following 4/17/01 IZ's  pt had tremors and tics. No fever, no crying or fussiness per Mom. Tremors lasted for 1 month.
Acute Angioedema.  Treated with multiple rounds of epinephrine, solumedrol, diphenhydramine, famotidine.  Admitted to the ICU for continued monitoring and treatment.  ICU time 42 hours.
Diagnosis: Frozen Shoulder  Taking physical Therapy from Phisycal Therapy (PT, DPT) for several month. Because I got shoulder pain that can be more severe  and longer-lasting than routine soreness that can follow injections.
vaccine admin @ 9:52 am. At 10:00 am pt c/o headache and feeling very warm. v/s 170/115 hr 73 o2 sat 100%. at 10:05 am v/s 134/84 hr 61 o2 sat 100 %. taken to emergency room via w/c
4/14/05 Phone call from mom. Right thigh small bruise and red area down from injection site. 4/15/05 Mom in clinic with patient. Left arm has red area down from HAV/IPV injection site 4-5" of small bruise. Warm to touch.
Syncope - patient passed out for approximately 2-5 seconds, and he recovered quickly. He was coherent, and able to stand afterward. We took a blood pressure reading, result was 144/75, HR 57.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 06-AUG-2015, the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX, (dose and route of administration were not provided), (lot # L005298, expiration date 17-FEB-2017; lot # L001325, expiration date: 13-JAN-2017, lot # L015046, expiration date 29-APR-2017; lot # L013827, expiration date: 21-APR-2017) route not reported. At the time of this report, no adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Follow up information has been received on 13-AUG-2015, from the nurse referring to the unspecified number of patients. Additional information has been requested.
upon withdrawal of needle from administering;pt rt deltoid was noted to begin swelling;pressure & bandaid were applied w/swelling of inj site;swelling approx size of a quarter;
I developed blood clots and had severe pain in my leg. I went to ER on July 29th 2021 and was admitted to the ICU after a CT scan showed I had clots in my lungs. An ultrasound showed I had clots in my legs. I was given an IV of Hepporin overnight. I stayed in the hospital for three days total. I then developed clots again in June of 2022 and stayed in the hospital again for 4 days.
The immediate 48 hours after the second dose was not a problem. It was around 72 hours in which acute muscle soreness occurred at the injection site on my right deltoid. I thought it would resolve like the first dose after three or four days, but this seem to last longer and then it mysteriously begin to travel down my arm. It seems like every one or two days it went more distal down my right upper extremity. It first went from my deltoid to my bicep and tricep. And then a couple days later it was in my elbow and forearm. Now it has been in my elbow for weeks leaving me with weakness and pain that nothing seems to help improve it. It?s like it is in my joint at my right elbow. There is a very specific soreness and pain which has cost me a significant discomfort and weekend my strength and the entire arm.
Approx 3-4 hrs post vax pt became very irritable; Proceeded to scream for 3-4hrs inconsolably; No local rxn; Fever 102 for 2-3 hrs p/DTP;
15min p/vax pt started coughing & c/o diff in breathing;Vital signs stable;lungs-mild wheezing;med given;
Day 1 started red, hot and bump - took TYLENOL for 1st 3 days and use ice pack on and off because it was hot. Had another bump 1 inch down. Started with headache, chills, tired feeling from days 1-3. Arm was tender and sore to where couldn't touch for 2-3 days. It became redder gradually and larger everyday. On 6/10/18 got larger, hot, itchy and took TYLENOL again. Slight headache on 6/11/18. Saw Doctor on 6/11/18 received Prednisone taper and VISTARIL.
Patient received Moderna Vaccination in Feb and March. I am sorry I don't have the exact dates on hand but could easily get them if you need.   She came for routine labs in July and had a new anemia. (all previously CBCs were normal. Last normal was in March). Anemia work up has been consistent with warm autoimmune hemolytic anemia. Humira and Lisinopril are both possible culprits; however, there are no case reports linking AIHA with Humira and only 1 linking it to lisinopril. While this is clearly only a possible link, her hematologist and I felt it prudent to report.
fatigue; soreness at the injection site; This is a spontaneous report from a contactable consumer (reporter's friend). A female patient of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified dates (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The 1st dose was very mild symptoms with a little fatigue and with the 2nd dose of the Pfizer vaccine, her friend had no headache or anything but had fatigue; her friend had soreness at the injection site and fatigue. The outcome of the events as unknown.  No follow-up attempts are needed. No further information is expected.
Vaccine trouble weeks after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine trouble weeks after second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine trouble weeks after second shot). At the time of the report, VACCINATION COMPLICATION (Vaccine trouble weeks after second shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
tinnitus, potential hearing loss, severe rash, severe right hip pain debilitating movement, lump at injection site, lymphadenopathy
10/27/10 - altered mental status; ? seizure non-febrile; intermittent apnea vaccines administered on 10/22/10 - transported to hospital on 10/27/10.
Mother states child developed a hard red swollen knot at DtaP site which was red and warm to touch. The red swollen area covered the deltoid area and approx. 2 inches below. Did not notice area until Sunday night. Child also states he did not notice any thing until Sunday night.  On Monday evening the area began to clear at the center where the shot was given.  Mother states as the red area began to clear, a red raised hive like rash developed around the skin that was clearing.  Child c/o intense itching. Has scratched some areas of skin and has broken the skin in several places.  Mother called MD and he sent child here today 7/2/14.  Child has a red band of raised rash starting just behind and under the deltoid area which circles around the arm to the front. At about the 7 o'clock area the rash widens and then becomes slightly smaller.  Rash stops just to the inside of the arm.  Does not go all the way around.  Widest part, rash is about 8cm wide. Smallest part of the band is about 3-4cm wide. Mother states she has put some anti itch cream on the area. Advised mother to contact MD for further recommendations.
On or about 16 hrs after receiving 2nd dose had very severe reaction ..severe pain and illness for 3 days still having pain in abdomen and some illness 5 days later..Worst illness of my life
Pt c.o anxious and dry mouth. B/p was assessed and elevated. Pt advised to f/u w PCP. b/p 148/90, p 81 o2 97%.
Information has been received through the Merck pregnancy registry from a consumer concerning her 15 year old daughter, with no medical history and no allergies, who on 20-FEB-2008 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine included a dose of meningococcal vaccine (unspecified). On 28-FEB-2008 the reporter learned that her daughter was pregnant. The patient was at approximately 2 months gestation. It was reported that the patient also developed a rash on her back. At the time of the report the patient had not been seen by a physician. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Within 5 minutes, I experienced light-headedness, dizziness, and a sense of confusion. This lasted for about 20 minutes, then subsided. After that, I felt increasing fatigue. After 8 hours, I experienced extreme shaking and tremors throughout my whole body. This lasted for about 1 hour. I did not feel chills or hot or cold during this time. I felt extreme fatigue and weakness and was not able to get up from my bed to seek help. It was very scary. After 24 hours, I felt normal and healthy again.
The night after my second Pfizer vaccine on 4/6/2021, I didn?t sleep well. I was tossing and turning all night. I started getting a bad headache. By the time I woke up on 4/7/2021, I felt like when you?re coming down with the flu- I had a really bad headache, my whole body hurt, and I was exhausted. I had a loss of appetite that day. I was able to sleep for 3 hours later that day, woke up, took Advil, and felt mostly better. I slept good the night of 4/7/2021, and after waking up on 4/8/2021, I felt much better. I still had mild muscle aches and a slight headache. At work I felt like I had some brain fog but by the evening of 4/8/2021, I felt completely back to normal. I knew these were expected side effects of the vaccine due to my immune system doing it?s job. I did not need to make any calls to my doctor or hospital.
Breakthrough COVID-19 infection. Patient tested positive on Aug 23 2021. Patient was fully vaccinated on June 9 2021.
got shingle shot, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received shingle shot and got shingles a month later, for his/her second time. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 23-year-old female patient who received BEXSERO (batch number 158701, expiry date 30th September 2017. On 31st October 2016, the patient received BEXSERO. On 31st October 2016, less than a day after receiving BEXSERO, the patient experienced injection site redness, injection site swelling, headache and general body pain. On an unknown date, the outcome of the injection site redness, injection site swelling, headache and general body pain were recovering/resolving. It was unknown if the reporter considered injection site redness, injection site swelling, headache and general body pain to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO in her left deltoid and within 24 hours the patient began to experience redness and swelling at the injection site, headache, and body ache. The reporter has given the permission to contact again. It was reported that there was no seriousness criteria associated with event (hospitalisation and death). This is one of the 5 cases reported by the same reporter.
Approx. 3-4 weeks after the shot, I began itching. Then I got horrendous sciatica pain at 6 weeks after the shot. Then 5 days later, I got shingles. I had to go to the dermatologist, the regular family Dr., the acupuncturist several times, the chiropractor several times, and the dermatologist several times. (Who is going to pay for this???)
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: she stated she had severe burning feeling in bilateral lungs that lasted for 24 hours
The patient is 17 years old which is under the recommended age requirement to receive the Moderna vaccine.  The patient is not experiences any side effects or adverse reactions to the vaccine at this time.
redness and itching near the injection site; redness and itching near the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. On 7th August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient reported redness and itching near the injection site that last 3 days.   The itching was milder than the redness. The reporter consented to follow up.
Varicella rash all scabbed at exam on 3-16-10. Rash started 3d after vaccine, < 20 spots.
Pt received IM injection of FLUZONE on 11/12/12. On 11/?/12 pt reported a red 1/2 inch circle on arm, was warm to touch and sore.
Vomiting, diarrhea, and nausea. Also some shakiness. Onset of nausea and vomiting approximately 7 hours after vaccine, lasted about 12 hours with no ability to keep in fluids, still some lingering nausea after that.
Janssen COVID-19 Vaccine EUA: Janssen COVID-19 Vaccine EUA: at clinic visit fifteen days after vaccination patient reports headache starting soon after vaccination. Referred to emergency department (ED). In ED patient presents with vital signs within normal ranges. Physical exam unremarkable. Diagnosed with migraine headache, administered intravenous fluids, NSAID, antiemetics, and antihistamines, prescribed prednisone, and discharged stable.