chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he did not sleep all night; This is a spontaneous report from a contactable consumer (Caregiver). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 08Sep2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, he (patient) did not sleep all night on an unspecified date. The patient received the 1st dose of the Pfizer Covid vaccine on 08Sep2021, and reported that he did not sleep all night, and would like to know if this a side effect of the vaccine. Added that "He stays up late, but it does not like him not to be able to sleep." Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient reports extreme fatigue upon waking day after injection; states she couldn't get out of bed until 4pm; Also, she reports a migraine headache, and she emphasized it was not a 'regular' headache (tension).
The day after exp bleeding in your stool and diarrhea. I contacted my PCP ordered  a stool test and prescribed Antibiotic. On the second day lots of fatigue and third day started to feel better. I did not miss any days of work.
He had arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prinzmetal angina, rhizotomy and ophthalmic herpes zoster.   On 20th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient reported that when he got his first vaccine, that was mixed it right in front of him. The patient had arm soreness, and at the time of reporting it was recovered. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020002543.
Narrative:  94 yo male died during inpatient hospice admission. Death was caused by: Acute myeloid leukemia. Pt had received covid vaccines on 1/13/21, 2/10/21, & 12/22/20. This death was not caused by covid vaccines.
Patient is feeling weak; All she wants to do is to sleep; This is a spontaneous report from a contactable consumer reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Apr2021 as 1ST DOSE SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient was feeling weak and all she wanted to do was to sleep and she did not know when she going out of the hospital. Patient was scheduled for the 2nd dose on 06May2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Right shoulder and elbow pain with inflammation of tendons.  Left knee pain with inflammation of the adductor tendons around the knee, enthesopathy of the right index extensor tendon
Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine). At the time of the report, MYALGIA (Is it ok to use advil for minor muscle aches in the first 24 hours post vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. Treatment information was not provided.
Initial misuse report received from a health care professional on 07 January 2014. A 7-year-old patient had received FLUZONE ID vaccine. No adverse event was reported. List of documents held by sender: none
pt says she had a rash develop on her neck with was very painful and she could barely move her head.  The rash spread on her arms, right knee, her back, right side of her leg, and her chest.  She went to her PCP 3/12/21 she was prescribed prednisone which did not help.  Her rash was not getting better so she went to UC on 3/15/21. Dr. prescribed triamcinolone medicine and another cream to mix together which did not help.  On 3/16/2021 she went to another Dr.  She was prescribed the medicine for shingles which didnt help.  She called them back to let them know she wasnt any  better and they referred her to a dermatologist.  She saw Dr. on 3/26/21 he gave her Clobetasol cream. He took a biopsy and sent her for blood test.  She went back have the stitches out was told her results were ok and that she had an allergic reaction  to the vax.  She says her symptoms are getting better
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-437865, MOD-2022-437824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Updated patient demographics (Height, weight and race); anatomical site of vaccination (left arm) was added; updated action taken from the initial document.
Reaction:  Sore arm, severe headache, joint and muscle pain, fever, fatigue, red swollen spots on arm. Treatment:  Rest and ibuprofen. Resolved with treatment after 48 hours.
After contracting covid-19 approx. Jan. 15 2022, I developed muscle pains in my left arm and then approx. Feb.9 2022 I was dianoised with Burcitis of the left hip and then less than a week later my lower back began to hurt. I was prescribed Percondone and 1000 mg of Ipuprotin.
12/30/03: Mother stated son had reaction from vaccine.  7 days after received Hep B vaccine.  He started complaining of wheezing, difficulty breathing with shortness of breath.  Son was taken to local ER and given some breathing treatment.  Son was given prescription of Trimox 500mg to take.  Son continues to feel ill after 2 weeks.  No he fine.
On 5/7 at 4 pm, fever started with aches and headache. 9 pm till 6 am on 5/8, my fever rose to 102.5. On 5/8 at 6 am till 2 pm, the fever was 99.5. The headaches were off and on thru 5/11.
102 fever, chills, aches for about 24 hours starting roughly 12 hours after FIRST shot of Moderna
Client received her second dose of the Pfizer Covid-19 vaccine (Lot # EW0161 Exp. 7/31/21) at 0917 at facility on 6/9/21 by a Licensed Practical Nurse (LPN #1). The 16 years old female client received her second dose Pfizer COVID vaccine two days early before her 21 days (due on 6/11/21). She received her first Pfizer COVID vaccine on 5/21/21 (lot # EW0177, exp. 7/31/21) at facility. Client stayed at the observation station for 15 minutes without any distress or any signs and symptoms of allergic reaction on her injection arm where she received the vaccine. Another vaccinating LPN #2 noticed client?s brother?s vaccine card had the same date for his first Pfizer COVID vaccine and aware client cannot receive his second dose today since it?s not been three weeks after his first dose of Pfizer COVID vaccine per CDC guideline. LPN notified lead nurse and aware per CDC guideline, the client?s second dose is due on 6/11/21 (not today). LPN #2 informed client?s mother and was able to recommend for the mother to take her two other children to get their second dose on 6/11/21 or after. Mother verbalized understanding. Lead nurse informed mother of child that CDC guideline was updated to recommend the second vaccination of Pfizer COVID vaccine at 21 days or after instead of a previous recommendation of three days early. The client denied any signs and symptoms of allergic reaction today after vaccination or from first dose vaccination. Lead nurse educated mother of child about the possible signs of an allergic reaction and provided her with the Pfizer vaccine fact sheet. Mother of child verbalized if any symptoms of an allergic reaction she will use emergency service. Client departed facility with her mother and brothers at approximately 0935 in positive disposition with a steady gait. Lead nurse educated all vaccinators and ancillary staff regarding confirming the correct second dose spacing for each client every time. Also, lead nurse recommended for the lead ancillary to remind ancillary staff to confirm each time for the correct timing for the second Pfizer dose moving forward.
Patient called to report that about 36 hours after vaccine she developed a sore Left nipple, this morning her whole left breast is now inflamed and red and hot to the touch.  I instructed her to contact her doctor to be seen.
So the day I go the shot, I got a fever of about 101, I took Tylenol so it didn't last super long. I went home and went to bed and probably slept about 14 hours. The next day I had a fever again and got extremely nauseas, I was also very very tired. I had nausea for about a week and the fever subsided after about a day. When that finally went away, three weeks later I started to get a severe pain in my right buttocks area that was excruciating. I took medicine thinking it would go away and then I started getting a rash and the pain was all underneath that rash. I went to the DR and he said it was 100% shingles but fit the description so he treated me for that and it lasted about two weeks more. He gave me gabapentin to help with the pain. It was considered a mild outbreak of shingles. A couple weeks later my face swelled up on the left side. I went to my dentist and found out that my body was rejecting one of my teeth, I had to be treated for an infection in my mouth and then do a temporary bridge.
Patient had episode of palpitations for one day following the first dose. He reports ongoing fatigue after the 2nd dose. He experienced near syncope on post vaccine day 6. No other cause could be found for the episode.
Information has been received from a pharmacist referring to a 40 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II HSA, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
Swelling and pain at injection site.  Excess redness.  Patient took diphenhydramine and ibuprofen.  Redness decreased and so did swelling and pain.
pt recvd vax; starts crying & falls down for no apparent reason; took to MD; said nothing was wrong w/ child;
Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue
Chills and hardness at injection site occuring several hours after injection. Patient developed redness surrounding injection site last night measuring approximately 3 inches.
No additional AE reported; Consumer received PROQUAD and VARIVAX both in the same day on 10/2/2020; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not reported.      On 02-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot# and expiration date were not provided) 0.5 ml and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route, lot# and expiration date were not provided) 0.5 ml for prophylaxis in the same day (inappropriate schedule of product administration). No additional adverse event (AE) reported.
From initial info received on 6/15/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a cluster of 3 female pts (no specific pt identification provided), received TD ADS ADULT vaccination, lot U1184AA, on "variable" dates. The routes and sites of administration were not reported. Within 24 to 72 hours, after receiving the vaccines, the pts developed redness, swelling and tenderness at the injection site. The pts' recovery status was not reported.
Within 72 hrs of receiving 4 month vaccine (PEDIARIX; Act HIB; PREVNAR; ROTATEQ) child had sleep disturbance and "high pitched scream-super high pitched scream."
Pt developed facial spasms, tingling in her lips and right sided facial droop. She cannot close her right eye. She was diagnosed with Bell's Palsy
Admit Date: 5/14/2021  Discharge Date: 5/15/2021        The patient is a 74 y.o. female, history of MS, history of cerebellar ataxia and gait instability at baseline who presents for evaluation of lower extremity weakness.  Patient received her second Covid vaccine yesterday.  Patient reports baseline right lower extremity weakness with foot drop.  She reports she awoke today and has had bilateral lower extremity weakness.  Patient reports she normally walks with a cane but has been unable to stand up and get out of her chair.  She typically uses a cane for ambulation but states she has been unable to complete her ADLs secondary to immobility.  She reports mild headache throughout the course of the day but no thunderclap quality or maximal headache at onset.  No neck pain.  No chest pain or shortness of breath.  She reports otherwise, "feeling achy."  No fevers.  No chills.                                                  At discharge:  #left lower extremity weakness: resolved overnight. MRI brain and L spine without acute MS flare, no signs of acute stroke or cord impingement. ? Reaction to Pfizer vaccination. Now returned to baseline. Cleared by PT for return home.    #Multiple sclerosis: chronic right upper and lower extremity weakness. Unchanged. No active MS lesions no MRI brain/L spine as above. Recommended routine follow up with her neurologist. No changes to medications at this time   #Hyponatremia: very mild, resolved on day of discharge   #Hypothyroid: continue synthroid
25NOV93 pt had DTP cranky, crying, t101, high pitched cry; 7PM on 25JAN92 kept fever of 102 until next evening 26JAN93 7PM t104; pt taken to ER bloodwork done pt given Pediaprofen & advil for children;
First 2 days couldn?t move my arm it was red swollen and hard as a rock. The pain was less day 3 redness spot is getting bigger at point of injection still hard to touch
died suddenly and unexpectedly; Initial information received on 27-Jan-2022 from regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who  died suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(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, expiry date, frequency, strength unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) died suddenly and unexpectedly.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (died suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event died suddenly and unexpectedly. No autopsy was done. The cause of death was reported as Sudden death NOS.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022: This case involves a patient with unknown demographics who  died suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any concurrent conditions precludes comprehensive case assessment.; Reported Cause(s) of Death: died suddenly and unexpectedly
Approx 11:05 A shot given as a Nurse only Visit. 11:20 A pt voiced feeling OK no reactions. Discharge into given to her and husband. Pt left went to lobby BR and came out talking of allergic reaction. Itching at lips, face and head v/s taken 98.50 20 56 102/62 O2 Sat 100%. Dr notified. He ordered BENADRYL 25 mg IM. given in (L) buttock Pt A and O sent to c/o just itching. 11:55 pt voiced feeling better.
I started with weakness in my legs about 72 hours after the shot. Proceeded to get worse. Then I was admitted to the hospital on 04/16/2015. I received 2 series of IVIG with no result. Then received 6 treatments of plasmapheresis.
After getting the first injection of the Pfizer covid-19 vaccine, she experienced a sore and tender arm; Tingling around her heart and chest; This is a spontaneous report from a Pfizer sponsored program. A contactable female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on Jul2021 (two weeks prior to this report) (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was asking can it be taken with a product to help with immunity that contains vitamins A, C, D3, E and zinc, selenium, quercetin dihydrate, wellmune yeast, elderberry, echinacea, ginger, turmeric, lactospore, bioperine, acai berry, garlic, response received that did not find information about a potential interaction, or interaction study, or administration with these products/drugs. This may not have been studied. Advised to consult with your doctor or pharmacist for further guidance and ensure that your health care providers know all the medications, including over-the-counter (OTC) products, that you are taking, have recently taken or are planning to take. On 2021, the patient experienced sore arm and tender arm which lasted longer than just a few days and has still not fully recovered and patient also experienced tingling around her heart and chest. Patient was concerned should she get a second injection of the Pfizer covid-19 vaccine because of what she experienced (side effects) after the first dose. She was afraid the second injection might be worse. The outcome of event for sore arm and tender arm was not recovered whereas outcome for tingling around her heart and chest was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Lower back pain, like at the bottom of the spine, around the kidney´s area; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area). At the time of the report, BACK PAIN (Lower back pain, like at the bottom of the spine, around the kidney´s area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Laboratory details provided. Treatment information was provided as acetaminophen.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a registered nurse (R.N.) concerning a 19 month old patient who on 09-APR-2009 was vaccinated with a first dose of ROTATEQ (lot # not reported). It was reported that the patient was given the vaccine past 32 weeks of age. No adverse reactions reported.
pt recv vax & 2min p/vax rt arm was red w/small bumps around site;pt eval by MD & given DPH;pt waited @ clinic for 30min;pt released by MD;
Traveled in July and per mom reports, she states that child was in the hospital for a few days due to temporary rheumatoid arthritis. Mom never notified this office when child had a reaction so everything from mom was word of mouth.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium
24 hours after administration of the varicella vaccine, pt began developing small red pustual type bumps on buttocks.  Continued to spread to face and hands.
Pt arrived at ER 12/17/16 (9 days after vaccines given) between 4 and 5pm with redness and swelling of right distal thigh. Parents reported sx's present for approximately 24hours. No fever reported.  Pt diagnosed with cellulitis and given 7 day course of bactrim. Warm compresses multiple times daily to reduce swelling.
After 24 hours inflammation at site with edematous and induration that lasted 2 weeks with residual capillary mottling that is persistent after 4 weeks
Thursday July 22, 2021 around 9PM, unusually loud ringing in both ears, most prominent in the left ear.  Reduced hearing levels in both ears, most prominent in the left ear.  Friday, July 24, 2021 purchased ear wax removal kit from store and cleaned both ears with no improvement.  Thursday, July 29, 2021 purchase Relief drops from store  and used them for several days with no improvement.  Wednesday, August 4, 2021 made first available new patient appointment with ENT on August 20, 2021.  Friday August 20, 2021 Hearing test showed hearing loss.  Injected steroids in left ear and started 7 day course of oral steroids with no improvements.  Condition may be permanent.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size), treated w/keflex po;rxn resolved p/approx 1wk;this is 1 of 8 patients reported from this facility who exp the above rxn
Was given the flu shot FLUVIRIN while pregnant and 10 weeks later was diagnosed with AML Leukemia. Caused life threatening drop in blood counts and premature labor.
Pt reports severe and itchy rash around two-thirds  of the upper arm.  Rash started the evening after injection was administered and remains itchy and red even 6 days after administration. Pt administered self-care of ice pack and benadryl to relieve itch.
Arm was red, swollen, hard, warm to the touch, no red lines or streaks. Discussed ice, Motrin, Benadryl and call back if looks worse. Called back at 8:17 PM arm looked worse, given an appt for next AM 01/26/2012. Presented with cellulitis of the upper arm 12 x 18 cm.