chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 year old female with obesity, asthma, depression and allergy to amoxicillin who on 22-APR-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 02-MAY-2008 the patient experienced fatigue.  The patient sought medical attention in the emergency room for evaluation but was not admitted.  Laboratory studies performed included erythrocyte sedimentation rate, mononucleosis serological test, complete blood count and all results were negative.  At the time of the report, the patient was recovering.  The physician stated she does not believe that the fatigue and the vaccination with GARDASIL are associated.  Additional information has been requested.
20 hrs p/vax pt did not feel well & couldn't breathe well; 911 was called & transported to hosp-unresponsive; all test neg x/arterial 02; sleeping alot; pale;
This spontaneous report as received from a registered nurse refers to about 5 patients of unknown age and gender. On an unknown dates in July 2014, about 5 patients were vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose not reported), intramuscular, that was improperly exposed to 35.06F for 72 hours (from 27-JUN-2014 until 30-JUN-2014). No known adverse effects were reported. Additional information has been requested.
sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive; sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 28Jan2021 (Lot number: EL3247) as dose 2, single and administration date 18Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Feb2022, outcome "unknown" and all described as "sx 2/21 & + home Ag test 2/21 sx mild fevers ST rhinorrhea congestion in the head and mild body aches/Home Ag: Positive". The patient underwent the following laboratory tests and procedures: body temperature: (21Feb2022) mild; sars-cov-2 test: (21Feb2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Complained of itchy ankles and wrist. Didn?t notice anything . Noticed rash on waist backside moved to inside of legs, plentiful inside knees. Slowly progressed. Moving to different locations. Went to doctor on day 5 do to it not slowing down with Benedryl  they gave her prescription antibiotic cream and told to take over the counter 24 hr allergy pill. Helped with itching. Took her back to doctor in day 7 because it kept advancing. Gave her predisone and by day 9 we saw improvement. Another 8 days and no sign of it.
Pt states about 8pm he started have stabbing muscle/joint pains then a few minutes later "hypothermia"-shivering, freezing, shaking.  Bundled up under the covers and after about 2 hours it finally stopped and he went to sleep.  States the next day 10/24/14 he had mild hot and cold sweats throughout the day.  States he did not check his temperature but did not feel warm to the touch so did not think he had a fever.
Patient noticed pain at injection site shortly after receiving vaccine, starting that next day pain radiated in whole arm muscle and now a week later and patients arm muscle is still very sore and she is having trouble lifting arm to drive and daily tasks. Patient will be following up with MD soon.
Blisters and itching from middle of stomach to middle of back, very painful for 3 week reaction to shingle shot: SHINGRIX 50mcg inj (IM) sngdse vl 10pk. At same time given flu shot: FLUZONE HIGH DOSE 2018-19 0.5ml syr at same time in left arm. At pharmacy by MD.
I received the Moderna COVID-19 booster on 12/19/2021. On 11/28/2022, I developed a sore throat. My brother, who lives with me, had recently tested positive, so I was alert to the possible signs of infection. On 11/29/2022, I developed a fever, which hovered between 100 and 101 and lasted for about 48 hours. On the morning of 12/1/2022, I took a home antigen test and got a positive result. I was very fatigued and developed a cough. I had both head and chest congestion, but my main concern was the cough, because I had previously had bronchitis over the summer of 2022. For this reason, I decided to contact my doctor, and she suggested that I stay on the lookout for severe respiratory symptoms, such as difficulty breathing and turning blue. She also prescribed me benzonatate to treat the cough. I had begun isolating on 11/28/2022, and I continued to isolate until 12/6/2022, which is when I tested negative. By 12/5/2022, my symptoms had begun to improve. I had more energy, and I no longer needed the benzonatate as consistently. At that point, I mainly had to take it at night. At the time of this writing, I am much better. I still have some shortness of breath when I climb the stairs. I also have not yet resumed my previous exercise routine, which I plan to resume after the New Year.
Information has been received from a certified medical assistant concerning a 62 year old male patient with no known drug reactions/allergies with gastrooesophageal reflux, diverticulitis, sleep apnoea, depression, hyperlipidaemia, arthritis and diabetes who on 20-JAN-2009 was vaccinated subcutaneously into the right arm with a 0.65ml dose of with ZOSTER vaccine live (Oka/Merck) (Lot #663196/1417X).  Concomitant therapy included CARDURA, CIALIS, DEPAKOTE, DETROL LA, METFORMIN, NABUMETONE, NEXIUM, SIMVASTATIN MSD and ZOLOFT.  The medical assistant reported that after vaccination (on unspecified date) the patient experienced a localized red, raised area with slight itching on the right arm.  The area was the size of a "plum".  The patient was told to apply a cold compress, take ibuprofen 3 tablet 3 times a day, and to call if any question or worsening of symptoms.  The patient sought medical attention by phone on 23-JAN-2009.  Additional information has been requested.  This is one of two cases from the same source.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
30NOV93 swollen glands, joint pain, numbness, tingling & aching from elbows to hands; swelling of hands & feet; given DPH & Advil w/ minor relief; several months numbness has resolved; minor swelling still exists;
A delayed allergic-type reaction of painful, red, itchy, swollen, firm rash developed on left arm at injection site, 8 days post injection. Large rash roughly the size of an adult hand, wrapping around the lateral aspect of left biceps area at injection site. A little online research told me this is called "Covid Arm" and is a delayed allergic reaction that has been reported in about 1% of people (mostly women) after having their covid-19 vaccine injection. Has been reported almost exclusively with Moderna vaccine. This is not considered a severe reaction and is not reason to delay or my cancel second vaccine dose.  Treated with 400mg Ibuprophen for pain and 50 mg benadryl for itchiness, both taken x 2 per day for 5 days. Also treated topically with hydrocortisone cream for first 2 days of rash. Rash resolved completely by 17 days post injection (4/13/2021). I plan to continue with my second dose of the Moderna vaccine as scheduled, but take ibuprophen and benadryl ahead of the injection and also get the injection in my other (right) arm.
I believe patient had a pretty severe injection site reaction to the flu shot today. It reacted instantly with swelling, a knot, and redness that expanded to be about the size of a baseball and felt firm like cellulitis. She had a benadryl in her purse and I had her take it. Monitored her for about 15 minutes and it started to look better. She stated she felt fine the entire time so I sent her home. PharmD, R.Ph.
Temp 101 deg, hands/feet swelling; tongue feels swollen, nausea, headache within 24 hours of Adacel in absence of any other cause
pain is aggravating; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and PAIN (pain is aggravating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On an unknown date, the patient experienced PAIN (pain is aggravating). On 28-Feb-2021, PAIN IN EXTREMITY (soreness in the arm) had resolved. At the time of the report, PAIN (pain is aggravating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
On 10/7/03 pt developed an itching, maculopapular rash from neck to thighs lasting approximately 5 days. On 10/8/03 pt experienced joint pain, swelling, fever, sore throat. Pt reports contracting measles at approximately 8 years of age. Joint pain persists. Diagnosis/work up in ER.
Systemic: Chills-Severe, Systemic: COLD (SEVERE) -Severe, Systemic: Shakiness-Medium
very ill/sick; fever ran between 101 and 102.5; in bed for two days; Severe headache; Eye pain; Chills; Feeling bad; do not feel strong enough to deal with the side effects; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Oct2020 (very end of Oct). The patient's concomitant medications were not reported. The patient experienced feeling very ill/sick, fever ran between 101 and 102.5, in bed for two days, severe headache, eye pain, chills, feeling bad, and do not feel strong enough to deal with the side effects in Mar2021. The clinical course was reported as follows: the patient ran a 100.5 fever and high fever (between 101 and 102.5) in Mar2021 and was in bed for two days with severe headache, and eye pain. The patient stated it was like having COVID-19 all over again. The clinical outcome of all of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290577 same reporter/drug, different patient, similar events
itching on the left upper portion of her mouth and then on the roof of her mouth Benadryl 25mg given
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case contains information for patient 69 out of 100 patients reported by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Mom reports while on vacation, child developed temperature of 104F. Went to local ER and was treated and released. He developed a pox rash from head to toe on 10/4/00. Mom reports that on 10/7/00, pox was gone.
ELS (excessive limb swelling) from shoulder to elbow. Erythema, pain, swelling, and a "pocket of fluid" near the elbow as evidenced by ultrasound. Given KEFLEX in ER and script for 3x daily x7 days.
My daughter had her first dose of GARDASIL the Summer of 2009, 2nd dose 12/2009 and third dose Spring of 2010. From 10/2009 through Spring of 2011, she experienced severe pain in her shins and legs. Her legs felt weak and heavy when she exercised. She had x-rays, MRI's and a variety of other tests to determine the problem. She was diagnosed with a stress fracture in one shin, but was experiencing the same pain in both shins, and continued to have these problems over a two year period, with no official diagnosis. After reading some reports about the GARDASIL drug we are now wondering if it could be the culprit during this time frame. We felt it was important to report her symptoms for this reason.
The first time he noticed the symptoms was on Wednesday (09/28/22) morning. Patient reports that his "mouth was twisted". Thursday (09/29/22) morning it was "worse". Friday (09/30/22) morning it was "really bad". Patient reports he and his wife called primary care physician (PCP), PCP instructed patient to go to the emergency room (ER). ER doctor checked the patient and ran some tests including a CT scan and lab work as well as other tests. ER doctor said the patient had not had a stroke. Patient was diagnosed with Bell's Palsy, given prednisone 20 mg (take 3 tablets by mouth once daily) & valacyclovir 1 GM (take 1 tablet twice daily). Patient is still experiencing the symptoms of Bell's Palsy today with no improvement after finishing medications.
This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were recovering/resolving. It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt reaction. The patient also suffering with muscle pain and joint pain months later. The patient stated above events were improving but wont take the second shot. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR200703, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR200703:same reporter.
12 year old incorrectly given adult dose of Moderna bivalent.  Mother called the next day, patient is feeling fine, minimal side effects (sore arm). No immediate adverse effects felt.   State Epi dept contacted, informed this RN that the dose is likely to be approved for that age group in the coming weeks. Basically just given early. Revaccination not necessary.
Difficulty walking, tingling hands, feet, and tongue.  Later transported to hospital and diagnosed with GBS. 8/27/07-records received for DOS 6/20-6/28/07- DC DX: Guillain-Barre syndrome. Secondary diagnoses: latent tuberculosis. chronic low back pain. erosive esophagitis. migraine headache. hyperlipidemia. C/O weakness. Presented to ED with leg weakness and sluggishness for approximately two days. Initially legs felt slightly stiff and now having difficulty walking fast. Feels pins and needles in fingers and toes and tip of tongue. Legs feel weak. Expresses anxiety about need to return to work in Africa. No difficulty swallowing. No trouble breathing. Positive for headache. Denies vision changes, memory loss, shortness of breath, nausea, vomiting and diarrhea. Had the beginning of a cold approximately three weeks ago, states she felt run down, however did not develop into any specific illness. Lives and works in Africa. PE: Mild Diminished reflexes in lower extremities. Treated with IVIG. Progressively developed ascending paralysis including facial nerve paresis. Lower extremity weakness began to improve on 6/24/07-Facial weakness continued at time of discharge to rehab. Difficulty chewing and difficulty moving her tongue.
Given first dose of oral typhoid by parents two days after dispensed.  Per parents who sought advice of a physician friend, she developed "target lesions" 24 hours after taking first dose of oral typhoid and 48 hours after yellow fever and Menactra injections were given.  He recommened Zyrtec, and symptoms resolved after two days.
The pt experienced a severe reaction described as a "brain injury" which resulted in the pt being diagnosed with mental retardation.
pt recv vax & then reported redness, swelling & warmth @ site;returned to office & exam;
A pediatrician reported that a child who received an injection of Prevnar developed pneumococcal sepsis two days post-immunization and subsequently died. No further info was available at the date of this report. *F/UP report on 3/31/03: Add'l info received on 1/14/03 from an MD provided further info about the event. Upon contacting the MD, the MD said that "he heard this story from a PT anecdotally." He had no info about the PT and indicated that he doesn't even know if this is a true story. The MD advised to disregard this report. No further info was available at the date of this report.
the patient got what she reported felt like a hot flash and very light headed for a short period of time and then it cleared up completely, she reported that it occurred about 15-20 minutes  after receiving the shot.
Got a series of hive like bumps around the injection site. Woke up with an upset stomach, which was a painful blot feeling. She also had a rash on her torsel and some hives on her lower back and thighs.
Red, raised and swollen at injection site and the red raised area is 3-4" in diameter and growing.
I had an absolute killer headache for about six hours, it was almost as bad as a migraine but not quite as bad. I also had a runny nose during this, but I had not really thought twice about that. The day before my husband did test positive for COVID-19 but since my headache and runny nose only lasted for about six hours, I did not think much of it. The next morning, I woke up completed drenched in sweat, I was drenched and so were my sheets. I then took a home COVID-19 test, and it was very faint, but it was showing positive. I then went into an urgent care and got a PCR test which was also positive. I ended up having a fever of 102 and was taking DAYQUIL and NYQUIL to get through. I had the body aches, chills, muscle aches, coughing, congestion, runny nose which was worse than that first day, muscle cramping, fatigue, brain fog, loss of smell, major sweating- almost like hot flashes, stomach pain, I was unable to concentrate on anything, The brain fog and concentration issues was so bad that I could not even remember conversations and would have pieces of things I could remember but it was bad and similar to when I had a concussion. Since recovering I am still having issues that I am dealing with and am meeting with my healthcare providers and working on issues which we have deemed as long COVID. I have this horrible back pain in my spine and the fatigue is still something I struggle with. I now am more asthma medications as that has gotten worse as well. I have very bad muscle cramping as well. My smell comes and goes but it is really weak when I can smell but there are many things I cannot smell at all. I also have started having menstrual spotting which I have not dealt with in over ten years. This is why I am putting that I have not recovered at this time.
Shortly after vaccine in left arm-muscle was in extreme pain and later atrophied. Patient is seeing her doctor for this.
A dull ache in injected arm 1 week after injection and continuing on to current day (over month from injection) the ache extends from the left deltoid, to the shoulder, under the armpit and feels like it radiates to left breast but really unsure. Hard to describe the feeling and exact location.
Pt c/o car sickness PTA, per his report. Pt reports he only drank gatorade and had one slice of bread PTA. Reports dizziness, blurred vision, diaphoresis prior to arrival to med obs #1. Denies LOC. Provided juice and saltine crackers. Mother and brother brought to bedside. Pt improves improvement of symptoms after eating/drinking. No s/s of distress noted. VSS. VS are as follows: 1137: BP 87/55, recheck 109/89, HR 77, RR 17, O2 sat 97% on RA 1142: BP 115/77, HR 66, RR 16, O2 sat 98% on RA
Patient states developed hard tissue/lump on arm of injection site. This resolved after 8 days. Patient states lump is now back bigger and feels warm to touch.(06/01/21)
Felt heaviness in feet, knees, hips and joint pain. Sought evaluation with lab work done. This vaccine was given as part of a wellness program for employees.
1.5 cm Nontender erythematous firm mass at injection site on right thigh, present since (DM?)