chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left leg pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (left leg pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left leg pain). At the time of the report, PAIN IN EXTREMITY (left leg pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.
Pt's arm became red, swollen and hot to the touch. Pt noted redness and some swelling on 11/14/01. Pt had no reaction to first hepatitis B injection. School nurse referred pt to private MD for evaluation.
This spontaneous report was received from a purchaser and refers to a 65-year-old female patient with an allergy to penicillin. The patient did not have pertinent medical history and concomitant therapies. On 06-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number reported as N005096, expiration date: 22-OCT-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis (reported as vaccination). Subsequently, on 07-APR-2017, the patient sought medical attention through a call she made to a facility in which she mentioned that she was experiencing hives, redness, and swelling at the injection site and it was "warm to the touch", however, no treatment was provided to the patient. The patient did not undergo any laboratory test or diagnostic procedure. At the reporting time, it was unknown whether the patient recovered or not from the adverse events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not provided. There was no product quality complaint involved. Additional information has been requested.
alot of redness around the injection site, warm to touch and swelling . soreness for last couple days
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2013, the patient was vaccinated with the first dose of ZOSTAVAX (lot # J001694, expiration date: 08-MAY-2014; dose and route were not provided). On 11-JAN-2016, the patient inadvertently received second dose of ZOSTAVAX (lot # reported as L035286, expiration date: 15-DEC-2016; dose and route were not provided). No adverse effects were reported. Additional information has been requested.
she was 80 years old and has heart issues; This is a spontaneous report from a non-contactable female consumer(patient).  A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: Unknown) via unknown route on 28Jan2021 as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she was 80 years old and has heart issues. Patient was watching the today show and they are telling viewers that you can wait 3-6 weeks to get the 2nd dose on an unspecified date. Patient stated that she would contact the local health department in (State name) and see if they will allow her to get the 2nd dose there and go from there. She wanted to know what happens if the health department tells her no and she cannot get the 2nd dose until end of Feb. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was sick for 3 days but no fever but nausea is really bad. nobody is giving me any answers I have no stomach ache or flu just bad nausea. please help me I never thought booster will do this to me.
urticaria, flushing Narrative:  Pt developed hives and redness/rash to right forearm and upper medial chest following first dose of covid vaccine, leading to ED visit. Developed nausea and vomiting with bile in the ED. Pt given IM diphenhydramine.
Information has been received from a nurse concerning an 80 year old male patient who on an unspecified date was vaccinated with a dose of Pneumovax 23, (lot # not reported) (manufacturer unknown).  The nurse reported that the patient received the Pneumovax 23 and developed a "Guillain-Barre syndrome" which made him develop pneumonia and the patient died as a result.  She reported that the patient was not treated or vaccinated at that practice and was not sure if it was Pneumovax 23, she said it was a pneumonia shot (manufacturer unknown).  No further information was reported.  Additional information is not expected.
Body aches, chills and fever.  Fever continued to rise up to 104 at 02:00 am on 2/23/11.
Nothing at time of injection. In the evening, soreness in the arm (strong but on par for what I would expect).   Next morning, I starting feeling sick, with flu symptoms. Aching muscles, sensitive skin, mild headache, sore eyes, and in the evening, nausea. Temperature gradually rose. ~99.7 at 6pm, 100.1 at 7pm, 100.7 at 8pm, 101.7 at 9:30pm. I took some Tylenol around 7pm, and then some theraflu at 10pm.   Fell asleep at 11pm. Periodically waking up every 30min from 1am onwards. Muscle discomfort, sweating, and nausea continued until 3:45 AM, at which point I was feeling better and was able to sleep continuously.   Feeling much better in the morning on March 4th. Temperature was 99.9, then rose to 100.0 at 11am. Now, at 3pm, feeling fatigue, exhaustion. No headache. Normal sense of taste and smell. No couch.  Taking another day off from work. Temperature is currently 100.0. Taking more theraflu now, have not taken Tylenol today.
Experienced pruritis immediately after injection.  Pt had pruritis with first vaccine 1/15/21 however, did not report symptoms and took Benadryl 50mg po and symptoms resolved on their own.  Pt thoroughly examined, no swelling noted to tongue, lips, uvula midline, vss, no urticaria present, no nausea.  Pt. Given 25mg po of Benadryl and observed for 30 mins: after and remains without s/s of anaphylaxis.  Pt. Reports improvement of itching.
Headache; Mild pain; Fever; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling). At the time of the report, HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt returned to pharmacy 2 days after administration, red, rash like area on arm below where shot administered, hot to touch. Visited urgent care.
At 8pm I developed a headache and slight stiff neck and didn't think much of it.  The next morning I woke up with a bad headache (which is unusual for me) , sore neck and slight chills.  I was out of commission the entire day.  No appetite, headache never really went away (it wasn't stabbing...more migraine) and I would feel a little dizzy/nauseaus when walking.  Never had a fever,cough, congestion.  Felt slightly better by bedtime.  On Thursday (I received shot on Tues, sick Wed) I felt pretty good most of the day but a little like I still had a touch of a flu.   At about 11pm I noticed a rash (flat, red, not itchy ) primarily on my right arm and left arm and some spots on legs and back.   I noticed my lip felt a little tingly but not bad.  My oxygen was fine, but my heart rate was a little high for just relaxing.  I took 2 Benadry at 11:30 and had no issues sleeping.  When I awoke at 4am to use the bathroom, I looked at my arms and they were almost clear....within minutes the rash reappeared.   I took one benadryl at 7am today and it seems the rash comes and goes but seems to be getting better.  My lips still feel a little tingly...almost like a windburn feel.   I have had hives twice in my lifetime but they were raised and itched.   I have never had a flu shot reaction prior to this (except getting a little sick a week or so later.)   I did call my Dr. s office and she was fine with just watching the symptoms unless they get worse.   I did not call the pharmacy.  Also, something I noticed was slight ear ringing and the joints in my fingers seem sore/stiff and sensitive to hot water.
Initial report was received on 05 July 2010 from the patient's parent. A 12 year old female patient received an injection of "Tdap" (lot not reported) and an injection of "MCV4" (lot not reported) on 18 May 2010. Two weeks later she developed puffy eyes, but had no other symptoms. The patient had no illness at the time of vaccinations. According to her father, she was a "very healthy child all of her life, up to about two weeks ago." No pre-existing medical conditions, allergies or concomitant medications were reported. She received no vaccines within 4 weeks of the vaccinations on 18 May 2010. The patient was seen by a pediatrician on 28 June 2010, was sent to the emergency room (ER) and subsequently hospitalized. The initial diagnosis was nephropathy with kidneys failing. A renal biopsy is scheduled for 08 July 2010. At the time of this report the patient remains in the hospital and has not recovered. Documents held by sender: None.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not have known allergies. Treatment start and stop date: 17Apr2023 and 21Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175485 Same reporter/patient, different product/AE;
Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 27Aug2021 at 11:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient had known allergies to amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sambucus nigra fruit (ELDERBERRY), loratadine (MANUFACTURER UNKNOWN) and smarty pants multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient received human papillomavirus (HPV) vaccine (MANUFACTURER UNKNOWN) in the left arm on 29Jul2021, within four weeks prior to the vaccination. On 27Aug2021 at 13:15, the patient experienced exhaustion. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event exhaustion was recovering at the time of this report.
Vomiting, and the vomit had visible blood cloths; This spontaneous serious Safety Report was received by Agency on 18-AUG-2021 and forwarded to Agency on 20-AUG-2021 from a health care professional.  A 2-month-old patient, with an unknown medical history, had been vaccinated with Vaxelis (dosing number and batch number unknown) on an unspecified date for prophylaxis.  The following co-suspect vaccinations were reported: Rotateq and Prevnar 13.   On 17-AUG-2021, the patient experienced vomiting, and the vomit had visible blood clots. The patient was admitted to the hospital and was hospitalized for one day on an unknown date.  The action taken with Vaxelis was unknown.  The outcome of the event was resolved on an unspecified date.   The reporter assessed the causal relationship between Vaxelis and the reported event of vomit had visible blood clots as not related.   Further information is expected.  Company comment:  Haematemesis was assessed as serious (hospitalization).  Haematemesis is unlisted for Vaxelis, as per the Agency.    Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Haematemesis was assessed as serious (hospitalization).  Haematemesis is unlisted for Vaxelis, as per the Agency.    Considering the current knowledge of the vaccine and the existence of alternative explanations (co-suspect vaccinations administered the same day), the causal relationship between Vaxelis and Haematemesis is assessed as not related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
21 month old received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 19-APR-2023, the patient received Kinrix. On 19-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 21 month old received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-APR-2023 The nurse reported inadvertent administration of Kinrix to a 21 month old child.  The vaccine administration facility was the same as primary reporter.  The date of outcome listed as 20th April 2023 was date first reported to GSK.  No additional adverse event details were available at that time per reporter. The reporter consented to follow up. The 21 month old patient received Kinrix, which led to inappropriate age at vaccine administration.
LOSS OF APPETITE; MALAISE; CHILLS; TIRED; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, penicillin allergy, alcohol use, and nonsmoker, and other pre-existing medical conditions included patients was not pregnant at the time of reporting. patient had no history of illicit drug use or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNWON) dose was not reported, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included metoprolol for hypertension.  On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced loss of appetite. On 11-MAR-2021, the subject experienced malaise. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 16-MAR-2021, malaise, chills, nausea, fever, and headache on 12-MAR-2021, and tired on 15-MAR-2021. This report was non-serious.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PARTIAL EPILEPSY ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/6/2023RECURRENCE OF SAME SYMPTOMS
Onset of rash and hives early am 10/24 over total body.  Very pruritic.  Vitals satisfactory.  No associated symptoms.  T/C to PCP midday 10/24.  Tx' D  with BENADRYL 25mg with little/ no relief.  ER 7pm 10/25.  Tx'D with steroid injection and PO MEDROL pack.  Slowly improving.
full body rash from head to toe developed 10 days after vaccination. Small pink bumps all over. Raised and itchy.  I am filling this out on day 3 of the rash appearing,, the bumps are now smaller but still covering his whole body and on his face as well.  Very irritable and sleep is disturbed from itching, appetite is lower.
Pt reported bilateral leg pains x 2mos with increasing pain over the last few days post IPV vaccination.  Increasing pain also involving wrists, ankles spinal pain. CBC,ESR,TSH,ANA,EBV Titers, Lyme Titer all within normal limits. Started on Naprosy 500mg twice dialy and referred to rheumatology
9/10/12 - Tightness in chest (not short of breath) BENADRYL given by pt's wife. No swelling, some choking; Difficulty sleeping at nights 9/10-9/11 heart racing, coughing slight tremor. 9/11 Cramps in legs, weakness in arms & legs, right arm.
Narrative: Pt reported reaction of swelling and injection site pain in response to receiving a flu shot. In the Allergy note, its states that the patient "had to get epi drip in ER". It is unclear when and where this event occurred. Pt received flu shots in 2000, 2002, and 2007 per employee
next morning after receiving the vaccine all the severe pain was gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing); "severe pain from Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "next morning after receiving the vaccine all the severe pain was gone". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
day of injection - small amount of angioedema to eyelids, lips, and throat tightness behind ears. Injection site redness/swelling/inflammation and heat to be expected however the injection site decreased mobility in my right arm and shoulder for several days - despite doing physical exercise/movement to the area to promote range of motion  20+ hours after injection - extreme fatigue, horrible headache, nausea, vomiting, fever of 103 that did not respond to tylenol/motrin for several hours nearly 12 hours for temp to move below 100. I had sensations of not being able to move my legs/arms even though I could physically move them - my sensation was not there that they were moving. The pain in my joints and specifically in my hips felt like someone poured boiling hot liquid into my joints and they were burning from the inside out. Decreased mobility due to pain in these joints. It is excruciatingly painful and the tylenol/motrin does not help with pain control.
Reported chills, fevers, muscle aches, and sweating ongoing since night of first injection on 8/13. Patient evaluated via telemedince and his face appears red/ruddy in color, pale lips, and significant diaphoresis observed on face.
Started with mouth going numb- 15 minutes after injection; tongue started swelling and boughts of dizziness- I believed it was due to dehydration; officially 20 minutes after injection- I requested an appt bc my tongue would block my air way and it was getting hard to breath- I was hooked up to an IV and Benadryl through IV- my sense of time became fuzzy- I know that I was hooked up to oxygen and my Blood pressure was high - 147/106, 139/100, 148/99, 145/105. I was put on an ambulance- given epinephrine. This would be an hour 1/2 after injection
I started having leg and foot cramps nightly.  The cramps occur every night and are quite severe so that I cannot sleep.  There is residual pain from some of the cramps for days afterward.  I also am experiencing all over body aches in both arms and legs.  I also am suffering unusual fatigue where I cannot keep my eyes open even during the day.  I am also experiencing occasional headaches.  I never had these issues previously except for occasional cramps related to unusual amount of activity but never every day and night.  I have tried massage, stretching, high dosages of Magnesium, drinking more water, etc.  Nothing seems to help.  Am currently taking  Hylands leg cramps PM pills at bedtime and they dont work either.  I visited my Primary Care doctor on August 27th.  He ran blood tests to see if anything abnormal and all came back in normal ranges.  He referred me to rheumatologist but I cannot get an appt til late Nov.
Redness and swelling of right ft/ankle, right hand noted with slight swelling, 1+pilling edema to bilat lower ext. C/o intense itching started last pm a few hrs after shot, cont's to present time.
Localized redness/warmth at injection site (Rt deltoid). Diminished erythema as of this date. No c/o's discomfort today.
Patient noted on the following day redness on injection site. Then on 4/4/17 she noticed redness had spread to a bigger area of arm, it felt warm and had hard knot on injection site.