chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My legs are in pain/My pain in feet has spread to legs; My feet and toes red; Walking painful especially when warm after walking; Fluttering in all parts of legs and muscle weakness in thighs; It is impacting my daily work at this point; Postive ANA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 30Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "Fluttering in all parts of legs and muscle weakness in thighs"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "It is impacting my daily work at this point"; ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "My feet and toes red"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "My legs are in pain/My pain in feet has spread to legs"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 2022, outcome "unknown", described as "Postive ANA"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Walking painful especially when warm after walking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Forwarded as an Adverse Event on 09May2022. Reporter provided verification of contact address on 06May2022. Received booster shot 30Jan and patient feet and toes red, pain in feet had spread to legs when walking painful especially when warm after walking patient have fluttering in all parts of legs and muscle weakness in thighs, after some test Dr had only found a new case of postive ANA. This came on after patient booster and was progressing and they can not treat patient. How long was this in patient system what help patient can get, t was impacting patient daily work at this point and night patients legs are in pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200695356 Pfizer
Cried for 6 hours after receiving vaccines on 8/14/2008. No Reaction
Pt recvd vax 30 mins p/inject had itch & erythema @ the site of inject that lasted for an hour; 48 hrs later the pt exp general body malsie, elevated, temp & mild flu-like synd that lasted for 72 hrs; pt was seen by MD;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/08/21 2nd dose01/29/21 Diagnosed covid positive:08/26/21 Symptom onset:08/25/21 Exposure: Symptoms:congestion, sore throat, sinus pain.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milligram. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: NERVE INJURY (disability), outcome "not recovered", described as "Nerve damage".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 1 am dov, I started trembling very bad. Was weak and couldnt lift my head off the pillow. Then an hour later, I started feeling like I was getting a fever. I checked my temp, and I did have a fever. Trembling lasted a couple of hours.  I had extreme fatigue, had to lay down and stay home from work for 2 days cause of me being so weak and fatigue. Fever lasted on and off for a little over 24hrs.  Then after I got pass the fever, I have a really bad headache. I still have a headache. I took tylenol for the fever. Then last night, I took some Benadryl to calm the reactions.  My upper arm is still  a little swollen and is still sore.
Pt recvd 2 doses of Engerix-B & 1 wk p/2nd inject exp a local reaction @ inject site & was raised, red & scabby; no tx was given; arm still red & scabby;
Patient first experienced tingling in her arms. She continued to get worse and is now in ICU for what the doctors believe to be Guillain-Barre syndrome.
MMR vaccine was given to my son on 2/25/04. On 3/1/04 he had a temperature of 99.3 F and was acting strange.  On 3/2/04 upon wakening, his fever was 102.8 F.  This was the first time in his life that he had a fever.  I took him to the doctor immediately and he was diagnosed with an ear infection (he never had an ear infection before, either). The doctor said it had nothing to do with the vaccine.  His fever broke after just one dose of Tylenol, but he continued to be lethargic, had no appetite and would barely drink any liquids.  By 3/4/04 he started to break out in a red rash on his face.  By the next day, 3/5/04 (exactly 9 days after the vaccine) he had a full blown measles like rash on his face and neck. Again, I took him to the doctor and she denied it had anything to do with the vaccine.  She said it was a "viral rash due to a virus".  My son has been extremely cranky for 5 days now, has no appetite, will have bouts of inconsolable crying that last for an hour or longer and is lethargic.  By 3/6/04, 10 days after the vaccine, his rash is worse, it spread a bit down his trunk and he cries out of the blue as if in pain.  On Monday, 3/8/04, I took him to a new pediatrician.  I told her the events of the past week and she said it was a reaction to the vaccine.  She also gave me an MMR vaccine information sheet that listed almost every symptom my son had as possible reactions.  She told me doctors were required by law to provide parents with the information sheets every time their child receives a vaccine.  My pediatrician never once provided me with an information sheet. My son was sick from Monday, March 1, 2004 until Monday, March 8, 2004.  By March 9, 2004 his rash was starting to fade and turning a brownish color and he had a little bit of an appetite.  On March 10, 2004 his eating and drinking habits returned to normal (actually he ate more than usual but I assume he is very hungry after barely eating for over 1 week. On March 11, 2004 he started acting normal, with high energy etc.  Today, March 15, 2004 he still has slight remnants of the rash on his face (very faded but still slightly brown dots on his cheeks).  He stopped showing signs of an ear infection (the new pediatrician said on 3/8/04 he had fluid in his ears and signs that an infection was present but to stop giving antibiotics-augmentin- that first doctor prescribed).  I am convinced that my son got the measles as a result of the vaccine and that is what also gave him an ear infection-he never had an ear infection before and I don't think it was just a coincidence that he got his first ear infection 7 days after the MMR vaccine and then 2 days later came down with a measles like rash. He was sick for 8 days starting 6-7 days after the vaccination.
felt warm 3 1/2 hrs p/vax; had h/a 8-10 hrs later which got worst the following day; had headache for 2day states had fever 26MAR93 (101-103); seen by MD 28MAR;
She got her vaccine, it turned out real red the following day, was the size of a silver dollar and then it spread and growing, just barely visible now and is bruised that she noticed today.  I was running a low grade temp of 100.4.  She had already taken her regular medicines that she takes and 2 Tylenol that morning.  She went to the doctor on 9/27/23 and was told that she had cellulitis.  They put her on antibiotics, Keflex.  She was told to put hot and cold compresses on it.  It was tender the touch to the point that she could barely touch it.    It is much better now and does not hurt right now, redness is gone now and just barely bruised.
No second dose after the recommended time; 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) had resolved.            concomitant medications were not reported. treatment medications were not reported.
4 months of heart symptoms: chest pain, dyspnea on exertion, palpitations and arrhythmia symptoms, decreased level of fitness. after initial 4 months, no longer had palpitations but ongoing and progressive worsening of dyspnea on exertion and level of fitness.
This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored RECOMBIVAX HB (Lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Pt recv vax on 10/3/98; approx 2 hr later pt exp hives over entire body; itchy throat.
AWFUL ITCHY RASH AFTER 2ND SHOT; Severe all over the body rash; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old patient of unspecified gender received second dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7485) via an intramuscular route of administration, administrated into arm left on 07Aug2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization at Pharmacy or Drug store. The patient medical history and concomitant were not reported. The patient previously took first dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7484) via an intramuscular route of administration, administrated into arm left on 17Jul2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization and experienced arm soreness. On16Aug2021 the patient experienced awful itchy rash after 2nd shot, and 3weeks now all over the body. On 16 Jul2021 the patient underwent lab test and procedures which included TB Skin test, Tuberculin test and diagnosed with negative results on 19Jul2021 got read. Therapeutic measures were taken for the AE and treatment included with Zyrtec and Pepcid still no change after taken meds so on 14Sep2021 went to PRIVACY after patient tried self-care with everything didn't work so urgent care i go. Prednisone and hydroxyzine HCL have been given, when rash was getting somewhat better before taking these meds over and treated With Hazel, Equate, Triderma Psoriasis control, Ivarest Poison IVY itch cream, Eucerin Intensive repair lotion, Equate Baby oil gel, Equate 1% Hidrocortisone, hibiclens, olene zing cleaner, hydrocortisone cream 1%, hydrocortisone cream, Allergy, Lomalux eczema pill, Pepcid complete. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from an office manager via company representative refers to a male patient of unknown age. In April 2014 the patient received a dose of ZOSTAVAX (lot #, dose and route not reported). Concomitant therapy was not reported. In approximately April 2014 (reported as while using ZOSTAVAX), the patient experienced left arm pain from the shoulder to wrist, swelling at the injection site, drainage at the injection site and cellulitis while using ZOSTAVAX. The patient sought medical attention and received intravenous (IV) antibiotic as treatment for the adverse events. The outcome of left arm pain from the shoulder to wrist, swelling at the injection site, drainage at the injection site and cellulitis was unknown. Additional information has been requested.
p/3rd dose Hep B vax pt devel hive like lesion(s) @ inject site w/severe itching that prompted ER visit 24 hrs p/innoculation;
Fever of 99.5 and headache. Sent home from school. On 11/8/2015 continued to have fever. Was taken to local ER. Given IV fluids for dehydration and sent home.
patient was having headaches all day and vomited, right upper outer thigh was swollen.
From correspondence received from Bayer Corp (200110163BBE) it was reported: "This report describes a 13 y.o. female treated with BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] for rabies post exposure prophylaxis at a dose of 20 iu daily on 8/15/01. PT also received IMOVAX (rabies vaccine) for the indication rabies post exposure prophylaxis on 8/15/01. Relevant history includes reflex sympathetic dystrophy (RSD). "PT received BayRab and Imovax on 8/15/01 at 1 p.m. At 3:30 p.m., the PT experienced difficulty walking. She then fell asleep for 2 hours. At 6 p.m., PT experienced numbness in legs, could not stand or maneuver and vomiting. Stop date of the events were on 8/15/01. The PT is due for a 2nd vaccine shot 3 days later." "For the suspect drug BAYRAB [RABIES IMMUNE GLOBULIN (HUMAN)] (rabies immune globulin, human), difficulty walking, numbness in legs, could not stand or maneuver and vomiting was considered to have a possible relation to the drug. Rechallenge is unknown. Dechallenge is unknown. Outcome of events: improved." From add'l correspondence received on 12/3/01, it was reported at 8:30 p.m. on 8/15/01 the PT needed wheel chair, assistance walking. Seen by physician, recovered at this time. At 11:00 p.m. the PT was able to walk and had good color. The next day the PT slept all day, but couldn't eat, was force-fed. The day after the PT again experienced difficulty walking. The hospital did not provide the vaccine lot # info. The PT reportedly recovered from this experience. From add'l correspondence received at Aventis Pasteur, Inc. on 2/27/02 the lot # for the Rabies Imovax produce was provided (lot #R0885-2). No further info. is anticipated for this report. This case is closed.
Pt presented to clinic 11/24/08 at 9am with c/o swelling, pruritis, erythema, and pain to L upper arm. Pt received DTap and IPV at that site on 11/21/2008 @ this clinic. Per pt's mother, symptoms are improving. No erythema appreciated. No current c/o itching. No fever, no streaking. Pt has been icing the site and taking tylenol for pain.
Pt recv vax on 7/10/96; on 1/8/99 pt exp chicken pox rash
Developed hyperglycemia in early Dec 2005. Symptomatic in early 2006 and diagnosed with T1DM in Apr 2006.
Headache and dizziness after vaccine.  Pt was given the vaccine lying down.  She waited in the office 20-25 min lying down for 20 min., sitting up for 5 min.
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of VARIVAX with the following lot numbers and expiration dates: M033211/13-JUL-2018, M049126/15-DEC-2018; also the ones reported as M045205/11-NOV-2018 and N014366/09-MAY-2019 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot numbers M045205 and N014366 has been verified to be valid lot numbers for varicella virus vaccine live (Oka/Merck). As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1707USA005187: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007.
fainted within 5 minutes of injections; drank water; recovered within 15 minutes; no other side effects
Rash all over body x3 days was seen 3 days later by physician and DX with varicella uncomplicated.
Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18 years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL Influenza vaccine, date of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states of medications.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality: unclassifiable/ unassessable.  Follow-up information received on 18-Nov-2008 from PharmD.  A 19 year-old female received AFLURIA by IM injection to the upper deltoid on the evening of 17-Oct-2008 (lot 02349111A).  At the time of vaccination, patient had no illness nor was patient receiving any other medications.  On 24-Oct-2008, the patient 'came down' with the chicken pox which was medically confirmed on 25-Oct-2008 by her physician.  Patient recovered (date not provided).  Follow-up information received on 19-Nov-2008 from PharmD.  Patient is not pregnant.  No additional information is expected.  The company considered this event as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report does not change the current safety profile of AFLURIA (FLUVAX).
This case was reported by a physician via call center representative and described the occurrence of pain in extremity in unspecified adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was unknown. It was unknown if the reporter considered the pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that, his office had probably vaccinated around 60 patients with SHINGRIX vaccine and half of them experienced a sore arm. No additional information was available. This case has been linked with case US2018094043, reported by the same reporter.
Pt received FLUVIRIN on 8-30-15. On 9-21-15 he was seen/tx/admitted 5 days for presumed viral transverse myelitis.
3" x 2" area of erythema, induration left deltoid. Benadryl 1 tsp 4-6 hrs. Motrin 1 1/2-2 tsp 6hr.
Information has been received from a 47 year old female patient with antibiotics and mold allergy and seasonal allergies, who on 28-JUL-2009 was holding her granddaughter while she was been vaccinated with a dose of VARIVAX (Merck). On 18-AUG-2009 the patient broke out in approximately 5 itchy blisters on her left leg, then on the top of her left foot and back of her left leg. The blisters started out hard and red under the skin and then swelled and developed into fluid filled blisters. The patient went to the nurse practitioner who diagnosed her with shingles. The patient was treated with generic acyclovir (unspecified) and a "cream" was prescribed. The patient stated that she was then treated with prednisone (unspecified), but it shot up her blood pressure to 218/128, so the patient went to the emergency room on 28-AUG-2009. The patient was not hospitalized but the attending doctor told her that she did not have shingles, since the blisters were not following a nerve route. The patient also mentioned that the attending doctor told her that she did not have chicken pox either, but the same virus as the chickenpox, since this was vaccine related to the her grandchild. On 30-AUG-2009, the patient developed 6 new blisters on her left leg. Additional information has been requested.
pt recv vax; swelling & redness to lt thigh; was better on 3rd day;
Left arm was sore for about 2 days after getting vaccine. Then 1 week after receiving vaccine, noticed a red, hive like circle on left upper arm (right below injection site).  It was itchy and warm to the touch. I didn't apply anything to it. Resolved gradually on its own after 2 days.
17 year 10 month old male received a booster dose of Covid vaccine as above.  CDC has not yet approved boosters for people <18 years of age.   Booster dose was > than 6 months from completed series.
Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21pfizer,Lot# 2nd dose:01/29/21,Pfizer,Lot#  Diagnosed covid positive:07/17/21 Exposure: Symptoms:cough, fatigue,muscle aches, loss of smell/taste,chills,runny nose,HA