chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weight loss/lost weight/can't get it back/legs look so skinny; very weak; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak). At the time of the report, WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak) outcome was unknown.            No relevant concomitant medications were reported.   It was reported that, Last year patient came down with COVID and went to the hospital (emergency room) for a couple days. They did not send her home with anything. She went back and they gave her an antibody infusion. Then they let her go back home that night. She did not take the vaccine before she got COVID. She had not gotten the booster. She wants to know if the infusion can cause weight loss. She lost weight and cannot get it back. Her legs looked so skinny. Her clothes did not fit anymore. She was very weak. The patient stated she took 2 Moderna shots after getting COVID and after the infusion. She thought it was 5 months later. She did not have the exact dates.   No treatment information was provided.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 07/03/2022. I tested with a home test. Symptoms runny nose, diarrhea, tired, sore joints and muscles. My head bones hurt too. I contacted a COVID-19 medical center and they prescribed the Paxlovid but I declined to take it because it interacted with my prescriptions. As of today, I am feeling much better.
Swelling and 1/2 dollar sized blistering at varicella administration site surrounding area of erythema and heat. CDC contacted. Tx = cold compress, analgesia, & BENADRYL. Patient instructed to go to ER if area worsens.
Starting 6 hours post vaccine - arm started to feel sore, unable to lift straight up without soreness 8-10 hours after - headache began, treatable with tylenol -- Tylenol dose lapsed Overnight arm increased in soreness, could not sleep because if arm moved it woke me up First thing the next morning - could not lift arm past shoulder, body felt stiff/sore/ very fatigued, headache -- tylenol helped get through the work day -- Extreme fatigue - took a 2 hour nap after work and still had to go to bed by 9p  The following day (48 hrs after): dull headache + sore arm but significant improvement - took tylenol to help  Arm stopped feeling sore after 72 hrs and no longer had headache.
Pt. had generalized reaction at injection site redness, swelling & inflammation. Pt also experienced fever, malaise. Followed up with doctor visit. Events occurred at home.
Onset Fri am-Lt arm from elbow to shoulder reddened, swollen,hot to touch,extremely painful.Followed by generalized hives over legs,trunk,arms.To ER Sat afternoon.27Mar still has 2" area of Lt arm reddened &swollen.Sore to touch /w pressure
No other AE.; the product was administered to a patient on 9/14/2021 after a temperature excursion.; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number u008183 has been verified to be valid, expiration date reported and established as 07-FEB-2023) as prophylaxis.   The vaccine was exposed to the following temperature excursions (product storage error): 12.9 degrees Fahrenheit during a time frame of 3 hours and 45 minutes, 11 degrees Fahrenheit during a time frame of 5 hours and 5 minutes, 13.2 degrees Fahrenheit during a time frame of 7 hours, and 14.9 degrees Fahrenheit during a time frame of 15 minutes. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.5°F) for 1 hour and 10 minutes.  The reporter confirmed that no other adverse event (AE) occurred.
Daughter called in today mother got recent shot on Sunday (aug. 30th) Noticed a raised, swollen, and red area where the shot was given and she had itching around the area. Patient had no changes to medications or any other detergents or anything else pATIENT would be reaching out to doctor for further follow-up was advised to take 1 benadryl to help control and avetiate the reaction
PATIENT CALLED PHARMACY TO REPORT ADVERSE REACTION TO VACCINE. PATIENT STATES SHE HAD DEVELOPED SEPSIS AND CELLULITIS FROM THE VACCINE SITE. PATIENT IS TAKING IM ROCEPHIN TO TREAT. PATIENT WAS REFUSED TO BE ADMITTED TO HOSPITAL. PATIENT WAS TREATED BY URGENT CARE.
Certain things smell and taste terrible. Peanut butter is a specific example.; Certain things smell and taste terrible. Peanut butter is a specific example.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 11:00 (Lot number: Ff5841) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fc3121, Location of injection: Left arm), administration date: 02Oct2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 25Oct2021, outcome "not recovered" and all described as "Certain things smell and taste terrible. Peanut butter is a specific example.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was  diagnosed with COVID-19. Since the vaccination patient was  tested for COVID-19. No known allergies. Facility type vaccine was Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
frequent and pain in urination; frequent and pain in urination; Lower abdominal cramps; headache; fatigue; Slight dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Slight dizziness), DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination), ABDOMINAL PAIN (Lower abdominal cramps) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps). At the time of the report, DIZZINESS (Slight dizziness), HEADACHE (headache) and FATIGUE (fatigue) was resolving and DYSURIA (frequent and pain in urination), POLLAKIURIA (frequent and pain in urination) and ABDOMINAL PAIN (Lower abdominal cramps) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 14-AUG-2014,t he patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
swollen injection site, fever, pt has history of SVT and had to go to Hospital with SVT on Thursday,  5/9, shot was given on 5/6
This spontaneous report was received from a pharmacist refers to a 69 year old female patient. No drug allergies reported. The patient's medical history included dormant tuberculosis. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiry: 24-APR-2014) 0.65ml, subcutaneously in the left arm. Concomitant therapies included simvastatin. On 18-JUN-2013, the patient experienced a 2 inch by 1 inch area that was red, raised and warm to the touch at the injection site. Patient sought medical attention: saw pharmacist. No treatment was given. Pharmacist also stated she had another patient that experienced the same reaction when given ZOSTAVAX from the same Lot #. Laboratory diagnostics studies performed was none. The outcome of the events was reported as not recovered. This is one of 2 reports from the same reporter. Additional information is not expected.
Upper respiratory bug; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness) in a 68-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
pt recvd vax; at 11:05 noted rash accross upper back & shoulders;also on scapula area but blotchy at inject site;no itching,dyspnea,edema & lungs clear;P=80;R=24 reg;BP=106/60; MD called but unavailable;
Patient had immediate reaction of swelling at injection site. Next day pain & swelling up arm & into neck.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 at 12:30 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety disorder" (unspecified if ongoing), no known allergies. Concomitant medication(s) included: DAYQUIL, start date: 09Jul2022, stop date: 11Jul2022; ZYTREC, start date: 10Jul2022, stop date: 11Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 10Jul2022 to15Jul2022.  Clinical course: Patient had received other medication in 2weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Post vaccine next day i had scapula pain and chest burning, as the days went the chest burning became more intense. Thought maybe covid,  took test and it was negative, so now 7 days post vaccine still chest burning and scapula pain is intermittent. Contact pcp, going for bloodwork and chest xray. Outcomes to be determined. Pcp believes this is a vaccine reaction.
Information has been received from a physician concerning her son who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Subsequently two months after vaccination he developed herpes zoster. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Localized red painful area on right thigh. Patient received multiple injections on the same day.
Erythema and induration on the (R) thigh surrounding inj. site, maybe 3cm in size. Treated with KEFLEX.
on 4/15/2021 Patient started to experienced fever and notice a 10cc oval shaped  maculopapular erythematous rash on left leg
Felt headache and light headed at 230 am. Went to use reset room and felt a cold spell and dizzy. Ended up passing out and regained consciousness as I was falling head first down stairs.
This spontaneous report was received from a Certified Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. In 2016, between 15-MAR-2016, the patients' were vaccinated with and improperly stored dose of VARIVAX (Merck) lot # L004653 with expiration date of 11-FEB-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported due to vaccination with VARIVAX (Merck). No product quality issue was involved. The Certified Medical Assistant (C.M.A), also reported that VARIVAX (Merck) was exposed to a temperature of 11.7 degrees F for 9 hours and 7 minutes and no other temperature excursion was reported for the vaccine. This is one of several received from the same reporter. Additional information has been requested.
Pfizer booster after JJ initial shot.  Patient called at 1pm following day to report "hives on legs." No injection site reaction.
Throat tightening, sneezing, rhinorrhea, swelling around eye, hive on neck that progressed over minutes. Signs consistent with anaphylaxis. Epinephrine IM given in office within 10 minutes of symptoms onset, patient transferred to ER for further observation and treatment. (antihistamine). He also noted itching (no rash seen) at sight of yellow fever injection on left arm.
COVID 19; body aches; fever; cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), COVID-19 (COVID 19), MYALGIA (body aches) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), MYALGIA (body aches) and PYREXIA (fever). On 24-Jan-2021, the patient experienced COVID-19 (COVID 19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold symptoms), COVID-19 (COVID 19), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rash on lower back at the same time of injection site rash showed up within a week and lasted about 3 or 4 days
Information has been received from a pharmacist concerning an adult male patient who on approximately 31-AUG-2009 was vaccinated with a dose of MMR II. Subsequently, in 2009, the patient experienced worsening pain at the injection site. The pharmacist reported that upon exam, the injection site showed no obvious reason for the pain; no redness, warmth or swelling. The patient sought unspecified medical attention. At the time of the report, the patient's worsening pain at the injection site had persisted. Additional information has been requested.
1st dose more than 6 months ago, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose more than 6 months ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-MAR-2023 The patient was the reporter. The reporter reported he received his first dose of Shingrix (no further information available/known) but it had been more than 6 months and he had still not had the second dose of Shingrix administered. Minimal information obtained. The reporter was not asked for consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
TRIGEMINAL NEURALGIA (TINGLING TO LEFT OF FACE,NUMBNESS TO LEFT SIDE OF FACE,LEFT EAR PAIN,HEADACHE); This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 139 pounds, and height was 61 inches. The patient's concurrent conditions included alcohol use occasional drinker, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced trigeminal neuralgia (tingling to left of face, numbness to left side of face, left ear pain, headache). Treatment medications (dates unspecified) included: carbamazepine, paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trigeminal neuralgia (tingling to left of face, numbness to left side of face, left ear pain, headache). This report was non-serious.
About 1 day s/p Tdap, Flu vaccine & ZOSTAVAX, pt developed fever to 102 degrees F, mild dyspnea & rash over face, neck & chest. Pt also appreciated rapid heart rate. She did not seek or take any treatment until 3 days later when symptoms nearly spontaneously resolved except for faint rash on neck & chest. Rec'd BENADRYL or loratadine per itching.
About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red  and under an ear got red and itchy.   over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good.  8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives.  I felt a bit foggy also.  I administered epinephrine pen to my thigh.  Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone.   My breathing felt fine.  I monitored signs and symptoms with no noticeable issues for the next day+.  This was the 1st time I ever used an epi pen.
Patient received improperly stored vaccine. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, the patient will need revaccination
In June, I start to feel nauseous, and was referred to a cardiologist. EKG was done. Very sleepy the day after for 24 hours.
aching at injection site; Low grade fever; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Batch/lot number: EN6201) via an unspecified route of administration on 18Feb2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization and allergy shots (unspecified) via an unspecified route of administration on 23Feb2021 at an unspecified dose for an unspecified indication. Patient gets five injections. Medical history and concomitant medications were not reported. The patient previously received the first dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and lot number: UNKNOWN) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. After the second dose of the vaccine, patient felt good. On the 23Feb2021, after receiving the allergy shots the patient experienced vaccine injection site was aching and had low grade fever. The outcome for the events was recovered on 24Feb2021.  No follow-up attempts are possible; No further information is expected
administered Higher dose (1 ml) -than-authorized dose (0.5 Ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)) in a 74-year-old female patient 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 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller also  stated that  it was their first  dose of a series for 4  out  of 5  patients involved,  and it was  the second dose of a series  for 1  patient and stated that no side effects have been reported from the patients involved.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-293191, MOD-2021-292849, MOD-2021-293520, MOD-2021-292850 (Patient Link).
Patient was given adult dose of Pfizer vaccine, should have received pediatric dose.  No negative signs or symptoms observed during post-vaccination observation period.
18sep90 pt vax 2nd hepta B. pt ex pain at inject site and viral syndromatic feeling w/ myalgias.   sx resolved in 3 days
mid JUN lt deltoid area became sore where shot was given, then the muscles & joints in lt arm became sore on daily basis;
dose was administered @ 21 days insteady of 28days . No adverse events to report
Extreme pain in both legs and mild pain in the left arm. Took two 8 hour arthritis pain relief tablets.
Reported a severe headache, temperature of 100 and severe body aches. Had similar reaction following Hep#1 which was diagnosed as a viral syndrome.