chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LUMPS UNDER SKIN; ITCHING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps under skin, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps under skin and itching was not reported. This report was non-serious.
01/12/21: Severe fatigue and brain fog 01/17/21:  Pharyngitis of unknown cause.  Fever over 102F, bilaterally swollen tonsils with white coating, bilaterally swollen lymph nodes in the neck, headache, fatigue. Initially prescribed Penicillin 500mg TID x 7 days (Telehealth).  After day 3, symptoms continued to get worse.   Strep test, Flu test, and COVID-19 tests were all negative. Prescribed Prednisone 40mg x 7 days. Symptoms began to subside on 01/21/21. Cause still unknown - possible viral infection (CMV, EBV). 01/21/21: Swollen, red rash began to develop at injection site. Subsided without treatment within 24 hours.
Developed cellulitis secondary to allergic reaction to PREVNAR. Localized edema; erythema; skin irritation.
Caretaker brought pt in at 10:47am 4/26/12 relaying noticed pt had rash in bil. legs, and arms <24 hours after receiving immunizations. Reports no changed in eating habits, 1 incident of diarrhea >12 hours ago. Temp today (1 m) at 11:00 99.9. Denied wheezing.
This spontaneous report as received from a registered nurse via a company representative refers to a 17-year-old male patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient at the age of 17 was vaccinated in error with PROQUAD for prophylaxis (exact dose, route of administration, lot# and expiration date were unknown). No adverse effects were reported.
I am having tenderness and the pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP/nurse). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 27Aug2021 08:30 (Lot number: FC3184) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "hyperlipidemia", start date: 2019 (ongoing); "migraines", start date: 2016 (ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; ROSUVASTATIN taken for blood cholesterol increased, hyperlipidaemia, start date: 2020 (ongoing); SUMATRIPTAN taken for migraine, start date: 2019 (ongoing); FROVATRIPTAN taken for migraine, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1 Time: 09:00, Lot no: EW0181, Anatomical location: Left Deltoid, Route of administration: Intramuscular), administration date: 06Aug2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "disc pain", "Severe depressed shortness of breath", "Severe sharp pain in left pleural space". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "I am having tenderness and the pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: consumer stated she is LPN. Confirmed as Licensed Practitioner Nurse. yesterday was her second shot. Confirmed the date of administration of first shot as 06Aug2021 and date of administration of second shot as 27Aug2021. So when she went to the health department she told them that this is the situation of the first one she got it on her left so she said okay this time put it on her right and then make sure that it is not, do not take same side again. So, she put it on her right. So, of course she had tenderness and the pain at the injection site but she do not feel the pain that is in her left area she do not feel like in her right side. Right yeah this morning she was in so much pain. Other medical conditions: Consumer stated no she do not have diabetes, she do not have hypertension. Causality: Consumer stated yes because I never had any pain in my body until I got it. Consumer stated yeah that is right the first one on the left and then the second yesterday was on her right that was all. When probed if consumer had any vaccination 4 weeks prior to COVID 19 Vaccine. consumer stated no she had not had any within 4 weeks those I had were from like a couple of months ago like about 5 or so months, so (voice not clear). The patient provided information regarding the reported adverse event(s) with the use of the product. Do you consider the Pfizer product had a causal effect to the adverse event: Yes  No follow-up attempts are possible. No further information was expected.
Patient developed a fever of 103 degrees Monday evening. Patient also complained of upper respiratory symptoms; Injection site is fine. Patient also complained of chills. This was patient's 3rd injection.
92/F came for her COVID vaccine. Provider grabbed 2 HD flu vaccines as her sister was getting HD flu. Before I gave the shot I confirmed with the patient that we were doing flu and she said yes. Shot was given and it was realized that she wanted COVID. Patient was notified and COVID shot was given per patient request
immediate gastrointestinal heat, sweating, lightheadedness, dizziness, disinhibition during questioning witnessed while teaching, begun on 10/01/2013 these particular symptoms lasted 48 hours  chronic "tinnitus" diagnosis, "tinnitus" beginning suddenly on March 7, 2014
Expired Hiberix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Hib (Hiberix) (batch number cH392, expiry date 22-MAR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Hiberix. On 03-MAY-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Hiberix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was medical assistant. The reporter did not consent to follow up. The patient was administered an expired dose of Hiberix which led to expired vaccine used. This case is linked with US2023064469, reported by same reporter.; Sender's Comments:  US-GSK-US2023064469:Same reporter (male patient)
A patient reported that she received an injection of FLU SHIELD (1995-96 formula) in 1996 and , subsequently developed a "migratory" rash which was itchy and oozed when scratched. She developed 2 infections as a result of scratching the rash. The patient has been taking prednisone since 1996 for the rash, and is currently being treated with ultraviolet light therapy which "seems to be helping a bit". This patient was recently diagnosed with an allergy to thimerosal. The patient also reported this event to a local health regulatory agency (Ref. no. U1999-00347). She told the agency that she was immunized in the fall of 1995. She also told the agency that thimerosal allergy was diagnosed by skin bispsy and patch testing. she said she had a past history of hepatitis (type not specified). Altough she specifically told Wyeth-Ayerst that she had received no vaccines within 4 weeks of FLU SHIELD, she told the agency that she had received tetanus toxoid and pneumococcal vaccine within 4 weeks of FLU SHIELD.  Follow-up information received from a physician on 30-NOV-1999 indicated that patch testing resulted in a "mild reaction" to thimerosal. Skin biopsy performed on 04-MAY-1999 "showed allergic contact dermatitis which could not be secondary thimersol given time frame." The patient has stasis dermatitis which improves when she is complaint with therapy. She also has intermittent eczema flares that are "not related to thimerosal injection 3 years ago."
Vaccination given on Saturday.  Flu-like symptoms, fever, body aches, fatigue,  occured Sun and Mon.  On Tuesday afternoon, had a rash of pin-sized water blisters on the upper right side of the torso.  Chest and breast were covered with them.  Popped when touched, water came out, then hurt.  Lasted an hour then went away.  I have never had any rash of this kind before.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 23-MAY-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L04407 exp date 06-OCT-2018) (dose and route not reported). The temperature and time of excursion was 11.6 degrees C for 120 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Vertigo, headache, vomiting, dehydration, low blood pressure, chills, numbness of legs. All symptoms 10 hours after vaccine.
Localized tender area of erythema and warmth of the left arm over the deltoid .Pt put on Cehaltxin x 7 days.
I woke up with acute pain in my left knee and lower leg-- I received a Cortisone shot in my knee.
Severe itching all over ? developed into pityriasis rosea on buttocks , thighs, underarms, that required treatment of non generic steroidal and anti fungal cream and oral prednisone. Generic creams did not work.  Still treating. The spots are slowly fading.
Uncontrollable shivering and freezing cold, 14 hours after shot. Fainting, 20 hours after shot.
given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown whether patient had allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19.  It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination.  It was unknown if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fluconazole, reaction: "Known allergy: Fluconazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Swollen face; red rash on face and torso front and back; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included Post hemopetic stem cell transplant in 2016 and allergic to Penicillin. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). Historical Vaccine included first dose of BNT162B2 (Batch/Lot Number: EL3246) in left arm on 14Jan2021 09:00. The patient experienced swollen face and red rash on face and torso front and back on 10Feb2021 12:00. Therapeutic measures were taken as a result of the events with antihistamine said by occupational health nurse. Outcome of the events was not recovered.
swelling; rash "moved and he felt it move from shoulder to stomach to legs; generalized rash / rash "moved and he felt it move from shoulder to stomach to legs; extremely itchy; pain in bone; hives; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced generalized rash, itchy rash, bone pain, hives, swelling and rash. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the generalized rash and rash were recovered/resolved and the outcome of the itchy rash, bone pain, hives and swelling were unknown.   It was unknown if the reporter considered the generalized rash, itchy rash, bone pain, hives, swelling and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced generalised rash, for about 5 days after vaccination. The patient was treated with over the counter calamine lotion. The reporter stated that, the rash was extremaly itchy, and moved from shoulder to stomach to legs and had pain all over through the bone. The pharmacist stated that, the pain, hives and swelling lasted for 4 days. The patient was seen in his physician's office, but the rash was resolved by the time he had his appointment.
had a stroke two weeks after he received his second Covid vaccination; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The patient had a stroke two weeks after he received his second covid vaccination on an unspecified date. He did not have any underlining conditions that could contribute to his stroke. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a pharmacist referring to her/his mother who was an adult. No concurrent or historical conditions were reported. In approximately 2014 (reported as about a year ago), the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# and indication unknown). There was no concomitant medication reported. On approximately 29-MAY-2015 (reported as last week), the patient started having shingle symptoms on her neck area. The outcome of the event was unknown. The relatedness of patient's adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Deltoid muscle atrophy which was first noted by patient on approx 6/08 as a depression in Left shoulder muscle of approz 2cm x 2 cm
Developed itchy rash starting and localized behind left ear on Saturday, 2 days after the shot.  Red itchy bumps and rash started to pop up on the right hip area of body and spread up the right abdomen.
Very Sore as of today (11/25/17) from the date given on 10/17/17. Patient says he could not pick up his arm initially, has gotten better but still very sore.
4 days post vaccine = developed vasculitis of legs/knees/ankles - left in 1 week. No fever, mild arthralgia.
Pt experienced a syncope episode with a few muscle twitches. Pt came around and did not know where she was. She became oriented 1 minute post and taken to treatment room laid down with feet elevated. Pt very pale in color. The pt was treated with Benadryl and instructed to go to ER if any symptoms persist. The MD thought this was a vaso-vagel response.
Information has been received from a consumer concerning his daughter, a 12 month old female who on 02-MAR-2011 was vaccinated with 0.5ml of PROQUAD (Lot # 667129/1366Z exp date 15-APR-2012) and 0.5ml of MMR II. Concomitant therapy included VAQTA (manufacturer unknown) and PREVNAR 13 on 02-MAR-2011. Consumer stated the physician ordered PROQUAD (Lot # 67129/1366Z exp date 15-APR-2012). At the time of this report, it was unknown if the patient sought medical attention and the patient as not experiencing any known symptoms. Follow-up information was received from a physician indicating the 12 month old female with no medical history or illness at time of vaccination who on 02-MAR-2011 at 1:05 p.m. was vaccinated Q in her LVL (Left Vastus Lateralis) with the first dose of 0.5ml of PROQUAD (Lot # 667129/1366Z exp date 5-APR-2012). Suspect second therapy included the first dose of 0.5ml of MMR II (Lot # 668070/1059Z, exp date Aug 2012) SQ in her LVL (Left Vastus Lateralis) and the first dose of VAQTA (Lot # 669749/1628Z exp date October 2012) IM in her RVL (Right Vastus Lateralis) on 02-MAR-2011 at 1:05 p.m. Concomitant therapy included PREVNAR13 (Lot # E12400 exp date May 2012) on 02-MAR-2011. The physician reported that macular popular rash was seen on 02-MAR-2011. At the time of the report, the outcome of the patient was not reported. No lab tests were performed. Additional information has been requested.
had quite a bit of arm pain; aches for about 24 hrs.; experience tireness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain) 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 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain). At the time of the report, MYALGIA (aches for about 24 hrs.), FATIGUE (experience tireness) and PAIN IN EXTREMITY (had quite a bit of arm pain) had resolved.            No concomitant medications were reported by reporter Treatment information was not provided.   This case was linked to MOD-2021-312981 (Patient Link).   Reporter did not allow further contact
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication was not reported.  This case contains information for the 6th of 40 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master