chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm hot; left arm hardness; left arm itchy; left arm swollen a little bit; 3 little red marks on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm hot), VACCINATION SITE INDURATION (left arm hardness), VACCINATION SITE PRURITUS (left arm itchy), VACCINATION SITE SWELLING (left arm swollen a little bit) and VACCINATION SITE ERYTHEMA (3 little red marks on left arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, AMLODIPINE and RIVAROXABAN (XARELTO) for an unknown indication.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (left arm hot), VACCINATION SITE INDURATION (left arm hardness), VACCINATION SITE PRURITUS (left arm itchy), VACCINATION SITE SWELLING (left arm swollen a little bit) and VACCINATION SITE ERYTHEMA (3 little red marks on left arm). At the time of the report, VACCINATION SITE WARMTH (left arm hot), VACCINATION SITE INDURATION (left arm hardness), VACCINATION SITE PRURITUS (left arm itchy), VACCINATION SITE SWELLING (left arm swollen a little bit) and VACCINATION SITE ERYTHEMA (3 little red marks on left arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient treated symptoms with ice.
some redness and her arm was sore; some redness and her arm was sore; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced some redness and her arm was sore. The outcome of the events was recovering.  Information on the Lot/Batch number has been requested.
pt recv vax & devel chickenpox;had a rash all over body;pt did not have a fever;
Information has been received from a physician concerning a 15 month old male with a history of Hepatitis B vaccine recombinant (yeast) (MSD) vaccination and a Haemophilus B conjugate vaccine (MSD) vaccination who on 12/18/00 was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis vaccine recombinant (yeast) in his left thigh. Concomitant therapy included varicella virus live, in the right  thigh. Subsequently a few hours later on 12/18/2000, the patient experienced superficial 3/4 cm clear fluid blister at the injection site on his left thigh and an erythema at the injection site on the right thigh. The physician suspects a super imposed Staph scalded-type localized infection. The patient was placed on therapy with Cephalaxin (Keflex) to cover for Staph and Strep cellulitis. The source of admininstration was contacted and an internal investigation did not reveal any other cases. On 01/16/00, the patient was seen at the office for a "routine cold" that included a stuffy nose, and fever, subsequently the patient recovered. Upon internal review, Staph scalded-type localized infection was determined to be an other medical event. Additional information is not expected.
Patient was vaccinated at our onsite clinic on 09MAR21 @ 2320.  At 0245 on 10MAR21, she returned to the vaccine room with a cup of ice water and a towel she was putting to her head and neck.  She reported to the RN that "about 45 minutes ago, she broke out in hot flashes and went to the bathroom."  She was talking a lot and appeared "antsy" (which was how she appeared when she got her vaccine). She sat down and had something to drink.  The RN checked her vital signs and reported they were normal.  After about 10 minutes, she reported she started feeling better.  She also told the RN that she had taken Advil before she returned to the vaccine room.  She had listed NSAIDS as an allergy on her consent.  Security escorted her out.  On 11MAR21, she called our onsite RN to report injection site pain, swelling and redness (left deltoid), muscle pain, chills and nausea/vomiting.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) and RASH (Rash) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm) and RASH (Rash). At the time of the report, VACCINATION SITE REACTION (covid arm) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.
When I first had the shot I started to experience a twitching of my muscles strong and painful in the bottom of my feet and other places. A burning sensation as well and ain different places of my body, as time has continued the twitching has gotten stronger then it would go away after a while. In the last month to six weeks  it has been gradually getting more consistent daily and in the last week daily and starting at my feet up to my waist.
Initial and follow-up information has been received through the Merck pregnancy registry from two Licensed Practical Nurses concerning a 24 year old female with seasonal allergies and allergies to penicillin, codeine, z pak, and ceftan who on 27-MAR-2007 was vaccinated IM with 0.5 mL of the first dose of Gardasil (Lot #655503/0012U). On 25-MAY-2007 the patient received the second dose of Gardasil (lot #657622/0388U). Concomitant medication included prenatal vitamins. The patient reported that she is now pregnant. Unspecified medical attention was sought. On 13-JUL-2007 the patient had an ultrasound reported as within normal limits. The patient's last menstrual period was 20-MAY-2007. The estimated date of delivery was 24-FEB-2008. Follow-up information indicated that in October 2007 the patient had an elective termination 20 weeks from her last menstrual period. The products of conception were underprocess of being examined. The fetus was not normal due to anencephaly with a heart defect. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
A report was received from a health care professional on 12/5/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on the same day. On 12/5/03 the vaccinee inadvertently received Fluvirin. At the time of the report, no adverse events have been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
On 12/28/21 I started noticing a sore throat in the evening. I also had congestion, runny nose, headaches, muscle aches and fatigue. On 12/30/21 I lost my sense of taste and smell. I went on 12/30/21 to get a rapid COVID test at the doctors office and tested positive. By 01/05/22 my symptoms were pretty much gone. I did not take any medication.
p/vax pt had nausea & vomiting x 30min;no edema on site, ROM limited on inj site;
Patient was administered the Janssen vaccine on 4/30/2021, after going to the state reporting program today on 5/1/2021 we noted that patient already has two vaccines listed as administered on 2/11/2021 and 3/11/2021 (COVID-19 mRNA, LNP-S, PF 100 mcg/0.5 mL dose). Confirmed with patient that he did not receive any COVID vaccines today. Reporting as possible duplication of COVID vaccines. No ADRs noted from patient.
The mother called and stated the are on right lower thigh was red, and sore on 5/2/01. Feels warm to the touch, states child not eating as well and was somewhat fussy. The pt has several bumps at the injection site.
PATIENT HAD A SYNCOPAL EPISODE; HE WAS NOTED TO SHAKE AND HEAD WENT BACK. HE WAS IMMEDIATELY ASSISTED TO A LYING POSITION ON THE FLOOR WITH HIS FEET ELEVATED. HE VERBALIZED THAT HE WAS DIZZY AND THAT HAPPENS SOMETIMES AFTER VACCINATIONS. PATIENT WAS GIVEN COLD PACKS AND OFFERED A SUCKER. HE WAS MONITORED FOR 30 MINUTES AFTER THE INCIDENT. HE REPORTED FEELING BETTER AND WAS DISCHARGED TO THE HEALTH SERVICES DEPARTMENT. VSS: 180/100 (RIGHT); 120/80 (LEFT); 120/76 (RIGHT); PULSE WAS REGULAR
This spontaneous report as received from a pharmacist refers to a 60 years old patient of unknown gender. On 25-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # 003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature was -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There were no power outages. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Pt was getting the flu shot and the nurse giving him the injection gave him an adult dose instead of a pediatric dose. The days following the injection he ran high fevers, was irritable and showed swelling in his thigh where the injection was given, also was red and raised
I got the vaccine on the 8th and then about at 8 at night on the tenth, and my throat started to close, and I couldn't breathe. I was sent to the hospital where I was intubated. I went into anaphylactic shock and cardiac arrest and then respitory  failure.
I have been injected with plenty of needles in the past and I have never had a problem with passing out, this was very odd.  On that day, 04/15/2021 I had a botox injection for my migraines and I passed out  as soon as the injection was done, I fell on the ground and I was out for like 4 minutes I had 2 prior botox injections prior to this and I never had a problem. I had on Jan 4,2021 I had the vaccine, Pfizer  Dose#1 and on  Jan. 14, 2021 I had a botox injection with no issue at that time .  I felt woozy a couple of days. I was taken to the ER after the .
Fever, body aches, cough, sore throat since day of vaccination lasting until now (10/27/21)
Client received a Stamaril vaccine at the Department of Health on 12/16/2019 and later traveled. Hecalled me, (principal investigator for Stamaril clinical trials) on 12/17/2019 advising that he was having severe lower back pain that began that day and he was having difficulty standing. He was referred to ER where he advised them of the vaccine administration the previous day. He received a discharge diagnosis of back pain and placed him on Ibuprofen 800mg and Methocarbamol 750mg. Follow up on 12/18/2019 he was not feeling better.On 12/20/2019 client stated that he went to Urgent Care and was given another prescription and is feeling better, they mentioned that they believe his symptoms are not related to the vaccine ; they thought it was due to extended travel time on plane.
This spontaneous case, initially received on 10-Dec-2016, was reported by a health professional and concerns a(n) 58-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 09-DEC-2016 to 09-DEC-2016. Dose regiment: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event. AFLURIA was administered following a temperature excursion of 46.6 F maximum temperature with maximum excursion of 11 hours 45 minutes. Follow-up information received 13-Dec-2016: The patient was not pregnant at the time of vaccination. The temperature excursion of 46.6 maximum temperature with maximum excursion time of 11 hours 45 minutes was the first excursion.
On 3/30/2022 at 1:40 pm patient came into clinic for a booster dose 0.25mL of Moderna and was inadverdently given a full 0.5mL dose of Moderna. Outdated material was reviewed and dose verified by another nurse before injection given. Updated material has since replaced outdated material. Moderna and DON was notified of the incidient . Patient has been notified and will be monitiered for the next seven days according to Moderna recommendation.
PT had a fever/ chills and fatigue off and on 5/28 and 5/29. He had a small mild rash at the injection site (left shoulder). He got huge swollen lymph nodes on his neck and axilla. His axilla was swollen (and painful) to the size of a racket ball about 6cm wide and 3 cm thick. His axilla is still tender today  but the swelling is much improved. His neck had a firm swollen node 2cm×1 cm on Saturday-Sunday. We treated him with occasional Tylenol and ibuprofen.
Information has been received from a registered nurse concerning a 9 year old twin female patient, who on 6/3/1998 and 4/15/1999 was vaccianted SC with a 0.5 ml dose of varicella virus vaccine live. On an unspecified date in May 2005 the patient broke out with lesions. There was no product quality complaint reported. Additionally, the nurse reported that another child in the class may also have varicella. The patient sought unspecified medical attention. The reporter mentioned that the patients twin sister broke out with varicella lesions following vaccination with varicella virus vaccine live (WAES0505USA01737). Additional information has been requested.
Hyperosmolality and/or hypernatremia - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Rash on both arms. In the left arm rash like bites. Itching. Scabs.
body aches and fever; body aches and fever; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was having body aches and fever. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
I have never had a bloody nose, 4/17/21 had a bad one21 lasted 20 min.  then 4/19/21,had one in AM, lasted 10 min, had another one 4/20/21 AM lasted 15 min.  Im talking bad bloody nose,  Later today; I coughed up a glob of blood,  Im wondering if this could be from the vacinne, Im seeing q ENT,this Thursday 4/22/21.
12-year-old pt. wrongly received the Pfizer vaccine appropriate for ages 5-11 as his first dose of the covid vaccine, as opposed to receiving the vaccine appropriate for ages 12+.  Pt was observed for 15 minutes post vaccination and reported feeling fine.  Pt left with guardian after vaccine.
It was reported that a female received Fluzone SV 98-99 USP on 10/23/1998. Reportedly on 10/24/1998 the pt complained of redness, "hard knot" 2x3" and red line shooting out from injection site. The pt also complained of metallic taste in mouth and throat swelling.
After each shot I felt like I had the flue with arm pain, chest pain, congestion, sore throat, headache, chills and very tired.
1. No previous history with any skin condition 2. Onsite of Psorarias secondary to Booster Shot of Pfizer mRNA 3. Started experiencing redness under breasts, circle dry patches on neck and forehead. Attempted to treat with OTC Hydrocortisone, .1% 2x/day, which seemed to provide some relief - but not for long.  4. More dark circles, with raised bumps, scalp itching, and scaling continued to the point where I had over 30 patches of dry spots on my  torso, back, neck, ears, buttocks, and right arm. 5. As things continued to get progressively worse, I went to see my PCP and he diagnosed me with the onset of psoriasis resulting from mRNA Pfizer booster.   6. by 5/14/22 - 75% of my hair has now fallen out due to dry patches, scalp flaking.
Approximately 20 minutes after the injection, patient was in vehicle with mom and seemed to pass out. He was pale. Mom returned to parking lot at the doctors office. By this time he was awake and alert, but still appeared pale. patient was examined by physician and exam was normal. skin color returned to normal. Released to home with mom.
Lethargy, Temp to 38.3C x 24 hrs.  Resolved by x36 hrs
R MCA THROMBOTIC STROKE REQUIRING COIL EMBOLECTOMY.   WAS ON FULL ANTICOAGULATION FOR AFIB BUT THE MONIOR AND THE PACEMAKER SHOWED NO EVIDENCE OF AFIB AROUND THE TIME OF THE STROKE.  INTERVENTIONAL RADIOLOGY REMARKED TO THE PATIENT THAT IT WAS A VERY LONG AND LARGE THROMBUS.   PATIENT WITH RESIDUAL MILD LEFT HEMIPARESIS.
Sudden extreme weakness, exhaustion, chills, blurred vision, difficulty standing and walking. Went home to bath tub to get warm and then to bed. Took TYLENOL 1000 mg and ATIVAN 0.5 mg. Body aches continued for another day, though much less severe.
After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 20 minutes.   From 7:00 thru 9:00pm had tightness in middle of chest and upper back discomfort.  Next morning no reactions other than sore injection site.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 14 of 27 adult patients described by the reporter.
Patient complains of approximately one month history of pain in her non-dominant left shoulder. She states her pain began immediately after receiving an influenza vaccine in her left shoulder. She states that vaccine was given subcutaneously instead of intramuscular and she noticed pain starting in her deltoid and radiating up to the posterior aspect of her shoulder, AC joint, subacromial space. She has tried treating her shoulder conservatively with rest and NSAIDs, but reports minimal improvement. She reports occasional popping in her shoulder as well. Her pain is worse with reaching, pushing, pulling, ADLs, getting dressed, above shoulder work, and laying on her left side. Her pain is better with rest and NSAIDs.
swollen lymph node; This is a spontaneous report from a contactable consumer (patient's brother)  A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE  ), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included haemochromatosis, weakened immune systems, low platelets, low immunoglobulin and has thrombocytopenia. Also fatty liver and iron overload. He also mentioned that he got senior shots of the pneumonia vaccine because he only has75% immunization. Concomitant medications were not reported.  Because he has fatty liver and iron overload, are scheduled for a blood draw. The patient had a swollen lymph node. He was  concerned since only got the first dose of the vaccine a week ago. He was afraid that it would decrease the amount of antibodies in his system. He wanted to know if it is safe to give blood / phlebotomy a week after the shot. The patient was so happy that he did not have major adverse events with the vaccine. He mentioned that he didn't have any discomfort after the shot. The outcome of the swollen lymph node was not reported.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm soreness after receiving the dose of SHINGRIX making it difficult to drive. No other details were provided. The reporter did not consent to follow up.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, the patients might have been vaccinated with doses of ROTATEQ (lot # M004883 with expiration date: 02-OCT-2017 or lot # K024700 with expiration date: 30-JUL-2016 (this lot number was not expired at the time of possible administration) strength, dose, frequency and route were unknown) which were stored improperly. This is one of the two reports that received from the same source. Additional information has been requested.
HEART RACING; ACHY ALL OVER; HEADACHE; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced heart racing. On 2021, the subject experienced achy all over. On 2021, the subject experienced headache. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, heart racing, fever and achy all over was not reported. This report was non-serious. This case, involving the same patient is linked to 20210328948.
Pt vaccinated with DTP taken to pediatrician's office within 1 hr after immunization, limp & experiencing hypervolemic shock. Hospitalized & treated with IV fluids. BP 77/50, fever 103 & neuroppenia.
pt fainted after immunization of Menactra pt was vaccinated with Menactra and within 2-3 mins. post vaccination, she had a dizzy spell, followed by fainting in her chair. Sister and spouse anticipated this reaction and told pharmacist not to call for EMT. Pt was laid on the ground and monitored. Circulation and breath were stable. After 10 mins., pt was up and able to smile and walk. pt states, she usually faint after vaccination