chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/9/07 received Variavax booster dose. Now has raised, red warm to touch 10x9cm area at injection site. No streaking, full range of motion of arm, no fever, no chicken pox lesions.
Patient states he went to his doctor when he had an oozing rash in several spots on his left forearm, left leg, and right knee 4 or 5 days after shingles vaccination.  He states MD gave him some cream and acyclovir.  Rash was not painful, did not burn but did itch.  I asked the patient if he had been doing yard work.  He stated that he had.
did not follow up with a second/No second dose administered yet > 3 months after the first shot; immune compromised and afraid to get the second vaccine; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021. The most recent information was received on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Overweight. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) (seriousness criterion medically significant). On 07-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not follow up with a second/No second dose administered yet > 3 months after the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not follow up with a second/No second dose administered yet > 3 months after the first shot) and IMMUNODEFICIENCY (immune compromised and afraid to get the second vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported no problems after the first shot but friends and family were sick for weeks after the second shot (Case# MOD21-118557 Cross-Linked). patient was concerned if healthy family members had such experience with the second shot, what will happen to an immune compromised individual like him.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant Follow up received on 07-JUL-2021 contains adverse events, patient history, concomitant medication and patient demographics were updated
4-6 wks after vaccine started with dysphagia, dysarthria, facial weakness, twitching
Client reports pain in left shoulder near injection site beginning 2 days after immunization. Pain and tenderness increased through 3rd and th day. Still has pain with certain movements and tendernees. Denies swelling,redness or induration. States feels like when he had a torn muscle. Took Tylenol. Also reprots exacerbation of "flu" symptoms, increase, cough, Mucus, slight fever 4-5 days after immunizations recieved.
Patient stated that he became ill shortly after recieving the vaccine and is still ill. He states he is nauseated, is urinating more frequently than normal, and feels as though he has no energy.
On 6/26/00, pt developed mumps. The pt sough unspecified medical treatment. Addtl info has been requested.
Information has been received from a health care worker concerning a female patient (age unknown). It was reported that the patient received GARDASIL (route and lot # not reported) on 28-SEP-2008 and on 29-OCT-2012. No adverse effect reported. Additional information has been requested.
A male patient (date of birth not reported) had received on 19 August 2014 a subcutaneous administration of ADACEL (lot number and site of administration not reported) and an unspecified amount of time later on the same date, experienced a sterile abscess. The patient's medical history and concomitant medications were not reported. Treatments were not reported. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This spontaneous report was received from a certified medical assistant and refers to a currently 4 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K011312, expiration date 14-FEB-2016 (route was not provided). Concomitant therapy information was not provided. On an unknown date, the patient experienced incorrect product storage as received improperly stored PROQUAD (Merck). No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
GARDASIL and Hep A-VAQTA pediatric was administered and approximately within 1 minute post vaccine patient stated that he felt lightheaded as he was still sitting in the same position as I went to lay him down he had a syncopal episode and went right into seizure activity which lasted 30 seconds or so before he opened his eyes.
c/o "feeling funny" "I'm having a reaction to the shot" "I have hives in my ears, in my hair and my head itches". Given Benadryl and sent to the ER via ambulance. No apparent shortness of breath., R 20 and easy/unlabored.
Adverse Event: Righ arm swelling, warmth, itching in site of immunization (Varicella) two days ago. Treatment: KEFLEX 500 mg capsule. Outcome: No evidence of ongoing infection. Provider plan: Ice, NSAID, or Acetaminophen if arm feels sore, and return precautions discussed.
Pain in extremity; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Monoclonal antibody immunoconjugate therapy since 28-Dec-2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in extremity). At the time of the report, PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment information was not provided; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded
Patient presented 7 days after ZOSTAVAX immunization with area of injection swollen, red, hot to the touch. No other symptoms other than some mild soreness. Referred patient to doctors office for evaluation.
Narrative: Patient is an 80 year old male. Only documentation regarding vaccine reaction was just "Bell's Palsy" written by provider
Pt. w/ swelling to (L) leg at injection site. 1 inch firm hard area w/ treatment: KEFLEX (250/5) 3.6 mL PO TID x 10 days. F/U at dr office 7/21/14 to recheck.
My left shoulder ached after the shot, then slowly my rotator cuff started hurting.  The pain steadily got worse and movement became impossible without pain.  I went to an Orthopedic doctor and got a cortisone shot.  This helped a little, but not much.  I went back 2 weeks later and was prescribed an anti inflammatory and physical therapy.  I have been through 12 sessions and have gained most of my movement back, but still have some pain.
Information has been received from a physician concerning a 42 year old female with allergic reaction to erythromycin who on 01-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y, 0.5ml, IM). Concomitant therapy included ALLEGRA and triamcinolone acetonide (MSD). On 03-JUL-2010 the patient developed large local reaction about the size of a baseball. It was so painful she couldn't move it. She went to an urgent care and they just recommended cold compress and MOTRIN. It got worse so she was admitted into hospital for the possible cellulitis. She was given IV vancomycin. Her creatinine went up to 2.0 and developed pulmonary edema. She also developed respiratory failure and was transported to intensive care unit (ICU). "Many lab tests" had been performed, details/results not listed. She was treated, recovered and discharged on 10-JUL-2010. Pulmonary edema and respiratory failure were considered to be immediately life-threatening. Additional information has been requested. A lot check had been initiated.
It was reported, that a pt (2 of 2) received a TD vaccination. Reportedly, sometime, post vax, the pt's arm became swollen and painful at the injection site. No specifics were provided.
Arm pain; Chills; Mild fever; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 10:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Jul2021 at 19:30, the patient experienced arm pain, chills and mild fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Aug2021, the patient underwent SARS-COV-2 test via nasal swab and the result was negative. The clinical outcome of the events arm pain, chills and mild fever were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 9 June 2009; VARIVAX (non-gsk); Merck; unknown given on 9 June 2009.  On 9 June 2009 the subject received 1st dose of KINRIX (.5 ml, unknown).  On 11 June 2009, at an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  The subject experienced an injection site reaction from shoulder to biceps.  At the time of reporting the event was resolved.
3:57PM 'FEELS LIKE PASSING OUT'. PALE, DIAPHORETIC.  STATES HE HAD RT HIP SURGERY 3 DAYS AGO. PLACED IN W/C, MOVED TO TENT (UNABLE TO LIE ON COT). COOL CLOTH APPLIED TO NECK.  4:06PM  'FEELING BETTER NOW'. COLOR IMPROVED. NO SOB, DYSPNEA OR DECREASED LOC. PINK, W/D. 4:15PM WIFE TO DRIVE PT HOME. NO ACUT/OBVIOUS DISTRESS. 3-5-214:10PM TC - STATES 'ALL S/S RESOLVED LAST NIGHT - FEELS GOOD TODAY'.
Right side of throat swelling, tongue swelling, and hives on face, neck, and chest.
Severe face swollen/everything from the neck up is swollen; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-127121) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Severe face swollen/everything from the neck up is swollen) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Severe face swollen/everything from the neck up is swollen). At the time of the report, SWELLING FACE (Severe face swollen/everything from the neck up is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was provided. No Concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Upon Follow-up Received : Reporter details added,  Dosage form and product start date added,
day p/recv vax pt exp 4 to 5 episodes within an hour explosive diarrhea; diarrhea resolved within 24 hours
c/o big pain in shoulder, fingers & arm (of lt arm);c/o shoulder hurt when arm lifted;also hurt under 4th finger;medicated w/APAP for pain;notified MD office;pain subsided pt slept;saw MD said probable rxn to hep b serum;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-SEP-2015, the patient was vaccinated orally with an unknown dose of ROTATEQ (lot # K004480, expiry date 05-FEB-2016), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient got ZOSTAVAX shot on 10/16/12 to left arm. Complained about redness on 10/19/12. Redness spreaded & aching, pain swelling got worsened on 10/20/12. Visited after hr clinic got some antibiotics. Now symptoms improving.
Information has been received from a registered nurse concerning a 16 year old female who on 08-AUG-2007 was vaccinated SC on left hand with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no illness at the time of vaccination. On 09-AUG-2007, the patient experienced red patch slightly raised itchy rash. On an unspecified date the patient recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is one of several reports received from the same source.
Menveo vaccine/ expiration date 3/2021/ was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA354A, expiry date 31st March 2021) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Reporter was vaccine coordinator and her title was Lawyer. Menveo vaccine was given to a patient which was already expired on 31st March 2021. The reporter consented to follow up by email.
Symptoms: Migraine/Headache, nausea, vomiting, fatigue   Treatment: bed rest
Pt given SHINGRIX vaccine at 1:15PM 6/16/18. Immediately C/O lightheadedness and dizziness. Vaccine given while pt seated. When pt tried to stand had to sit down again D/T lightheadedness. Pt not in pain or have SOB. Two attempts to take BP unsuccessful. Pt became less responsive so called 911. Pt took deep breath when I asked he "are you ok". When EMT's arrived, pt was doing better with less dizziness and was able to talk. Pt walked out of pharmacy with help of husband's assistance at 1:50PM.
Noticed shortness of breath approx. 2/2/21 but thought nothing of it until I went for my second shot on 2/17/21. After my second shot I asked to see my Dr. to talk about this shortness of breath issue as it had gotten progressively worse. He was not available so I was brought in to see a nurse, who checked my vitals etc  and told me  she was calling an ambulance to bring me to a hospital of my choice. I was brought to the hospital and the found my blood count down to 5.1. My last blood count check was in January and it was at 11.0. I have never had a low blood count issue prior to this. While at the hospital I was given three pints of blood and as of this day 3/11/21, I have received nine more pints and no resolve as of yet.  There is no internal bleeding evident.
Patient was to receive 2nd COVID 19 dose of vaccine today. Facility staff member instructed patient to receive dose after patient had refused initially. Patient verbally agreed. Vaccine was administered. Patient then reported that they had an additional Vaccination Record Card would we like to see it. The patient produced a card that had a dose record given. Upon looking into the records, patient was given a third dose of vaccine today as a result of facility confusion. Patient is doing well, no complaints at this time.
18 mo. old boy received DAPTACEL in his left vastus lateralis on 6/7/16. That night developed redness. Seen in ER on 6/8/16. Diagnosed with cellulitis, treated with clindamycin.
Muscle Cramps; Vomiting; Fever; 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 MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) and PYREXIA (Fever) 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 MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information provided. No Treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-may-2021 contains non-significant information
mom found pt in crib morning of 16JUN92 not breathing-says had not been ill was seeing MD frequently due to cleft lip & palate;
blotches on upper leg forearm/Rash on lower back and lower abdomen; This is a spontaneous report from a contactable consumer (patient). An elderly male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: en6200) dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:15 as dose 2, single for COVID-19 immunization. Patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history was none. Patient had no known allergies. The patient's concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On Mar2021 the patient experienced rash on lower back and lower abdomen, blotches on upper leg forearm which occurred 13 and 14 days after second dose. No treatment was received. The clinical outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
I woke up with fever; Severe headache; Eye and neck pain; Eye and neck pain; Body aches; Nausea; Vomited; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 06Apr2021 at 14:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, clotting disorder, MTHFR gene mutation, shellfish allergy and MSG allergy. Concomitant medications included apixaban (ELIQUIS) and levothyroxine sodium (SYNTHROID 112); for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 04Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 05:00, in the morning the patient woke up with fever, severe headache, eye pain, neck pain, body aches, and then nausea. The patient vomited throughout the day violently and took promethazine for the nausea and immediately vomited that up. Before deciding to go the hospital, the patient tried promethazine suppository for nausea and 1 vicodin (these medications prescribed for a surgical procedure) and took them 3 times during the day as vomiting recurred after drug wore off. The medications offered some relief. On 08Apr2021, the patient had low grade headache and body aches and light nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with promethazine (MANUFACTURER UNKNOWN) and acetaminophen-hydrocodone (VICODIN). The clinical outcome of the events fever, severe headache, eye pain, neck pain, body aches, nausea and vomited were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.