chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle weakness; Diarhea; Vomitting; Chills; Shaking so bad all over; Fever; Nausea; Could not move; Warm but not running a fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move), Warm but not running a fever, MUSCULAR WEAKNESS, DIARRHOEA, and TREMOR (Shaking so bad all over) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOKINESIA (Could not move), Warm but not running a fever, and Nausea. On 14-Apr-2021, the patient experienced Fever. On 14-Apr-2021 at 11:00 PM, the patient experienced TREMOR (Shaking so bad all over). On 20-Apr-2021 at 6:00 AM, the patient experienced MUSCULAR WEAKNESS, DIARRHOEA, VOMITING, and CHILLS. The patient was treated with TYLENOL for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency and IBUPROFEN for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency. On 15-Apr-2021 at 5:00 AM, TREMOR (Shaking so bad all over) had resolved. On 29-Apr-2021, MUSCULAR WEAKNESS, DIARRHOEA, Fever, VOMITING, and CHILLS had resolved. At the time of the report, HYPOKINESIA (Could not move), Warm but not running a fever, and NAUSEA outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Additional information received on 03-07-2021. Reporter's details product batch number was added and event outcome was updated.
14 yo male received Seasonal flu vaccine IM and H1N1 vaccine IM at a drive through clinic venue, while exiting in from clinic, pt fainted in his car, paramedics on site responded.
I had the first dose on 8-17 and that night felt like I was burning up throughout the night. The next night I developed pain in my left hip that lasted for a bout 3 days. Also felt very tired. The 2nd dose was on 10-26-18 in the afternoon. I developed chills in the evening about 7 pm that lasted throughout the night and had high fevers. On 10-27 I awoke and had a headache, fatigue and felt like I had the flu. No appetite and continued to have the chills and headache throughout the day. On 10-28 I developed back pain to left lower back and this is just now going away. Tylenol was taken throughout this to help relieve the symptoms.
pt became quite irritable & diff to console despite APAP usage p/vax;lt leg red,warm to touch throughout thigh;saw MD p/prolonged crying;sx subsided p/Advil use
No Adverse Reaction.   Pfizer 12y (+) was given for the 4th dose instead of the Pfizer Bivalent. Our office did not receive the Bivalent injection until 9/21/2022
received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported.  Patient received vaccine from a vial that was stored in the refrigerator beyond 30 days. There were no side effects reported so far.   This case was linked to MOD-2022-446648 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLAMMATION (Inflammation), MYALGIA (A sore all over my body, body ache, woke up with body ache) and LYMPHADENOPATHY (Huge lump under my armpit, between my breast and the armpit, like 3 inches, on my breast and armpit, left arm, same as the injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The patient's past medical history included Vasectomy. On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PAIN (Pain), INFLAMMATION (Inflammation), MYALGIA (A sore all over my body, body ache, woke up with body ache) and LYMPHADENOPATHY (Huge lump under my armpit, between my breast and the armpit, like 3 inches, on my breast and armpit, left arm, same as the injection). The patient was treated with IBUPROFEN for Pain and Inflammation, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), INFLAMMATION (Inflammation), MYALGIA (A sore all over my body, body ache, woke up with body ache) and LYMPHADENOPATHY (Huge lump under my armpit, between my breast and the armpit, like 3 inches, on my breast and armpit, left arm, same as the injection) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided.
Patient said he left the pharmacy area and walked across the aisle to the jewelry dept and all of the sudden his legs went numb and he felt dizziness and confusion and lights were affecting his vision (couldn't think straight).
This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a adult female patient who received Flu vaccine. In 2013, the patient received Flu vaccine. In 2013, unknown after receiving Flu vaccine, the patient experienced local reaction, drug administered at inappropriate site and possible inappropriate route of vaccination. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the drug administered at inappropriate site and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the local reaction to be related to Flu vaccine. Additional information: Reporter states that in 2013 she received a flu vaccine in her arm. She expressed concern that it was given inappropriately because it was lower on the arm than it should have been, and she thinks it might have been administered subcutaneously. She experienced a local site reaction, which she photographed and sent to her physician.
After vaccine administration, patient had loss of consciousness for about 5 seconds. Did not hit floor, parent caught. Patient was anxious before vaccine.
Cellulitis to site of Varicella vaccine on left posterior arm and not cramps, but cramp-like soreness to lower extremities - mild.
15 mo. Imm. given at WCE on 10-04-13. Mom called office on 10-07-13 and spoke with phone triage nurse. Mom reports s/s to (Lt) as 2-2 1/2" area of redness and edema beginning after imm. on 10/4/13. Mom reports decreased s/s 10-07-13; afebrile, no streaking or dischg. (No tx or O.V. - call report only; s/s resolving spontaneously at time of report).
Fever, chills, headache, extreme fatigue, loss of appetite. Tylenol for fever
Gave Novartis H1N1 vaccine (4yrs and older) 0.5ml IM. Should have given Sanofi Pasteur H1N1 vaccine (6 months and older) 0.5ml IM.
Information has been received from a physician concerning a 17 month old male who on 13-MAY-2010 was vaccinated intramuscularly into the leg with a 0.5mL dose of PNEUMOVAX 23 (lot number 665707/1407Y). Concomitant therapy included PEDVAXHIB (dose, route and lot number not reported). No adverse effects were reported at this time. It was not specified if the patient sought medical attention. Follow up information was received from a Health professional. It was reported that the patient had no pre-existing allergies, birth defects, medical condition or illnesses at the time of vaccination. On 13-MAY-2010 at 03:00p.m., the patient's mother called to say that her child was not walking (refusing to walk) and developed fever (99.4 in office). It was noted that the patient was also fuzzy. The patient was seen again in the office on 14-MAY-2010 and was improving. The patient recovered on 16-MAY-2010. Additional information has been requested.
I broke out in extremely itchy hives about a week and a half after getting my second dose. I visited urgent care and the doctor said it is an allergic reaction. The doctor wasn?t sure what could have triggered it, he said it could be an allergic reaction to literally anything. He prescribed me a 5 day dose of prednisone.
Since administration of both the Hepatitis B vaccine and the Tdap vaccine, I have had visual disturbances, including more blurry vision and photophobia. Also, I have had a chronic headache since the occurence as well as a cough +productive, producing sputum as well as what feels to be a "head cold." I have also noticed an increase in insomnia as well as muscle aches and pains.
Swollen lymph nodes on left collar bone area on neck; Neck muscle pain, left arm muscle pain near armpit; This is a spontaneous report from a non-contactable nurse(patient). A 26-year-old female patient received first dose BNT162B2( lot number EL1284) , via an unspecified route of administration at Arm Left on 29Dec2020 15:30 at the 26 years old at single dose for COVID-19 immunization.  The medical history was none. There were not known allergies. The concomitant medication included fluoxetine hydrochloride(PROZAC). On 06Jan2021 the patient experienced Swollen lymph nodes on left collar bone area on neck, neck muscle pain, left arm muscle pain near armpit. There was no treatment received for the events. There was no other vaccine in four weeks. There was not covid prior vaccination. There was not covid tested post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a female who in July 2007 was vaccinated with a first dose of Gardasil. The patient may have been vaccinated with another unspecified vaccine in the opposite arm. Subsequently the patient fainted. Patient was monitored in the office and recovered. Additional information has been requested.
one day fever on 8th day, then six inch rash has formed around injection site on 14th day. Looks similar to cellulitis, red, itchy warm.
Patient received AFLURIA 2016/17. Fainted after 3 min. Patient was pale, fainted, face red, then recovered within 30-60 sec. Pt was put down on the floor to prevent injury. Pt has history of passing out (7 times).
Pt received vaccine on 6/16/17; reported bump and slight redness Friday thru Mon. On Tues noted increased redness radiating up to shoulder and increased warmth. Denied pain/discomfort. Presented to clinic on Wed. Redness in upper left arm from mid upper arm to shoulder. Increased warmth. No pain. Just started antibiotic therapy.
p/vax pt red, splotchy area on leg;both legs red rash: swollen both feet swollen, purple, calves hard, pain, couldn't stand on feet;bruising still present, Henoch Schonlein, purpura;
Lymph node soreness left armpit, mild headache, fatigue.  All symptoms started 4 days after shot
Left thigh with red, warm area at site of injections. Immunization received on 4/12/10 school nurse called mom on 4-13-10 with symptoms temp 98.8 degrees F @ appt on 4-13. Seen in clinic - treatment of warm packs for comfort and MOTRIN for discomfort.
General fatigue/soreness started the evening of 3/23/2021. Experienced chills, fatigue, body aches, and headache the morning of 3/24/2021.  Tylenol helped to manage these symptoms but they have still not abated.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. Since 02-SEP-2015 or after the date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # K020216 with expiration date of 17-SEP-2016 or L004754 with expiration date of 10-NOV-2016, dose and route unknown). The excursion was reported as temperature at 47 F for 23 hours and no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I26.99 ACUTE PULMONARY EMBOLISM 4/2/2023 ACUTE PULMONARY EMBOLISM
In addition to arm pain, Tingling from tongue to toes lasting about 3 hours.
had side effects on sunday , day of inoculation; felt like head cold , some fatigue , heavy chest ;started after ~ 3 hours , gone by next morning ; I believe that sleep helped ; My sleep schedule is problematic , so that may have contributed to this ;  pain at site of  inoculation , mostly gone now , 2 days later ;
Weakness and headaches. It worsened to I had a fever. I was unable to breathe right; coughing; sore throat. I would walk for a couple of steps and I would be very, very tired. No appetite. If I took something even dry crackers I would vomit. I was off for two weeks. I had an in person doctor appt. First they gave me an antibiotic and that didn't work. I was placed on prednisone (two rounds) and I had breathing treatments nebulizer. These helped with the symptoms.
HAVE DEVELOPED A "KNOT' AT THE INJECTION SITE, LEFT UPPER ARM.  3-4 ON PAIN INDEX, SLIGHT SWELLING, CAUSES WEAKNESS IN LEFT ARM WHEN LIFTING OR PUSHING OBJECTS (BURNING SENSATION AND PAIN).
his wife and him were not feeling so good, due to allergies; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 52-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated his wife and him were not feeling so good, due to allergies on an unspecified date. The caller stated that, received both doses of the Pfizer Covid-19 vaccine, but the second dose was rescheduled to be given after 5 weeks instead of 3 as his wife and him were not feeling so good, due to allergies. He wanted to know if the vaccine would be as effective if it was not given at 3 weeks. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021536037 same reporter/drug/event, different patient
Patient's mother made an appt with the call center to have out of states vaccine record input into system and have needed vaccines administered at same visit. Office manager informs the mother that it would take a while to have the information put in. Mother becomes upset stating that is the reason she made an appt. The office manager input the information into system and had me check behind her. During this time the mother is in the waiting room waiting for her child to be seen. I reviewed the forms and inadvertently missed one dose of PCV being put into system. Mother informed that the child would need Hep A and PCV to be up to date and receive an UTD. She agrees to the child receiving the vaccines. Vaccines are administered and discharge/aftercare instruction given to the mother. When told that the child needs to remain for 20 minutes after vaccination per protocol to watch for adverse reactions she comments that she cannot stay 20 minutes, they had already been there over an hour as it is. They did remain for a brief period in waiting room before leaving.
She said she felt poorly, and then developed diffuse itching about 10-15 minutes after receiving the vaccine.  She then developed a few hives on trunk and arms.  She was given Claritin and Pepcid PO.  Symptoms improved in about an hour.
On 8/13/2021 patient was vaccinated with 1st dose Pfizer vaccine . On 9/5/2021 patient came with her parents  for the second dose and upon checking in at registration patient  was identified to be under age and second  dose was not administered
Pt received 2nd dose of Engerix B approx 19Jul90 pt presented to Dr /w nausea, vomiting, & jaundice.
BRAIN BLEED; RECURRENT GUILLAIN BARRE SYNDROME; BROKEN HER FOOT; DISLOCATED HER FOOT; SMACKED HER HEAD; FALL; This spontaneous report received from a consumer concerned an 8 decade old female. The patient's weight was 191 pounds, and height was 66 inches. The patient's concurrent conditions included: penicillin allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 23-AUG-2021) dose was not reported, Frequency 1 total administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that few weeks after vaccination the patient started developing arm weakness and went to see her HCP who "misdiagnosed it as rotator cuff injury". After waiting to let that try and heal, the event progressively worsened, to the point that she could not perform her activities of daily living because of the weakness. On an unspecified date in Sep-2021, the patient became weaker, she fell at home and had broken/dislocated her foot during that fall, and smacked her head and had a brain bleed on holiday weekend. The patient was sent to the Emergency Room and subsequently hospitalized. There she was diagnosed with Guillain barre syndrome (GBS), after having an MRI (Magnetic resonance imaging), CT (Computerized tomogram) scan, and lumbar puncture was done, and the patient was started with 5-day treatment of antibodies. The patient was in hospital for about 2 weeks, and she improved greatly and was then sent for strengthening to a rehabilitation facility. At around 10 days into rehabilitation, the Guillain barre syndrome (GBS) symptoms started again. She was sent back to hospital again from the rehabilitation, and had another round of 5-day antibody treatment, was discharged back to the rehab this time with weakness still in her legs and not at 100%. The patient was in rehab at the time of reporting, and she is reporting that two days ago the same GBS symptoms started again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent guillain barre syndrome, and the outcome of fall, broken her foot, brain bleed, smacked her head and dislocated her foot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211058478- COVID-19 VACCINE AD26.COV2.S- Fall, broken her foot, dislocated her foot, smacked her head and brain bleed. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211058478 -COVID-19 VACCINE AD26.COV2.S -Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related.
Vaccine at 10:30 am; general malaise onset around 1 pm; sore arm started around 4 pm; body aches, injection site was hot; chills/hot flashes started around 8:30 pm; insomnia; joint pain.  lymph node tenderness.  Symptoms were mild - medium (not severe).  Mostly uncomfortable.  24 hours lymph node under injection arm swollen - and as of now it still is.  the only remaining symptom at 7 am 5/2 is swollen armpit / lymph node on injection arm.
Tender, red raised wheal, 4 cm in diameter. Began next morning, and is beginning to resolve after 48 hours. No rash, fever, pruritis.  Was 26 pregnant at time of injection. No known pregnancy complications.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with an unspecified doses in series of RECOMBIVAX HB lot number J007943, expiration date 05-FEB-2016 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
My symptoms were severe headache, congestion, consistent dry cough, body aches, and general weakness with muscle/joint pain. That started on 12/10/22. I originally thought it was allergies until the body and joint pain started. I took it easy over the weekend, lots of fluid. The body and joint pains started to increase even with medication, so before I went to work on Monday I took an at home COVID-19 test, it was positive. I had a tele-health appt with my PCP that same day, and he prescribed PAXLOVID. I picked it up same day, and that night my body aches got even worse. Then after 24 hours that subsided, I just had the metallic taste in my mouth from the medication. My symptoms kept getting less and I just stayed home for 5 days. I had to report to work my temperature everyday, and I never had a fever.
Upper lip swelled to three times its normal size two hours after shots were administered.  Called doctor and was told to give benadryl.  Swelling went down by 10 am the next morning. Massive swelling on spot of shots on one leg and hives all over body two days after shots were administered. Took to emergency room where they gave him a dose of orapred and a prescription for benadryl and zantac.  Swelling subsided by morning.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
HEART PALPITATIONS; TINGLING INSIDE FEET AND LEGS; THROBBING MOVEMENT INSIDE FEET AND LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heart palpitations, tingling inside feet and legs, and throbbing movement inside feet and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, tingling inside feet and legs and throbbing movement inside feet and legs was not reported. This report was non-serious.