chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CANNOT STOP SHAKING; COLD; BACK HURTS; MUSCLES HURTING/MUSCLES ACHE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old of unspecified sex. The patient's weight was 275 kilograms, and height was 76 inches. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced cannot stop shaking. On 10-JUL-2021, the subject experienced cold. On 10-JUL-2021, the subject experienced back hurts. On 10-JUL-2021, the subject experienced muscles hurting/muscles ache. On 10-JUL-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot stop shaking, cold, back hurts, muscles hurting/muscles ache, and headache. This report was non-serious.
Information has been received from a certified medical assistant concerning a 61 day old female with no pertinent medical history reported and no known drug allergies who on 04-Jun-2009 was vaccinated orally with her first dose of ROTAVIRUS (lot number 662738/1358X). There was no concomitant medication. The certified medical assistant reported that on 04-Jun-2009, the patient vomited after receiving the dose of ROTAVIRUS. The patient recovered form the event on the same day. No lab tests were performed. The patient sought medical attention in the office. This is one of two reports from the same source. Additional information has been requested.
Initial report received from 01 Sep 2010: On 01 Sep 2010, this patient inadvertently received intramuscular dose of lyophilized A powder reconstituted with liquid a health care professional on from Hep B vaccine MENVEO (batch number 023011, expiry date 20 Apr 2011). The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. The outcome of the event was not reported. Follow up report received from a health care professional on 28 Sep 2010. The outcome of the event was reported as complete recovery.
pt recv vax;following 4th dose & devel a local rxn w/ 2" swelling, soreness & redness the "size of a baseball" at inject site;pt had rubbed area & did not know if that affected the rxn;sx resolved w/in 5 days;anti-HBs =201.8;
By around 2:00, heart palpitations lasting about 10 min. Tiredness. Upon waking after sleeping 2 hours, heart pounding, lasting about 15 min. At night, itchy all over. Took Benadryl. Was fine by next day.
Could not move left arm over shoulder or behind body. On 11/23/2015 had the same problem with both arms. On 11/24/2015 I saw FNP and she changed the antibiotic (Levofloxacin) for sinusitis to AMOX TR-K CLV thinking it was the problem. I continued to have more and more pain and lack of arm movement. On 12/02/2015 at Rheumatology they were alarmed at the severe lack of arm movement and gave me a cortisone injection and a dose pack of cortisone pills and referred me to physical therapy. I have been treated three times a week since then.
SHINGLES; LEFT EYE SWOLLEN; SORENESS ON THE HEAD; This spontaneous report received from a patient concerned a 64 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: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-APR-2021, the subject experienced shingles. On 25-APR-2021, the subject experienced left eye swollen. On 25-APR-2021, the subject experienced soreness on the head. On 28-APR-2021, treatment medications included: valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles, and the outcome of soreness on the head and left eye swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient was given a second ZOSTAVAX vaccine. Patient had one already on 9/19/14.
right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treatment. Patient states that it resolved on 01/14/21.
It started with pain throughout my arm and left side within minutes of the injection. Within two hours my limbs were weak and my muscles were sore. By 5 hours after the injection my muscles were cramping or slightly spasming, my skin felt bruised or like it was sunburned, and any contact, even with clothing was incredibly uncomfortable. I itched everywhere, but scratching did not ease it, because it seemed to be coming from under my skin. I could not cool off, again, it was like having a severe sunburn. This subsided for the most part within a few hours. The next morning I felt better, though I still had muscle/joint aches, until about 1 in the afternoon, so about 17 hours after the injection, when I became very tired. Within another hour a fever, headache, and flu-like symptoms set in. They continued for about 24 hours. After the first two days the muscle/joint pain and headache were all that lingered, but extreme fatigue would come over me in waves, and I would need to sleep for several hours at a time throughout the day. This lasted for three additional days.
A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a child patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in Mar-2011. The patient received expired FLUMIST on 26-Aug-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
01/23 Eye discharge.Visit PA -01/23. Given Tobramycin.No improvement. 01/25 Eye area swollen with discharge. Dr.  - switched to Maxitrol and Augmentin. Vaccine related?  Dr. mentioned he saw somebody the same day with the identical symptoms.....
Pt experienced pain later that day and next morning. States arm was swollen, tight, painful from elbow through shoulder and up neck. Pain on movement. Relief with OTC APAP.
This spontaneous report as received from a medical assistant (also reported as nurse) via field representative refers to children of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 for prevention of HPV. The reporter mentioned that 2 friends with children who received GARDASIL 9 (lot # and expiry date were not reported) went downhill and one had to go to Clinic. The outcome of general physical health deterioration was unknown. Causality assessment was not provided by reporter. No other AE information reported. No PQC involved.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer calling on behalf of her. A male patient of an unspecified age received the 1st dose TRUMENBA, (Lot # M95612, NDC # 0005010005) at 0.5 ml, single on 09Aug2016 for immunisation. Medical history included pancreatic insufficiency before since he was much younger, probably from birth. Concomitant medication included ENZYMEDICA DIGEST BASIC oral for pancreas. The patient was given different vaccines. On 09Aug2016 the patient experienced fatigue, fever, headache, muscle pain, joint pain from the injection, pretty much in bed most of the time, weak, all for 5 to 7 days after. The symptoms slightly got a little bit better 5 days after and may be about 7 days after the patient was doing better. The outcome of the events was recovered completely 7 or 8 days after the shot. No treatment received. Laboratory work were done just to ensure he was doing okay. He was due to have his second dose. He was on the 3 dose series. He was on way to college and he would not be back in time for his second dose, so the reporter queried if her son could wait till Thanksgiving for his second dose.
Mom stated Pt developed hearing loss to both ears Dec 07 shortly after completing GARDASIL series. Dose #1 1/23/07 - Dose#2 3/29/07 - Dose#3 8/6/07 - Pt now wears hearing aids.  7/8/09 Medical records received DOS 8/6/07 to 6/24/09. Assessment: Hearing impaired in both ears. Patient's parent reports that child has failed school hearing test, now wears hearing aids. Acne, headaches, fatigue. Palpitations. Urinating more frequently. Dizziness. Mood swings. Menstrual cycles heavy and irregular. Thoracic spine, mild curvature to the left.
stated her throat was hurting--took benadryl and it subsided. also stated her arm was hurting in some areas and numb from her elbow down stayed longer than 15 minutes with the arm not getting better
pt recv vax 19FEB97 & 20FEB97 pt devel a terrible sore throat-feels like golf balls & a temp;
Pt recvd flu vax & the following wk pt lifted arm while getting dressed & felt sharp pain @ a site well above the inject site; arm then became black & blue & swollen;
Patient described waking up with reddish rash located approximately 4-5 inches below the site if the IM injection.  Rash was NOT hot to touch, but there was some minor swelling.  Rash was slightly itchy.  Rash was about the size of half a dollar bill.  Patient stated that rash had gotten smaller over the course of the day.
had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it; had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had her first dose only of the Pfizer COVID-19 vaccines and has COVID and is still testing positive for it". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037142 Same reporter, drug & event; different patient
High fever 100 plus.  Highest has been 100.5 at 5:00PM today.  Took 3 reading today 99.5 in the morning, 100.2 this afternoon and 100.5 at 5:00PM.
Symptomatic COVID after "full vaccination" with Moderna COVID-19 vaccine .COVID Dx date: 12/26/21 presented to ED with shortness of Breath Decadron and prednisone  Oxygen Requirements: Intubation 1/11/22 ; tracheostomy placed 1/27/22. Not a candidate for toci/barcitinib due to rituximab per pulmonology.
Received updated Pfizer covid vaccine 09/18/2023 and blood pressure increased again. Already on amlodipine 10mg from previous vaccine doses and additional losartan 25mg prescribed.
Starting shortly after receiving the vaccine, I developed soreness in the right arm. It has remained sore, achy and, even with recent steroid injection for Bursitis in the shoulder, the soreness did not resolve. Therefore, I feel its more related to the vaccine/injection.
Drenched in sweat; Rigors; chest pain; Shortness of breath; myalgias; muscle spasm.
Pt was "unresponsive." Patient's husband described patient sitting at table with eyes open but did not respond to vocal cues or to touch; he stated it lasted about 30 seconds; he said he almost called 911, but patient eventually responded.
Cellulitis & lympadenitis with tender left axillary left arm, major reaction to vaccinia vaccination.
Started with my lips and the tip of my tongue went numb and tingling later that night and the next day low grade fever chills fatigued body and joint pain headache
During the week of 17APR2023 I noticed some hearing loss in my right ear and some ear pain, I thought I had an ear infection. I also had a swollen lymph node behind my right ear. I started to take amoxicillin that I had on hand then 24APR2023 in the afternoon I noticed that the right side of my face was partially paralyzed, I recognized this immediately as probable bells Palsy which my brother had years ago. I researched Bells Palsy and stopped the antibiotic, I scheduled an appointment for 26APR2023 with my Doctor, substituting for my doctor said I may have had Covid lately but my only symptom was a runny nose. A test I did that evening was negative. I was prescribed one week prednisone and valaciclovir, my facial muscles and tone are improving.
5:45 am on 9/10/21 L arm was cold and numb and tingly and painful to squeeze hand. That lasted for approx 24hrs. The adverse cold feeling went away the next day. He is still having numbness and tingling in his hands that is random and increases with functional use of his hand.
I exclusively nurse my 2 month old baby and on Wednesday morning my son began to have hematemesis and coffee ground stool. He had it the morning of 1/20 and then again he spit up Frank red blood early morning of 1/21 and darkening stools. He continued to have hematemesis sporadically until midnight 1/21 when he stopped eating and went NPO. We took him to the ER per our pediatrician?s advice around 1pm on 1/21 and stayed overnight to do an endoscopy in the morning. His CBC and PTT were normal and the endoscopy showed stomach ulcers had developed. Biopsies were taken and culture for H. Pylori sent . Biopsies showed no pathology and h.pylori did not grow on culture. Currently, I have no explanation  for his stomach ulcer development and I feel that the close proximity to my first vaccination should be further evaluated.
with 1st and 2nd Covid vaccines, patient developed vomiting. The 1st one within 24 hours of the vaccine. The second within 72 hours of the vaccine. With the second vaccine, patient got dehydrated and required IV fluids at an emergency room.
Angina pectoris; Heart rate irregular; Lethargy; Malaise; Chills; Pyrexia; This case was received via the Regulatory Authority (Reference number: 1592143) on 02-Nov-2021 and was forwarded to Moderna on 02-Nov-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGINA PECTORIS (Angina pectoris) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, FUROSEMIDE (LASIX [FUROSEMIDE]) and GABAPENTIN for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ANGINA PECTORIS (Angina pectoris) (seriousness criterion medically significant), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, ANGINA PECTORIS (Angina pectoris), HEART RATE IRREGULAR (Heart rate irregular), LETHARGY (Lethargy), MALAISE (Malaise), CHILLS (Chills) and PYREXIA (Pyrexia) 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.   Lab test included Holter monitor in June and Electrocardiogram ambulatory in 06 Mar 2021 and results was not provided. Medical history included heart. It was reported that, patient experienced fever chills heart pain irregular heartbeat ongoing lethargy Increase in heart medications needed as abnormal lack of wellness continued through June.; Sender's Comments: This case concerns a  81-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Angina pectoris. The events occurred approximately 1 day after the unknown dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 Vaccine, is not affected by this report.
Immediately after vaccine given patient states she felt dizzy and fell from sitting to lying position on stretcher. She aroused with tactile simulation. States she passed out. Was unresponsive for only a second.
Blisters and rash on nape of neck, rash on throat, rash on right  shoulder. The physician on- call prescribed Zovirax 1000 mg and Neosporin. Patient still has rash and blisters and is being compliant with treatment but it has only been two days so far.
DEEP VEIN THROMBOSIS IN LEFT LEG; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, alcohol user (occasional average one drink per month), non-smoker, mobic allergy, latex-mild allergy, and drug allergy (Interferon Beta A-1). The patient had no drug abuse or illicit drug usage. On an unspecified date, the patient was previously received Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer biontech covid-19 vaccine (tozinameran), the patient experienced severe anaphylactic reaction (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, 1 total administered in arm on 19-JAN-2022 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported.  Patient reported that he first noticed something with his leg in mid FEB-2022, and then it became worse in late MAR-2022 to early APR-2022 (Dose number in series 2). The patient was transported to emergency room. The patient experienced deep vein thrombosis in left leg (Dose number in series 2). On 27-APR-2022, the patient was admitted to the hospital. On 29-APR-2022, patient was discharged after having the blood clot removed (Dose number in series 2). The patient was hospitalized for 3 days. On around 02-MAY-2022 or 03-MAY-2022, the patient followed up with his PCP (Primary care physician). The patient visited physician office and emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep vein thrombosis in left leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220534919-Covid-19 vaccine ad26.cov2.s-deep vein thrombosis in left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one of the nurse administered the vaccine that was unpunctured, and refrigerated, for more than 12 hours) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.
Child woke up in AM with low grade fever  99 degree Faren., mild sore throat
pt recv vax 28DEC98; on 31DEC98 pt presented w/fussiness & a mucous stool, tinged w/blood;pt hosp for 1 or 2 days & disch;1JAN99 had bloody diarrhea, then began passing just blood;MD dx sigmoid intussusception which was reduced w/an enema;
The past 2 menstrual periods following vaccination  I have experienced extreme menstrual pain and heavy flow.  These periods are unlike any experienced in the past.
I woke up on 3-19-2021, about 48 hrs after the vaccine, with swollen lips. They also have a light metallic taste. My sense of taste seems to be slightly affected. This is the reaction I have had in the past to antibiotics I am allergic to.
Initial unsolicited report received from a nurse on 23 February 2016. This case was linked with 2016SA037709 (same product and reporter). This case involves a three patients (gender was not reported) who was vaccinated with a intramuscular dose of Adacel (batch number U5298AA, expiration date, dose, dose in series were not reported, site of administration was reported as unknown) on February 2016 (reported as 11 February 2016 to 16 February 2016). Patient's medical history and concomitant medications were not reported. On an unspecified date in February 2016, one day (reported as next day) following the vaccination, patient developed redness and swelling about 2 inches. Lab data and corrective treatments were not reported. The patient was not recovered from event. List of documents held by sender: none.
Hasn't felt good since the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (She mentions her husband gets the flu shot every year). The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Hasn't felt good since the vaccine".  Additional information: The caller (patient wife) mentions her husband and is eligible for his third dose, but the withheld is not giving Pfizer. The withheld is only giving Moderna and Johnson&Johnson. She was told they are not to mix vaccines, so she did not know what to do about her husband. Her husband cannot even get the Pfizer vaccine from his own caregivers. The caller states she did not know if she should get him the third shot or what. She knows they said not to mix vaccines. Her husband said he had not felt good since he took the first two shots, but they have seen anything like they did with her. She did not know what to do.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Lost of balance Dizziness throughout the day Unstable  Unbalanced Headaches
pt recv vax JUN95 & it was reported that the pt did not seroconvert p/the first dose;