chrisvoncsefalvay/vaers-outcomes huggingface dataset:
URINE WAS COKE LOOKING; MUSCLE WEAKNESS ON BOTH LOWER EXTREMITIES; INTENSE WEAKNESS; NAUSEA; TEMPERATURE 101.2 TO 102; LOST 9 POUNDS; TACHYCARDIA; LOW BACK PAIN; NECK PAIN; VACCINE FOR COVID WORKED AS ASTHMA CONTROLLER AND FOR WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, exposed to TB, and high weight, and other pre-existing medical conditions included patient did not took other medications including no Tylenol or NSAIDs not even for a cold and had no reactions until 3 hours after vaccination. patient had no vomiting, appetite, malaise feelings, headaches for the last 30 years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fluticasone propionate for drug used for unknown indication, salbutamol for drug used for unknown indication, and bupropion hydrochloride for weight loss.  On MAY-2021, the subject experienced vaccine for COVID worked as asthma controller and for weight loss. Laboratory data included: Body mass index (NR: not provided) 29. On 19-MAY-2021, the subject experienced tachycardia. On 19-MAY-2021, the subject experienced low back pain. On 19-MAY-2021, the subject experienced neck pain. On 19-MAY-2021, the subject experienced lost 9 pounds. On 19-MAY-2021, the subject experienced intense weakness. On 19-MAY-2021, the subject experienced nausea. On 19-MAY-2021, the subject experienced temperature 101.2 to 102. Laboratory data included: Blood pressure (NR: not provided) 80-110, Body temperature (NR: not provided) 101.2 to 102, and Heart rate (NR: not provided) 110. On 21-MAY-2021, the subject experienced urine was coke looking. On 21-MAY-2021, the subject experienced muscle weakness on both lower extremities. The action taken with covid-19 vaccine  was not applicable. The outcome of the tachycardia, intense weakness, low back pain, neck pain, nausea, urine was coke looking, muscle weakness on both lower extremities, temperature 101.2 to 102, lost 9 pounds and vaccine for COVID worked as asthma controller and for weight loss was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Itchy, swollen rash running from her chest up to her eyes; occurred 12 days after vaccination, but patient insists nothing else has changed that could have caused it. Was treated successfully w/prednisone.
Subsequent to receiving one dose of varicella virus vaccine live, the pt developed a moderate rash with 8 -10 lesions all over her body. Pt was seen by a physician who diagnosed chickenpox. The physician felt that the pts experience was vaccine related.
Local reaction @ site of injection, first red then became purple in center of local reaction, 8/28/08 observation per provider noted nickel size purple area.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a non-pregnant 10 years old female patient. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the M-M-R II vaccination schedule (as indicated in the Prescribing Information), the patient presented to a clinic with cheeks "really swollen" (not further clarified). Later on the same day, the patient was diagnosed with mumps. Treatment given was unknown at the reporting time. The outcome of mumps was reported as not recovered/not resolved. The relatedness between the event and the suspect therapies was not reported. This is one of two reports received from the same reporter (cross-referenced with MARRS number 1805USA004102). Sender's Comments: US-009507513-1805USA004102.
I first received GARDASIL 03/16/2007. The first dose made my arm go numb. Eventually i could feel it again. 2 months later 05/15/2007 I received the second dose and it did the same thing only much more. When my mother and I went to check out at the OBGYN front desk, I told my mom that I didn't feel well. I will never forget it because this was the first time anything like this has ever happened to me. My heart raced so fast and my vision started to Black and my hearing started to fade. For some reason, my mother thought I was joking. I never joke about anything like this. The very next thing I know, I'm thinking I'm dead. I can vaguely hear voices I was looking around underneath my eyelids to look for anyone that I knew who had passed away. I didn't seem to see anyone that I knew or even God, so I ruled out the fact that I could be dead. My hearing started to improve again and I overheard a doctor say that they saw my eyes fluttering. I started to open my eyes and they were shining a light in them. My hearing has completely returned and my mother is bawling her eyes out screaming at them over and over again, "WHAT DID YOU DO TO MY BABY?!" They got my mom to calm down and they asked me if I was okay. I told him that I guess I was but I thought I was dead because I have never passed out in my entire life until that moment. My mom explained to me that after I told her I didn't feel good and I blacked out she tried to catch my head and prevent it from hitting the floor and all of my body weight brought her down to the floor with me. She said that she immediately started asking them what's wrong and what just happened and started crying. She then, had immediately regretted getting me the vaccine. The nurses told her and I that some patients do faint from GARDASIL and that for the final dose, I should have more on my stomach and that might help. I received the final dose 09/20/2007. It nearly made me pass out even though I actually had something on my stomach this time. They made me lie down on the couch in the waiting room.
This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2015, the patient was treated by a physician at a medical office, for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events is unknown. Additional information has been requested.
Follow up to FAERS 18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
This spontaneous report was received from a physician concerning a female patient who on an unknown date "an unspecified number of years ago" was vaccinated with a dose of GARDASIL (dose, frequency and lot # not provided). On an unknown date, the patient developed unspecified multiple sclerosis type symptoms. The patient sought unspecified medical attention. At the time of the report, the event outcome was unknown. The relatedness for multiple sclerosis was unknown for GARDASIL. Upon internal review "unspecified multiple sclerosis type symptoms" was determined to be an other important medical event. Additional information is not expected.
Information has been received from a consumer concerning his 12 week old male son with food allergy and prophylaxis who in approximately June 2008, was vaccinated with a dose of PEDVAXHIB (OMPC) (dose, route and Lot# not reported). Suspect vaccine included a dose of DTP (manufacturer unknown) (dose, route and Lot# not reported) on the same date. Concomitant therapy included, vitamins (unspecified), DTAP + HIB+ IPV and PREVNAR. The consumer stated that in approximately June 2008, the patient screamed for 7 hours after receiving PEDVAXHIB (OMPC) (manufacturer unknown) and DTP (manufacturer unknown). It was also reported that his doctor felt that it was from the pertussis component. In approximately June 2008 the patient recovered from this symptom. The patient sought unspecified medical attention. The patient subsequently experienced worsening of eczema while on therapy with hepatitis B virus vaccine (Lot# not reported) (MSD, WAES 1012USA02826). Additional information has been requested.
Left arm is extremely sore and patient is having difficulty moving arm. She also has a red warm rash on left arm.
nausea; HEADACHE; cough; muscle pain also at injection sight; exhaustion; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via unspecified route of administration, administered in right arm on 06Mar2021 11:30 as dose 1, single for COVID-19 im-munization (age at vaccination: 56-years-old). Medical history included breast cancer. Concomitant medications included anastrozole (ARIMIDEX), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) and meloxicam all were taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 23:00 the patient experienced nausea, headache, cough, muscle pain also at injection sight and exhaustion. Patient not tested for covid post vaccination and no covid prior vaccination. The patient had no other vaccine in four weeks. Ther-apeutic measures were taken as a result of all events with rest, fluids and ibuprofen. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
REDNESS, HOT, ITCHY AROUND INJECTION SITE. SLIGHTKY SWOLLEN AND PAINFUL.  PT DID NOT TAKE ANY MEDICATION FOR IT.
Information has been received from a physician concerning a 24 year old female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). Shortly after receiving GARDASIL vaccine (yeast) the patient experienced progressive ataxia and motor neuropath. It was reported that the patient was being worked up right now for progressive ataxia and motor neuropathy. One of the pediatric rheumatologists  who had been heavily involved did believe there was a very plausible link. This is one of two reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2008. Additional information is not expected.
Patient discharge summary: " Patient admitted because he had increased SOB and weakness.  He couldn't get up out of a chair because of weakness and thigh pain.  He was noted to have hypoxia in the ER.  Admitted for this weakness. Therapy recommended home with therapies but patient doesn't have insurance so can't get therapy at home.  Respiratory panel was run after admission.  He was found to be COVID positive.  He was offered Paxlovid but declined as he is not able to afford it.  Patient was encouraged to use his home oxygen if oxygen dropped again to 90%.  He was given Decadron.  He was encouraged to take increased dose of vit c, d and zinc.  Because of the steroids he was instructed to increase his dose of lantus while on the steroids.  Both patient and wife were given instructions."
Patient received the vaccine and shortly after became light headed and dizzy.  We told her to remain seated and got her a water. She then vomited into the trashcan. She stayed in the pharmacy waiting area with her brother until 6 pm when she said she felt fine and left with him.
Healthy 26 year old with no previous health conditions or hair loss/ shedding incidents.  Hair loss began two weeks after the second dose and gradually escalated to severe hair loss. 40% of hair has been lost. Bald spots and thinning are clearly visible. Hair loss has not stopped or slowed down.  I have tried biotin, nutrafol, protein and home remedies such as rosemary, aloe vera and oils to stimulate hair growth consistently since the hair loss began with no results. Informed both PCP and Endocrinologist that the hair loss occurred after receiving Pfizer vaccine.
Patient reported chest congestion, lungs producing phlegm constantly every evening and morning starting about three to four days after immunization date. Does not feel sick otherwise. Saw his primary care provider who ordered a chest x-ray. Patient reports his physician saw no concerns on x-ray or physical examination.
PATIENT HAD SWELLING AT INJECTION SITE AND INFLAMMATION/REDNESS/WARMTH IN THE SURROUNDING AREA - SHE TOOK BENADRYL, APAP, AND APPLIED AN ICE PACK. I COUNSELED HER TO CONTACT PCP IF ANYTHING WORSENS.
4MAY91 17 days post vax t102, sz x 1- via ambulance to Hosp; Tx: Amoxicillin, Phenobarb x 5 days; Dx: FUO
coughing; Shortness of breath; Chest tightening; Chills; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Chest tightening), CHILLS (Chills) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). On 10-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening). On 10-Feb-2021, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) had resolved. At the time of the report, COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Swollen lower lip, swollen tongue, swollen throat, swollen glands in throat, swollen stomach (upper), swelling in left ankle, inability to breathe to full capacity (est 60% to 65% capacity), throat swelling closed, dizziness, disorientation, feeling hot and chills.
Large area of erythema, raised and warm to left thigh at vaccine site. Mildly pruritic.
Fever,  muscle/body aches. Stiff neck  Arm VERY sore.  Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch.  Arm painful for 3-4 days
Narrative: Headache, Myalgia, Tachycardia, SOB
Information has been received regarding a case in litigation concerning patient who on 13-MAY-1994 at the age of 10 weeks, was vaccinated in the right thigh with a 0.25 ml dose of Recombivax HB (lot # 607023/0301W). Concomitant vaccination included a dose of TRIPEDIA (lot # #C51043) given in the right thigh, an oral dose of ORIMUNE (lot # 0688L) and a dose of Hib (unspecified carrier) (manufacturer unknown) (lot # MISOKL) in the right thigh. On an unspecified date the patient experienced an unspecified adverse event. Medical records received indicate that the patient's vaccination history includes: 0.5 ml dose of Recombivax HB given in the left upper thigh on 12-JUL-1994 (lot # 611785/0539A) and the right thigh on 14-OCT-1994 (lot # 611785/0539A or "0539P") ; dose of TRIPEDIA given in the right thigh on 12-JUL-1994 (lot # 4K51154) and in the left thigh on 14-OCT-1994 (lot # 4W1169); a dose of DTaP (+) HIB (+) tetanus toxoid (lot # 386987 given in the left thigh on 14-APR-1995; oral doses of ORIMUNE on 12-JUL-1994 (lot # 0700H) and 14-OCT-1994 (lot #073M); a dose of HIB (unspecified carrier) (manufacturer unknown) given in the left thigh on 12-JUL-1994 (lot # MOO5KA) ; a dose of HIB (lot # 609541/0787A or "0787H" given in the right thigh on 14-OCT-1994; a dose of MMR II (lot # 609876/0481A) given in the left arm on 14-APR-1995. No further information was provided.
infected even though she had been previously vaccinated against covid; infected even though she had been previously vaccinated against covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) 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 "infected even though she had been previously vaccinated against covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: POSITIVE.  Clinical course: Caller reported that the companion (female) got infected even though she had been previously vaccinated against covid, not knowing if the vaccine was Pfizer or Moderna.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 2 month old female who on 07-AUG-2008 was vaccinated with her first dose of ROTATEQ vaccine live (human-bovine) (lot number not reported). Concomitant therapy included PREVNAR vaccine (CRM197), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) and study vaccination (unspecified). On 07-AUG-2008 the patient's mother called and stated the child developed a fever and she gave her OTC TYLENOL. The child then started to vomit and that continued into the evening. A follow-up call to the mother on 08-AUG-2008 was made, and the mother said that her child was improving. Additional information has been requested. 12/3/08 This is in follow-up to report(s) previously submitted on 9/15/2008. Information has been received from a physician concerning a 9 week old female with no medical history or allergies who on 07-AUG-2008 was vaccinated with her first dose of ROTATEQ (lot #660599/0208X). Secondary suspect concomitant therapy included PREVNAR (lot #C65934), PEDIARIX (lot #AC21B143AA) and Hib conj vaccine (manufacturer unknown) (lot #UF37AA). On 07-AUG-2008 the patient's mother called and stated the child developed a fever and she gave her OTC TYLENOL and she began vomiting until she dry heaved which continued into the evening. The mother was instructed to keep the child elevated for 20 minutes after feeding with good burping. A follow-up call to the mother on 08-AUG-2008 was made and it was reported the emesis resolved, but the child still had a temperature of 100. The mother was further instructed to continue OTC TYLENOL prn for fever if tolerated by the child and to call the office back if emesis returned or new symptoms appeared. It was reported the child recovered from emesis and fever in one day. Additional information is not expected.