chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; 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 CHILLS (Chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not given.  Concomitant medication were not provided.
Ever since a couple weeks after the second dose, I have had cysts pop up on different places of my body. I have had a total of 6 cysts so far. One was removed but it came back. I have been prescribed different antibiotics when they get infected and the infection goes away but I still have scars from all of them. It has been awful and and I hate it.
Pt. states woke up on 12/31/20 at around 8:00 and had blurry vision. States can see some things far away but can't see close up... Denies having any blurry vision prior to vaccination. States blurriness has neither improved or worsened. Denies any other symptoms or problems. Referred to Emergency Department for care regarding blurry vision. Encouraged pt. to call and notify health department of emergency departments assessment.
No adverse effects; PROQUAD was administered to a 7 month old child through the intramuscular route; PROQUAD was administered to a 7 month old child through the intramuscular route; This spontaneous report was received from a nurse and refers to a 7-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R017802, expiration date: 19-DEC-2019, dose was not provided) through the intramuscular route for prophylaxis. No adverse effects were reported.
Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date and in August 2013, the patient was vaccinated with the first and second dose of GARDASIL, (lot number, expiry date, dose and route were not reported). By the reporting time of 31-MAR-2015, the third dose had not been received. The physician asked whether the 3rd dose should be administered or repeated the series. Additional information has been requested.
Headache INJECTION SITE SORE/RED; FATIGUE Narrative:  BOOSTER
patient reported body aches from head to toe and chilling beginning at 3am the morning after vaccination
After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pills but I also had heavy eyes. Very dry mouth.   Today I?m in pain from my neck to my hand. My entire arm feels swollen and burning. My hand is swollen and my finger tips are tingly. The severity of this pain started about 4 hours ago.
Chills, tiredness, injection site pain, dizziness. The injection site pain started immediately after the injection. The chills, dizziness, and tiredness happened the next morning.
injection site pain - tiredness - headache - muscle pain - chills - joint pain - fever 101.9 - nausea - feeling unwell
The vaccinating pharmacist inadvertently mixed the Pfizer Covid-19 Pediatric vaccine with sterile water for injection instead of 0.9% sodium chloride. The patient was then administered the vaccine. The patient's father reports the patient had her first menstrual spotting the next day, but unsure if it was due to the vaccine.
Injection at 9:00 am on Oct 4. Everything fine until sudden onset of fever at 5:00 pm the same date. Fever throughout the night and pain as well as redness in the upper arm. It is now 24 hours later and there is still pain in the upper arm and redness in a radius of 4 inches as well as fever. The redness is a severe jagged bold red line. Fever and redness still continues as of 8:15 the next morning (0ct 5).
Patient says she experiences pain and discomfort in her left arm soon after receiving a flu shot on 10/26/19. She describes that her left arm has difficulty moving and that the pain causes her to not sleep on her left arm. On 11/3/2019 she said that the numbness has spread down to her fingers in the left arm. As the reporter, I noticed no redness or swelling of the left arm.
shortly after vaccine, experience chest tightness, palpitations, dyspnea, cough, sweating and fever. Admitted to hospital 3 days later, found to have new pericardial effusion, secondary to acute pericarditis from possible vaccine. Pericardiocentesis removed 250ml proteinaceous material. Also experienced flash pulmonary edema which required intubation x1 day but resolved quickly.
Immediately after receiving Hep A she said she "felt funny". She moved from Imms room to waiting room. She hadn't eaten so ate her sub. We used ammonia inhalant & gave her 4 tsp BENADRYL. She started improving & talking etc. Then 15 min later she started going downhill. We laid her on floor with feet elevated & started O2. With no improvement we called 911 - In ER till 7pm.
started with a fever on 8/13/09 rash started 8/16/09 mostly on his truck and right side of his face BIG RED SPOTS..  He now sores in his mouth, red gums and and started to bleed on 8/17/09.  Took to denist on 8/17/09 who said it could be Fifth Disease.  He was seen by Dr. who cultered and put child on amoxicillian.  He does not go to daycare.
I have had mild tinnitus for four years. Three days of taking the first dose of the Pfizer vaccine my tinnitus suddenly became louder and debilitating. It has not subsided.
Seizure with fever (? Febrile seizure) taken to the ER, labs done, hospitalized overnight for observation.
Rapid heart rate for four to five days following second vaccine dose. My resting heart was rate significantly higher than normal, and any activity, including standing up made my heart race faster, as high as my typical running heart rate.
severe pain in right side rib cage area of back and side -pain like a broken rib feels, pain in hips and groin area, ache in both legs, very sore arm and neck on the right side of my body. redness around shot the 4th day. sore throat and swollen glands on both sides of upper neck. chills, dizziness, flu like symptoms mostly the 2nd third and fourth days. felt feverish but no fever. shot area still feels tender 6 days after injection. I had a tender spot on my right side of forehead running down the right side of my nasal area felt like i had hit my head on something. My rib soreness was the worst part of the symptoms, this along with the leg and hip pain kept me awake for 2 nights. I felt intermitted  nausea for about 3 days.
7 year old patient received a dose of Flublok instead of Fluzone with no adverse event; 7 year old 1 day; Flublok and Fluzone do look very similar with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist was received and transmitted to Sanofi on 12-Oct-2020.  This case is linked to case 2020SA283692.  This case involved a 7-years-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date was unknown for both) via an unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age) and (Wrong product administered) on an unknown date.  It was a case of an actual medication due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: Same day).  The reporter also reported that both the vaccines looks very similar (Product confusion)  (Latency: Same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable physician. A 17-year-old male patient received TRUMENBA, intramuscular in the arm, on 19Sep2018, at 0.5 ml single, for immunisation and influenza vaccine (unspecified trade name), via an unspecified route of administration, on 19Sep2018, at unspecified dose, for immunisation. Medical history and concomitant medications were none. The patient developed a fever 101.9 on an unspecified date, at the site had pain on an unspecified date, pain in his arm on an unspecified date, felt pretty miserable for 48 hours on 20Sep2018. Outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 101.9. Therapeutic measures were taken as a result of the events and included treatment with Advil. The Advil didn't help, so then he took Tylenol. The reporting physician stated there could be a relationship.
Heavy menstrual period began 06-28-2021 and is still ongoing.  I am in peri-menopause and had not had a period for over 10 months.  I have not yet seen my provider, but plan to follow up if bleeding doesn't stop in the next day or two.  I am submitting this for reporting purposes .
I contracted COVID, showing symptoms on 11/06/2021 and testing positive for COVID 11/08/2021.
Patient received his vaccine and was waiting in the post-vaccination waiting space. Within 5-10 minutes he slumped in his chair and became unresponsive. Became responsive to voice but was slurring his words. Patient was diaphoretic. HR in 90s, O2 98%. His eyes rolled back in his head  suspecting vasovagal episode, we moved patient to the floor  and raised his legs. He became more responsive. Was fully oriented although did not seem incredibly alert. Cycled multiple BPs with 100s-110s/60s-70s. HR 70s-80s  supine, O2 sat 96-98%.  EMS was called for transport to ED given patient's lack of prompt recovery. We  attempted to sit patient up and he again became lightheaded and had to lie back down. While in supine position, remained with normal and stable VS. At no time did he manifest any rash, respiratory symptoms, throat or chest tightness,  abdominal discomfort, or other overt signs of anaphylaxis.   Patient was transported to the ED where ROS was reported as:   - CONST: +fatigue, denies fevers or chills  - EYES: Denies vision changes  - ENT: Denies rhinorrhea, sore throat  - CV: Denies new chest pain  - RESP: Denies SOB or cough  - GI: Denies abd pain, n/v, diarrhea  - GU: Denies dysuria  - MSK: Denies new joint swelling or pain  - SKIN: Denies new lesions or rash  - NEURO: Denies new HA, numbness, or weakness  - PSYCH: Denies suicidal ideation Vitals: BP 116/67, O2 99% on RA, Temp: 97.7F, Pulse 79.  ED provider felt this was most likely vasovagal episode given occurrence following vaccine administration and associated sxs. EKG without evidence of dysrrhythmia. No PE risk factors, SOB or CP. Pt with HA that was not thunderclap nor severe in nature and was consistent with prior migranes, thus do ot suspect SAH. No hx to suggest anemia and no anemia on blood work today. No report of  seizure. Pt is alert without report of post-ictal period.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 ADENOMATOUS POLYP, COLON ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 HX OF ACUTE KIDNEY INJURY
Fever up to 102; chills; Body aches; soreness at site of injection; This is a spontaneous report from a non-contactable consumer. An adult male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced Fever up to 102 and chills for 2 days following vaccination. Body aches and soreness at site of injection was as well reported. No treatment was received for the events. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Some tenderness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced some tenderness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having no reaction, just some tenderness for a few days. No treatment information was reported.   Action taken with mRNA-1273 in response to the event is not appplicable.   The outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Several hours after the Varicella vaccine, this infant woke up from a nap screaming. He had twitches as described by the mother and was crying. He did briefly stare at the ceiling. He never lost consciousness. He had trouble drinking fluids, this resolved after 1 hour and 45 minutes. Exam in office normal. Advil helped.
No additional AE reported; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U024508 with an expiration date on 02-FEB-2023) administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion of 8.3F Fahrenheit (°F) during a time frame of 0 hours, 15 minutes and 0 seconds.  No additional adverse events were reported.
Left arm pain that began around 5pm. Chills and headache started around 7pm. Low grade fever, hot flashes and cold chills persistent all night.
On the 8th day after receiving the 1st shot the injection site was: itching, round area that was red/rash, warmer than other areas, slight swelling/tightness. Lasted 2.5 days
Pt received flu shot on 9/13 given by RPh. She came to pharmacy the next day with red raised spot at injection site. She did not break out in a rash. Shot not given in muscle per pt.
Headache, Fever, CHILLS,TIREDNESS, ACHES Narrative:
Chills, Muscle Aches, Fatigue, & Arm Hurts Bad. Symptoms Not As Bad As 2nd Vaccine. Later very red neck and trouble catching breath. Started December 16, 2021 the night of the booster shot around 11pm.  December 17th, still having same side effects, but neck started turning very red and still red on December 18th. Started having shortness of breath December 18th and sweating. It is almost 8 am on December 18th, as I report these symptoms and I am still experiencing arm soreness, very red neck, shortness of breath as and lethargic.
Severe body chills and aches  Headache that turn into a migraine  Fever 101F Joint pain and swelling
01/18/2021 worse headaches and transient double vison-01/26/2021  01/30/2021 I was hospitalized till 02/02/2021 was treated with high dose steroid  -prednisone will there and Actemra injection once weekly, off steroid now but still have the injection once a week
inconsolable crying for 3 days; leg swollen from area of inj site to ankle, hard, red & tender according to family; ER told family not to bring pt in for exam;
C/O numbness left face ~ 3 hours after injection given, no numbness at time of exam, located ~ 12 hours.
Information has been received from a registered nurse concerning a 13 month old female with no medical history and no allergies who on 13-MAR-2007 was vaccinated with a 0.5ml subcutaneous dose of Proquad (Lot#655845/1350F). There were no concomitant medications. On 01-MAY-2007 the patient developed two itchy varicella like lesions, one lesion on the left side of her chest and one lesion on the left side of her back. There were no laboratory or diagnostic tests performed. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
I noticed severe lower back pain a few days after the vaccine, but couldn't figure out what had caused it until I also noticed a chicken pox like rash about four to five  days after the vaccine.  I called the doctor's office and they said these symptoms are extremely rare and they would only last a few days.   The rash, which was worst on my upper legs and upper arms, as well as scattered on my back and chest, was itchy and somewhat raised.  Some places were blotchy and raised on the back of my arm close to my armpit.  Most of them were just spread-out red spots.  The rash almost completely disappeared after three weeks, but the back pain has continued, but decreased in severity.  The first week was extremely painful and I could hardly walk or move due to the back  pain.  Moving the wrong way would shoot pain in my back.  This happened for a few weeks and now it's just sore for the most part.   I had experienced pain at the injection site on my shoulder since receiving the vaccine and it was painful for about a week.  I had also had the flu vaccine the same day in the other shoulder, but it only mildly hurt for about a day or two.  I also experienced bad headaches, but they are not entirely abnormal for me so I didn't think much about them.   The biggest concern for me is that my back pain is still not recovered entirely.
sudden on-set of the worst rheumatoid arthritis flare-up of my entire life.  (With the exception of a few minor flare-ups, before April 25 I was about 20 years in remission, after having JRA during my childhood and having my left knee replaced.)   I have never in my life experienced an arthritis flare-up like this one.  I have extreme pain and stiffness in my wrists, both hands, all knuckles of every finger, right shoulder, jaw, and left ankle.  Before this recent flare-up, I never had problems with my hands or wrists, and I never experienced this type of extremely sudden on-set, extreme pain, stiffness and many joints affected at one time.
Large red itchy rash developed at injection site on day 7. Grated with Benadryl and Zyrtec. Rash resolving.
patient fainted five minutes after receiving vaccine.  regained consciousness and emts evaluated but did not have to go to hospital
Ever since I took the vaccines my health went downhill and I lost many things in my life due to my health being purposefully tampered with.
Spoke with mother on phone. Patient has been crying non-stop for last hour. Spoke with mom at 5:00 pm - pt has started to settle down - less crying.
A week after receiving the vaccine he went to the hospital with high blood pressure; Was light headed; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (A week after receiving the vaccine he went to the hospital with high blood pressure), DIZZINESS (Was light headed), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (A week after receiving the vaccine he went to the hospital with high blood pressure), DIZZINESS (Was light headed), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HYPERTENSION (A week after receiving the vaccine he went to the hospital with high blood pressure), DIZZINESS (Was light headed), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included high blood pressure medications.
Dyspnea, SOB, increased heart rate, pale mottled skin Treated with: benadryl and 1 dose of steroid in ER.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 months old patient of unknown gender who received vaccines ACT-HIB and 0.5 ml first single dose of PENTACEL (lot UI966AA (expiry date: 07-Jul-2020) via unknown route in the right thigh) instead of PEDIARIX on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered, extra dose administered and wrong vaccine administered. It was not confirmed whether patient developed any reaction to vaccine (reported that the patient would likely not develop any adverse reactions). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt fainted falling forward off the exam table after receiving vaccines. Examined by physician vital signs and neuro check done, within normal limits.
An attorney alleges that an 18 month old male, now 9 years of age, received Hib-Titer, Orimune, MMR, Varivax, and DTP vaccines on 8/30/95 as part of a routine childhood immunizations. The reporter stated that the child was diagnosed with mercury poisoning sometime in 1999. It is alleged that as a result of the mercury poisoning, the child developed permanent neurological injuries resulting in his regression from a normally developing child into a severely impaired individual. The reporter attributes the events of the presence of thimerosal. No further information was available.
Patients mother reported temperature of 99.8 F, right leg swelling and redness about a ald dollar size, and fussiness.
Lower eyelid infection right eye 6 days after vaccine dose 2 and dose 3. Currently have an abscess eyelid with facial swelling under eye, painful , itchy. I have   had some gland swelling and tiredness. Same symptoms I had in April with second shot after 6 days vaccinated was treated by drs for stye, then allergic pink eye after for two months.Prior to this haven?t had a stye since childhood, no prior eye allergies.