chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client was accompanied by her mother and father. Client reported feeling dizzy to RN. Client ambulated and sat down in the anti-gravity chair. The anti-gravity chair was adjusted to a low fowler's position. Lead RNs responded. The following was obtained with RN translating between Spanish and English. Vitals obtained at 03:42PM were as follows: HR 85, O2 97%. The client's parents denied any chronic conditions or known allergies. The client denied any other symptoms. The client was provided a juice and crackers and began eating the crackers and drinking the juice. Vitals obtained at 03:44PM were as follows: BP 100/73. The client denied any dizziness, nausea or shortness of breath. The client reported arm pain in the right arm where she received the Flucelvax Quadrivalent vaccine. The anti-gravity chair was adjusted to a high fowler's position. The client denied any dizziness. The client ambulated unassisted with a steady gait to the observation area at 3:48PM and sat down in the anti-gravity chair in a high fowler's position. Vitals obtained at 3:52PM were as follows: BP 109/72, O2 98%, HR 89. The client denied any symptoms. RN provided education regarding possible adverse events and when to seek care. The client and her mother voiced understanding of this education. Repeat vitals obtained at 4:04PM were as follows: BP 105/71, HR 80, O2 99%. The client reported feeling tired but denied any other symptoms. The client ambulated unassisted with a steady gait out of the vaccination site at 4:11 PM.
Mild fever, left arm swelling around injection site, soreness, redness, hot to the touch. Patient was given acetaminophen for swelling.
low wbc / neutrophil labs; low wbc / neutrophil labs; had a lymph node appear on my mammo which they say is common but not 8 month later; got terrible rashes; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, 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 experienced WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs) and RASH (got terrible rashes) outcome was unknown and LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) Patient reported had a lymph node appear on his/her mammo stated that it was mentioned as common but was not 8 months later. On an unknown date, White blood cell count: low (Low) low wbc / neutrophil labs.         Patient was due for the booster and stated that extremely worried about the potential of aggravating his/her immune system.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-399764 (Patient Link).
Injection site developed large hive measuring 6 inches in diameter with elevation of approximately 1/2 inch, hot, painful, extremely itchy.
On 10/2/99, he ran fever of 101-103F (axillary), with oral Ibuprofen, it would drop to 99F (ax) for 4-5 hrs. Fever lasted about 48 hrs. He had crankiness about same time the fever broke, a red pinpoint rash appeared on trunk,but gone w/o tx
Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Fever of 102.4. Severe chills. Bodyaches; Skin hyper sensitive to touch; Severe pain in area of Liver like when I took Tylenol during covid; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Hands and feet feel like blocks of ice but soles of feet feel like on fire; Bad tummy ache; Muscle weakness; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Also, the mild depression & brain fog which has remained since I recovered from having covid from 02Dec-26Jan is even worse now; Barely able to function physically & mentally; This is a spontaneous report from a contactable consumer. A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:00 as DOSE 1, SINGLE (at the age of 63-year-old) for covid-19 immunisation. Medical history included coeliac disease, autoimmune thyroiditis, gluten sensitivity, covid-19 (I had in Dec & Jan when I had covid for 50 days), feeling abnormal. Concomitant medications included levothyroxine sodium (SYNTHROID).  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's 1st Vaccine was received on 31Mar21. The next day on 01Apr2021 06:00, patient's reaction symptoms include several of the symptoms patient had in Dec & Jan when had covid for 50 days. They includes fever of 102.4, severe chills, body aches, skin hyper sensitive to touch, severe pain in area of liver like when patient took Tylenol during covid, hands and feet feel like blocks of ice but soles of feet feel like on fire, bad tummy ache, muscle weakness, barely able to function physically & mentally. Patint'e symptoms were some of the many that patient had when patient was very ill with covid. Also, the mild depression & brain fog which has remained since patient recovered from having covid from 02Dec-26Jan was even worse now. The patient underwent lab tests and procedures which included body temperature increased: 102.4 fahrenheit on 01Apr2021, sars-cov-2 test: positive on Dec2020 symptoms I had in Dec & Jan when I had covid for 50 days. The patient did not received the treatment for events. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a 4 year old patient was administered FLUBLOCK with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via  Medical Information  (Reference number- 00831464) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case involves a four-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, lot UT7316JA, expiry date: 20-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product administered to patient of inappropriate age (latency: same day).  It was reported "The caller states that a 4 year old patient was administered FLUBLOCK."  At time of reporting, no adverse event 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 the 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.
Heavy menstrual cycle that lasted for 9days with very heavy bleeding on day 4, 5, and 6 of my period. After 1 week of being done with my period, I had another period, but this time the bleeding was like I normally have.
none. given expired covid 19 vaccine: expired. 11/22/2022 Given: 12/13/2022
About 10 hours after receiving the J and J vaccine, I woke in the middle of the night shivering uncontrollably, teeth chattering.  Following that I had a headache, nausea, flu like symptoms, body aches, and a fever. Missed 2 days of work. My symptoms from the vaccine were worse than when I had the COVID virus.
Noticed Thursday sept 9 while washing my face and neck there was a marble sized lump in my lymph nodes on the left side near my collar bone just feels a little sore?. My left shoulder joint is also sore feels very fatigued  I panicked at first but then started reading about some side effects
Vaccine administered on 10/13/08, patient states approximately that evening experienced abdominal pain with flatulent and diarrhea next 48hrs had greater than 12 bowel movements, on 10/15/2008 awoke with arm swollen, red with pain and warm to touch.
Tested positive for Covid 19 one week following vaccination; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injectioN, Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient's concomitant medications were not reported. On 29Jan2021 the patient tested positive for Covid 19 one week following vaccination by nasal swab test. No treatment was received for the COVID-19. Outcome of the event was recovering.  Information on the lot/batch number has been requested
Left arm swollen quarter size hard, painful warm to touch and red - phone message pt a college unable to seen in office at this time.
REDNESS, SORE AND SWELLING AT INJECTION SITE. WOKE UP THE NEXT MORNING TO ARM SWOLLEN ABOUT THE SIZE OF A BASEBALL.
In the evening of the say I received my Covid booster I began to lose vision in my left eye. Symptoms included difficulty seeing/focusing on objects, tunnel vision in left eye only. When I woke up the following morning everything was fine and back to normal.
Mother case: Case number PHEH2014US021768 is an initial spontaneous report received from a health care professional (pharm resident) on 27 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that she was expecting and was vaccinated with a dose of FLUCELVAX (batch number: not reported) intramuscularly on 13 Oct 2014. She was vaccinated with another dose of FLUCELVAX (batch number: not reported) intramuscularly on 13 Oct 2014. She was vaccinated again with another dose of FLUCELVAX (batch number: not reported) on 27 Oct 2014. No adverse events were reported following the maladministration.
24 hrs post/vax, child developed erythematous macular lesions on face, trunk & extremities; not involving oral mucosa, soles/palms. Lesions worsened over the next 24 hrs. Child tx'd with Benadryl.
Patient's body broke out in welts and hives mainly to bilateral arms and legs. Left leg (thigh) at the site of the vaccine injection was identified as reaction vs. cellulitis. Area was marked and parents were advised if it spreds, gets warm to the touch to return for evaluation. Mom was instructed to give the child 2ml of children's Benadryl q8'prn
had COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (had COVID-19). At the time of the report, COVID-19 (had COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had COVID on an unknown date of 2022, but had been vaccinated and recovered with no residual effects. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694621, US-MODERNATX, INC.-MOD-2023-694616, US-MODERNATX, INC.-MOD-2023-694623 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up included non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694616:Reporter case US-MODERNATX, INC.-MOD-2023-694621:Reporter case US-MODERNATX, INC.-MOD-2023-694623:Husband case
Breakthrough covid case. Pt presented to ER on 6/26/22 with c/o chest congestion, cough and malaise x 4 days. Hx of Pfizer vaccine x 3 doses. DC home.
Almost immediately, thumb (which was in recovery) went completely numb. Over the next few weeks, the numbness has faded to half of the thumb - half, cut down on the left side.
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was administered an expired 0.5 ml third dose of PENTACEL (Powder lot C5439AA, expiry date: 29-Oct-2018, Liquid lot C5264AA, expiry date: 26-Oct-2018) via intramuscular route in the left thigh on 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; and INFLUENZA for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse reactions 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. List of documents held by sender: none.
3 days following TDAP vaccine developed swelling, erythema & soreness to 2/3 of upper arm mostly distal to injection site. Bruising at injection site.
I started experiencing pain in my back left thigh. I then had pain/tingling in my hands, and some in my feet. The pain in hands became unbearable, as did the pain in my back thighs. I had pain/tingling in my calves, some in my upper arms. The pain was so severe! I have never had such excruciating pain in my life. My hands felt as if they were freezing, but someone touched them, and to the touch, they weren't.  My feel were cold and tingling as well.  I had a little pain in my neck. I couldn't sleep because of the pain and didn't sleep for 5 nights. I was restless and my hands were in so much pain and felt ice cold to me.
Pt complained of pain and stiffness in elbow joint approximately 5 min after injection.
Muscle and Joint pain 3 + days, Headache 3 days, dizziness 3+ days.  Shortness of breath still 6 days later. This was way worse than having the COVID.
2:40pm Patient reported feeling "weird" after seeing blood after receiving Pfizer vaccine. Patient's pulse was elevated and felt her "heart racing" and "nausea". Vitals taken every 5 minutes. Patient given 25mg of Diphenhydramine by mouth. Patient was alert and oriented.
Patient has been terrified of sleeping in her crib since the vaccine was administered. She acts panicked and desperate and has been sleeping in parents' bed in order to get rest. She has also increased her liquid  intake and dramatically decreased her solid food intake.
my arthritis has gotten much better; my arthritis has gotten much better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis and Arthritis. Concomitant products included GABAPENTIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 03-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better) outcome was unknown.            The patient reported that after her second dose of mRNA-1273 her arthritis has gotten much better. Consent given for Safety follow-up with patient. Consent given for Safety follow-up with HCP.
Developed Uticaria rash 5 days after 4th Anthrax shot.  Rash spread to distal forearms, hands, shoulders, face, back, upper chest, knees.  He couldn't work for 3 days because of sleepiness.  Treated with Atarax and prednisone.
This case was reported by a healthcare professional and described the occurrence of body feeling warm in a 31-year-old male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 4 October 2007 the subject received 1st dose of Flulaval at 0.5 ml in the left arm.  In the evening of 4 October 2007, less than one day after vaccination with Flulaval, the subject experienced body feeling warm, sweating and joint pain.  On 5 October 2007, the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with Flulaval.  Follow-up was received from the healthcare professional.  The subject had no relevant medical history.
Received 2nd dose of Moderna COVID19 vaccine on 3.8.2021. Patient developed high fever the next morning, had confusion/mental status change, and was not able to move his legs, and needed assistance to sit up. 911 was called and he was brought to hospital. His blood pressure was severely elevated. Patient had altered mental status with blood pressure 217/108. Patient was admitted and discharged on 3.16.2021. As per neurology MRI revealed acute to subacute stroke from hypertensive emergency which was propogated by the COVID vaccine. Since that time, he has been hospitalized several times for elevated temperature and change in mental status. Patient has been receiving speech therap
Red, swollen, warm, itchy upper right arm also indurated on exam.  Treatment: Benadryl and incase this is cellulitis: cephalerim orally.
Immediately following vaccination my daughter became not herself she was listless and had a high fever. She woke up from her nap covered from head to toe in hives. Her skin went from being smooth baby skin to dry as sandpaper and broken and bleeding constantly she suffered from this skin condition in its severity for over 6 months. I took her back to her pediatric doctor who couldn't find a cure for it also to a dermatologist and at one time we had an emergency room visit. She still is troubled by these hives as has not completely healed.
pt recvd vax jUL95 & post vax antibody titer was obtained in SEP95 & was found to be neg;pt was positive for antibodies against  MMR but was neg for hep A & hep B;MD questioned whether 4th dose of vax could be given
pt recv vax 19MAY95 & 21MAY95 pt devel  2-5 lesions;the following day had approx 15 lesions by 23MAY95 had approx 50 lesions;MD felt pts sx were probably a naturally occurring varicella; pt recovered; No further details were provide
Fully vaccinated patient (2 doses plus booster) admitted for COVID pneumonia and subsequently died.  Provider discharge note below:  "67 yo male, with PMH significant for follicular lymphoma s/p chemotherapy, HLD, OSA, and hx of one kidney (born that way), who presented to ED on 10/18/21 after testing positive for COVID. He had received all 3 COVID vaccinations, though is immunocompromised from recent completion of follicular lymphoma and chemotherapy.  CTA was done on day of admission and was negative for PE. Respiratory failure with hypoxia from covid pneumonia was initially managed on HFNC but respiratory status worsened and he was transferred to CCU on 10/27/21. BiPAP therapy was started and pt required precedex and fentanyl gtts to tolerate BiPAP.  He was treated with decadron and was fully anticoagulated with lovenox. Remdesivir was declined by pt due to having only 1 kidney. Regeneron was given on 11/3/21.  No improvement in respiratory status, and oxygenation was marginal despite BiPAP with 100% O2 with pressures of 18/12. Intubation was considered, but pt did not want to be intubated.  The pt developed SQ emphysema. Imaging did not show pneumothorax, but pneumomediastinum was seen on CXR 10/28/21.  Tube feedings were initiated for nutritional support.  Pt intermittently required pressor support for circulatory shock, initially with phenylephrine, then later with norepinephrine.  Ongoing discussions regarding goals of care and code status were held with pt and family throughout hospitalization.  Pt continued to decline intubation. Code status was changed to DNR/DNI but continue aggressive care.  Clinical condition continued to decline. PRN morphine was started for air hunger and comfort.  By 11/4/21, the pt was unresponsive, hypotensive and requiring norepi for BP support, oliguric with rising creat. Increased work of breathing on maximum BiPAP support with O2 sats ranging from low 70's to low 90's. Wife was informed that pt actively dying and no escalation of care added to code status.  The pt died on 11/5/21 at 1336 with wife at bedside. "
Redness at injection site 4 days, swelling of hands after a few weeks, woke up to her "chest pounding", a few weeks after injection.
Pt received Pnu-immune in right deltoid on 5/12/2000. On 5/13/00, pt experienced redness, swelling at injection site. On 5/14/00 pt became progressively worse. Went to ER on 5/14/00 and was admitted. Rule out cellulitis, osteomyelitis, allergy.
Dtap (dose number 5 in series) was ordered. Nurse administered Tdap instead. Provider made aware and mother made aware. No harm to child.
RAISED RED LUMP 4.3 CM BY 6 CM. AREA WAS WARM TO THE TOUCH AS WELL WHERE PROQUAD WAS ADMINISTERED.
Almost immediately after receiving the shot I felt my heart rate elevate. My neck was very warm. It took a good 1 to 2 hours for my heart to go back and for me to feel ok.