chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.
This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of PEDVAXHIB, lot # L030868, expiry date 09-JUN-2018, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Pt recvd vax 6AUG92 & a few hrs later exp malaise, achiness in lt arm;later exp redness @ inject site; tx DPH;7AUG92 exp fatigue & gastrointestinal distress; became diaphoretic & gastrointestinal upset inc;h/a, dizziness & skin felt clammy;
Adverse reaction more than any vaccine I have experienced.  Approx. 12 hours after injection, rash covering stomach, pounding headache, chills (average), severe dry mouth, body aches (average), loss of appetite. Rash on stomach is still there 60 hours after injection. Aleve was taken as soon as reactions developed
The pt experienced a fever, then a rash developed which was non-pruritic. Mostly macular and some slightly papular pink lesions to the trunk and extremities. Rash persists upon exam.
2' red patch at injection site using Hydrocortisone Cream Redness seems to be fading on 01/25/2021
This is a spontaneous report from a non-contactable consumer received via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENDA on 22Jun2016, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in right calf when walking on an unspecified date in Jun2016 with outcome of unknown. No follow up attempts possible. No further information expected.
Felt panicky and nervous. Pulse 105 SPO2 97 B/P 110/78 Getting back to normal to go home.
12/29/2009 4:07:54 PM > had WCC and shots today at 1100.  Mom states that she was fussy just prior to shots being given.  Vomited x 4 since getting home (not just spit up), Right is swollen around injection site & seems very stiff (Pentacel given in this leg).  No fever.  Very irritable and not resting (I can hear her screaming while in another room). 12/29/2009 4:27:14 PM > apparent pertussis reaction with irritability after vaccination.  Recommend Tylenol at 0.6 cc of the infant drops every 4 hours around-the-clock x 24 hours.  Recommend lukewarm baths to help sooth the child.  Pedialyte p.r.n. this evening and advanced to regular feedings by tomorrow. 12/29/2009 4:34:59 PM > advised mom of MD rec, VU.
When I received the first Moderna vaccine on 02/23/2021 in my right arm at the public health dept., I was okay but feeling a little dizzy after the second day, In about two weeks from the shot on the 12th of March I passed out at my granddaughters home, my granddaughter said that I was saying I was hot and dizzy, she said I then sat down in the recliner and put my legs up and when I did she sat me up and I passed out. She said my lips turned white and my eyes rolled in my head and I was completely out of it for two minutes. EMS was called and the meds rushed here to assist me. I was hooked up to monitors in the home they could not get a pulse and heart rate reading. They said I was dead for around two minutes. I was then taken to the hospital where I stayed in ICU for around two days. They then said I had multiple blood clots in which my lungs where filled with them, it also effected my heart in which caused a blood clot from the heart to the lungs. I stayed those two days and then was sent home on blood thinners which I will be on for the rest of my life due to this vaccine. I was referred to many doctors in which I can list if needed.
Passed out; Feels worn out; Cramps like she never did before; Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 63-year-old female patient 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 was provided by the reporter.    On 20-May-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) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (Cramps like she never did before) and URTICARIA (Broke out in hives). On an unknown date, the patient experienced FATIGUE (Feels worn out). The patient was hospitalized for 2 days due to LOSS OF CONSCIOUSNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), MUSCLE SPASMS (Cramps like she never did before), URTICARIA (Broke out in hives) and FATIGUE (Feels worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Haemoglobin: abnormal (abnormal) out of whack.         The patient stated she experienced cramps like she never did before, broke out in hives everywhere, passed out, and now feels worn out. Th patient reported she did not experience any side effects from the first dose of the vaccine, which she received a few weeks prior. The patient noted she had never taken drugs prior to her second dose administration and she was perfectly healthy until now.  Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications, if any, were not provided by the reporter. Treatment medications also included steroids (unspecified) at the hospital, and an antihistamine (unspecified).  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 months old female patient who was vaccinated with a 0.5 ml of  FLUZONE lot UJ005AC expiry date: 20-Jun-2019 (frequency once) via unknown route in the left thigh on 28-NOV-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due overdose. It was reported that 2.5 years old received 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was not reported whether the patient had any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Bradycardia and hypotension; hypotensive for 2-3 hours; responded to 1 liter of normal saline. BP syst 80-90; pulse 45; 3 hours to recovery to go home.
2 days after the vaccination, 02/12/2021, my left hand was in such severe pain that I couldn't stand the pain. My left arm was  swollen like a balloon and very painful. By that night I was in so much pain in every joint in my body, that I couldn't given get up. On Tuesday, 02/16/2021, I went to the ER because I was in such pain I could not even walk and it wasn't getting better. Treatment given: IV and a pack of steroids. I was discharged after 3 or 4 hours. It has taken me months to get better. My hand was swollen for over 3 months and I had no feeling on the tips of my fingers, but it has subsided. Prior to my vaccine my thyroid was stable. My thyroid is now unregulated.
Pt has had pain in biceps and deltoid and trapezius since about 2-3 days, post vax. She denotes loss of function secondary to discomfort. No headache or fever. Clinical picture is with polymyalgia rheumatica.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: hypoglycemia, and concurrent conditions included: penicillin allergy, idiopathic thrombocytopenic purpura, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced low grade aching, low grade chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade aching, low grade chills, and fatigue. This report was non-serious. This case, involving the same patient is linked to 20211214362.
Information has been received from a nurse practitioner concerning a 23 year old female with no pertinent medical history and no drug allergy who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (lot# 0074). On 18-MAY-2009 after vaccination the patient has persistent aching in her left deltoid which is the area where she received the vaccination. She was seen in office and has been prescribed over the counter ibuprofen. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Flu like symptoms; Arm pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm and headache. On an unknown date, the outcome of the influenza-like symptoms, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient's wife reported the case. The reporter stated that, the patient had flu-like symptoms, arm pain, and a headache after receiving his Shingrix vaccine. No further information was provided. The reporter did not give consent to follow up.
Mom states pt cried all night the night vax recvd, & ran high temp; Mom reported rxn to MD & was told not to take Pertussis;
KILLED; This spontaneous report received from a consumer via media concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported) dose was not reported, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had death (killed) from an unknown cause. It was unknown whether an autopsy was performed or not. It was reported as "Just a quick reminder that the covid vaccine killed my Mom". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230363489-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient passed out after injection. Patient replied "no" to previous reaction to vaccine on intake form, but upon questioning stated that this happens every time he gets a flu shot.
Reports approx 8pm 8-5-15 that her (L) arm was red and swollen approx 2 inches in diameter from injection site of tetanus shot.  On 8-6-15 at 11 pm, she reports becoming nauseous & vomiting x 3 this AM (8-7-15) at approx 7:30.  Patient is unsure if nausea & vomiting if related to immunization or possibly food poisoning.  Reports taking Dramamine this morning for nausea and plans to continue use for nausea.  Advised to apply cold compress to site and Ibuprofen or other NSAID for swelling to area.  May also use Benadryl if needed.  Reports no fever or drainage from injection site.  Advised uncertain if nausea/vomiting related to vaccine, however, to monitor for fever for this as well and to insure hydration.  If she feels she is becoming dehydrated to seek medical intervention at MD or ER.
Pt experienced 2 episodes of left chest pain, over 2-3 hours, 2nd episode was associated with numbness and tingling of left arm and left leg. Presented with left chest pain and numbness and tingling of left arm and weakness of left leg on 9/19/06-had mild chest discomfort in past but never had numbness or weakness of any part of his body. Chest pain was not associated with SOB, cough, fever or headaches. on 9/15/06-annual PE WNL except for mild sore throat which resolved in a day or two. Received Menactra on that day. PMH: diagnosed to have mild Ehler-Danlos syndrome at age 11. Characterized with dermatitis and hyperflexible joints. No evidence of any cardiac abnormalities. PE: alert oriented, walking normally. Decreased cutaneous sensation on left forearm and lower left leg. Muscle power, tone, balance and reflexes were normal. EKG and blood normal. Neurological exam normal and was DC from ED with diagnosis of Costochondritis. Follow-up in office on 9/22/06 and 10/2/06. No further episodes of chest pain, tingling, numbness or muscle weakness. On 10/2/06 he mentioned for the first time that for the past several months he has been having mild-moderate morning headaches 5-6 times per week. No nausea, vomiting or visual problems. Referred to neurologist for further evaluation.
5 marks below shot (bl and blue ?). Took more than a week to heal. Hurt in the arm muscle.
Pt described her arm as "my deltoid was red and very painful". Pt reported swelling and pain approx 24 hours after injection. (L) arm involvement starting at top of shoulder to bicep/deltoid area. Pt treated with ice and alternating with MOTRIN and TYLENOL. Pt offered prednisone but declined.
mild headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (mild headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Colonic obstruction on 19-Feb-2021. Concurrent medical conditions included Urinary tract infection and Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified, CEFDINIR for Urinary tract infection, PARACETAMOL (TYLENOL REGULAR) for an unknown indication.  On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced CHILLS (Chills) and HEADACHE (mild headache). At the time of the report, CHILLS (Chills) and HEADACHE (mild headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Reported by mother- 3 inch in diameter, red, raised, warm are located around the injection site.  Administered Tylenol and applied ice.  No streaking and no systemic fever.
Large local reaction on arm, 10 cm x 3 cm area of erythema.
Breakthrough case admission after three doses Pfizer 3/15/21 Lot# EN6207 Pfizer 4/6/21 Lot# ER8733 Pfizer 2/8/22 Lot# FM0698
Severe flu, violent shaking, 101 fever, stomach ache, headache. Did I say severe flu. So sick, I couldn't drive myself to the ER. Took 3 days to act normal.
Venous Doppler on left leg, 2 blood clots found.  Taking Xareto.
Tachycardia and palpitations, received IV medications in the hospital, currently has a heart monitor
left facial paralysis starting on the second day after the booster shot. Symptoms include: eyelid difficulty raising, drooping lips, cannot chew, headache, ear popping
Information has been received from a nurse practitioner concerning a 6 year old black male with no known medical history who on 4/21/98 was vaccinated in the right arm with the first dose of varicella virus vaccine live. Concomitant vaccination on that same day included the fourth dose in the left arm of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 7L81673) and the fourth dose PO of poliovirus vaccine inactivated (lot #776A1). There was no illness at the time of vaccination except for a slight fever. The NP reported that on 8/28/03, the subject developed a vesicular rash on the right temporal area, laterally around the right eye and upper lid. It was noted that the vesicular rash did not cross the mid-line. A diagnosis of shingles was made. Unspecified medical attention was sought and the patient was treated on an outpatient basis with acyclovir. Within a couple of days, the vesicles crusted over and the patient's shingles subsequently resolved. The NP also reported that another patient developed shingles after being vaccinated with varicella virus vaccine live. Additional information is not expected.
woke up with lots of soreness /body hurts; fatigue; temperature is 102.6degF /Tylenol is not reducing his temperature; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up with lots of soreness /body hurts), FATIGUE (fatigue), PYREXIA (temperature is 102.6degF /Tylenol is not reducing his temperature) and MYALGIA (muscle aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 022M20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included INSULIN HUMAN (INSULIN RAPID), INSULIN HUMAN INJECTION, ISOPHANE (INSULIN N), METFORMIN, LOSARTAN, GLIPIZIDE and FISH OIL for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (woke up with lots of soreness /body hurts), FATIGUE (fatigue), PYREXIA (temperature is 102.6degF /Tylenol is not reducing his temperature) and MYALGIA (muscle aches). At the time of the report, PAIN (woke up with lots of soreness /body hurts), FATIGUE (fatigue), PYREXIA (temperature is 102.6degF /Tylenol is not reducing his temperature) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
itchy; rashes; 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 PRURITUS (itchy) and RASH (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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy) and RASH (rashes). At the time of the report, PRURITUS (itchy) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Fever, very sore, red, hot, swollen entire upper arm and under armpit into chest, distinct red lines running down torso under right arm, feeling ill, vomiting, difficulty breathing. Came home from getting vaccine complaining of pain approx. 3 hrs. later, got fever (100.8) and increasing pain with swelling starting about 8 om. Went to bed with ibuprofen for pain/fever, awoke 1 am in pain, more ibuprofen. Awoke next morning (7a) in pain, (gave BENADRYL and ibuprofen) very swollen and large red area around site. Visit to dr - gave more BENADRYL circled site - advised to call if extends beyond border or pain worsens. About 8 p gave more BENADRYL, swelling getting worse, redness intensifying, complaining of extreme pain. Gave ibuprofen and BENADRYL every 6 hrs. Awoke in morning vomiting complaining of more pain, redness traveling up/down arm into chest, very swollen, saying she felt terrible. Was instructed to go to ER - admitted, breathing difficulty/wheezing.
Joint pain. Weakness, tired. Fallin asleep. Edema (legs, arms, joints). Symptoms started 15 days after shot.
Patient experienced headache, fatigue, chills and fever for a day and a half following the vaccination. Then those symptoms went away, she then noticed a red bump/bubble slightly lower on her arm than her injection site that appeared 2 days after vaccination. The red area was warm to the touch and the patient stated slightly painful to the touch and had grown since she had first noticed it.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by healthcare provider, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown. The reported considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).