chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26MAY91 pt became feverish, irritable @ 1PM; Given APAP q 4 hrs; @ 11PM t105, had 1 grand mal sz; Taken to ER via ambulance; 27MAY91 9AM t103, taken to family MD dx rt otitis media & acute pharyngitis;
From initial info received at manufacturer on 8/29/02, it was reported that an 18 y.o. male received a vax of Menomune A/C/Y/W-135 on 8/28/02. The PT developed red spots on his neck, shoulder and back, but no respiratory difficulties.
Pt called reporting that she had a fever after getting vaccinated. She also reported that the injection site was red and swollen and that area was "the size of her hand".
[she] does not appear to convert the vaccine to immunity/ she is not showing serological immunity/ she "may be part of a group of people that does not achive immunity/ "titer tests" performed "in 23-08-2022; [she] does not appear to convert the vaccine to immunity/ she is not showing serological immunity/ she "may be part of a group of people that does not achive immunity/ "titer tests" performed "in 23-08-2022; Caller states that she was also administered "booster" MMR on 1/6/2011 at 20 years of age and 2 more MMR vaccines; MMR stating she received MMR as a child on the following date: 31-JAN-1992; This spontaneous report has been received from a female medical assistant (also reported as a nurse) via a Merck employee, referring to herself when she was 15 months old. The patient's historical condition, current condition and concomitant drugs were not reported.  On 31-JAN-1992 (product administered to patient of inappropriate age) (the interval time was calculated as 465 days based on the patient's DOB and first vaccination date, which was more than 15 months of age) and 01-JUN-1995, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), respectively. On 06-JAN-2011 at 20 years old and 11-FEB-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot#: 1740Y has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 11-DEC-2011; lot#: K014832 with expiration date:14-SEP-2016) (extra dose administered), respectively. In 2017, she had had titer tests performed, which result was not provided. On 01-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot#: R001659 with expiration date: 17-JAN-2020). The indication for suspect vaccine was prophylaxis. The dose for suspect vaccine was 0.5 ml. The strength and route for suspect vaccine was not reported.  She recently had suspect vaccine titers drawn on 23-AUG-2022, which results showed rubella antibody was less than 0.90 AU/ml (rubella antibody negative), measles antibody was less than 13.5 AU/ml, mumps virus was 9.13 AU/ml. The patient was informed that she was not showing serological immunity (vaccination failure). She stated that a medical doctor informed her that she might be part of a group of people that does not achieve immunity. The patient stated she could be contacted via email. The outcome of the rubella antibody negative and vaccination failure was unknown. The causality assessment between the vaccination failure and suspect vaccine was related. The causality assessment between the rubella antibody negative and suspect vaccine was not provided.
5/9/05 Mother reported via telephone child had hives on right arm at the site of injectionafter receiving immunizations 5/4/05.  Also developed high pitched, wheezing cough pm of 5/4/05.  The child had fever for three days after immunizations were administered.  Hot packs were applied to right arm which relieved discomfort.  Mother also gave the child Benadryl for the hives.  Plans to see physician regarding immunization reaction.
Flu-like symptoms to include fever, headache, body aches, nausea, extreme tiredness, pain, redness, swelling, hard knot the size of an Olympic medal at injection site, chills, swollen lymph glands, all of which began late in the day the injection was given (11:00 in the morning) and lasting for two full days, fatigue and arm soreness, redness and knot lasting into the third day. (today)
Tingling & burning sensation throughout entire body; rt arm around inject site red, swollen & painful; muscular aches down rt side & arm & side of neck; pain in whole upper arm to elbow; redness @ inject site & extending to underarm;
pain at injection site; This case was reported by a consumer via Shingrix GSK and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix vaccine and experienced pain at injection site. The patient was enquiring if he/she could take Tylenol or Ibuprofen to relieve pain at injection site. Follow-up would not be possible as no contact details available.
Arm swelling at injection site with severe pain. 12 hours later redness developed at site. Approx 10cm ring of redness. Tylenol, ice, and Benadryl given. 48 hours later still with pain, swelling, and redness, although lessened in severity.
RESTLESS LEGS SYNDROME LIKE FEELING; FEELING THAT I HAVE TO MOVE THE LEGS; CRAMPING OF BOTH LEGS, CALVES AND BEHIND THE KNEES/CRAMPING OF BOTH THIGHS AND HAMSTRINGS; TIGHTNESS OF BOTH CALVES; PINS AND NEEDLES FEELING; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had No known drug allergies. The patient had No History of chronic illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A,  expiry: UNKNOWN) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2020, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 28-OCT-2021, the patient experienced restless legs syndrome like feeling. On 28-OCT-2021, the patient experienced feeling that i have to move the legs. On 28-OCT-2021, the patient experienced cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings. On 28-OCT-2021, the patient experienced tightness of both calves. On 28-OCT-2021, the patient experienced pins and needles feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pins and needles feeling, restless legs syndrome like feeling, cramping of both legs, calves and behind the knees/cramping of both thighs and hamstrings, tightness of both calves, and feeling that i have to move the legs. This report was non-serious.
swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as  vaccine received)
vomiting; head ache; nausea; arthritis pain in my hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands) 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 VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands). At the time of the report, VOMITING (vomiting), HEADACHE (head ache), NAUSEA (nausea) and ARTHRITIS (arthritis pain in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Non-serious case received from a patient's parent on 30 September 2009. A nine-year-old female patient experienced upper lip swelling two days after receiving an intramuscular left deltoid injection of FLUZON (lot number unknown) and a dose of hepatitis vaccine (type, trade name, manufacturer, lot number, route/site not reported). The lip swelling was relieved by treatment with BENADRYL. Three days post-vaccinations, the patient's upper lip swelled again and was relieved by BENADRYL. Four days post-vaccinations, the patient experienced lower lip swelling, relieved by BENADRYL. At the time of the report, the patient's outcome was unknown. Documents held by sender: None.
Pain at injection site radiating down the arm with numbness and tingling in fingers, sever pain in elbow and forearm
on 28JUL98 pt recv 2nd dose of vax, 29JUL98 pt devel injection site bruising, then on 14AUG98 the pt devel ``localized rxn'' described as a wheal, which was red, hot & 1-1.5 inches in size.
Headache, Fever, Diarrhea, NauseaVomiting, malaise Narrative:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age, unknown gender. On an unknown date the patient was vaccinated with GARDASIL (lot number, route, site and dose unspecified). The patient was administered the first two doses in the GARDASIL vaccination series "two years ago" (date unspecified) and the patient would be administered the third dose in the GARDASIL series on 20-MAY-2013. No adverse effect reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Fever 100.9 F, chills,  body myalgias,  multiple joints arthralgias, injection site soreness, generalized weakness for 24 hours. Self treatment: Acetaminophen 650 mg every 8 hours x3 doses , hydration and bedrest for 1 day. Symptoms  completely resolved in 24 hours.
Within 12-24 hours, patient noted to have altered mental status - transferred to ICU where it was later discovered that patient had an intracranial hemorrhage
COVID breakthrough. Patient is asymptomatic and tested for unrelated reason but came back COVID positive.
got achy; runny nose; don't feel well; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-DEC-2020.  This case involves a patient of unknown demographics who was achy, had runny nose, and did not feel well from the shot (Pain, Rhinorrhoea, Malaise), while having received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got achy, runny nose, and just did not feel well all over from the shot this year for about 4 days (Pain, Rhinorrhoea,  Malaise).  It was not reported if the patient received a corrective treatment for the events.  The patient had recovered from the events, at the time of reporting.  There will be no information available on the batch number for this case.
Vaccination was given subcutaneous instead of Intramuscularly.  Patient had redness and pain in injection area, hard knot in center of injection area, hot to the touch, and itching in injection area day after vaccination.  Patient took benadryl and tylenol to help with itching and pain  Did improve slowly over the next 3 days.  Redness and pain was improving 4 days after vaccination
Patient came in to clinic for immunizations. Patient is a 7 year old female. Patient needed a Td vaccine and received a DTaP vaccine.
whimpering & crying temp @ ER 103-mom stated took temp & it was 105 axillary;rx APAP & Ibuprofen;
12:00 am - 2:00 am: chills, minor headache, body aches, low grade fever 5:00 am - 11:00 am: headache, body aches, hot flashes 11:00 am - now: minor headache, body aches, fogginess, minor weakness No treatment
Chills beginning at 8pm and continuing until 3pm, lower pack pain, fatigue, rapid heart rate.
The pt experienced soreness which began on 5/16/2001. A red area with warmth to the touch.
Paramedic reports patient feeling dizzy and sweaty. VS are manually taken with values BP 97/70, P-62 and o2-99. Patient lies down and legs are raised. Doctor R. is notified. He's left in observation. Patient responds to treatment, VS are retaken BP 112/80, P-75, o2-99. Patient leaves the clinic with his wife oriented X3.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 12-NOV-2015 at time- 04:25, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L004754 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Violent Headache 3 plus days, fever for 2 days. Fatigue.
Chills; Lethargic after 2nd SHINGRIX vaccination on 6/16/2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown date patient received 1st dose).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills) and lethargic (Verbatim: Lethargic after 2nd SHINGRIX vaccination on 6/16/2023). The outcome of the chills and lethargic were not reported.   It was unknown if the reporter considered the chills and lethargic to be related to Shingrix.     It was unknown if the company considered the chills and lethargic to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The patient received 2nd dose of Shingrix. Patient experienced chills and being lethargic after the vaccination.
Temperature 104F; injection sites raised - larger than the size of a quarter on both legs.  Injection sites on right leg - purple in color also.  Decreased appetite and fluid intake parents using Motrin every 6-8 hours when needed.
I noticed my eye, could not see properly, the light was bothering me so bad. I could not open them up. It felt like I had cotton in them. The day after my vaccine, I woke up and went outside to go to work, I could not see, my eye were very sensitive. At work a nurse looked at my eyes and my eyes were fully dilated at 9mm. I called my PCP and she told me to go to the ER. By the time I got to ER, my BP 205/190, thought I was having a stroke. I got a CT scan, EKG, some blood work and they said I was okay but they could not figure why my eyes were like that. They told me after few hours, to follow up with a neurologist and an ophthalmologist.  I also saw a Dr., neurologist. I went to ER at local medical center. I also went to an eye doctor. My right eye keeps dilating still right now and ever since my eyes starting this dilation thing, I can not see up close. I have to wear glasses now.  When my right eye gets dilated, I feel a pressure sensation and also get a lot of headaches. I always had migraine on and off through my life but since the vaccine I have never had eye problems. Ever since the vaccine, I have constant headaches. I do not have lot# to provide.
About 15 minutes I started feeling a burning sensation all over my body. I went home and my symptoms got progressively worse. I continued to have a numbing and tingling all over; chest pain and a hard time swallowing I went to the emergency room, and I was given 500cc's of SOLUMEDROL via IV. My blood pressure was also high at 186/90.
Patient received Td injection on 06/16/06 and contacted the doctor on 06/19/06 stating that he developed a fever (101.9F), weakness and body aches later on in a  day after receiving Td injection. Patient took 2 capsules of Advil and the fever was gone in 5-6 hours. On the day of the call (06/19/06) patient felt better but still had a fever of 101.5F. Follow up received on 06/27/06: Patient completely recovered.
Nurse documented that Hepatitis A Adult formulation was administered when a pediatric/adolescent dose should have been given.
Information has been received from a physician assistant concerning a 14 year old female with penicillin allergy who on 13-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  On 13-AUG-2007 the patient experienced insomnia and has had trouble sleeping every night.  The patient took BENADRYL for a couple of nights to help sleep and it did help a little.  The patient has not been consuming caffeine.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Approximately 8 months after my first Covid-19 vaccine, I developed firm, painless lumps on my face.  On May 15th, 2021, I visited my dermatologist and had hyaluronic acid fillers injected along my cheek bones and around my nose and mouth. I had a second round of filler injections on May 28th, 2021. It was determined that the lumps (aka, granulomas) were most likely a result of an overactive immune response related to the Covid-19 Vaccine.
Strictly my heart racing. It felt as if I ran, a marathon, It was beating that fast. And all I was doing it sitting a chair. I didn't pay it any attention until I took a covid test the next day. I received the results and I had covid.
Patient mild ill appearance, erythematous rash over sternum.  Also bright red erythema around injection site warm to touch, approx 5-6 cm.  Pt complained of flu like symptoms, fever, shortness of breath.  Patient treated with KEFLEX for local infection and with fluids/rest for the "flu like" symptoms.
This spontaneous report as received from a physician refers to a 6 month old infant patient. Drug allergies, reactions and medical history were not reported. On 19-DEC-2013 the patient was vaccinated with an expired ROTATEQ (oral, lot # H010052, expiration date 02-NOV-2013, dose 2 ml). No concomitant medications were reported. No adverse effect were reported. This case is linked to the same reporter cases MARRS 1402USA013045, 1402USA013519 and 1402USA013520. Additional information has been requested.
night of vaccine had joint pain in both feet, both ankles, back pain, hand pain ongoing now for 3 weeks
Pt was admitted to clinic with warm red areas on bilateral upper extremities.  Pt rec'd vaccines on 6/3/09. MENACTRA in (R) arm and Tdap in (L) arm IM.  Pt warm, red swollen area on (R) arm measured 5.5x3.5 inches; warm red, swollen area on (L) are measured 3x1.5 inches.  Pt treated by Dr., Dx- Rash + non specific skin infection, started septra 05x10 days.
13 minutes post vaccination (while still being observed) this person began to experience some nausea and weakness. She was assisted to move from chair to an available bed where her blood pressure (154/94), pulse (73) and Sp02 (90% on RA) were collected. 5 minutes later her BP had increased to 166/100, HR was 68 and Sp02 was 91% on RA. EMS was activated at 1005am and assessed this person and eventually transported her to the ER for observation/follow up with a provider. She was observed and sent home and advised to receive the second dose of this series as scheduled. When I spoke to the person she reported that she had no reservations about 2nd dose and would return as scheduled.
4.5 hours after second dose of Moderna sudden face/chest flushing, hot and red for about 1.5hrs, red and hot area 30x10cm on the right arm (non-vaccine arm), redness at the vaccination site for the same time length.  Symptoms started to subside slowly after 1.5hrs, at the same time took cetirizine hcl 10mg, symptoms resolved fully at about 2-2.5 hrs after onset.
Case PHEH2016US028853 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to elder female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in right deltoid on 12 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
Left arm basilic vein thrombophlebitis. Onset of left elbow/forearm pain on 25 OCT 2021 (12 days post vaccination). Ultrasound confirmation of thrombus extending from mid-forearm to proximal upper arm on  01 NOV 2021. Treatment with aspirin and NSAIDs ongoing.
Checking Heartbeat level and noticed that it was different, first time I listened it was 26, checked again and it was 64. I took him the ER, did EKG and it looked fine but continued to have irregular rhythm, saw Pediatrician on 09/4/2022 and saw his regular Cardiologist 09/08/2022. Did a chest X-ray and ordered an Echocardiogram on 09/29/2022.
a patient was given back to back Flublok vaccines in different arms, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 56 years old male patient who was given back to back 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number QFAA2017 and expiration date:30-Jun-2021 (same batch numbers of both regimens)) via intramuscular route in different arms that is one in the right deltoid and other in the left deltoid as prophylactic vaccination on 15-Sep-2020 (extra dose administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive concomitant medications.  It was an actual medication error case due to extra dose administered (same day latency).  No adverse event reported at the time of reporting.  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.