chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Red circular spots noted on face, torso, back and upper extremities. Denies itching or pain.
Local reaction at (L) upper arm laterally with swelling (3 x 4 cm) NT, mild warm. No erythema. Rx - cold compress and pain meds as needed.
Reports fever of 100.2 F approx 12 hrs after injection lasting approx 6 hrs.
Approximately 1 hour after vaccination  I had a severe headache (specifically in the lower back of my head) It was very unusual for me. I took a total of 4 Tylenol tabs. I had the headache consistent for 3 days then after that it was intermittent. I checked my blood pressure and it was (145 over 81) - I did a continuous check for 1 week and I had a consistent high blood pressure which is not normal for me. I called my Cardiologist for an appointment  tomorrow (01/27/2022) and up to this day 01/26/22 there's no improvement with either headache and my high blood pressure.
Patient experienced nausea/vomiting and lethargy approximately 10 minutes following vaccination. 15 minutes after vaccination, patient began to experience itching beginning around his neck, which quickly spread to the ears, eyes, legs, and throat. Patient did not have trouble speaking. Vital signs taken, age appropriate dose of Zyrtec administered. Patient was then evaluated by the pediatrician while a second set of vital signs were obtained. Patient then transferred to the ER for further evaluation. Patient did not required an Epi-Pen administration and walked to the ER one his own while escorted by a RN and parent.
Large local reaction of erythema, pain, warmth and swelling with body aches and malaise. Severe enough patient required a MD visit and treated with corticosteroids (oral and topical).
Major behavioral change. Screaming, irritability, major tantrums, not able to communicate, extreme anger, violence.
Patient waited additional 30 minutes after vaccine administration due to history of reactions.  Fine for monitoring at hospital when the patient left she had facial flushing and itching.
On 11/10 woke up with diplopia, felt very wobbly/ weak when standing. Called sister, to take to Urgency Room. Cat scan was able to rule out stroke/ aneurysm/tumor. Sent to Hospital Emergency Department - EKG and MRI - no abnormalities. Sent home and recommended Ophthalmology and Neurology. Appt for Ophthalmology - on 11/12 seen sinus pressure on MRI. Sent to ENT, ENT - seen same day at 2PM - wanted to drain sinus pressure but did not do Sent to Neurology - labs drawn, no infection seen with CBC. Admitted to hospital 11/12 admitted to Hospital - many tests done including CT/ MRI/ Spinal Tap on 11/15 diagnosed with Miller Fischer Syndrome and started treatment IVIG for 5 days. Sent home, residual symptoms - instability had improved, close up vision improving, soft palate function improving. Deep tendon reflexes continued to be absent. Follow up apt 11/30 with Neurology.
Pt developed headache the day following the vaccine.  It was severe the first week, limiting daily activities but then became more mild but lasted 4 weeks.
arm swelled up to 2x normal size and extended down to elbow. After 48 hours, arm is still visibly swollen. No redness, no temp, skin sl warm to touch. In process of recovery.
April 21, 2021 - After second shot, couched heavily and constantly for 4 days. 4 days later noticed dark blind spot in upper left vision. Went to eye doctor and was told it was floaters. 3 days later blind spot covered nearly half the vision in my left eye, went to ER. ER sent me to Retina Specialist in fear of retina tear. Retina specialist sent me for MRI as it was not retina related. Discovered Optic Neuritis in left eye and referend me to Neurologist. Neurologist admitted me into hospital for IV Steroids and PLEX. Released and started tapering off oral steroids. When tapering, right eye became affected and was determined to have Optic Neuritis as well. November 2021, second attack on optic nerves. Legally blind. April 2022, third attack. All known testing has been done and cannot be associated with any other disease/cause. Permanent vision loss bilaterally.
after the 3rd vaccine twinrix,  immediate fainting  by falling off of the chair on to the floor and one leg shivering for a minute. Came back to consciousness and didn't know what happened. Patient bumped the head to the other chair and got bruised
Patient developed baseball-sized area swelling around injection site and a rash that provider felt might be shingles on her right forearm.  Prescriber prescribed 7 day course of Valtrex 1gram three time daily and a 10 day course of Keflex 500mg three times daily.  Patient is to follow up with PCP if needed.
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L02946, expiration date: 06-AUG-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one the two reports received from the same reporter. Additional information has been requested.
Pruritic rash and immunization site inflammation - right arm 6/9/07 (vaccines 6/8/07)
Pt presented in office on 2/6/08 with rash starting 2/4/08 15-20 lesions
Got 3 punctured wounds from an animal and had to go to the urgent care; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (non-serious), outcome "unknown", described as "Got 3 punctured wounds from an animal and had to go to the urgent care". Additional Information: Caller's daughter got the Covid vaccine yesterday and then after getting the vaccine she went to work and got 3 punctured wounds from an animal and had to go to the urgent care. They want to give her a tetanus shot, but wasn't sure they could so they told her to call Pfizer first.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Tuesday, March 17th, 2021 I noticed that my upper left arm was really red, swollen, and warm around where I got my injection.  The redness starts at the top of my arm and measures downward about 6 inches in length in the shape of an oval. Today it is still the same size, red, warm, and itchy.   This reaction started a week after I received my Covid Moderna shot.
Wheezing, hives all over body, itching. Treatment: EpiPen, Benedryl. Hives and itching still present.
have it on my leg; Extreme pain; itching; numbness; burning cannot stand for anything to touch my leg; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: have it on my leg), pain (Verbatim: Extreme pain), pruritus (Verbatim: itching), numbness (Verbatim: numbness) and burning leg (Verbatim: burning cannot stand for anything to touch my leg). The outcome of the shingles, pain, pruritus, numbness and burning leg were not reported.   It was unknown if the reporter considered the shingles, pain, pruritus, numbness and burning leg to be related to Shingles vaccine.   It was unknown if the company considered the shingles, pain, pruritus, numbness and burning leg to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had one shingles shot. The patient had shingles on his/her leg.  The patient experienced extreme pain, itching, numbness, burning could not stand for anything to touch his/her leg. The follow up would not possible as no contact details were available.
pt recv vax 2SEP98 & 4SEP bili back up to 19.3;all other liver function tests, thyroid, etc WNL;
did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and she had a RSV vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 26Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for hypercholesterolaemia. Vaccination history included: bnt162b2 (Dose 1, single, lot number: EN6202), administration date: 29Jan2021, for COVID-19 immunisation; bnt162b2 (Dose 2, single, lot number: EN6208), administration date: 17Mar2021, for COVID-19 immunisation, reaction(s): "inappropriate schedule of vaccine administered"; bnt162b2 (Dose 3 (booster), single, lot number: FE3292), administration date: 11Oct2021, for COVID-19 immunisation; bnt162b2 (Dose 4 (booster), single, lot number: FJ4991), administration date: 09May2022, for COVID-19 immunisation; bnt162b2 (Dose 5 (booster), single, lot number: GJ6665), administration date: 12Oct2022, for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 6 (booster), single, lot number: RA5325), for COVID-19 immunisation. The following information was reported: SARS-COV-2 TEST POSITIVE (non-serious) with onset 26Oct2023, outcome "unknown", described as "did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and she had a RSV vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sars-cov-2 test positive.  Additional information: She stated that she tested positive for COVID while she was in hospital. So, she was given, treatment with Paxlovid which she took, her last dose on Monday morning. She previously received other COVID-19 vaccines in the past. She said they were all Pfizer although she may have got one that was Moderna. She did have a vaccine one month prior to tested positive for COVID, she had the Flu vaccine (Unspecified Flu vaccine) and on 26Sep2023, she had RSV vaccine.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
The vaccine did itch a little immediately, but that quickly stopped.  Later in the day, I noticed that my arm was sore if I touched the area.  The next morning when I showered, it was very painful to touch.  When I looked in the mirror, I could see that there was a swollen, hard, red area about four inches by two inches.  It was hot to the touch.  I considered going to a doctor, but I'm away from home and don't have a doctor in this area.  This area continued to grow.  By that night, it itched a lot.  On the third day, the red area had grown to about five inches by three inches, but the area was less defined.  Ice helps relieve the itching, but the pain had spread into my armpit.  The pain and itching have kept me awake each night.  Today, the fourth day after the vaccination, it is some improved.  The area is not as large and not as hard.  It is still warm to the touch. I have pain in my armpit, and it itches intensely.
Pts recv vax on unspecified date; on unspecified date pts exp rx of injection site of redness &warmth; soreness of entire arm of injection.  Pts imp in 48 hr.
This spontaneous consumer report (received on 26-APR-2013) concerns a 52 year old male patient, who had a medical history of penicillin allergies. At the time of the event, concomitant medications included simvastatin. In JAN-2013, the patient received the flu vaccine (batch number not provided) in his upper left arm only a few inches from his shoulders. The patient believed that the vaccine administered was manufactured by Merck. Since receiving the vaccine, the patient has had pain and discomfort in his arms and shoulders with any rotation or movements. The outcome was reported as not recovered.
stomach sick; diarrhea; did not feel right; felt weak; could not move around my herself; sore left arm; blood pressure was elevated; sugar levels were elevated; was shaking so bad, that she had 8 attempts to finally manage to get her sugar levels tested; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), BLOOD PRESSURE INCREASED (blood pressure was elevated), BLOOD GLUCOSE INCREASED (sugar levels were elevated), TREMOR (was shaking so bad, that she had 8 attempts to finally manage to get her sugar levels tested) and ASTHENIA (felt weak) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure on 06-Feb-2021, Cholesterol on 06-Feb-2021, Insulin on 06-Feb-2021, Diabetic on 06-Feb-2021 and Anxiety on 06-Feb-2021. Concomitant products included CHOLESTEROL and INSULIN INJECTION for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), BLOOD PRESSURE INCREASED (blood pressure was elevated), BLOOD GLUCOSE INCREASED (sugar levels were elevated) and TREMOR (was shaking so bad, that she had 8 attempts to finally manage to get her sugar levels tested). On 07-Feb-2021, the patient experienced ASTHENIA (felt weak) and BRADYKINESIA (could not move around my herself). On 08-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel right). On 10-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach sick) and DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (sore left arm), BLOOD PRESSURE INCREASED (blood pressure was elevated), BLOOD GLUCOSE INCREASED (sugar levels were elevated), TREMOR (was shaking so bad, that she had 8 attempts to finally manage to get her sugar levels tested), ASTHENIA (felt weak), BRADYKINESIA (could not move around my herself), FEELING ABNORMAL (did not feel right), ABDOMINAL DISCOMFORT (stomach sick) and DIARRHOEA (diarrhea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided
Delayed type hypersensitivity, localized (L) upper arm, itch & redness about 2 - 3 day, pealing at day #5.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 21-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Mar-2023 The reporter consented to follow-up by email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
SICK; COLD SYMPTOMS; SEVERE BODY PAIN; BLOOD PRESSURE VERY HIGH; COUGHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (hypertension).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced sick. On 2021, the subject experienced cold symptoms. On 2021, the subject experienced severe body pain. On 2021, the subject experienced blood pressure very high. On 2021, the subject experienced coughing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure very high, coughing, and cold symptoms, and the outcome of severe body pain and sick was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of GARDASIL lot number L035105, expiration date: 14-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was hospitalized via ambulance due to adverse side effects. Swelling at site of injection mostly on left arm. Patient was stabilized and discharged on same day.
This spontaneous report was received from a registered nurse refers to a 3 year old male patient. On an unknown date, the patient may have been vaccinated with a dose of M-M-R II, (lot#, expiry not reported). On an unknown date, the patient experienced speech delay. The patient sought medical attention-contacted the office. The outcome of speech delay was reported as not recovered. Additional information is not expected.
The client noted redness and a knot the size of a thumb print at injection site. Denies feeling itchy at the site.  Each day has gotten progressively more red and hot. Denies fever.  States she has used cool compresses.  Notes soreness in the arm, muscle and bone.  Sent pictures of her arm from the last few days.  Shared with Lead Immunization RN and Medical Director. Contacted RN and relayed instructions rec'd from Medical Director.
Patient stated the second day after getting the vaccine she became very tired and did not want to eat. She also stated that her seizures are happening more often. Patient stated that she also is doing a lot of twitching. Patient also has  a rash on the side of her face and chin. They disappeared and then came back. Patient also stated that she is feeling very depressed.
3 days after shots did not feel well. Then following day fever developed, next day she fainted in the shower (5/13/08). In the ER she had low WBC - platelet count and admitted for work up - in w/u splenomegaly. 8/4/08-records received for DOS 5/13-5/15/08-DC DX: Syncopal episode. leukopenia. Thrombocytopenia. Splenomegaly. C/O nausea, chills and leg pain on 5/11/08, followed by not feeling well, temperature 100.8. Fainting with loss of consciousness and hit elbow now swollen and tender.  Developed rash on back.
Patient stated that she had pain in the arm, and in progressed to the point that should could not lift or move. It went away and then came back 5 days later. She then went to and urgent care and was given anti-inflammatory and told to ice the arm.
Initial unsolicited report received from a pharmacist on 06-Aug-2018. This case involves an unknown demographic patient (age and gender not reported) who was vaccinated MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. It was reported that the 5 days apart the patient requested the B series and was given MENACTRA instead. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to drug dispensing error. It was not reported whether the patient had adverse event. 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 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.
Narrative: Pt developed rash/hives on his forehead, upper back, arms, and legs 4 days after receiving 4th Pfizer COVID-19 vaccine on 8/4/22. Pt stated he took diphenhydramine and used calamine lotion which initially resolved the hived, however, they started to slowly come back on 8/9/22. Pt was prescribed methylprednisolone dosepak and famotidine to use in combination with diphenhydramine which resolved the reaction.
Shot at 4:40PM, reacted by 9:30AM the following day. Extreme fatigue, nausea, diarrhea, aches all over body, back being really bad, mild fever and headache.
Started to feel tingling in left shin after vaccine.  Lethargic next day.  On 4-17-2021 Tingling in left fore arm and shin date.  Subsides some .  On 4-18-2021 tingling returned to shin and forearm.  Some in left groin area.  4-19-2021 tingling itching in left shin, some in groin, left face under eye. Injection site mild itch and tingling. Spoke with primary care provider who said monitor symptoms.
Breakthrough COVID first dose 9/21/2021 062E21A, second dose 10/19/2021 048F21A.  COVID positive 6/2/2022.  65-year-old obese, recent ex-smoker with a complicated past pulmonary history, which includes COPD with associated pulmonary hypertension as well as obstructive sleep apnea syndrome.  No recall on the amount of pressure used at home for CPAP and 2 L of oxygen therapy on an as-needed basis.  She is on a maintenance regimen that includes "p.r.n." Combivent, albuterol, Symbicort, Advair and Trelegy. With this background history, she seeks medical attention for a subacute course over the past 48 hours of worsening cough, nonproductive, associated with chest tightness, wheezing, headaches, fever & myalgias