chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced chills; experienced fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient experienced fever and chills after vaccination. The reporter asked because of the Coronavirus is it safe to get the booster shot or should I delay. The reporter asked if experience these side effects does it compromise immune system making more vulnerable to getting Coronavirus.
mild side affects from the second shot /chills; mild side affects from the second shot /headache; mild side affects from the second shot / body aches; This case was reported by a consumer via media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had got both the shingrix shots and it was not covered in his Insurance.It cost him 190 dollars for the first and 100 dollars for the second. The patient had some mild side affects from the second shot like chills, headache and body aches. Patient had taken Tylenol as a treatment drug but it could not help. Consent to follow up was not asked.
Information has been received from a female patient with no medical history or allergies who in approximately October or November 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included LIPITOR, esomeprazole magnesium (MSD) and unspecified thyroid medication. In November 2007, after vaccination, the patient began itching uncontrollably. She then developed boils that never erupted and some of the boils looked like chickenpox on her groin area, buttocks, and chest. Unspecified medical attention was sought. Unspecified blood work was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Rash, macular in some spots, maculopapular in other areas, more in face, chest and abdomen lasted for 3-4 days. Rash appeared 24-30 hrs after immz.
pt recv vax 2JUL97 pregnancy confirmed 28OCT(7, LMP 3rd wk SEP97;miscarriage D&C 3DEC97;
Myalgia  12/24 pm Swollen Lymph node above R side clavicle, then progressed to 2 more swollen Lymph nodes-total 4 by 12/30 12/30 am chills  Narrative:
Headache that has not gone away; vomiting; diarrhea; fatigue; soreness of the joints.
-large welt at injection site after 12 hours, lasted for 1 week  - fever, chills and body aches after 24 hours., lasted for 24 hours. - Eyes irritated- feel like they are coated with something and skin around eyes is itchy, still going on.
Very mild, no systemic symptoms, just localized swelling and a few papules at injection site
Last period was in August 2021, and since I've had both shots, I have not had a period since.
Per recipient, 11/24/21 was out of state when experienced significant heart palpitations, felt like heart racing out of her chest, concerned having heart attack, migraine with loss of vision to right eye, had not had a migraine in a long time but when occurs usually presents as visual disturbance rather than pain, concerned might be having a stroke, took Excedrin Migraine, didn't feel right, heart palpitations increased, couldn't catch breath, called doctor on 11/29/2021 and instructed to go to ED, went to Hospital Emergency Department at 2 PM, short of breath, memory issues, D-Dimer elevated, kept in hospital for 24 hour observation, diagnosis pulmonary embolism, Lovenox 90 mgm, twice a day began 11/29/21 continued through 1/11/22, then reduced to 80 mgm twice a day with plan to continue through 5/22 and then reevaluate.
A HCP reported that an 11 year old female received Flu Shield vaccine on 02-JAN-2002 at 10 AM. The pt's concurrent illness includes Lupus. The pt was enrolled in an unidentified research study at the time of immunization. On 02-JAN-2002 at 2 PM she "lost her vision" and could only see light and dark. On 02-JAN-2002 she was admitted to the hospital and a work-up was negative. The reporter noted that this symptom may be due to a "Lupus flare up" but is not certain. The pt was discharged from the hospital and her vision is improving. No additional information was available as of the date of this report. Follow up info received 5/6/02, from healthcare provider via telephone. The pt recovered within three days of onset. She was discharged from the hospital on 1/5/02. The pt was re-admitted to the hospital for another episode of blindness due to another lupus flare-up. The reporter is "confident" the blindness was not caused by Flushield but was caused by a lupus flare-up. The pt is being treted with anti-inflammatory agents (not identified). Follow up also include dpt's date of birth.
Numbness and tingling of the face and interior of mouth/tongue.  Began 40-60 minutes after the injection, and lasted for 30-45 minutes. A 25mg Benadryl had been taken roughly ten minutes prior to the adverse event beginning. The Benadryl was taken for preventative reasons.
Woke up every 1 1/2 hour all night.  Sore joints, headache, body aches , tiredness, weakness,
Swelling of hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of hands). At the time of the report, PERIPHERAL SWELLING (Swelling of hands) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.   Reporter did not allow further contact
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:49 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 16-Sep-2021 at 11:49 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 11:49 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported.   Reporter did not allow further contact
Patient showed a blister like lesion on the spot where she got her vaccination. The skin looks like a blister but it is not painful or itchy. It looks like an oval shaped lesion (oval pea size) that is red/pinkish and is shiny (such as stretched skin/new skin that looks like is healing). Pt reports having the lesion for a year and does not go away. She made her doctor aware and asked her to monitor.
Patient received first vaccine in Left Deltoid(T-Dap). Patient did well with that vaccine. Then patient had MCV4(MenQuadfi) injected in Rt arm. Immediately patient stated that he could not see & hear out of Rt ear. He was profusely sweating & hot. I started talking with him & had mom to keep speaking with him. We used a cold compress on neck & cold wet compress on forehead. Patient did state he thought he was going to get sick. He did dry heave in the trash can. We than got him a juice & crackers. He sipped slowly on the juice & ate crackers. Patient never passed out. He started feeling better after the juice & crackers.
Fever at 1100pm 3/31/21, muscle soreness from the start of injection, a little nauseous around 1100pm 3/31/21.
Abdominal muscle spasm, weakness, fatigue and constipation. Went to ER. No treatment.
spasming pain; Couldn't lift her head; Neck spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced MUSCLE SPASMS (Neck spasms). On 19-May-2021, the patient experienced HEAD DISCOMFORT (Couldn't lift her head). On an unknown date, the patient experienced PAIN (spasming pain). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. On 21-May-2021, MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment narcotic (unspecified)  for pain medicine.
Experiencing a side effects after getting vaccinated a couple months ago; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing a side effects after getting vaccinated a couple months ago) 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 VACCINATION COMPLICATION (Experiencing a side effects after getting vaccinated a couple months ago). At the time of the report, VACCINATION COMPLICATION (Experiencing a side effects after getting vaccinated a couple months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.
Information has been received from a registered nurse concerning a female (16 or 17 years old) who on an unknown date was vaccinated (route unknown) with a first dose of Gardasil (Lot # unknown) and fainted.  The nurse indicated that she did receive 4 total vaccines (therapy unspecified) when she fainted.  Subsequently, on an unknown date, the patient recovered.  The nurse also reported that the patient had received her second dose and was fine.  Additional information has been requested.
Pt said she felt like she "was dying". Said she's always been healthy up until the vaccine. When I talked to her on the phone, she sounded like she had trouble breathing. She said her vision is dim, has rectal bleeding, body aches. I advised she seek medical help immediately, but she said she doesn't have a primary provider. I told her to go to emergency room or urgent care
This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. On an unknown date, unspecified number of unspecified patient was vaccinated with ZOSTAVAX, (lot#, route, dose and indication were not reported). On an unknown date, the patients were experienced arm pain when ZOSTAVAX was administered. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
p/vax pt c/o trouble breathing;c/o h/a, trouble breathing;c/o severe h/a, heart pounding;SOB, fever 102;allerg rxn;
This case was reported by a physician and described the occurrence of anaphylaxis in a 10-year-old male patient who received TWINRIX. Co-suspect products included ADVAIR inhalation powder for an unknown indication. On 1st March 2018, the patient received TWINRIX. On 28th February 2018, the patient started ADVAIR at an unknown dose and frequency. On 3rd March 2018, 2 days after receiving TWINRIX and 3 days after starting ADVAIR, the patient experienced anaphylaxis (serious criteria GSK medically significant and life threatening). TWINRIX was continued with no change. ADVAIR was discontinued on 1st March 2018 (Dechallenge was negative). Rechallenge with ADVAIR was positive. On 4th March 2018, the outcome of the anaphylaxis was recovered/resolved. The reporter considered the anaphylaxis to be related to TWINRIX. It was unknown if the reporter considered the anaphylaxis to be related to ADVAIR.
This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016). On 14th October 2014, the patient received ROTARIX (oral). On an unknown date, the dose was an unknown dose. On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: RN reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician office that day to receive the vaccine and diluent product. No AE's were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over Vaccine manufacturers.
Received booster vaccine without symptoms and positive antibody serology test. Day 3 after vaccination had headache, fever (100 F), sore throat, body aches and inability to perform ADLs. Day 3 after vaccination + COVID antigen test, continuation of same symptoms. Day 4 after vaccination, + COVID PCR test, continuation of same symptoms. Day 5 - continuation of same symptoms. Day 6 and 7 (today) - no fever, however continuation of body aches, headache and new onset chest discomfort.
Patient called stating her arm is still extremely sore, inflamed and red. She did state it is getting better. She is icing it to help with inflammation.
BODY PAIN; BODY HEAVINESS; FELT TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: UNKWON) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced body pain, body heaviness, felt tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt tiredness, headache, body pain and body heaviness was not reported. This report was non-serious.
Onset 48 hrs. after injection. 2 areas of swelling near site of injection 1.5 & 1.0 cm - left deltoid. Slightly tender with palpation - slight itching.
Taste disturbance--still has bad taste on 3rd day after shot. The night of the shot she woke up and could not place words--she could think the sky was blue for example but couldn't come up with the word blue. She also felt very disoriented and could not read her writing when she wrote out words.
This was the patient's 4th dose (2nd booster) and she was supposed to receive 0.25 ml but instead received 0.5 ml (the third dose volume for immunocompromised patients). Patient is not upset and has not experienced any side effects yet.
The pt developed fever, erythema, discomfort and swelling on left upper arm. Treated with pepcid, steroids, Benadryl and Audptic
Pt to receive FLUZONE 0.25 ml, but received FLUARIX. MD order and electronic medical charting stated pt. received FLUZONE; however, mother of child (who is a MA) noticed the differences in syringes and stated both of them received the same vaccine. At this time, no known complications noted.
pt exp strange sensation down arm, & up into neck & chest 10min p/vax on 11OCT96;pt described it as like but not really numbness;it lasted about 45min & there were no residual effects other than soreness @ the site;also exp a migraine h/a;
06/21/2003: Rash swollen patches of red bumps on posterior neck, cheeks, under eyes and on legs.  Diagnosis after viral examination.  06/26/2003: Doctor visit.  06/26/2003.
Pt's right upper arm became red, swollen and painful to move. Symptoms started AM after shots were given. Redness and swelling extended from shoulder to below elbow. Symptoms began improving 4 days after shot given.
shot site very painful;extreme dizziness;equilibrium was effected, even setting in a chair;severe h/a comes & goes;pain goes to dull ach;had to take sick leave;home & in bed;
This case was reported by a nurse via call center representative and described the occurrence of whiteheads in a 36-year-old male patient who received RABAVERT (batch number 626011A, expiry date 31st March 2020). On 28th February 2017, the patient received RABAVERT. On 28th February 2017, less than a day after receiving RABAVERT, the patient experienced whiteheads, pain and feeling abnormal. On an unknown date, the outcome of the whiteheads, pain and feeling abnormal were unknown. It was unknown if the reporter considered the whiteheads, pain and feeling abnormal to be related to RABAVERT. Additional details were reported as follows: The patient had white pimple like bumps on his left arm, opposite of the injection site. The patient was not feeling great, which was clarified as feeling achy.
Severe body aches continuing for 36 hours post-vaccination. Unable to do activities of daily living.
Patient went to waiting room to wait 15 min following vaccines. She got up during this wait time and went to the restroom. While standing at sink after using the toilet she fainted and hit her L forehead/L eye brow on the floor. Mom called from the bathroom for help and Dr and I both went to help. I found her on the floor on her left side, unconscious, I rolled her over to her back and she opened her eyes. Mom sat her up. Patient did not communicate verbally (normal for her) but would nod yes/no. I asked where she had pain and she pointed to her forehead/L eyebrow. Dr and Mom carried patient to an exam room and we had her lay down on exam table. She looked quite pale and tired, initial BP was low 78/60, HR 45. Patient denied feeling nauseated but admitted to feeling tired. We sat her up, gave her applesauce and some water. Mom reported she had not eaten anything yet today. I had her lay down to rest. 10 min later we rechecked BP which was 100/76, HR 60-70s, color in face much improved. Patient ready to sit up. Sat for 5 minutes w/o any recurrence of symptoms so helped her stand. She left office in stable condition, exam normal except for a bruise to L forehead/eyebrow. Instructed Mom to keep her home today and be sure to feed her prior to her booster dose of HPV in 6 months.
Immediately developed itching to back of throat and both hands.  Then stated a "strange" sensation on tongue, but no swelling observed.  Symptoms resolved on their own in approx 10 minutes.  Per the attending physician, patient given benadryl 25mg PO.
Fatigue started a few hours after receiving the booster shot.  Overnight, body aches began.  Also developed occasional chills lasting a few days.  Body aches lasted for four days.  Fatigue continues today (six days) after receiving booster.
This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced myalgia, fatigue and shivering. On an unknown date, the outcome of the myalgia, fatigue and shivering were recovered/resolved. The reporter considered the myalgia, fatigue and shivering to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced myalgia, fatigue, shivering after receiving SHINGRIX. The events lasted for 2 to 3 days. The reporter did think events related to the vaccine. The reporter agreed to to follow up from GlaxoSmithKline.
temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported (lot number S038698, expiration date reported and validated as 01-DEC-2021) for prophylaxis.  On an unknown date, the temperature excursion was -10.2 degrees Celsius (C), for 1 hour and 53 minutes. There was no previous temperature excursion. The digital data logger was involved.   This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014798: US-009507513-2008USA014803:AE Case # 01697199 US-009507513-2008USA014705: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014937: