chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, fever (100 to 103.4), weakness & malaise, severe generalized aches, swollen & tender left arm (including injection site).  Treatment was hydration, analgesis, antipyretics, bed rest for 72 hours before fever began to break.
Pt had redness and hives the size of (2) 25 cent pieces at the injection site of the VARICELLA vaccine within 5-7 minutes of receiving the vaccine injection.  Pt was given 2 tap of BENADRYL and observed in our office for 30 minutes with no difficulties.
Pt. states day of vaccine, injection site developed with hot, red swelling, decreased the next day to  purple color and still hot, currently there is a rash that is very itchy. She is taking Benadryl , Motrin and applying ice. Informed pt. to present to the UC now or contact PC P in the am.
I took my shot around 11:00 am, I didn't feel no symptoms after that. At about 3:45- 4:15pm my arm started getting numb. By 4:30pm I started feeling a sharp pain on my spine bone. it felt like a pulsing pain. By 6:40pm I couldn't walk no more, if I put pressure on my spine it began hurting. The pain on my spine lasted about three days. No other symptoms, but arm ache and Spine bone ache.
Patient reported back to the pharmacy 3 days after receiving vaccine. Her arm has a red patch around where the vaccine was given. It is about 3 in wide by 3 in tall. It is hot to the touch.
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 5-year-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 10-SEP-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025608, expiration date 18-AUG-2021, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported) that was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in a temperature of -14°C to-10°C (-12.50C) for 1 minute and -14°C to-10°C (-14C) for 1 minute (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
Vaccines at 4 mo well visit: PENTACEL, PCV, Rotavirus. One week later, mild diarrhea, green with flecks of blood. Resolved in a few days without sequelae.
Patient was vaccinated on 1/13/2021 with second dose of pneumonia vaccine and that evening developed muscle aches on and off temperature ranging from 100-101, also chills noted. Patient  stated that the second day was when she noticed the increase in muscle aches so she called for follow up.
Narrative:  Patient is a 61 year old male who received first dose of Moderna COVID-19 vaccine on 02/23/2021. Patient reported chills, temp of 100.0 F, and headache 5/10 on pain scale. Also reprots feeling tired but denied body aches, N/V, diarrhea. Patient received second dose of vaccine on 4/8/21 with no reported complaints/side effects.
Difficlty breathing, Chest Pain, Dizziness  Patient was put on O2   IV started by ENT
10/9/21 pt had a positive COVID test; 10/10-10/12/21 hospitalized for COVID pneumonia and splenic infaction; dc'd to home; 10/22/21 pt back to ED with worsening SOB; generalized weakness; admitted; CXR showed bilateral interstitial infiltrate; NRB; A Fib with RVR, treated with medication; hypotensive; treated with medication; acute renal failure; AHRF and severe acute respiratory distress syndrome secondary to COVID; mechanical ventilation; condition continued to worsened; cardiac arrest; pt expired in the hospital
Pt developed chills for approx. 1 hr, felt achy all over, genital area turned red with some swelling, no pain 24 hrs later, now has pain in genital area. Genitals pain, swelling, redness for 8 days. Fever, dematitis contact, rigors
My symptoms started on January 14th, 2022. The first day I had a sore throat and sinus headache. I treated myself with acetaminophen. The second day my taste buds were off. On the third day I had a severe runny nose with clear phlegm. The fourth day I felt better, like nothing never happened. I did a rapid test at home that came back positive.
According to mom who is a registered nurse fell asleep after shots, ate something then began unusual crying and screaming and thrashing around in car was trying to tet out of car seat when removed from car seat was trying to band head on window, in DR office F/U no hives no injection site reaction, no wheeze no increased WOB no fever, very fussy and crying, eventually calmed down later that evening but fussiness continued about 48 hours later, initially difficult to get pt to bear weight.
Initial symptoms included redness with swelling 7 cm x 7cm, tender warm to touch, itchiness reported by patient. Symptoms progressed to right upper outer arm mildly swollen with no localized area- there is a diffuse red rash over the area of swelling down to the elbow-all of this on the outer upper arm.
VESICULAR LESIONS, 6-7, ON FACE, TRUNK AND 1 LEG OCCURRED.  19 DAYS AFTER IMMUNIZATIONS, AFEBRILE.
Approx 8 hours after receiving injection, had onset of high fever, complete body sweating, nausea, violent chills and uncontrolled shakes lasting approx 3 hours.  Had pain in injection site for next 3 weeks.
administered IM instead of SC; This spontaneous report was received from a physician referring to a 64 year old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 21-DEC-2020, 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 # S039311, expiration date  04-DEC-2021 for prophylaxis (strength, dose and frequency were not reported). The vaccine was administered via intramuscular rather than subcutaneous.  No further information provided.
Pt called with c/o low grade fever since dose since 6/14/21 PM.chills and body aches. Tolerated dose 1 well.
Patient said she felt that she was going to pass out. We sat her on the floor, applied a cool compress to head and wrists. A couple minutes later she was feeling better, but she was asked to remain sitting for another 10 mins to monitor her. She claimed to be dehydrated, and had not eaten much of anything today. Her friend brought her some water and food. After eating a bit and drinking the water she said she was feeling almost normal. We provided a motorized cart for her even though she said she was fine to walk. I gave the patient a follow up call a few hours later and she claimed to be feeling fine.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration in Mar2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced paralysis of both legs lasting 24 hours after vaccine on Mar2019. The outcome of the event was recovered. The information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 06-JAN-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013915:
Fever of 102 degrees F; migraine headache 12 hours after injection lasting 24 hours.
Rashes in torso area and minor dry cough. Improved after taking Benadryl.
Woke up at midnight with intense chills, sweating, and body aches. Body pain rated about a 6. Panic attack ensued until about 12:30am. Body aches relieved by advil. Chills/sweats continued until about 10am, Body aches continued past 11:30am.
Started with tingling and numbness in 2 fingers in both hands, then gradually developed weakness in both arms and hands and both legs. Eventually totally paralyzed, no walking and using hands. Hospitalized received intra vain high dose Steroids. Discharged, then hospitalized to another hospital. Received intra vain Steroids and plasmapheresis for 7 days. Then inpatient rehabilitation for 3 weeks. Still currently is not able to walk or use his hands.
No adverse event; 3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (3-year-old patient received Expired Bivalent Moderna COVID-19 vaccine 27MAR2023).    No concomitant medications were reported.  Patient Initially received First Primary monovalent dose on 26-Sep-2022, Lot no was AR9236B and Expiry date was reported as 11-Feb-2023, then Second Primary monovalent dose on 28-Oct-2022 with Lot no. AR9236B and Expiry date was reported as 11-Feb-2023. 30 Day beyond use date for Bivalent drug was 26-Mar-2023.  There was Individual vial inside opened carton with vial size 0.4 ml. Date the vial was initially stored in the refrigerator was Unknown. The vial did not undergo any temperature excursions. No treatment details were reported.
Infant died of SIDS 12/17/2001 at 8:38 AM. No adverse event following administration of vaccine occured other than death from SIDS 21 days post injections.
Patient was in school and apparently had a blanking out type episode and was not responsive to teacher.  Patient taken to ER.  ER provider reports that patient had muscle related seizure like activity and was afebrile.  Patient was transferred to another Pediatrician for monitoring.  Patient has never had a episode like one reported and Providers are unsure of cause.  Only known recent change had been vaccination.
Starting the evening of receiving the vaccine, I had a headache. It continued for days. It would come and go with medicine and progressively worsened over the 2 week period. By this past weekend, the throbbing was so bad that I contacted my doctor. My doctor is going to do a few tests, including an MRI and blood tests to rule out inflammation. I have the MRI scheduled for this evening, and the results of the bloodwork have come back as normal.
Couldn't move. Almost felt paralyzed. Muscle aches were so severe, I could hardly move. Spent the entire day in bed. No fever.
No additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II.; temperature excursion; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 10-MAY-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) injection (lot #W029552, expiration date 14-MAR-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis, instead of dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (Wrong vaccine administered, Product storage error).  On unknown dates, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD)suffered from a non supported temperature excursion of 8 degrees Celsius for 1152 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
burning in arms and legs; tingling in arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs) in a 36-year-old male patient 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 BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs). At the time of the report, BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
pt recvd vax accidentally;usually avoid flu vax due to hx of GBS;devel psychomotor sx;had sz while sleeping & was examined in er;dx of epilepsy & started on dilantin;
tremendous pain to my muscles/got worse after the booster; all joints and nerve pain/got worse after the booster; nerve pain; nerve pain/got worse after the booster; suffering so much pain in daily bases; memories are getting worse; horrifying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "all joints and nerve pain", "tremendous pain to my muscles", "all joints and nerve pain"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "memories are getting worse"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "horrifying"; Covid-19 vaccine (Dose number unknown, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles/got worse after the booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "all joints and nerve pain/got worse after the booster"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "nerve pain/got worse after the booster"; PAIN (non-serious), outcome "unknown", described as "suffering so much pain in daily bases"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying".  Additional information: Patient had been experiencing tremendous pain to muscles, all joints and nerve pain ever since received first dose of vaccine and got worse after the booster. Patient was suffering so much pain in daily bases. Patient never had pain in the life before the vaccine. Also memories were getting worse. Patient was horrified.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200057825 same reporter/patient/AE, different drug dose;
injection site pain, headache, left ear ache, sore left eye. Ongoing on second day. Took 1 aspirin. Still have swollen lymph gland from first shot 3 weeks ago.
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2015, the patient was vaccinated with a dose of ROTATEQ, "2ml, 10 unit dose tube", lot # K020183, expiry date: 25-JUN-2016, orally, which was improperly stored at 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours and 8.88 Celsius Degrees (48 Fahrenheit) for 32 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
tiredness; generalized rash and itchiness all over body; high fever (103.0Fahrenheit); injection site redness and soreness; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00835143) and transmitted to Sanofi on 29-Oct-2021.  This case is linked to case 2021SA366585 (same patient).  This case involves a 7 year old male patient who had high fever (103.0 fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included Ipol on 09-AUG-2010 for prophylactic vaccination. The patient had pyrexia, vaccination site inflammation, rash pruritic and fatigue as a reaction to the vaccine.  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 30-Oct-2014, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C4644AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 30-Oct-2014 the patient developed non-serious high fever (103.0fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No other relevant test was reported.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the events were resolved.  The reporter did not report the causality of events with suspect.
This patient came in for his second pfizer covid-19 vaccine, however after pt was administered the vaccine it was later discovered that the diluent used to dilute the vaccine was sterile water for injection instead of Normal Saline 0.9%. No adverse event was expected and patient contacted and confirmed only had bit or sore arm which resolved within couple days. We are completing this only to report vaccine admin error.  Sterile Water for injection has not been studied thus unsure if vaccine on 8/25 would be effective.  It was thus recommended that Patient be revaccinated and pt came in on 9-17-21 and was revaccinated. Again no Adverse event occurred with patient!
Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to nearest ER.
Extreme fatigue after receiving the injection. She slept for 20 hours of the next 24 hours and now three weeks later she is sleeping nine hours compared to her normal sleep pattern of seven hours. She blacked out in her bathroom on the third night after the injection.  The patient is still having some mild dizziness.
Vaccine administered on 2-6-11, pt came back to pharmacy today with a softball sized red raised area over the administration site with bruising on the bottom. Patient states it is itchy & hard spot.
Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot.  Sneezing, aching in joints., headache,  chills with second shot.
A 44 year old female came in for 2nd dose vaccination of Moderna to left deltoid. Had History of hives all over and takes oral benadryl 50 mg. Noted to have redness and swelling to bilateral  lower extremities and was given IM Benadryl 50 mg to right deltoid area. Vitals are 167/110, 103, 20 and O2sats at 99% RA. Lungs CTA.  Patient with diagnosis of Narcolepsy, Hypertension, Depression and PTSD.   Medications taken are Remeron 30 mg once daily and Adderall 30 mg once daily.  Also Metoprolol 100mg once daily.  Allergies: NKDA - Denies anything else  Patient took an extra dose of Adderall 20 mg as an as needed dose prior to coming for vaccination.  Patient felt better 10-15 minutes after shot. Advised to stand up and walk to see how she is feeling. Patient was able to go to the bathroom with no problem. Latest vitals are 171/121, 106, 20 and with O2sats at 98% RA.   Advised to follow up with PCP due to high diastolic blood pressure by staff and myself . Patient seems not concerned about  but acknowledged it.  Patient with no acute distress, able to move all extremities well, breathing non labored and with steady gait. Redness to bilateral lower extremities greatly reduced.   Discharged to home with husband as transportation.
Vaccine was exposed to storage temperatures outside of the recommended ranges. Patient experienced headaches, chills, and rash on her skin. She also presented swelling on her left breast and underarm but did not worry because those were the same symptoms she had when she received the previous fours doses.