chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm on site of injection with first Moderna Covid-19  injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 020B21A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM (VALIUM) and PREDNICARBATE (TOPIMAX [PREDNICARBATE]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection). At the time of the report, VACCINATION SITE PAIN (Sore arm on site of injection with first Moderna Covid-19  injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Tylenol, Hydroxyzine, Phenergan,Hyoscyamine.125 and 10mg .Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Body Ache starting 9 hours after. Main concern, I fainted while walking from the bathroom and split my eyebrow open. Could?ve been much worse but is a bad side effect. This occurred about 16 hours after vaccine
projectile emesis, "intermittent episodes of writhing and knees to the chest" x5 total, high suspicion for intermittent intussusception
Information has been received from a medical assistant supervisor who reported that an unknown number of patients (unknown age and gender) received GARDASIL 9 (lot #N002720, expiration date 12-MAY-2019); ROTATEQ (lot #M041765, expiration date 02-MAY-2018); and PEDVAXHIB (lot #B000327, expiration date 25-OCT-2019) on unknown dates in June 2017 (dosages and routes of administration not provided). Past medical history, concomitant medications, past drug history and laboratory data are all unknown. These vaccines had experienced a temperature excursion outside of the recommended storage range of 59°F-77°F. As of 27-JUN-2017, the outcome of administration of the vaccines stored outside the recommended storage range is unknown. Dates of excursion: Unknown. Total time in range 31°F/-1°C or colder: None. Total time in range 32°F to 35°F (0°C to 1°C): 34 F, 5 minutes. Total time in range 47°F to 77°F (9°C to 25°C): 48 F, 16 minutes. Total time at 78°F (26°C) or warmer: None. Data logger involved: Yes. Previous temperature excursion: No. Additional information has been requested.
hard raised area 1 inch, no discoloration, on her arm; Chills; Fatigue; Arm soreness/sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm soreness/sore to touch) and VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm) in a 45-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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm soreness/sore to touch). On 14-May-2021, the patient experienced VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm). On 06-May-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 09-May-2021, PAIN IN EXTREMITY (Arm soreness/sore to touch) had resolved. At the time of the report, VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
pt recv vax 9FEB98 & 10FEB98 pt devel a rash;pt recovered p/several days;
covid arm; swollen arm; hot to touch; red down my arm, extreme pin all down my arm into my fingers; sore arm, extreme pin all down my arm into my fingers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), PERIPHERAL SWELLING (swollen arm), FEELING HOT (hot to touch), ERYTHEMA (red down my arm, extreme pin all down my arm into my fingers) and MYALGIA (sore arm, extreme pin all down my arm into my fingers) 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 SITE REACTION (covid arm), PERIPHERAL SWELLING (swollen arm), FEELING HOT (hot to touch), ERYTHEMA (red down my arm, extreme pin all down my arm into my fingers) and MYALGIA (sore arm, extreme pin all down my arm into my fingers). At the time of the report, VACCINATION SITE REACTION (covid arm), PERIPHERAL SWELLING (swollen arm), FEELING HOT (hot to touch), ERYTHEMA (red down my arm, extreme pin all down my arm into my fingers) and MYALGIA (sore arm, extreme pin all down my arm into my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
Temporary nail psoriasis on all 10 fingers; no symptoms on the toe nails. Hair breakage.   Supplements recommended by chiropractor, Symplex F and a connective tissue supplement Dermatrophin PMG
Swelling; itching; hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch). At the time of the report, SWELLING (Swelling), PRURITUS (itching) and INDURATION (hard to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
RN drew a 0.5ml dose into a syringe using a 25 gauge, 1" needle from ancillary supply kit.  Nurse injected patients left deltoid and began to administer vaccine, when syringe/needle malfunctioned and dose came out of the syringe, spilling onto nurses hands and outside of patients arm.  Patient did not receive any dose, there was still more than half a dose remaining in the syringe.  Nurse removed needle from patients arm, and drew up another dose of 0.5ml (per CDC guidelines) and administered that full dose to patient in left deltoid.
Information has been received from a nursing supervisor concerning a 6 year old white female with no drug reactions, allergies or medical history who on 24 Feb 2000 was vaccinated SC in the left arm with a first dose of Varicella.  There was no concomitant medication.  There was no illness at the time of vaccination.  On 04 Nov 2004 the patient broke out with a case of chickenpox.  It was described as scattered vescicles and the number were unknown.  Unspecified medical attention was sought.  A product quality complaint was not involved.    Follow-up information was received from a physician who indicated that on 03 Nov 2004 at 08:00 am the patient developed Varicella disease, fever, and a diffuse rash typical of Varicella.  The patient recovered on 10 Nov 2004.  No diagnostic laboratory tests were performed.    No further information is expected.
Menstrual period started the night I recieved the vaccine. The period started 7 days earlier than expected/ regular period was set to start. Bleeding was heavier than normal
pt recv vax 5JAN99 & 18JAN99 petechial rash on groin ?myoclonic jerk, ROM;20JAn99 abn EEG w/spike wave complex;
At 1245 patient received vaccine IM. At approx. 1246-1247 patient stated that he was "lightheaded and felt funny". He immediately became pale and diaphoretic. We laid him down on gurney and took vital signs. HR 52, BP 156/89, 02 sat 98% on room air.  Patient stated that baseline HR is in 50's and baseline BP is 120's-130's over 80's. We gave patient 2 cups of apple juice but patient stated that he was still lightheaded. Per patient he had eaten a few hours prior. Only takes a multivitamin.  Heart sounds were normal upon auscultation. 911 was notified and arrived on scene at approx. 1:10pm.  Patient never  had loss of consciousness but was consistently lightheaded and stated he had chest pressure. BP on 3rd time was 139/85.
2nd Pfizer vaccine received 9:05 am 4/19/2021.  At 10:00 am 4/20/2021 I began to feel cold.  I started a fire in the wood stove and wrapped in blankets.  After about 2 hours, I warmed up, but then started feeling feverish.  I had a fever the rest of the day, never going over 100.8.  I also felt tired, headachy, had muscle aches and was lethargic.  I went to bed at 10:00 pm, and felt fine the next morning.
10 days after injection developed redness, induration, warmth c/w localized infection. He was treated with KEFLEX. He improved.
she developed a red rash and swelling there; she developed a red rash and swelling there; she developed a red rash and swelling there; she developed a red rash and swelling there; Initial information regarding this unsolicited non-valid non-serious case via The Agency (reference number: 00317925) was received from other health care professional on behalf of a consumer and transmitted to Sanofi 15-Oct-2020.  This case involved a 79 years old female patient who developed a red rash and swelling there (vaccination site inflammation associated with vaccination site rash, vaccination site erythema and vaccination site swelling), where she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included hydroxyzine hydrochloride and medrol.  On 12-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious (vaccination site inflammation associated with vaccination site rash, vaccination site erythema and vaccination site swelling), unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was she developed a red rash and swelling there.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
2 weeks after the vaccine his osteoporosis disappeared; 2 weeks after the vaccine his osteoporosis disappeared; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 79-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included osteoporosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient experienced 2 weeks after the vaccine his osteoporosis disappeared and wondered if you already knew this. The clinical outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a health professional (Nurse). This case is linked to case 2018SA208051 (4-year-old patient unknown gender, same reporter). This case involves a 4 years old male patient, who received vaccines, ADACEL and MENACTRA instead of 1st dose of PROQUAD and 5th dose of DIPHTHERIA TETANUS ACELLULAR PERTUSSIS. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 20-Jul-2018, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5839AA via unknown route in the left arm. On 20-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5898AA via unknown route in the left arm. It was a case of actual medication error due to Inappropriate age at vaccine administration (patient received ADACEL at aged 04-year) and wrong vaccine administered. It was not reported whether the patient experienced any adverse reaction. 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. List of documents held by the sender: None.
herpes outbreak; This is a spontaneous report received from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 04Mar2021 at age of 80-years-old as single dose for covid-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Feb2021 in arm for covid-19 immunization, and approximately 7-10 days after vaccination 1 had outbreak of herpes. No other prior vaccination (within 4 weeks). The patient experienced herpes outbreak on 14Mar2021 with outcome of recovered. Seriousness criteria: important medical event. Treatment included resume use of Valtrex.   No follow-up attempts are needed. No further information is expected.
Incorrectly aministered a Dtap instead of a Tdap vaccine for the patient, patient had no other symptoms in regards to administration of the shot or otherwise.
Nausea, fatigue for one week after vaccine administration. Seen in clinic on 04/14/09. Afebrile, WT 150#, BP 130/67. HEENT-negative, abdomen soft, non-tender, no masses. Patient current on depo provera.
Itch on chest and back. Then developed rashes on chest and back and arms and legs. Total about > 50 a few developed blisters. All over in 4 days.
Rash, swelling, red, tender, fever, nausea and vomit.
Re-emergence of chronic idiopathic  urticaria after having no symptoms for past six years.
Site of injection feels hot; Numbness on her arm; Her left hand and arm had tingling; Feel a sleep; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an age 38 (unspecified unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she received her first dose of the Pfizer covid vaccine today and 30 minutes later her left hand and arm had tingling and feel asleep is this normal. Patient just received the first dose of the COVID-19 vaccine today (04Apr2021) and her 2nd dose schedule would be on 14May2021. She said that she is experiencing numbness on her arm and she added that the site of injection feels hot. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Pt experienced chills, flu like symptoms, aching muscles, referred to allergy clinic for evaluation for true reaction.
Arm swollen, red and a bit warm to the touch. Mom will continue to ice and keep and eye on area.
developed Fever and chills; temperature was going up and down; rash at the injection site was at first, it was raised, now it was more macular and red and itchy; pain in her arm at the injection site; This is a spontaneous report from a contactable physician (patient's mother). A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on 19Aug2019 at a single dose for meningitis B vaccination given at physician's office. Medical history included food allergy, asthma and allergies (unspecified). Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies. It was reported that the patient received meningococcal group b rlp2086 on 19Aug2019. She started with a pain in her arm at the injection site on 19Aug2019 and then she developed a rash at the injection site on 22Aug2019. The paint in her arm started out severe and had since decreased. She also developed fever and chills. She felt that her temperature was going up and down. She never took her temperature but felt like it was going up and down. Treatment for these events included alternating with Ibuprophen every 4 hours and then Tylenol. The rash at the injection site was at first, it was raised, now it was more macular and red and itchy. Treatment for the event rash at the injection site was Zyrtec at night. Outcome of the event "pain in her arm at the injection site" and "rash at the injection site was at first, it was raised, now it was more macular and red and itchy" was recovering while unknown for other events.
Day after DTaP given mom noticed redness to right upper arm. Child reports discomfort. Mom described area as having a knot. Today and yesterday mom notices it clears in the morning and is more red in the PM mom has been giving Tylenol PRN discomfort.
Patient received 1st dose of COVID vaccine today 2/16/21 at around 1009 am.  Patient complained of dizziness and blurry vision after 30 minutes. Patient stated she is diabetic and has not eaten her meal yet. Patient also stated she was not able to have a good sleep a night ago. Vital signs taken and was stable. Po hydration (water) and hard candy given to patient.  Apple juice was also given.  Blood sugar taken and is 160 mg/dl. Patient monitored for 30 minutes  and was stable after.
Every day: afternoon-evening temperature between 100 -101.8 starting the day after  getting the shot 12/29/2022 to present. Fatigue, headache, sinus pressure, muscle aches. Have to rest.
Information has been received from a licensed practitioner nurse referring to ten unspecified patients of unknown age and gender. Since 17-JUN-2015, the patients were each administered an improperly stored dose of PEDVAXHIB (dose, strength and frequency were not reported, lot # K026533, expiry date: 07-AUG-2017). All the patients received improperly stored doses from the same lot of PEDVAXHIB. No adverse effects were reported. Additional information has been requested.
I believe it was the Shingles vaccine that caused bodyaches that last 48-60 hours and fever of 100.0 degrees which lasted approximately 24 hours.  3 weeks later I am experiencing the same bodyaches again but with no fever.
EXTREME FATIGUE, MUSCLE SORENESS ENTIRE BODY, EXTREME JOINT PAIN ENTIRE BODY - ALL THIS BEGAIN AROUND 4:00AM ON 04/28 AND CONTINUED UNTIL AROUND 3AM 04/29.  AT THAT TIME PATIENT NOTICED A FULL BODY RASH WHICH WAS VISIBLE AS WELL AS VERY ITCHY.  ALL OTHER SIDE EFFECTS HAD SUBSIDED AND AT REPORT TIME 11:00AM ON 04/29/2021 RASH SEEMS TO BE THE ONLY SIDE EFFECT REMAINING.
No further AE; Patient was administered an improperly dose; This spontaneous report as received from a office manager and refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported.  On 14-JAN-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T021821 , expiration date 25-JUN-2022) for prophylaxis.        Temperature excursion was 5°F to 14°F (6.7°F) during a time frame 12 minutes. There was a previous temperature excursion of 5°F to 14°F (5.2°F) for 2 minutes Digital  data logger was involved.
hearing loss; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age or gender. No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 22-MAR-2016, the pt was administered zoster vaccine live (ZOSTAVAX) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers for the following injuries resulting from the pt zoster vaccine live (ZOSTAVAX) use: hearing loss (Deafness). Outcome of the event was not provided. Causal relationship of deafness was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness was determined to be medically significant event.
I was sitting down and had a very sharp quick pain in my right back. Down where the lumbar goes into the sacral and I didn't know what it was because it has never happened before. I didn't think anything about it until the next time. I would have 3-4 of these a day when getting up off the sofa. I was told to see a doctor right away and I had to go a doctor who did an x-ray. He also had me doing physical therapy for that. Since then it has changed from a quick sharp pain to a longer duration sharp pain. In the last two weeks the pain seems to be in the buttocks area rather than the side of the spine.
Immediately after the injection my right shoulder felt "odd" and seemed to be popping and clicking more than usual. I experienced severe pain of the shoulder joint about 4 hours after the injection. At this time I took 400 mg of ibuprofen and the pain was eased by about 50 percent after about an hour. The next day I went to work without any medication and could barely lift my arm without severe shoulder pain inside the joint. The muscle did not feel too bad. Mobility of the joint was possible but limited by pain. I mostly used my other arm to adjust the position of my right arm. After work that day I took 800 of ibuprofen and went home to bed. I felt better the next day but took another 600 mg of ibuprofen to get through the work day. Same for day 3. It is now approximately 80 hours since the injection and my shoulder joint is still fairly tender and stiff but improved. I fear possible SIRVA because the shot seems to have been delivered fairly high on my arm.  I do have a history of rotator cuff issues with this shoulder but it was never as painful as it was on the day of the vaccine and the shoulder has been well for the last two years. I received the flu vaccine in the same arm a few months ago with no problems.
Woke up on morning the day after the vaccination and could not walk orotund on my legs. Husband carried me to bathroom and I was unable to walk to stand the entire day, even at bedtime. Went to bed, got up the next morning and was able to walk and stand ok. No further problems