chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; injection site sore,Arm sore; site was also itchy; heat; hardness under the skin; not feeling well; A spontaneous report was received from a consumer concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/Vaccination site pain, redness/Vaccination site erythema, heat/Vaccination site warmth, hardness under the skin/Vaccination site induration, fairly large as the size of three eggs, not feeling well/Malaise, injection site itchy/Vaccination site pruritus, injection site sore/Vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore.She has chronic fatigue syndrome and understands that her immune system is not the strongest  Treatment details included most heat, Tylenol, hydrocortisone cream, and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore was unknown.
pt recv vax 26OCT96 & 8hr p/vax pt exp lt arm pain & devel swelling @ the inj site, which progressed to edema of the entire lt arm;28OCT96 presented to MD & was treated w/unspecified ATb;arm swelling began to improve;pt recovered;
It was reported to a health department that a baby had died. An Autopsy is being done. The cause of death is probable SIDS. Further studies pending.
Started getting very bad cramping; Now heavy blood; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Started getting very bad cramping) and HEAVY MENSTRUAL BLEEDING (Now heavy blood) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (Started getting very bad cramping) and HEAVY MENSTRUAL BLEEDING (Now heavy blood). At the time of the report, DYSMENORRHOEA (Started getting very bad cramping) and HEAVY MENSTRUAL BLEEDING (Now heavy blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on a Birth control and does not get her period.  No treatment information was provided.
Swelling below injection site, redness, all developed within 24 hours of shots.  No streaking.  Treatment by warm soaks, did require office visit.
Patient is here for covid booster consent reviewed, EUA given/offered, and pt monitored for 15 min post vaccine, tolerated well- vaccine card given to guardian.  Shortly after receiving the vaccine, patient became pale and shaky. Immediately took the patient vitals. Provider called to the room to assess. Monitored the patient for 1 hour. Vitals repeated 2 more times before letting the patient leave. Patient was given an apple juice and 2 pediapops while being monitored.
Pt devel a sterile abscess following 1st dose of HIB; No further details were provided;
Headache that began at approx. 7:00 pm on the day I received the vaccination. Went to bed at 10:00 pm and woke up with severe headache that I felt tightening from forehead around to base of skull.  Also noticed at the same time, muscle aches in my wrists, ankles, and lower back. Difficult to sleep the rest of the night. Arose around 5:30 to take coated aspirin and returned to bed. Stayed in bed the entire day with headache, backpain, and complete loss of appetite. Some nausea but no vomiting.  Arose the 2nd day at 5:45 am & took a shower and returned to bed. Approx. 8:00 am, headache started to abate. Stayed home & had small amounts of food. 3rd day (08/04/2018) up & around with slight headache & aches.
Information has been received from the mother of a male infant with no medical history and no allergies who in January 2001 at two months of age and March 2001 at four months of age was vaccinated with a first and second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant, respectively. There was no concomitant medication. It was reported that the child stopped talking for one to two months after receiving the vaccination. It was noted that the child was seen by the doctor about this reaction. The mother did not want to provide the doctor's info. Upon internal review, aphonia was determined to be an other important medical event (OMIC). Additional info has been requested.
Returned to clinic reporting Left arm numb, lethargic, pain in left shoulder. Reports feels like will pass out. Looks like dazed. Responds appropriately to all questions. Grips equal and strong. BP 110/70 , blood sugar 105, pulse 80, Resp 29. Pt reports ate doughnuts and drank Dr. Pepper after shot. Negative medical history. 8/25/04: at 2:50 :spoke with mother. Reports pt doing much better. New area complaint is sore arm. 8/26/04: spoke with pt, doing well.
1 minute after first dose of moderna covid vaccine patient had lightheadedness, neck and jaw pain, hot flash, elevated blood pressure and HR, and near syncope; required transport to ER. Resolved with Benadryl and Zofran and iv fluids.
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 4 months old male patient who experienced coughing alot, sneezing, he is waking up every one to two hours while he received vaccines PREVNAR, ROTAVIRUS VACCINE and PENTACEL. The patients past vaccination(s) included rotavirus on 07-MAY-2018 and PREVENAR and PENTACEL vaccine on 07-MAY-2018. The patients past medical history, medical treatment(s) and family history were not provided. On 09-Jul-2018, the patient received a Primary second dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur orally. On 11-Jul-2018, the patient received a Primary second dose of suspect PREVNAR not produced by Sanofi Pasteur lot number not reported. On 09-Jul-2018, the patient received 0.5 ml Primary second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: C5439AA, expiry date: 29 Oct 2018 in leg. On an unknown date he also received a Primary first dose of the same vaccine. On an unspecified date, the patient developed a non-serious coughing alot (cough), unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. On an unspecified date, the patient developed a non-serious sneezing Unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. On an unspecified date, the patient developed a non-serious he is waking up every one to two hours (sleep disorder) Unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Unknown latency following the administration of ROTAVIRUS VACCINE and Unknown latency following the administration of PREVNAR. It was an actual medication error due to product preparation error as HIB part of Pentacel was only mixed with Sterile water. Final diagnosis was hib part of pentacel was only mixed with sterile water (product preparation error), he is waking up every one to two hours, sneezing and coughing alot. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for hib part of pentacel was only mixed with sterile water, as Unknown for coughing a lot, as Unknown for sneezing and as Unknown for he is waking up every one to two hours.
redness and warm rash like reaction at site of administration on left arm, and recurrence of suspected shingles outbreak on back where shingles out break has happened before
big red blotch; big red blotch; looks like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite). At the time of the report, RASH MACULAR (big red blotch), ERYTHEMA (big red blotch) and ARTHROPOD BITE (looks like bug bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable pharmacist (patient). A 72-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in arm left on 12Feb2021 09:45 (at the age of 72-year-old) as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP), high cholesterol, macular degeneration, osteopenia, allergy to sulfa antibiotics, Latex, IVP dye. Concomitant medications included losartan; simvastatin; vitamin D nos; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). No other vaccines administered in four weeks. The patient previously took first dose of bnt162b2 (Lot number: EL9261) in arm left on 22Jan2021 10:00 for covid-19 immunisation and experienced mild itching, clarithromycin (Macrobid) and experienced allergy. After second dose, on an unspecified date of Feb2021, the patient experienced major flare up of eczema that had not been an issue since she was a child. Tinnitus began in right ear that had never been a problem. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment of events included Prednisone Dosepak, Steroid Cream. The outcome of events was not recovered. Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. 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, and Investigators, as appropriate.
a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient had received 2nd booster. The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  Treatment information was not reported.
A few days after my second dose I had heart palpations or irregular heart beat. It lasted for a few days and caused me to run out out of breath while walking. 7 months later I still have arm pain, causing arm weakness and makes it difficult to sleep.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, 10 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The patient received SHINGRIX vaccine in the left arm. The patient had some soreness at the injection site that lasted a couple of days. The patient had denied permission to contact their physician.
Patient received vaccine in deltoid muscle on 9/29/09.  Later that evening noticed fatigue and malaise.  When patient woke in the morning, pt noticed itchy blisters on chest and abdomen.  She started taking tylenol after noticing the blisters.  On 10/1/09 patients presented to clinic with vesicles on her chest and abdomen.  No other complaints were noted.  Lot Number: U3197AB
says she cannot get her right foot to move correct but thinks this is due to MS; injection site was like touching a heating pad; Bright pink rash at injection site that was itchy and went 2 inches above elbow; Bright pink rash at injection site; Nauseous for a few hours; Woke up dizzy after turning to side in bed; Bright pink rash at injection site that was itchy and went 2 inches above elbow; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced DIZZINESS (Woke up dizzy after turning to side in bed). On an unknown date, the patient experienced GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow), VACCINATION SITE ERYTHEMA (Bright pink rash at injection site), VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours). At the time of the report, GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) outcome was unknown and VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she cannot move her right foot correctly and she thinks that it might be due to multiple sclerosis.  Concomitant drugs included blood pressure medication.  No treatment was reported by the reporter.
"Small raised hives", pt also reported 2" diameter swelling of deltoid muscle of injection site & 1" raised above skin lasting 5-7 days after administering on 29Jan2011. Pt admits never having flu injection before and only had nasal-live spray in the past. Pt informed at next drill of reaction (12Feb2011).
tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number LL552, expiry date 8th June 2021) for prophylaxis.   The patient's past medical history included tinnitus (had brief periods of tinnitus before but this was constant).   On 20th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, immediately after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was recovering/resolving.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The caller stated that she received Shingrix on left arm and shortly after that she stated she has experienced tinnitus. She noted it started within a day.  She had already notified her physician of the issue.  She was concerned and wonders if she should get the 2nd dose at the time of reporting.  The caller was referred to have that discussion with physician to look at risks and benefits.  The reporter did not consent to follow up. The health care professional declined to follow up.
Rash. Erythematous, plaques, pruritic, on extensor surfaces of elbows, anterior ankles, extensor knees, wrists, and medial fingers, suspect psoriasis. No previous hx.
Patient started to have stiffness, swelling and redness in the left upper arm the first night after the vaccines were administered. No shortness of breath or lip swelling was reported. Patient arm after coming a couple days later (4/29/20) was red in the area and swollen. Patient reported that she could barely move her arm and was in a lot of pain.
Approximately 10 minuets after the injection a Non- elevated , itchy, red rash distal to injection site from left deltoid. Area spread to posterior neck and upper back to lower back.
On 1/16/01, pt in for complain of soreness at injection site on left deltoid and across back, previously between shoulder blades since flu vaccine received on 11/7/00. States pain had been across chest also but that pain has since been relieved. States he saw MD on 12/15/00 for complaints and was treated with anti-inflammatory RX. Pt was advised to return to PMD ASAP. Pt was treated with Voltaren po and Flexeril po; dx was thoracic paraspinous spasm; pt was not recommended for additional follow-up after 12/20/00 appt.
Moderna COVID-19 Vaccine EUA Woke up in the middle of the night Saturday morning with a horrible headache and intense body aches and joint aches.  It hurt to have heavy bed covers on me so I slept in the other room in just my down sleeping bag because it was so light and I could barely feel it.  Slept most of the day.   Sunday I was insanely tired and fatigued and laid around and watched movies.  Felt trashed most of the day.  Monday morning I was fine.
Moderna COVID-19 Vaccine EUA Received vaccine 8:30 AM, started feeling nauseous approx. 9:30/10 AM which lasted for 36 hrs accompanied by chills, headache and fatigue with sore arm at injection site and tingling in hand and arm .  By Sunday  1/24, I started feeling better., but am still having  sinus congestion and occasional chills  Monday  1/25 I experienced a racing heart which  came and went throughout the day, same happened  on Wednesday the 27th also developed  welts on my arms  that I put cold compresses on, and were gone within a few hours.  On 1/29 started having facial swelling , especially nose, with burning and tingling sensation to face and ears. Called Dr. told me to see how I feel by 2/2/2021, and to make appointment if not better. Feeling better as of now.
The vaccinee reportedly received Lymerix during 2 subsequent pregnancies. Concurrent conditions and concurrent medication were not specified. On 2/25/00, the vaccinee received her 1st injection of Lymerix (lot LY130B9; expiry 8/4/02). She received her 2nd injection (lot LY130B9; expiry 8/4/02) on 3/24/00. In 5/00, she reportedly began to experience joint pain, especially in her left shoulder. The joint pain "improved". The vaccinee considered it to be associated with the 1st injection of Lymerix, even though it did not occur until 2 months after the 2nd injection. On 1/13/01, the vaccinee received her 3rd injection of Lymerix (lot LY146A9; expiry 1/18/01). This immunization was received "early" in the 1st trimester of the 2nd pregnancy. It was reported that the joint pain subsequently recurred in approx. 5/01. It reportedly had increased when compared with the 1st episode and now also involved her knees, feet and elbows. The vaccinee considered this increase in joint pain to be associated with the 2nd injection of Lymerix, even though it did not occur until 4 months after the 3rd injection. The vaccinee stated that she "required cortisone shots". It was reported that she also experienced tiredness. Since she "showed symptoms of Lyme disease", she was reportedly referred to a "blood disease specialist" who tested her for Lyme disease. As of 9/01, the tiredness and joint pain had reportedly improved. The vaccinee stated that she sometimes felt pain in her elbows, but the pain was "very insignificant compared to spring 2001". The vaccinee considered the joint pain and tiredness to be possibly related to Lymerix administration. The adverse event "joint pain" does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
weakness was probably side effects; haven't got the second vaccine; chills; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (diarrhea), ASTHENIA (weakness was probably side effects) and PRODUCT DOSE OMISSION ISSUE (haven't got the second vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (chills) and DIARRHOEA (diarrhea). On 16-Apr-2021, the patient experienced ASTHENIA (weakness was probably side effects) and PRODUCT DOSE OMISSION ISSUE (haven't got the second vaccine). On 05-Apr-2021, CHILLS (chills) and DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (weakness was probably side effects) and PRODUCT DOSE OMISSION ISSUE (haven't got the second vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.   Treatment medication included stool pills.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Did not have reaction to vaccine but did get COVID symptoms and tested positive for COVID on 08/13/2021
Client reports within minutes he felt dizziness that lasted 15-18 and resolved on its own.