chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child rec'd Kinrix vaccine on (L) thigh on 6-9-21 Mom states child's leg started reacting that evening getting a little red. Gradually got worse with redness & swelling -- which prompted a Dr visit to check it. Site of RXN was 13 mm in diameter on 6-11-21 at visit. Dr prescribed Benadryl; mupirocin, Augmentin & Ibuprofen. To F/u as needed
On the day the reaction started i had the following: -Burning Sun Burn type feeling on my entire body -Itchiness all over body -Rash with Hives on  head, neck, back, chest, arms, hands, legs and feet
The evening of my 2nd covid vaccine had episode of HR 136 irreg that resolved within 3 hrs to HR 90's after rest.  Have had no other arrhythmia episodes since then. But continue to take Eliquis and Cartia XT as ordered by cardiologist.
Migraine, nausea, bladder, loss of motion, cramps in arms and legs, fatigue.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder; pt recvd a booster dose of Engerix-B 15NOV91;
When injection given felt intense pain down left arm (like hot lava being injected) arm was sore for a few days .. then arm began to have "pins and needle " feeling . Happened 1 year ago today .  HAs not improved.. has become more intense from shoulder to finger tips
Ipsilateral axillary lymph node swelling, fever, fatigue after day 1 of vaccination. Fever resolved, but lymph node  swelling still present and became tender to touch on day 2.
Exactly one week after my booster I began to bleed (heavily with large clots) vaginally accompanied by cramping. I soaked through 3 adult diapers with blood. Two days later I passed more blood, clots and the embryonic sac,
fever; Chills; muscle pain; joint pain; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
105.8 fever and  seizures for several hours. Woke up the next day at 1am. ER didn't admit me on 6Sep2021 at 11pm . Shakes and chest is feeling weird.  Pain in shoulders, hip and knees. My heart is going weird. Still have fever at 101. About an hour ago , there is pain in my chest. I have a slow heart and its beating at 90.
pt developed reaction described as cellulitis.  PT still reports limited range of motion in injection arm and states that it "locks up".  Continuing pain and swelling below elbow, PT may require readmission to hospital.
Treated in an urgent care facility-cellulitis-Dx 02/07/2003. Treated with Ceflexin, reaction resolving with ABX. Vaccines given 02/06/2003
pt recvd vax; reemergence of Reiter's synd 1 wk p/vax; also GBS;
Nothing happened for a few weeks after vaccine. Started noticing itchiness, swelling around hands and arms. Continuous itchiness, scabs, puss, healing, and repeat.
feeling hot but no fever, slight headache, slight nausea, general  tiredness . atypical for me. 36  hours
I had vaccine at 0800 on Monday morning 1/4/21 by 0100 on 1/5/21 woke up with chills and fever of 39.4 then came tremendous aches in bilateral hips and legs; migraine headache; had fever most of the day; also nauseous unable to eat
I was vaccinated on 10-1-21 with the Janssen 1822809.   Since then I have blacked out twice and I am menstruating after seven years of no periods I am now!  - heavy. and pain on top right foot which lasted two days Regarding black outs-My brother had called 911 the first time on 10-2-21  - responders came my sugar level was 90 and BP 126/72   We bought a monitor and my blood sugar has been in a normal range   Second time I blacked out was 10-12-21.   No changes in eating habits- still juicing in the am and high protein all day. Same diet as the last five years. Pain on right foot roughly two inches in circumphrence - no bruising   Blood test ordered for 10-13-21
break out with a rash on the upper right side of my back just below the shoulder blade. Other areas began to develop rash on my trunk included abdomen, buttocks and thighs; The rash is very itchy; sites of the rash are thick and colored reddish/purple; Itching one of the sites results in a burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in right arm on 28Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included hypertension. The patient's concomitant medication(s) included ramipril (RAMIPRIL) taken 10 mg, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken 25 mg, and lovastatin (LOVASTATIN). Patient had no known allergies. Patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in right arm on 07Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On May2021, approximately two weeks after receiving the final vaccination, the patient started to break out with a rash on the upper right side of my back just below the shoulder blade. Other areas began to develop rash on trunk included abdomen, buttocks and thighs. The rash was very itchy and the sites of the rash were thick and colored reddish/purple. Itching one of the sites results in a burning sensation. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received treatment of Valacyclovir 1gram tablet and Clobetasol %0.05 for an event. Seriousness reported as non-serious. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected
side effects; Five days after the first shot, my arm swelled pretty bad; warm to touch; little bit bruised; week after, my period came early and it lasted for 11 days; large red area; fatigue for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised) and MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (side effects), PERIPHERAL SWELLING (Five days after the first shot, my arm swelled pretty bad), VACCINATION SITE WARMTH (warm to touch), CONTUSION (little bit bruised), MENSTRUATION IRREGULAR (week after, my period came early and it lasted for 11 days), VACCINATION SITE ERYTHEMA (large red area) and FATIGUE (fatigue for a day or two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.Treatment medication was not provided
Pt experience pain radiating  down left arm for 2 weeks after flu vaccine was administered. She recieved a course of Prednisone and was doing better.
POTS; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an 18-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis. On an unspecified date in 2010 (reported date of injury), the patient experienced Postural orthostatic tachycardia syndrome (POTS) and fatigue. According to reporter, the events were related to the suspect therapy.
Patient received vaccination that was not age appropriate. Patient is 7 years old but received pfizer-Bivalent for age 12+. Discovered 2 days after vaccine was administered. Patient was admitted to urgent care on 11/06/22 due to high fever and chills. Ibuprofen was prescribed by physician at Urgent care and patient is stable as of 11/07/22
Starting 11/26 afternoon, she started developing headache and fever (102-103) , her right breast also started to swell up. Right breast  remained swollen until 11/29 and it?s slowly improving. It?s still swollen today 12/2, however not as significant. Her fever also improved Monday to about 100F, and finally resolved yesterday 12/1. She was on Tylenol and ibuprofen around the clock from 11/26-11/29.
Four to five days after the shot I woke up and was extremely dizzy. Required help for major life functions, had to be out of work for 3 days, required assistance for bathroom and ordinary life functions. Extreme fever couldn't drive for two weeks, returned to work after 3 days later, throw up, confusion began too. Second dose didn't cause adverse event.
Lethargy, vomiting (one day so far), loss of appetite, congestion, runny nose for 5 days so far - still going. Treatment: fluids and sleep/rest.
Client had driven off to another appointment.  When she got to her appointment 20 minutes later, she complained of her face tingling, SOB, chest tightness and elevated pulse and BP.    She went into her dental appointment and they proceeded to check her pulse and BP.   She feels better now except when private called to follow-up she says she just feels a little "off" but she cannot put her finger on it.  Other than this she feels fine.
Thinks it is shingles or chicken pox; Itchiness on neck; Itchiness on arm; rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Thinks it is shingles or chicken pox), RASH PRURITIC (Itchiness on neck), PRURITUS (Itchiness on arm) and RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS) for Arthritis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck). On 08-Mar-2021, the patient experienced RASH PRURITIC (Itchiness on neck) and PRURITUS (Itchiness on arm). On an unknown date, the patient experienced HERPES ZOSTER (Thinks it is shingles or chicken pox). The patient was treated with DIMETICONE, MENTHOL, PRAMOCAINE HYDROCHLORIDE (GOLD BOND ANTI-ITCH) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Thinks it is shingles or chicken pox), RASH PRURITIC (Itchiness on neck), PRURITUS (Itchiness on arm) and RASH (rash on both arms/rash went up to back and belly/Rash on both legs/Rash on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Body aches, fever at 99.9.  Used ibuprofen. Redness spreading where injection occurred. Pain to the touch.
Patient's father reported that patient had fainted. Patient was found  sitting on the floor and was pale. After sitting for a little while and drinking some water, patient was fine and left the pharmacy with her father. Patient's color also returned.
My head collapsed in on itself. I could not see, move, or think. I was more incapacitated than I have ever been in my life. I believe I nearly blacked out. This lasted for about two minutes, then slowly cleared up.
patient stated 2 days 9/10/22  after getting the monkey pox vaccine when he woke up felt sob and palpitations. Patient stated  "I kinda freak out but when I start to walk I felt okay and symptoms went away".  Patient stated he had 2 episodes of waking up with shortness of breath that went away after he walked around and relaxed.  These episodes happened 2 days and 4 days after first Jynneos vaccine.
Very low body temperature; little ache on his arm; This is a spontaneous report from a contactable consumer (patient) received from Pfizer-sponsored program Support. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on an unknown date, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced very low body temperature and little ache on his arm. The patient underwent lab tests and procedures which included body temperature: low. It was reported that, the patient wanted to confirm what he needs to do before taking the second dose vaccine tomorrow (on 06Mar2021). The outcome of events was unknown.  Information on the lot/batch number has been requested.
I was having painful menstruation with a lot of blood clots. Since the vaccination my period has been very irregular. The painful periods and blood clots lasted until July. I went to the doctor, and they did and ultrasound and they found a cyst on my left ovary. I had left breast pain and I also had a left breast cyst. The doctor just said to watch and we will do an ultrasound next year. I was diagnosed with EKG changes in October. Since July I have been having muscle twitches all over and feeling like something is crawling under my skin.
Member received dose #2 of Moderna Covid-19 vaccine today (03/24/2021).  Later discovery that member had received dose #1 on 03/17/2021. Member was counseled on possible side effects and observed for >30 minutes.  No adverse events/side effects noted. Member then released to leave vaccination site at 10:06 am.  **Box 5 is estimated time discovered date discrepancies.
I experienced cough, dry mouth, aches and pains, fever, congested, tiredness and loss of smell & taste.
Allergies occurred after being vaccinated. Before vaccination no allergies were had. After being vaccinated, severe hives and rash occurred all over body and trouble breathing occurred.  A year after being vaccinated, symptoms are still occurring, severe rash, allergies and trouble breathing (tightness in chest). Inhaler was given but does not always help with breathing problems or chest pains.
Severe anxiety disorder with impending doom. Heart races, sob. I don't feel like I'm the same person after the vaccine.  I feel like I'm going to die. If my life is at risk I shouldn't be made to get booster.  If could potentially kill me by excessive anxiety and depression.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            Patient experienced headache after second dose of vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624213 (Patient Link).
reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness following vax;
This case was reported by a other health professional via call center representative and described the occurrence of hives in a 44-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Flu vaccine (received every year). On 11th October 2017, the patient received the 1st dose of FLULAVAL QUADRIVALENT. On 11th October 2017, 8 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced hives. The patient was treated with hydrocortisone, steroid pack (nos) and BENADRYL (nos). On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The reporter (patient for this case) was a social worker for the hospital. The patient received a FLULAVAL QUADRIVALENT on left upper arm at 12:00 hours at lunch time in the hospital last Wednesday, before the reporting date. The patient noted that, she got Flu vaccine every year, but was not sure if she had ever received FLULAVAL vaccine before. About 8 to 10 hours vaccination, hives appeared on her abdomen. The next day the hives were on her elbows, thighs, neck and scalp. The patient was seen on Thursday at urgent care and given a steroid dose pack. The patient also used BENADRYL and hydrocortisone cream. The hives had about resolved at the time of report, just very faint presence was existed. She saw her primary physician on 17th October 2017, who had referred her to an allergist next Monday on 23rd October 2017. The patient did not know the dose and no lot number was available.
Well demarcated firm redness on thigh 10 x 9cm (left thigh)
Subsequent to receiving three doses of Lymerix, the pt possibly may have developed Lyme disease, reportedly. As of 09/11/2000 the outcome of the event is unknown.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Date the vial was initially stored in the refrigerator was 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022).    No concomitant medications were reported.  It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 42 doses of 6M-5Y vaccine were administered after 30 day use by date to patients. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for patient 18 out of 42 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
WEAKNESS, SHORTNESS OF BREATH, EXCESSIVE PAIN AT INJECTION SITE, DIFFICULTY SPEAKING - MOTOR SKILLS IMPAIRED, BACK OF THROAT FELT HOT.