chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaken so bad; Stiffness; Couldn't walk to the bathroom; Joint pain; Chills; Fever; A spontaneous report  was received from consumer concerning a 50Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pyrexia, Tremor, Chills, Arthralgia, Joint stiffness and Gait disturbance.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:039k20A) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 30-DEC-2020, The patient experienced the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 30-DEC-2020 the outcome of the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness was unknown.  The reporter assessed the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness related to study drug was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient vaccinated 4/21, came to facility 1/22,  patient had CLABSI and CAUTI 4/8/2022, patient expired and coded on 5/20/2022
Initial report was received from a health care professional on 26 Jan 2010: This patient inadvertently received the S-OIV FLUVIRIN 0.5 ml, intramuscular (batch no. 1013262P) on 26 Jan 2010. It was reported that after five minutes of vaccination during the posy vaccination watch for an allergic reaction the patient mentioned that patient already had received a H1N1 vaccine in Dec 2009. No adverse events were reported.
Information has been received from a healthcare worker (also reported as certified medical assistant (C.M.A)) referring to unspecified number of patients of unknown ages and genders. On 19-JAN-2014 the patients were vaccinated with improperly stored VAQTA (route, lot#, dose and frequency unknown). No adverse effects reported. It was not specified if the patients sought for medical attention. Additional information is not expected as the correspondence physician didn't hope to be contacted.
How long do side effects last? This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (How long do side effects last?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do side effects last?). At the time of the report, VACCINATION COMPLICATION (How long do side effects last?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact
I am in menopause and had a cycle, lots of clotting and cramping like when I was a young woman. I have not had a cycle in 3 yeas.
Pfizer-BioNTech COVID-19 Vaccine EUA headache  injection site pain general malaise
Patient received the bivalent Moderna COVID19 vaccine after receiving another bivalent COVID19 vaccine in the past; Revaccination with different COVID-19 Vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent Moderna COVID19 vaccine after receiving another bivalent COVID19 vaccine in the past), COVID-19 IMMUNISATION (Revaccination with different COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent Moderna COVID19 vaccine after receiving another bivalent COVID19 vaccine in the past), COVID-19 IMMUNISATION (Revaccination with different COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent Moderna COVID19 vaccine after receiving another bivalent COVID19 vaccine in the past), COVID-19 IMMUNISATION (Revaccination with different COVID-19 Vaccine) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent Moderna COVID19 vaccine after receiving another bivalent COVID19 vaccine in the past) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 Vaccine).    Patient received 1st dose of Moderna vaccine in 20-Feb-2021, Second dose of vaccine was from Pfizer received on 27-Sep-2021 with lot number FF8841. Third dose was received from Moderna on 14-Apr-2022 with lot number 002m21a. Fourth dose was received from Pfizer Bivalent on 30-Sep-2022 with lot GJ5342. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714738 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714738:Bivalent Dose Case
Initial unsolicited report received from non-healthcare professional via other company (Pfizer) on 12 May 2016. Manufacturer Report Number: 2016244653. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of (TDAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported.  On an unknown date, following the vaccination, the patient had developed skin redness and a little swelling at the injection site. The patient's laboratory and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Administered Kinrix vaccine to child aged 1 year 9 months, later staff entering paperwork informed nurse that I had admnistered a vaccine to child under recommended age,
Pt recvd 1st dose of Recomb on 15JAN91 & several hrs p/vax pt devel upper abd & chest pain which later dx as dyspepsia; Pt was taken to ER & tx Lidocaine, Zantac; pt later recovered;
after taking the first dose, his husband was positive with the COVID; after taking the first dose, his husband was positive with the COVID; This is a spontaneous report from contactable consumer (wife reported for her husband). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included blood cholesterol abnormal, kidney stone and blood pressure high. Concomitant medications included atorvastatin oral at 40 mg of unknown frequency taken for blood cholesterol, start and stop date were not reported; allopurinol at 300 mg of unknown frequency, potassium citrate at 1080 mg three time daily,  sodium bicarbonate at 650 mg three times daily, all taken for kidney stone, start and stop date were not reported; lisinopril taken for blood pressure high, start and stop date were not reported. After taking the first dose, patient was positive with the COVID on 21Apr2021 with outcome of unknown. Patient had not got any treatment. Second dose was scheduled on 28Apr2021.
No additional AE reported; Caller reports that a dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 01-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0,5 milliliters (ml) as prophylaxis (lot number: U029496, which was determined to be valid, with an expiration date on 21-SEP-2022) (scheme, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of 7.7 degrees Fahrenheit (F) for 30 minutes. It was reported that there was a previous temperature excursion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007693: US-009507513-2206USA007710: US-009507513-2206USA007717: US-009507513-2206USA007675: US-009507513-2206USA007839: US-009507513-2206USA007845: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910:
None reported. Patient was given her second ZOSTAVAX shot on 10/23/14 after having received her first ZOSTAVAX shot on 8/22/13. Patient reports no adverse effects. Duplication discovered upon routine review of patient profile on 12/13/14.
it is hot,; My arm at the injection site swelled up; It was red, sore,and around 6 in.; It was red, sore,and around 6 in./painful.; Horrible headache; Vomiting; Nausea; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.) and HEADACHE (Horrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 026L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event (no medical history.). Concomitant products included LOVASTATIN (LOVAX) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it is hot,). At the time of the report, VACCINATION SITE WARMTH (it is hot,), VACCINATION SITE SWELLING (My arm at the injection site swelled up), VACCINATION SITE ERYTHEMA (It was red, sore,and around 6 in.), VACCINATION SITE PAIN (It was red, sore,and around 6 in./painful.), HEADACHE (Horrible headache), VOMITING (Vomiting), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Advil, Zyrtec and Benadryl.
Lightheaded, nausea, profuse diaphoresis which disspiated after 30 mins. Tx with cool water to drink, ice pack to back of neck. VS remained stable throughout reaction. BP 120/78, P-70 and regular.
Patient received Moderna for first dose of Covid vaccine 4 weeks ago.  Today, Patient was given Pfizer in error for second dose.
On 01/13/2023 I started getting a runny nose and slight fever. I woke up next day with a cough and feeling really tired. I tested positive for Covid and reached out to my health care provider I was prescribed Paxlovid and symptoms  progressed and I lost since of smell and loss control over my bowls. after taking the Paxlovid symptoms lasted a week getting better each day. However i started getting an allergic reaction after going in the pool. I believe that covid enhanced my allergic reactions.
Information has been received from a RN concerning a 14 year old male with no known drug reactions/allergies and whose mother is allergic to latex who on 15Dec04 was vaccinated IM with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 643399/0367P). Suspect vaccination that day included diphtheria toxoid/tetanus toxoid (manf unk). On 15Dec04 the pt developed itchiness and raised areas like hives on his inner thighs, the back of both knees and his groin area. It was reported that the pt was afebrile. The pt was treated with diphenhydramine hydrochloride (Benadryl) capsules and cream. On 21Dec04 the pt was seen in the office with what was described as faint areas of redness but no raised areas noted. No further treatment was required. No lab diagnostic studies were performed. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional information has been requested.
Pneumonia administered with flu imm on 11/18/05 - That evening pt states arm - lower 2/3 of upper arm (above elbow) started to swell and was painful. Pt states used treat on it Fri pm only. By Sunday swelling and soreness began to subside. As edema subcided orange discolorization began to appear. Today arm not sore but has orange skin color in lower 2/3 of upper arm. Pt reports no sob resp problems. High temp as any general reaction.
Mom says that she cried for 2 days inconsolable crying after 2 months vaccines.
thought it was early dementia/ this was much worse; Headache; chills; sweats; redness at injection site quite large and swollen; redness at injection site quite large and swollen; Mind wouldn't relax to sleep; couldn't concentrate or remember; couldn't concentrate or remember; extreme tiredness; foggy headedness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301358A), via an unspecified route of administration in right arm on 26Sep2021 at 12:30 (at the age of 68-years-old) at dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. She has no COVID prior to vaccination. Concomitant medications included influenza vaccine (FLU), via an unspecified route of administration in right arm 16Sep2021 at dose number unknown, single for immunization and vitamin D NOS (VITAMIN D). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 08Feb2021 at 10:00 (at the age of 67-years-old) at dose 1, single (lot number: EM9809) and via an unspecified route of administration in right arm on 01Mar2021 at 11:00 (at the age of 67-years-old) at dose 2, single (lot number: EW6201) for COVID-19 immunization and experienced foggy headedness and early dementia. She also previously took BIAXIN and experienced allergies. Vaccination facility type was reported as pharmacy or drug store. She was not tested for COVID post to vaccination. On 26Sep2021 at 15:00, the patient experienced headache; chills; sweats; redness at injection site which was quite large and swollen; her mind wouldn't relax to sleep for 3 days (as reported); she couldn't concentrate or remember what was just told to her for 3 days (as reported), she couldn't remember what she just read or watched on TV; extreme tiredness for a week; and foggy headedness. She had a shot on Sunday morning, 26Sep2021, and symptoms, except tiredness which lasted for a week, were gone by Thursday, 30Sep2021. The foggy headedness had her concerned and was scary. Her husband was concerned as well. She thought it was early dementia, she had a little of that with the second shot, but this was much worse after the third shot. She did not receive any treatment in response to the events. The outcome of the event "extreme tiredness" was recovered on 03Oct2021 and recovered on 30Sep2021 for all other events.   Follow-up attempts are completed. No further information is expected.
ACUTE NON ST ELEVATION MI 6/27/2022 ACUTE NON ST ELEVATION MI
Reported a side effect; I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reported a side effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reported a side effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND). At the time of the report, VACCINATION COMPLICATION (Reported a side effect) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have the three of moderna but I'M NOT TAKE 8 MONTH FOR THE SECOND) had resolved.            No concomitant medication was reported.                   No treatment medication was reported.   Reporter did not allow further contact
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There were no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of M-M-R II (lot # K021151, expiration date 02-NOV-2016 and lot # K009192, expiration date 27-JUN-2016) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.
42 days after administration of Gardasil #1 and 42 days after administration of Gardasil #2 this child attempted suicide.  11/08/2007 MR received for DOS 7/25-31/2007 for D/C DX Depressive Disorder NOS, Mood Disorder NOS, ADHD, and Reactive Attachment Disorder R/O Borderline S/P overdose with Tylenol and DOS 10/4-12/2007 with DX: Depression, NOS. Mood disorder.  Very strong traits of borderline personality disorder, superficial cuts, self inflicted. Pt was admitted to hospital on 7/25/07 after recent attempted suicide by overdosing with Tylenol.   Improvement during hospital stay however struggling with self-harming behavior. Readmitted 10/4/07 after engaging in self abusive and self destructive behavior.  Carved 666 on leg and was popping pills wanting to kill herself. Pt remained at risk for self harming upon D/C. Per 60 day follow up: Pt was referred for two suicide attempts after GARDASIL. Pt was depressed before episodes, and remains in treatment for depression, etc. causation unclear. 1/12/2010 Still has mood disorder (bipolar) and Tlc disvrei refraction to meds. She is a cutter.
rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy.  There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.