chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a sore arm, so sore that he ended in the hospital for 2 days; he couldn´t move his arm; it still hurts and goes into his neck; A spontaneous report was received from a consumer concerning, an 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sore arm, he couldn't move his arm, and it still hurts and goes into his neck.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# not provided]) intramuscularly for prophylaxis of COVID-19 infection.   The patient's wife stated that the patient had the vaccine and then 5 days later he had a sore arm, so sore that he ended up in the hospital for 2 days (dates not provided). The patient couldn't move his arm and it still hurts and goes into his neck. The patient did not plan on receiving the 2nd dose of the vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of he ended in the hospital for 2 days, he couldn't move his arm and it still hurts and goes into his neck were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Diarrhea and vomiting  beginning 1 am January 31, 2021 - passed out on way to bathroom - extreme chills - lasted approximately 2 hours.  Chills continued for approximately 12 hours.
had booster at Pharmacy on 12/8/21 around 7 pm. noticed hands, scalp and palms itching around 11-12 that same night. then noticed blotchy, raised, red rash on palms and felt palms were very hot. since then has had rash on palms mostly and not going away. no other symptoms.
Pt presented 48 hours after given (R) deltoid GARDASIL IZ. The area involved (R) forearm with swelling, warmth, large bullous and red streaking up posterior of upper arm pt sent to ER for eval of cellulitis and presumed lymphangitis.
In may i started some truble with shortness of breath when walking. Felt like trying to breath through a mask when i was not wearing a mask.  In June the ymptoms seemed to clear up and were not a noticeable exceptwhen climbed stairs. had a chest xray which came back clear.   The end of August the symptoms started again especially going up stair.  Around September 8 they got worse with having great difficulty breathing when walking. by September 14th early morning I could catch my breath at all and went to the  ER around 4 am.
Cough, Runny Nose. Doctor saw the patient today. He has got ear infection. I think the root cause is this vaccine. He was perfectly fine before he was given the vaccine. Has been prescribed Zithromax by the pediatrician.
Patient called the office the day after immunizations stating his right arm was very painful and he was unable to lift his arm up because of the pain. He denies any redness, rash, or swelling.
Information has been received from a pharmacist referring to a 65 year old patient. Patient's medical history and concurrent conditions was not reported. On 06-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J014851, expiry date: 24-OCT-2014) (dose, route unspecified). No adverse experience has been reported. No product quality complaint (PQC) involved. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 76 year old female with an allergy to "Sulfa" who on 30-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y). On 01-MAY-2010 the patient experienced cellulitis. The patient went to the emergency room (name of hospital was unspecified) but was not admitted. The patient was treated with ROCEPHIN IV and discharged on clindamycin, 300mg, 4 times a day. The nurse was requesting a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
HCP was transferred from specialist to evaluate expired PNEUMOVAX 23(PFS) inadvertently given to a patient. HCP stated no side effects have been reported. HCP confirmed there was no T/E. HCP stated it was an MA who administered the vaccine. HCP was s; HCP was transferred from specialist to evaluate expired PNEUMOVAX 23(PFS) inadvertently given to a patient. HCP stated no side effects have been reported. HCP confirmed there was no T/E. HCP stated it was an MA who administered the vaccine. HCP was s; Information has been received from an specialist via a health care professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-SEP-2023, the patient was inadvertently vaccinated by a medical assistant (MA) with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.   The reporting health care professional confirmed there was no temperature excursions.
feel fatigue after one week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feel fatigue after one week) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feel fatigue after one week). At the time of the report, FATIGUE (feel fatigue after one week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was provided.   Reporter did not allow further contact
Mom reports redness, swelling, and hot to touch at injection site. Started the evening of the day the vaccines were given, got progressively worse. Mom called PCP's office the next day to report. Also stated the site was very hard. Advised mom bring child in to be evaluated by MD. MD evaluated and measured a 5cm x 5cm area of redness and warm skin surrounding the injection site. Diagnoses of "adverse reaction to vaccine" given. No treatment prescribed.
Severe and unbearable anxiety and panic attacks. Everyday to the point where they are debilitating and causing me to not be able to sleep or eat normally.
Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 2 ml, ROTATEQ, (lot # was reported as K005396, expiration date 28-FEB-2016), (lot # J008740, expiration date 22-MAR-2015), (lot # K001935, expiration date 08-DEC-2016), (lot # was reported as K008139, expiration date 15-APR-2016), oral which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
COVID twice; COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had COVID twice once before the vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID twice". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 120 to 130 over 80; heart rate: 79 to 81.  Clinical Course: Patient have had no health or heart problems. Heart rate is 79 to 81 BP is 120 to 130 over 80.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site soreness; Full arm soreness; Generalized fatigue; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 01896589) via an unspecified route of administration in the arm left on 31Mar2021 at 11:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included Arthritis in both knees and allergic to purex laundry detergent. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:30, the patient experienced injection site soreness, full arm soreness and generalized fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events injection site soreness, full arm soreness and generalized fatigue was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
After 10 minutes of the injection, I started feeling a mild tightening in my throat. It still ongoing, after 2 hours of the injection. No other symptoms were observed. I'm breathing normally.
Pt. complains about a stiffness in the arm going into the neck. Slight discomfort when lifting the arm.
Arm became swollen and unable to move.   Had taken 2 Motrin right after Tdap was given.  Took 2 more Tdap @ 10 PM.  @ approx 2 AM the next Morning, chills started and pain in left arm, shoulder and side started.
Client fainted after injection, BP 78/54 took pt to lie down BP increased 106/68 and she started feeling better (5-7 min)
RIGHT SHOULDER PAIN, INABILITY TO MOVE ARM ABOVE HEAD. DIFFICULTY WITH FULL RANGE OF MOTION. SHOOTING PAIN FROM DELTOID TO BICEPS.
feels tired; fatigued; very drained; lethargic; thought a bolt of lightning struck her because she had very severe arm soreness; knot at the injection site; looks slightly bruised; little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site) and VACCINATION SITE BRUISING (looks slightly bruised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VITAMIN D [VITAMIN D NOS] for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, LATANOPROST, ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and MAGNESIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D [VITAMIN D NOS] (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (little bit sore). On 31-Mar-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (fatigued) and FATIGUE (very drained). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (feels tired), FATIGUE (fatigued) and FATIGUE (very drained) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Had my COVID Janssen single shot on March 18, 2021. Became sick with chills, fever (100F), fatigue, headache, body ache after 9 days.  Lasted 4 days before improvement.  Decided to take a COVID test  3/29/2021. Result negative.
Patient was vaccinated on 2/3/21 and 2/24/21, so was fully vaccinated when testing positive for COVID-19 on 10/7/21.
Information has been received from a registered pharmacist concerning a 51 year old male with history of psychiatric issues, history of seizures "that occurred a long time ago" who "one week ago" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml), intramuscularly. Subsequently, the patient experienced seizures. The patient was treated with levetiracetam (KEPRA), and "is much better now." The reporter considered seizures to be other important medical event (OMIC). Additional information has been requested.
My husband and I received the flu vaccine on 10/22/2020.   Eight days later he became very tired and fatigued, and developed a dry cough. Two days later he developed a fever of 102.5,   treated with Tylenol.  The following day max temp. was 101.  Now, day5, he still has a dry cough, fever so far max of 100.2, and remains feeling weak and tired. Meanwhile I feel fine, with no symptoms or side effects.  His sense of taste and smell are normal.  No other possible side effects.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: covid arm
7 days p/vax 6MAY98 pt devel bumps on face, knees & hands-fever 101 & longer than usual naps (3-4hr);mom verbalizes this as a severe rxn;this lasted approx 5 days;pt recovered;mom concerned about child having to eventually recv #2 MMR;
9/28/12 Phone call from dr - states 12 - 24 hour after immunization pt started localized reaction 4 x 6 cm. Hot, painful, burning. Treating with OTC meds.
Reported headache, throat ache and leg ache at vaccination. Elevated temperature (not sure how high). Tylenol was given at 16:00, 20:00 and at 02:30. Approx. 06:00, he had a seizure and was transported to ER. Discharged to home and is to follow-up with PMD on 2/23/01.
Disequilibrium / moving head back or down; Dizziness upon laying down; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included heart valve disease. Concomitant medications were not reported. The patient previously received tetracycline (MANUFACTUER UNKNOWN) on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On unknown date in 2021, the patient experienced disequilibrium and dizziness upon laying down, moving head back or down. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events disequilibrium/moving head back or down and dizziness upon laying down. The clinical outcome of the events disequilibrium/moving head back or down and dizziness upon laying down were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt present for booster shot; Pt expressed nervousness about getting shot; Per pt's mother pt fainted when she received her initial series shots. Pt sat in vaccine chair, vaccine administered, pt c/o of nausea. Pt immediately experienced syncopal episode for 5 seconds. I sat pt upright in chair. I called her name pt responded by looking at me. I asked her questions. Pt responded to questions appropriately but still had distant stare. I continued to refocus her attention to me and to my questions. Pt closed eyes and shook head. Pt continued to answered appropriately and eventually engaged in conversation. We offered water and juice. Pt accepted and drank them. Pt indicated she was ok. I assessed for alertness. She continued to engage in conversation and wanted to stand. we assisted in standing and pt walked with steady gait under her own power.
This spontaneous report as received from a pharmacist refers to a 72 years old female patient with hypertension and depression and a history of "urinary continence". The patient was vaccinated with 0.5 ml PNEUMOVAX23 (Lot number was reported as "H8009826") intramuscular onto right arm on 31-JUL-2012. No other co-suspects were reported. Concomitant medications included metoprolol, ACTONEL, LEXAPRO and VESICARE. In the night of 31-JUL-2012, the patient had a fever. In addition she had swelling (not only at the injection site but spread throughout her right arm, pain (not only the right arm, but generalized pain throughout her body like the flu) and warmth at the injection site. The patient was in pharmacy at the time of reporting and the pharmacist advised the patient to follow up with her health care provider. Pharmacist stated that patient was treated with TYLENOL and cold packs at the injection site as needed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
6 hours after administration, developed localized rash right arm that progressed and generalized to bilateral arms/chest/anterior thighs.  Patient complained of severe burning and pruritis.
3/10/2021  at 630 pm, 2 hrs after vaccine had headache and mild fatigue.  This lasted until 3/12/2021 Fri, woke up Fri morning and felt fine.  Sun 3/14/2021 late evening 1100 pm started having chills and running fever. Woke up Mon 3/15/21 at 6am with headache ( with   sensitivity to light), extreme fatigue, joint pain all over, severe pain in my hips and knees. nausea. This has continued through today 3/16/2021.
Red, inflammation spot, 3 in. diameter, near injection site. No raised bumps, slowly spreading.
On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine; Stomach cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included MAGNESIUM for Supplementation therapy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included pepto bismol and Imodium to alleviate the symptoms. It was reported that Imodium had been helpful but not for long It was reported that diarrhea slowed after about 10 days along with all other symptoms. The patient was concerned that chemical polyethylene glycol in the shot could have an effect on his system. The patient discovered that he was taking magnesium supplement which could have been the culprit or could have been both. The patient went off the supplement and his system settled down in 10 day period. It was reported that most of the diarrhea happened in the morning time which was when most of his Inflammatory Bowel Syndrome (IBS) seemed to happen.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Outcome of events updated,  medical history added
On day 10 following the vaccination, child developed a fever and loss of appetite. His fever went up to 101 and shortly after he started breaking out in red bumps on his face. They increased onto both cheeks, forehead, neck, throat, both arms, torso and on his legs. He was taken to the doctor and it was confirmed that it was a reaction to the vaccination. His rash increased in severity but his fever broke and his appetite returned. The rash is still there as of this report.
Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021) outcome was unknown.            Patient did not experienced any symptoms with the previous two doses of the Moderna COVID-19 Vaccine. Patient had a Cholesterol condition for which she was taking Cholesterol medication. No treatment medications were reported for primary doses.   This case was linked to MOD-2022-525811 (Patient Link).   Reporter did not allow further contact
Swollen and painful lymph node under right arm (in armpit area) noticed the day after the 2nd vaccine.   Lymph node is still swollen and painful on day 3 after 2nd vaccine. Swollen and painful mass (I'm assuming it's a lymph node), in right clavicle area noticed on day 3 after 2nd vaccine.  Swelling has increased slightly as the day continues.
There were 4-5 individuals at the local clinic on 1/19/23 that received the 6 months to 5 years monovalent formulation due to a preparation error. Clinic is unable to determine which 4-5 individuals out of 14 actually received the monovalent formulation instead of the intended bivalent product.  Moderna monovalent Lot number was AS1414B with manufacturer expiration date of 2/13/23.  No adverse reaction symptoms
AREA OF VACCINATION (RIGHT THIGH): HARDENING, REDNESS AND HOT TO THE TOUCH.