chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and smoker, and other pre-existing medical conditions included patient had no known drug allergies and no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 14-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced headache.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Subject, a 49 year old female with no previous medical conditions, received the 4th dose of Anthrax vaccine on 03Aug00. No other vaccines were given on this date. Concomitant medications at the time of the event included PREMARIN and ranitidine. The pt did not have any illness at the time of the event. Reactions to previous vaccinations are unknown. In Oct 2000, the pt began experiencing multiple joint pain. Her personal physician examined her in Nov2000 and blood tests were performed with negative results. Naproxen 500 mg was used to treat the event, however the joint pain continued. The pt did not fully recover from this event due to the persistence of pain. Information received 08/27/02: the pain in multiple joints lasted approximately 6 months. All pain has resolved. No current symptoms. The pt did go through physical therapy for knees. No longer taking naproxen, stopped drug treatment when pain stopped.
Felt like they could not get enough air; Chest hurt; Every once in a while they feel like they need to take a deep breath; Coughed all night; A little sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night), DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm). On 06-Feb-2021, the patient experienced COUGH (Coughed all night). On 07-Feb-2021, the patient experienced DYSPNOEA (Felt like they could not get enough air), CHEST PAIN (Chest hurt) and MALAISE (Every once in a while they feel like they need to take a deep breath). On 09-Feb-2021, DYSPNOEA (Felt like they could not get enough air) and CHEST PAIN (Chest hurt) had resolved. At the time of the report, PAIN IN EXTREMITY (A little sore arm), COUGH (Coughed all night) and MALAISE (Every once in a while they feel like they need to take a deep breath) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: 93 (normal) Then it went up to 95 and 96..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-160014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Updated patient contact information. Updated Concomitant product use.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-160014:2nd dose case
Generalized symptoms before 08/12/2003: Malaise, aches, fever etc.  ER 08/13/2003: Fever (102.3F) erythema, pustular vesicles around site.  By 08/25/2003 rash spread including pustules into axillia.  Keflex 500mg 4 times a day started.  Also antihistamines (itch) NSAIDS and dressing changes.  Discharged from medical care-to full duty 08/09/2003.
Felt awful. Every but of me hurt. I got very Shakey. Chills. No appetite. Weak, No treatment. Felt better in 36 hours.
Information has been received from a female pharmacist (under 50 years old) via a company representative referring to herself. Information about patient's concurrent conditions and medical history was not reported. On unknown dates the patient was vaccinated with two doses of (Merck) VARIVAX (lot#, dose and route not reported). Concomitant medications were not provided. The patient reported that on an unspecified date after receipt of these vaccines, she had laboratory work conducted which showed negative titers for the varicella virus. Outcome of the event was unknown. The causality was not provided. This is one of two reports from the same source (other linked case # 1510USA010950). Additional information has been requested.
Patient was nervous about receiving vaccine. After approximately 10 minutes patient vomited after receiving vaccine. Patient was given ice packs for neck and forehead. Patient left pharmacy after 30 minutes.
Mother was 37 weeks for her first COVID vaccination and was 40 weeks for her second vaccination. The neonate was born with no complications at birth. The neonate began to develop severe sweating episodes while breast feeding and 3 weeks post-birth was diagnosed with Congestive Heart Failure with reduced LV function with an EF of 37%. The neonate was admitted to the pediatric ICU for critical care management of her CHF. She was placed on IV milrinone and IV Lasix. After two days she was transitioned to oral Enalapril and oral Lasix.  She was subsequently discharged to home in stable condition with oral Enalapril and Lasix.
shriek x approx 2 sec-limp, unresponsive, blue around eyes, mouth; disoriented, sleepy seemed nl by arrival in ER; To hosp poss UTI vs sz disorder; 1 episode of diarrhea; pt seen for apneic episode; t100.9; pt did not want to breast feed;
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status
Fever to 101.8 degrees Rectal temp, likely secondary to immunization, vs viral syndrome, several hours after 9/25/12 influenza vaccine.
a 11 yr old child was by mistake given Fluzone HD/No AE; a 11 year old child was by mistake given Fluzone HD/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who received by mistake 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ287AA, expiry date-28-05-2020 via unknown route in unknown administration site on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma without complications. No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
It was reported that a patient 4 of 4 received a Rabies Imovax ID vaccination. Reportedly 24 hours following immunization the pt developed tingling in fingers, neck pain and disorientation. Further information requested.
Chills/ Severe shivers which lasted about 4 to 5 hours, uncontrollable shivers; Joint pain; Nauseous; I had some swollen lymph nodes; My heart beat was going pretty fast and that lasted for about 40 hours; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown and Expiration date was not reported), via an unspecified route of administration in arm right on 09Mar2021 (at the age of 73-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the patient wanted to report some adverse effects from the COVID 19. Stated that, the first shot was no problem, the second shot, he thinks 10 hours after he got the shot, on an unspecified date in Mar2021, the patient got the chills and severe shivers which lasted about 4 to 5 hours, uncontrollable shivers, joint pain, nauseous, he had some swollen lymph nodes and his heart beat was going pretty fast and that lasted for about 40 hours. Stated that, the patient just wanted to let them know what kind of effects that he had in case someone else had the same thing. Stated that, the chills weren't bad but when he started shivering that was the worst part and that have lasted for about 4 hours constantly. The consumer stated that, he took Tylenol and that knocked it down. But after about 3 to 4 hours after when Tylenol went off and he started getting the chills again. So, he took second dose of Tylenol and that was it after that. So, he took 4 Tylenol over a 12 hour period. Stated that, the patient just wanted to let them know what happened to him. Stated that, his wife had no problem and other people he knew don't have no problem but for some reason he just got nailed. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included My heart beat was going pretty fast and that lasted for about 40 hours (heart rate), resulted as increased. The outcome of the events for joint pain, nauseous and I had some swollen lymph nodes was unknown while for the other events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible, information about batch/ lot number cannot be obtained.
Patient states that the vaccine administered to his left arm worsened his left arm weakness. He had surgery as listed earlier on 12/2/2020, he then mentioned to multiple healthcare providers on 12/21/2020 that he could not lift his left arm past his nipple line. He was then started on dexamethasone for three days. The vaccine was then given on 12/24/2020 to the left deltoid. Of note, PPSV23 was given to his right arm that day as well. The patient then states that a few days later and according to our documentation (1/2/21) he could no longer lift his left arm past his navel. He has been getting occupational/physical therapy with minimal to no improvement.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy:amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Covid-19 treatment; (Jul2022) Negative, notes: Day 7 of paxlovid; (Jul2022) Positive, notes: Tested positive with mild symptoms on Day 10; (Jul2022) Negative, notes: on Day 5 of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was treated with anti-viral product for COVID 19 Treatment (Paxlovid) from 03Jul2022 to 07Jul2022. Patient was tested negative on Day 5 of paxlovid and again 2 days later (Day 7). No symptoms from Day 5-9. Tested positive with mild symptoms on Day 10. Covid rebound on 12Jul2022 and treatment was not received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache  Body aches  Fever Fatigue  Body pain  Nausea
pt recv vax 7JAN97 & 3NOV97 pt devel a rash (less than 50 lesions);pt was afeb;
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 86-year-old male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received SHINGRIX (intramuscular). In November 2018, 7 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, rash scaly and blister. The patient was treated with valaciclovir hydrochloride (Valacyclovir), gabapentin and hydrocortisone. On an unknown date, the outcome of the ophthalmic herpes zoster, rash scaly and blister were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, rash scaly and blister to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The patient received SHINGRIX on the left arm. Approximately a week later, a scaly rash presented at the top of the right side of his head. It traveled down to the right eye brow, right eye lid and right cheek bone. A few days later the blisters appeared in these areas. The right eye ball was also affected. The patient had seen a physician assistant in a dermatology office and an ophthalmologist. Both healthcare professional diagnosed it as shingles. The reporter said that the pharmacist could provide the batch number in follow up. The reporter gave consent to follow up. This is 1 of the 3 linked cases, reported by the same reporter.
Patient developed local injection site reactions, bruise, redness, swelling overnight. Tender to touch.
has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose on 12th November 2020, intramuscularly in left deltoid, batch number 453S4, expiry date 19th March 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter gave a consent to follow-up with himself. He provided his email address.
Excessive swelling, pain, redness and heat at the site of injection. Given Tylenol to manage pain.
Itching; Arm swollen; Hot to the touch; Redness has an extension of 4 inches; Redness at the injection site; Stomach pain; Itching all over the body; Pain in the upper part of the back; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching) and PERIPHERAL SWELLING (Arm swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back) and HEADACHE (Headaches). On 16-Mar-2021, the patient experienced PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Back pain, at an unspecified dose and frequency and IBUPROFEN for Back pain and Headache, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PRURITUS (Itching all over the body), BACK PAIN (Pain in the upper part of the back), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Redness has an extension of 4 inches), HEADACHE (Headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
minor sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 01Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "atrial fibrillation", "heart palpitations", "some very slight lesser functioning on the left side of her heart"; Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Sep2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "minor sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: Apr2022, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "minor sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "minor sore arm". Additional information: the dose was given in late Sep2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289194 same patient and event, different dose;
No adverse event; received a bivalent booster as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (received a bivalent booster as a first dose).    No concomitant information was reported. No treatment information was provided.
extremely dizzy/lightheaded; everything went "topsy turvy"; This is a spontaneous report from a contactable consumer (patient). A 84-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581, Expiry date: not reported, age at vaccination: 84-year-old), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 14:15 as dose 2, single for covid-19 immunisation administered in Doctor's office/urgent care. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's Thyroiditis from an unknown date and unknown if ongoing (taking Synthroid daily). The patient had known allergies many and she avoids them all. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL3249), in Arm left on 18Jan2021 at 14:15 for covid-19 immunization. The patient did not receive any other vaccines in four weeks and did not receive other medications in two weeks. No covid prior vaccination and not tested for covid post vaccination. The patient had her second Pfizer vaccine dose yesterday, Monday, 08Feb at 2:15 pm and felt fine the rest of that day. This morning (09Feb2021) at 08:30 Am she got up to go to the bathroom and took one step and suddenly feeling extremely dizzy. She reached out to grab hold of the dresser and everything went "topsy turvy". Her head hit the side of the wall on a framed picture and she fell totally out of control ending up in the corner of the room. Her hip hit the floor hard and head hit the wall. She was in a half reclining position. she never had this happen before. She sat for a few minutes and still felt dizzy. Then got up slowly and got into bed. In bed she continued experiencing waves of dizziness. Throughout the morning she felt waves of dizziness and light headed but nothing like she experienced when she first got up out of bed. It is now around 1 pm 09Feb2021. She was feeling better and hoping she will not have another episode. She wanted to known is this an adverse side effect to the vaccination or not. No treatment was received for the events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Daily facial flushing. Hand and feet swelling turns red and hot, burning pain on body .  Every day occurrence since 4/26/21