chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; fever; aches; tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever), MYALGIA (aches), FATIGUE (tired) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M02A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation on 12-Mar-2021, Obstructive sleep apnea syndrome on 01-Nov-2013, GERD on 12-Mar-2012 and Mixed hyperlipidemia on 12-Mar-2012. Concurrent medical conditions included Drug allergy and Allergy to antibiotic. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]) from 2016 to an unknown date and FLECAINIDE from 2016 to an unknown date for Atrial fibrillation, EZETIMIBE (ZETIA) for Cholesterol high, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 2016 to an unknown date for GERD, EZETIMIBE from 06-Nov-2020 to an unknown date for Hyperlipidemia, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 04-Feb-2021 at 10:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (fever), MYALGIA (aches), FATIGUE (tired) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 08-Mar-2021, CHILLS (Chills), PYREXIA (fever), MYALGIA (aches), FATIGUE (tired) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 101.3 (High) 101.3 degree F.         The patient's height and weight were reported as "64" and "140" respectively. The fever never crossed 101F. The symptoms lasted for 6-8 hours.
Sweating a lot; She does not feel well,Vaccine is knocking her down; Sick as a dog; wanted to throw up; Nauseous; Headache; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up) and NAUSEA (Nauseous) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Penicillin allergy.    On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Oct-2022, the patient experienced HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating a lot), MALAISE (She does not feel well,Vaccine is knocking her down), ILLNESS (Sick as a dog), VOMITING (wanted to throw up), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter. On 26-Feb-2021, the patient received first dose of Moderna COVID-19 Vaccine (Lot number-WT012AZ1A). The patient received the bivalent booster of the Moderna Covid 9 vaccine in the morning and at 3 or 4 o'clock she started to have the events.
p/vax pt red, fiery arm from flu shot;reddened area the size of small saucer;told to use ice on arm;reported no SOB, wheezing, told to seek medical care if w/o improvement;severe local rxn;
Case number PHEH2014US000714 is an initial spontaneous report received from a consumer (wholesale distributor) on 06 JAN 2014. This report refers to a patient of unknown age and gender. This patient was given only MenCYW liquid component of MENVEO (batch number unknown) without being reconstituted with MenA, intramuscularly on an undetermined date. No adverse event was reported following this administration error (inappropriate preparation of medication).
I had COVID-19. I had a fever, loss of sense of taste and smell, coughing, and sore throat. I had loss of appetite. I got OTC vitamins, Tylenol, and Vitamin D. I had the symptoms for about 7 days.
Fever, headache, body aches, joint pain petechial rash and erythematous macule that were slightly elevated mostly on the lower extremities.
Patient received 2nd Moderna dose during vaccination clinic, which is her employer.  She previously received her 1st Moderna dose, with no adverse reactions reported to Pharmacy, on 1/15/2021.   On Monday, 2/22/21, patient reported to her school nurse, located at SSchool, that she developed a "tingling sensation from the bend of the arm down to the top of the hand."  She reports this began on 2/12/21, the day she received the vaccine, and states it "has not gotten better nor worse" since.  The school nurse, may be reached at mobile phone number.  Both nurse and Executive Secretary to the Superintendent Schools, advised patient to see her primary care provider as soon as possible.
Pain starts in my right bullocks then moves to the side and front of thigh. Making it difficult to walk.  I've used Diclofenac Na seems it helps a little. Hurts mostly after I wake up and after working hours.
No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine).    No concomitant product use was reported.   On 14-Oct-2022, a dosing error occurred with a couple of patients. Doses of Blue capped purple-bordered (Ages 6-11 MONOVALENT) given instead of Blue capped gray-bordered (Ages 6 and older BIVALENT) booster doses.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659880:
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: A pharmacist reported that a patient received an expired dose of Bexsero on 17th August 2022. The vaccine expired on 31st July 2022.  The reporter was consented to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
hives all over; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's comment: This case was reported by the patient via (Shingrix GSK) interactive digital media. The reporter stated that he/she had got a shot one day before reporting and was experiencing hives all over at the time of reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
2x2 in redness at the site of injection; Itching at the site of injection; Pain at site of injection; Muscle sore (not severe); A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of pain at the injection site, muscle sore, 2x2 in redness at the site of injection and itching at the site of injection.  The patient's medical history included difficulty breathing. The concomitant medications reported included levocetirizine.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the experienced pain at the injection site and muscle sore. The treatment information included paracetamol.  On 31 Dec 2020, the patient experienced 2x2 in redness at the site of injection and itching at the site of injection. The reporter stated, the patient took a missed dose of levocetirizine.   The Action taken with mRNA-1273 in response to the events was No change. The date of return for second dose is 20 Jan 2021.  The outcome for the events, 2x2 in redness at the site of injection and itching at the site of injection 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.
She had a lot of sickness, so she couldn''t do it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "She had a lot of sickness, so she couldn''t do it". Additional information: On confirming the name of the vaccine, reporter stated, she took the first dose in Oct2021. Then she was taking (Voice not clear) because she had a lot of sickness, so she could not do it. The concern is that their mother, she had her second shot of COVID up there like a month after she had the first one. She is not feeling good since she had the shot. She has like muscle pain, bones pain, gas, headache. I want to know if this is a normal thing that happens to elderly people after the second shot. She did the second shot 2 days ago, 2 or 3 days ago and since then she is not feeling good. She has a headache, muscle pain, bones pain, gas, feeling tired. They just wanted to know if this is a normal reaction that an older person has. She is 91 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (29Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101775542 Same patient and drug, different dose
About an hour after the vaccine, I started having a headache and rectal bleeding. Later that same night I started feeling like I had the flu or a virus. My body felt like it was on fire with no fever, Nauseous, major head ache, fatigue. The next day I have experienced the same symptoms and am experiencing bleeding from the mouth as well. It's not severe bleeding from mouth or rectal bleeding but enough to feel it should be reported.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: Patient feeling faint, nausea and clammy skin with chest tightness.  At 4:30pm Blood pressure 112/74 pulse 80. At 4:45pm feeling better and less nausea and less chest pressure.  At 5pm bp 123/79 pulse 77.
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, -09248 and 2011-09250. A five-month old female infant received a DTP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and had onset of seizures within 24 hours post-vaccination. After the seizures, the patient manifested developmental delay. Multifocal infarctions were found when she died seven years later. Documents held by sender: None.
Information has been received from a physician concerning a 14 month normal, healthy female with no significant medical history including no immunosuppression and no recent exposure to chickenpox, shingles, or other viruses who on 03/21/03, previously report as 06/21/03, was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 643593/0868M).  The physician indicated that she was not aware of the child experiencing any post-vaccination rash, fever, or injection site pain following vaccination.  On 03/25/03, the child started vomiting. On 03/26/03, the child had a 2-3 minute generalized seizure, which was the first of five 2-3 minute generalized seizures. The child was then admitted to the hospital. The reporter indicated that a CSF sample was sent out for PCR analysis. It was also noted that a prescription drug was required, the events were considered life threatening, and unspecified medical attention was sought. Follow up information received on 03/28/03 from a physician indicated that on 03/25/03 the child began to vomit and have seizures. It was noted that the child had a total of 5 seizures, each lasting 2-3 minutes.  She reported that the child did not have any fever prior to having the seizures; however she had "1-2 temperature spikes during some of the seizures". No rash was noted. The child was hospitalized in the intensive care unit and was undergoing a complete evaluation, including blood cultures. Additionally, while hospitalized, the child continued to have some vomiting, and had also developed loose stools. The physician noted that they were investigating possible GI sources for the child's sign/symptoms. The physician indicated on 03/28/03 that "to date, they do not have a diagnosis". As of 03/28/03, the child was much improved and was out of intensive care and back on a regular floor. It was noted that the child was sitting up and eating, though there was still no final diagnosis.  Additional follow up information indicated that "the results of the PCR analysis showed that it was an adequate specimen and that it was negative for both the wild-type varicella zoster virus and the vaccine strain virus".  It was also noted that the CSF specimen was obtained on 03/26/03, and the results showed that the VZV DNA was not amplified and the B-globin DNA was not amplified. Follow up information also indicated that on 03/26/03 the pt had a maximum temperature of 100.0F.  It was reported that the pt recovered. Additional follow up information received from a physician indicated that the CSF was negative and that the child has not had any further seizures associated with the vaccination. However the physician felt that it was necessary to report this adverse experience and investigate the VZV ID program since the vaccine had been administered 5 days prior to the onset of the seizures. Since the fever had occurred after the seizure, the physician did not consider these febrile seizures. It was noted that the physician felt the child had completely recovered. No further information is expected.
Patient had soreness and raised, painful, bruised, rash at sight of injection and under it as well.
Four days after receiving his vaccinations the patient developed a sensitive area to the skin of his left shoulder which progressed over the next couple of days into a small rash.  Additionally, he developed pain in his left shoulder that radiated up into his neck and skull.  On 10/5/20 patient saw a physician and was diagnosed with shingles and given a prescription of valacyclovir and oxycodone/apap.
S-rlt stayed red for a long long time, then turned into a bruise w/a knot in it; O- area on upper RLT w/o redness or swelling, firm lump 1.2 x 1.2 cm palpated sl beneath skin;
patient just had a sore arm 2 days an felt alittle bad for 2 days; patient just had a sore arm 2 days an felt alittle bad for 2 days; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient just had a sore arm 2 days an felt alittle bad for 2 days (feeling abnormal) and (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient just had a sore arm 2 days an felt alittle bad for 2 days (feeling abnormal) and (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE. Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.
soreness at injection site; Shot site has redness; Shot site has tenderness, slight pain/ Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness at injection site), VACCINATION SITE ERYTHEMA (Shot site has redness) and VACCINATION SITE PAIN (Shot site has tenderness, slight pain/ Soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Shot site has redness) and VACCINATION SITE PAIN (Shot site has tenderness, slight pain/ Soreness at injection site). On 18-Jan-2021, the patient experienced TENDERNESS (soreness at injection site). At the time of the report, TENDERNESS (soreness at injection site), VACCINATION SITE ERYTHEMA (Shot site has redness) and VACCINATION SITE PAIN (Shot site has tenderness, slight pain/ Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information provided.
8 days after 2nd Covid shot, right arm swollen, very red in and around the area of shot about 5" down/around from injection area.
Information has been received from a physician concerning an approximately 6 month old male with a milk allergy and eczema who on an unspecified date was vaccinated orally with a 2 mL second dose of Rotateq. Within 24 hours of getting the second dose of Rotateq the patient developed bloody stool. Unspecified medical attention was sought, there were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information from the nurse indicated that the patient was vaccinated with first (lot # 656381/0875U) and second (lot # 657670/0901U) 2 ml doses of Rotateq on 29-AUG-2007 and 31-OCT-2007 respectively. The patient did not go on to receive a third 2 ml dose of Rotateq (lot # 657673/0904U) on 02-JAN-2007. The nurse had no additional information. Additional information from the physician indicated that the patient was not seen for the condition. The information was phoned in only. The patient had only one episode of bloody stool, was afebrile and had no loss of appetite. No treatment was required. The association between the event and the vaccine was unknown. Upon internal review the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.