chrisvoncsefalvay/vaers-outcomes huggingface dataset:
and a "bad cold"; "Throwing up"; "has had a low grade fever 99.2 degrees"; 2nd vaccine received at 38 days after 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ("Throwing up"), PYREXIA ("has had a low grade fever 99.2 degrees"), NASOPHARYNGITIS (and a "bad cold") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine received at 38 days after 1st vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), Eletriptan, promethazine and Dihydroergotamine                                               for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine received at 38 days after 1st vaccine). On 07-May-2021, the patient experienced VOMITING ("Throwing up"), PYREXIA ("has had a low grade fever 99.2 degrees") and NASOPHARYNGITIS (and a "bad cold"). On 07-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine received at 38 days after 1st vaccine) outcome was unknown. At the time of the report, VOMITING ("Throwing up"), PYREXIA ("has had a low grade fever 99.2 degrees") and NASOPHARYNGITIS (and a "bad cold") outcome was unknown.  Treatment information was provided i.e., Tylenol  The Action taken with mRNA-1273 in response to the events was unknown.
102-102.5 fever sustained for 12 hours  Headache  Severe body aches  Sever left shoulder pain  Nausea/vomiting  Fatigue   Started 11pm, about 12 hours after vaccine.   Treatment: alternating ibuprofen and Tylenol
pt recvd Typhoid vax & devel fever & chills for 2 days; also devel redness & swelling @ the inject site;
Possible vaccine hypersensitive anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) in a 70-year-old female patient 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 ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Possible vaccine hypersensitive anaphylaxis) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Reporter stated they got a vaccine hypersensitive anaphylaxis follow up form that only had initials and age of the patient involved and because of that they wouldn't be able to fill the form.  Company comment: This spontaneous case concerns a 70 year female with no medical history reported. who experienced Serious ( medically significant ) , expected event of Anaphylactic reaction which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination also was not reported . The re-challenge for this case is not applicable since the outcome of the event was unknown and also the dose numbers are unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Followup received contains no new information.; Sender's Comments: This spontaneous case concerns a 70 year female with no medical history reported. who experienced Serious ( medically significant ) , expected event of Anaphylactic reaction which occurred on an unknown date with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , date of vaccination also was not reported . The re-challenge for this case is not applicable since the outcome of the event was unknown and also the dose numbers are unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Lump in right armpit - noticed while taking a shower. Internet research shows that a lump in the armpit is linked to the Pfizer vaccine.
Low grade fever; Body aches; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were reported as follows: The nurse reported for herself. The age at vaccination was not reported. The patient received the dose of Shingrix and after this experienced body aches and a low grade fever.  The nurse also mentioned that they say that dose was worst. The reporter consented to follow up.
I had received the first shot of the vaccine and about 30 minutes later, I felt a little bit of "pain". I say this in quotes because it isn't actual pain, it just feels as if I'd pulled a muscle or had been working out too hard. A little bit of movement of the arm brings up this feeling but the feeling is lessened by moving my arm.
Pt recv vax on 11/7/98; on 11/8/98 pt exp lesions at vax site; 11/27/98 pt exp rash
My sinuses are flaring with a stuffy head and stuffy nose along with cough.  After it first started it just hung on for weeks. I went to urgent care to get something to settle it down. There they gave me a steriod shot and five days of prednisone medication.  I feel some better, but I still got symptoms. They have improved though, I have headache, sneezing, itchy eyes and hoarse voice.  Small Coughing not much it's not gone though.
Meniere's disease; Leg cramp; Itching; Restlessness; Rash; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOZAPINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, MENIERE'S DISEASE (Meniere's disease), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medications included sleep aid.  Treatment for the event included the reporter will consult HCP if symptoms persist.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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. Further information has been requested.; Sender'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. Further information has been requested.
Irritability, low grade fevers and 6 pustules appeared on 5/19/13.
they got the virus; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that her parents received the first dose of bnt162b2 vaccine. Then, after a week, they got the virus on an unspecified date. The reporter said that they got it from the doctor's office. The reporter also mentioned that her parents are still recovering and are still on quarantine. The reporter wanted to know if they should still receive the 2nd dose of the vaccine. The reporter was also concerned because they were scheduled to receive the 2nd dose 3 days earlier than the recommended 3-week-interval, and wanted to know if that was acceptable. The patient was recovering from the event.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130214 same reporter/drug, similar event, different patient
No adverse event, patient came for second vaccine and identified pfizer should be primary. Contacted CDC Guidelines for notification and direction. Directed to give second dose pfizer. Patient had no reaction to moderna dose. Only sore arm on 11/07/2021.
the arm was sore for several days; several reddish, bruised-like blotches appeared on the upper arm; The blotches were accompanied by soreness and warmness; The blotches were accompanied by soreness and warmness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 11:30 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications included: LEVOTHYROXINE; TYLENOL; OMEPRAZOLE. Past drug history included: Bnt162b2, start date: 11Feb2021, stop date: 11Feb2021, for Covid-19 immunisation, reaction(s): "arm was sore", notes: Dose 1, lot number: EL9269, administration time: 03:30 PM, vaccine location: Right arm.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "not recovered", described as "the arm was sore for several days"; RASH MACULAR (non-serious) with onset 06Mar2021, outcome "not recovered", described as "several reddish, bruised-like blotches appeared on the upper arm"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 06Mar2021, outcome "not recovered" and all described as "The blotches were accompanied by soreness and warmness". Therapeutic measures were not taken as a result of pain in extremity, rash macular, vaccination site pain, vaccination site warmth.  Additional information: Patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks. Other medications in two weeks. After first dose patient arm was sore for several days and then things went back to normal. Then the patient received the second dose of the vaccine and again the arm was sore for several days, but things didn't go back to normal. Six days after the vaccine, the blotches were still there, with some sign of improvement. Patient did not diagnose with covid prior vaccination. The patient not tested for covid post vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 18 years old patient who was vaccinated with 0.5 ml once second dose of MENACTRA (lot number: A12113, expiry date, route and site of administration were not reported) on 27-Jul-2013 at the age of 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL on an unknown date. It was a case of actual medication error due to extra dose administered. It was reported that the patient was given MENACTRA at the age of 12 and again at the age of 13. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
No other AE; expired dose of MMR II was administered to a patient; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 16-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (ml), administered subcutaneously (SQ) as prophylaxis (dose number, vaccine scheme and anatomical site of vaccination were not reported; lot number S006051 has been verified to be valid, expiration date reported and established as 27-FEB-2021) (expired product administered). No additional adverse events (AE) reported.
swollen red welt/rash that is oval in shape, about 5cm long and 2cm wide where injection was administered. slightly warm to the touch and itchy but otherwise easy to ignore
Following administration of MENACTRA vaccine, the pt felt lightheaded and was sweating. PAC was notified and drink was offered to pt, but he refused. He was then helped to exam table to lay down and a cool washcloth was applied to his forehead. He laid down approx. 10 minutes and then was helped sit up. His father was with him and he left clinic in stable condition.
Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) in a 37-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. Reporter had stated that no adverse events were reported by patient.
Swelling arm, fever, pain, diarrhea, problem focusing when reading still. Feel very weak, problem walking.
60-90 sec, tonic, staring spell 9 hrs; LP, CT, EEG, Chem nl;
Headache Body ache and pain  Nausea  Fatigue  Tired  Sleepiness
ER with son present stated that he has been" in and out" and very lethargic when he arrived at his dad's home that afternoon.  His son states that he was unable to stand on his own and had to call EMS.  At baseline he does have urinary urgency and incontinence at night and to the best of his son's knowledge he has not had any vomiting, diarrhea, cough or congestion. Patient found to be positive for COVID-19, sepsis was supported with a temperature of 101.7, lactic acidosis of 2.4 after fluid resuscitation was 1.5 and he has leukocytosis of 15 K.  He was not hypoxic, his saturations have been in the mid 90s throughout his hospital stay.  He is vaccinated but has not had his booster shot yet.  Apparently the patient lives in his own home, family does help him during the day but at night the documented bed and then come back . the following morning.  He has been quite impulsive, requiring one-to-one sitter says he does not understand that he is weak at baseline and unsteady on his feet and is a fall risk. Patient did present with initial complaint of 3 days worth of diarrhea at home but has not had any further diarrheal episodes while hospitalized.  And required no antimotility agents.  Urinalysis with negative and blood cultures were negative.  Because of the sepsis presentation he was started on Zosyn in the emergency room he did have a procalcitonin of 0.61 and the CT findings were plus minus findings appropriate for COVID versus enteritis.  COVID can cause some inflammatory changes within the bowels, but needless to say he has improved with treatment of antibiotics.  He was discharged home with Augmentin 500 mg p.o. 3 times daily for additional 7 doses. Patient has a history of CKD stage III with his previous creatinine of 1.53.  On admission his creatinine was 2.39 he did receive a liter of IVF while his work-up was being completed in the emergency room and then was just encouraged to drink plenty of water.  Kidney function on day of discharge is good with a creatinine level of 1.39.  Still encouraged him to drink plenty of fluids, cont w/ his aricept. See his primary clinic MD next week for follow up. Could discuss new medications for behavior changes example low dose Seroquel as needed. Will let Dr. discuss w/ family. PT and OT evaluations recommend 24/7 support at home which the family states they can support, will order home PT and OT and if they feel appropriate they will arrange for an RN to come visit also.
covid booster 10/1/22 cough, chills, fever 10/18/22 dignosed with pneumonia 10/23/22 currently taking  prescribed antibiotic and cough medication 10/26/22
Got Covid virus in February,  Mild trouble with smell, sinus congestion. Was not hospitalized Then received COVID vaccinations #1  May 15th, on  May 17th started having left groin pain. Set to the ER and was found to have arthritis in his bilateral hips? Nothing else revealed pain source.  Saw Dr. - June 1st who gave him a hip injection. apparently ortho didn't know if arthritis was really the cause of pain He was taking some pain medications which were not helping.   #2 Covid shot 6/4/21 July 6th got another hip injection. Did feel some minor relief, but not fully resolved. In June/ early July, he started having  language trouble ,   " acting funny " per wife, having a lot of " frustration with his words"  .  PCP ordered CT brain.  7/16- CT scan Subacute infarcts involving the left frontal lobe/insula and left occipital lobe which subacute would date back 2-3 weeks surrounding the timeline of the second vaccine.   MRI brain on 9/2/2021 confirmed the infarcts in the bilateral MCA and PCA territories. D-Dimer was taken
Onset was soreness in arm muscle. Soreness got progressively worse over the next few days. Noticed swelling in arm. Soreness spread to shoulder and upper left back then down left arm.
Patient was suppose to receive booster dose 0.25ml of Moderna.  Patient received first dose of Janssen at other store last year.  However, due to miscommunication from pharmacy staff.  Technician did not see that patient received Janssen dose previously and asked it patient would go ahead start series of Moderna dose.   Technician then relayed to immunizing pharmacist that patient will be getting first dose 0.5ml of Moderna.  It was not until after patient received the vaccination that error was discovered by immunizing pharmacist.
PT DEVELOPED A RASH ALL OVER HIS BODY. RASH DID NOT APPEAR TO BOTHER OR ITCH PATIENT. PT DID NOT HAVE FEVER. WAS ADMINISTERED THE IMMUNIZATIONS ON A WEDNESDAY AND CAME IN FOR A CHECK-UP ON THE RASH THE FOLLOWING MONDAY. PT'S FATHER SAYS THAT THE RASH BEGAN THE DAY FOLLOWING THE SHOTS. PT WAS RECEIVING HIS 4 MONTH IMMUNIZATIONS AT 7 MONTHS.
09/14/2010 Mild other patient was supposed to receive MMR, but was given PROQUAD instead.
8 days after vaccine injection, left arm swollen, red and itching at site of injection.
feels some tightness in his chest; kind of an ache in his chest; soreness in the arm; ache; warmness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest), PAIN IN EXTREMITY (soreness in the arm), PAIN (ache) and FEELING HOT (warmness) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 036A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PAIN (ache) and FEELING HOT (warmness). On 24-Dec-2021, the patient experienced CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest) and PAIN IN EXTREMITY (soreness in the arm). On 23-Dec-2021, PAIN (ache) and FEELING HOT (warmness) had resolved. At the time of the report, CHEST DISCOMFORT (feels some tightness in his chest), CHEST PAIN (kind of an ache in his chest) and PAIN IN EXTREMITY (soreness in the arm) had not resolved.            Concomitant medications were not provided. Treatment medication were not provided.
After her flu shot, She started having low grade fever and unrest sleep on Sep/24/2010. Today Sep/27/2010 starting at 8:00 AM started vomiting and has vomited 4 times by this time 2:08 PM. Her condition seems to be worsening.