chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and selling at injection site, red rash 4 inches down from injection site, strong migraine headaches - both lasting four days in duration
sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; sore arm swollen hard left bicep. Became red and itchy; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     HSV 2.  The patient's past medical history included HSV infection. Previously administered products included for Product used for unknown indication: Flu shot (Regular not senior) on 18-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy), PRURITUS (sore arm swollen hard left bicep. Became red and itchy), FATIGUE (fatigue) and PYREXIA (low grade fever). On an unknown date, the patient experienced ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy). The patient was treated with HYDROCORTISONE (topical) at a dose of 1% OTC and ACETAMINOPHEN at a dose of 1/2 dose a day. On 13-Oct-2023, PAIN IN EXTREMITY (sore arm swollen hard left bicep. Became red and itchy), PERIPHERAL SWELLING (sore arm swollen hard left bicep. Became red and itchy) and PRURITUS (sore arm swollen hard left bicep. Became red and itchy) had resolved with sequelae. At the time of the report, FATIGUE (fatigue), PYREXIA (low grade fever) and ERYTHEMA (sore arm swollen hard left bicep. Became red and itchy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported.  It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Began as sniffles, developed into  major sinus drainage (post-nasal drip). Went to doctor for covid test next day. Developed a cough that lasted for 2 weeks. On 3rd day from first symptom, developed major headache that lasted 2 days, and mild fever that lasted 3 days (never above 100 degrees). On 5th day from first symptom, lost sense of smell that lasted for 2 weeks.  Never had difficulties breathing or fatigue, blood oxygen level (measured at home) remained normal.
pt recvd MMR vax 11APR91 & 25APR91 devel a generalized pruritic rash; presented to MD & recovered;
pt recv vax 21APR97 & on 24APR97 pt exp a local rxn, all around the inj site, down the arm, that was also red, swollen, hot & tender;
Patient received the Moderna vaccine on 1/22/21 and 2/19/21 so was fully vaccinated when they tested positive for COVID-19 on 9/21/21
Client presented with redness, circumference for  arm with localized swelling at injection site. Redness noted on 04/13/05
Real painful golf-ball sized clavicle lymph node; Golf-ball sized clavicle lymph node/lymph node was swollen; A spontaneous report was received from a consumer who was also a 36-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced golf-ball sized clavicle lymph node/ lymphadenopathy and real painful golf-ball sized clavicle lymph node/ lymph node pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Jan 2021, approximately 5 days prior to the onset of the symptoms, the patient received their unknown dose of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, patient had a golf-ball sized clavicle lymph node. The patient had a hospital visit and 2 doctors confirmed patient's lymph node is swollen on clavicle nd it is painful.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; 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. Further information has been requested.
Moderna Dose 1 under 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021 at 3:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021 at 3:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old). On 07-Sep-2021 at 3:34 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Dose 1 under 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07-Sep-2021 at 3:34 PM, received second dose via intramuscular in left deltoid was noted. Patient's height is 5.7 inches.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow Up received, updated Reporter's information,  patient demographic details (female) and details about the both doses of the suspected vaccine.
She gave the dtap portion and tried to give the Acthib but realized it was a powder; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (pharmacy-other).  This case 35 week old male patient who was vaccinated with only DTAP portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: Suspension for injection, Information on the batch number was requested) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique.  It was reported that nurse didn't realize that she had to reconstitute both vials and thought that both were already reconstituted. She gave the DTAP portion and tried to give the ACTHIB but realized it was a powder.  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
the patient had received Fluzone High-Dose twice in a year with no AE; patient was supposed to be getting a pneumonia vaccine at the pharmacy with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (Reference number- US-SANOFI-00361900) and transmitted to Sanofi on 17-NOV-2020.  This case involves a 65-year-old male patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ491AAand expiry date: 30-Jun-2021) twice in a year via an intramuscular route in an unknown administration site for prophylactic vaccination (extra dose administered), instead of PNEUMOCOCCAL VACCINE at the pharmacy (wrong product administered).  The patient medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications not reported.  It was an actual medication error case due to extra dose administered and wrong product administered (latency same day).   It was reported that patient was supposed to be getting a pneumonia vaccine at the pharmacy but received the Fluzone high dose quadrivalent vaccine twice.  At the time of this report, no adverse event 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.
Pt. c/o pain, swelling and redness in left arm within 1 1/2 hours of injection on 1/11/16, took TYLENOL, BENADRYL and applied ice. Repeated treatment 1/12/16 but says left arm continues to swell, have erythema and pain. Measured left deltoid at 15.75", compared to unaffected arm at 14.5". Hot to touch, but very little erythema today. Will continue BENADRYL, ibuprofen and elevation of left arm, talked to PCP today with those recommendations.
Wheezing, low SpO2, teeth pain, chest pain, anaphylaxis.
Numbing sensation in lips with slight swelling, and higher blood pressure for about an hour and half after injection.  Again swelling and itchy face about 4 hours after shot.  Swelling in the arm muscles lasted for about 48 hours.  Flu symptoms started about 24 hours after shot and lasted for about 72 hours from that point: nausea, aches and chills fever.
Information has been received from a consumer concerning a female family friend who on unspecified date was vaccinated with GARDASIL (dose number, lot number not reported). The patient developed numbness and was in a wheelchair after vaccination. The patient saw a neurologist. It was unknown if there were lab studies performed. At the time of the report, the outcome of the patient was not reported. Upon internal review, being in a wheelchair was considered to be disabling. This is one of several reports from the same source. Additional information has been requested.11/23/2009 PCP records 7/23 and 5/30/2008, patient with c/o's facial numbness. rt lip numbness, jaw soreness and clenching. No tx noted. no labs noted
positive Covid test; positive Covid test; congestion; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid test"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; HEADACHE (non-serious), outcome "unknown", described as "slight headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: I have a positive Covid test. Minimal symptoms, but they include congestion and a slight headache. Received all 3 Pfizer vaccines. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial report was received from a consumer, who was also the patient, on 03 December 2012. This case also involved a case of misuse (inappropriate age at the time of vaccination). A 70-year-old patient (reported as 71-years-old) had received an intradermal injection in the left deltoid of FLUZONE INTRADERMAL (lot number not reported) on 06 November 2012. On 20 November 2012, the patient developed vertigo and nausea. The patient was seen by a nurse practitioner and was told the exam was negative except fluid in ears. The patient was sent to a physician, diagnosed with vertigo and treated with Valium 2mg three times a day (TID). The patient also had tests for vertigo. Symptoms persisted. The patient had no illness at the time of vaccination. Concomitant medications included SAM-E, green coffee extract, vitamin D3 and CoQ 10. Outcome was not recovered. Documents held by sender: None.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. On 23-DEC-2014 the patient was vaccinated with an improperly stored VAQTA (lot # J000366, expiry date 22-AUG-2015) dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
In addition to generalized injection site pain, my left arm and armpit glands were swollen, retaining water and quite painful. I had similar reaction to 2nd shot. However, I had a pretty much debilitating headache that rendered me bed ridden for the day. On the second day after the booster shot I am still experiencing headaches when I move from sitting to standing. My blood pressure- taken today was 117/76 which is within normal range.
large red bright red bumps on forehead and top of skull that is painful/irritation to touch, off and on nausea , intermittent headache
First does of Pfizer was given on 3/16. After 30 mins of waiting period, she left and started to have tongue itching, Left arm numbness, and loss of taste. Lasted 48 hours and all symptoms disappeared.  This Second dose given in EMS room and patient is staying longer than 30 minutes. @410PM slight arm numbness- requested to have her do range of motion to the left arm and offered water, She drank water and did range of motion @0420 numbness resolved and no other symptoms. Patient chose to leave at 0425PM.
the red inflammation was not smaller/grown in size/from shoulder down to elbow; the red inflammation was not smaller/grown in size/from shoulder down to elbow; late reaction: Rash on the Injection Site, the size of her hand; Injection Site is warm to the touch.; She was so tired and went to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE WARMTH (Injection Site is warm to the touch.), ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand) and FATIGUE (She was so tired and went to sleep) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (She was so tired and went to sleep). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection Site is warm to the touch.) and VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand). On 01-Mar-2021, the patient experienced INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow) and ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE WARMTH (Injection Site is warm to the touch.), ERYTHEMA (the red inflammation was not smaller/grown in size/from shoulder down to elbow), VACCINATION SITE RASH (late reaction: Rash on the Injection Site, the size of her hand) and FATIGUE (She was so tired and went to sleep) outcome was unknown.            Treatment detail also included Cold Compress. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up received and events added.
They have a patient who after the 1st dose he got low blood pressure and they had to call an ambulance; This is a spontaneous report from a non-contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (BNT162B2), PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. It was reported that, the patient experienced they have a patient who after the 1st dose got low blood pressure and they had to call an ambulance on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on low blood pressure.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus and occasional dizziness.  Has not diminished 10 days later.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD)
PATIENT EXPERIENCED CELLULITIS TYPE REACTION AT SITE OF PNEUMONIA VACCINATION AND VISITED HIS PHYSICIAN, PHYSICIAN ASKED FOR REACTION TO BE REPORTED BUT NO TREATMENT WAS GIVEN.
Took the shot at noon, and by midnight it caused copd exacerbation. It dropped my oxygen in the 80s. I am now on oxygen daily since taking this vaccine. My doctor advised me to fill this out. I am scared to get the second dose.
01/11/2003- Headache - hot to cold- nausea- evening 01/12/2003- Headache- hot to cold- nausea- all day 01/13/2003- Headache- hot to cold- nausea- lower back pain - all day 01/14/2003- Headache- nausea- all day 01/14/2003- Seen personal MD- Headache and nausea meds
20cm x 30cm area of induration, warmth 48 hours after pcv vaccine.  No systemic illness.
Patient received his vaccine around 9:30AM. Felt fine in 15 min. observation area. Returned to work and began feeling "tingling and numbness in my legs, pressure in my head, ringing in my ears, my arms got heavy and it was hard to move, I had trouble using the phone so told coworker to get his boss" He stated, "I was slouching in my chair, sliding out of it, and my eyesight was blurry". Nurse was summoned and laid him flat w/feet elevated. He ate a "few donuts and peanut butter crackers after his shot". He felt better when lying flat but as soon as he sat up, symptoms returned three times. BP-142/88 initially, then rose to 149/106, Pulse-92 10 min. later. On third attempt to sit up, BP 153/99. Patient says his BP has never been above 128/84 and that he just had his annual physical two weeks prior and it was good. EMTs were called since symptoms kept coming back. BP was 170/100s. Was transported to Hospital. He said they did a "brain test" having him touch his nose w/his finger, slid heels down shins, etc. but no other testing was done." He was discharged to home around 3PM and was told "he had an anxiety attack". He said they never really asked him what happened. Later that evening at 9:30PM, symptoms returned and he had to lie down. He had "pressure in his head, ringing in ears, and couldn't get up." Wife called EMTs. His vision was blurry. BP 150/110 upon exertion (movement) and 138/103 at rest, Pulse btw 105-110. He refused going back to hospital since they did nothing the 1st time. I spoke with him Monday morning and he had seen his Dr. She put him on a Beta blocker still his BP was still elevated. He still feels "cotton headed, muddled, w/constant ringing in ears." Did not go to work on Monday. Felt frustrated that ER "blew it off and said it was anxiety, which he said he was not feeling anxious until his symptoms began and would not go away".
pt recvd vax;vax caused pt to have high pitched cry for 3 hrs; pt fell asleep,awoke & cried for 2 more hrs non stop;mom states cry was high pitched & very unlike;mom reported to MD; onset occured in same 24 hrs as inject;
got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A child patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Nov2021, outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2021) Positive, notes: 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid.  Additional information: Caller is a Pediatrician, asking regarding 3 patients ages 5-9 years of age, for the Pfizer Covid-19 vaccine Orange cap, 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid, and never got the 2nd primary series dose after that. On 11Nov2022, these 3 patients received a primary dose of the Pfizer Covid-19 vaccine Orange cap, caller is asking if it is considered as a 2nd dose or need to repeat the doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive 14 days after first dose of BNT162b2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-PV202200103524 Same reporter/drug/AE, different patient.;US-PFIZER INC-PV202200103531 Same reporter/drug/AE, different patient.;