chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; ACHY; EXTREMELY TRIED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced achy. On 10-MAR-2021, the subject experienced extremely tried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, chills, and extremely tried. This report was non-serious.
7/7/11 "Rash with sores on both legs from hip to ankle". 7/11/11 visit to Dr. who diagnosed a reaction to the vaccine. Gave steroid injection. 7/20/11 a lot better - most places are gone. Uses anti-itch powder.
I tested positive for COVID-19 on December 7, 2022. I contacted doctor and got prescription for Paxlovid on December 8th. My symptoms for the infection included fatigue more than anything. I had nasal congestion. I did not run a fever. My symptoms lasted about two weeks.
Minutes after injection, numbness in lips, metallic taste in mouth, and flushed skin. All subsided after a few minutes.  Approximately 10 hours later, fever, chills, and body/head aches. Ongoing as of form submission.
Information has been received from a physician concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of GARDASIL 9 (dose and frequency unknown) (lot # L036301, expired date 20-DEC-2017; Lot# M017983, expired date 30-MAY-2018) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The GARDASIL 9 was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1611USA010289: US-009507513-1611USA010288.
got positive for covid-19; got positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 22Jun2022, outcome "unknown" and all described as "got positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: got positive for covid-19 today (22Jun2022).  Additional information: A Pharmacist called in and said they have a patient who got their Pfizer booster shot yesterday and got positive for covid-19 today (22Jun2022). Now they are asking if that was the booster Shot or if they really have a covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient was vaccinated for COVID-19 on 4/29/21, so was fully vaccinated when testing positive for COVID-19 on 4/29/21.
Left side of face feels slightly numb/numbness started in jaw and felt like it moved up into cheeks and towards head; Headache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient had no known allergies to medications, food, or other products.  Concomitant medication included birth control (MANUFACTURER UNKNOWN); taken on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 13:45, the patient experienced left side of face feels slightly numb. The numbness started in jaw and felt like it moved up into cheeks and towards head. This feeling was getting less intense as times went on, but still felt it five hours she received the vaccine. The patient also had a headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left side of face feels slightly numb/ numbness started in jaw and felt like it moved up into cheeks and towards head and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pseudomonas aeruginosa abscess of her face; Pseudomonas aeruginosa abscess of her face; C diff coliits; This is a spontaneous report from a contactable physician (patient). A non-pregnant 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9231), via an unspecified route of administration in left arm, on 14Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), and aciclovir (ACYCLOVIR). The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 22Dec2020 at 09:00 AM at the age of 61 years for COVID-19 immunization (intramuscular in right arm); and triamcinolone acetonide (KENALOG) and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 14Jan2021 at 12:00 PM, the patient developed a Pseudomonas aeruginosa abscess of her face for which she needed interventions including drainage, antibiotics, and eventually surgery. As a result of needing repeated doses of antibiotics, the patient developed Clostridium difficile (C diff) colitis in 2021 for which she was still taking oral vancomycin of a tapered dose as of 05Apr2021 (about to end by 07Apr2021). The patient received antibiotics including clindamycin, amoxicillin/ clavulanic acid (AUGMENTIN), and levofloxacin (LEVAQUIN) for at least 2 months for the abscess in her face due to its recurring nature. The patient was able to be operated on 17Mar2021 (resection of abscess). The abscess was gone, and the patient felt better. C diff colitis was better, but the patient's gut has not gone yet without antibiotics to ensure the colitis is gone. The patient underwent COVID-19 nasal swab test post vaccination that was negative on 16Mar2021. The patient was recovering from "C diff colitis". The patient recovered from the other events in 2021.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
get a flu shot every year but this year i caught it anyway; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who get a flu shot every year but this year caught it.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of   get a flu shot every year but this year caught it anyway (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  An unknown corrective treatment was received for the event.   Outcome: Unknown
First Moderna vaccine (01/05/2021) injection site became red, very itchy, hot and rash - 7 days after the injection. Second shot (02/02/2021), injection site became VERY itchy, red and rash-like on 02/03/2021 and also included flu-like symptoms for 12 hours (chills, fatigue, aches). Today is 02/05/2021 and arm is still very itchy and red.
I got chills, body aches and fever on Saturday. I started on Sunday night. Back aches, body fatigue lasted Tuesday morning.
This spontaneous report as received from a Medical Assistant refers to a female patient of unknown age. It was reported that the patient received GARDASIL on 20-SEP-2011 and 09-NOV-2011 and was in the office to receive her third dose today on 19-OCT-2012. No adverse symptoms reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-FEB-2019, the patient was inadvertently administered a dose of ROTATEQ, orally, lot# N010707, expiration date 03-DEC-2018, (exact dose was not reported), that was expired. No adverse effect was reported.
pt recv vax  & felt like had a bite on lt arm where shot was given;pea sized sl below site was painful & red;felt like itching it;called ER @ local hosp;pt massaged site & took warm shower;pt seen 27OCT96 330PM & appeared nl;
Moderna COVID-19 Vaccine EUA. Dizziness and weakness; Chest pain, persistent; Difficulty breathing.
Severe diarrhea after the vaccine on day 1 and day 2 following administration. Felt better on day 3.; This is a spontaneous report from a contactable consumer (other-HCP). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 12Feb2021 12:45 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 21Jan2021 10:00 as 1st single dose (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included AFib. The concomitant medication included rivaroxaban (XARELTO). The vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive prior COVID-19 vaccination. Patient was not tested for COVID-19 post vaccination. On 13Feb2021, patient experienced severe diarrhea after the vaccine on day 1 and day 2 following administration and felt better on day 3. Patient was not given any treatment for the adverse event. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2x3 cm erythema around inject site; 1 cm wheal around inject site; cool compresses applied, DPH given & in 1 hr all sx had entirely resolved;
Pain, redness, swelling and hot to touch at inj site. Pt reports has taken tylenol for treatment. This begin 71321.
Erythema, induration, discomfort @ inject site; 2 day duration;
Associate came back post vaccine after leaving, left hand fifth digit numbness and tingling. VS: T 97.7, HR 61, BP 129/84. Doctor notified, 12:40pm doctor monitored for 25 minutes, patient reported no other symptoms and stated he wanted to leave and was feeling better.
arm was sore; could lift it above the waist without being painful; bright pink ribbon rash that looked like the northern lights; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), MOBILITY DECREASED (could lift it above the waist without being painful) and RASH ERYTHEMATOUS (bright pink ribbon rash that looked like the northern lights) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037B21H) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), MOBILITY DECREASED (could lift it above the waist without being painful) and RASH ERYTHEMATOUS (bright pink ribbon rash that looked like the northern lights). At the time of the report, PAIN IN EXTREMITY (arm was sore), MOBILITY DECREASED (could lift it above the waist without being painful) and RASH ERYTHEMATOUS (bright pink ribbon rash that looked like the northern lights) outcome was unknown.            Concomitant medication and treatment drug were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-073724 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073724:Crossed linked
pt. reported to civilian MD.  Larger area of erythema and color secondary to a meningococcal vaccine and was treated.
a rash on the rt arm;in the back of the lt side on the elbow, lt side;devel rash 3 days p/vax;
Prolonged menstrual bleeding - beginning 11/17/21 (day following vaccination) and ongoing as of 12/04/21
Pt received both doses of the Moderna COVID-19 vaccine, on 3/23/2021 and 4/19/2021.  On 7/26, pt called her PCP clinic, stating that symptoms started 7/24/2021.  Symptoms included mild cough, low grade fever, sore throat, congestion, sinus pain, headache, fatigue and myalgia.  Outpatient care only, drive thru covid testing on 7/26/2021 that resulted positive.
PAIN IN UPPER LEG; FLU-LIKE SYMPTOMS; COLD SWEATS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included testosterone replacement therapy, and concurrent conditions included hereditary familial cardiovascular risks.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and testosterone. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced cold sweats. On an unspecified date, the subject experienced pain in upper leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, cold sweats and pain in upper leg was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a 17 year old patient who on 29-APR-2013 was vaccinated with a dose of PROQUAD (dose, route and lot# not reported). No adverse symptoms reported. Additional information has been requested.
Fever to 101.8, decreased activity, fussy, tachycardia. Treated with TYLENOL and PO hydration. Fever persisted for 36 hours. Then patient was back to normal.
This spontaneous report was received from a medical assistant refers to a 04 year old female patient. None pertinent medical history, drug reactions/ allergies and concomitant medication. On 14-DEC-2012, the patient was vaccinated with first dose of VARIVAX, lot# h010558 (expiry date: 24-MAY-2014), subcutaneously. On 10-NOV-2015, patient was vaccinated with second dose of VARIVAX, lot# 1023589 (expiry date: 26-JUN-2017), subcutaneously (Inappropriate schedule of vaccine administered). On 23-JUN-2016, when she sought medical attention for chickenpox from her healthcare professional, tested positive for varicella zoster (chickenpox). The patient received unspecified treatment for the event. No Product Quality Complaint (PQC) was involved. The outcome of the event (chickenpox) was resolving. The reporter did not provide any causality assessment between event (chickenpox) and VARIVAX. Additional information has been requested.
Clients states at 4:00 pm on 11/4/19 headache that was not resolved with Tylenol.  At 11:00 pm through the next morning  client vomited x3.  Headache continues and now nausea. Call received from client at aprox.. 9:30 on  11/5/19.  Nurse spoke with provider and information relayed to client to seek attention with urgent care or her provider for the nausea.  Client advised headache may be a side affect from the vaccine.  Site of immunization injection has no redness/swelling or irritation.  Client verbalized to nurse no other symptoms exist at this time.
Patient had complaints of weakness, burning sensation in upper extremities, back, and lower extremities, severe back pain, urinary retention, difficulty walking. Patient admitted to Medical Center on 9/1/07 and discharged on 9/7/07.  Patient diagnosed with possible Guillain-Barre-like syndrome.  09/18/2007 D/C Summary received for DOS 9/1-7/2007 for D/C DX of Polyneuropathy 2' to meningitis vaccine and/or viral myelitis. Pt initially seen in ER on 8/31/07 for c/o upper body muscle pain which radiated to hands and arms with accompanying numbness/tingling. Pt reports being unable to hold pencil or play musical instrument. Labs and Diagnostics all (-) so pt D/Cd with DX of Neuralgia.  Recent meningococcal vaccine. Returned to ER 9/1/07 with increasing c/o as above with new onset of difficulty emptying bladder and leg weakness and pain.  Pt had several episodes of vomiting in past 24 hrs.  Started on IVIG for potential GBS, acyclovir,  and treated with abx for UTI. D/C home feeling much better.
I had an allergic reaction to the Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to sulfa" (unspecified if ongoing); "allergic to fish" (unspecified if ongoing); "allergic to seafood" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergic to Cipro". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I had an allergic reaction to the Pfizer Covid vaccine". The event "i had an allergic reaction to the pfizer covid vaccine" required emergency room visit.  Additional information: In the ER, the patient was told to not get any more boosters from Pfizer and Moderna. Later the patient was able to get a J& J plus a booster. However, since then, the patient was not able to get any more Covid boosters.   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.
This is a serious observational study case, initially received from other health care-professional on 26-Nov-2018, concerns a 27-year-old, adult, female pregnant subject of body weight 96 lbs, height 60 cm and body mass index (BMI) 18.7, enrolled in a prospective observational safety study. The subject's historical drug included SYNTHROID for thyroid. The subject's historical condition included thyroid (from 01-Aug-2018 to 31-Aug-2018). The subject had one previous pregnancy with full term live birth. The subject had no history of offspring with major congenital malformations. The subject had no relevant maternal and paternal medical history with major congenital malformations. The subject did not use tobacco, alcohol and illicit drugs during pregnancy. The subject's current condition included low iron (since an unspecified date). The subject's concomitant medications included OB complete one (as reported) for healthy pregnancy and Ferrous sulfate (reported ferrouSul) for low iron. The subject's last menstrual period (LMP) date was 12-Aug-2018. The type of pregnancy was singleton. On 16-Jul-2018, the subject underwent first trimester screening and no major congenital malformations were noted. On 18-Jul-2018, the subject underwent fibrosis mutation analysis and no major congenital malformations were noted. On 31-Aug-2018, the subject underwent third trimester screening and no major congenital malformations were noted. On 16-Oct-2018, at gestational age of 25-weeks (second trimester of pregnancy) the subject was administered influenza vaccine (batch number: 252232, dose, route of administration, anatomical location, and expiry date: not reported]. On an unspecified date, after vaccination, the subject had preterm labor with not resulting in live birth. The subject's estimated delivery date (EED) was reported as 29-Jan-2019.
I experienced chills, shortness of breath, congestion in my lungs, severe wheezing, and severe joint pain.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Additional Details: Rapid onset of symptoms within minutes of recieving the vaccination. Provider was able to assist and stepped in. Paitent's symptoms subsided within 10 min and left on her own accord.
5/9/03 Hep A and Td given. 5/16/03 Rash on arms and legs. 5/19/03 Rash on trunk.
Took 4th dose of oral Typhoid (VIVOTIF) 4/28/17 hives appeared on backs of arms and back cleared Saturday 4/29/17. Reappeared and worsened Sunday AM 4/30/17.-All over body and lips/face, saw doctor - was given BENADRYL - Re-appeared again on Monday. (worsened)