chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone pre-filled syringe was apparently leaked while patient was receiving the vaccine/ NO AE; Fluzone pre-filled syringe was apparently leaked while patient was receiving the vaccine/ NO AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a female patient (age unknown) who while receiving 0.5 mL INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) (batch number, expiry date, route and site of administration not reported) was apparently leaked (syringe issue and underdose) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of syringe leak and vaccine underdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
pt had fever of 105.3, vomiting, & irritability;the noc of the shots, this was treated w/Ibuprofen & APAP;the next day pt was sleepy;
Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
Tested positive for covid after first shot; Tested positive for covid after first shot; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got first dose of vaccine. Tested positive for covid after first shot. The patient was advised by his HCP to quarantine for 10 days, ending on 31Mar2021, and proceed to get second shot on 01Apr2021. Wanted to know if he should wait another week before getting second shot or if getting it on 01Apr2021 was okay. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced a rash on her left arm that required her to seek treatment at urgent care. She was prescribed clindamycin to treat the rash and it resolved without further incident.
Patient recieved first dose of of COVID-19 vaccine on 02/18/21  and was given the COVID-19 vaccine. When the patient returned late for a second dose on 03/25/21 the patient was given the other manufacturer COVID-19 vaccine.
I felt dizzy right after the shot, but that may be normative. The adverse event was that approximately 1/2 hour after the shot, I developed numbness and redness in my ears than then traveled across my face and head. There was numbness and tingling that also began to affect my right eye. This episode subsided in approximately 1 hour. I did not see a doctor at that time. Across the week following the shot, I continued to experience numbness and tingling in the face off and on. I first went to a walk in clinic on 5/6/21 and my vitals were checked. A recommendation of trying an antihistamine was made in case the reaction was sinus related. The antihistamine did not appear to help. I saw my primary care physician on 5/12/21 with head/face numbness/tingling still continuing. She noted that this was called Paresthesia and prescribed 100mg of Gabapentin to be taken for two weeks. I am just beginning that treatment at the time of this report. My doctor recommended that I make a report to VAERS since this began right after my vaccine injection. Overall, at this time head/facial parensthesia and off and on dizziness has remained for 2-weeks since my first vaccination shot of Pfizer.
pt. reports feeling lightheaded & anxious.  Hx of anxiety.  Medical present.  pt. denies any other s/s.  pt. monitored for an additional 15 mins.  symptoms resolved with comfort measures.
Patient presented to the ED with severe dizziness on 3/14/21 and was hospitalized for 43 hours. It was also noted he had NSTEMI. This visit is within 6 weeks of receiving COVID vaccination.
1). Fever (100.1) 2). Body ache  3). Lower left Leg moderate pain 4). Right under Arm pit swelling and moderate pain
pt recv vax 20MAR96 & 11APR96 pt devel expiratory wheezing, fever & 25 round, red lesions (pox) on face & stomach;pt treated fever w/APAP;pt recovered;
COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (at the age of 54-years-old), as a DOSE 2, SINGLE, and dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: EP6955) as a DOSE 1, SINGLE for covid-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient had no Known allergies and other relevant medical history. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient experienced covid-19 on 26Jul2021; Received a positive COVID-19 test result. The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 27Jul2021 by Rapid test. Treatment received for the event was none. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Tdap on May 14. Symptoms of redness of the injection site on 5/20/08. Also warmth and tenderness. Also another similar area on the neck on the same side as injection.
feeling achy; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling achy) and VACCINATION SITE PAIN (Sore arm at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-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 23-Jul-2021, the patient experienced MYALGIA (feeling achy) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, MYALGIA (feeling achy) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Headache, Myalgia, Fever, arm swelling, chills Narrative:
"Saw doctor 9 days after injection, was told I had Cellulitis.  Was given antibiotic and steroid.  Nurse giving injection failed to inform me of moving arm and massaging it.  She told me I needed to do nothing even after I specifically asked."
Patient given 0.5ml instead of correct dose of 0.3ml. No adverse events or signs/symptoms reported.
won't get the shot and have never been sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 14-Dec-2020.  This case involved a unknown patient who reported won't get the shot and have never been sick (Illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported (non-serious) won't get the shot and have never been sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case
injection site reaction; wrong route of administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site reaction. The pharmacist stated that a nurse told him that the patient received a dose of Shingrix subcutaneously, which led to inappropriate route of vaccine administered. The reporter did not consent to follow up. The reporter declined follow up because he did not have additional information.
Lichen Planus; reddish, inflammed gums; reddish, inflammed gums; White spots; it would burn; covid mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots) and GINGIVAL PAIN (it would burn) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 04-Mar-2021, the patient experienced LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth). At the time of the report, LICHEN PLANUS (Lichen Planus), NONINFECTIVE GINGIVITIS (reddish, inflammed gums), GINGIVAL ERYTHEMA (reddish, inflammed gums), GINGIVAL DISCOLORATION (White spots), GINGIVAL PAIN (it would burn) and ORAL DISORDER (covid mouth) outcome was unknown. Not Provided          No concomitant medications reported. Patient reports her dentist diagnosed her with "Lichen Planus" and gave her an oral wash, spray and gel to help treat the pain and swelling. Patient reports one of the medications was Stella Life.
Information has been received from a 65 year old female patient with no drug reactions or allergies and a history of polymyalgia rheumatica in 2006 who on 09-AUG-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route not reported). Concomitant therapy included BONIVA, OS-CAL, fish oil (unspecified) and vitamins (unspecified). The patient reported that about 40 days after receiving ZOSTAVAX (Merck) (also reported as 45 days by the patient), on 23-SEP-2011, she experienced the first stabbing pain in her left leg. She experienced the next pain in October 2011 and then in February 2012. The patient reported that she never developed shingles, but at the time of reporting, she had intermittent stabbing pain in her left leg. The patient called the pain debilitating and stated that she had stopped working because she did not know when the pain might strike. The patient also stated that in January 2012 she experienced a sensation described as electric shocks in her left leg. It was unclear just how often the electric shock sensation was experienced. It was reported that the patient sought unspecified medical attention. The patient had magnetic resonance imaging MRI and ultrasound performed (results not reported). The patient was given ibuprofen and then gabapentin as a treatment for the events. At the time of reporting, the patient had not recovered. Stabbing pain in her left leg was considered to be disabling. Additional information has been requested.
Patient reported feeling faint and nauseous immediately after receiving the Pfizer booster. Patient was escorted to the nurse clinic where he was assessed. Vitals were taken with soft BPs noted. Patient reported  having a history of fainting and history of vasovagal after receiving vaccines. Patient was repositioned to a trendelenburg position and closely monitored. Patient reported feeling better and back to normal after a few minutes of rest.
Vaccine given 9/25/13. Woke up 9/26/13 with swollen tender lymph node in right axilla. Today swelling has gone away. Still mildly tender.
Several hours after vaccine administration, patient's arm begin to hurt and continued the next day as well it got better, but 2 days later the pain returned and has been getting worse there is no redness, swelling or hardness at the injection site, no fever or chills to report. It hurts to raise his arm, but the pain does get better after taking an ALEVE the patient is concerned that the pain has been present for 2 weeks now.
Several maculopapular spots on trunk and face started 2/26. Fever to 102 started 2/24/04. Crabby started 2/24/04.
Information has been received from a 57 year old female consumer with no medical history or allergies, who on 28Jan05 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. It was reported that the vaccine was given IM but some was erroneously administered ID. There was no concomitant medication. On 30Jan05, the consumer experienced edema, swelling, induration, myalgia and paresthesia. On 01Feb04, the consumer reported that her muscle tone of her deltoid muscle is flaccid. Subsequently, the consumer reported that she was recovering from edema, swelling, induration, myalgia and paresthesia. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A 16609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen (Motrin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 07-APR-2021, and had not recovered from sore arm. This report was non-serious.
Right Lower extremity aching that progressed to bilateral Lower extremity tingling and numbness with physical exam changes the morning following the administration of the flu vaccine.  Later that day (10/16/2012), weakness of right lower extremity developed and numbness/tingling progressed to bilateral hands.  I went to the Emergeny Room, where physical exam showed R foot weakness and changes in sensory exam of bilateral lower extremities (right foot worse than left foot).
Sore, swelling and redness at injection sight. After 1 week itching at  injection site
I got up one morning to go to work and I noticed that my arm was a little red, I didn't pay any attention to it and the nurses at work saw it and thought it was cellulitis and they could feel hit from my arm. by the end of the day the redness was wrapping around my arm. so I went home and the next day I called my doctor and I had an e visit. she said that she really couldn't see it that well and needed me to come in to look at it. I left work early the next day and went to the doctor and was told it was cellulitis and got a prescription to help it go away. With in 3 days my arm was so much better the swelling and redness went down. I still have issues with my shoulder and my elbow in that same arm (right arm). 20 years I had something in my right shoulder and took medicine and it got better, 10 years ago I had tennis elbow and got a shot and it had been better. ever since I got the shot I now have problems with both and it hasn't bothered me in years
(5/2) Next day.. 5 pm-felt sick to stomach/belching. 8pm-chills/shaking/sweating. 11pm-felt like vomiting (dry heaves) by next am (5/3) all resolved. Pt asked me to documeny as she thinks symptoms from vaccine.
Fever, chills, severe body aches and joint pain and severe headache.  Symptoms lasted on and off for 36 hours.
General malaise; Injection site Itching; Injection site swelling; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), INJECTION SITE PRURITUS (Injection site Itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PAIN (Injection site tenderness) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Feb-2021, the patient experienced MALAISE (General malaise), INJECTION SITE PRURITUS (Injection site Itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, MALAISE (General malaise), INJECTION SITE PRURITUS (Injection site Itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was linked to MOD-2021-166690 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR: AE progress 1st dose and 2nd dose
Headache the evening of vaccine administration. Throughout the night flu like symptoms, sore arms, shoulders, neck, back. The next morning, 8/30/21, chills, shakes, fever, still very sore. Symptoms persisted throughout the day and the evening of 8/30/21 I noticed red rashes under both breasts and both arm pits. Throughout the night and into the morning of 8/31/21 sweats, still sore in right arm and rashes remain with a new rash on right side of neck. I would like to note that I am a breastfeeding mother.
15-20 minutes after Bexsero vaccination and lasting for 10 minutes, student develop nausea, headache, chills, dizziness and fingernails turned blue. Associated some chest tightness. Student notified academic advisor who called 911. On ER arrival, Temp 100.6, labs WNL, IV fluids. Complete symptom resolution within 2 hours.
Patient received Pfizer Bivalent vaccine and then within 1 minute, lost consciousness while sitting in chair.  Patient was supported the whole time and did not experience and injury.  Patient became pale and did not respond to stimuli.  Pulse palpitated and breathing normal.  Called 911.  Blood pressure was 95/65 mmHg and heart rate 65 bpm.  Patient regained consciousness, but quickly lost it multiple times.  By the time paramedics arrived within 10 minutes, patient was conherent and was able to talk again.  Paramedics evaluated patient and monitored him.  After 20 minutes, patient was able to leave.
Sx 7/22/21 cough, nasal congestion, fever, headache & loss of smell. Traveled via airplane 7/20 to 7/22 Tested on 7/25/21 which resulted as positive.
This spontaneous report was received from a medical assistant and refers to an 18 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored doses of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
shortness of breath; chills; low oxygen saturation; spiked a fever of 101; This is a spontaneous report from a contactable nurse (patient's daughter).  An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 09Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. She started experiencing symptoms yesterday including shortness of breath, chills, low oxygen saturation, and spiked a fever of 101. She called to ask if other people her age experienced similar symptoms. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
w/in 2 hrs of vax had 3 hrs of constant high pitched screaming & crying;
2hr p/vax pt devel inconsolable high pitched screaming;pt was seen in ER & adm to hosp for observation x 12hr;all sx resolved p/2hr;