chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle and joint problems/pain; muscle and joint problems/pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not re-ported) as single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 13Feb2021 for Covid-19 immunization. The patient was experiencing muscle and joint problems/ pain in Mar2021. The outcome of the events was unknown.  The information on lot/batch number has been requested.
Pt. got a flu shot at 0815 and by 0915 she was dizzy, nauseous and had a posterior head ache. At 1015 came to see me with symptoms. BP 120/84. No respiratory distress. No hives. No injection site reaction. Pt was flushed and nervous. She was given fluids to drink. We called 911 to have the EMT's look at her. The EMT's arrived. Vitals were done. Pt said she was feeling better, but within a few minutes said she was lightheaded and nauseous. She was encouraged by me and the EMT's to go to the hospital to be checked out.
Severe cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Severe cough) and RHINORRHOEA (Runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Severe cough) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Severe cough) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.No treatment was reported for the events.
Fever, chills, headache and body ache starting 3 2-3 days after vaccine was received. Headache and chills has resolved, but fever is still reaching 100.0 without the use of Tylenol accompanied by bodyaches.
Pt. complain about pain from shoulder to elbow started 2 days after injection and today is 7th day and pain is getting worse, injection site is swollen, red, hot to touch, and itchy. Spoke to patient she saw her primary care on 4/2/19 for swelling & redness MD gave her Prednisone. 4/10/19 No pain & redness & swelling cleared up. she is doing ok now.
I started to develop bullseye rash a couple of days after vaccine. Rash is about 3.5 inches in diameter and raised. Redness went down but area continued to feel hard when touched. Approximately 10Mar2021, the rash came back and is now itchy and warm. Area is red again and feels hard to the touch.
evening of vax muscle & joint pain, limping, affected sleep, serum sickness, allergic reaction;
NO Adverse effective reported.  fully vaccinated received a monovalent instead of bivalent pfizer  booster.  We notified the client today that she was vaccinated with the Pfizer Monovalent instead of the Pfizer Bivalent booster. We provided assurance that there are no safety issues with the vaccination she received today.    We informed her that the Pfizer monovalent vaccine is still used as a first and second COVID vaccine and was previously used as a booster.  We informed her that the monovalent dose she received yesterday would not give her the full range of coverage of the current bivalent dose.   We advised her in 2 months; she will be able to receive the Pfizer Bivalent Booster if she wishes.  We answered all her questions.    She verbalized her understanding of all information given.  She was grateful for the information we provided and assured us she will get the bivalent in two months.
Pt recv vax on 9/21/98; 1/2 hr later pt exp sleepiness,limp,fever (99.1-100.3) for 36 hr; tx=Tylenol.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Less than 10 min after the shot I passed out in the car. I felt like I was dreaming almost immediately after the shot and everything was surreal. My wife was with me and she drove me home and pulled over several times. I threw up in the car and could not hear her asking me if I was OK. We almost went to the emergency room but I felt better after an hour.  Almost two hours later I feel somewhat better and I have a headache but my sinuses are irritated and I keep blowing my nose.  Feel a bit weak.
On 10/26/06 influenza virus vaccine administered to 2 month old pt listed above instead of Prevnar. Was not reported to MD.
Very sore arm, couldn't lift or move w/o bad pain, also had warmth in my bicep. Couldn't do anything with my arm for 4 days. Very painful. There was some resistance in my arm when shot was given.
Information has been received from a physician concerning a 20 week old patient who on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 661934/1441X) instead of PREVNAR.  It was confirmed that this event was a result of human error, not product confusion.  No adverse effects were reported.  Additional information has been requested.
FOSTER MOM NOTICED HIS LEFT UPPER ARM WAS RED, EDEMATOUS, HARD AND WARM TO TOUCH. SHE SAID HE DID NOT COMPLAIN ABOUT IT AT ALL. SHE CALLED THE ER DEPT AND THEY TOLD HER IT IS A NORMAL REACTION. THEY TOLD HER IF IT WAS NOT BETTERBY SUNDAY OR GOT WORSE TO TAKE HIM TO THE ER DEPT. SHE SAID IT WAS BETTER THE NEXT DAY.
Left arm is inflamed, bright red, warm to the touch, itchy, sore. Outer ring is spreading.
patient noted that after 1st Gardasil in August 09 there was swelling and redness at sight of injection.  After current vaccine (2nd Gardasil) there was same swelling and redness at sight  but this episode also had lots of swelling and itching around anterior neck and face.  Advised pt to take benadryl and not get 3rd gardasil.
Pt had the TDAP vaccine 10-29-08. Later that day after vaccine administration, patient complained of weakness, dizziness, chills and body aches. Lasted 2 days. Reported these events today 4-14-09.
Currently no adverse event reported after 3 hours and 45 minutes.  Vaccine diluted with  1.3 ml instead of 1.8 ml or 38 mcg instead or 30 mcg  dose.  I was not able to reach customer. Wireless customer unavailable try back later. Tried 4 times.
Information has been received from a NP concerning a 6 year old white female who on 12/05/97 was vaccinated in the right arm with a dose of varicella virus vaccine live (Lot # 624249/1103E). There was no illness at the time of vaccination. On 09/29/03 the pt was seen with a break through case of varicella. The pt had approximately 20 lesions. Unspecified medical attention was sought. No lab tests or diagnostic studies were performed. A product quality complaint was not involved. Follow up information indicated that the pt developed a mild case of chickenpox on 09/26/03. Subsequently the pt recovered. No further information is expected.
Pain on left side of face, nasal cavities, mouth. Dull headache, fatigue The following morning when I woke up the left side of my face was drooping especially in cheek and mouth areas
Severe headache similar to migraine started about 5 hours following vaccine. Took excedrin migraine with no improvement.
patient was administered expired fluzone quad (with no reported adverse event); Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult male patient who was administered expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at dose of 0.5 mL, once (1x) (formulation., strength: standard) (lot UJ705AB and expiry date: 30-Jun-2022)  via intramuscular route in the right deltoid for immunization which was expired with no reported adverse event expired product administered) (latency: same day).  Action taken was not applicable.  Outcome was unknown for the 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 the 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.
Raised pink patch approx 3x2? at injection site. Burning sensation. Lasted 5 days, but burning sensation stopped after 2 days.
Patient is a 97 year old female, received first dose on 12/29/21 and second dose on 02/09/2021. Patient had previously tested positive for COVID on 12/07/2020. Patient was living in a long term care facility, when she was sent to ER for abnormal labs, where she again tested positive for COVID on 03/09/21.  She did not have any symptoms of COVID. Patient was discharged back to the care facility for hospice care and died on 03/13/21.
Patient had red, warm, swollen lump at injection site day after immunization. Lump progressively got harder, redder and more swollen in next 2-3 days. Pt felt sick and feverish. Was diagnosed with cellulitis. Given antibiotics. Recovered 10 days after injection. Site still sore and slightly red.
chills; headache; chills; headache; nausea; sneezing; mother has a fever/she has now fever 100.9 Celsius; This is a follow-up spontaneous report from Pfizer-sponsored program  Support. A contactable nurse (daughter) reported for her mother that a 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC number: unknown), via an unspecified route of administration in arm on 10Feb2021 (age at vaccination was 78 years) at around 3 pm as dose 1, single for COVID-19 immunisation. Medical history was not reported. concomitant medications were none. On 12Feb2021 the patient experienced chills, headache; On 15Feb2021, experienced nausea, chills, headache; On an unspecified date in Feb2021, had fever and sneezing. Additional Context received as, the reporter reporting for her mom on the COVID vaccine who received the first shot on 10Feb2021 and afterward on Friday patient had the normal symptoms, chills and headache. The patient got better on Sunday but on Monday she had chills, headache, and nausea. Is it normal to have the delayed response. The patient knows it was normal to have a reaction 1-3 days after getting the shot but patient got better and then the symptoms returned; chills, headache, a fever of 100.9, and nausea. It was confirmed the shot was given on 10Feb2021. The symptoms of chills and headache started that following Friday, 12Feb2021. They resolved on 14Feb2021. But then on Monday, 15Feb2021 her mom experienced nausea, chills, and headache. It was explained that her temperature was checked on 16Feb2021, that was when patient noticed the fever of 100.8. The patient also reported having sneezing during this time but was not congested. The patient was wondering if her mom might just be getting sick. No treatment other than Tylenol. The events were no happened at emergency room and physician office. The report was non-serious. Outcome of the initially had events chills and headache recovered on 14Feb2021 and the reoccurred events nausea, chills, headache, fever and sneezing were not recovered.  Follow-up attempts completed. No further information expected.
I26.99 ACUTE PULMONARY EMBOLISM 8/31/2022 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 8/31/2022 ANEMIA DUE TO BLOOD LOSS
Weakness, fever, mild dehydration, leukocytosis, neck stiffness and confusion. Is recovering.
arrythmia;involuntary movements occasionally to lt arm;flushed feeling initially p/vax;h/a 6hr p/affecting rt eye;some SOB though not initially afterwards;
a 64 years old patient received a dose of Fluzone High Dose Quadrivalent/ No AE; a 64 years old patient received a dose of Fluzone High Dose Quadrivalent/ No AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via The Agency (Reference number- 00324247) and transmitted to Sanofi on 29-Oct-2020.  This case involves a 64-years-old patient who received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported that, the patient was 1 year under age when administered with FLUZONE HIGH DOSE QUADRIVALENT and he was requested for information regarding this incident.   It was also a case of an overdose (latency: same day).  Product used: Used  At the time of report, 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 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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a 65 years old female patient reporting on herself, who approximately in August 2012 (at least 2 or 3 months) was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: LIPITOR. The patient reported that after receiving the vaccine, a few weeks later, "a month or so" (approximately in October 2012), she exhibited a rash from her chest to mid thighs "little red patches" and also had one blister on her chin. No itching just the rash. Blood work (dates unspecified) concluded the patient had herpes "titer 1 and 2". Unspecified treatment was given for an AE. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
inadvertently administer  the vaccine 11 days after expiration date; The expired vial was stored in the refrigerator on 27may2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A, 037B21A and 026A21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown if patient had ever tested positive for COVID. Patient had no acute or chronic illness at the time of vaccination. It was unknown if the patient took any other vaccines within one month prior to Moderna covid-19 vaccine.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022). On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (The expired vial was stored in the refrigerator on 27may2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The height of the patient was reported as 5 foot and 3 inch. The vial was initially stored in the refrigerator on 27-May-2022.No temperature excursion was reported for the vials. It was unknown if the patient took any medical care because of events. Also it was unknown if the patient had similar events in the past.  No treatment medication information was provided.
I have gone thru menopause and quit having my period for many months.  Just over a week of getting my second shot,  I had one of the worst and heaviest periods I can remember with horrible cramps.
Mom called stating during evening, noticed "big red spot that looked swollen on left arm" Also stated that patient was "scratching at it all night". Mom took child to ED next day and was told it was infection/possible reaction to shot and placed on 3 day course of cephalexin by ED. Scheduled appointment for follow-up with provider on 03/09/2016.
Hives over entire body, around eyes, pale. Intense itching. Tongue swollen. She chose to take 75mg of diphenhydramine without our knowledge. 10/30/09 Medical records received for date 9/23/09.DX: systemic allergic rx. Presenting SX: presented with hives on neck and body, difficulty breathing, no tongue swelling after receiving vax mist 2 days prior. Pt. treated self with antihistamine medication. No further f/u. denies any egg allergy.
Day 1 after injection, 3/13/21 Saturday morning, patient woke up with a generalized pin point red non-raised rash. It does not appear to be itchy. Patient has been fussy. No fever or change in PO intake. Sleeping through the night.  This rash continued until the morning of 3/16 this rash seems fainter than over the weekend. On 3/17 mom called the clinic to see if patient needed to be seen and that  he had developed a new rash that was described as slightly raised with a white center bumps located on his face but mostly on the right side, neck, back, and legs but mostly on the right leg. However, a photo was taken of the rash and it was located on his left leg.  Pt was evaluated by a provider in clinic and parents instructed to give benadryl and monitor.  Pt was seen in clinic and a photo was taken for his chart. The rash appears to be on his left leg rather than   Vaccines admin on Friday: Hep A R - upper vastus lateralis, IM Hib - right lower vastus lateralis, IM MMRV - Left lower vastus lateralis, SQ PCV13 - Left upper vastus lateralis, IM  Pt scheduled for a SD with Dr. for this evening
Pt reports feeling "out of body", lightheaded, impending doom, nauseated and diaphoretic.
Very sore and aching muscles, kind of flu like symptoms the first 2 days, better the third and fine the fourth day.
Rash to neck and face. Patient's mother called the pediatrician and was told to give BENADRYL. The mother denied any other symptoms. No shortness of breath, wheezing, fever or decrease in appetite.
5-10 minutes after vaccination area itchy for a few minutes then "went away". Next morning area felt like someone "punched it" on movement only. No redness, no swelling, no induration, no fever. Relief w/BENADRYL ointment and/or movement. Seen by Nurse Practitioner on 10-25-13 who did not see any evidence of infection and recommended warm compresses TID. Client reports this is helping.
This initial spontaneous case, was received from other health professional (registered nurse) on 01-Jun-2017 and concerns students in an academic campus, who received flu vaccine. This case deals with fourth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 15-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 18-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE compliant was the result of the fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. The narrative was amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
I started with extreme abdominal pain, back pain, fever, dizziness, fatigue, hip pain.  I also felt like I had needles in my back.  I had a headache as well.  All of this started about 12 hours after the vaccine.  I also had a sore arm, itchy and swollen.  I did go to the emergency room due to numbness in my right hand and the left side of my face.  I also was experiencing fast heart rate.  As of today, I am lightheaded, and my heart will get out of rhythm.  I am also having numbness in my right hand. My fatigue seems like it is getting better.  I am currently waiting for test results to come back.
Red itchy rash on lower legs.. also a bit swollen , red bumps Lasted for 3 days
Tested + 4 days PTA, arrived with increasing SOB. R pleural effusion. On 2-3 L supplemental O2 temporarily. Weaned to RA at time of review. Treated with Vit-C and zinc. Discharged home.
11/7/16 later in the day after shot were given seen my MD 11/9/16 arm swollen-silver dollar size, bruising, redness, swelling.