chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.         No concomitant and treatment medicine has been reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-079434 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079434:First Dose
Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive, 16 days after Paxlovid treatment.         Patient had not any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that post vaccination with Moderna vaccine, patient was treated with Paxlovid for COVID-19. On 22-MAY-2022, 16 days after Paxlovid treatment, the patient tested positive. No treatment medication given for COVID-19 post treatment with Paxlovid. Device Date : 24May2022.  Company Comment:  This is a spontaneous case concerning a 50-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, in the context of a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since the exact event onset date was not provided. Patient was given a six-day-course of Paxlovid treatment for the initial COVID-19 infection. However, sixteen days after the treatment with Paxlovid, patient tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 50-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, in the context of a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since the exact event onset date was not provided. Patient was given a six-day-course of Paxlovid treatment for the initial COVID-19 infection. However, sixteen days after the treatment with Paxlovid, patient tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt c/o itching & sl rash on lt side of back 1wk p/vax;no fever-rash lasted approx 10 days;not on any meds (ATB or any others);
Myalgia, Fever, CoughWheeze, nasal congestion, sneezing, injection site pain Narrative:
Patient complained of itching and redness on neck, tingling around lips, apprehension, heart palpitations. BP 172/82, HR 128.  Fifteen minutes later BP 180/90, HR 80. Patient monitored in clinic by physician, no medications administered.  Discharged home ambulatory with spouse.
Burning sensation from the injection site of the deltoid down the arm to the wrist ongoing for 2 months.
TINGLING, PAIN, BURNING OF BOTH ARMS INCLUDING THE HANDS (IN THE EARLY HOURS THEY BECAME WORSE, CAUSING INSOMNIA) AND EXCESSIVE HAIR LOSS.
Exhausted,  no energy, unable to work, depressed feeling with NO motivation for 2 days. Better today.
Patient is the mother of a patient of mine. She received her flu vaccine in our office. She was admitted to the hospital for Guillain-Barre. I do not know the details of her symptoms.
Moderate soreness at injection site lasting 24 hours; Moderate fatigue; This is a spontaneous report from a non-contactable consumer (patient)  A 35-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) Lot# EH9899 on 19Jan2021 18:00 at SINGLE DOSE for Covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. No Covid prior vaccination. Facility where the most recent COVID-19 vaccine was hospital.  The patient experienced moderate soreness at injection site lasting 24 hours on Jan2021, moderate fatigue (12-24 hrs post injection) on Jan2021. The patient had not been tested for COVID post vaccination . Outcome of the events was unknown.  No follow-up attempts are possible.No further infromation expected.
Patient, 23 year old female, was accidentally given ZOSTAVAX instead of being given Varicella vaccine. Pt has not had any reaction that we know of.
Received vaccination between 10:30 am and 11:00 am.  Around 2:15 pm began to get hoarse, experience difficulty swallowing and breathing.  Palms began to itch.  Admitted to ER around 2:50 pm.  Around 3:30 pm was treated with IV Solu Medrol and Benadryl.  Symptoms lessened and was discharged around 4:00 pm with a course of prednisone and benadryl for the next couple of day.
Rheumatoid arthritis flare up; Fibromyalgia worsened; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296449-00 (Agency).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Dec2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster) single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number: unknown; route: Intramuscular), administration date: 20Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, Single; Lot number: unknown; route: Intramuscular), administration date: 11May2021, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; FIBROMYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fibromyalgia worsened".  Clinical course: It was stated that shortly after taking booster dose, had rheumatoid arthritis and fibromyalgia flare up that seemed to be worsened. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was related to Covid Vaccine. The reporter's causality for the events of rheumatoid arthritis flare up and fibromyalgia flare up with Rinvoq was no reasonable possibility. The reporter's causality for the events of rheumatoid arthritis flare up and fibromyalgia flare up with BNT162B2 vaccine was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known drug temporal relationship and Limited information in the case report a casual association between reported events  with the suspect product BNT162B2 cannot be excluded 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
This spontaneous prospective pregnancy report as received from a female patient of unknown age, reporting on herself, who was vaccinated with a dose of VARIVAX (Merck) single standard dose (dose, route and lot # not reported). The patient explained that she was 5 months and 2 weeks pregnant and had now received the VARIVAX (Merck) vaccine today (on 17-MAY-2013). The patient was exposed in the second trimester. Last menstrual period was approximately on 03-DEC-2012, Estimated delivery date would be approximately on 09-SEP-2013. The pregnancy outcome was outcome pending. Fetal outcome was unknown. Additional information has been requested.
Patient presented for Covid -19 vaccination based on the fact that he is a caregiver and qualifies under said rules. About 10 minutes into the 15 minute observation. Patient reported to the observer that he was having just a little bit of difficulty swallowing and felt a little warm. He denied shortness of breath, he was brought into the evaluation area. He was  mildly uncomfortable but was able to speak in full sentences, did not appear short of breath and was articulate and cooperative with the exam. Initial vitals revealed that his pulse is 122,O2 sat was 98%,  blood pressure was 220/120.( Denied known HTN) He had very mild wheezes bilaterally.(Denied H/O asthma or wheezes) He reported feeling warm. He asked for something to drink and after taking several sips stated that his swallowing felt a little bit better describe the situation that is the back of his throat but a little lower. Oral exam revealed slightly red and posterior pallet with chronically enlarged tonsils without exudate, neck is supple, no adenopathy. He was able to swallow without difficulties. He was warm. He was given a cold compress which he stated improved his symptoms. Reports he does not have underlying asthma, has not had such a reaction before and had not been ill in the preceding days,   patient was given a chewable Zyrtec. After approximately five minutes blood pressure was re-checked and it was 160/88 with a heart rate of 98 and O2 sat is 98 wheezes appeared to improve slightly but were persistent. Patient stated in general he was not feeling any better and feeling slightly worse BP was again noted to be 220/110. Concern was for an allergic reaction as demonstrated by the wheezes and sensation of difficulty swallowing but given his persistent significantly elevated blood pressure epi-was not indicated but emergent transport was. 911 had already been called for transport to the hospital for further evaluation.  EMS was transferred care. He was transported to the hospital. He was discharged several hours later.  Review of ER notes revealed he was hypertensive at 187/87 with a pulse of 95 ,he did not have any active wheezes or oral pharyngeal swelling on their exam. he was given a G.I. cocktail for his "itchy" throat. No specific conclusion was determined as to the cause of his reaction, other than a possible ?post injection inflammatory reaction? and was discharged to home without any other treatment required.  Was was transported back to the vaccination facility by private vehicle and appeared to be in good condition but tired according to the vehicles driver.   MD dictated on March 30, 2021
After the injection my arm got really sore.  I began to feel really tired and begin to have chills and shakes.  I started having diarreah and began throwing up. I had  a sever headache and body aches which all symptoms lasted for about 3 days and I felt so bad so on Wed 12/30 I went to Urgent Care and was given fluids which did make me begin to feel a little better. On Monday I was sent for a COVID test which was negative.  On Friday 1/1 i was finally able to return back to work.
First started with minor rash on 2/07 which disappeared.  On pm of 2/10 started itching again and felt warm in the area. On the morning of 2/11  the area  of the shot site was swollen, very itchy, red, warm and uncomfortable until today 2/13.  Applied hydrocortisone, ice packs and wore sleeveless tops. It has slightly affected down to my elbow area.  I've taken Advil on two occasions and have not seeked medical treatment.
Joint pain and swelling that continues over a year later. Fatigue. Flare up of eczema
Approximately 1 week after my vaccination I experienced the following: Chest Pain, Headache, Bruising. I saw my doctor and he performed Laboratory work, EKG and Chest X-ray  for assessment. After my results came my doctor said everything was normal and was not prescribed with any medication. Up to this day 01/20/2022 I am still experiencing headaches and chest pain with no improvement and has been increasing.
Information has been received regarding a case in litigation received from a consumer concerning her an approximate 3-year-old son, with no pertinent medical history or allergies, who in approximately 2006 ("2 years ago") was vaccinated with a dose of MMR II. There was no concomitant medication. Within a month after receiving the vaccine the patient started developing behaviors that were described as "cute". In approximately November 2007 ("three months ago"), the patient was diagnosed with moderate to severe autism. The patient sought unspecified medical attention. On an unspecified date the patient had a "vitamin count check" diagnostic lab performed. At the time of the report the patient's status was not recovered. The patient's mother insists that the diagnosis was due to the MMR II. A product quality complaint was not involved. Upon internal review, autism was determined to be an other important medical event (OME). No further information is available.
Hospitalized 11/7 Unctrl DM, Microalbuminurua& urosepsis.         Low platelet count documented for 11/22/09. Thrombocytopenia diagnosed on 12/1/09,but Low platelet count also noted in the record for 3/13/2009.
Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered.    Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout  and   the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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.
Approximately 3 weeks after receiving 2 vaccines in right arm - RABAVERT in right deltoid; STAMARIL (yellow fever) in right upper arm SQ tissue; began having right upper arm pain. Pain causing difficulty sleeping, as she usually sleeps on right side. Pain & difficulty raising right arm overhead & moving right arm behind back. Unable to straighten right arm overhead. Pt reports that pain sometimes radiates into neck or down arm. No fever or chills reported. No arm swelling noted.
On 02/13/2020 client was checked  out at 10:43, her mother was advised to remain 30 minutes after vaccine injection was given. On 03/18/2020 mother called around 3:30 pm and states her child has had a reactions to some vaccines that was given on 02/13/2020. She stated she started having the reactions the next day. She also stated she called 2 days later and did not get an answer but she left a message. I told her the facility is closed on weekends, and I was not given a message of the call, and no calls was on my telephone. She continues and stated she called a Doctor and was told she need to return to the facility that the child received the vaccines.  the mother continued and states she gave the child Benadryl 25mg from over the counter. I ask her if she took the child to the emergency room? she stated no but she called. At this point i ask if the child was still itching, she said yes. I told her to bring child to the Health Department now, and said she could not because she had to go to work but she would bring her the next day when we open. I told her the Health department opens at 8:00am. on 03/19/2020 patient was accompanied by her mother and her brother at 9:15am. No sighs of stress. V/s BP 101/68- P. 69- Resp. 18 Temp: 95.6. I received a statement at this time from the mother. She said the her child started itching  10 minutes after receiving the vaccines, but they left about 10 minutes after receiving the vaccines. I showed her the statement she signed advising her to remain 30 minutes after any injection. She then said I did not say, I did not sign. I said, "I just left around ten minutes after receiving the vaccines". I then told her she could have come back to have the child checked out. She said well I called the next day (02/14-2020) around 4pm or I do not know the exact time. It was when the rash started. She stated the Benadryl was started about four to six hours after she called on 03/14/2020. she stated that Coco butter was applied about a week later because the rash was getting worse and they continued to give the child Benadryl.   On 03-19-2020 here  at the Health District. My finding was patient had a red spot on the inside of her  bottom lip and a dark patchy rash on her right and left thighs with a very dry appearance. She stated it was still itching. Her mother wanted to know if we could give her some sort of cream for the itching. I told her the only advise I could give was to go to the emergency room if the itching continued. Mother also stated patient  was not on any other medications and did not have any allergies.  LPN/ Immunization Coordinator Health District
Patient had midsternal chest pain stabbing for 5mins. Patient took ibuprofen and pain resolved after 10mins. Headache and tired on 05/24/21 and 05/25/21. Provider encouraged rest and fluids and referred to see cardiology specialist.
HIVES, GENERALIZED EDEMA OF FACE AND HANDS, LIP SWELLING ONSET 3 HOURS POST VACCINATION. TX: PO BENADRYL AND PREDNISOLON GIVEN IN OFFICE TODAY (07/08/2021). DISCHARGED HOME WITH RX: PREDNISONE AND HYDROXIZINE. RECHECK IN 24 HOURS.
Lead Ancillary reported to PHN around 1100 that patient (DOB 4/26/1960) had received dose 2 of the Moderna COVID (lot 041B21A, exp 5/13/2021) at approximately 0945 by vaccinator PHN. The patient received dose 1 on 3/19/2021, dose 2 was administered early as it was not due until 4/16/2021. PHN relayed information to Manager and Supervisor. The patient had completed his observation period and left the site before PHN was notified.
5 Minutes after shot in this order -1st - pain and swelling of lymph nodes in the right side of the neck                                                                             2nd - body began feeling hot                                                                              3rd - felt dizzy like I was going to pass out                                                                                4th - A little upset at my stomach All happened within a minute of each other. The feeling of being hot and dizziness went away within an hour  Nausea has come and gone over the last 48 hours.  Neck pain and swollen lymph nodes in neck stayed for about 48 hours.       36 hours AFTER injection, the lymph nodes in my right armpit began to hurt and swell.  72 hours after the shot, nodes in the right armpit still hurt, but hurt less than the day before.
pt recv vax 12noon;mom reports pt fell asleep for couple of hr & mom c/o can't wake pt (420PM);stated pt had dark circles under eyes & some redness;sl redness under rt eye;
Numbness and Tingling R Arm which got progressively worse. Upon being seen by Physician he noted tender, warm, red arm at 3rd anthrax site numb, tingling, nerve pain and tremors, no rash noted. Prescribed KEFLEX, and MEDROL. Outcome: As of date of this VAERS, there is still lingering numbness, tingling, and nerve pain which on a pain scale of 10 being a 2 at its worse and occurs at random times. Health Care has been notified and is recommending the nerve conduction test.
Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
Menstrual irregularity (late menses (5 days late), light flow) 14 days after vaccine administration
Seizures began 01/24/2002. Staring; shaking of arms, more sleepy than usual, decreased tone. Referred to neurologist 02/01/02. Began on Phenobarbital 2/1/02; subsequently changed to Topomax.  Annual follow up report states: "Had seizures-still treated by neurologist as well.  Decreasing months for seizures as of 01/03.  EEG normal.  Development seems to be back on track.  Will not give another Pertussis Immunization."
I received my initial Shingrix vaccination on 8/20/19 and on 8/29/19 I developed a right sided Bell's palsy. My HSV IgG titer is negative, VSV IgG is positive (I've had chicken pox as a child) with IgM titers pending. I'm a physician by the way. Thank you.
Information has been received from a registered nurse concerning a 57 year old female who on 27-MAY-2008 was intended to receive ZOSTAVAX (Merck) (MSD), but inadvertently was vaccinated with VARIVAX (Merck) 0.5ml SC in the left arm (Lot #: 659212/1507U) due to human error. The reporter confirmed this was not a case of product confusion. Later on the same day, the patient received ZOSTAVAX (Merck) (MSD) 0.5ml SC in the right arm (lot#: 658208/0886U). The patient called a week later. The patient reported that she had no local reaction. But she stated that she had a sinusitis with fever a few days after the vaccination. The sinusitis lasted for a few days and finally the patient recovered. It was unknown if the patient sought medical attention. Additional information is not expected.