chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; Swelling; Allergies: Prevnar 13; This is a spontaneous report received from contactable reporter(s) (Physician).  An 80-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; SWELLING (non-serious), outcome "unknown"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergies: Prevnar 13". Additional information: Allergies: Prevnar 13 - Itching, Swelling.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Shingles - right gluteal region -  S2 dermatome - 7 days after dose 2; This is a spontaneous report from a contactable physician (the patient). A 46-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266, Expiration date: Unknown), via intramuscular, administered in right arm on 17Feb2021 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunization. Patient previously received first dose of bnt162b2 on 22Jan2021 for covid-19 immunization. The patient had known allergies with Latex, adhesive, perfume, fragrance, pollen. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks and no other medication within 2 weeks. 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 medical history and concomitant medications were not reported. On 23Feb2021 08:00, the patient experienced shingles - right gluteal region - S2 dermatome - 7 days after dose 2. The patient was not given treatment. Outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Information has been received from a Nurse concerning a female who on an unspecified date, was vaccinated with a dose of Gardasil (route, site and lot# not provided).  It was reported that the patient fainted after administration of vaccine.  It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2008.  Information has been received from a Nurse concerning a female who on an unspecified date, was vaccinated with a dose of GARDASIL (route, site and lot# not provided).  It was reported that the patient fainted after administration of vaccine.  It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information is not expected.
No reaction immediately following vaccine other than sore arm. Approximately a week later: Joint pain, and pretty bad brain fog. Joint pain subsided after 3 weeks. Brain fog still present, worse when attempting to workout. I'll workout and a few hours later I'm hit with a big wave of brain fog, difficulty concentrating, diminished cognitive ability and fatigue. I've also notice coffee no longer provides me with clarity (doesn't wake me up as it used to). Anxiety has definitely increased.
Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down.  On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F.  Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21
Early Sept 2021 I started having neck shoulder and little bit in my chest, scapular, down my arms, muscle pain and aches. I felt weak and tired and went to the Dr. The Dr. ran a lot of tests on me and antinuclear antibody was positive, that's the only thing they found. They wanted me to have a second one done but I didn't do it because the pain went away. I am going for a follow up this Friday with my doctor.
Developed acute-onset, sharp right pelvic/groin pain radiating to right groin and flank the day after receiving first Pfizer COVID vaccine.   Non-contrast CT abd/pelv revealed right ovarian cyst which resolved on follow-up vaginal ultrasound 1 week later.  Within about 2 days, the sharp pain progressed to burning neuropathic-type pain across the pelvic/pubic region and down bilateral inner thighs to knee level.  Pain was constant.  After 10-14 days, the pain transitioned from burning sensation to sensation of feeling cold (both on skin and deep tissues) that would feel normal to the touch.  It is symmetric on both sides and begins at the level of umbilicus and involves both groins and medial thighs. Symptoms worsen with sitting or standing up for prolonged periods of time (and become more noticeable/bothersome) and as the day progresses.  About 2 weeks later, the severe burning pain progressed to include bilateral buttocks and outer thighs as well.  MRI brain/cervical/thoracic/lumbar spine largely normal (tarlov cysts S2-S3, small left disc protrusion C5-C6).  CBC, BMP, TSH, B12, B6, lyme titer, ESR normal.  Currently being treated with gabapentin 300mg TID.
Patient states had vaccine at 3pm on 11/9 and woke up at 2am on 11/10 with horrible pain in her neck.  She states the pain in her neck was on the right side opposite of the left side where she received her injection.  She was unable to turn her head, pain radiated across her shoulders and down both arms.  Patient even had trouble bending her fingers.  She reported this information to me today 11/12/23 at 2:26pm.  She did not seek medical treatment and only took an advil to help relieve the pain.  Patient is still experiencing some stiffness in neck today but not to the degree it was on the 10th.
can't breathe well; This is a spontaneous report from a Pfizer-sponsored program [COVAX US Support]. A non-contactable male consumer reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Breathing difficult. The patient reported that he already got the shot and noticed that he can't breathe well. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills, dizzy, vertigo, muscle and joint aches.  Needed to go home from work.
Pain at site and upper left arm approx. 3 1/2 hr after injection.  Pain continued to worsen all day and into night.  I am now at 2 1/2 months out from the injection and still have pain in my upper left arm,  at the site and upward to the top of arm.  I do not have a hx of arthritis or other joint pain.    The person administering the injection injected the med. very high on my arm.  I have given hundreds of flu injections and knew immediately that it was too high.
This case was reported by a physician and described the occurrence of stroke in a 79-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. In May 2018, the patient received the 1st dose of Zoster vaccine. In May 2018, 2 days after receiving Zoster vaccine, the patient experienced stroke (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). Zoster vaccine was discontinued. On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Zoster vaccine. Additional details were provided as follows: The reporting physician was relative of the patient. The age at vaccination was not reported but the patient could be 78 or 79 years old. The patient was notified that it was time to receive her 2nd dose of Zoster vaccine. When she looked at paper with date of 1st dose, she noted that she had a stroke in May 2018, 2 days following the 1st dose. The event required surgical or medical intervention and improved. Therefore, she decided not to get the second dose. She did not mention name of vaccine. The patient did not die. The event did not result in a congenital anomaly or birth defect.
12/8/03. I became ill with fever. (Pre-vaccination)  12/9/03 Sought medical attn. Doctor advised me that I had the "same cold that everyone else did" He recommended that I get the Pneumonia Vaccine before I left his office to ensure that I didn't get worse. Received Pneumonia vaccine at approximately 9:15am   12/10/03 In the evening my arm was very sore. On a scale of 10 with 10 being the most painful, my arm was a 10. The arm pain subsided to a 7 as the week progressed, but it is still quite painful.   12/12/03 With the arm pain still at a 7, I woke up to find my thumb and the adjoining muscles were swollen, painful, itchy, and red. Movement of that thumb and hand is quite limited. I again sought medical attention, and a blood count was taken where they found no trace of infection. I was prescribed 40MG per day Prednisone to alleviate the swelling. I will start this medication 12/13/03.
Patient reported feeling flushed and having difficulty breathing; rapid respiratory response called, patient monitored; no medical treatment needed, was discharged home in vehicle with spouse.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
On 8/5/2022 client and parent presented to clinic for first pediatric Pfizer Covid-19 vaccine. The vaccine vial was brought to CMA by RN Nursing Supervisor.  RN had CMA verify the vaccine that had been handed to CMA. The pediatric vials are to be reconstituted with 2.2cc of 0.9% Sodium Chloride and 0.2cc is to be given IM. The Pfizer vaccine was not reconstituted before it was administered to the client. The vaccine error was not discovered until the client came in for the 2nd dose on 8/26/2022. The parent reported no adverse reactions or side effects from the vaccine given on 8/5/22. RN asked how the client responded over the weekend. The parent reported she "did fine". No problems or reactions noted.
HAD 1ST ROTATEQ 06/25/2009 AND PRESENTED TO OFFICE 7/10/09 WITH COMPLAINTS OF BLOODY STOOL. AT THAT TIME WAS THOUGHT TO HAVE QUESTIONABLE PROTEIN ENTEROCOLITIS.  CHILD BREASTFED, THEREFORE MOM HAS OMITTED MILK AND MILK PRODUCTS, ALONG WITH SHRIMP AND SHELLFISH. 2ND ROTATEQ GIVEN 8/13/2009 AND AGAIN PRESENTED TO OFFICE TODAY WITH BLOODY STOOL
Narrative: He reports on the 3rd or 4th day after Moderna vaccine he developed shaking chills without documented fever, rash or joint swelling. The chills last 3-4 hours and was followed by generalized asthenia, chest discomfort and sensation of insufficient air with inhalation. There was no pleuritic pain and no prior hix of similar chest discomfort. The chest complaints resolved over several hours but asthenia lasted for 2 days.He is now at baseline.No phx of sensitivity to medications or vaccines and no hx of reactions to injections of steroids that might ocntain PEG.
Severe flu like symptoms. Fever. Aches. Fatigue. The first dose I had no reaction. Only 2nd dose. Bedridden for 2 weeks. Still after effects.
gainning more weight/eats twice a day; feeling tired; lazy; Stated she is currently sick; getting fever; getting fever & headaches; This spontaneous report has been received from a consumer, referring a female patient of unknown age. Concomitant medications included tofacitinib citrate (XELJANZ XR). The patient's medical history, and concurrent conditions were not provided.  On an unknown date of 2022 (also reported as last year) the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection (strength, dose, frequency, administration route, lot number, and expiry date were not provided) indicated as prophylaxis.  On an unknown date, the patient started gaining more weight but eats twice a day (weight increased), was feeling tired (fatigue), lazy (laziness) and was getting sick every other week (illness). She was currently sick and had lasted approximately 10 days with fever (pyrexia) and headaches.  The outcome of the events and the causality assessment was not provided.
Prolonged redness; Swelling; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The two vaccines were administered in the same arm. The patient's medical history and concomitant medications were not reported. The patient experienced prolonged redness and swelling both on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever/chills, extreme body aches, extremely sore arm, sore throat - 48+ hours
30 mins p/vax pt devel swelling in rt neck that resembled mumps; allerg react; rt neck swelling;
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K022993, expiration date 20-OCT-2016; lot # L000568, expiration date 10-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Mother reports patient developed a fever of 103 degrees. He was treated with tylenol close to 1AM. Later during the middle of the night he started to have a seizure. Mother reports it lasted over 1min. Mother called 911. EMS took him to Hospital.
Thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and was given on March 16, 2023.; No adverse event; we've had a COVID-19 vaccine administration accident wherein a March 11, 2023 expiration date was given on March 16, 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we've had a COVID-19 vaccine administration accident wherein a March 11, 2023 expiration date was given on March 16, 2023), PRODUCT STORAGE ERROR (Thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and was given on March 16, 2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (we've had a COVID-19 vaccine administration accident wherein a March 11, 2023 expiration date was given on March 16, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and was given on March 16, 2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we've had a COVID-19 vaccine administration accident wherein a March 11, 2023 expiration date was given on March 16, 2023), PRODUCT STORAGE ERROR (Thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and was given on March 16, 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (we've had a COVID-19 vaccine administration accident wherein a March 11, 2023 expiration date was given on March 16, 2023) and PRODUCT STORAGE ERROR (Thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and was given on March 16, 2023.).    Concomitant medications were not reported.  Reporter stated that they had a COVID-19 vaccine administration accident wherein a 11-Mar-2023 expiration date was given on March 16, 2023. Vaccinator explained that they thawed out the vial on 21-Feb-2023, counted 30 days later for its BUD and mis looked the expiration date on the sticker label (we always have a sticker label indicating its expiration date). Vaccine had been properly stored in the refrigerator throughout the timeframe. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2023: Live significant follow up received. Updated reporter details, patient age group added, updated suspect product coding and narrative. On 17-Mar-2023: Live significant follow up received. Updated reporter country, added suspect product batch number and updated narrative.
This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with RECOMBIVAX HB (dose, strength,  route and lot number were not reported). which on an unknown date experienced an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Started as redness and pain on 13 December. Change to painful full arm cramp from neck to hand on left side.  Heat or Cold did not help. had to hold arm over head or place over couch to relieve some pain. Pain decreased daily but numbness down arm and into thumb remain as does site pain. Finally decided to see medical to report the event on 21 December.  Doctor was not concerned and sent me away with recommendation to have nerve testing.  Left the Doctors Office and she called me back 45 minutes later a little concerned because she looked up other cases like mine and stated that there have been 54 other cases with same or worse. Prescribed steroids and referral to have an MRI.
Severe rash on torso, very red, burned and then itched, scabs in places as it healed
Bleeding of a minor laceration that was hard to control, developed "brown spots" in mouth, bleeding from mouth. Flew for vacation and went to a local ED.  Platelets 2,000 on admission.  Dx: ITP and undergoing treatment with Rituxan.
VACCINE WAS NOT DISPOSED OF DURING THE PREVIOUS NIGHT. MORNING SCHEDULE WAS HECTIC WITH MANY PATIENTS EARLY FOR VACCINE APPOINTMENTS AND REQUIRING TRANSLATORS. INTERN PHARMACIST CAME INTO ADMINISTER VACCINES AND DID NOT DOUBLE CHECK IF THE VACCINES WERE JUST OPENED AND DREW VACCINE THAT WERE OPENED THE DAY PRIOR. VACCINES WAS 4 HOURS POST 12 HOURS PUNCTURE EXPIRATION. PATIENT WHERE GIVEN MODERNA AS 2ND BOOSTER. PATIENT WAS CONTACTED AND REPORTED NO ADVERSE EVENT FROM THE VACCINE .
Localized rxn at injection site 10 cm2 induration. No systemic sx - no wheezing, fever etc.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with , decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
Severe headache, loss of balance, feeling very cold, and unable to get warm. shaking, Nausea, pain in the elbow and knee
Receive 2 doses of the moderna vaccine within a 10minute period of each other; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 mg. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at an unspecified dose and frequency. On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receive 2 doses of the moderna vaccine within a 10minute period of each other) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is on blood pressure concomitant medications.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Received Follow up 30 MAR 2021: Updated reporter Email address. Patient demography and Medical history. Lot/Batch number of vaccine, Dose units, Anatomical site and route of administration. Treatment medication reported. On 15-Jul-2021: Non-Significant Follow-up Appended on 15 JUL 2021: No new information.