chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 60 year old male patient, the patient had no allergies or drug reaction. On 07-JUN-2015 the patient was vaccinated with one dose of PNEUMOVAX23, (0.5 ml, intramuscularly (also reported as "per protocol"). On 08-JUN-2015, the patient developed swelling and induration at the injection site. Lab diagnostic studies were not performed. The patient sought medical attention (was seen by an unspecified healthcare provider). No treatment was given for adverse events. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected. The reporter did not wish to be contacted.
vaccine arm is swollen shoulder down to elbow ("hard as a rock") and itches, redness, warm.  Has applied ice which didn't help per pt. This started 8/3 in middle of night (approx 0200).  Having difficulty bending elbow.
Vaccine administered was outside of approved storage and handling Instructions.Pfizer manufacturer recommended revaccination,because it does not have data to support vaccine stability.
This spontaneous case report was received from a nurse practitioner regarding a male child currently with a current age of 3 years. It was reported that the child was exposed to the VARIVAX (Merck) via, transplacental route as the patient's mother received the vaccine during her 1st trimester. The baby was born at 35-36 week (Premature baby 33 to 36 weeks) (medically significant). The child weight was reported as 3130 grams and height was 18 3/3 inches at the time of birth. No congenital anomalies were reported. The outcome of premature baby was reported as recovered. The relatedness of the event "premature baby 33 to 36 weeks" with the suspect product was unknown. The case was linked to another case via parent-child link. Additional information is not expected as no further information was available.
Info has been received from a nurse practitioner concerning an adult female who on 10/23/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot 641116/1160L). On 10/23/2002, the pt developed redness and swelling. The pt was treated with warm compress, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). On 10/28/2002, the pt's symptoms were resolving. The nurse indicted that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
Shoulder Pain and sever neck pain on left side up the cervical and thoracic spine into head and skull, feels nerve intense plus muscular. Some numbness down left arm.
Pt had irritation at site, went to Dr who extracted a small black speck from site.
Unusual vision (blurry, hard to read words, bands of dots) headache around right eye, severe nausea, heavy prickling forearms.
Hives on face/neck, "itchy" face, "itchy" throat. BENADRYL 30 mg PO. BENADRYL 12.5 mg PO. Symptoms not resolved->911->
Pt vaccinated with DTP slept continuously for seven hrs, awoke briefly to eat &  was fussy at this time.
Case number PHEH2015US026853, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 54-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 06 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse event reported following this medication errors (incorrect storage of drug). No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
TWO BLOOD CLOTS BEHIND SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient got the vaccine shot and experienced two blood clots behind them. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two blood clots behind shot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211229802-covid-19 vaccine ad26.cov2.s- thrombosis, deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Local reaction at vaccine site. Area 2.25"x1" erythema, heat, 3 papules; no vesicles.
I had some chills and low-grade fever for one day after receiving the vaccine. I began not feeling well on 11/24/2022 with a headache and just didn't feel good. I thought I was coming down with a cold. My symptoms got worse, and I went to the emergency room. I had difficulty swallowing and I had a high fever. I tested positive COVID-19 on 11/26/2022. I got a prescription for PAXLOVID and a pain medication. I tolerated PAXLOVID.
pt recv 2 doses of vax 4wk apart;lab testing indicated that pt had not seroconverted;no f/u titers were performed;
pt recvd vax 8MAR96 w/in 24hrs redness, swelling w/tenderness (+itching) lt thigh inj site w/induration
Face (cheeks, forehead, chin)  red  (sunburn look)  and swollen.    Occurred  several hours after receiving vaccine.
Information has been received from a registered nurse (RN) concerning her 7 year old daughter who, in approximately 2001, at 12 months of age was vaccinated with varicella virus vaccine live (Oka/Merck), at a military base. Subsequently the patient developed a break through. The patient has about 30 lesions on her extremities and trunk. No additional information was provided. The outcome was not recovered. Additional information has been requested.
Shingles outbreak in area of vaccine starting about 1 week after vaccine, tx with acyclovir. Also had outbreak on back.
Palpitations reported by patient.  35 minutes monitored Vital Signs within normal limits Symptoms resolved. Released to home.
Patient received 1st dose of Moderna covid 19 vaccine on 3/31/21. Patient was not of the recommended age of 18 and older. No symptoms or side effects reported by parent. After reviewing the CDC guidelines, patient was given the 2nd dose Moderna covid 19 vaccine on 4/28/2021.
Initial misuse report received from a healthcare professional on 09 October 2013. A kid patient had received FLUZONE a 0.25 ml dose instead of a 0.5 ml dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Parent stated RA swelled and reddened, area measured 3"x6" with said red streak in it." Took child to ER observed + reminded to not get Varicella #2. Parent stated area affected was where Varicella was placed.
Local reaction on right arm of erythema, warmth to the touch extending down medial aspect of arm to elbow as well as fever measured at home of 101.
Very intense headache - top of head and behind the eyes and slight / low-grade fever, tiredness - Sunday evening into Monday morning, swollen and sore lymph node under left arm - Monday and Tuesday
Pt was monitored for 30 minutes after administration and discharged with no symptoms. Pt returned to observation area a few minutes after discharge complaining of diffuse pruritus and "tightness while breathing". Vital signs stable at all times on room air. Expiratory wheezes auscultated in bilateral bases of lungs upon assessment. Pt received 25mg PO Benadryl and 2 x 2 inhalation of albuterol, spaced 15 minutes apart. Pt reported total resolution of symptoms after 45 minutes of monitoring. Pt was discharged in stable condition with instructions to follow up with physician.
Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.
itching to back-neck lt hive noted to neck area-head itching took ASA around 430AM 16OCT97;
Red, warm, swollen area on arm just under injection site.  It measured about 3 inches by 6 inches.  My doctor said she had never seen anything like it.  She said she did not think it was cellulitis, but gave me an antibiotic just in case.  It was three weeks before it completely faded.
7 days after initial vaccination, developed a rash with redness, swelling, tenderness, and itchiness.
1124 End of 15 minute observation period. Per witness,  attempted to stand and fell forward onto floor.  Seizure noted  for one minute, responded to name and answered  questions appropriately. Stated he "felt dizzy".  Vital signs 118/60, 99%, 54.  Blood glucose 97. Physician Assistant, present.  Questions answered.  1131 Attempted to stand patient up again with assistance/supported  X2.  Stated he "felt dizzy again and blurry vision".  Fainted while supported X2.  Positioned  on left side and immediately responded. Positioned supine.  1133 Vital signs 110/60, 96%, 72.  1142  Sitting up awaiting EMS, answers questions appropriately..  EMS present 1145 Vital signs 128/76, 100%, 72.
Mother stated child has swelling from shoulder to elbow of left arm with redness, warmth and tenderness. These symptoms began 24hrs after injection. Patient given Tylenol on 10/21/08,  1/2 hr after injection. Applied ice to area on 10/22/08 one time.
shingles episode with h/o varicella immunization, no h/o clinical chicken pox. (Could not reach parent back for more info--phone disconnected)
shoulder got very sore; the arm that they gave the shot in, my shoulder got very sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included 'arthritis in my shoulder.' The patient's concomitant medications were not reported. The patient was not reporting a severe reaction. Patient sated that "I have arthritis in my shoulder, the arm that they gave the shot in, my shoulder got very sore" on an unspecified date. The patient wanted to know if it was okay to take something for it like Acetaminophen or something. Somebody told the patient that Ibuprofen or Aspirin should not be taken. Patient did not know how many days it was not supposed to be taken for. Patient wanted to know if something could be taken for it or not. The patient still wanted to get the second shot. Outcome of the events was unknown.     No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
One dose of Moderna vaccine given from a vial of Moderna vaccine expired on 10/13/2021 but kept in the refrigerator ( 2nd does )  Lot number 048c21A expired 10/13/2021 - Manufacture expiration date 11/09/2021 - removed from freezer on 09/13/2021 and kept in the refrigerator until 10/18/2021
This spontaneous report has been received from a physician concerning a child patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unspecified date, the patient received his third dose of ROTATEQ, oral (lot #, exp. date, strength and dose were not provided). The child spit up most of the dose immediately after third dose was administered. Therefore, the physician had administered an "extra"/fourth dose of ROTATEQ. At the reporting time, the outcome of infantile spitting up was not reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician declined to provide any additional information.
Arm numbness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101504479 (Pfizer).  A 15 year-old female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Arm numbness".  Additional information: Caller stated she had a patient come in that got her vaccine yesterday and was reporting arm numbness. Caller was asking is there any follow up concerns or is this a common effect as its not one she has seen before. This was not a side effect she had encountered before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; This spontaneous report was received from a nurse, refers to a 59-year-old male patient with hypertension, arthritis in right knee and who was overweight. The patient had drug reaction or allergies to morphine.  On 07-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency unknown) lot# S009945, expiry: 10-AUG-2020, intramuscular for prophylaxis. Concomitant therapies included aspirin, chlorthalidone (HYGROTON), esomeprazole magnesium (NEXIUM), losartan, multivitamins and naproxen sodium (ALEVE).  The patient mentioned to the reporter that, on 08-JUN-2019 his arm became red (injection site erythema), swollen (injection site swelling), hard (injection site induration) and painful at the injection site (injection site pain) and down his arm (pain in extremity) after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The reporter requested a lot check on the report.  The outcome of injection site swelling, pain in extremity, injection site induration, injection site pain and injection site erythema is unknown. Causality assessment was not reported. Product quality complaints was not involved.  This is one of 3 cases with similar adverse events.; Sender's Comments:  US-009507513-1906USA005194:
Was so sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Was so sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient wasn't planning on getting vaccinated, but he/she had a transplant and they wouldn't let me proceed without one. The patient was guaranteed to get shingles if he/she didn't get the shot. The patient had no complications! well, if patient did he/she wouldn't have noticed.  The patient was so sick The follow-up could not be possible as no contact details were available.
Panic attack; Heart rate increased; Chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate increased), CHEST DISCOMFORT (Chest tightness) and PANIC ATTACK (Panic attack) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Palpitations, Palpitations, Reaction hypersensitivity (NOS) and Panic attack. Previously administered products included for an unreported indication: BETA BLOCKING AGENTS.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) and CHEST DISCOMFORT (Chest tightness). On an unknown date, the patient experienced PANIC ATTACK (Panic attack). At the time of the report, HEART RATE INCREASED (Heart rate increased), CHEST DISCOMFORT (Chest tightness) and PANIC ATTACK (Panic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications an treatment information were reported.
Headache, and sinus frontal pain. Erythema and bruising surrounding the injection site. Patient was treated with Keflex and naprosyn.
Exactly one week after receiving the shot, I developed a raised itchy red spot around the injection site
After receiving flu shot and GARDASIL vaccine c/o SOB and wheezing with tightness of chest. MD notified and meds administered BENADRYL-25mg PO, Albuterol-Duo Nebulizer, Prednisolone-60mg PO, EPIPEN-injection, O2 6L-content. Transferred ER via ambulance.
Chills; Weakness; Headache; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:00, the patient experienced chills, weakness, headache, dizziness, and nausea. The patient reported that the most severe lasted from 12 to 26 hours after dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, weakness, headache, dizziness, and nausea were resolved on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
4/3 immediately after vaccine had lightheaded, tingling. 4/4 fatigued and slept alot.4/5 started with palpitations, and heart racing often to 110. 4/6 bad enough to go to ER with normal EKG, monitoring, Chemistry and CBC, troponin and CXR. released and saw me 4/7 with symptoms all resolved.
complains for numbness and tingling of tongue, lips and thick tongue.  60mg Allegra given, observed, all vitals within normal limits.  Patient stated her tongue and lips are better, still with "thick tongue" but also complains for funny feeling in back of throat.  911 called to transport to ER for observation/treatment.
Patient seen in clinic for wellness exam. Bivalent dose of Pfizer ordered per provider, as it is the only formulation carried in clinic. Patient had received 2 doses of Moderna monovalent vaccine prior to this date on 7/5/22 and 8/26/22. As Pfizer is a 3 dose series, and the only formulation available in clinic, clinician mistook that the primary series was not complete, and that the bivalent Pfizer would serve as the completion of the series. Prior to administration, clinician attempted to determine if series was valid. Due to a misunderstanding of the following from the CDC website, clinician determined that a mixed series was acceptable: "Children ages 6 months?4 years who received 1 monovalent Moderna and 1 monovalent Pfizer-BioNTech vaccine dose for the first two doses of the primary series (in any order: Moderna then Pfizer-BioNTech or Pfizer-BioNTech then Moderna) should follow a 3-dose primary series schedule. The third primary series dose can be either a monovalent Moderna vaccine or a bivalent Pfizer-BioNTech vaccine. Currently, children in this age group who receive a mixed 3-dose primary series with any combination of Moderna and Pfizer-BioNTech vaccines may not receive any booster dose." Dose was administered after reading this information, after which time the following was found in another link within the CDC page: "Ages 6 months ? 4 years and completed the Moderna primary series: 1 bivalent Moderna booster dose. Ages 6 months ? 4 years and completed Pfizer-BioNTech primary series: No booster dose is recommended at this time." Which was interpreted to mean that the Pfizer does was not a valid dose as the primary series of Moderna is only 2 doses and was a completed series and the pfizer is not currently approved as a booster dose. State DOH recommended advising parent to get a bivalent moderna booster dose in a minimum of 8 weeks to complete the series.
menstrual cycle started early and still has it; Fever; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (menstrual cycle started early and still has it), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-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 10-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). On 17-Apr-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual cycle started early and still has it). On 11-Apr-2021, PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) had resolved. At the time of the report, MENSTRUATION IRREGULAR (menstrual cycle started early and still has it) outcome was unknown.            No treatment information was provided Concomitant medication included unspecified birth control pill. .
Starting passing out n headaches brain forgetfulness,  told doctor sent to heart specialist,  still complain  n went to another doc. Had dappled of neck n heart, heart monitor, mri of brain,  heart is great but now have white matter on brain after shots, but didn't have 2 year before, still just passport, n life is so different