chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNCONTROLLABLE BLOOD PRESSURE (190/110); This spontaneous report received from a consumer via social media  through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced uncontrollable blood pressure (190/110). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 190/110 unit unspecified. The reporter posted that "another got uncontrollable blood pressure190/110, and this is supposed to be safe, not." The action taken with covid-19 vaccine  was not applicable. The outcome of uncontrollable blood pressure (190/110) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220245849.; Sender's Comments: V0:20220245881- covid-19 vaccine - uncontrollable blood pressure (190/110). The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Initial report was received from a healthcare professional on 03 November 2011. A 31-year-old female patient had received an Intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3947BA) in left deltoid on 18 October 2011. On the same day of the injection, the patient developed pain at the injection site. The pain was so severe that she was unable to move her arm without experiencing pain. As of 03 November 2011, the pain persisted. The patient received corrective treatment with TYLENOL and warm compresses. No further information was available at the time of the report. The patient outcome was reported as unknown. Documents held by sender: none.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 10 week old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 14-SEP-2016, the 10 week old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported.  The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported.  The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004973: US-009507513-1705USA004965: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1608USA012794: Original case US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004950: US-009507513-1705USA004949: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004943:
Intense migraine day after (3/24); Joint and body pains day after (3/24); Joint and body pains day after (3/24); Minor fatigue immediately following(3/23), extreme fatigue day after(3/24), lingering fatigue following 2days (3/25-26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); Tightness, soreness, and pain in injection site day of and 3 days following (3/23-3/26); This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included fibromyalgia, raynaud's and attention deficit hyperactivity disorder (ADHD). Concomitant medications included duloxetine hydrochloride (CYMBALTA), testosterone cypionate (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 12:15, the patient experienced minor fatigue immediately following vaccination and had tightness, soreness and pain in injection site day of and 3 days following. On 24Mar2021, the patient experienced extreme fatigue, intense migraine, joint and body pains. On 25Mar2021, the patient had lingering fatigue for next 2 days. The patient underwent lab tests and procedures, which included COVID test (nasal swab) on 04Feb2021 and tested negative. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, tightness and pain at the injection site was recovered on 26Mar2021 and of the intense migraine, joint pains and body pains was recovering at the time of this report.   No follow-up attempts are needed. No further information expected.
LOC syncopal episode, anxiety of vaccination, blood and needles 114/76, 64, 99.1, 18 patient fell and small bump noted to top of head
p/vax pt exp redness & swelling of the arm;the swelling was noted to be 1 to 1 1/2 times the nl size;1 day later pt recovered;
In March IBS started which I?ve never had before. Everything I ate turned into what felt like rocks , I got so constipated I couldn?t use the bathroom. I started to become nauseated every day. I was up every hour of the night. I tried drinking water to flush my body and stomach, I had trouble eating. I ended up losing 3lbs a week up to 20 lbs. total. I ended up in ER on March 17, 2021. I had to be wheeled in because I was so weak, I couldn?t walk. I had CT scans and bloodwork done. I was sent home after I had a bowel movement. I was also given laxative to take at home. I went to the ER again on 4/23/21 @ 5pm ( 2nd ER visit ) I had CT Scans with contrast, enema, and lab work. I was also hooked up to an IV. I had no blockages from CT Scan. The CT Scan showed impaction, I had to drink stuff in ER to flush system and was given another enema. Once I had a bowel movement I was released with laxative.  I now take generic brand laxative and generic brand of medication every day. I was advised that it could take my intestines a long time to return to normal. After following up with doctor, he decided I needed to have a scope done on my lower GI. I am still having complications.
Shingles about 2 months after injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: "nuts" (unspecified if ongoing), notes: mouth swelling. The patient took concomitant medications. Past drug history included: Propofol, reaction(s): "Hives". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 10Dec2022, outcome "recovered", described as "Shingles about 2 months after injection". The event "shingles about 2 months after injection" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: The patient received Multivitamin during two weeks of vaccination. The patient received Valacyclovir as treatment for Shingles. There was no covid prior vaccination and no covid tested post vaccination.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced cellulitis at unspecified location an unspecified amount of time after administration of PNEUMOVAX 23. The reporter stated that he had reported this adverse event to Vaccine Adverse Event Reporting System (VAERS) (no VAERS number was provided). At the time of the report, the outcome of cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with PNEUMOVAX 23.  Upon internal review, cellulitis was determined to be medically significant. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA001550:
Immediately following the shot, patient had loss of appetite, cognitive decline and Dizziness...resulting in falling and severe injury. While visiting nurses came in to bandage back, Son (CNA and later Nurse educated/trained)   also stayed with dad to provide Nursing care. Patient had heart attack in front of Son. Ambulanced to hospital and 2-3 days later discharged. Found Deceased 27 August 2021.
This spontaneous report as received from a registered nurse refers to a 3 month old male patient (weight 17 (units unspecified)). No concurrent condition or medical history reported. On 21-APR-2015 at 15:00 hours, the patient was vaccinated with one dose of RECOMBIVAX HB, (Lot# L001456) intramuscular (LVL) which was exposed to temperatures outside of the recommended range. On the same day, the refrigeration temperature was out of range for 30 minute (-1.8 degree Celsius). It was advised that the vaccine was not stable to be revaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public funds. Additional information has been requested.
Pt noted pruritis at the injection site on the afternoon after administration followed by erythema and a burning sensation also localized to the injections site.  She was seen 4 days later when the erythema measured 13 x 7.5 cm.  There were no other sx, constitutional or otherwise.
Dramatic flu symptoms.  Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit.  Still not feeling well.  Symptoms have decreased and can now sit in a chair as apposed to lying in bed.
No adverse event; VARIVAX was administered to a patient on 12/12/2022 after a supported temperature excursion that took place on 12/1/2022.; This spontaneous report has been received from a Health Professional and refers to a 15-month-old male patient (reported as 13-month-old). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W018825 verified as valid, expiration date upon internal review established as 14-JUN-2024, administered subcutaneously for prophylaxis in the right thigh (strength was not provided) after a temperature excursion that occurred on 01-DEC-2022 at a temperature of 19.47 degree Fahrenheit for 30 minutes (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001100:
Received GARDASIL #1 6/25/08; Developed body aches and fever, joint pain 4 days after receiving vaccine. Seen by a rheumatologist - Diagnosed with systemic onset juvenile inflammatory arthritis requiring Kineret injections. 8/22/08-records received for DOS 7/16/08-presented to rheumatology clinic with C/O fever and arthritis which began 17 days ago with pain in right hip then pain all over. Fevers are down during day but up at night. Shaking chills and then defervesces with drenching sweats. Rash began on 2nd or 3rd day with red blotchy areas on extremities. Appetite poor and lost 6 pound in past week. Pain seems to be in joint with joint swelling. Dizziness.  Office visit 8/11/08-Joint pain improved except shoulders are not strong. Tapering prednisone. Assessment:Systemic onset juvenile inflammatory arthritis on kineret. Possible adverse reaction to Gardasil.
Skin on arm near injection site left arm  swollen with discomfort - red warm to touch- itchy with larger red circle.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 08:32, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Pt had a vasovagal episode roughly about 2 minutes after receiving Menquadfi and Tdap vaccines about 08:56. She slowly fell from her chair face first. She hit her head on the floor but did not bruise. She appeared pale after episode. Nurses elevated her feet and fanned her. She quickly returned to be alert oriented and responsive. Blood pressure check was 102/72 at 9:00 am. pt sat up and ate some candy and her color returned prior to leaving clinic. Guardian states that she has a lot of anxiety.
Patient received vaccine on 12/26/2020; on 1/3/2021 patient experienced rash covering chest and part of back. Patient took a couple of bendaryl capsules for relief.
tingling of abdo needle-like, also general malaise; bitten by stray cat which was not found; vax administered in ER; 8SEP92 f/u w/each inject pt felt warm, ache under sternum @ time of inject; metal taste in mouth, arm felt heavy, SOB;
Patient was administered with Covid 19 vaccine 15 days after expiration date.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.).    Concomitant medications details were not reported by the reporter. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Treatment details was not reported by the reporter.
pt recv vax 13DEC92 & devel severe pruritus & a 10cm. area of erythema & induration @ the inj site which persisted 1wk post vax;pt recovered;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with seasonal allergies. On 11-APR-2014 the patient was vaccinated with an unspecified dose number of ZOSTAVAX, 0.65 ml, once, (reported lot# 30OCT2014 and expiration date 30-OCT-2014) subcutaneously in the left arm. Concomitant therapies included LEVOCETIRIZINE, SINGULAIR, ALBUTEROL INHALER and azelastine hydrochloride, DYMISTA. On 11-APR-2014 the patient experienced red bump at the injection site and started forming pustules and blisters in her hairline which have increased over the last 2 days. It was reported that she had been putting generic MUPIROCIN ointment on the lesions after the blisters popped which seemed to drying them up. N diagnostic tests were reported. At the date of report on 13-APR-2014 it was unknown if she would receive another ZOSTAVAX the red bump at the injection site and pustules and blisters in her hairline continued but some of them were starting to dry up. The outcome of red bump at the injection site, pustules and blisters in her hairline were reported as not recovered/not resolved. The relatedness between all the events and ZOSTAVAX was not reported. Additional information has been received regarding lot # 30OCT2014 which is an invalid lot # for ZOSTAVAX. Additional information has been requested.
I have had an IUD for 3 years and every month I have light spotting for 2-3 days maximum. Beginning with my first menstrual cycle after my fist vaccine I had extremely heavy menstration for 5-7 days at least and increased cramping.  I am otherwise healthy, have had consistent and predictable cycles that I have tracked for years.  The only change I have had was the Covid vaccine and began experiencing the heavier and longer flow with increased cramping in my cycle immediately following my first vaccine dose.
1-2 days after vaccination, swollen lymph nodes in arm pit of arm where vaccination administered. This lasted for one week. One week after vaccination, swelling and redness at injection site that lasted 2 days
doses given after temperature excursion; Vaccinated after the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403721 (Patient Link).
9/24/14 2:30 pm sx: dizziness, difficulty breathing and swallowing, felt like "throat was closing", nausea, numbness in both hands (Lt worse than Rt); no hives/rash, no audible wheezing. TX: O2, 1.5L face mask, BENADRYL 25mg IM, Rt delt at 2:30 pm. EPIPEN 0.3 mg, IM (left thigh) at 2:53 pm. 3:05 pm to ER, via ambulance.
pt recv vax & exp nausea, difficulty swallowing, because throat swelled & vomiting which lasted for 2 days @ which time pt fully recovered;
Not quite 2 weeks since my vaccination I developed a slight rash, redness and some swelling in my upper left arm. I think slightly below where I received the shot. Not sure if it had to do with vaccination. Just letting you know.
24 hours after injection patient developed an itch at the time a 4x6cm induration was present 72 hours later total erythema 6x9cm.
Vaccine administration error: Moderna booster given before 6 months after completion of primary series (1st and 2nd dose).
This spontaneous report as received from a nurse practitioner refers to a 6 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 13-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Raised, red area below the site the vaccine was administered. Patient complained of the area being warm to touch and itchy. No further symptoms.
Information has been received from a drug representative and her 25 year old female friend who on 21-MAY-2008 was vaccinated with a third dose of GARDASIL 0.5 ml IM.  Approximately beginning on 08-JUL-2008 the patient experienced neck pain and back (also reported as spine) pain with no cause or injury.  The patient's neck pain and back pain persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced a seizure. At the time of the report, it was unknown if the patient had recovered from the seizure. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.