chrisvoncsefalvay/vaers-outcomes huggingface dataset:
APRN was notified of possible reaction to COVID-19 vaccine (lot # EN9581, exp. 5/31/21) at 2:18 pm.  Patient initially complained of tongue pain and a headache; she then began to develop throat tightness and her voice began to change and she began to clear her throat and developed a "tingling" sensation. EMS was called at 2:25pm. First dose of epinephrine 0.5mg was administered IM right anterolateral thigh at 2:25pm, the sensation of her throat closing persisted at 2:30pm and another dose was administered of epinephrine 0.5mg was administered IM left anterolateral thigh at 2:30pm.  EMS arrived and patient left in ambulance at 2:35pm. Vitals:  2:20 pm BP 110/64 HR 85 O2 sat 97% 2:25 pm BP 102/64 HR 93 O2 sat 95% 2:30 pm BP 112/60 HR 87 O2 sat 95% 2:32 pm BP 120/82 HR 90 O2 sat 98%
pt rcvd vax; lab test done & was neg for anti-HBs but pos for anti-HBc; repeat labs showed the same results;
TC from mom pt had vax 12AUG94 area where shot was given looks infected; areas is red, raised w/a scab; mom stated pt has no fever; mom has used ATB cream but feels it is not doing anything; adv to contact MD;
SEVERE SHINGLES IN MY SCIATIC NERVE!! LONGTERM NERVE DAMAGE!!!!!!
immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: IMMUNODEFICIENCY (hospitalization, medically significant), outcome "unknown", described as "immunocompromised". The event "immunocompromised" required physician office visit. Clinical course: Patient had an adverse reaction to the first Pfizer booster that landed the patient in the hospital x 2 and resulted in physicians telling to never, ever get any type of Covid vaccine. Therefore, patient was very immunocompromised.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
3 episodes of cardiac arrest with no previous heart issues.  No found reason for the cardiac arrest episodes. No symptoms prior to episode. Spent 10 days in hospital - 7-8 in ICU.  Had impella pump placed and intubated for days.  Now have implanted ICD device.  Began 06/29/2021
At 12:40 02/23/2021 I started having chills, nausea, and I was dizzy. I went to sleep for an hour and at 5:00PM my heart started having functionating. elevated pulse, low blood pressure, I was having conversation but I was out of it and my husband was about to take me to the hospital but he didn't. I believe I was better the next day.
Case number PHEH2012US025217 is an initial spontaneous report received from a nurse on 20 Dec 2012. This case refers to an 8 month old male patient. His medical history and concomitant medications are not reported. The patient was vaccinated with MENVEO (batch number: X11081) on 20 Dec 2012 through intra-muscular route. No side effects are reported. The seriousness, causality and outcome were not reported.
Early pregnancy miscarriage; 2 lumps near neck; This is a spontaneous report from a contactable consumer (patient). A 31-years-old pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 16:00 (Batch/Lot Number: Unknown) 1ST DOSE, SINGLE for covid-19 immunization.  Facility where the most recent COVID-19 vaccine was administered was a Pharmacy or Drug Store. The patient medical history was not reported.   There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   On 26Apr2021, The patient experienced early pregnancy miscarriage, 2 lumps near neck. The patient reported she became pregnant while taking bnt162b2.  The mother was 5 Weeks pregnant at the onset of the event and  was due to deliver on 22Dec2021.  The adverse events resulted in a Doctor or other healthcare professional office/clinic visit.  The clinical outcome of the event was reported as not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501603 baby case
Headache, Myalgia, Arthralgia, Fever, Localized pain; chills, fatigue Narrative:
covid; covid; This is a spontaneous report from a contactable consumer. This Consumer reported similar events for 2 patients. This is 2nd of 2 reports. This Consumer reported for a (Age: 21; Unit: Unknown) female patient. A female patient of an unspecified age (age: 21, unit: unknown), received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 10Mar2021 19:31:34 UTC as UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The reporter on behalf of two college students, who wish to remain anonymous stated the patient has covid (covid positive), however it was not clear whether she received the 1st or 2nd dose of the Pfizer covid vaccine from callers report:  It was reported that 2 college students are in this situation. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263662 similar report from same reporter
On 12/12/99, the pt experienced an increase in swelling, as well as warmth, inflammation, and redness at the injection site. There was an approximate 3 cm difference in the size of the leg.
Getting hot then cold, migraine headache, bodyaches and pains, at times unable to keep food down, nausea, weakness, dizziness, I sometimes don?t focus, where the injection site is it is red and it is going down my arm, shaking at times, trouble concentrating or thinking.
Patient describes feeling hot, clammy and lightheaded about 5 minutes after vaccine administration.  BP:109/69 P:72 O2Sa:100% Patient states that injection site feels ok.  Got patient a juice and had her sit for another 15 minutes.  BP: 118/63 P:74 O2Sa: 99% Patient has normal hand and arm strength bi -lat.  After patient had cold juice and was able to breath without her mask on she felt much better.  Patient was able to stand and walk without dizziness.  Patient stated the she did not feel she needed further treatment.
Information has been received from a registered nurse referring to a one year old patient of unknown gender. On an unknown date in June 2015 (reported as "last week"), the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB (strength was reported as 2.5/0.5 (unit was unknown) and a dose of PEDIARIX simultaneously (dose, lot# and route were unknown for both vaccines) (overdose). No adverse effect was reported. Additional information has been requested.
Irregular bleeding, abnormal ultrasound, uterus enlarged, endometrial pelvic, abnormal multiple cysticareas, left ovary solid component, 3.5 cysts with septations: left ovariectomy, endocervic D & C, endometrium D & C, simple hyperplasior laparoscopy ovary evaluation, hyperoscopy evaluation of endometrium operation procedure.  Did tests, x-rays, electrocardiogram, hematology. 8/14/08-records received-8/14/08-records received for DOS 3/6/08-Same day surgery for C/O menometrorrhagia and uterine fibers. US sholwed left complex ovarian cyst and abnormal endometrial.Laprascopic adhesiolysis with left oophorectomy. Hysteroscopy with dilatation and curettage.
Noticed right arm redness while using curling iron. Mild soreness. Able to move arm fine.
This is a spontaneous report from a non-contactable nurse via a Pfizer company representative. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA at single dose on the arm (deltoid) via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling at the vaccination area (on the shoulder) on an unspecified date. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018102267 same reporter/product/event, different patient.
Initial report was received from a consumer, who is the patient's parent. A 16-month-old female patient developed a fever and bulls-eye rash, 21 days after she had received an injection of ACTHIB, lot number UE577AA (route and site not reported), (corresponding sanofi pasteur SA lot number Y0404-2). The patient had received concomitant injections of MMR (dose one), lot number 11869 (manufacturer Merck, route and site not reported), and VARIVAX, lot number 0446P (manufacturer Merck, route and site not reported) and PREVNAR, lot number A65653C (manufacturer Wyeth, route and site not reported). According to the reporter, the patient had no medical history and had not experienced any reactions after previous immunizations received. On 28 April 2005, 21 days after she had received the vaccines, the patient developed a fever of 103 degrees Fahrenheit and was administered Ibuprofen. The patient woke in the AM with approximately 15 areas of a bulls-eye rash throughtout her body. Her fever increased to 104.7 degrees Fahrenheit and she was screaming and had an arched back. The patient's mother stated she felt the patient may have had a seizure. Approximately one week later, the patient began to grind her teeth, spin in circles, seemed to lose eye contact and stopped interacting with family members. Chronic diarrhea and gas were reported to have started at that time. The reporter provided the patients past immunization history. On 26 January 2004, the patient received RECOMBIVAX (manufacturer Merck, lot number not reported). On 08 March 2004, the patient received TRIPEDIA, lot number U1028CA, IPOL, lot number X01462, COMVAX (Merck, lot number 0367N), and PREVNAR (manufacturer Wyeth, lot number 495-033). On 08 June 2004, the patient received an injection of RECOMBIVAX (manufacturer Merck, lot number not reported). On 19 April 2004, the patient received an injection of TRIPEDIA, lot number U1028CA, IPOL, lot number X05542, PEDVAX HIB (manufacturer Merck, lot number 0656N), and PREVNAR (manufacturer Wyeth, lot number 495-033). On 08 June 2004, the patient received TRIPEDIA, lot number U1028CA, IPOL, lot number X05542, RECOMBIVAX (Merck, lot number 0218N), and PEDVAX HIB (manufacturer Merck, lot number 0656N). The patient has also received a dose of PREVNAR on 09 September 2004 (manufacturer Wyeth, lot number A57560C). According to the reporter, who is the patient's mother, the patient had not experienced any adverse events after receipt of these vaccines. On 26 August 2005, subsequent to the reported event, the patient received DAPTACEL, lot number C2253AA and PREVNAR (manufacturer Wyeth, lot number A94451K). The patient received a medical exemption following vaccination on 26 August 2005 and had not received any immunizations since that time. According to the reporter, the patient was subsequently diagnosed as having Autism Spectrum Disorder (captured in case 2005-01988). On 10 August 2006, the patient was subsequently diagnosed with an immune dysfunction (captured in case 2008-01478). No further information was provided. This patient had two additional serious adverse events which have been captured in case numbers 2005-01988 and 2008-01478.
rash which was prevalent in the evening located on her stomach and arms; rash is itchy; swollen lymph nodes; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen lymph nodes), RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergy to cats and aspirin, no concomitant medical conditions.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (lot number 039K20A ) on 14-Jan-2021, Moderna COVID-19 Vaccine (lot number 031L20A ) on 11-Feb-2021, Moderna COVID-19 Vaccine (1st booster, lot number 012F21A ) on 30-Nov-2021, Moderna COVID-19 Vaccine (2nd booster and lot number 038H22A) on 01-Jul-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Allergy to animal and Drug allergy.    On 15-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced OROPHARYNGEAL PAIN (sore throat). On 18-Dec-2022, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 24-Dec-2022, the patient experienced RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen lymph nodes), RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient was fine from 15-16-Dec-2022 but on 17-Dec-2022, she came down with a sore throat. On 18-Dec-2022, patient had swollen lymph nodes under her jaw on the right side (the bivalnet booster was administered on the left arm). From 24 to 27-Dec-2022, she noticed rash which was prevalent in the evening located on her stomach and arms. The rash is itchy. The patient stated that the lymph nodes have gotten smaller and the rash lighter. No treatment medicine were reported.
delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311023 and 2019SA311025 (same reporter)  This case involves a 41 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 1DEC97 & that evening pt exp leg pain;pt cont to exp leg pain @ noc until 6DEC97;
Large 19 1/2 x 11 cm hot, red, swollen area around injection site. Cool compresses, BENADRYL and AUGMENTIN ES 600/5 1 3/4 tsp PO BID x 10 days.
Neck and body aches starting day of vax. Itching, redness and swelling on the site - induration and erythema involves approximately 3 cm above injection and 15 cm below injection.
Seizure - left side arm - ribs, spine - Dr. sent me to physical therapy - some relief but spine still needs adjusting. Still having headaches (same day as vaccination). Enc copy X-rays report - pharmacy billing. Received the vaccine 4/29/2012 (AM) as I drove home had a headache, then dizzy, the head started swelling like a balloon. Used ice & took Ibuprofen, laid down. Had to use bathroom which is 4 steps from bedroom. Bathroom very small with bathtub on left - sink on right. My left side of body is weaker than right. I had a seizure my upper body flared hit bathtub on left arm (still bruised & painful) broke left ribs (report enclosed). Spinal area damaged from seizure - still out of alignment. Doctor sent me to physical therapy very little improvement - still pain in ribs, neck, upper back & shoulder on left. I hope to see a chiropractor (if possible) to align my spine then perhaps physical therapy will be more effective. Still have headache & pain (on pain medication). Insurance did not pay for vaccine (do they approve this required vaccine?). Why are Dr's required to make the elderly population take something that could damage their bodies? I will never again take Dr's desire - I will research myself and make my decision. I was prescribed years ago FOSAMAX - took several years till dentist said it was taking bone from my mouth. Then I was put on EVISTA till last order had a side effect report with prescription - it causes strokes, heart trouble and leg vein problems - I will not take anything that harms me.
MD had originally ordered the peds dose but later placed order for the 2 dose adult dose (11-15 yo), by mistake. All of these orders were available to use. This error was not caught during chart review.   Patient got the peds dose in June, based on the original order (0-19 yo). This was correct. However was incorrectly given the adult dose for the 2nd dose. This error was not discovered until reviewing her chart for the 3rd dose.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 13 August 2011 the subject received 1st dose of KINRIX (.5 ml, unknown route, left arm). On an unspecified date, less than one week after vaccination with KINRIX, the subject experienced injection site redness, injection site warmth, swelling injection site and injection site pruritus. The healthcare professional noted that there was no fever or pain. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. Follow-up information was received on 27 September 2011. It was reported that the subject experienced a "vaccine reaction" at an unspecified time following administration with KINRIX. Vaccine reaction and previously reported events of injection site redness, injection site warmth, swelling injection site and injection site pruritus were improved at the time of follow-up and attribution of the events to KINRIX was probable.
I had my vaccination on 10/26/2021. I started to not feel well on 09/07/2022.  I called my doctor who ordered a PCR test at urgent care. The COVID-19 test was positive on 09/07/2022. I was prescribed Molnupiravir. I was diagnosed dysautonomia since having COVID-19.  I was referred to a COVID clinic and referred to physical therapy to resync my nervous system with my body. I do have a follow up with the COVID-19 clinic 02/2023.
This spontaneous report was received from a registered nurse and refers to a 12-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N017686 with expiration date on 02-FEB-2020 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 27.4 degrees Fahrenheit for 4 hours and 30 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA007294: US-009507513-1712USA003239.
Fever; Chills; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 01Jul2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program Service Line. A contactable consumer (mother) reported that a 17-year-old female patient received meningococcal group b rlp2086 (Trumenba) second dose on 01Jul2017 at around 10 AM at single dose on left arm for Immunisation/Preventative. Medical history included allergic to Gelatin. Historical vaccine included meningococcal group b rlp2086 (Trumenba) first dose for immunization about a year prior to the time of report and a flu shot for immunization and experienced allergic to Gelatin. Concomitant medications were none. Consumer wants to know if gelatin is part of the ingredients list, as her daughter is allergic to gelatin. Her daughter did get fever and chills on 01Jul2020 after receiving the vaccine around 2 or 3PM. Mother reports that this was her daughter's second dose of Trumenba, she had one about a year ago and caller doesn't recall if her daughter had a reaction after that one. She states that her daughter reacted badly to a flu shot that had Gelatin in it in the past, and she just wishes it was more apparent whether the vaccines contained Gelatin or not. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vomit x 3 roughly 45 post vaccinations. Temp. 99.5 degrees.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information