chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of depression who on 23-JAN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included possible meningococcal vaccine, and hormonal contraceptives (unspecified). On 23-JAN-2007 immediately post vaccination the patient "blacked out and then threw up." The patient arrived home and she felt like she "passed out or fell right to sleep", when awoke she developed chills, low grade fever, sweating, nausea, no appetite, and felt like she "could not move." This happened two or three times all night between sleeping, and waking cycles with symptoms. However, at 4:00AM all symptoms stopped. Unspecified medical attention was sought. On 24-JAN-2007 patient recovered. Additional information has been requested.
bilateral intraventricular intracranial hemorrhage; death; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concomitant medication, current condition and historical condition was unknown. On or around 13-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden onset headache, altered mentation and intracranial bilateral intraventricular bleed and was diagnosed with bilateral intraventricular intracranial hemorrhage. As a direct and proximate result of these injuries, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 21-DEC-2018. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of bilateral intraventricular intracranial hemorrhage was considered as not recovered. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Bilateral intraventricular intracranial hemorrhage was considered as disabling. Upon internal review, bilateral intraventricular intracranial hemorrhage was considered as medically significant.
pt states he had a positive COVID test on 8/18/21 and was told by his dr (name not in medical record) to self-isolate; since then he has progressive fatigue and SOB; EMS brought him to ED on 8/23/21; positive for COVID; O2 saturations in the 80s; placed on O2 supplementation; AHRF, hypertensive urgency, AKI, hyperlipemia; hypertension treated also given decadron, vitamins, zinc; transferred to ICU; respiratory status worsened; given Tocilizumab; renal function worsened; pt made a DNR; poor prognosis; comfort care and placed into inpatient hospice where he passed away
The patient received her second booster dose of COVID vaccine  on Friday 4/15/22, at approximately 12:30 pm.  She received 0.25ml of the Moderna COVID-19 vaccine in her right Deltoid. This was the patient's 2nd booster dose. She received 3 doses of Pfizer vaccine previously (primary 2-dose series and 1 booster, with her booster given 11/11/21). She did not report any side effects to the Pfizer vaccine.  After vaccination, she stayed for observation for 15 minutes and left with no complaints. The patient reported on 4/19/22 that on Monday 4/18/22, she began to notice her torso (stomach/under breasts) was itchy. She said that the area became red. The patient applied triamcinolone 0.1% cream to the rash and reported relief from the itching. The cream was previously prescribed by her PCP, for the treatment of an itchy rash she developed after her first dose of Shingrix vaccine. Patient reports no difficulty breathing, swelling, or hives. She plans to follow up with her PCP for further treatment if needed and has reported the adverse event to her PCP.
Pain in left arm; Muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 09:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), theanine (L-THEANINE) and multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown start date. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 15:00 the patient experienced pain in left arm and muscle pain. 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. The clinical outcome of the events pain in left arm and muscle pain was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lt cheek rash, bump on chin. Lt forehead small area on rash. Fine rash, above rt eye, would not scratching.
Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot (Pfizer). Within days, fatigue and weakness set in with some sporadic joint and stomach pain. Symptoms persist today, six weeks later.
I was called by pts coworker stating she developed a high fever the day after the vaccine was administered and was hospitalized for possible encephalitis. 11/27  received update from coworker that doctors did not feel she had reaction to vaccine.  2/6/07 Received medical records from hospital which reveal patient experienced fever, sore throat & diarrhea s/p flu shot.  Admitted 11/16-11/22/06.  ID & GI consults done & w/u revealed c diff.  Improved on Flagyl & was d/c to home on Flagyl for 2 more weeks. FINAL DX: clostridium difficile diarrhea, hx of recent flu shot & hx IBS.
6-22-12 she developed redness at injection site, itching, & slight swelling. No fever. She had a 4cm by 3cm area of erythema in an oval shape on anterior (L) thigh question of induration.
Significant stomach cramping/spasms with nausea and vomiting.  Started about 12-14  hours after the vaccination and continued for 5+hours. Very painful stomach spasms every 5 seconds or so, felt similar to contractions I had when giving birth to my children, but in my stomach.   I was brought to the ER at Hospital and given  iv fluids and Zofran which helped, but not right away.  I just had the Moderna bivalent vaccine yesterday (11/3/2022) and the same symptoms happened again.   I took sublingual Zofran 3-- once prophylactically and again twice during the course, but nothing helped.
no adverse effects; Improperly stored doses administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 07-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally (strength and dose were not reported)  lot # R033252, expiry date 29-JUN-2019, for prophylaxis. The suspect vaccine was stored in a temperature below 36 Fahrenheit (F) degrees ( 34 F) for 24 hours. There was no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA003061: US-009507513-1907USA003060: US-009507513-1907USA003059: US-009507513-1907USA003062: US-009507513-1907USA003058:
Generalized tonic clonic seizures x4, all lasting < 2 minutes, starting < 24 hrs after IPV treatment began at 24 hrs after vaccine. No fever. Given dose of Dilantin, parents declined ongoing treatment. 10/18/02 Per review of medical records add vomiting x 2 reported prior to onset of seizures.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ NEUROPATHY 10/29/2022,  12/6/2022,  11/20/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Iron low; A spontaneous report was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events iron low.  The patient's medical history was not provided. Concomitant medications reported were periodic iron infussion for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, before the second dose of vaccine, the patient showed Iron low.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event iron low,  was unknown.
Stated that she felt coldness to her L Hand.  Lasted for over 20mins.
After BOOSTRIX & hep B ENGERIX vaccinations pt became pale, nauseated & pain at the site of shot, hands decreased.
General, fatigue,muscle /joint pain,chills lymph nodes swelling,redness still red  one week later
EUA - young moderna dose 1. Patient moved away during administration and only received a partial dose (majority of solution was not injected). Parent informed and clinical team. Patient was re-vaccinated per guidelines. no issues/reaction noted to scriber during time of this report.
Started developing severe chronic diarrhea.  This has been going on from the beginning of Oct 2019 (about a week after administration of vaccine) till present.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received FLULAVAL (batch number JL7X5, expiry date June 2015). Previously administered products included FLULAVAL (lot: XJ595, exp: June 2014 no reaction). Concomitant products included PNEUMOVAX. On 23rd January 2015 15:40, the patient received FLULAVAL (intramuscular) .5 ml. On 23rd January 2015, an unknown time after receiving FLULAVAL, the patient experienced injection site swelling, injection site inflammation, injection site pain and injection site warmth. On 24th January 2015, the patient experienced wheals and pruritus. On 27th January 2015, the patient experienced injection site wheal and injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, injection site erythema. On 25th January 2015, the outcome of the injection site swelling, injection site inflammation, injection site pain, wheals, pruritus and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site wheal was unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain, injection site wheal, wheals, pruritus, injection site erythema and injection site warmth to be related to FLULAVAL. Additional information: Patient received a FLULAVAL injection on 23-JAN-2015 at around 3:40 pm. That same evening when she got home she noticed that it was: really swollen at the injection site, hot to the touch at the injection site, inflamed at the injection site and soared at the injection site. By Saturday 24-JAN-2015 the injection site had welts around the injection site, welts to the back of her arm, welts close to her armpit, welts started itching. It lasted through Sunday 25-JAN-2015. Today 27-JAN-2015 the patient noticed a triangular pink shape area like the size of a quarter next to the injection site as well diamond size welts around the injection site. Patient received the FLULAVAL in the lower arm and patient stated that all side effects happened around that injection site, and not where the PNEUMOVAX was injected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L040054 exp 26-DEC-2017 exposed to 47°F to 77°F for 20 hours. No adverse event was reported. Data logger was not involved. Additional information has been requested. Sender's Comments: US-009507513-1707USA000447.
SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching; Pain localised; VACCINE CAUSED SORE ARM; Head pain; took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching), PAIN (Pain localised), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 01-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching), PAIN (Pain localised), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020). At the time of the report, PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching) had not resolved, PAIN (Pain localised), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020) outcome was unknown and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            No concomitant medication were reported. The patient experienced scalp had been itchy and noticed it started right before taking humira and vaccine caused sore arm.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up included events and narrative updated.
she did not have any bad reactions to the previous COVID-19 vaccines other than soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Tetanus toxoid (she had allergies before with the tetanus toxoid), reaction(s): "allergies"; Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "She did not have any bad reactions to the previous COVID-19 vaccines other than soreness". The following information was reported: PAIN (non-serious), outcome "unknown", described as "she did not have any bad reactions to the previous COVID-19 vaccines other than soreness". Additional information: Female patient wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and how often elderly female patients experienced side effects. Caller mentioned that her doctor recommended her to get it. Caller mentioned she had allergies before with the tetanus toxoid and could not take any diphtheria toxoid. Caller stated that she did not have any bad reactions to the previous COVID-19 vaccines other than soreness. Caller also wanted to confirm if the vaccine was still being studied and under emergency use. Caller wanted to know what the Pfizer COVID-19 Vaccine Bivalent contained and if it contained any tetanus toxoid or diphtheria toxoid. Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report. Product: Pfizer's 4th vaccine shot, the COVID-19 vaccine, the latest vaccine for the Omicron. She wanted to know what were the adverse effects? She was 82-years-old and is leery of taking this vaccine. She reacted before to Tetanus toxoid. There were other vaccines she cannot take because they contain the diphtheria toxoid. No other product names provided. Asked if the COVID-19 Vaccine had diphtheria toxoid in there and what were the expected side effects in the elderly and how often was that happening. Patient worked as a medical secretary. Asked Pfizer to please not sell her phone number. She had a hard time hearing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300087801 same patient/event, different vaccine dose;
Day 1-3   Left upper shoulder pain from injection. Day 4-8   Headache, tiredness, fatique, nausea, vomit (1),  knees joint pain. Day 4 to present - some tiredness, continued severe knee joint pain (left and right)
24 hours severe pain, fatigue, high fever. Low grade fever every night (99.8-100.1) for one month, followed by systemic inflammation and polyarthralgia, swelling, pain, hot to touch (ankles, toes, knees, elbows, wrists, fingers). Does not respond to NSAIDs. Resulting in severe pain and physical limitations, even now at over 2 months post vaccine. No day symptom free since second shot.
On Thursday felt like a steam locomotive hit me, extreme brain fog, headache, tired, more easily fatigued...  I still went to work.  I kept misplacing my box cutter (very uncharacteristic of me)  had the shot Wednesday... that night light nausea.. but Thursday night nausea was so bad I wanted to puke and almost did but it came on when I was doing bedtime with my kids so I fought back the urge  Nausea was a nightly occurrence in varying degrees for almost a week and was fairly prevalent fatigue that whole week
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash, injection site bruising and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and injection site bruising were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a dose of SHINGRIX was inadvertently administered subcutaneously, which led to incorrect route of vaccination. The patient subsequently developed a rash, followed by bruising at the site of injection. The healthcare professional declined to provide patient's date of birth.
This retrospective pregnancy case was reported in a literature article and described the occurrence of gastroschisis in a newborn of unspecified gender whose mother was vaccinated with DTPa (with small D & P), manufacturer unspecified), HPV vaccine (non-gsk). On an unspecified date, the 15-year-old mother of the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site), unspecified dose of HPV vaccine (Non-GSK) (unknown route and injection site). The mother's last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine approximately at 8 weeks of gestation. On an unspecified date, after unspecified weeks of gestation, the neonate was delivered by unspecified method. Birth defects were noted. The neonate experienced gastroschisis which was assessed as a congenital anomaly by GlaxoSmithKline. The subject was hospitalised. At the time of reporting the outcome of gastroschisis was unspecified.
consumer was accidentally administered 2nd dose at 14 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demographics added. First dose date updated. Second dose details added.
No additional AE information; vaccine was going through temperature excursions since 1NOV2020 through the end of Feb 2021 and it was administered to patients during that time; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S027465, expiration date: 02-MAR-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown dates between 01-NOV-2020 and the end of February 2021, the dose of the vaccine was exposed to unspecified multiple temperature excursions. The call was due to digital data logger. No additional adverse event was reported.