chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had very bad reaction to covid shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had very bad reaction to covid shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product METHYLPREDNISOLONE ACETATE (DEPO MEDROL) for an unknown indication.    Concurrent medical conditions included Drug allergy (Allergy to chemical in glycol propylate).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and METHYLPREDNISOLONE ACETATE (DEPO MEDROL) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (She had very bad reaction to covid shot). At the time of the report, IMMUNISATION REACTION (She had very bad reaction to covid shot) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient had a bad reaction to COVID shot. They found out about an allergy to glycol propylate cause of the reaction that occurred. Now has health issues that include a possible surgery. Its a sinus thing to have polyps removed so she was given steroids to shrink that and that's when they found out has a reaction to the chemical. Has had a reaction to the shot and has reported to Moderna.  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
Urinary bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Urinary bladder infection) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CYSTITIS (Urinary bladder infection). At the time of the report, CYSTITIS (Urinary bladder infection) had not resolved.            Chronic conditions or any medication stated as none. Treatment details stated Twice a day, 11 hours apart with name unspecified. No concomitant medications were mentioned.   This case was linked to MOD-2021-411779 (Patient Link).
strong dizziness/felt like was falling; Pressure rose to 165; weakening; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (strong dizziness/felt like was falling), BLOOD PRESSURE INCREASED (Pressure rose to 165) and ASTHENIA (weakening) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN, VITAMINS NOS, MACROGOL 3350 (CLEARLAX [MACROGOL 3350]), FINASTERIDE and TAMSULOSIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (strong dizziness/felt like was falling), BLOOD PRESSURE INCREASED (Pressure rose to 165) and ASTHENIA (weakening). On 31-Mar-2021, DIZZINESS (strong dizziness/felt like was falling) and BLOOD PRESSURE INCREASED (Pressure rose to 165) had resolved. At the time of the report, ASTHENIA (weakening) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was received. The doctor listened to his heart and lungs, and he measured oxygen saturation and pressure.   This case was linked to US-MODERNATX, INC.-MOD-2021-079968 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079968:Wife's Case
Swelling / "in the armpit; Tenderness "in the armpit; This case was reported by a pharmacist and described the occurrence of local swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On 7th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced local swelling and axillary pain. On an unknown date, the outcome of the local swelling and axillary pain were not recovered/not resolved.   It was unknown if the reporter considered the local swelling and axillary pain to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix in left arm. The patient experienced swelling and tenderness in the armpit. Till the time of reporting the symptoms were not resolved. Lot and expiration dates were unknown. The reporter consent to follow up.
12 month patient received Kinrix; Patient received kinrix instead of Infanrix; Received a fourth date of hep B (Engerix B Pediatric); This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix, Kinrix Pre-Filled Syringe Device and the 4th dose of Engerix B pediatric. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter stated that the patient needed a dose of DTaP and they accidentaly gave Kinrix to the patient instead of Infanrix, which was how they received an extra dose of IPV.  This was the only dose of Kinrix the patient had ever received. The reporter reported that the patient also received fourth dose of Engerix b pediatric. The reporter reported that the patient was already reported this to the system. The reporter did not consent to follow up. Additional supportive information:The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Infanrix and inadvertently administered Kinrix instead of Infanrix , which led to wrong vaccine administered. The patient received extra dose of Engerix B pediatric in error, which led to extra dose administered.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 29 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, swelling lump over both thigh. Redness at right thigh was seen on 3/13/07. Temp 104F. Tylenol 0.6cc at 9:28am.
TACHYCARDIA, TACHYPNEA, PALPITATIONS, THROBBING PAIN IN BILATERAL FEMORAL ARTERIES AND CAROTID ARTERIES, DIAPHORESIS, NUMBNESS AND TINGLING IN THE LIPS, HANDS AND FEET, DIZZINESS. ACUTE PHASE LASTED 12 HOURS, CHRONIC PHASE LASTED 5 DAYS.
Transient Ischemic Attack with no identifiable cause. Symptoms included: one-sided numbness and weakness, dysphasia, confusion, weakness
This is a serious spontaneous case, initially received from other health professional on 18-Feb-2019, concerning a male neonate patient. The patient's 37 year old mother had 5 previous pregnancy reported with all full-term live birth. In one of the pregnancies, major congenital malformation was noted. The infant had anencephaly. The mother's current condition included headache and allergy. The patient got expose to tobacco as his mother use to consume 20 cigarettes/tobacco products per day during pregnancy (explicitly coded as fetal tobacco exposure). The concomitant medications included hydroxyzine for allergies and Metrogel for vaginitis. The mother's last menstrual period (LMP) date was 25-May-2018. On 19-Nov-2018, mother's Q Natal test was performed, and no major congenital malformation was noted. On 19-Nov-2018, at gestational age of 25-weeks, the fetus was exposed to FLUCELVAX QIVc (cell-culture-derived, route of administration: transplacental, batch number: 252664, dose, anatomical location and expiry date: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On 26-Nov-2018, mother's ultrasound, cystic fibrosis mutation analysis, spinal muscular atrophy and haemoglobin electrophoresis were performed and no major congenital malformation was noted. On 24-Jan-2019, mother's ultrasound was performed and no major congenital malformation was noted. On 31-Jan-2019, mother's ultrasound was performed and no major congenital malformation was noted. After vaccination the mother delivered a premature female neonate at 35.9 weeks gestation (pre-term birth), vaginally. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 2715 grams, head circumference was 31.8 cm and body length was 51.4 cm. The APGAR scores were 8 (one minute), 9 (five minutes) and there was no data for 10 minutes. There was no major congenital malformation was noted. The outcome of the events was unknown. The mother's estimated delivery date (EDD) was reported as 10-Mar-2019. This case is linked to 201901995 (mother case).; Reporter's Comments: A female neonate was delivered vaginally at 35.9 weeks gestation (coded to premature baby) to 37-year-old mother, 2 months 21 days after administration of FLUCELVAX QIV at 25-weeks of gestation (coded to foetal exposure during pregnancy). Despite the plausible temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and therefore the event of premature baby was assessed as not related to the vaccination. The maternal age, gestational history (5 previous pregnancy full-term live birth and one anencephaly), fetal tobacco exposure and co-administered drugs (hydroxyzine for allergies and metrogel) confound this case. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Tested positive for Covid-19 through both At-Home and PCR test.  I had slight muscular pain, sinus congestion / very runny nose, fatigue, and complete loss of taste and smell that is still in the process of recovering.
This spontaneous case was initially received on 28-Oct-2015. The case report was received from a health professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received unspecified Influenza Vaccine. Additional suspect drug(s): PNEUMOVAX and ZOSTAVAX. On an unknown date, the patient received PNEUMOVAX and unspecified flu vaccine at the same time, in the same arm about an inch way (non serious, outcome: Unknown). For relevant test results see appropriate report section.
Covid Vaccine x 3. Tested positive for Covid on 7/7/22. Admitted to Medical Center  on 7/21/2022 and expired on 8/24/22.
Made list of shots needed from pt, opened freezer grabbed ZOSTAVAX put back turned around & looked at list again did my KINRIX & PREVNAR. Went back to freezer opened & grabbed bottle to right drew up & had employee double check. Thought it was PROQUAD not ZOSTAVAX. Employee had asked me to look at the kids immun rec. to see what they needed. I made her the list of what they needed. Employee drew them up, asked me to check them I read all of them & checked dosages. For some reason it didn't click that it was ZOSTAVAX for kids and I okay'd her. I will forever now verbally read aloud every vaccination when checking someone.
Tightness and pain (dull and sharp) in chest. Racing heart. 3 weeks so far and still going. Headache for 10 days straight.
Chills, muscle aches, cough each beginning at about 1830 the same day as the injection.  Cough and chills were resolved by 7am the next day, muscle aches lasted until the next evening but less severe.
Injection site is very red and inflamed. Patient did not notice this until today. No pain or itching, just redness.
nausea; Headache; Chills; Sweats; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Dec2020 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; DULOXETINE; KYLEENA; IUD NOS. The following information was reported: NAUSEA (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (14Dec2020 22:00), described as "nausea"; HEADACHE (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (14Dec2020 22:00), described as "Headache"; CHILLS (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (17Dec2020), described as "Chills"; HYPERHIDROSIS (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (17Dec2020), described as "Sweats". Therapeutic measures were taken as a result of nausea, headache, chills, hyperhidrosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: 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. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The pa-tient took tylenol and calcium carbonate to alleviate symptoms.
Case number PHHY2012US051529 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse event (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with trivalent inactivated influenza vaccine (seasonal influenza vaccine, manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051523). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born with upper limb reduction defect. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
Symtoms are fever/chills, weakness, headache, muscle and joint pain, nauseous, loss of appetite, light headed/dizzy, lasting four days. I am still not 100 per cent recovered.
skin lesion on left forearm; swollen; red; painful; low grade fever; body aches; fatigue; very sensitive to light touch; This is a spontaneous report from a contactable consumer. This consumer reported for a 66-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: En6200) via an unspecified route of administration on 22Feb2021 at 07:00 AM on left arm as dose 1, single for COVID-19 immunization. The patient had no medical history and no allergies. It was mentioned that patient received no other vaccine in four weeks, did not covid prior to vaccination and was tested for covid post vaccination. The patient's concomitant medications were not reported. On 02Mar2021 at 07:00 AM the patient experienced skin lesion on left forearm, swollen, red, very sensitive to light touch, painful, low-grade fever, body aches and fatigue. No treatment was received for events. The patient was recovering.  No follow-up attempts were possible. No further information was expected.
48 hrs post vaccination large area of erythema and excessive warmth in upper R leg. Punctuate lesion in center of this area presumed to be injection site. Tx: Augmentin 600mg BID X 10 Days.
warm rush; numbness in/around mouth; Burning around lips; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "warm rush"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numbness in/around mouth"; ORAL DISCOMFORT (non-serious), outcome "unknown", described as "Burning around lips"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue". Additional information: The patient stated that, she had a reaction to shot 1; warm rush and numbness in/around mouth just after she left facility. Burning around lips for 24-hrs and extreme fatigue for 2 days. Not sure if she should get second dose of Pfizer or change to another shot maker. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer Covid vaccine stored in regular freezer for longer than 2 weeks and patient received.
the vaccine was very hard to draw/no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved adult patient for whom the vaccine was very hard to draw/no ae (Product quality issue) was reported, while patient received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number- UJ355AA and expiration date- 24-Jul-2021) via unknown route at unknown administration site.  On an unknown date, the vaccine was very hard to draw/no ae (Product quality issue) was reported for the patient.  At the time of reporting no adverse event was reported.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was not applicable at the time of reporting.
Large red, warm 14 cm irregular rash with splotchy red macular eruption beyond primary site. Also small splotchy red macular spots on thighs.
pt mom reported pt had rash on face w/in 30min of vax on 6JAN97;describes the rash as having been a fine rash over face, not coarse or thick & mainly concentrating on chin & mouth area;
Information has been received from a physician concerning a 49 year old female who on 05-APR-2005 was vaccinated with a dose of Pneumovax 23 (lot# 650330/0748P). Subsequently, the pt experienced "hives and swelling in the area where the shot was given, all around the arm." She also developed headache and chills, 24 hours after the vaccination. The pt was treated with Tylenol and supportive measures. The pt was considered to be recovering. It was also reported that another pt had an adverse experience (WAES0504USA00903). Additional information has been requested.
1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
I seem to have what others have described as "Covid Vaccine Arm" which seems to more typically be caused from the Moderna shot and develops 8 or so days post injection.  It is a 4"x6" patch of skin at injection site that developed 48 hours post injection.  It is hot to the touch and has 100.3 temperature while my forehead shows 99.2 degrees.  It is swollen, raised and red.  It is slightly sore where it has not been in the 48 hours post injection.
1. Elevated BP 238/126 2. Dizziness  Onset of symptoms within 20-30 minutes of vaccine administration.
Months after receiving my vaccine in December, I got bronchitis with an asthmatic reaction. My doctor prescribed me Doxycycline and Prednisone, and Albuterol nebulizer treatment to aid for breathing. It took me about 2-3 weeks before I was back to my normal self. However, again around the middle of February, I got sick again. I had a lot of mucus buildup and was difficult to keep anything down. I went to an urgent care center; both COVID-19 and influenza tests done on me came back negative, so they're best suggestion was I was having a sinus infection since my mucus congestion had changed colors. I was again prescribed Doxycycline and Prednisone for treatment. I've been making a steady improvement since then with little to no residual symptoms.
pt had a positive COVID test on 1/16/22 and was in a Hospital locally; was dc'd 24-48 hours ago from a HCF; arrives to ED via EMS for respiratory difficulty; while assessing pt on the EMS stretcher he stopped spontaneous respirations; DNR form at bedside; pt passed away in the ED at the local Hospital.
Full body rash that was controlled with Benadryl and prednisone at an outpatient clinic 45 minutes after vaccination.  Adverse rash and allergic reaction still present 48 hours later.
Patient developed >20 erythematous macules (approx. 2mm with central papule) discreet lesions over face, trunk and extremities 9 days after 12-month immunizations. Parent reports patient developed low-grade fevers up to 101 for 3 days prior to outbreak of lesions. No other symptoms reported or observed.