chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of a headache, then patient was losing consciousness and gasp for air. EpiPen was utilized due to being unresponsive then began to seizing. Patient started to flatline and an AED was used while a paramedic came. Patient was put on her side then facility gave something for seizures. Lastly, ,ambulance took her to the hospital.
Right arm is swollen, bruised, and very painful to move. Hurt immediately but worsened after 2 hours.
Pt. received vaccine at 1520.  At 1530 pt. started with itching, burning pain and patchy erythema without urticaria.  No dyspnea, angioemdema or wheezing.  Pt. also experienced mild anxiety with O2 sat at 99, pulse 90 and BP 120/84.  At 1535 50 mg diphenhydramine given IM in R deltoid and ice pack applied to L shoulder.  At 1550 pulse 90, O2 sat 99%, BP 130/90, respirations unlabored and pt. reported mild dizziness, but not feeling like fainting.  At 1615 itching reduced, pt.'s primary care provider, contacted and situation was reported to triage nurse and on-call provider.  Provider advised pt. okay to go home if responding to the diphenhydramine.
Patient is showing signs of cellulitis in the upper right arm, swelling, redness and bruising.
Temp 99-101 deg F started 05/26/02-0/28/02. Started rash 06/03/02 after bath 50 + spots to trunk, back and buttocks complaining of itching.
After patient was given her 2nd Covid-19 Injection at 4:24 she was told to  sit for 15 minutes for observation. After the 15 minutes patient states that she is feeling dizzy and her head is spinning. I sat with her to relax her down and asked her to take deep breaths. After 30 minutes I called management to the scene, they asked if there was family member that we can reach out to since she didn't want us to call an Ambulance, she stated no. She sat for another 30 minutes  and was still dizzy but a little better and she said should would go with the Ambulance. The EMT checked  her blood pressure.
No side effects reported. No additional AE; HCP calling to report AE for VARIVAX. Patient received administration of improperly stored VARIVAX. See case 02413182. No patient demographic information provided. HCP gave permission to contact. No side effects reported. No additional AE/PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 19-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not provided; valid lot number W012163 with an expiry date of 12-APR-2024). The administered dose of the vaccine experienced a temperature excursion 45 degrees Fahrenhei (F)t for 84 hours. It was not reported if the information was recorded or not by a data logger. There was no adverse effect reported.
Elevated kidney levels; shoulder was sore for 4-5 days; Bruise, it was elongated; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise, it was elongated), RENAL DISORDER (Elevated kidney levels) and ARTHRALGIA (shoulder was sore for 4-5 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cirrhosis of liver.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CONTUSION (Bruise, it was elongated) and ARTHRALGIA (shoulder was sore for 4-5 days). On an unknown date, the patient experienced RENAL DISORDER (Elevated kidney levels). At the time of the report, CONTUSION (Bruise, it was elongated) had resolved and RENAL DISORDER (Elevated kidney levels) and ARTHRALGIA (shoulder was sore for 4-5 days) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MODERNATX, INC.-MOD-2021-092229 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow up received. TCR attached. Patient relevant medical history and event Arthralgia were updated.; Sender's Comments:  MODERNATX, INC.-MOD-2021-092229:Same reporter, different patient
Information has been received from a physician concerning a 6 month old male who was vaccinated with three doses of ROTATEQ. Two weeks after the third dose, the patient was hospitalized with intussusception. This occurred a few months ago. The patient had surgery, and was fine at the time of report. Intussusception was considered to be immediately life-threatening, and an other important medical event. Additional information has been requested.
Extreme bouts of dizziness and vertigo that last 5-15 seconds.  Every time I get out of bed in the morning or stand up suddenly or turn my head quickly.
Lump under arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump under arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (Lump under arm). At the time of the report, MASS (Lump under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
This spontaneous report was received from a physician via a company representative, and refers to a patient (encounter key# 73222) of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 mL, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 32 F (reported as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
EXTREME fatigue, nausea, vomiting, abdominal pain, diarrhea, diaphoresis, fever from 5/25 - 5/26; then developed severe itching, skin eruptions, scabs and scarring diagnosed as eczema. Oral and topical steroids (multiple courses) antihistimines, other topical ointments/sprays, occasional asthma (new onset requiring inhalers), blood work, skin biopsy, avoidance of dairy, soy, and peanuts. Was advised never to receive DTaP again. This vaccine was given as part of my pre-employment physical and is required for me to work in the neonatal intensive care unit.
I experienced chest and arm pain and pressure, irregular heart beats, and myocarditis.  I had the Pfizer dose.
Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 24Jan2021 (08:00) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the school/student health clinic. Medical history included asthma. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (14:00), the patient had "lump" nodes swelling; was feeling unwell; had nausea; headaches; dizziness; weakness; and injection site pain. The patient did not receive any treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Approximately 6 days of fatigue, poor sleep, head ache similar to sinus cold without congestion, fever of 99.8 F. Positive COVID-19 antigen test result on Day 4 of symptoms. Negative COVID-19 antigen test on day but persistent dry, intermittent cough with no sinus or throat congestion.
Patient given 1st dose COVID vaccine.  No history of allergies or  reactions to vaccinations.  Immediately following injection, patient c/o of dizziness, clamminess, skin color became pale and he appeared diaphoretic.  BP 153/93, P = 103 .  He stated not having breakfast or lunch.  Vitals repeated.  BP 154/88, P 94.  Rapid response team called at 1317.  Patient given water and Reese cup.  EKG completed.  BS = 88. Vitals retaken - BP 158/88; P 95.  Continued c/o dizziness and clamminess/  Moved to cart and monitored additional 30 minutes without further issues.  MD came at 1405 and evaluated patient; patient cleared to go home.
chills, fever, diarrhea, abdominal cramps, headache, body aches
Child received 3 vaccines on 9-28-10. Next day Mom reported that (L) upper arm had swelling and redness. Arm has about 8 cm x 8 cm indurated area which is red, swollen and warm to touch at site of VARIVAX SQ injection.
NUMBNESS DOWN THE ONE SIDE OF HIS BODY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced numbness down the one side of his body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness down the one side of his body was not reported. This report was non-serious. This case, from the same reporter is linked to 20211232675.
1 day after receiving 2nd vaccine developed left supraclavicular lymph node enlargement (was tender at the beginning, but not now). Today is day 5 with the swelling to left clavicular region.
She was very light headed; She slept for 24 hours; Her arm was hard around injection site; She was very tired; She was nauseated; Her arm was swollen around injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired) and NAUSEA (She was nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and LEVOTHYROXINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (BONINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. states that after receiving the 1st dose of J&J 08/13/2021, started experiencing symptoms 08/14/2021 of arm swelling, throbbing pain lasting 24hr, nausea, and dizziness. No noted Primary visit, symptoms lasting 3 days.
Dr. received an urgent request to call a local Justice of the peace regarding one of her patients who was found dead in her home today.   At this time no foul play is suspected.  Dr. said the patient was relatively healthy with no major issues other than some hypertension
patient came in to receive their 2nd Pfizer dose, and was given Moderna instead. I spoke to the patient and provided them with information from the CDC and directed them to notifytheir doctor immediately
Initial misuse report received from a healthcare professional on 23 July 2013. A 06-month-old patient was administered both ACTHIB and PENTACEL. No adverse event was reported. List of documents held by sender: none.
Severe diarrhea for three days following shot beginning 12 hr post injection. (No consumed food suspected of causing this.)  Gastrointestinal tract noisy and gassy...gastritis. I eat healthy I.e. gentle, bland goods since starting diarrhea Sunday morning (currently Tuesday). Today I read the ingredients and two of them DO CAUSE digestive issues. Nit many reports of this symptom but maybe not enough people talk about it.  This is CRAZY diarrhea.  Other than this, my symptoms have been typical and mild.
Immediate sore vaccine site and increasing swelling.  2 weeks later. Itchy red sore left eye followed by open lesions on the skin between eye and nose that got progressively worse which was diagnosed as shingles.  On going left axilla and breast swelling and tenderness lasted about 6 months.
very severe itching sensation; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very severe itching sensation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (very severe itching sensation). At the time of the report, PRURITUS (very severe itching sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Information has been received from a nurse concerning a female who was vaccinated with Gardasil (lot# not reported), injection. Subsequently the patient experienced numbness in her arm and legs. The patient sought unspecified medical attention. Additional information has been requested.
pt recv vax w/o any difficulty it was reported that a student fell & hit lt facial area on radiator;pt was conscious, diaphoretic, oriented x 3;BP 110/60;pt recv laceration on lt side facial forehead;sl redness, no swelling;c/o being hot;
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 31Mar2021 [reported as 1:00 or 1:30 pm] (Lot Number: EW0150; Expiration Date: Jul2021) as a single dose for covid-19 immunisation (didn't want to get COVID again or the variants; also due to age group). The patient reported that she had Covid illness back in Jan2021 and she tested positive for antibodies afterward (2021) after the COVID infection. The patient had no family medical history relevant to the adverse events. The patient's concomitant medications were not reported. The patient did not receive additional vaccines administered on same date of the Pfizer suspect or history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive other vaccine within 4 weeks prior to vaccination. She has started her vaccine series with the Pfizer-Biontech Covid19 vaccine and was due for her second dose 27Apr2021. She recently took a rapid Covid test that came back positive on 20Apr2021. She inquired if she can still go for her second dose as scheduled. She states that she had a scheduled nuclear stress test that she had to reschedule because of her testing positive. She stated that she called her PCP and he stated that with all the antibodies she has, she shouldn't have to quarantine, and she would be able to get the second vaccine, but also to check with Pfizer. Her doctor doesn't think she is contagious or anything since she has the antibodies, so she was just trying to get a second opinion. She also stated that her symptoms were just the same as the first time she had COVID which are fatigue and headache which started the afternoon of 20Apr2021. She confirms these symptoms are still persisting. She's been treating the headache with Tylenol. She mentioned that the events did not require emergency room visit or physician's office visit. She made the comment she believes she can take the vaccine from what she gathered. The outcome of the events was not recovered.
3 dark, quarter-sized, discolored spots at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 31st March 2022, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR178699   Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comments: The reporter was the patient's mother and also an unspecified healthcare provider.  The patient received her first Bexsero dose into left deltoid and immediately after, she developed three dark, quarter-sized, discolored spots at the injection site.  Nothing else was reported.  The reporter did not consent to follow up.  Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR178699.; Sender's Comments:  US-GSK-US2022AMR178699:Same reporter
(L) cervical lymphadenopathy "golf-ball" size. Seen in Hospital Emergency 1/4/13.
Pt stated "I just wanted to report that for 3 days following my Hep B i was having facial edema and hand swelling, along with itching. (no hives just arm and head itching.) It was relieved with Benedryl. I did not have a temp, no cough, no tiredness, no respiratory distress. After 3 days it went away. Just puffy face, lower eyelids and both my hands were swollen."
Miller Fisher Syndrome; This is a literature report for the following literature source(s): (privacy)  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic painless vertical diplopia" (unspecified if ongoing); "inflammatory pseudotumor" (unspecified if ongoing); "painless paresthesiae of hands" (unspecified if ongoing); "severe gait ataxia" (unspecified if ongoing); "COVID-19 infection", start date: Feb2021 (unspecified if ongoing); "painless paresthesiae of feet" (unspecified if ongoing); "2 falls" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 15Jan2021, reaction(s): "COVID-19 infection". The following information was reported: MILLER FISHER SYNDROME (life threatening), outcome "recovering", described as "Miller Fisher Syndrome". The patient underwent the following laboratory tests and procedures: antibody test: (unspecified date) equivocal, 31 iv, (arup); csf protein: (unspecified date) 218 mg; csf white blood cell count: (unspecified date) 6, notes: cells/hpf; investigation: (unspecified date) was notable for limited movement of the right, notes: lateral rectus, right medial rectus, right inferior oblique, and left superior rectus with mixed diplopia in all directions of gaze; lumbar puncture: (unspecified date) showed albuminocytological dissociation with a csf, notes: protein of 218 mg and a CSF nucleated cell count of 6 cells/hpf; magnetic resonance imaging head: (unspecified date) unremarkable; magnetic resonance imaging neck: (unspecified date) unremarkable; sars-cov-2 test: (Feb2021) positive; (unspecified date) negative; vital capacity: (unspecified date) 1.1 L; (Feb2021) 1.8 L, notes: increase. Therapeutic measures were taken as a result of miller fisher syndrome.; Sender's Comments: As there is limited information in the case provided, the causal association between the event miller fisher syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Since day 5 post-vaccine, I have been having short, stabbing pains in various areas of the body, but primarily legs. These pains last anywhere from just a second to maybe a full minute before going away and coming back - sometimes within a couple minutes, sometimes longer like 30 minutes.
Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Patient stated the only symptom patient is experiencing is arm soreness, no S/S of infections
Redness, swelling and heat at the site of injection about 4x5 inches.