chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLIENT CAME IN TO GET 3RD HEPATITIS B SHOT AND STATED THAT WHEN HE GOT HIS 2ND MMR SHOT, HE HAD TO GO TO EMERGENCY ROOM AND GET TREATED FOR "RASH" ALL OVER HIS BODY. HE STATED HE BELEIVES IT IS FROM THE MMR VACCINE, HE STATED THAT AFTER HE GOT HIS SECOND ONE, HE FOUND HIS CHILDHOOD SHOT RECORD WHERE HE HAD MEALSES ON 3/14/75 AND RUBELLA ON 5/16/75. HE ALSO STARTED THAT HE RECEIVED 2 MMR SHOTS FROM THE MILITARY BUT HE DOESN'T HAVE WRITTEN PROOF FOR THOSE.
Tachycardia, hallucination, headache, fever, and hypertension.
Fatigue, nausea, fever, diarrhea, body aches, headache, loss of appetite.
01/09/2017 - Redness approx. 4 3/4" wide and warm to touch.
1st dose in 2018, never came back for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix back on 2nd July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient never came back to get the second dose of Shingrix. The reporter unable to provide vaccine lot and expiration details. The reporter called to inquire would the patient need to restart Shingrix series. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Initial report was received 27 October 2010 from a health care professional. A 36-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, lot number U3784AA on 26 October 2010 and one hour later, she began having respiratory symptoms (not specified). The patient took ZYRTEC but symptom progressed to SOB (shortness of breath), pruritus, and throat was closing up. She went to the emergency room and recovered an unspecified amount of time later. The patient had no concurrent illness, no pre-existing medical conditions and she had not been taking any concomitant medications. Outcome was recovered. Documents held by sender: None.
severe redness and swelling in her arm; severe redness and swelling in her arm; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. An 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at a pharmacy, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient experienced severe redness and swelling in her arm on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.
15DEC92 nauseated, sl dizziness, arm & shoulder ached; 16DEC same sx plus diarrhea; 17DEC vomiting x 1, t100, blisters on hands; 18DEC stomach cramps & blister on hand 19DEC; hands started itching; BP elevated; 20DEC t101, hands swollen;
Considerable amount of bubbles in the serum; Considerable amount of bubbles in the serum; Considerable amount of bubbles in the serum; This spontaneous report was received from a health care worker referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2020 (reported as yesterday), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, batch/lot# and expiry date were not provided) for prophylaxis. On the same day, it was reported that there were considerable amount of bubbles in the serum and while tried to extract the plunger came right out of the syringe. It was not specified if this dose was administered (circumstance or information capable of leading to medication error, poor quality product administered and product quality issue). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever 104.7 degrees farenheit, headache, dizziness, extreme fatigue, increased thirst, chills
10Sept2016; 12:35 PM; Complained of itching on her body and on her head. Noticeable bump/raised skin on member left wrist. Denies any issues/complications with her breathing/ respiratory, or any swelling of tongue/ lips. Member instructed to immediately go to the local Urgent Care. She has also been instructed to submit documentation from the Urgent Care to the medical office as soon as possible.
This spontaneous case, initially received on 20-Sep-2016, was reported by a non health professional and concerns an 81-year-old patient (gender not reported). Weight: not provided: Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 10-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 11-Sep-2016, the symptoms began. The patient's arm hurt and he experienced pain at injection site (outcome: recovered / resolved). On 12-Sep-2016, the symptoms became acute and the patient experienced redness, swelling / swelling between shoulder and elbow and then it reached to below the elbow. The symptoms lasted for a total of 7 to 8 days. The patient took diphenhydramine. The outcome was reported as recovered / resolved.
Face began to burn and became itchy with red blotches. Scalp , ears and neck became itchy and developed a rash. Burning, redness, and itching on face and neck has gotten worse (received shot Saturday and it is now Tuesday).
After receiving vaccination, patient was sitting in post-vaccination waiting area.  After approximately 2-3 minutes, patient fainted and fell forward and lacerated forehead and nose on the floor. Patient was taken out of the facility via ambulance.
Booster; Oxygen levels were too low. Patient had to be hospitalized; This is a spontaneous report received from a contactable reporter (other health care professional (HCP)).  A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient had not known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, lot number unknown), for COVID-19 Immunization; Bnt162b2 (Dose 1, lot number unknown), for COVID-19 Immunization. The patient had not received any other vaccines within four weeks. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "Booster"; OXYGEN SATURATION DECREASED (hospitalization) with onset 23Dec2021, outcome "unknown", described as "Oxygen levels were too low. Patient had to be hospitalized". The patient was hospitalized for oxygen saturation decreased (hospitalization duration: 5 days). The event "oxygen levels were too low. patient had to be hospitalized" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (23Dec2021) too low. It was unknown if therapeutic measures were taken as a result of oxygen saturation decreased and if patient was tested for COVID-19 post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.
Wife did not know she was pregnant at the time, had the vaccine and miscarried the child at 12 weeks. OBGYN stated baby had miscarried 2-3 weeks earlier. D&C procedure performed 2/23 to remove remains of fetus.
Pt received Pfizer x2.  Pt tested COVID + on 8/22/21 and admitted to hospital for COVID on 8/22/2021. Pt received remdesivir and dexamethasone.
Patient reported breathing difficulty, swelling, feeling sick. She visited urgent care morning of 8/2/18.
Since 4/25 I have had a persistent 'buzzing' sound in my ears. It has been constant, but the buzz is 'louder/softer' at times. Last week (5/5) I thought it had stopped, but has since returned. I am making an appointment to see a doctor regarding this issue.
palpitation for short period of time; Dizziness; little bit of anxious; This is spontaneous report from a contactable consumer (Mother). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Upper Arm Left on an unspecified date (Batch/Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that, her son he got the vaccine and an hours ago like around say 6 O' Clock and he had palpitation for short period of time and the dizziness. The reporter stated that, like an hour after the vaccination he started experiencing the Problem and It last about 40 seconds the palpitation. The patient experienced palpitation for short period of time, dizziness and little bit of anxious on an unspecified date. Reporter stated that, the patient did not receive any treatment for the events and he just sat down he was drinking a lot of fluids. The patient was not still experiencing the events, but he was little bit of anxious. She did not know if it was from the shot or not. Outcome of the event little bit of anxious was not recovered and other events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
systolic blood pressure which has risen to 130s from usual (113); felt like heart was going to burst out of chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (felt like heart was going to burst out of chest) and BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, CALCIUM, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]), CARVEDILOL, MONTELUKAST, AMLODIPINE, IRBESARTAN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), UBIDECARENONE (CO Q 10 [UBIDECARENONE]), LYSINE (L LYSINE [LYSINE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PALPITATIONS (felt like heart was going to burst out of chest). On an unknown date, the patient experienced BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)). At the time of the report, PALPITATIONS (felt like heart was going to burst out of chest) and BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure which has risen to 130s from usual (113)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 130 (High) 130. On an unknown date, Heart rate: 88 (normal) 88.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 23rd February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain. On an unknown date, the outcome of the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain were unknown. It was unknown if the reporter considered the injection site pain, injection site itching, arm discomfort, limbs stiffness, pain in arm and lymph node pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the vaccination with SHINGRIX felt no different than FLUARIX did. On 23rd February 2018, 1 hoursafter vaccination, the patient experienced a bit of local itching at the injection site and it went after 3 hours. The patient had no more local discomfort than after flu vaccination. The patient was feeling a little fullness in the patient's arm and a bit stiff, but he reported that it was no big deal and he was ready for dinner at his favorite restaurant. In February 2018, less than a week after vaccination the patient woke up from a rather vivid dream in which he had developed an egg-sized tender mass at the injection site which he had named Caedlyff, in fact there was no mass, though his upper arm was definitely moderately tender. The patient reported that, he needed to check package insert about weird dreams. The patient's local inflammatory response check showed cell trafficking and was checked. In February 2018, less than a week after vaccination, the patient was beginning to feel slight ache in axillary nodes as antigen presenting cells begin to migrate in and do their magic. All consistent with AS01 mechanism of action. This case has been linked with case US2018GSK032395, reported by the same reporter.
pt recvd vax & the next day (5AUG93) exp fever, inject site pain & flu-like sx; pt was seen by MD; pt sx have subsided;
Narrative:  88 yo M with a hx of HLD, CAD, BPH, GERD, carcinoma of colon, and hypothyroidism received two doses of moderna vaccine on 01/20/2021 & 02/18/2021. Pt died on 8/06/2021. Death is not likely related to vaccinations due to age and time from vaccine administration.
Information has been received from a physician concerning a 2 month old male who was vaccinated with a dose of Rotavirus vaccine (lot 654970/0777F). Concomitant vaccines on the same day included his other 2 month vaccines. On 11/10/06 the pt experienced diarrhea with a little blood in the stool. It was noted that bloodwork wad done. No other information was provided. Upon internal review, blood in stool was considered to be other important medical event (OMIC). Additional information has been requested.
Covid-19; arm was sore; Case reference number MOD-2021-012197 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021  , which refers to a Male aged 43 Years .  The patients has not reported about his past medical history .  On  04-JAN-2021, the patient was participating in the mRNA-1273 Emergency Use program at the hospital and developed  sore arm on the same day. After a couple of days. on 06-JAN-2021  the patient was exposed tp covid 19. And then on 11-Jan-2021 he received monoclonal antibodies to treat that.   No details of concomitant medicines were provided.
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated, in a series, with the doses of GARDASIL 9, 0.5 ml, via intramuscular route (also reported as "inter-muscular"). The patient received first dose on 23-OCT-2013 (lot# and expiry date not reported), second dose on 01-JUN-2016 (lot# and expiry date not reported) and third dose on 01-AUG-2016 (lot # M011117 with expiry date: 07-DEC-2017). No adverse effects and no product quality complainant (PQC) involved. No further information provided. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a 36 year old pregnant female patient and refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck), subcutaneous (dose, lot # and expiration date were not provided). It was unknown how many doses of VARIVAX (Merck) the patient had received and if she was pregnant before or after receiving VARIVAX (Merck). The last menstrual period (LMP), date of conception and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Additional information is not expected as the reporter did not provide any contact details.
This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient thinks his body did a reaction to spike protein) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna third booster dose was administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A, 048A21A, 053E21A and 00SM21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Medication with codeine). Concomitant products included ATORVASTATIN, METOPROLOL and TAMSULOSIN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna third booster dose was administered). On an unknown date, the patient experienced IMMUNISATION REACTION (Patient thinks his body did a reaction to spike protein). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Patient thinks his body did a reaction to spike protein) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna third booster dose was administered) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies negative: (Negative) Negative. On an unknown date, Arthritis: (Negative) Negative. On an unknown date, Blood test: (Negative) Negative. On an unknown date, Colonoscopy: (Negative) Negative. On an unknown date, Computerised tomogram: (Negative) Negative. On an unknown date, Dengue fever: (Negative) Negative. On an unknown date, Echocardiogram: (Negative) Negative. On an unknown date, Heart rate: 102 bpm. On an unknown date, Hepatitis viral test: (Negative) Negative. On an unknown date, Lyme disease: (Negative) Negative. On an unknown date, Magnetic resonance imaging: (Negative) Negative. On an unknown date, Pulmonary function test: (Negative) Negative. On an unknown date, X-ray: (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient feels his hearth beating all the time and stated that before receiving the vaccine he was a healthy man. Patient believed that these symptoms were caused by the vaccine since he had heard of thousands of people that are experiencing similar symptoms. Reportedly, patient never tested positive for COVID-19. Patient did not took any treatment except for vitamin C.
Received Janssen COVID-19 vaccines on 12/17/2021 at 09:45; admitted to hospital; started to feel palpitations, tachycardia, dizziness increased blood pressure, became nauseated and headache.
Chest pain/same problem; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporting consumer had been rushed to the hospital last night (30Apr2021 at around 11:00PM) because she thought she was having a heart attack; she had really bad chest pain. She reported another guy (patient) at the hospital had the same problem as her. The guy said he was healthy and had just gotten the COVID-19 Vaccine. The patient experienced chest pain on an unspecified date in Apr2021. The clinical outcome was not reported.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490608 same reporter/ drug, different patient, similar & different events
Clinically stable and asymptomatic. Found to have a faint petechial rash around his forehead and BL cheeks without mucosal involvement. Mother stated that rash developed about 30 minutes after vaccinations administered.
I tested positive for COVID-19 September 12, 2022. I had a fever, cough, and a runny nose. I contacted my doctor and he did not prescribe me PAXLOVID because it does not go well with my current prescribed medication.
My mind is foggy, my body feels numb, I am extremely exhausted, I cant concentrate, forgetting more than usual, headache, body aches, week no energy.
massive/really bad headache; His arm still hurts and its swollen; His arm still hurts and its swollen; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EN6207), via an unspecified route of administration, on 12Mar2021 at 17:00, as a single dose, for COVID-19 immunization. Medical history included diabetes mellitus, heart disease and a weight problem (reported as being fat). The patient's concomitant medications were not reported. The patient reported that after he received the BNT162b2 vaccine, he woke up with a massive/really bad headache in the middle of the night. He took one dose of NyQuil as treatment. The throbbing headache kept him from getting back to sleep. The patient also reported that his arm still hurts and its swollen. The clinical outcome of the events massive/really bad headache and arm still hurts and its swollen was unknown.   Follow-up attempts are completed. No further information is expected.
pt recvd vax 22DEC93 & devel facial swelling, a florid, macular rash & poss rubella synd & went to ER; No further details were provided;
I felt really tired and achy. My joints all hurt and my muscles were tight. I took a sick day to try and get some rest and relax. I let my doctor know. I am also stressed so this may be a result of the anxiety, stress and the shot
Fever X 5 days (day 12-17) post vax. Had a rash and left testicular swelling. To be followed.