chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By evening my arm around injection site was very sore, on the second day my entire upper arm up into my neck was so sore I didn't want to move the arm. The next morning I was stricken with sudden onset vomiting.
HPV; This spontaneous report was received from a consumer via company representative referring to a female patient around 28 year old. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, the patient had human papillomavirus (HPV) strain Wart strain which was not covered by the vaccine.   The outcome of HPV was unknown. The causality assessment between the event and suspect vaccines was not provided by the reporter.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2011USA010820: US-009507513-2101USA003844:
Very bad headache for 3 weeks now with no relief. Extreme fatigue - so severe I pass out with no warning once, sometimes twice a day. Eyes feel as if they are going to pop out of my head, feel as if they are bulging out of my head and it never stops. Documented high blood pressure from both home monitoring and physician monitoring. Very difficult to think straight and lose track of actions and thoughts, lack of concentration and ability to focus. Shortness of breath when moving (walking, carrying, etc).
This spontaneous report as received from a 73 years old female patient without drug reactions or allergies. The pertinent history of the patient was "blood pressure and thyroid hormone". The patient was vaccinated by her physician with PNEUMOVAX 23 (lot number 643784/0676M: expire date 22-MAY-2004) (dosage, injection site and route were not reported) on 04-NOV-2005 "but it was expired and the expired date was 22-MAY-2004". No other co-suspects were reported. Concomitant medications were given but the patient declined the specified the names. On 09-JUN-2012 the patient was diagnosed with pneumonia. "The physician listed was the one who provided the vaccine but she no longer sees him". No laboratory diagnostics studies were performed. Treatment LEVAQUIN was given. The adverse event was improved on therapy. On 09-JUL-2012 the patient was recovered. The patient has sought unspecified medical attention. Additional information has been requested.
Vaccine given at 2PM. Symptoms started around 8PM, seen in ER after midnight. Symptoms include: dizziness, nausea, chills, stuffy nose, 100 degrees T, headache, increased HR (119). ER-gave 2 bags of fluids and 2 shots, and said to stay home a day from work.
Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient developed a rash all over the body. unspecified medical attention was sought. The patient was told to take BENADRYL. Subsequently, the patient recovered. No additional information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
RASH BACK OF SHOULDERS, EXTREME FATIGUE, NAUSEA /  VOMITING AT HOME X 3 DAYS.  ADMITTED TO HOSPITAL 10/6/21 WHEN DEVELOPED SEVERE WEAKNESS, UNABLE TO GET UP, SHORTNESS OF BREATH, DIAPHORESIS,  TEMP 99.7. ARRIVAL IN HOSPITAL - HAD TEMP > 101.  ADMITTED TO HOSPITAL.  WORKUP DONE AS BELOW. POSSIBLE ENCEPHALITIS WITH ENCEPHALOPATHY -  IN ADDITION TO ABOVE SYMPTOMS - SOME CONFUSION, VERY LETHARGIC, VERY DROWSY
Dystonia in face and neck increased significantly. In large muscle in neck became very painful. Scan and MRI with/without contract @ hospital did not reveal any issue. Botox injections that had previously controlled spasms with medications ceased to be effective to control spasm. Additional dose of larger Botox still didn't do the job
Developed flu like illness after vaccine with fevers, myalgias, ultimately admitted to hospital 11/16/2021 to 11/18/2021 with diagnosis of pericarditis and also new onset Afib
Experienced pain on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experienced pain on the injection arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experienced pain on the injection arm). On 22-Jan-2021, VACCINATION SITE PAIN (Experienced pain on the injection arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not want to be contacted. He said his side effect got better. No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient did not want to be contacted.
Sweating, palor, fainting, clammy skin.  Patient laid down for 15 minutes and recovered afterwards
Narrative:  COVID infection after completion of COVID vaccine series: 01/22/2021 COVID vaccine dose #1 02/12/2021 COVID vaccine dose #2 07/10/2021 Pt presented to ED c/o nausea and vomiting, abdominal pain, SOB, and productive cough. Pt stated neighbor having similar sx. Administered IV dexamethasone and Zofran. 07/10/2021 COVID positive per nasopharyngeal swab. PaO2 was 66. Pt admitted to Medicine inpatient service. Remdesivir therapy approved and initiated since pt was a candidate. 07/11/2021 MD attending reported pt fairing well. Remdesivir and dexamethasone therapy continued. Pt received 2L NC O2. 07/12/2021 MD attending reported pt improved symptomatically but remains on supplemental O2. Pt reported having wrist pain similar to RA flares in the past. (Biologic therapy had to be d/c due to remdesivir.) 07/13/2021 MD attending reported pt improved symptomatically and wrist pain resolved. Continuation of remdesivir and dexamethasone therapy.
Patient received 4 doses of vaccine (2 moderna, 2 pfizer). She used two different first names and different addresses. Also signed different. Denied getting any other COVID vaccines previously.
5 minutes after injection developed headache and pulmonary congestion.  Self-limiting. Took tylenols.  At night developed severe chills, temp of 100.7F, redness, swelling and itch at injection site.  For one week post injection developed hive at bilateral joints. Started on Lt and Rt elbows on day 4 after injection.  Painful, redden and itchy.  On day 5 hive on knees.  Day 6 at upper thighs. (severe) associated with pain, itch.  Appeared at 30-40 mosquito bites.  No treatment required .  Lasted approximately 15-20 minutes.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 30-AUG-2013, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck)(Lot number J0050177, expiry date was 11-MAR-2014, route was subcutaneous) instead of ZOSTAVAX. No adverse effect was reported. Additional information is not expected.
1-9days had headaches, 10th day heart palpitations , 11th and 12th day chest tightness and pains, 13th air felt thick, alittle hard to breath. Wore a heart monitor and blood drawn
Follow up information provided clarification of the event reported, additional suspect vaccines, test results, patient medical history, and a change in the relatedness assessment by the investigator. Information regarding Prevnar was received from an investigator concerning a 4 month old white male participant in a study who experienced neutropenia. At 4 months of age, the participant received the second dose on 7/11/00. The participant also received the second dose of Hib-Titer Vaccine, the second dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and the second dose of Poliomyelitis vaccine Inactivated on 7/11/00. The patient's concurrent illness includes hyper IgE syndrome with a history of recurrent staphylococcal skin infections and neutropenia originally documented on 1/5/00. The indication for Prevnar was immunization. The product was administered on 7/11/00. The dose regimen was 1 dose 1 time per day. Additional suspect medication included Hib-Titer Vaccine, Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine, and Poliomyelitis Vaccine Inactivated. Concomitant medications were not reported. On 7/17/00, the child was hospitalized for neutropenia with a neutrophil percentage of 22% (normal: 16-60 and a WBC count of 22.5 K/uL (normal: 6.0-17.0). No additional information was available at the time of this report. The investigator considered neutropenia possibly related to Prevnar administration. The medical monitor considered neutropenia not related to any of the study products but related to the patient's history of neutropenia.
After patient was vaccinated, it was discovered that there was approx 1.4 mL of vaccine left in the vial of Moderna vaccine. Eye-witness accounts from fellow staff members report that patient may not have received a full dose of the vaccine. Guidance was sought and it was recommended by CDC that this dose needs to be repeated. Pt was called and dose was repeated same day at approx 17:30.
Pt recv vax on 9/11/97; on 2/1/99 pt exp 20 chicken pox lesions
pt recv vax & exp a measles-like rash from neck down which lasted one month;
Symptoms of cold; nasal congestion; little bit of itchiness in throat; Feeling sleepy; dry cough; Diarrhea; Sore throat was because of repeated sneezing; Sore throat was because of repeated sneezing; Little tiny cramps in some part of my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in arm left on 28Apr2021 (age at vaccination 62 years) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Other Products was reported as no. She stated that she just wanted to report that, what was supposed to be considered abnormal symptoms to the vaccine, Pfizer vaccine, so after 48 hours of getting the vaccine on 30Apr2021, she started with a symptoms of cold, which were nasal congestion, feeling sleepy and some diarrhea. She stated today on 30Apr2021 she got a new symptoms that was a sore throat but it was just for few hours and she thought that sore throat was because of repeated sneezing because she didn't feel any pain in her throat or mouth. She further stated it was 1st shot, she also felt like little tiny cramps in some part of her body, now she did not feel bad and this has been since friday last week and she feel some symptoms and little bit of itchiness in throat, its dry cough, all cold symptoms she did not experience all this symptoms until 48hrs after the vaccine all events experienced on 30Apr2021. Seriousness of the events was non serious. The patient did not receive any treatment for the adverse events. The outcome of the event nasal congestion was not recovered and all other events was unknown.  No follow up attempts are needed. No further information expected.
1/6/04- Patient stated that although she told the vaccinator that she had a history of eczema, she was given smallpox vaccine- developed "hives" on left anticubital fossa- sx resolved within 1 ½ hour. 1/9/04- anthrax #2- no problems 1/14/04- developed a mild left cervical lymphadenopathy and left arm lymphangitis 1/16/04- noticed rashes (7 lesions) on her left shoulder and upper back area.  Rashes pruritic but non-tender.  Left cervical lymphadenopathy and left arm lymphangitis worsening. 1/20/04- Above sxs "better"- rashes resolving 1/23/04- feels well- no medical complaints
Extreme soreness in left shoulder, followed by redness around the upper arm and shoulder. I also believe it caused a cold sore due to stressing out my immune system.
Pt was in office  for a well check up. When patient made it to our building lobby started to have cough, and redness of skin. Brought back up to office where he was actively wheezing and had sats 94%. Given 1 tsp of BENADRYL and 0.01 cc of epi in office. Within minutes wheezing and cough stopped. Patient observed in office for 1 hour and had sats of 100. D/c home with close obs instructions and BENADRYL dosing. Will obtain phone f/u tomorrow. Pt to see Dr. in a couple of weeks.
Patient was flush and having palpitations after receiving her second Pfizer covid vaccine.  Patient was feeling anxious.  Her original pulse and B/P check at the clinic were low but increased to normal range by the time an ambulance arrived.  No chest pain or difficulty in breathing. Patient was transported just to be checked out since she had a new born at home. Patient was treated as anxiety from the shot.
Hyperparathyroidism; Proteinuria; Hyperkalemia; I am having Hyperparathyroidism, Proteinuria, and Hyperkalemia, in other words, kidney issues; After my vaccination, I got blood work exams, showing that my creatinine level was very high risk; his kidney was at 15% capacity; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Lot Number: EW0173) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Jun2021 12:00 patient experienced hyperparathyroidism, proteinuria, and hyperkalemia, in other words, kidney issues. After his vaccination, patient got blood work exams, showing that his creatinine level was very high risk. Patient went to the hospital. As a result, his kidney was at 15% capacity. The patient was hospitalized for the events for 2 days, admission dates not provided. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was received for the events. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination. The patient underwent laboratory tests and procedures which included COVID-19 nasal swab test PCR negative on 04Nov2020. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
Two days after physical exam with immunizations. Patient developed pain, swelling and warmth in left deltoid region.  Also complained of headache, stiff neck, fever 9did not take temperature) and shortness of breath.  Our diagnosis was adverse vaccine reaction versus cellulitis and he was treated with 10 days of OMNICEF and BENADRYL.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age (who is now 41 years old). The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date (reported as "many years ago, when the patient was a child"), the patient was vaccinated with M-M-R II (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis; which was reconstituted with the sterile diluent (manufacturer unknown). It was stated that the patient's physician did a titer for measles, mumps and rubella which showed the patient ''failed to seroconvert" (date unspecified). It was unknown why the patient was getting titers done. The pharmacist reported that "the patient was scheduled for revaccination (unspecified what date) with M-M-R II." The outcome of seroconversion test negative was reported as not resolved. No further information provided. The causal relationship between the event and the M-M-R II vaccine was not provided.
Shaking and increased heart rate tiredness aches sourness heavyness (from second shot )  (First shot) no effects just sosr arm
Fatigue/tired; Headache; Chills; Fever; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 008BT1A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, FATIGUE (Fatigue/tired), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Nausea, vomiting, excessive uncomfortable burping, dizziness beginning about 2-2.5 hrs after vaccine administration.
strange body rash on her left arm; Perfect little circles of red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red). At the time of the report, VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 16-Apr-2021 does not contain any new information.
Tingling in forearms & hands about 24 hrs p/OPV dose administered; 3DEC90 reported some tingling in both legs. No change in upper extremities.
right arm was a little sore; his right arm was warm at the site of the shot; felt kind of blah; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Feb2021 12:30 (Lot number: EN6198) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Feb2021, outcome "recovered" (17Mar2021), described as "right arm was a little sore"; VACCINATION SITE WARMTH (non-serious) with onset 21Feb2021, outcome "recovered" (22Feb2021), described as "his right arm was warm at the site of the shot"; FEELING ABNORMAL (non-serious) with onset 21Feb2021, outcome "unknown", described as "felt kind of blah". No follow-up attempts are possible. No further information is expected.
Arm rash plus  hard lump  just below the injection site. Rash  started six or seven days after the injection and lasted  5 or 6 days.  Itchy entire time.
Pregnant in her third trimester; Vial the dose was gave from was reconstituted yesterday; And the vial was stored at room temperature/vial the dose was gave from was reconstituted yesterday; And the vial was stored at room temperature; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 26Oct2021, outcome "unknown", described as "Pregnant in her third trimester"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 26Oct2021, outcome "unknown", described as "And the vial was stored at room temperature"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 26Oct2021, outcome "unknown", described as "And the vial was stored at room temperature/vial the dose was gave from was reconstituted yesterday"; PRODUCT STORAGE ERROR (non-serious) with onset 26Oct2021, outcome "unknown", described as "Vial the dose was gave from was reconstituted yesterday".  Additional information: The attached storage information: diluted vaccine was stored in the vial at 2 degree C to 30 degree C for up to a cumulative period of 24 hours (i.e., 6 hours time at 8 degree C to 25 degree C described in the Prescribing Information + additional 18 hours excursion time at 8 degree C to 30 degree C in the VIAL ONLY. Reported called about the Comirnaty booster vaccination because she says she has got someone who was given a booster today and this vial the dose was gave from was reconstituted yesterday. She said when she looked at date on the vial she thought it was the time, she thought they reconstituted today but it was 25Oct. She said she needs to know need to do anything or if they need to give the dose again. She says that she just gave the patient the dose a couple hours ago, and she doesn't have much information to give. Height/weight was unknown, caller says she does know the patient is pregnant and in her third trimester. Report was not related to a study or programmed. Patient was pregnant. Patient was bot a reporter.  The lot number for bnt162b2 was not provided and will be requested during follow up.
FEVER ON 9-3-2020 OF 102-103, VOMITTING 9-4-2020, NO REACTION AT INJECTION SITE. PRIMARY CARE VISIT SCHEDULED FOR 9-4-2020 @1:30 TO ASSESS IN CLINIC
Patient had a severe flare up of psoriasis after getting his second dose of SHINGRIX. It developed all over both arms and legs.