chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She states she is swollen; she states she had sore arm for a while / she is sore.; she is still having some pain in the exact spot where the shot is; She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     treatment medications was not provided.  Concomitant products included METFORMIN, LISINOPRIL, NAPROXEN and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen). At the time of the report, SWELLING (She states she is swollen), MYALGIA (she states she had sore arm for a while / she is sore.), VACCINATION SITE PAIN (she is still having some pain in the exact spot where the shot is) and LYMPHADENOPATHY (She states that just in the last couple of weeks there are swollen lymph nodes in her left arm/lymph nodes under her armpit/lymph nodes over the left breast/lymph nodes over the clavicles/she statesshe is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-278968 (Patient Link).
pt recvd vax; 2 wks later devel severe joint pain; mild sore throat; shooting pain from inject site, neck, lower arm; sxs began resolving 4-5 days after onset; now resolved;
pt rcvd vax;  lab test done & revealed pt was HBsag neg;
Started to feel sluggish, ill that evening 1/26/16. The next day scratchy throat. On 1/28/16 ran fever of 102.7 ill started to get fever blisters around lips. Had fever until 1/30/16.
patient is given an expired Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patient is given an expired Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Number of doses/vials: 19 doses: 1 dose was a 2nd primary series dose, and 18 doses were booster doses. Date the vial was initially stored in the refrigerator: 14-Dec-2021. As per HCP, the vial did not undergo any temperature excursions.
couldn't swallow saliva, resp distress, tachycardia, tachypnea, wheezing, needed 02, proventil inhaler, ischemia epi inhalation, epi sub Q, IV solumedrol & DPH;observed 18-24hr in ped ICU;
Initial information received for this unsolicited case from a consumer on 23 February 2015. The reporter also reported another event for this patient which is captured in case number 2015SA023949. A female patient who is approximately 50 years old was vaccinated intramuscularly with Flu vaccine, manufacturer, batch and site of administration were not reported. It is unknown if the patient had other vaccinations within 4 weeks. It is unknown if the patient was ill at the time of vaccination. On an unreported date, the patient experienced a "bad reaction" to the flu vaccine and had a 105 degree temperature with complete loss of bowel and bladder. She was hospitalized for a week. The reporter was not sure of the time frame or vaccine. The reporter considered the event life-threatening and the patient required an ER doctor visit. The patient's concomitant medications and medical history are unknown. It is unknown if the patient was ill at the time of vaccination. The patient also experienced a "severe reaction" on an unreported date to a pertussis vaccine in the distant past requiring hospitalization when she was a child. The patient outcome is recovered on an unknown date. Documents held by sender: None.
This spontaneous case was initially received on 07-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 refer to the appropriate report sections. The patient received AFLURIA. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced urticarial. For relevant tests results see appropriate report section.
Fever 101.7 April 30th 4:30 PM, tylenol 500mgm given and fever resolved. Fatigue.  Tues, May 2nd @ 1PM. approximately 4inch circular red area upper lt deltoid area,  hard, and warm to touch with few white raised areas with red streak to elbow region. Unable to obtain approval with PCP, told to go to urgent Care.
The pt experienced extreme diarrhea for 3 weeks plus. Given a prescription to control fever of 102.
Patient received first dose of Pfizer vaccine at 1600. Patient reported feeling 'light-headed" immediately after vaccine administration and also reported that "this happens after I have blood drawn." Raised patient's legs up on another chair. Patient progressively had decreased level of consciousness, pupils dilated, diaphoretic. BP 84/70, HR thready 80, O2 sat 97%. 911 called and NP on site administered Epinephrine  to left thigh (LOT # 022c20aa exp. 01/2022) at 1608 with good effect.  EMS arrived and transferred patient to Hospital ED in stable condition. Patient transferred at 1625, VSS with BP 100/70 at time of transfer. Patient was diagnosed in ED with syncopal episode, monitored and discharged at 2044.
Pt had a negative HCG the day she received the vaccine.  However, 5 days later, her HCG was positive and she had pregnant for 2 weeks prior.
(R) wrist and hand swelled after PNEUMOVAX in (R) delt. and TDaP in (L) on 11/8/12. Still swollen but improving on 11/12/12.
Headache, nausea, and night sweats, starting less than an hour after shot.  Lasted off and on for ~2 1/2 weeks.
Severe pain from shoulder all the way down to fingers including arm pit and side from 6 days. On day 5 sever chest pain started. It was so horrible I thought I was having a heart attack. Pain got worse when I laid down flat. Continued for a day.
104 fever 3 days, febrile seizure, high blood pressure. he was able to  sit by himself, crawl and pull himself up onto couch before vaccination and now he can barely do it
Had symptoms of fibromyalgia ramp up. She had a generalized inflammation and pain in body. She experienced acute pain in her hip, buttocks, left leg to the point she could not walk. After 6 days she was well enough to visit pharmacy but was in obvious discomfort. She saw her doctor Monday and plans to see doctor on Wednesday. Md thinks 2nd dose SHINGRIX triggered a fibromyalgia flair.
no vital signs of life; unresponsive to stimuli; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 87 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "oxygen dependent" (unspecified if ongoing); "hospice" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing); "heart failure" (unspecified if ongoing). Concomitant medication(s) included: DIGOXIN; ELIQUIS, start date: 21Sep2022, stop date: 21Sep2022; ALBUTEROL [SALBUTAMOL]; DUONEB; LORAZEPAM; MORPHINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 21Sep2022, outcome "fatal", described as "no vital signs of life"; UNRESPONSIVE TO STIMULI (medically significant) with onset 21Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (21Sep2022) 97.8 Fahrenheit, notes: at 9:47am; Oxygen saturation: (21Sep2022) 98 %, notes: on 2L oxygen at 9:47am. The patient date of death was 21Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: Patient showed no signs and symptoms of adverse event after vaccination, but patient was found around 9:00 pm unresponsive, no vital signs of life.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be 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.; Reported Cause(s) of Death: no vital signs of life
No adverse event; needle came apart while administering a bivalent dose so patient could not get the vaccine; needle came apart while administering a bivalent dose so patient could not get the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine), UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 vaccination.     The patient's height was unknown. The patient had no allergies.  The information was unknown whether patient had ever tested positive for COVID-19 diagnosis. Specific product reported as yes, specific product known from provided information.     On 23-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine), UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine).    The patient could not received the vaccine. The was adult and in 50's. The patient received the first and second dose on an unknown date.  No concomitant medication was reported. No treatment medication was reported.
had two shots he now has the shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had two shots and he now had the shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Redness with mild swelling 3-4 inches in diameter with some induration posterior (L) arm. MD saw pt - cellulitis - KEFLEX 500 mg qid x 7 days.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of VAQTA (lot# N012324 exp 05-APR-2018), RECOMBIVAX HB, (lot# M036156, exp. 23-FEB-2019), ROTATEQ (lot# N003401 exp.13-OCT-2018), and PROQUAD (Lot# N002915, exp. 24-JUL-2018). Reconstituted with properly stored STERILE WATER DILUENT. No adverse effects reported. No further information provided. Vaccines VAQTA, RECOMBIVAX HB, ROTATEQ Temperature: 47°F to 77°F Time frame: 1 Hour 35 Minutes No previous temperature excursion Digital Data logger report was involved. Vaccines involved: PROQUAD Temperature: 6°F to 14°F Time frame: 55 Minutes No previous temperature excursion Digital Data logger report was involved. Lot number N003401 has been verified to be a valid lot number for ROTATEQ. Additional information has been requested.
pt received boostrix on 4/12/22 and then received adacel on 8/13/22, missed previous dosage of boostrix- doctors office caught the duplication, patient is not experiencing any side effects at this time.
Tempature 100, pain in arm, knot in arm at injection site, body ache,
horrible case of eye infection; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION (horrible case of eye infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2. On an unknown date, the patient experienced EYE INFECTION (horrible case of eye infection). At the time of the report, EYE INFECTION (horrible case of eye infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 6/9/2023 Discharge Date: 6/10/2023  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   Patient is a wonderful 92yo M w/ PMH of COPD admitted briefly to obs for covid19 PNA with possible COPD exacerbation complicated.     Patient presented with worsening dyspnea and tested positive for COVID19 and he was started on decadron for this and COPD.  CXR showed atelectasis vs possible lingular PNA so patient was started on CAP coverage.  He also was noted to have a small non-occlusive RLE DVT on US.  Given lack of fever, no leukocytosis, and imaging not convincing for lobar PNA images were re-reviewed and procal was obtained; antibiotics were held as bacterial infection was felt to be very unlikely.  Patient improved significantly by AM.  He was discharged on paxlovid, decadron, and eliquis with plan for a 3 month total course.  Given interaction with paxlovid and eliquis he will need to take 1 pill BID for 5 days, 2 pills BID for 2 days once off paxlovid, then 1 pill BID which was reviewed with patient and son.  They will f/u closely with PCP.   Addendum - of note, patient's BC grew 2 different coag negative staph species highly suggestive of contamination/poor sampling.  Case reviewed with ID who recommended no further workup given very low suspicion for bacteremia.
Left arm was red & swollen around injection site. It was a little sore & warm to the touch. Swollen area did increase in size, patient was told to ice the area.
Some Vx was lost , no full dose administered; This case was reported by a physician via interactive digital media and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 11-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The medical physician inquiring about an issue with Shingrix administration. The medical physician administered patient's 2nd dose of vaccine and unfortunately, some vaccine was lost at the point where the needle attaches to the syringe and therefore, patient did not get full dose of 2nd vaccine.  The medical physician reported that case she/he administer a 3rd dose of shingrix. The reporter did not consent to follow up  Additional Supportive Information: The patient did not get full dose of 2nd shingrix vaccine., which led to incomplete dose administered.
Swelling, heat, redness at injection site and pain. Swelling from elbow to shoulder. Chills, fever, body aches. Only treatment: acetaminophen, rest, time.
COVID-19 positive requiring 4-day hospitalization after receiving 2 Moderna vaccines plus one booster.
Developed nausea, vomitting, abdominal pain and early heavy menstral bleeding. Previously on oral contraceptive with normal periods. Got period a week earlier (while still taking oral contraceptives) and had a much heavier period. Had nausea and vomiting that awakened her from sleep the morning preceding the bleeding started.
pt recvd vax; rt hand tremors/spasms,lasting 5-10 secs; nl t;21sep94 convuls/sz; no tx;
Feel tingling feeling on left nose; Continued pain at site of injection; arm numb; ears numb; Bell's Palsy; Left arm (injection arm) went numb; "Charley" horse like pain in left neck; Charley" horse like pain in left face; Tingling feeling on left ear; Tingling feeling on left face; Felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), FACIAL PAIN (Charley" horse like pain in left face), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), HYPOAESTHESIA (arm numb) and PARAESTHESIA EAR (ears numb). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Continued pain at site of injection). On 14-Mar-2021, the patient experienced PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose). On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose), HYPOAESTHESIA (arm numb), PARAESTHESIA EAR (ears numb) and VACCINATION SITE PAIN (Continued pain at site of injection) outcome was unknown and FACIAL PAIN (Charley" horse like pain in left face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment included Tylenol, Benadryl and Prednisone.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Event Bell's Palsy was diagnosed.; 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.
Evening of vaccinations. Began falling down (was walking well prior) continues to suddenly fall down when walking, denies increase temp, loss of appetite, N/V, playing as normal. Does have H/O of otitis media. referred to PCP.
a patient that was intended to receive an HPV vaccine received Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594) for prophylaxis.   On 22-SEP-2023, the patient received Boostrix. On 22-SEP-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: a patient that was intended to receive an HPV vaccine received Boostrix instead).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 25-SEP-2023 A nurse called to inform that, a patient that was intended to receive an HPV vaccine received Boostrix instead, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter.                                                                The reporter consented to follow up.