chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From telephone contact with reporting physician it was stated that an adult female patient received a YF-Vax vaccination on 7/13/01. Reportedly on 7/14/01 the patient developed a local reaction of redness, swelling and hardness. Patient was treated with Benadryl and the symptoms resolved. From additional correspondence received on 9/27/01, it was reported that the Benadryl treatment made the symptoms resolve temporarily. Four days later due to persistent swelling the patient was treated with Dicloxacillin with complete resolution of symptoms. This case is closed.
06/01/2021 muscle pain, right side of the body, right upper shoulder, right neck. Treatments: ibuprofen, lidocaine,   diclofenac gel patches, I will start physical therapy, prescribed by Doctor.
I've had pain in my heart various times throughout the weekend.  I've had it more today than on Saturday and Sunday- I'd say at least 6 different times today.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Other medical history: Cancer more than 20 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Jul2022) Negative, notes: home test showed negative on 21Jul; (24Jul2022) Positive, notes: home test showed positive again on 24Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive and other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 13Jul2022, Treatment stop date: 17Jul2022. Adverse event: No adverse event, home test showed negative on 21Jul. But runny nose started again on 23Jul, home test showed positive again on 24Jul. Which is exactly a week after I finished 5 days of paxlovid. No fever, a little bit cough. No treatment will given to AE. Patient have no known allergies:   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fainting, dizziness, weakness. 4 am and 9 am next morning. (Vaccine admin at 6:00 pm the night before).
Vomiting 2x on day of vaccination 1/28/21. Muscle tenderness, tiredness. Low-grade fever day after 1/29/21.   Treatment with OTC infant pain/fever reducer. Vomiting subsided on its own. Reporting due to vomiting.  Mild reactions still present, (low-grade fever, tenderness, fussiness)
The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022; Received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known allergies.  Concurrent medical conditions included GERD and Hyperlipidemia. Concomitant products included OMEPRAZOLE and SIMVASTATIN for an unknown indication.    On 06-Apr-2022 at 11:17 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 11:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25 Mar 2022. Reporter confirmed that the patients were not experiencing any side effects yet. No treatment medication was provided.
chills; Achiness; soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), PAIN (soreness), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever). On 13-Jan-2021, the patient experienced MYALGIA (Achiness) and PAIN (soreness). On 10-Feb-2021, the patient experienced CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 14-Jan-2021, MYALGIA (Achiness) and PAIN (soreness) had resolved. On 11-Feb-2021, PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment included Ibuprofen
Information has been received from a physician concerning a male who was recently exposed to his wife (WAES # 0611USA04592) who was vaccinated with a dose of varicella-zoster virus vaccine live (Oka/Merck) on 03,  Nov 2006. Subsequently the patient contracted a rash form his wife. No additional information was provided. Additional information has been requested.
Left my arm so sore; I can barely lift it; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got his/her Shingles vaccine and left his/her arm so sore, he/she could barely lift it, but he/she stated bet this was mild compared to getting the shingles. The patient also stated he/she have to get the booster in 6 months. Additional supportive information: The follow-up would not possible as no contact details were available.
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine.  Took her pulse and lay her on a cot, gave her water.  After about 20 minutes of rest, she felt well enough to drive home.
SHINGLES-SEVERE PAIN IN THE LOWER RIGHT SIDE OF THE BACK- RASH AND BLISTERS  ACROSS TE RIGHT SIDE OF THE LOWER BACK AND  DOWN THE LEG. PRESCRIBED VALACYCLOVIR & GABAPENTIN. THIS HAPPENED 30 DAYS AFTER THE 2ND MODERNA SHOT.
Redness, swelling, warmth and pain around left uper arm injection site. Redness measures 12cm x7.5 cm. Treated with 7 days of Augmentin for cellulitis.
pt recv vax 2OCT96 in lt upper arm & since this shot pt lt arm has been getting inc weaker until today was unable to lift child or hardly anything;it is very painful to lift lt arm;
BODY ACHES AND BODY SORENESS; DIFFICULTY IN BREATHING; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, colitis, seizures, diabetes, and cholesterol, and other pre-existing medical conditions included the patient had no known drug allergies, not allergic to any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included azathioprine for colitis, lamotrigine for seizures, zolpidem for sleeping, meclozine for vertigo, amoxicillin, atorvastatin, hydrochlorothiazide, infliximab, olmesartan, ondansetron, potassium, potassium chloride, propranolol, and venlafaxine. On APR-2021, the subject experienced body aches and body soreness. On APR-2021, the subject experienced difficulty in breathing. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and body soreness, difficulty in breathing and tired was not reported. This report was non-serious.
5 days of fever, chills snd right sided Bells Palsy   Bells Palsy is still present
Suspected vaccination failure/I got my shingles and I've had shingles for over 10 years now; I've had shingles for over 10 years now; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; Red swollen itchy painful mark on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, pruritus, pain in arm and erythema. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the swelling arm, pruritus, pain in arm and erythema were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, pruritus, pain in arm and erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shingles shot and got a huge red swollen itchy and painful mark on his/her arm that lasted a whole month. The patient have had shingles for over 10 years now that comes and goes and it was very debilitating. The patient was due again and was hesitant.  The patient stated that thank goodness have had his/her acyclovir.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt said approximately 2 hrs after vaccination, she broke out in hives around the torso area.  The next morning she was extremely tired and vomited.  Hives went away in approx. 2 days.  No rash or pain at site.  Pt reported this in passing on 9-25009 but she can't be absolutely sure it's due to the vaccine.  She said she gets vaccine every year and never had a problem. She said she just thought she'll mention it.  She said she's fine on 9-25-09 but thought she'll let me know.
L upper arm swelling the evening of vaccination.  Increased swelling with redness the next morning, 10/2.  Seen in clinic 10/3 with slight decrease swelling, decrease redness, mildly tender.
After 10min of administering the vaccine she started feeling nausea and sweating, later she felt itchy throat and funny ears and slightly stuffy nose.
Moderate chills (2+ hours uncontrolled shivering) despite electric heater and 5 layers of blankets, mild headache, mild soreness at injection site akin to tetanus shot pain but milder
27OCT89 pt vax w/hepta B; 01NOV89 felt weak, tired, sick, & had PVC's assoc w/mitral valve prolapse.  Sx reoccurred after 2nd vax.  Tx w/cardiac meds for PVC's atrial fibrillation & bradycardia. See worm...
Right after patient received the vaccine, she complained of dizziness and lower back pain. The paramedics were called and patient was evaluated. After around 15 to 20 minutes, the paramedics determined patient was alright and gave her a ride back home.
She had cardiac arrest as a result of blood clots in her lungs. She had no history of blood clots. They could not stabilize her, she had numerous heart attacks back to back, she was on life support. She would have died if paramedics weren't there. They placed stents in her lungs to break up clots.  She remained in the hospital for 3 weeks. She lost the ability to walk, rehab has helped with this.
PT WAS WORKING W/ PT AND WENT UNRESPONSIVE, R SIDE FACIAL DROOP, LEFT SIDE TWITCHING AND BIL WEAKNESS,  BLE SWELLING, CONFUSION, SENT TO ER- ADMITTED  TIA, ANEMIA, WEAKNESS
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EW0178), in right arm, on 08Apr2021 at 13:00 as dose 2, single (Lot number: EW0178), in left arm and on 11Oct2021 at 15:00 as dose 3 (booster), single (Lot number: EW0178) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiac disease" (unspecified if ongoing); "stents" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Jul2022 to 18Jul2022 with lot no. GD3258.  No known allergies were reported and no fever (temperature normal)
Patient was recently hospitalized for left BKA from 7/19-8/27 and transferred to rehab. Patient coded and passed away on 9/01. Death doesn't not seemed attributed to vaccine based on patient's PMH.
About 1 month after my booster. I started feeling a scratchy throat and thought maybe it was strep throat. Went to testing clinic and it was negative. I felt worse and went to doctor, they performed another strep test and covid. Covid was positive and strep was negative.  I went home and rested and took cold medicine and was better in 7 days.
Information has been received from a medical assistant concerning her friend's child who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). The medical assistant reported that the child got shingles after receiving VARIVAX (Merck). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck), approximately one week later he developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information indicated no new information. Additional information is not expected.
3-4 minutes after injection, throat swelling/tightening (I could still breath just tightening) and heart racing (tachycardia)
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-JUL-2017, the patient was vaccinated with an expired dose of M-M-R II (expiration date 22-JUL-2017; dose, route and lot # were unknown) reconstituted with sterile diluent (lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported.
5 minutes after shot administered, became very hot and flushed. Felt tingle in throat. Turned bright red. Sent to ER. Throat tingle subsided after about 30 min. No anaphylaxis. Given Zyrtec for slight itchiness
Patient received COVID-19 vaccine on 1/4/2021.  Later that day developed chills/sweats, body aches, cough, nasal congestion, sore throat and shortness of breath.   She continues to have shortness of breath and has not been able to return to work.
07/29/2022 In the morning we had the vaccination and it was his six month check in. He also received other multiple vaccinations that day as well. We did notice spotting in his bowel movement of blood and there was one at 4 that evening. Another bowel movement at 7 that had much more blood in comparison. A third bowel movement around 12 that evening and the blood spots reduced as well. When we looked up his other vaccines and their symptoms they did state that it may have been a different vaccine's. The doctor stated that they believe the symptoms may be caused by lactose intolerance. Check-up in two weeks to see improvements.
This spontaneous report as received from a pharmacist via a company representative refers to a 56 year old female patient. The pertinent medical history and drug allergies/reactions were unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot details not specified). The concomitant therapies included unspecified hormone patch and anti-inflammatory medications. On an unknown date, the patient experienced redness, warmth and lump around the injection site. No treatment was advised for the events. The action taken with ZOSTAVAX was not applicable. All the events resolved by itself in six days. The causality was not specified. Additional information has been requested.
Information has been received from a pharmacist concerning an 80 year old female with drug hypersensitivity to DEMEROL and no pertinent medical history who on 20-SEP-2010 was vaccinated at left arm with a dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). There was no concomitant medication. On 21-SEP-2010 the patient presented to the pharmacy with a swollen area at the site of the injection that was red and warm to the touch. The reaction was localized to the immediate area surrounding the injection site. No other areas of redness appear on her body. No lesions or hives or varicella like rash appears anywhere. The patient was also stating that since the injection she had had a feeling of generalized weakness/fatigue. No medical attention was sought. At this time of reporting, the patient was not recovered. Follow-up information was received from the registered of pharmacist who reported that the female patient with no illness at time of vaccination on 20-SEP-2010 at 17:00 was vaccinated subcutaneously into her left arm with the first dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). On 21-SEP-2010 the patient experienced swollen area at injection site that red and warm to touch, generalized weakness and fatigue. The patient did not seek medical attention. The outcome was not reported. No further information is available.
Dose administered from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
SWOLLEN AT INJECTION SITE FOR 4 DAYS, HURT BACK OF ARM FROM SITE OF SHOT TO ELBOW.
Patient said he has abdominal pain about 24 hours later after getting the flu shot 1 day (24 hours) earlier. Patient said he went to ER to find out what it was they ruled out appendicitis and checked for kidney stones, which has yet to be determined once he gets the results back. Pain has subsided.
My arm has never stopped aching since I received shot. My range of motion is limited and I wake up at night in psin
Hypotonic hyporesponsive episode approx 7 hrs p/vax; duration of episode approx 1 minute; no treatment;
Developed headache 6/16/21 Developed metallic taste in mouth 6/17 Developed exhaustion 6/17  Vaccinated 6/15/21
11/8/16 C/O headache, fever and muscle aches. 11-17-16 presented with macular itchy rash over entire body, sore throat and joint pain. 11-25-16 increased rash/on body, lesions over lower extremities.
Patient  presents to the ED with a Chief Complaint of Alcohol intoxication and Fall after receiving one dose of covid vaccine on 12/17/21. Per guidelines, all hospitalization are reported.
My right arm where the shot was given was sore for about 2 days, there we no other reactions to this 1st dose.
Bruise-like flat red/purple rash above right eye/on eyelid. There was no injury to the eye and it is not tender.
Patient was tested positive for Covid-19 on 12/9/20.  Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing,  muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine.  On 1/22/21:  patient was seen by medical provider for "altered behavior". Per medical provider's documentation: "Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit". We did MMSE today: 22/30 score "mild dementia"  On 1/23/20:  "Patient  was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am."