chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have a red circle around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the vaccine for shingles (roughly 3 days ago) and had red circle around injection site. The follow-up would not be possible as no contact details were available.
Reported a large red warm area to right deltoid measuring 3 in by 3 in.
Patient felt dizzy following immunization of Moderna -Covid vaccine.  Patient stated she felt dizzy about 10 minutes into wait time following immunization.  I gave her a bottle of water, we talked with her about her symptoms, gave her wet towels as cool compress and called the person who was accompanying her, who was shopping in store.  Patient sat and drank the water as we monitored her.  She felt better after about 30-40 minutes and left with her companion.  Patient denied needing further aid or emergency services
This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, and anatomical location, were unknown) with lot # N010497 and expiration date 13-JAN-2020 for vaccination. Pharmacist stated that 10 minutes after administration of the GARDASIL 9, the patient stated she was experiencing headaches, and 2 and a half hours after administration of the GARDASIL 9 she experienced nausea. Pharmacist stated there was no treatment provided to the patient, and no laboratory diagnostics or studies were performed. At the time of the report, the outcome of headache and nausea was reported as not recovered. The pharmacist  did not mention the causality assessment between headache and nausea, and GARDASIL 9.
Report described rash on palms of hands in a male vaccinee of unspecified age who received hep A vaccine. Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received his first dose of Havrix. Two days prost-vaccination, he developed a rash on the palms of his hands. As of 06/20/2001, the outcome of the event was unknown.
Patient began sweating profusely approximately 10 minutes after his vaccine.  He went to his parent's car and asked his father to turn on the air conditioning as he was hot.  he then passed out in the back seat of the car.  His mother came inside and asked for assistance.  I grabbed an epi-pen and ran outside to the car.  Patient was breathing and had a pulse rate of 64.  He aroused shortly after I began asking him if he could hear me and asked if he could tell me his name.  He was pale (notably his lips were quite pale) and confused.  He could not say his name but could nod appropriately to questions when asked.  We immediately called EMS for assistance.  They arrived within 4-5 minutes and transported the patient to hospital.
Pt was given Pfizer primary dose vs Primary Booster. Pt waiting 15 mins post vaccination. No symptoms or concerns detected.
High fever over 3 1/2 days, nausea, painful joints, pain in neck, lower back, headache.
Post vax, that evening, child developed fever of 102.6F. He was seen in the ER and experienced a seizure. The pt was observed in the ER for several hours where a dx of "febrile seizure vs Prevnar reaction" was made. He was discharged from the ER; his diarrhea persisted and he was prescribed Tylenol for his fever. The reporter indicated that his brother developed fever and diarrhea; however, he was not immunized with Prevnar.
was horrible, Fever; was horrible, chills; was horrible severe, headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-OCT-2022 Reporter's comment: This case was reported by patient's wife via interactive digital media. The patient got the Shingles shots. Second one was horrible, fever and chills with severe headache. Additional supportive information: Follow up would not possible as no contact details were available.
This spontaneous report was received from a consumer (patient mother) refers to a male patient of unknown age. The patient was allergic to tetracycline. On an unknown date in April 2008 (also reported as 5 or 6 years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant medication included some kind of antibiotic. On an unknown date, the patient experienced aspergillus, which is a fungal infection in the lungs. The reporter also stated that she was not known how long after receiving the vaccination his symptoms started. The reporter stated her son was very ill and has sought medical attention several times, and has an upcoming appointment with a specialist. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Per mother/grandmother on 03-05-12 at office visit. Stated "healthy 4 day old got his 1st dose Hep B, didn't cry, tolerated well initially.... that at 2:15 pm.... about 6 pm he became very fussy.... at 8, 9, 10 pm he crying uncontrollably became stiff whole body, began jerking all over, eyes rolled into head. Lasted only few seconds. But he had 2 more seizures just like the first one during that night.... he had another seizure a week later". No treatments/per our office notes.
Patient received COVID-19 vaccine on 1/28/21. She inadvertently received different covid vaccine on 2/25/21 (Lot number EL9266, given IM in left deltoid). It was not noted that this happened until 3/2/21. Agency director called, Dr., who in turn notified the Medical director. Patient called on 3/3/21 and left message. Spoke to patient on 3/4/21 with Dr. on phone. Notified patient what happened and that did not need to have any vaccines repeated according to the guidelines. Patient had not any untoward from receiving 2 different brands of the COVID vaccine.
I was mandated by my employer to get the vaccine and I was given a deadline in October.  To not lose my job or be charges extra fees, I reluctantly got the vaccine on 09/10/21 to fall into their compliance dates.  About 1 month and a half later, the right side of my face drooped.  My husband took me to Urgnt Care.  The physician I saw believed I had Bells Palsey but transferred me to a hospital to have a cat scan to rule out a stroke.  My husband took me to ER.  The ER Physician also beleived I had Bells Palsey. A cat scan was completed and an MRI was suggested but the hospital did not have an MRI.  I was given Prednisone and antivirals and diganosed with Bells Palsey.  I am in the process of follwoing up with my primary physician so she can review tests results and see if an MRI is necessary.  I will continue the course of RX for Bells Palsey.  The right side of my face is droping effecting my lip and cheek at this point.
Patient lied about not receiving covid vaccine in the past. We gave them a 3rd covid shot because they lied on their paperwork and verbally.
A report received from a nurse on 10/02/01, concerning a 55 year old female who experienced redness and swelling at the injection site on 09/22/01 after being injected with 0.5 ml of Fluvirin at the right deltoid area on 09/21/01. The patient was treated with Tylenol and her current condition was described as better at the time of reporting. It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication to the event probable. See PJP200100298 and PJP200100299.
I had mild pain in my arm later in the day. That evening I had a brief runny nose and sore throat that lasted for a few hours. Then the following day I was very tired. On the 3rd day I was extremely tired. My body ached and was in pain. I had sinus pressure in my face and in my eye. I had a lot of drainage in my throat, and I felt nauseous. I went to the doctor on 11/9/2021. My temperature was normal. They diagnosed me with a sinus infection. I was given a Z-Pak to take 2 by mouth and then 1 by mouth for the next 4 days. I'm starting to feel better now.
Patient stated "I had COVID in November 2020, and I received monoclonal antibodies two weeks ago". This was approximately five minutes after receiving the vaccine. The CDC currently recommends waiting ninety days after receiving monoclonal antibodies before receiving the vaccine.  No Symptoms were observed.
Chills, fever, extreme lethargy starting about 12 hrs after injection.  Chills and fever lasted about 24 hrs.   I'm at almost 48 hrs after injection now and lethargy remains, though I'd say it's only half as bad as yesterday
Frozen shoulder; mostly pain free; This case was reported by a consumer via interactive digital media and described the occurrence of frozen shoulder 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 frozen shoulder and pain. On an unknown date, the outcome of the frozen shoulder and pain were recovering/resolving.   It was unknown if the reporter considered the frozen shoulder and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient got the shingles vaccine and ended up with frozen shoulder from it, 7 and 1/2 months of agony. The patient was finally pain free mostly. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
During post-vaccination monitoring, the employee verbalized complaints of a "heavy chest" and "chest tightening." Vital signs were taken at 7:15 AM: BP 169/96 mmHg, HR 78 bpm, 99% O2. Employee reports this feeling has "happened in the past" and that he takes medication. Employee monitoring continued, was offered PO fluids. Vital signs at 7:35: 171/96 mmHg, HR 74, 98% O2. At time of second vital signs (7:35) employee reported resolution of chest tightness. He believes it was stress-induced (on the job stress). He reports chest pain occasionally a which he manages with  "distraction." Saw his PCP 2 months ago for hypertension.
Arm with the shot feels like skin is stretched and tight, sensation of glue being stuck on the arm
Vertigo (positional, worse when on side or back). Nausea started 24 hours after vaccine. Continuing for 6 days. Patient went to urgent care recovered antivert on day 4. Slightly relieved but still present slowly improving.
Information has been received from a registered nurse concerning a 19 month old white male with no past medical history and no known drug allergies who on 29DEC2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The child had bilateral otitis media serous at the time of vaccination. ON approx. 25MAR2003 the patient broke out with lesions of chickenpox. The patient was seen and treated on 28MAR2003. The reporter indicated that the patient recovered. No diagnostic tests or laboratory data were reported No further information is expected.
"Received flu shot on 10/12/11, area is tender and slightly swollen, arm is somewhat numb and warm to the touch."
Sore injection site through the night and the next day, small bruise Fever 38.6C through the next day after administration (9/23 starting at 9 am, still high at 2 pm) Shivers Headache
dad called the office on 10/28/20 to report that injection site was red, warm to the touch and had a bump.
Fever, tremors. Area of the left arm like burned (still today you have the marks in the area). A ball on the right arm of which you still have the mark in the area.
got really sick; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional via social media.  This case involves a patient of unknown demographics who got really sick (Illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that had a flu shot years ago and got really sick (Illness).  haven't had one since and have never gotten the flu. Was not get one this year. patient thought that there was no way that people can build their immune systems when everything was done for them,  (non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for sickness, at the time of reporting.  There will be no information available on the batch number for this case.
pt recvd vax 17JUN92 930AM-10AM started crying @ 11AM cried steadily until 2PM; crying differently then nl according to mom;
Patient received her vaccine and waited in the pharmacy area for a bit. She felt fine so the patient, her Dad and sister walked around the store. After a little bit the Dad came back and said she was bleeding and needed a new bandaid. While getting gloves on and a bandaid, the patient fainted from the standing position. I ran to attend to her and she had already come to. 911 was called and since she did hit her head on the floor when she fell, the Dad thought it best she be taken to the hospital.
This case is a cluster of 6 patients who tested positive for pertussis following administration of Tdap. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02348, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. An 11-year-old male patient had received a 0.5 mL dose 5 injection of Tdap (manufacturer, lot number, route and site of administration not reported) on 05 September 2005. The patient was 4-years-old at the time. On 07 September 2005, the patient received a 0.5 mL dose 4 injection of IPV, a 0.5 mL dose 2 injection of MMR and a 0.5 mL dose 1 injection of Hep A (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 09 January 2012 with complaints of cough for the last month, fits of cough, can't catch his breath, brings up mucus and a low grade fever. The patient's sister and dad have the same cough. The previous weekend the patient was vomiting with the stomach flu. Upon examination, the patient had erythema on tonsils, no cervical lymphadenopathy, good air movement with no crackles or wheezes, sandpapery feeling skin with colored papules on back. The physician's assessment was cough and pharyngitis. A rapid strep test was done and results were negative. The patient's sister tested positive for pertussis so the patient was treated for pertussis as well with azithromycin. No laboratory testing was done for the patient to confirm pertussis. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of headache and unspecified disorder of male genital organs. The patient's vaccine history included 4 previous doses of TRIPEDIA (sanofi pasteur Inc): lot number U0356CA on 13 March 2001, lot number U0378AA on 25 May 2001, lot number U0532DA on 17 August 2001 and lot number U0549AA on 26 July 2002. The patient was up-to-date on HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Awaken around 5 am with a head ache and as morning progressed I had mild nausea on and off. With lunch at noon I took 2 acetaminophen.Head ache and nausea went away.
Inadvertently administered Moderna 0.25 ml booster to said pt six weeks after pfizer booster.  Pt reported no other symptoms on follow up visit except for slight sore arm.  No other symptoms reported to this pharmacist on follow up 12/20/21 visit
About an hour after the vaccine, I developed a rash on my neck and a slight itchy feeling. It's been about 5 hrs and it's gone down a lot but still feels tight, stingy. About 3 hours after the vaccine I developed 1 mouth ulcer on my lower lip.
Case completed Moderna vaccine series on 2/18/21, then was admitted to hospital on 8/24/21 for Covid pneumonia
Flu-like symptoms, low-grade fever, body aches, chills, night sweats.  Symptoms only occurred at night.
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: AUG-2022) dose was not reported, administered on 24-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 24-OCT-2022, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.
Information has been received from a physician via a field employee referring to a 76 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 20-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (unspecified strength, dosage, frequency, route, lot number and expiration date) and also received another vaccine concurrently described as: a "high dose flu shot in the same arm due to the patient refusing to have vaccines in two separate arms". The patient experienced a reaction afterwards that same day described as: a "red, hot, swollen arm and a low grade fever". The patient's arm was still "red hot and swollen this morning on 21-SEP-2016 and the patient passed out and went to the hospital" (hospital was unspecified). The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
w/in 5min p/vax pt became cold, clammy, nauseous;recovered w/in 10 to 15min;this is 1 of 3 pt from this site to devel these sx p/vax;
Hypoaesthesia; neurological problem s for the past 5 months; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) 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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (Hypoaesthesia). In 2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months). At the time of the report, HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) had not resolved.            Concomitant product use was not provided by the reporter.  Had multiple pathological and biopsy test.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received contains event of neurological disorder and action taken updated from unknown to not applicable.
Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid.  Exploratory laparotomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy completed within 12 hours of presenting symptoms
This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored GARDASIL 9 (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Immediate tingling throughout my body when injection started.  Stayed 25  min.  in clinic following injection.  Tingling remained but no breathing problems developed.  Tingling lessened  by next morning.  Did have increased aches and pain sand more headaches on day 2.  Contacted MD on Fec. 2 and she was aware of others having the full body tingling but said she  thought it was OK to get 2nd dose Feb. 20.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 04/09/21.
This spontaneous report as received form a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, lot# and expiry date, route unkonwn). Other suspect therapies included corticosteroids (unspecified) (manufacture unknown)(strength dose, frequency, lot# and expiry date, route and indication unknown). On an unknown date at the time of ZOSTAVAX administration the patient was taking an unspecified low dose of an unspecified steroid (manufacturer unknown). A couple of years later on an unspecified date, patient developed a severe case of shingles with post herpetic neuralgia. Patient visited physician for medical attention. The outcome of severe shingles, at the time of ZOSTAVAX administration patient was taking an unspecified steroid and shingles with post herpetic neuralgia was unknown. No further information provided. Additional information is not expected.