chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports she had localized pain and swell on date of administration. Patient reports that she woke up on the morning of 9/4/12 with upper arm with raised pink area (14 1/2 cm x 9 1/2 cm) given 1 gm ROCEPHIN IM and BACTRIM. Vital signs 98.8, 183/87 P 71 RR 18.
2y.o female with fevers to local and B/L arm soreness s/p Moderna Covid Vaccine in Right Arm & Pneumovax23 vaccine in left arm 48 hours ago. Also with 2in x 2in area of erythema at Left arm injection site
Pt. states that after receiving the 1st dose of Moderna 09/08/2021, started experiencing symptoms of vomiting, muscle aches, loss of appetite, loose stool, double vision, and extreme fatigue. (Lost 9lbs in 4 days) Primary communications ER visit treated with Zofran. Primary visit 09/13/2021. Still continuing to experience symptoms.
Felt dizzy immediately after vaccine. Waited 15 minutes and symptoms resolved without intervention. HR 81, O2 sat 99%
Rash or erythema started on Sat. evening at inj. site. It spread to below her elbow and became painful by Sun. morning. MD gave BENADRYL & steroid cream and it subsided by Tuesday.
Patient claims that she has had radiating harsh pains down her entire left hand side since receiving the vaccine. It started soon after she received it and progressively got worse. It has been 5 months since the vaccine and she is still in constant pain. She describes it as if a hot iron is pressed on her entire left hand side of her body along with burning, feeling like needles are poking her, and possible nerve damage. She even claims to have had to been hospitalized due to the pain associated with the vaccine.
Eye infection symptoms: Red, itchy, swollen, tearing and felt like something was in my eye. Treated with erythromycin ophthalmic ointment. Infection cleared after five to seven days.
On December 5th,tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On December 5th,tested positive for Covid) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, 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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form, dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (On December 5th,tested positive for Covid). At the time of the report, COVID-19 (On December 5th,tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2022, SARS-CoV-2 test: Positive.         No concomitant medication information was provided. It was reported that patient had four Pfizer Covid vaccines, and one Moderna covid booster. No treatment medications were provided
Pt. requested flu vaccine. Is allergic to eggs, within 15-20 min of receiving the vaccine he c/o urticaria. BENADRYL 50 mg given STAT. Coughing - Albuterol 90mcg/puff - 2 puffs STAT - had "itchy throat" - cont. tried to clear. Within 20 min of tx all symptoms resolved. Pt. released to home.
The only symptom I experienced from my Pfizer booster was very swollen and sore lymph nodes in my left armpit. It was like a big swollen sac under my armpit that started Saturday after I had my booster on a Friday. Then Sunday it was still sore, but swelling went down, then Monday it was sore with minimal swelling. I know this is most likely an immune response from my body meaning that the vaccine is working, but wanted to report this symptom since this did not happen on my first two doses of the vaccine, which was the Moderna.
1 inch red, knot palpated on L deltoid. Client phoned on 6/2/11 and visited our office.  Noted a 1 inch red area and 1/4 inch pus filled head in center of red area.
Patient got dizzy and light headed.  She then went still and had seizure type reaction.  eyes rolled back, hands were clenched, mouth was odd, patient passed out.  upon awakening, she was very weak with low BP.  called 911
3 days after receiving vaccine dose, patient experienced an asthma attack.  Patient self-administered rescue inhaler and EMS was called.   Patient has had persistent headaches ever since, taking acetaminophen daily to treat.
This case was considered medically important. Information regarding Dryvax was received from a literature source regarding a 32-year-old male patient who received a dose on an unspecified date, and three years later developed basal cell carcinoma in the dermal vaccination scar. On an unspecified date, three years following smallpox vaccination, the patient developed basal cell carcinoma in the dermal vaccination, confirmed by a shave-skin biopsy (see test results below). Treatment and patient outcome were not reported and are unknown. The author noted that this patient's basal cell carcinoma had a short latent interval and an apparent interaction between the live vaccination and scarring. The author's concluded that the relatively short interval from the time of vaccination to the development of carcinoma necessitates further studies on the carcinogenic potential of different strains of vaccinia. Biopsy skin (results: shave skin biopsy of tumor identified, nodular basal cell carcinoma) was done on an unspecified date. See attached literature article. No additional information was available at the time of this report.
On 10/29/07 pt reported to PCP office left arm very sore after receiving flu & pneumonia vaccines 10/25/07.  Was seen in ER at hospital 10/27/07 for symptoms.  Pain improving 10/29/07.
Hospitalized 04/24/2022-04/25/2022; COVID-19 positive 04/24/2022; fully vaccinated plus booster  Date of Admission: 4/24/2022 Discharge Date: 4/25/2022 DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 88 y.o. female who presents today with weakness . pmh parkinsons, hypothyroid, chronic fatigue, pad . She has received x3 doses of covid vaccine .   In ed tested positive for covid -19 . Found to be hypoxic to 88% with activity . cxr showing Multifocal chronic changes. No acute interval change. Oxygen placed . hospitalist service contacted for admission .  She was continued on supplemental oxygen.  Patient was treated with systemic steroids and antiviral agent Remdesivir.  PT/OT evaluated recommended home with home health short-term PT/OT.  Patient's supplemental oxygen was weaned to room air with adequate oxygenation at rest and with exertion.  Support specialists consulted for discharge planning and any outpatient services.  Electrolytes were monitored and repleted throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days.  She will continue 3 Duchenne all days of dexamethasone and antitussives. Patient voiced understanding was agreeable with plan of care discharge.
COVID-19 VACCINE.  ADMINISTRATION ERROR:   Patient possibly received 3 doses of vaccine.  Resident received first dose of COVID-19 vaccine on 1/11/21.  Patient was vaccinated on 2/22/21 under the impression she had only had 1 dose previously.  Patient recalls getting second dose on 2/1/21 and records show dose given but facility deferred many doses due to COVID infections that day and records were in question. Patient has no adverse reactions reported to date.
Information has been received from a physician concerning a 11 year old female with a history of convulsion disorder who was vaccinated with Gardasil. It was reported that the patient had a seizure after receiving a dose of Gardasil. Unspecified medical attention was sought. It is not known which dose this was in the series. Lot number was not available. No further information was given. Additional information has been requested.
Low grade fever, Malaise, Myalgia; TX: Ibuprofen 400mg q 6 hours
Initial unsolicited report received from a pharmacist on 04-Oct--2016. This case involves a 68-year-old female patient, who was vaccinated with FLUZONE HD (batch number: UI672AA, expiry date: 17-Apr-2017) (route, dose and dose not reported) in right deltoid on 28-Sep-2016. Patient's illness at time of vaccination was reported as none. It was also reported that pre-existing physician diagnosed allergies: eggs and birth defects, medical conditions are none. It was also reported that patient had one dose of Fluzone last year. Concomitant medications were not reported. On 04-Oct-2016, six days following the vaccination, the patient experienced pustules on knees and hands. Lab test was none reported. Concomitant medication was not reported. Outcome of the events were reported as unknown. Documents held by sender: none.
Symptoms - Mild swelling of checks and throat. Time Course - Started about 20 minutes after shot, ended after about 30 minutes
There is an area of erythema left lateral upper extremity that measures approximately 2 1/2" by 1 1/2 of induration. There is some excoriation surrounding the lesion. The edge is irregular. 0.1% ointment to rash twice a day until clear. Atarax for itching was prescribed.
When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The next day  I could be rly wake up, my arm was incredibly sore and I felt sick to my stomach in waves. (rolling nausea)  During the day I had off and on headaches that became a full on migraine my dinner. My arm stayed sore and hard to use all day and at night about 7:30 - 8:00 a sharp pain started lancing through my thigh to my knee, after a half hour or so it moved to include down to my ankle, then spaced out between the three randomly till about nine wen it moved to my side for about twenty minutes or so before becoming a dull throb in my leg till I fell asleep.  The next day I felt a slight ickyness that last off and on all day as well as a light headache that got worse in the evening. The soreness in my arm dulled down and was just about gone by night, as well as rolling nausea all day though light. Today I woke up a little icky, very tired, and with a headache that has lasted all day and worened during the night, the soreness in my arm is gone.
Pfizer vaccine, orange cap for ages 5-11yoa was taken out of refrigerator and was allowed to get to room temperature.  Vaccine was not mixed with 1.3 ml of diluent mistakenly and  0.2 ml of vaccine was given to patient at left arm.  She was monitored for 15 minutes after vaccine was given, no side effects of vaccine noted at that time.   Once RN noted that vaccine was administered without diluent, Nursing supervisor and Primary Care Provider were notified and Family was called.
Rash, itching lasted about 1hr. Took 25mg BENADRYL with great results.
arm pain/ arm pain in the injected right arm/pain from the top of the arm to the elbow; arm pain/ arm pain in the injected right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in elbow in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, immediately after receiving Shingrix, the patient experienced pain in elbow and pain in arm. On an unknown date, the outcome of the pain in elbow and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain in elbow and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in September 2019. Immediately after the vaccination she had arm pain in the injected right arm. The patient described it as pain from the top of the arm to the elbow. The pain in arm persisted till the time of reporting. The reporter did not consent to follow up.
My first symptom was a low-grade temp, then I had cough and fever and feeling so sick. It was several days before I lost my taste and smell. I had shortness breath, I went to ER I was coughing so bad, I would cough till I passed out. They gave me IV fluids and a steroid inhaler and cough medicine. I could not stay up right. My fever came back, and I could not stay hydrated. I feel like I still have shortness of breath and my chest just hurts. I still have days where I don't feel well. I took ivermectin for 3 days and started to feel better.
Client called HD and reported that he had pneumonia shot in a.m. Arm was sore and red and swelling. Was told to apply warm compress take Benadryl and/or Tylenol and report if no better or gets worse. Pt denied fever. Unable to follow up as phone number is disconnected according to nurse at health department.
Chills. High fever. Weakness. Pain in joints. Tiredness. Nausea.
ARMS FEEL SLEEPY/FACE SENSATION; DIZZY; DROWSINESS; HEARS A BEEP IN BRAIN; HEART BEATING FASTER THAN NORMAL; TONGUE SENSATION; FEVER; This spontaneous report received from a patient concerned a 48 year old female. 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F, and Heart rate (NR: not provided) heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced arms feel sleepy/face sensation. On 10-APR-2021 19:00, the subject experienced dizzy. On 10-APR-2021 19:00, the subject experienced drowsiness. On 10-APR-2021 19:00, the subject experienced hears a beep in brain. On 10-APR-2021 19:00, the subject experienced heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced tongue sensation. On 10-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arms feel sleepy/face sensation, dizzy, fever, drowsiness, hears a beep in brain, heart beating faster than normal, and tongue sensation. This report was non-serious.
Soreness at injection site Tiredness, Fever, Muscle Soreness, Headache
Patient is stating that his arm has been sore since he received the shot over a month ago and he thinks that we tore his rotator cuff.
Exhaustion, body aches, fever, tired feeling "as a truck hit him". Stayed in bed trough night and following day. Call to PCP, advised to go ER for assesment. Hydrated in ER+Tylenol/Advil given.
Initial unsolicited report received from physician on 26 Feb 2018. This case involves male patient (Age not reported) who was vaccinated with dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, patient had anaphylactoid response. Physician saw this as an allergist and learned of reaction. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: anaphylactoid response. List of documents held by sender: none.; Sender's Comments: The patient experienced anaphylactoid response post-vaccination with TDaP vaccine (unknown manufacturer). Time to onset is unknown. Additional information including vaccination details, dechallenge outcome, patient's demography, allergic history, concomitant vaccination details, past vaccination history and tolerance, lab test to confirm cause would be needed to assess causal relationship with the vaccine. Based on limited information available, the role of vaccine cannot be evaluated.
Pt received covid vaccine then flu vaccine (lot 49LC5) right after.  Started having seizure like episode.  MD stat and EMTs called.  Pt went to local ED via ambulance.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the second of 3 reports. A patient of unspecified age, race, ethnicity and gender received on the same unspecified day PREVNAR 13, at single dose and influenza vaccine, both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot for immunization on an unspecified date. The patient was sick after getting the flu shot plus PREVNAR 13 on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018080772 same suspect products, event, different patients; US-PFIZER INC-2018080774 same suspect products, event, different patients.
Patient is 3 y/o male given Tdap injection instead of DTaP injection.  This should have been his 4th dose of DTaP
itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms.; This is a spontaneous report from a contactable other health care professional (patient, self-reported). A 38-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3246, expiry date was unknown), via an unspecified route of administration, in Arm Left, on 19Jan2021 at 17:00, as single dose for COVID-19 immunization. Medical history included Slight anemic and slight Vit. D deficiency. Concomitant medication included ethinylestradiol, levonorgestrel (VIENVA) as birth control (in two weeks of vaccine). Patient previously took sulfamethoxazole, trimethoprim (BACTRIM), ibuprofen (MOTRIN) and Ibuprofen; had known allergies with these medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19 post vaccination. Patient reported that day after vaccine (20Jan2021, 06:00) got a very itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms. Events resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-histamine and steroid cream. Outcome of the event was not recovered.
This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 16th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site burning. On 16th June 2018, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the injection site burning was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient went to pharmacy to receive Shingles vaccination, she was given a bandage to cover the injection site after removing the bandage that evening on 16th June 2018, the patient's upper arm was extremely red and itchy. The patient stated that at the time of reporting had a tattoo like burn on her arm and it seems to be getting worse. The patient claims she would now seek the care of a dermatologist.
This spontaneous report was received from a physician via two company representatives from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 25-SEP-2015 the patient was vaccinated with improperly stored ZOSTAVAX (0.65 ml, once, lot #: L021609, expiry date: 10-SEP-2016, subcutaneous) in the left arm. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 4 year old female who on unspecified dates was vaccinated with the full series of ROTATEQ as an infant. The physician reported that the patient was immunocompetent. The patient got rotavirus and developed encephalitis in approximately April 2011 (reported as 3 or 4 months ago). The patient was hospitalized for an unspecified timeframe. The patient performed serotyping and other unspecified tests (results not reported). The patient sought medical attention via office visit. The patient recovered on an unspecified date in 2011. Additional information has been requested. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome 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 medications were reported. No Adverse events were reported.
Initial and follow-up information has been received from a Medical Assistant refers to a patient of unknown age and gender, medical history and concurrent conditions were not reported, who on 30-APR-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) that was exposed to temperatures outside of the recommended range during 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Reporter information and Product tab were updated.