chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster; Freezing after booster; Body ache from the top of his head to the bottom of his toes after booster; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 039K20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open Heart Surgery 10 years ago.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking violently for 4 hours, after booster/Thought he was having a seizure, after booster), FREEZING PHENOMENON (Freezing after booster) and MYALGIA (Body ache from the top of his head to the bottom of his toes after booster) outcome was unknown.     No any concomitant medications were reported. Patient had Pacemaker on 2019. Patient does not had a medical history of seizures.
Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.
This spontaneous report as received from a physician refers to a 40 year old male patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 29-AUG-2016, the patient was vaccinated with VARIVAX lot # L029472 with expiration date 06-AUG-2017, subcutaneously (dose was not reported). The patient had no concomitant medications. On an unknown date in 2016, following the administration of VARIVAX, the patient developed sore throat and chicken pox. The patient was seen by the physician and did not receive treatment for the events. None laboratory diagnostic studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and VARIVAX was not provided. Additional information has been requested.
Localized reaction to injection site, possibly systemic. Pt admitted to hospital. Pt is HIV positive.
The pt experienced a white bumpy rash which itched for a short time and then hurt and then started to swell and turn red, hot, the size of a silver dollar. The pt was seen by an MD who did not feel this was a reaction to the vax, feels was a bug bite reaction.
4 YO FEMALE FOR FOLLOWUP WITH PINK EYE.  GRANDMOTHER STATES PATIENT HAD A LUMP TO INJECTION SITE TO DTAP (RT THIGH.)  PATIENT WAS SEEN IN ER DUE TO THE DEVELOPMENT OF AN EXTENSIVE ERYTHEMA THAT COVERED MOST OF THE ANTERIOR THIGH WITH INDURATION IN THE AREA CIRCUNDANT TO THE SITE OF THE DTAP GIVEN IN THIS OFFICE.  SHE WAS GIVEN BENADRYL IN THE ER AND MOM WAS TOLD TO APPLY WARM COMPRESSES TO THE THIGH.  REDNESS AND WARMTH TO THIGH LASTED 3 DAYS ACCORDING TO MOM.  NO FEVER.  SHE APPLIED THE EYE DROPS AS PRESCRIBED AND STATES THAT CHILD'S EYES ARE NO LONGER PRESENTING WITH MATTED MATERIAL IN THE MORNINGS.  MOM STATES THAT CHILD HAS HAD 2 DAY HISTORY OF NASAL CONGESTION AND RHINORRHEA.  SHE HAS A MILD, OCCASIONAL NOCTURNAL NONPRODUCTIVE COUGH.
"silver dollar" sized red, raised welt noted on back of left upper arm.  Itchy.  Client taking Benadryl for treatment.  No pain or heat noted.  Noted on Friday, Aug 3, 2007 around 2pm.  Client called today stating effected area is slightly smaller in size today.
"Covid Arm" Hot feeling to touch in about a 4 inch radius , Burning and itching .
100 - 102 degree F  fever, body aches, joint pain:  Rash at injection site.  Symptoms began to subside after 36-48 hours.
Patient developed moderately painful vesicles on both arms, reported to our urgent care 2 days later and prescribed acyclovir course.
Pt recv vax on unknown day; post vax pt exp lightheadedness & dizzy
Red, slightly warm to touch, swelling right upper arm approx 8in x5in. Patient applied "anti-itch" cream.
Pt developed pneumonia 4 days following MMR II. Fever, cough, radiographic + infiltrate. Oral Azithromycin. Improving as of 9/29/08.
Diarrhea/loose stools; stomach cramps and pressure; stomach cramps and pressure; Overall achy feeling of being unwell; Overall achy feeling of being unwell; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in Left arm on 28Feb2021 11:30 (at the age of 67-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Migraine headaches, hernia, GERD (gastroesophageal reflux disease), asthma, Known allergies to Z-Pac and Brazil nuts. Concomitant medications included omeprazole, cyanocobalamin (B12), topiramate, nortriptyline, citalopram, fish oil, rosuvastatin, magnesium, melatonin, curcuma longa (TURMERIC), polycarbophil calcium (FIBER), vitamin A [RETINOL], vitamin d3, calcium and multivitamins [vitamins nos] received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 01Mar2021 at 06:00, the patient experienced, Diarrhea, stomach cramps and pressure for about 3 days. Then loose stools, cramps and pressure for 5 more days and overall achy feeling of being unwell. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient received the vacccine on Friday (9/11). Patient said that "cold-like symptoms" began on Saturday (day after vaccination), with "drainage and weakness" beginning on Monday. The patient said she had to call off work due to the severity of her symptoms. By Friday (one week later), she felt better. The patient noted that her other family members were sick with similar symptoms before her symptoms began, so it was likely a coincidence that she experienced these symptoms after receiving her flu shot.
From 2/28/21-3/6/21, I experienced weakness and a heaviness sensation in my legs. Arms were fine and I was able to ambulate without difficulty.  Since the symptoms resolved on 3/6, I did not see my PCP for further evaluation.
after accideantlly administering a dose instead of Infanrix; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 12-SEP-2023, the patient received Kinrix. On 12-SEP-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: after accideantlly administering a dose instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Sept-2023 A nurse called in to request information about Kinrix after accideantlly administering a dose instead of Infanrix. They requested their information not be logged in the database and gave partial information and declined follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received a dose of Kinrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
This prospective pregnancy case described the occurrence of cleft lip and palate in a male patient. The 17-year-old mother was a subject enrolled in an open label study. The subject received Flu Seasonal QIV Dresden .5 ml on 23rd March 2016. The mother's last menstrual period was on 27th November 2015 and estimated date of delivery was 2nd September 2016. The patient was exposed to Flu Seasonal QIV Dresden at week 16 of gestation and during the second trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. At 39 weeks and 4 days, the patient was born via vaginal delivery and weighed 3177 grams (7lbs 0oz) at birth. APGAR scores were 8 and 9. The patient was diagnosed with cleft lip and palate. Serious criteria included GSK medically significant and congenital anomaly. Additional event(s) included maternal exposure during pregnancy. The outcome of cleft lip and palate was recovering/resolving. The outcome(s) of the additional event(s) included maternal exposure during pregnancy (unknown). It was unknown if the investigator considered the cleft lip and palate to be related to Flu Seasonal QIV Dresden. See case US2016GSK046433 for details regarding the mother case. Additional details were reported as follows: The patient did not have any maternal medical history and diagnostic details. The patient had left cleft palate including 20 to 30 percent incomplete cleft of the lip and a complete cleft of the posterior hard and entire soft palate. On 11th January 2017, the left cleft palate operation (repair) was schedule. The birth defect was not evident from prenatal test. No medications were given to the neonate directly in utero or post-delivery.
1st shot last Summertime, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in last summertime).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-FEB-2023 Reporter's comment: The drug store said that they would call reporter when he/she need the second shot and they never did. The reporter enquired that he/she need to start over again, or do need just the second shot. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
5.5 cm in diameter, raised, red, tender area, (L) arm developed 2 days after injection.
Non-ST Elevation Myocardial Infarction  ED Course as of Mar 30 0128 Tue Mar 30, 2021 0107   Troponin T, Baseline, 5th gen(!): 770 0107   D-Dimer, P: 341 0127   Initial troponin is significantly elevated at 770. Heparin initiated along with aspirin and Plavix for non-STEMI.  Contacted for transfer to facility with Interventional Cardiology, she will is accepted to by Dr. She is currently chest pain-free, pulse has improved to 90. She remains hypertensive.  D-dimer is negative.
This spontaneous report as received from a female pharmacist of unknown age concerning herself. The pharmacist called to report of topical skin exposure and eye exposure to herself after some reconstituted ZOSTAVAX (lot# was unknown) sprayed out during withdrawing of the solution in a syringe on 16-OCT-2012. No adverse effect reported. PQC filed. Additional information is not expected.
Patient received the second dose for the Moderna covid 19 vaccine a week earlier from their due date on day 28 (3/1/23). We contacted the patient and he states that he experienced chills as of 2/23/22.
fever; Chills; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Mar2021 (reported as two weeks ago last Saturday, as of 22Mar2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Consumer stated he and his wife received the first dose of the Pfizer COVID vaccine two weeks ago last Saturday and last night his wife experienced some side effects. Consumer stated his wife had a fever and chills but also had a couple glasses of hot water before her temperature was taken. Consumer stated the fever went away fairly quickly and it may not be related to the vaccine but he just wanted to call to check. Consumer stated they were scheduled to receive the second dose this Saturday. Treatment measures received for fever and chills. The outcome of the event fever was recovered on unspecified date, while of the other event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known on available information and quite long time interval (more than 1 week) between event onset and vaccination, the event Fever is more likely represent an intercurrent condition and unrelated to suspect product BNT162B2.
Injection site had 3 x 2 inch red circle/oval; Injection site was hard; Injection site was hot; if it was touched and slight soreness; Arm not hurt much, but only if it was touched and slight soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. On 4th January 2020, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site induration and injection site warmth. In January 2020, the patient experienced injection site pain and tenderness. On an unknown date, the outcome of the injection site pain, injection site induration, injection site warmth and tenderness were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, injection site warmth and tenderness to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm and reported it did not hurt much afterwards, but only if it was touched and slight soreness.  The patient not observing her arm until 4th January 2020 where the injection site had 3 by 2 red circle and oval that was hard, hot and very red.  The patient reported that the area was approximately one third to half its original size and that it was light red and light pink. The reporter consented to follow up.
Area around injection site with 2-3 in x 2-3 inch redness, able to see where immunization given. no warmth or drainage, pain with deep touch. Stated 1 day prior to office visit (given SubQ) cellulitis.
Dizziness 3 days after shot.  Rash on injection site day 8 after injection!
Incorrect product storage (unknown if vaccine was administered); This case has been considered invalid-Unspecified AE.  COVID-19 Vaccine temperature related enquiry by a costumer  Product and costumer information:  Product description: Pfizer BioNTech COVID-19 gray cap Batch/LOT number: FP7135 Expiry date: Nov2021 Date of shipment arrived at costumer and reference number for shipment (If applicable): 09May2022 Number of product unit impacted: 30 vials Costumer type: Pharmacy Temperature excursion information:  Is the product diluted or undiluted: Undiluted Where the product stored when excursion occurred?: Freezer  Maximum and minimum temperature reported/Measured during excursion: -5 to -6degree F Duration of excursion: 49 Provide the completed temperature data during storage at costumer location: Attached If Pfizer has not delivered product o the costumer location where excursion has occurred, provide the temperature data for the transport to this location to confirm this stock has not experienced any other /previous excursion: Pfizer delivered to this location  Follow-Up (30Jun2022): Follow-up attempts are completed. No further information is expected.
Erythematous confluent, urticarial rash on trunks, extremities:? erythema multiforme. T 99.4-101.3
Pt states she developed redness an induration at the site of application of VZV vaccine. She states she developed a mild fever which lasted two days. As of 6/20/ 17 she states she began to develop red, itchy rashes on her face arms, abdomen, chest and back.
Back aches; Headache; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No patient medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included high blood pressure medications and antidepressants.    Reporter did not allow further contact
1st dose on 30Dec2019, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th December 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The practice manager reported that the patient never received the second dose of Shingrix.   The reporter did not have the lot number and expiration date information for the first dose. The reporter gave permission for follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Starting 07/05/2022, I got this massive headache that is like a migraine. It spanned from the back of the head to the front. I had to take off work for it. Also, I experienced blurred vision and imbalance issues. After I took a nap, the headache subsided. Unsure if its related to heat or not.
Extreme fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, for tolerance refer case US2022AMR107005).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingrix and experienced extreme fatigue. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR107005:same report, other dose
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox. Pt was treated with Benadryl and hydrocortisone.
His dad informed us at an appointment a few days later for his own vaccine that his son had had some numbness and tingling  and paralysis starting on the left side of his face that he went to the ER for and has seen his PCP.   I spoke with patient last week when he brought his mother for her vaccine and his issue was resolved however he did decide not to get his own second dose,  the numbness and tingling and inability to close his left eye lasted about 3 days.
Resulted in subacromial bursitis, went through 6 weeks of physical therapy, still experiencing pain in shoulder
Patient was given Anthrax, PPD and TDAP without her HCG results. Patient is pregnant.
Pt found face down & not breathing on 2NOV91 AM; an ambulance was called but the pt could not be revived;
Significant eye pain.  Saw flashes of light in my left eye then many floaters. My vision since has been cloudy and difficult in my right eye. Went to eye dr. following morning, she advised I have acute eye inflammation, visceral detachment, floaters and also had ocular migraine.  She prescribed a strong eye steroid for me to take for 7 days.  I'm on day 3.5 of treatment, seeing/feeling some relief but still having significant vision difficulties in my right eye.
Pt had H1N1 vacc on 12/4/09 and 2 days later felt her R thumb was numb and achy on the nail bed, then R arm was sore and the thumb looked blotched and tingly. The 2nd finger on the nail bed was achy as well. The pt took ADVIL and FLEXERIL and used warm compresses that helped some. Last night did not take FLEXERIL and woke up with a feeling of having a vice around her upper arm with numbness and tingling to hand and fingers with thumb feeling cold and numb. Pt broke out with fever.
Patient developed pruritic rash and throat itching shortly after vaccines administered. Given BENADRYL and observed in office with resolution of symptoms.
Swelling & redness at/or below shot injected. Referred to PCP on 10/7/11 told to take IBU and ice.