chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient left the observation room 15 minutes after being vaccinated. He came back and stated he is feeling dizzy, high and tingling in feet and legs. Per patient he has history of smoking and anxiety , but no other health problem or allergic reactions to food or medications. Checked patients vitals sign after he was lying down . BP 121/73, HR 75, O2 sat 96%, pain 0/10.  Patient was given a bottle of water after stating he did not have any fluid since morning. Per patient he had breakfast before coming to the clinic. No signs of hypoglycemia noted at this time. Patient was asked to to stay 15 more minutes in the observation room to monitor him closely. Patient stated he is feeling better. Did not notified the paramedic since patient was feeling better with stable vitals signs . Patient was educated on s/s of anaphylactic reaction and when he needs to ask for help  before he left .
Myalgia, Arthralgia, Fever, fatigue, malaise Narrative:   Other Relevant History:
Drag himself even after using a walker which makes it harder for him to walk.; Become physically weak; has to walk very slow and drag himself even after using a walker which makes it harder for him to walk; Lost his physical ability; Wet himself; Lost his  mental ability; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Lost his mental ability) and MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Lost his  mental ability) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) and URINARY INCONTINENCE (Wet himself). On an unknown date, the patient experienced ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) (seriousness criterion medically significant) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk). The patient was treated with Physical therapy for Mental impairment; Physical therapy for General physical health deterioration; Physical therapy for Mobility decreased and Physical therapy for Gait disturbance. At the time of the report, MENTAL IMPAIRMENT (Lost his  mental ability) and GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) had not resolved and URINARY INCONTINENCE (Wet himself), ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was provided.  Treatment information include that the patient had seen by a physical therapist but stated that there was no any improvements.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a Nurse, concerning a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in December 2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). The nurse stated that the patient received the second dose of GARDASIL 9 on an unspecified date in April 2018. No adverse effects were reported for the patient.
MAXILLARY EMBOLISM; PROFUSE NOSE BLEED; SEEMED TO BE A 3-4 INCH LONG WORM IN THE VEIN OF HIS LEFT OUTER THIGH; FELT LIKE CRAP; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronary stent, and concurrent conditions included alcohol use (a beer or two a day after work), and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1total, administered on 05-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cefalexin for infection, acetylsalicylic acid, atorvastatin calcium, lisinopril, and metoprolol.  On 05-APR-2021, within the first hour after vaccination, the patient felt like crap (feeling sick) and took a bath and relaxed after that he felt better. On 14-APR-2021, while he was taking bath he yelled at his wife and also the patient experienced profuse nose bleed which lasted for 20 minutes. These nose bleeds occur at least 4 times daily lasting about 20 minutes each time. On 20-APR-2021, the patient went to emergency room and he had a plug procedure and was discharged. On 25-APR-2021, the patient went to the hospital because his bleeding was ongoing and his Platelet count (NR: not provided) Not reported and treated him with some platelets and cauterization procedure was done. On 26-APR-2021, he was discharged from the hospital. On 27-APR-2021, still his bleeding was ongoing and he was taken back to the hospital. On 28-APR-2021, a surgery for maxillary embolism was performed and he was discharged from the hospital on 01-MAY-2021. This was very stressful for the patient and his entire family. The patient was not prone to nose bleeds and so this has been scary. A week and half after vaccination, there seemed to be a 3-4inch long worm in the vein of his left outer thigh. The patient walked it off and it do go away relatively quickly. The patient's wife was not sure that what will happen next. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seemed to be a 3-4inch long worm in the vein of his left outer thigh on 14-APR-2021, and felt like crap on 05-APR-2021, had not recovered from profuse nose bleed, and the outcome of maxillary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210509176-covid-19 vaccine ad26.cov2.s-maxillary embolism, profuse nose bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210509176- covid-19 vaccine ad26.cov2.s-felt like crap. This event(s) is labeled per RSI and is therefore considered potentially related.
Initial and follow-up information has been received from a registered nurse concerning a 72 year old male consumer with high blood pressure, high cholesterol, benign prostatic hyperplasia, CORICIDIN allergy and history of eczema and chickenpox (date unknown) who on 08-APR-2008 was vaccinated SQ in the left arm with 0.5mL zoster vaccine live (Oka/Merck) (lot # 659267/1836U). Concomitant therapy included lovastatin, NIASPAN and fish oil. Subsequently, the patient developed a bilateral rash 2-3 hours after vaccination. It was a diffuse rash that looked like chickenpox. It covered his trunk, arms and one leg. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information indicated that the patient developed more than 100 lesions all over on his legs, buttocks, and trunk. It was noted that there was no recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesions was collected and received in the laboratory on 30-APR-2008. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicle lesion was an adequate specimen, no VZV identified-Negative. Additional information has been requested. This is in follow-up report(s) previously submitted on 6/24/2008.  Initial and follow-up information has been received from a registered nurse concerning a 72 year old male consumer with high blood pressure, high cholesterol, benign prostatic hyperplasia, CORICIDIN allergy and a history of eczema and chickenpox (date unknown) who on 08-APR-2008 was vaccinated SQ in the left arm with the first dose of 0.5ml ZOSTAVAX (lot # 659267/1836U).  Concomitant therapy included LOVASTATIN, NIASPAN and fish oil.  Subsequently, the patient developed chicken pox type rash on trunck and extremities 3-4 hours after vaccinations.  It was a diffuse rash that looked like chickenpox.  It covered his trunk, arms and one leg.  Medical attention was sought in the office.  There were no lab studies performed.  Subsequently the patient recovered.  There was no product quality complaint involved.  Follow-up information indicated that the patient developed more than 100 vesicular lesions all over on his legs, buttocks, and trunk.  It was noted that there was no recent exposure to chickenpox or shingles.  The patient was enrolled in the in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WTI VZV strain or with the OKA/Merck vaccine strain.  The sample of the lesions was collected and received in the laboratory on 30-APR-2008.  The sample was taken from a vesicular lesion.  The PCR results for the specimen from the vesicle lesion was an adequate specimen, no VZV identified-Negative.  Additional information is not expected.
syncope; POTS; fatigue; Dizziness; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2010, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Extreme fatigue, slept for most of Saturday; Extreme fatigue, slept for most of Saturday; This is a spontaneous report from a contactable health care professional, the patient. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 at 13:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Dec2020 at 09:00, the patient experienced extreme fatigue and slept for most of Saturday (as reported). Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "extreme fatigue, slept for most of Saturday" was resolving.  Information on the lot/batch number has been requested.
Flu like symptoms. Body aches, head ache, stuffy, runny nose. Swollen raw throat to the point I could not talk. Vaccinated at 3:18 AM current time is 3:34 PM symptoms are current and ongoing.
Information has been received from a physician concerning a father who's one year old son on 01-JUN-2009, was vaccinated subcutaneously with 0.5 ml of VARIVAX (Merck). The one year old son did not develop a rash or adverse experiences, however, the father reported he "now" has shingles. The physician was not interested in the VZV analysis by PCR. It was reported that medical attention was sought for the 1 year old son via a phone call. The father's outcome was unknown. Additional information has been requested.
Patient presented to emergency department 7/25/2021 with complaints of cough and weakness. Hospitalized for three days and discharge home with home health care on 7/28/2021.
PATIENT RECEIVED FIRST FOSE COVID19 VACCINE AT 10:20AM TODAY, SECONDS TO A MINUTE AFTER THAT PATIENT FAINTED FOR A FEW SECONDS BUT RECOVERED IMEDIATELY NOT KNOWING WHAT HAPPENED.  911 WAS CALLED STAT AND ARRIVED  WITHIN APROX 5 MIN. PATIENT WAS COMUNICATIVE IMEDIATELY AFTER INCIDENT, SAID HE FEELS GOOD NOW BUT DIZZY BECAUSE HE DID NOT EAT FOOD IN THE AM.  FATHER WAS PRESENT. EMT NOTICED PATIENT'S BLOOD PREASURE VERY LOW AND TOOK PATIENT TO THE HOSPITAL RIGHT AWAY. PATIENT DID NOT WANT TO GO TO HOSPITAL IMEDIATELY BUT AGREED AFTER ADVICED TO DO SO. PATIENT DENIED TROUBLE BREATHING OR ANY OTHER SYMPTOMS WHILE PRESENT AT PHARMACY.  PATIENT AND EMT LEFT SITE BY 10:39AM
pt reported diff breathing & rash the day p/vax;came 2 days later into clinic, erythematous, fine rash over trunk & arms;eyes red & puffy, breathing non labored, lungs cleared given DPH then pred taper
Seen by MD for localized reaction @ site of inject red, tender, swollen, hot - no abscess increasing in intensity rt p/inject until seen in E.D.
mild anaphylaxis reaction; head feels heavy; itching; hives; swelling in the lips; swelling in the tongue; Mild arm soreness; A spontaneous report was received on 06 FEB 2021 from a consumer concerning an 73-years-old, male patient who received Moderna's COVID-19 vaccine and developed mild arm soreness,  mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 FEB 2021, approximately at 1:30 pm, patient received their first of two planned doses of mRNA-1273(Batch/Lot # 011M20A) intramuscular injection for the prophylaxis of COVID-19 infection.   On 05 FEB 2021, on the same day of receiving vaccine, the patient had mild arm soreness. On 06 FEB 2021, Patient experienced a mild anaphylaxis reaction at 3:30AM, Itchiness, hives, swelling of the lips and tongue, head feels heavy. Patient shared that she recently had Allergy Vaccine (Serum) last February 3rd as he knew to have an allergy to everything (he stated). Treatment for the events reported was Benadryl.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, mild arm soreness, mild anaphylaxis reaction, itching, hives, swelling in the lips, swelling in the tongue, head feels heavy, were unknown.  ; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of ANAPHYLACTIC REACTION along with a NS unexpected event of head discomfort and NS expected events of urticaria, pruritus, myalgia, lip swelling, tongue swelling.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Benadryl. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe chills started later same day and resolved by morning; muscle aches in back and arms and headache also resolved by next day; redness at injection site extending over top of shoulder (about a 4" x 2" area that looks like a sunburn) still exists after 3 days.
the patient received improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-SEP-2019, the patient received improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose intramuscularly, in left thigh (lot # S007770, expiry date 24-JUL-2020) for prophylaxis. Previously, the patient was administered one dose of hepatitis a vaccine, inactivated (VAQTA). Storage temperature was 1.4 Celsius degree during the time frame of 20 minutes. Previous temperature excursion was 10.5 Celsius degrees for 56 minutes. The digital data logger was involved. The outcome of product storage error was unknown.
Mom states pt had fever of 103 R; states gave pt APAP as instructed; pt vomited, had diarrhea, no appetite, would not sleep, very irritable x 1mo; mom called MD seen by MD 2 days later;
Choking cough, threw up mucus, intensely started scratching abdomen...suddenly blanket of hives/ welts appeared completely cover full chest/ abdomen, neck, parts of face/back. Face getting intensely red, lips swelling, trouble breathing (wheezing). Dr treated with prednisone and 2 tsp Benadryl almost gave epi pen, wanted to see how she responded to those treatments. Medicine was given within 7 minutes of initial reaction. Continuing to monitor and give same does every 6hrs for next 24 hrs.
I do NOT KNOW what type of FLU vaccine was given to my daughter please contact the dr's office for this information. My daughter woke up early in the morning relaying her throat was bothering her and she could not speak well. She was able to breath well however her throat was a little red. The next day she vomited at least three times and said she felt hot she was pale and complained her throat was bothering her. She blew her nose and a tinge of blood came out a few times and mucus color ranged from clear to slight yellowish/ light brown. The 3rd day she spit up liquids twice, complained of still having discomfort in her throat and stuffy nose throat bothering her so I brought her to the walk in urgent care center the dr. told us it was viral and most likely an adverse reaction to the flu vaccine.
no fever;had sz, eyes rolled back in head;turned blue around lips;head was jerking slightly;
Had dizziness, mild swelling, abdominal pain after HPV 2-3 hrs ago.
Mild fever for 2 days (8/13/01-8/14/01) that ranged from 102.3F to 99.0F. I gave her Motrin IB/Infants Formula at 02:00 on 8/13/01 to bring down the fever of 102.3F then fever went down to 100F. I gave her some more on 8/14/01.
The evening of the injection, the patient began to experience itching on her right arm distal to the injection site. By the next morning, her arm was swollen as well as itchy and red. She also experienced nausea, dizziness and headache. Her symptoms resolved in about 24 hours.
pt recv vax 9DEC97 & 6JAN98 pt left US to visit Finland, Estonia & Russia & returned home 24JAN98;approx 31JAN98 pt became ill was hosp dx w/hepatitis A;dx established on basis of an antibody rise to hep a virus;
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on approximately 11-MAR-2008, in the last two days, was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 11-MAR-2008, in the last two days, the patient experienced an injection site reaction. There was a large red area that was swollen and painful. At the time of this report, the patient had not recovered. The reporter is requesting that a lot check be done on this lot number. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Has had nausea and diarrhea, was vomiting even through nose, for a day and a half. Took some Pepto Bismol, stool finally began to harden today. Pt feeling much better.
Pt started vomiting 15 minutes after receiving first dose of COVID-19 vaccine, therefore was given ondansetron. NauseaVomiting
Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female with no medical history or concurrent condition who on 26-MAY-2009 and 30-JUL-2009 was vaccinated intramuscularly with her first and second 0.5 mL dose of GARDASIL. There was no concomitant medication. The patient had "missed her last three menstrual periods". The patient performed a home pregnancy test which was negative. At the time of report the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to an approximately 76-year-old female patient. The patient's medical history included shingles and prior history of post herpetic neuralgia pain in the right shoulder. The patient had no allergies and no drug reactions. On an unspecified date, in 2015 reported as "earlier this year", while she was suffering from shingles, she was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not provided). Concomitant therapies were not reported. On an unspecified date, in 2015, the patient experienced shingles again. At the time of this report, she was treated with prednisone (manufacturer unknown), acyclovir and ZITHROMAX. The outcome of the event was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sore arm continues 1 month after injection. Recommending anti-inflammatories.
pt recv vax 8MAY97 & pt devel swelling, redness & several colors @ inj site & presented to ER;
red dot went away over the weekend and woke up on Wednesday and was itching my arm . it is red and raised and hard and very itchy
It puffed up for about 4 to 5 days but now there is a bruise under the skin. It doesn't hurt or itch anymore; It puffed up for about 4 to 5 days but now there is a bruise under the skin. It doesn't hurt or itch anymore; This is an spontaneous report from a contactable consumer (patient) reported for herself via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 07Apr2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced it puffed up for about 4 to 5 days but now there was a bruise under the skin. It doesn't hurt or itch anymore on an unspecified date. Will that go away. This Wednesday will be 2 weeks. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient contacted me about one week ago and states that her shoulder has been in pain since the vaccine.  States that she tried icing it and taking medicine for the pain but it still persists.  Patient was visiting and has now returned to home.