chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chief Complaint: Respiratory distress. Additional Medical History:  This 68-year-old female was brought to the ED by an ambulance from a nursing home in a state of respiratory distress. The paramedics state that the patient's oxygen saturation was in the low 70s when they arrived at the nursing home. They applied the CPAP and transported the patient to the ED. The paramedics were told that the patient has been having a chest congestion for the last 2 days. It appears that her tracheostomy was reversed in August 2021.
LOCALIZED PINK ROUND AREA, PAINFUL TO TOUCH, WARM TO HOT FEELING, SIZE IS GROWING IN A DAY.
Patient report (today on 4/25/13) nausea, vomiting, arthralgia and malaise since the first rabies vaccine on 03/25/2013.  She report that it is getting better.
Noticed skin reaction on opposite arm...not a rash, but wrinkling of skin, like it is crumpled tissue paper. It has progressively spread to other arm, breast area, and now neck. It is not itchy or bothersome.
Fever, chills, fatigue, ache, at injection site minor soreness. This went on for about 32 hours
Hives and rash on left forearm. Took antihistamine for 24 hour period to reduce itching. Hives and rash disappeared within 48 hours.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 10-SEP-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is on of several reports received from the same source. Additional information has been requested.
in process of administering Rotarix when she took off the cap; a drop squirted in her eye; This non-serious case was reported by a nurse via sales rep and described the occurrence of occupational exposure while administering product in a 21-year-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced occupational exposure while administering product (Verbatim: in process of administering Rotarix when she took off the cap) and exposure via eye contact (Verbatim: a drop squirted in her eye). The outcome of the occupational exposure while administering product and exposure via eye contact 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: 26-MAY-2023. Medical Assistant was in process of administering Rotarix. When she took off the cap, a drop squirted in her eye. She went home and rinse her eye and notified office manager. A portion of the Rotarix dose leaked on the pharmacist eye, which led to exposure via eye contact and occupational exposure while administering product. The reporter agrees to follow up from GlaxoSmithKline.
Information has been received from a published literature article. The patient reported here is a 5-month-old boy born to non-consanguineous parents who presented with lethargy, dehydration, and failure to thrive. He had developed chronic diarrhea beginning at 2 months of age and had poor weight gain over the month before admission. He had been vaccinated with ROTATEQ at 2 and 4 months. Before his admission, a stool sample had grown Salmonella. His blood cultures on admission grew Salmonella that was promptly treated with antibiotics. Further testing of his stool revealed Rotavirus antigen as well as persistent Salmonella. A diagnosis of severe combined immune deficiency was suspected and then confirmed (TB-NK, IL-2RG mutation). He quickly decompensated after 48 hours of admission with onset of respiratory distress and was diagnosed by bronchoscopy to have Pneumocystis jeroveoi. A stool sample was assessed by RT-PCR for the genes VP6 and NSPI. They matched the ROTATEQ strain exactly. One month later, he continued to demonstrate rotavirus antigen in his stool. He is currently awaiting stem cell transplant by unrelated matched donor. Additional information has been requested.
Tingling mouth and tongue, and body itching - given Benadryl PO 50 mg.
A physician reported that a male pt received an injection of Pnu-Imune 23 and subsequently, developed tachycardia and a fever of 99.8F. He also developed an injection site reaction characterized by swelling and warmth. His blood pressure was 112/74. Follow-up information received from the physician on 4/3/01, indicated that a 43 year old male received Pnu-Imune 23 and Fluvirin (Evans) vaccines on 12/5/00. The following day, he developed tachycardia, fever and an injection site reaction at the site of Pnu-Imune 23 administration. The pt recovered.
It was administered really high in the arm, I started bleeding right away, no other pain at the time really. In the middle of the night I woke up in extreme pain, I couldn't lift my shoulder or move without being in so much pain.  The first dose was a normal pain but this one I couldn't move my shoulder. This lasted days with extreme pain. I am still having issues with range of motion in my arm, certain ways I move my arm still causes pain but not extreme.  I did a virtual visit on the next day after the 2nd dose and he prescribed a mild pain medication and recommended if it wasn't better in a week to come in and see someone. The pain didn't get better so I went in to see someone.  The did an xray and nothing was wrong. and didn't know what exactly was going on and said it was  varsities.  He recommended doing cortisone injections but I opted out.
Sore arm, mild cold symptoms on Day 1 & 2, was expected, didn't worry. Then all was normal again until Day 9, which was 1/11/21 appx 2:00 am. Sore arm awakened me. Area at and below injection site red, swollen, about 2" x 2" diameter. By 2:00PM, area had grown to 7" x 4", very swollen, very warm to touch, burning sensation. Got home from work about 7:00pm, took benadryl, applied cool compress and massage, went to sleep. (Had called my doctors office, was waiting for call back.) Next morning about 4:00am, arm didn't hurt as much, was less red and swollen, but now itched very much. Whole body felt itchy, including inside my ears. I called out sick to work, took more benadryl, and planned to go to urgent care if needed. Doctor called me about 10:00am, waking me from benadryl sleep. They advised observation if no worsening, urgent care if it did. Since then, flat red patch on injection area, mild itch, mild swelling. Co worker just informed us she had same symptoms today (got her vaccine on 1/5/21) & is diagnosed cellulitis & prescribed antibiotics, so now I'm worried about my arm again, and worried about the lot number and reporting this reaction.
Patient was unable to walk steadily the night of her immunization, she had three falls. She had recovered by the next day. There was a similar occurrence when the patient was 2, she had been walking for quite a while after DTap was unable to walk for three days, crawled during that time then did recover and walk again.
pt recv vax;pt was discovered to be covered of rash from head to toes;raised,itchy spots; to er; had allergic rxn per hosp;dph given; still breaking out on hives;
Redness, itchiness, swelling about quarter size around injection site.  Started today, 2 days after injection.  No medication taken yet, may take Benadryl.
Approximately 3 to 5 minutes after immunization, patient was observed  in a waiting room chair unconscious, unresponsive and not breathing (respiration was not immediately observable or recognizable).  Patient was carefully and quickly placed in a supine position on the floor.  Pulse was present but the patient was completely unresponsive.  Respiration was not observed.  EMS was immediately notified.  Pharmacist and staff prepared for resuscitation and utilization of Epinephrine if needed.  Patients face was flushed, arms became flushed and the patients skin became moist.  After approximately  45 seconds in the supine position the patients eyes opened and he became responsive to auditory communication.  Respiration became reestablished.  BP was recorded at 130/91 with a pulse of 91 BPM.  EMS arrived on scene and provided further evaluation.  After an additional 5-10 minutes, patient was completely conscious and coherent.  Patient indicated that he had a similar experience in a grocery store over 1 year ago that was unrelated to immunization and was attributed to dehydration.  Patient refused additional medical care or transport to ED.  Patient was released to a friend who drove him home.  Patient was observed 1 day later picking up his car from the pharmacy and has recovered.  Patient was advised to seek additional medical evaluation to assess the root cause of this event.
Information has been received from a physician concerning a 10 year old female who on 15-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 15-JUN-2007 the patient experienced injection site reaction. The patient's injection site reaction persisted. No further information is available.
Dizziness and quickened breath after injection and then fainted about a minute or so after injection
Pt received shot at noon, 4 hrs later experienced fever, loss of energy and appetite, and nausea. Better next day but not 100% until 10-4.
Pt verbalized that HE DEVELOPED A "LUMP" ON HIS RIGHT PALM BY THE MIDDLE METACARPAL JOINT AND HIS  RIGHT NDEX FINGER.  HE VERBALIZED THAT HE NOTICED THE LUMP 0.5CM 3 DAYS AFTER RECEIVING THE VACCCINE, DECEMBER 3, 2021.  HE STATES THAT HE RECEIVED THE VACCINE ON HIS LEFT DELTOID, BUT THE LUMP CAME UP ON HIS RIGHT PALM, WHICH IS TENDER TO TOUCH 4-5/10 PAIN. HE VERBALIZED THAT HE DOES NOT HAVE ANY NERVE PAIN , BUT WANTED TO COME TO THE CLINIC TO HAVE THE REACTION DOCUMENTED. HE DENIES HAVING ANY OTHER  SYMPTOMS.
A few days after the second dose I had this sudden weakness come over me. It is very similar to when I have a blood sugar crash but without the dizziness that I usually get when that occurs. I noticed that in my left hand I could not grip anything very well it was weak and just not functioning correctly. The weakness went away but the the grip in my hand has never come back. I had this occur a few weeks later and then it went on for a few weeks and I ended up going to the urgent care and they sent me to the ER. They did many tests at the ER and could not find anything that would be causing this weakness. This now happens every once in awhile where this weakness comes on and it will last a few days to a few weeks and then it will go away but the hand weakness has never returned. I have since met with my PCP and they stated based on the tests that this could be because of the vaccine. I also do not have the lot number for my first dose of the series.
indurated rash around the injection site, no blisters, treated with keflex for possible cellulitis
Swollen Clavicular Lymph Node (still swollen as of this writing); Headache ~ Mild to Severe (continues as of this writing) Body Ache x3days
My son just turned 12 years old on 7/28/2009. He received his 1st dose of the Pfizer covid-19 vaccine on 8/3/2021. He started experiencing a cough the next day with no other symptoms. His cough still lingers daily. It's just one cough every so often. He has not been sick nor in contact with anyone with the covid virus. He is not sick nor running a fever. You should know this symptom was caused by the vaccine. Thank you
Swelling of lip and rash on lip - lasted 2 hours Nausea, fatigue, temp of 101-102, exhaustion for 96 hours after shot. Did not seek medical help- treated with pain medicine, ice packs, heat packs.
Redness about 1-2 inches below injection site that began 2 days after vaccine. No pain associated or any other symptoms.
No adverse events at this time.  Patient had vaccine on last normal menstrual cycle with positive pregnancy test this date.
About 10 hours after vaccine muscular aches fever 103 headache,fatigue  next day achy no fever fatigue,slight headache, next day fatigue a week later noticed hard knot at injection site and sore arm itching a few weeks later noticed swollen lymph nodes under left arm into breast went to doctor and waited a few weeks and got mammogram and was ok
I started having severe diarrhea and watery stools 6-10 times a day. I was experiencing cramping, headache, off and on low grade fever, and nausea. That went on for about 10 days. I had a sudden intense pain under my left breast. I broke out into a cold sweat. That lasted for about 15 minutes and in the midst of that we called the squad. They did an EKG and didn't find anything. They believe it was related to my digestive issues. The next day my doctor had me admitted to the hospital. I was there Wednesday through Friday. They did a colonoscopy and a CT scan. They did a biopsy on my stool. They diagnosed me with microscopic lymphocytic colitis. I have now had that for about 3 and a half weeks. I am currently on some medication called Cholestyramine twice a day. It seems to be helping. I am now having about 4 loose stools a day but they are no longer watery. I am not experiencing as much discomfort.
Patient received her first Covid Pfizer vaccine in our facility today. Due to  allergy HX patient was instructed to wait for 30 mins in observation.  Patient received vaccine at 10:48am at 11:18am patient complained of itchy throat and presented with a cough. Provider was notified immediately and ordered for the patient to receive 25 mg of Benadryl IM. After administration of Benadryl patient was observed for another15 mins. Patient  reported feeling ok  with no itchiness or cough present. Patient educated and given literature of what to expect after vaccination and instructed to  call 911 or report to nearest ER immediately if any severe reactions are displayed. Patient discharged to home accompanied by her husband.
COVID infection with symptoms starting 9/23/2022. Sore throat, headache/migraine, body aches, fatigue, nasal congestion, chest congestion. took Paxlovid for 5 days and feeling better on Day 10, 10/3/22.
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-APR-2017, the patient was vaccinated with PROQUAD (lot number M043307, expiration 24-APR-2018) for prophylaxis. The nurse was unable to provide the lot number and expiration date for the sterile diluent used to reconstitute the vaccine. The nurse reported that PROQUAD was not given inadvertently. The patient had no prior history of receiving M-M-R II,  PROQUAD or VARIVAX. No adverse events reported. No additional information available. Lot number M043307 has been verified to be a valid lot number for PROQUAD. Additional information has been requested.
Patient received AFLURIA vaccine on 10/18/14 and came to pharmacy on 10/30/14 to report trouble fully moving arm and arm pain.
approx 4hr p/vax vision narrowed & loss of vision lt half of both eyes;dx from ER w/subsequent test w/o stroke or MS poss;tx w/ASA & pred;vision problems started 11/3/99, partial vision recovered;60 day follow-up / no additional data.
Vaccination site pruritus; Vaccination site swelling; Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). On 03-Feb-2021, VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.            No concomitant medications were provided by the reporter Treatment medicines include Some Allergy medication (not specified)   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received , updated second dose information and event outcome was updated from unknown to recovered.
Approx 8hrs p/2nd dose experienced a flu-like illness w/sore throat, diaphoresis, URI, h/a, n & pain in lt deltoid, @ site of inject, which radiated to wrist;
Sore arm; itching; 2-3 inch rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (itching) and VACCINATION SITE RASH (2-3 inch rash around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032LZ0A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease, CIPROFLOXACIN and DENOSUMAB (PROLIA) for an unknown indication, MULTIVITAMIN [VITAMINS NOS].   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (2-3 inch rash around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching). On 12-Jan-2021, VACCINATION SITE RASH (2-3 inch rash around the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and PRURITUS (itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that the first vaccine and second vaccines had the exact same rash on each arm from the shoulder to elbow. Concomitant medications also included Probiotic, Caltrate and Milk Thistle. She also stated that her dermatologist had suggested to apply Hydrocortisone to lessen the itching and oral Benadryl.   This case was linked to MOD-2021-208080.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received (New event added.); 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.
Patient got purplish blisters on opposite arm the vaccine was given. Went to urgent care and got acyclovir.  Patient symptoms resolved and feels better.
On 10/30/2021, patient received 2nd Pfizer COVID-19 vaccine. Pharmacy instructed the patient to sit down for 15 minutes. However, patient and a family member were standing and talking while the pharmacist was giving a shot to another family member. The patient fell and injured his forehead and wrist. Patient lost consciousness for about 15-20 seconds. Pharmacist observed minor scratches on his forehead and bruise on his wrist. Pharmacy provided water, food and sat the patient down on a chair. After observing the patient for 30 more minutes, pharmacist provided education on post-vaccination safety and instructed the patient to take ibuprofen or acetaminophen for the pain and Neosporin on the forehead scratches. Patient left the pharmacy in a stable condition.
Left arm edema, tenderness, fatigue onset 15 hours after injection. Felt arm pain with movement 15 hours after injection. Unable to move arm without pain. No fever, chills, no erythema at injection site. Ache into neck.
Flu like symptoms on March 13 & 14.  Dizzy, fatigue, lightheaded started March 15.  I went to the Emergency Room on March 15 and told them I was having a reaction to the vaccine.  I waited for over an hour and no one helped me but they helped everyone else who came after me, and with Covid so I left. I called Dr and went to his office that day.  I had a hyperbaric oxygen chamber treatment and he put me on glutathione, multiple vitamin, zinc, Vitamin C, minerals.  I continued  seeing Dr and continued with the oxygen chamber treatments until I left New York to return home to Cape May, NJ. on May 3. I then rented a Hyperbaric Oxygen Chamber on May 4 that I continue to use daily to this day, as I continue with fatigue, dizziness, lightheadedness , although it is lessening.
Arm hurts; headache; fever; nausea; throwing up; hot to touch on arm; itchy; feeling very run down; Swollen arm around area of vaccine administration,; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced fever and nausea. In September 2022, the patient experienced injection site swelling, vomiting, skin warm, pruritus and fatigue. On 15th September 2022, the patient experienced pain in arm and headache. On an unknown date, the outcome of the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache were unknown.   It was unknown if the reporter considered the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache to be related to Shingrix.     Additional Information: GSK receipt date: 14-Sept-2022 and 15-Sept-2022 Reporter's comment: The patient had received a dose of Shingrix and on the same day of vaccination in the evening, the patient reported fever and nausea. 1 day after vaccination, the patient reported throwing up and fever. 2 days after vaccination, the patient reported swollen arm (around area of vaccine administration), hot to touch, itchy and feeling very run down. 3 days after vaccination, the patient had nausea, arm hurts, headache, hot to touch on arm/itchy and feeling very down. The reporter consented to follow-up. Additional supportive information: Based upon the intake response 'Yes, that is correct the events described on September 15th occurred on the 15th. I assumed I could include that information given I was writing the report on the 15th.', new tracking memo was created considering that on 15th September 2022, events were reported and for arm hurt and headache onset date was considered as 15th September 2022, as per response both events occurred of this date.
LOW OXYGEN SATURATION; HEALTH ISSUES; HIGH FEVER; SEVERE FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced low oxygen saturation, health issues, high fever, and severe fatigue. Laboratory data (dates unspecified) included Body temperature (NR not provided) High, and Oxygen saturation (NR not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, severe fatigue, health issues and low oxygen saturation was not reported. This report was non-serious.