chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard time sleeping/Patient has been sleeping from 3am to 7am; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Cardiac operation. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), TAMSULOSIN, FUROSEMIDE, METOPROLOL SUCCINATE (METROL [METOPROLOL SUCCINATE]) and PANTOPRAZOLE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am). At the time of the report, INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. The event is probably related to the patient's comorbidities
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (13Aug2023) 80 over 50; SARS-CoV-2 test: (13Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: patient has had both Pfizer boosters. He contacted Covid on 11Aug. He was tested on the 13th and started Paxlovid on the 13th.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
When injecting, needle not securely attached to barrel. Vaccine sprayed out of the barrel onto patient's arm. Patient was re-dosed as he almost certainly did not get vaccine.
Elevated Temp of 101.6. Body aches, chills, headache.  Large rash and swelling near injection site.  Treated symptoms with ibuprofen, and Benadryl.  The elevated temp lasted  approx 16hrs.  Injection site swelling and rash is still present 51hrs after injection.  The headache is still present 51hrs after injection.
This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX at 9 AM and by 3 PM on the same day, he had flu like symptoms, which resolved the next day. No other information was offered for this report. The reporter did not consent to follow up.
low energy; headaches everyday; joint pain increasing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), HEADACHE (headaches everyday) and ARTHRALGIA (joint pain increasing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ASTHENIA (low energy), HEADACHE (headaches everyday) and ARTHRALGIA (joint pain increasing). At the time of the report, ASTHENIA (low energy), HEADACHE (headaches everyday) and ARTHRALGIA (joint pain increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Vomiting and dehydration started within 2 to 4 hours post vax, later admitted for IV fluids for 2 to 3 days. (3/17/00 to 3/19/00). 60 day follow-up dated 7/10/00 provided no additional data. Discharge summary states final dx as acute viral gastroenteritis w/dehydration and strep pharyngitis, new. Started on amoxicillin 250 mg t.i.d. in ER and continued for 10 days.
uncertain how much vaccine was given to patient; Needle and syringe malfunctioned and disconnected from each other while administering PROQUAD.; No adverse event; This spontaneous report was received from a nurse concerning to a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.  On 17-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), by subcutaneous route, lot # U029322 with an expiration date of 19-MAR-2023, for prophylaxis (strength, formulation, anatomical site of injection were not reported).  At the moment of the administration of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), the needle and syringe malfunctioned and disconnected from each other (device connection issue and incorrect dose administered). It was uncertain how much vaccines was given to patient and if should be repeated. No additional adverse events.   The causality assessment between incorrect dose administered and device connection issue regarding measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was reported as not related.
Infant not as physically active as prior to vaccination, favored left side not want to put full weight on the leg that was vaccinated.
did not get Covid until after I had both initial doses of the [Pfizer] vaccine.; did not get Covid until after I had both initial doses of the [Pfizer] vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "did not get Covid until after I had both initial doses of the [Pfizer] vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I did not get Covid until after I had both initial doses of the [Pfizer] vaccine.  Clinical information: patient was still not comfortable getting the booster. patient took care of family members with Covid and did not get the virus. patient did not get Covid until after patient had both initial doses of the [Pfizer] vaccine. So, for patient personally, didn't think the vaccine did any good at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports - hives on hands, arms, thighs, whole back, & face & contact points of clothes, neck itching. No fever, no respiratory involvement FYI spouse received same lot of FLUVIRIN ZOSTAVAX with no ill effects at same time. Tx with hydroxyzine with hydrocortisone PO/orally.
The Adult version of the Bivalent Covid vaccine was administered instead of the pediatric version.  Pharmacist reached out to patient's guardian several times after the event. The father of patient stated that the patient is doing fine and just had sore arm.
No other adverse event terms were provided.; Expired vaccine used; This spontaneous report was received from a registered nurse, concerning a 22 year old female patient. Information on concurrent conditions, medical history and concomitant medications was not reported.   On 29-NOV-2019, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, dose number, route of administration and anatomical location were not reported) (lot # R030120, expiration date: 15-NOV-2019) for prophylaxis. It was not noted that the product was expired until after it was administered. No other adverse event terms were provided.
Pale, less responsive, limp, "couldn't breathe", goose bumps, no hives, no angioedema on exam, slightly pale, air not moving. Epinephrine & O2 Bronchospasm & fever.
Shot given 10/20/15 first symptom - (R) knee joint on 10/21/15, (R) ankle joint. 10/23/15 (R) ankle joint. 10/24/15 both ankles no weight bearing - admitted to ER then hospital 10-24-15.
PERSISTENT SHARP PAIN IN BACK OF LEFT ARM AFTER INJECTION.  PAIN WORSE WITH EXTENTION OF ARM.  NO REDNESS, NO FEVER, NO MASS.
Starting 4 hrs after I was vaccinated, I developed a 102 degree fever, body aches, chills, fatigue, pounding headache, fast heartbeat. I was very sick for 20 hrs, and then I developed humming/ringing in the ear and vertigo for several days after. It has been a week after now and I still am not 100 percent myself, have ringing in ear and vertigo periodically and fatigue.
Chills, bad headache, fairly large rash  on upper arm with soreness and swelling.  Stomach pain, fatigue and weakness.  Lasted 5 days.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/07/21 2nd dose01/27/21 Diagnosed covid positive:08/19/21 Symptom onset:08/17/21 Exposure:Travel Symptoms:fever, cough,fatigue,muscle aches, sore hroat,loss of smell/taste, chills,runny nose,HA
The County Health Department was on-site at Senior Living Community for a scheduled FLU Clinic on Wednesday, October 9, 2019. The event started at 10:00 a.m., but  we had been asked to visit the homes of two immobile patients in the community to administer their FLU shots. We learned that patient had a fall the previous day. which we believed was the cause of his immobility. I received a call from Hospice to report heightened disorientation which she noticed today (10/10/2019) from her patient in Hospice care for COPD. She said she was aware there may be no connection to the vaccine, but she wanted to report it since she had seen changes in mental status of both of her Hospice patients who had Flu vaccine at yesterday's off-site Clinic. Hospice said she had given the patient Roxenal to settle him down. When our Nurse was there to administer the vaccine, she noticed the patient seemed tired but was able to answer all her questions. His wife signed the Consent because he asked her to since he was so tired from having just gotten up to go to the bathroom.
Patient received third dose (0.3 mL) of Pfizer Covid vaccine. Promptly after vaccination, patient's spouse reported patient had increased sweating, pale face, feeling of lightheadedness, and low-grade fever. Patient was instructed to sit, patient's temperature returned to normal to 96.1 F after several minutes. Pharmacy offered to call 9-1-1 for emergency services at time of event and patient declined. Patient received water while sitting. Patient returned to baseline after ~15 minutes with no sweating, normal face color and no feeling of lightheadedness. Patient was monitored throughout the event and patient indicated he felt stable and wished to return home after ~15 minutes of monitoring.
seizure like activity / the patient's eyes fluttered and his hands twitched; This spontaneous report was received from a registered nurse via a company representative and refers to an 11 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On 17-JUL-2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) for human papillomavirus (HPV) prophylaxis; with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route of administration, lot# and expiration date were not reported) and with meningococcal acyw conj vaccine (crm197)(MENVEO) (dose, route of administration, lot# and expiration date were not reported). On the same day, after vaccines administration, the patient experienced seizure like activity. It was reported that "the patient's eyes fluttered and his hands twitched". The patient was in the office when the seizure like activity occurred. No treatment was given for the event and no laboratory diagnostics was performed. The outcome of seizure was not reported. The relatedness between the event and suspect vaccines was not provided.      Upon internal review, the event of seizure was considered to be medically significant.
Nauseousness came in a wave, very hot sweating, could see perspiration, very very dizzy, increased BP
my lymph system on the whole side was, on the side where I got my shot must have been inflamed or something and I just noticed that it is on the paper now that swollen lymph nodes; it was like the whole lymph system on my left side where I got my shot on the left and it was like I was sore on the whole side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 2022, outcome "unknown", described as "it was like the whole lymph system on my left side where I got my shot on the left and it was like I was sore on the whole side"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "my lymph system on the whole side was, on the side where I got my shot must have been inflamed or something and I just noticed that it is on the paper now that swollen lymph nodes".  Additional information: Consumer stated, Patient got the vaccine (Pfizer COVID 19 Vaccine) and patient don't know what one patient got. patient thought there was only one type but it sounds like there was two, was there like, patient wanted the new one and that's the Bivalent. Consumer further stated, Experiences with the Pfizer product. So you mean like if there was problem with the vaccine or something is what you handle ,any side effects you mean. Patient didn't have it this time. Patient do have one question if it was something you can answer. Patient think it was the last one (Unspecified vaccine) patient got or the one before that, patient think patient lymph system on the whole side was, on the side where patient got shot must have been inflamed or something and patient just noticed that it was on the paper now that swollen lymph nodes. patient don't know it wasn't like in patient neck, if you see a picture of your lymph node it was like the whole lymph system on my left side where patient got shot on the left and it was like patient was sore on the whole side and then it seemed to go to the right side a little bit but most of it was on the left. was that a normal reaction they have seen with the lymph nodes.  No follow-up attempts are possible. No further information is expected.
mom reports pt no longer makes eye contact, lost speech, lost sociability, no longer responds to human voice, would not smile or respond;began running, flapping hands;mom states pt still does not speak;began infant rage attacks;autism;
Information has been received from a pharmacist concerning a 69 year old female patient with no known medical history and no known drug reactions/allergies who on 29-SEP-2010 was vaccinated in the left deltoid with a 0.5 ml of PNEUMOVAX 23 (lot # 665904/0966z, exp 04-JUL-2011). There was no concomitant medication. In the evening of 29-SEP-2010 the patient experienced "discomfort", fever, whole left arm was red and a burning sensation in the left arm. On an unspecified date, the patient recovered from discomfort, fever, whole left arm was red and a burning sensation in the left arm. There was no lab diagnostics studies performed. The patient sought unknown medical attention. "Pharmacist would like lot check." A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Felt fine all day after the vaccine, about 12 hours later I started feeling bad very quickly. Fever, chills, headache, uncontrollable shivering, difficulty walking and breathing due to back pain and clenching of muscles, tried to sleep it off but woke up a few hours later from a sharp pain in my head. Alarmingly I found my face was red and swollen, I was very weak, and had difficulty breathing, my legs and chest felt tight, my headache was very severe. I had a fever of 102.1 F. I was very dizzy especially when laying down and had a slight ringing in my ears. I had shortness of breathe and some stomach pain. I tried to decide weather or not to call an ambulance since I live alone. I took 2000 mg of Tylenol and waited. My symptoms started to decrease after 2 hours and I drove to the hospital. They monitored my vitals for 3 more hours as my symptoms continued to decrease. I left feeling weak and shivery, with muscle soreness and dizziness around 7:00 am. Day 2 I had a headache and fever off around 99-101, and dizziness. Mild dizziness and soreness in my arm continued for the next week.
Headache, still on treatment; anxiety disorder, depression-on treatment; chest pain-on treatment; feet, knee, hand joint painful; eyes difficult, itching, allergy, pain-on treatment.
Tiredness; This case was reported by a consumer and described the occurrence of tiredness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: It was reported that patient received the dose of Shingrix and experienced tiredness. The reporter consented to follow up.
Nerve pain RT knee; Weird Stinging sensation behind my right knee; also had a high fever; had a high fever and chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jun2021 12:00 (Lot number: EWO187) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing), notes: Sulfa drugs. Concomitant medication(s) included: PANTOPRAZOLE taken for oesophagitis (ongoing); ALPHAGAN taken for glaucoma (ongoing). The following information was reported: NEURALGIA (non-serious) with onset 01Jul2021, outcome "not recovered", described as "Nerve pain RT knee"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Weird Stinging sensation behind my right knee"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "also had a high fever"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "had a high fever and chills". The events "weird stinging sensation behind my right knee", "also had a high fever" and "had a high fever and chills" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of neuralgia, paraesthesia, pyrexia, chills. Additional Information: Facility type of first dose was Vaccine Pharmacy or Drug Store. Patient did not receive any other vaccine. Adverse event: Weird Stinging sensation behind my right knee since my first vaccine that has not yet gone away. There is no other logical explanation for this to start. I also had a high fever and chills. My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away. It resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Covid tested post vaccination, covid test type post vaccination was Nasal Swab on 28Jul2021 with covid test result Negative.    Follow-up attempts are completed. No further information is expected.