chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning her 17 year old daughter with attention deficit disorder and an allergy to over-the-counter cold preparations, who on 04-MAR-2008 at 16:30 was vaccinated with a third dose of Gardasil. Concomitant therapy included ADDERALL TABLETS. On 05-MAR-2008, eight hours post vaccination the patient experienced a high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting and was hospitalized. It was reported that the patient tolerated the first and second doses of Gardasil well. At the time of the report, the patient had not recovered. No product quality complaint was involved. The high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting were considered to be disabling. Additional information has been requested.  4/10/2008 MR received for ER visit 3/5/2008 with DX: Primary DX: R Flank Pain.  Additional DX: Fever-unknown origin. Pt presented to ER from MD's office with fever, chills, sudden onset R sided flank pain, nausea and vomiting. Pt reports fatigue and weakness as well. PE (+) for tenderness at the R CVA, fever, and pain.  D/C home in improved condition.    5/13/2008 MR received for DOS 3/6-8/2008 with no clear D/C DX.  Rheumatology Impression is: Back pain that is probably of a systemic problem. ID consult Impression: Fever and infection of the back, r/o sacroilitis, r/o vertebral osteomyelitis, r/o non-infectious etiology. Pt presented unable to walk 2' to back pain. Pain is localized to SI joint area. 5/06/2008 MR received for ER visit 3/10/2008 with DX: Headache. Pt presented following D/C from inpt stay with worsening h/a assoc with neck and back pain.  07/21/2008 MR received from Allergy/Immunology consult dated 3/12/2008 to 6/20/2008 with DX: Gardasil induced vasculitis. On the evening of the 3rd Gardasil vax pt awoke with fever, feeling delusional with aching chills. Pt continued to have fevers, excrutiating headaches and back pain which worsened following LP. PE (+) for glassy eyes, dehydration, unable to stand, diffuse weakness.  Pulse increased from 50 to 90 upon standing. Started on Prednisone with 80-90% improvement. Seen again 6/20/08 with improvment of sx of vasculitis.  Reports post-exercise exhaustion.
I had headache, lightheadedness, stomach pains, stomach cramps, and diarrhea. These lasted for about 5 days but the diarrhea is still ongoing. I went to the doctor about this. They did stool test, positive for a bacteria. I also had a COVID-19 test, negative results.
This spontaneous report as received from a pharmacist refers to a 41-year-old male patient. The patient has a medical history of arteritis, treated with REMICADE infusions, and diabetes. The patient was allergic to AVELOX, LEVAQUIN, and amoxicillin(reactions unspecified). On 17-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K021881, expiration date 30-JUL-2016 intramuscular in the left deltoid (dose was not reported). On an unspecified date approximately in June 2015, the patient developed erythema, pain and a rash at the injection site of the left deltoid area. The patient initially called the office and was suggested to take TYLENOL. The patient was subsequently evaluated at a unspecified emergency room on 20-JUN-2015 due to fever of 103F, vomiting, and chills. The patient was treated in the emergency room with intravenous ANCEF and was sent home with a prescription for a 10 day course of oral KEFLEX. The outcome of injection site erythema, chills, vomiting, pyrexia, injection site rash and injection site pain was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested. This is one of several reports received from the same patient.
pt recvd vax & 3 to 4 hrs following vax pt had a large amount of swelling @ inj site, which was also red, hard & hot;the nurse felt a concern about the particular lot of vax;pt recovered in approx 3 days;
slow growing Non-Hodgkin's lymphoma; This case was reported by a pharmacist via call center representative and described the occurrence of non-hodgkin's lymphoma in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2019, the patient received the 1st dose of Shingrix. In March 2019, 14 days after receiving Shingrix, the patient experienced non-hodgkin's lymphoma (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the non-hodgkin's lymphoma was unknown.   It was unknown if the reporter considered the non-hodgkin's lymphoma to be related to Shingrix.  Additional case details were provided as follows: Two weeks after the 1st dose of Shingrix, the patient was diagnosed with slow growing Non-Hodgkin's lymphoma.  The patient started chemotherapy one month later and received chemotherapy once monthly. The reporter stated that, since the patient received 1st vaccine at another pharmacy, the information regarding the responsible practitioner or vaccine given was not available. The reporter consented to follow up.
Patient had severe weakness, dizziness, disoriented and fatigue and poor balance and coordination. Her left is in pain even after 5 days. Balance and coordination getting better.
Lymph nodes of the patient are swollen/ lymph nodes are the size of a plum and her node on the left side is bigger than the other one; Fatigue; This is a spontaneous case, initially received from pharmacist on 04-Jan-2019, concerning a 51-year-old, adult, female patient.  The patient had no relevant medical history and concomitant medications.  On 31-Dec-2018, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252684 and expiry date: 30-Jun-2019) for influenza prophylaxis.  On the next day after vaccination, the lymph nodes of the patient were swollen, and she was fatigue. Her lymph nodes were the size of a plum and her node on the left side was bigger than the other one.  The patient didn't receive any treatment.  At the time of the report, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  Non-significant follow up received from pharmacist 14-Jan-2019: Added reporter detail (pharmacy) in the general tab. Added reference number (Info Number: SEQ19-00247) in the additional information tab. No new information was received as the reporter did not follow-up or gave the permission to follow-up with the patient. No changes were done in narrative.; Reporter's Comments: A 51-year-old female patient developed swollen lymph nodes and fatigue on the next day after receiving Flucelvax QIVc. The company assessed the causality of the events as related due to plausible temporal relationship between suspect vaccine and the events.
Retuned home started to eat lunch had weird feeling in my neck.. lymphnodes enlarged and getting larger. Left side .then right Went to ER
pt recvd vax & 10 days post vax exp fever & weakness;sx resolved w/in several days;
This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 12-JUN-2018, the patient was vaccinated with VAQTA lot # N002921 with expiration date 08-APR-2018, at a dose of 1 ml, intramuscularly for prophylaxis. No adverse effects reported. No further information provided.
SOB, numbness, difficulty swallowing, loss of ROM of R arm, severe headache, joint pain, difficulty swallowing, muscle twitching
pt recv vax 11Jul97, on 02Oct97 pt had an unspecified # of vesicles. Mother felt case was not severe.
Arm red, swollen, and hot to touch. Red spot is about as big as a tennis ball.
gastroenterology problem; pain on the back of her leg; body ache; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (gastroenterology problem), PAIN IN EXTREMITY (pain on the back of her leg), PAIN (body ache), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced GASTRIC DISORDER (gastroenterology problem), PAIN IN EXTREMITY (pain on the back of her leg), PAIN (body ache), HEADACHE (headache) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GASTRIC DISORDER (gastroenterology problem), PAIN IN EXTREMITY (pain on the back of her leg), PAIN (body ache), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Occasionally takes  medication for raising her blood pressure   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Additional information received
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 03-Jan-2013. The patient experienced ADMINISTER EXPIRED FLUMIST which started on 03-Jan-2013. The outcome of the event of ADMINISTER EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Expired vaccine used.
This spontaneous report was received from an employee, referring to an adult male "who was 41 or 42" years old patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot # and expiration date were not reported)for prophylaxis (drug administered to patient of inappropriate age).  Other suspect therapies included sterile diluent (STERILE DILUENT).
I felt fine for the first few days then on the 4th day developed sharp pains in my lower left back and side. The pain was intense and continued all night, so I went to an urgent care clinic the next day. I thought perhaps it was kidney stones, but everything seemed clear.  Two days later I developed a small rash on my left side and stomach that was determined to be shingles.
first Shingrix vaccine in September of 2020/never got the second dose; itching on her arm for the next 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced itchy upper limbs and incomplete course of vaccination. On an unknown date, the outcome of the itchy upper limbs was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for 2nd dose. After receiving 1st dose of Shingrix, the patient experienced itching on her arm for the next 2 weeks. The symptom resolved after 2 weeks. No lot or expiration date was known for the first vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient declined to provide healthcare professional information. The reporter did not consent to follow-up.
pt admitted to hosp post cardiac arrest; family states pt hasn't felt well for a few days; found her unresponsive and called EMS; renal failure, shock; positive for COVID; respiratory failure secondary to COVID; severe acidosis; transferred to ICU; treated with steroids and vasopressors; pt's condition worsened; code blue called but staff was unable to achieve ROSC; pt died in the hospital
Nausea, vomiting, diarrhea, dizziness, swelling, and soreness at the injection site, unable to raise arm  without pain
extremely fussy beginning the afternoon p/vax & lasted 2 1/2 to 3 wks; had sz for 1 wk; EEG's showed some abnormality;
Very sore arm for about 5 days, with onset of tiredness and slight cold like symptoms with nasal congestion. Loss of appetite. On 11/23 experienced an outbreak of cold sores on the mouth and another outbreak the following day. Tiredness continues.
Severe chest pains found to not be myocarditis or pericarditis. However, the vaccine may have inflamed a previously unknown heart condition.
Shingles and Epstein Barr virus activation (w normal white blood cell for some reason). Pain (stabbing right chest through to back) started and shingles rash appeared a few days later, as confirmed by Emergency Room doctor. Positive EBV blood test after a few weeks of extreme fatigue.
On 2/4/17, began experiencing vertigo (feeling that the room is spinning when she lies down). Cold symptoms, 1 week prior. Meds: JUNEL. Normal exam. Prescribed medicine for vertigo.
Horrific shooting pain in her right ear/it felt like a needle in her ear; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2022 14:15 (Lot number: FL3209) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EM9806, Expiration: unknown), administration date: 10Feb2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "She did not have reactions on first two doses"; Bnt162b2 (Second dose, Lot: EN6205, Expiration: unknown), administration date: 03Mar2021, when the patient was 74 years old, for COVID-19 Immunization, reaction(s): "She did not have reactions on first two doses". The following information was reported: EAR PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (2022), described as "Horrific shooting pain in her right ear/it felt like a needle in her ear"; TINNITUS (non-serious) with onset 09Jan2022, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of ear pain, tinnitus.  Additional information: There were other products and investigation assessment reported. She never had any pain in her ear ever. That pain lasted a minute and knew something was very wrong, it was coincident to the shot. Tinnitus started very shortly after that. No additional vaccines were administered on the same date of the Pfizer suspect. AE(s) did not require a visit to Emergency Room and Physician Office. The patient did not receive any vaccine, prior vaccination (within 4 weeks). There was no AE(s) following prior vaccinations. It was reported, thousands and thousands, over 13,000 people have reported the exact same thing, not just tinnitus, it occurred in a certain time frame, certain tone and escalated after subsequent doses. She was asking why isn't Pfizer is not sharing this.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04FEB2022): Follow-up attempts are completed. No further information is expected.
Patient reports that he felt "woozy" or dizzy a little bit after getting the injection. This was short lived and no further side effects.
No symptoms reported.  Found dead seated on couch the day after vaccination (3/14/2021).  Autopsy performed on 3/15/2021 showed no evidence of anaphylaxis.  Cause of death = Cardiomyopathy of Obesity.
Pt vaccinated with Pneumovax 23 developed pain, swelling & erythema at injection site; chills & fever.
It begin early AM. 101 fever and extreme body ache, body aches lasting 36 hours and then went away. Nausea lasted a week. Difficult to eat and drink lots of fluids. I had aches and fatigue for 36 hours. Didn't work for 2 days. I was exhausted. It affected my joints as I had arthritis.
treatment, if any:   Narrative: Patient received 1st dose of Moderna Vaccine 02/22/2021 @09:45 and 2nd dose of Moderna Vaccine 03/22/2021 @09:30. Patient tested positive for COVID-19 11/10/21.
STARTED WITH STRONG HEADACHE, PHOTOPHOBIA, FEVER, BODYACHE, JOINT PAIN , LEFT ARM PAIN SINCE 2/2/2021 12AM
Patient received Janssen Covid shot on 8/12/21 around 1:30pm and stated she noticed hives started to appear later that night. She claims when she was younger she used to get hives from unknown causes. She stated she didn't think too much about it. The next day around 8 pm she said she noticed that the hives had gotten much worse. She also described a feeling of having a "ice cub" stuck in her throat and she was experiencing chest pain.  She got worried and headed to Hospital Friday night (8/13/21). Prior to going to the hospital patient had administered claritin and ibuprofen before going to the hospital. At the hospital patient received prednisone, benadryl and famotidine. Patient was seen by practitioner which was supervised by Doctor.
On day 8 I have swollen lump on my arm.  It is very itchy and feels warm to the touch.  No reactions until today.
Sore left arm for 5 days, the lipoids under my left swelled up and still sore after 5 days.  Ran fever for 3 days, body aches going on 5 days and feel extremely tired.  Still not recovered from the booster after 5 days.
This spontaneous report was received from a Registered Nurse and refers to a 32 year old female patient. Medical history and concomitant medications were not provided. On 29-JUN-2017, the patient was vaccinated with and expired VAQTA (lot # M009786; expiration 26-MAY-2017). No adverse events were reported. The outcome was unknown. Additional information has been requested.
Patient died at home in the night of 03/30/21 to 03/31/2021.  Time of death unknown.
Information has been received from a certified medical assistant referring to a patient of unknown age. On 09-MAR-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # J011342, expiration date 29-MAY-2015, dose unknown) orally. No adverse effect was reported. This is one of several report received from same source. Additional information has been requested.
dizziness, light headed, feeling of faint around 1:20 pm 10/17/22. Treated with ice and having pt lay down.
Fever, Pt has had a fever since receiving his immunizations on 4/24. This am he woke with a 103 temp this resolved with some Tylenol, then he went back to sleep, waking 2 hours later screaming, he is very fussy, screaming every time he is laid down, decreased appetite.
03/2022 vaccination. 05/09/2022 sniffles, runny nose. I had thought that it was allergies. 05/10/2022 felt flu like symptoms. I tested COVID-19 at home; positive. With my cancer history they put me on PAXLOVID. Felt better within 4 days tested negative within 4 days. Testing negative presently.
Localized maculopapular mildly erythematous - multiple discrete lesions 2-4 mm clustered in 1" x 2/5" area @ site of influenza vaccine. Rash was not pruritic not vesicles w/o underlying swelling. No tenderness. No systemic symptoms. Improved 24 hr w/ po BENADRYL/ improving after 24 hrs
I was having lot of leg pain went to the doctor on 02/11/2022 at 01:00PM & they said that both legs have blood clots which was causing extreme pain. I now have to stop doing my everyday run and now I am prescribed blood thinners and eventually will have to get surgery and remove the veins in follow up appointment in six weeks.
24FEB93 mom reported adverse reaction to DTP #1; 23FEB93 p/ 1 hr of sleep in car APAP given p/immun recvd then slept 1 1/2 hrs more; fed bottle & burped well; 4PM 3 hrs p/shots; painful crying began; painful crying was cont for 3 hrs-scream
fever, chills, chest tightness, shortness of breath, used abuterol inhaler, called clinic line, no admit
Bruised elbow area of vaccinated arm hot to touch, doctor consulted, pt told to monitor area at home, bruise result of blood under the skin from vaccine per MD.
Non painfull bloody stools appeared the day following the vaccine. The child remained completely with out symptoms but the blood appeared up to 1 month following the vaccine. The child continued to thrive. No further work up was indicated. The child is breast fed. Parents declined second dose at 4 months.
Information has been received from a physician concerning a 9 week old male with no pertinent medical history reported who on 13-MAY-2009 was vaccinated orally with first dose of ROTATEQ (dose and lot number not provided). Secondary suspect therapy included RECOMBIVAX (manufacturer unknown), PENTACEL and PREVENAR. The physician reported that the patient's mother brought the patient to the office because he had been having "stool with blood and stringy mucous in it for the past three weeks" (also reported as 22-MAY-2009). The mother also reported that the patient was recovering from a cold. The patient sought unspecified medical attention. Upon internal review stool with blood was considered to be an other important medical event. Additional information has been requested.
Fever/as high as 102.6 tympanic/temperature was 101; This is a spontaneous report from a contactable other HCP.  A 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3246), intramuscular in left arm on 12Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, rosuvastatin, acyclovir [aciclovir] (ACYCLOVIR), lisinopril, and fenofibrate. The patient previously received the first dose of bnt162b2 on 22Dec2020 09:00 intramuscular in left arm. The patient experienced fever that started at 8pm to 9pm on 12Jan2021. The fever reached as high as 102.6 tympanic. On 14Jan2021 at 7am, temperature was 101. The outcome of the event was not recovered. No treatment was received for the event. This was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
pt recv vax;began to suffer from flu-like sx which lead to hearing loss,tinnitus,leg cramps,HA,& autoimmune thrombocytopenia;f/u indicated stomach cramps & T of 104;hospx5days;MD record stated rxn due to hep B vax;skin test on same day
Initial and follow up information has been received from a Licensed Practical Nurse concerning a 71 year old male patient who in approximately 1970 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 06-NOV-2007, at 09:44 AM the patient was vaccinated into left deltoid IM with a second dose of pneumococcal 23v polysaccharide vaccine lot # 658449/0989U. Concomitant therapy included lovastatin, atenolol (MSD), IBUFEN, lisinopril-HCTZ (MSD), HYTRIN, finasteride (MSD) and FLOMAX. On 08-NOV-2007 at 10:30 AM patient developed local reaction at the injection site of erythema and warmth. Patient came with his wife to the office and was examined by his physician and was prescribed KEFLEX 500 mg 1 tablet four times a day for 10 days. In follow up it was reported that improvement noted after two days and he recovered. Additional information is not expected.
patient was 15 at time of receiving the dose. He received both doses before age was caught on 1/21 & 2/11. Tried to contact the patient's guardian, but they didn't answer after 3 attempts.
Seizure.  Pretty mild, absence seizure but non responsive during seizure and slept afterward.