chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some of the dose dripped down the patients arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Jan-2021, the patient experienced DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm). At the time of the report, DEVICE CONNECTION ISSUE (some of the dose dripped down the patients arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
saw a greyish black thing, wonders if this is a hallucination; scared the living daylight out of her; A spontaneous report was received from a consumer who was a 84-year-old, female patient and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a greyish black thing go from the ceiling to the floor/hallucination, and it scared the living daylight out of her/fear.  The patient's medical history included a hip fracture.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included trazadone, clonazepam, Aleve PM and Aleve for hip pain related to surgery.  The patient received their first of two planned doses of mRNA-1273 (lot number unknown) on 06 FEB 2021 for prophylaxis of COVID-19 infection.  The patient stated that after her vaccination she looked up at the wall and saw a greyish black thing go from the ceiling to the floor.  She stated that it was a black glove/streak/paintbrush that went around in a half circle on a white wall.   The patient stated that the pictures on the wall disappeared and then reappeared.  She wondered if it was a hallucination caused by the vaccine.  This lasted a couple minutes.  She was very scared and was crying on the call.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of these events, a greyish black thing go from the ceiling to the floor/hallucination, and it scared the living daylight out of her/fear were  considered recovered.; Reporter's Comments: 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.  Further information has been requested.
Spoke on 9/27, red, swollen to 1 1/2 to 2 inches wide around injection site. Warm to touch. As of 10/1/18, redness and size are decreasing in size and improving.
COVID Arm... 7 days after first shot, injection site became itchy, swollen and red
Mild nausea and dizziness the morning after receiving  the Moderna COVID-19 Vaccine EUA. Chills, lightheadedness, and fever started noticeably around 1:30pm. Stomach and uterine cramping started in the morning as well,  possibly around 10:00am.
Febrile seizure X 2 and required medication to stop. Had a fever for 2 days and a rash on thorax. Discharge summary also indicates URI site NOS.
Nauseous; Sick for 2 days; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received dose 2 of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unknown date for COVID-19 immunization and experienced sore arm. While calling to refill pregabalin (LYRICA) the patient reported on an unspecified date after dose 2 of BNT162B2 she was sick for 2 days and was nauseous. The outcomes of sick for 2 days and nauseous were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
he is in isolation at this time and have not tested for covid yet.; This is a spontaneous case is received from a contactable consumer or other non hcp. A 35-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced he is in isolation at this time and have not tested for COVID yet. (exposure to sars-cov-2). The outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
RECEIVED VACCINE AND RETURNED TO WORK.  RETURNED TO CLINIC WITH C/O VOMITING AND CHILLS. VITALS: 169/90, 79, 97%, 20,  DENIES PAIN. THEN C/O ANXIETY AND FEELING FLUSHED. EMS CALLED BY EMPLOYER. PATIENT REFUSED.
I do not know if my symptoms are a result of the Covid Booster vaccine. It was suggested that I should report it. Six weeks after booster I began having signs of a sinus infection. Went to my Allergy Dr. Prescribed Ceftin for 14 days. Showed slight improvement, but was concerned I was developing a cough and a ton of mucous. Called back to Allergy Dr. Added 10 days Prednisone and given Azythromycin for 11 days. Seemed better, but cough would not leave. Decided to go to my Pulmonary Dr (treated me for Farmer's Lung in Spring 2020). Said my lungs sounded very normal, but he felt I was having Rhinosinusitis. He added Singulair. Stopped Singulair within 4 days because I felt worse with all the mucous production running out of control. A few days later (around Feb. 11) returned to Allergy Dr. Said he needed to use Levaquin to try to get the inflammation and mucous stopped. Finally I got a good check-up on Feb. 28. Nose clear, sinuses were mostly clear, nasal inflammation was minimal, lungs sounded clear. Instructions are to continue with Allergy med daily and nasal antihistamine daily.
administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a Physician.  This case involves a 4 months old male patient who got administered an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5v (Rotateq) for Prophylactic vaccination and Vaxudence.  On 23-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ786AA and expiration date- 10-Dec-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Generalized aches, weakness, chills X 24 hr, with firmness and slight calor, minamally tender at injection site.
Pt has H/O headache. 3 days after immunizations dizziness, fatigue, and increase in headaches. Pt seen in my office on several occasions, 2 separate neurologists and ENT.  The pain is improving. Normal Blood work and CT Scan.
Several hours, post vax, she noted weak sensation in extremities. Also, later with twitching of right shoulder (administered in left deltoid).
Day p/HIB vax given, t101R, on third day, t103.8R @ 4AM; Seen in ER, MD told mom throat sl pink; not sure what causing inc temp; Given APAP & Amoxicillin & Pedialyte in ER;
Given vaccine at 11:39 am 12-1-10. At 2:30 pm developed chills, headache, felt unable to eat. Soreness at site of injection. Felt weak when woke up on 12-2-10. Weakness completely resolved and arm pain at injection site 50% improved on 12-3-10.
Fatigue started four hours after injection and continued all day. At fourteen hours began soreness around injection site, chills, joint and muscle pain, difficulty sleeping. These conditions lasted about sixteen to seventeen hours, then went away.
Pt experienced numbness/tingling in left cheek, around mouth, and in left arm. Resolved with 25mg Benadryl.
One week after vaccine pain and redness and itchy at site of injection in a 2 inch by 6 inch pattern
Two days after the vaccine, I experienced tinnitus. It was 8/10-10/10 high pitch that lasted all day and night. It would wake me up at nights. I could not hear anything like TV or anything outside. I did affect my work listening to patients. It was very scary and disruptive. About a week later, I went to my doctor and she stated there was nothing I could do. I went to an ENT and he did state that there was nothing that could be done. My doctors do believe that it could be due to the vaccine. I have tired an OTC medication, lipo-flavonoid 3x a day. I was also prescribed Xanax to deal with the noise which I do not want to take. I do still hear the ringing but it is not as loud but it is still disruptive.
Myalgia, Arthralgia, Malaise, lymphadenopathy Left axilla Narrative:
Within 5 hours of shot: slightly raised body temperature, chills, extreme fatigue, headache and muscle ache.  Raised body temperature and chills lasted for about 14 hours. Fatigue, headache and muscle ache for 30 hours.  After 30 hours: sore left arm (where shot was administered)
Patient reported experiencing a "weird taste" in her mouth upon injection of the vaccine. A few minutes later she experienced sudden nausea (? vomiting) and diaphoresis lasting <4 minutes. Patient was evaluated by EMTs at the vaccination clinic - VSS, Sa02 98% and above. Pt recovered quickly and did not require transport.
Can't lift my arm days later, feel nauseous and extreme exhaustion. Also have shooting pains all over. No appetite.
Pt given 1st dose of vax 12OCT89 then on 13NOV89 given 2nd dose; later exp achiness in her elbows, achiness in knees, pain in neck & shoulders; To ER dx serum sickness; tx NSAIDS; 13APR90 3rd dose w/no noted problems;
Patient first received Moderna COVID vaccine on 2/11/21 and 3/11/21. On 9/22/21, patient received Moderna COVID vaccine dose #3 even though she's not moderately/severely immune suppressed and the criteria used for rationale of giving the patient a third dose was age>65. This is an error as we are not yet giving third booster doses to non immune suppressed patients and Moderna has not been approved for booster doses. No adverse event to the patient.
flu like symptoms; body aches; Dizziness; brain fog; malaise; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd July 2019, immediately after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise. On an unknown date, the outcome of the influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise to be related to Shingrix.  Additional details were provided as follows: On 14th April 2019, the patient received the 1st dose of Shingrix. The patient immediately after receiving 2nd dose of Shingrix in the right deltoid experienced flu-like symptoms, body aches, dizziness, brain fog, and malaise lasting for one month. At the time of reporting all the events had resolved. The reporter did not consent to follow up.
Information has been received from a foreign legal firm concerning a currently 9 year old male. In 1991 at the age of 1 year old, it was noted that immediately before the pt received the vax, the pts mother asked the MD to check her son as he had a chest infection. Subsequently post vax, the pt developed severe developmental, social, and communicative delays consistent with autism. The day following the vax, the pt became hot, irritable, and flushed. While feeding, the pt put his hands to the side of his head and emitted a high pitched scream. He convulsed, his eyes rolled upwards and he made a choking noise. The pt's eyes were starring vacantly and he was limp and drowsy. A rash appeared on his face. He became sleepy and lifeless. He was unresponsive, stopped smiling and laughing. For approximately 2-3 weeks post vax, the pt had consistently high temperatures. Within one year, the pt's social skills and interaction stopped completely. By two years, the pt had developed behavioral problems. By three years, the pt had become obsessional. By four years, the pt's behavior had deteriorated even further. The pt would urinate in the street and displayed inappropriate behavior towards strangers, not knowing that these actions were wrong.
Patient complained of 2 x2 in. red, warm area on arm that itches at injection site. She noticed it on 8/4/12. I counseled her to apply a cold compress & BENADRYL & I paged MD & MD agreed w/ my advice.
Headaches, Body aches, fever, chills, nausea, fatigue, cough, swollen lymph node under injection arm
Dizziness, lightheaded, mental fog. Severe muscle weakness x 2.5-3 wks then developed hypothyroidism & fibromyalgia.
6AUG91 @ 1PM pt recvd an Engerix-B inject; Approx 12AM "that evening"  pt exp a "bad onset of nausea & vomiting"; Also had a t102; tx bedrest, fluids the following day, nausea, vomiting & fever continued through the following day;
This spontaneous report was received from a licensed practical nurse (L.P.N.) referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot# K007825; expiration date 13-JAN-2016) (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Approximately 2 hrs after immunization 18 month old baby had extreme pain as evidenced by crying, dystonic type cramping  located in toes and joints bilateramly, her ankle and knees became rigid. The next day she began limping. ER visit was sought 24 hours after the injections.  Child continues to exhibit pain
severe headache; terrible stomach pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach pain) and NAUSEA (nausea). On 17-Jan-2021, the patient experienced HEADACHE (severe headache). At the time of the report, ABDOMINAL PAIN UPPER (terrible stomach pain), NAUSEA (nausea) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient says that she had right arm pain from Pneumonia vaccine that turned into bone pain that radiated up her clavicle into her neck. Advised patient to see MD as this is not a normal vaccine reaction.
not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had not feeling well.
This spontaneous case (PVX2019-929) was received from a caregiver on 18-Apr-2019. It describes a female consumer who lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF for typhoid prophylaxis. Case report: The consumer started VIVOTIF on 19-Mar-2019, and since then she had been vomiting almost daily, along with constant stomach pain and occasional headache. She lost about 10-pound weight as she did not want to eat. As per the reporter, vomiting VIVOTIF was either bile or stomach acid and was either green or yellow. At the time of the report her weight remained the same and she had not lost any additional weight. In addition, it was reported that in late February or early March, before VIVOTIF administration, the consumer attended an environmental camp where she, along with multiple other children became sick. She had vomiting and fever, but no diarrhea. The health department indicated that the children had contracted norovirus. As she was recovering from norovirus, the caregiver held VIVOTIF course and stored it in the refrigerator. After she recovered from the norovirus and everything returned to normal, she started VIVOTIF administration on 19-Mar-2019. Laboratory test included stool samples, H pylori testing, bowel blockage testing, full blood panel, thyroid test, and pancreatitis test. All of the tests were normal. However, according to the bowel X-ray, she had constipation. The reporter additionally mentioned that the consumer had not complained of constipation, however she had "battled with it in the past, a really long time ago". The consumer's past medication included Zantac (ranitidine) for possible reflux, but it had not helped. Action taken with VIVOTIF for the events was unknown. The consumer had not recovered from the events lost 10-pound weight , vomiting, stomach pain, and occasional headache. However, the outcome of the events constipation and loss of appetite was unknown.; Sender's Comments: Company Comment:  In this case, it was reported that an 11-year-old female consumer lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF. The case has been considered serious as the consumer had significant weight loss.The causality of the events "lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache" is assessed as possible as the events were reported with reasonable time relationship to intake of the vaccine.
PATIENT SUBSEQUENTLY TREATED FOR CELLULITIS WITH KEFLEX. PATIENT REPORTED PAIN, SWELLING, REDNESS, TENDERNESS AND WARMTH AT INJECTION, WITH VOMITING AND NAUSEA.
Patient felt like he was going to pass out after receiving the vaccine. He was monitored for 45 minutes, vital signs remained stable.
Case received Covid-19 vaccines on 2/5/2021 and 3/5/2021, and was subsequently hosptialized for Covid Pneumonia on 7/31/21.
Raised, swollen area, edema, redness on 6/17/06 on left arm-upper. He had received DTaP in this area on 6/16/06. Mother used ice and Benadryl with minimal relief.
I skipped my period after my second dose. I am not pregnant. I am on birth control for 10 years. This is the first time this has ever happened.
Sore; Big patch; Red; Warm; Intermittent headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), SKIN DISCOLOURATION (Big patch), ERYTHEMA (Red), FEELING HOT (Warm) and HEADACHE (Intermittent headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, LISINOPRIL, LEVOTHYROXINE and QUETIAPINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Sore), SKIN DISCOLOURATION (Big patch), ERYTHEMA (Red), FEELING HOT (Warm), HEADACHE (Intermittent headaches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (Sore), SKIN DISCOLOURATION (Big patch), ERYTHEMA (Red), FEELING HOT (Warm), HEADACHE (Intermittent headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not reported.
Injection site was red, warm, large lump, very itchy and tender on Day 2.  I took Tylenol.  Day 3 the same.  Day 4 today, lessening of the symptoms
Mild arm soreness; 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 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization, reaction(s): "Mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm soreness".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
@ 10 PM, I STARTED GETTING HIVES BEHIND MY LEFT KNEE. THEY GOT WORSE, SPREADING AROUND MY ENTIRE LEG &  @ 12" HIGH. I TOOK A BENADRYL TABLET, APPLIED TOPICAL CORTISONE MULTIPLE TIMES, USED BENADRYL SPRAY MULTIPLE TIMES.  I DID THIS TIL @ 11:30 WITH NO IMPROVEMENT.  I WAS AFRAID TO GO TO SLEEP, SO WE HEADED TO THE ER.  @ 20 MINUTES LATER, THE REDNESS & SWELLING STARTED TO SUBSIDE. WE GOT TO THE HOSPITAL, BUT DECIDED, SINCE THE AFFTETED AREA WAS NOW NORMAL, THAT  WE WOUD GO HOME. mY ONLY GUESS, IS THAT THE MEDICATIONS HAD FINALLY TAKEN EFFECT.  I DO HAVE A PHOTE, IF YOU ARE INTERESTED IN THAT.
Red, raised, hot, tender area of injection around 3" approximately 24 hours after injection.  Treatment Ceclor.