chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; FEELING SUPER TIRED; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 165 pounds, and height was 66 inches. The patient's concurrent conditions included: hypothyroidism, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time reporting. The patient had no other medical conditions or medications. The patient had no known allergies/ had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855791, and expiry: UNKNOWN) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On 13-DEC-2021, the patient experienced body aches. On 13-DEC-2021, the patient experienced feeling super tired. On 13-DEC-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling super tired, had not recovered from headache, and the outcome of body aches was not reported. This report was non-serious.
Approximate 48 hours after receiving the Tdap injection, report of worsening pain, difficulty accomplishing ADL's due to decreased shoulder ROM and pain, and difficulty lifting things with left arm. Sought out treatment by an orthopedic surgeon who RX PO steroids and a sling. Was given a joint injection X 2 Anterior/posterior approach. Since this second injection she feels nearly back to baseline but lacks confidence in dexterity and strength to do procedures. (pulmonologist) Procedures like intubation, bronchoscopies etc.
w/in a few days had loss of nl activity-sleeping;c/o noc sweats, gen weakness-then able to walk & move normally;severe weakness w/fever spiking to 102;given ATB
Violently ill; Losing hearing in the left ear; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear). At the time of the report, ILLNESS (Violently ill) and HYPOACUSIS (Losing hearing in the left ear) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
On 10-1-10 approx 15 mins. after injection, had numbing pain down left arm along with numbness in fingertips and wrist pain. 5 min. later, had pain under left armpit (along bra line). Took ADVIL prn. Noted bruise that evening. By late 10-3-10 arm was feeling better. Today, bruise noted on left deltoid area. Denies pain or numbness. Recommended notifying physician and follow-up as needed.
Injection site is sore and tingles. Muscle in arm aches. Difficulty using arm to hold objects at angle.
teeth started to hurt AND teeth feel achy; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (teeth started to hurt AND teeth feel achy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), GABAPENTIN, MIRABEGRON, DULOXETINE, MULTIVITAMIN [VITAMINS NOS] and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TOOTHACHE (teeth started to hurt AND teeth feel achy). At the time of the report, TOOTHACHE (teeth started to hurt AND teeth feel achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
day after injection, slightly raised and red area around injection site but began to travel down his arm to his bicep. patient reported that it was slightly itchy but seemed to be getting better. Was told to monitor rash and call his doctor with any worsening symptoms.
Mild erythema from distal deltoid to mid humerus mild tip. Not not no swelling.
Patient developed muscle and joint pains and fatigue roughly 3 weeks after the first dose of the vaccine. Developed swelling and pain in the hands. He developed difficulty walking due to joint pains. Received 2nd dose of vaccine on 5/28/21. Came to the ER on 6/4/21 due to persistent hand swelling. Labs sent on that day showed proteinuria for which he was sent to rheumatology (serology done for SLE came back positive) and nephrology. Patient has been diagnosed with systemic lupus eryhtematosus with renal involvement.
Between hour of 6:30 A.M. and 8 A.M. she received flu vaccine at her place of employment through "clinic" ran by local health dept. VIS available. Questionnaire filled out by pt and reviewed by RN giving injection. No contraindications noted.
Got the vaccine, had shingles/Suspected vaccination failure; Shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 and 07-MAR-2023 The case  was received from the patient via interactive digital media. The patient got the Shingles vaccine and had shingles 3 times afterwards.  The patient stated that apparently, the vaccine could trigger outbreaks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips) outcome was unknown.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow up document received on 23-06-2021. contain Non significant information On 28-Jun-2021: Reporter contact information updated.
HCP calling to report AE for Supported TE for PROQUAD. Unknown Administered Date; This spontaneous report has been received from a nurse and refers to a 4-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a single dose of a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that had suffered a temperature excursion. (lot number X007358 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 08-SEP-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). Temperature excursion happened in a timeframe of 18 minutes at a -13 degrees Celsius (C); previous excursion's timeframe was for 26 minutes at a temperature of -13.8 C.; Sender's Comments:  US-009507513-2310USA001447:Case # 02485007
Tinnitus in left ear (high pitched frequency), dizziness, loss of concentration, anxiety and trouble sleeping.
Called hospital call center with c/o wheezing, dizziness, and ab cramping. Pt had received dose 1 of pfizer on 8/4/21. Pt was advised to go to ED.
less than 24 hours after vaccine developed tachycardia which broke, no fever at that time noted, 24 hours after injection developed rigors and temperatures greater than 104 for going on 48 hours.  Severe severe joint pain and arm swelling a injection site with lymph node swelling.
Not sure if it?s related but I ended up in the ER a few weeks after the shot with acute appendicitis.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 07-JUL-2014 the patient was vaccinated with M-M-R II lot # H012571. The vaccine was expired (expiration date 29-JUN-2014), but the patient experienced no adverse symptoms. The outcome of the patient having received expired M-M-R II lot # H012571 is unknown. Additional information has been requested.
Felt really tired, arm pain. Then shooting pain all over body to knee caps. Had chills, felt foggy. Sweating and said he was burning up. Headache and felt he was thinking slowly. Could not track thoughts well.
Pt reported that the afternoon of receiving the vax, he felt achey and nauseated. He vomited several times that evening. One day post vax his fever rose to 101 - 102 degrees and he continued with achiness. Two days post vax he felt fine. Pt reported no local reaction at injection site.
For the last three months, I have been waking up in the middle of the night around 11:30-12. I have trouble getting back to sleep, but when I do I wake up around 3:30am. I never had sleep issues prior to the second vaccine. There were at least three occasions in April that I woke up around 3:30am with a panic attack. I was diagnosed with anxiety about 6 years ago and I have experienced panic attacks in the past, but they have been under control through seeing a therapist, nutritionist, and acupuncture. I have never been woken up in the middle of the night with a panic attack. I tried continuing acupuncture but it did not help. I started Lexapro 3 weeks ago. It has helped with my anxiety, but I am still not sleeping a full night.
Severe chills, hallucination, pain after 8 hours of second shot of Shingrix
a patient was administered doses of Pentacel and Fluzone Quadrivalent before finding out the products were not viable/ No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant).  This case is linked to cases 2020SA238410 (same reporter).  This case involves a six months old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] before finding out the products were not viable (poor quality product administered) on 01-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for prophylactic vaccination and CEFTRIAXONE SODIUM ([CEFTRIAXONE SODIUM]) for an unknown indication.  On 01-Sep-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA and expiry date 14-Feb-2021) via intramuscular route in the left thigh and also received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number an expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination respectively.  Case details: Medical assistant called to report that two doses of Pentacel and Fluzone Quadrivalent were administered before administered before finding out the products were not viable.  It was an actual medication error due to poor quality vaccine administered.  No adverse event symptoms.  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 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.  There will be no information on the lot number for this case (for suspect Fluzone Quadrivalent)
(L) arm injection site. Red, raised area. Bruised light area. Tender to touch. Warm to touch.
Pt was given expired Covid-19 dose that was not removed from our refrigerator after expiration date had passed. Pt observed for 15 minutes, no reactions noted.
Bleeding in the nose; He coughed, he saw blood; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 10-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 6:00 PM, the patient experienced EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood). At the time of the report, EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with cold water.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received reporter details updated.
Reoccurrence of breast cancer.  Previously diagnosed and treated in 2014.  Clean bill of health since then.  Until localized reoccurrence of same cancer in September 2022.
Pt vaccinated with DTP developed high temp, vomiting, sore arm and shoulder X 24 hrs. Dx Febrile reaction to DTP vaccine.
Headache and nasal congestion. Really bad runny nose for 8 hours. General malaise. Arm pain at injection site.
24 hours later, patient had severe abdominal pain, was found to have pancreatitis, confirmed by labs, CT scan and ultrasound scan, was admitted to Hospital.  Very quick recovery,  According to mother, he was given intravenous fluids, bowel rest, and nothing else.
Had raising heart beat and dizziness  the with the first shot in the evening of 3/12/2021 it happened about two times and it went away.  Second dose 4/2/2021 Heart palpitations started immediately after the second dose. Did not mention anything to the staff at the workplace vaccine event.  I kept having heart palpitations, on 4/13/2021 I had a sharp pain on the left side of my chest that radiated down my left arm.  I made an appointment for the next day. 4/14/2021 I left work at about 9:30 for dizziness, blurry vision, vomiting, and sharp left side head pain. I had a doctors appointment at 2:30 on 4/14 they did an EKG and it came out abnormal, blood pressure was borderline.   Was put on blood pressure medication for 3 months.
Patient stated that is symptoms started on 1/26. He will need to quarantine until 2/4. He can return to work on 2/5. Work note provided.   Exposure to COVID-19
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 0814. Alert and oriented and Anxious. Patient was sitting 2 minutes of the 15 minute observation and reported feeling dizzy. She walked to the triage area without any assistance. 0817: BP 103/49, P 80, 98% Oxygen saturation. She says she took Atarax at home at 0730 for her anxiety and she says the way she feels is that she needs to sleep the medication off. She says the last time she took it, she felt dizzy and the need to sleep, then was better afterwards. 0825: BP 100/82, P 79; 0830: Standing BP 99/88, P 85. I had her to walk around and she says she feels fine, steady on her feet.    Actions taken:  Vitals sign taken  VAERS form obtained and completed.   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 20  minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is going to pass out. Provided water, cold towel and being monitored by nurse. Denies any shortness of breath or difficulty breathing. States symptoms persist for the next 30 minutes while refusing to go to ED. Daughter arrives and instructs patient to ED. Escorted to ED with the patient still complaining of persistent dizziness, lightheadedness, and brief chest tightness which subsided within 5 minutes.
4 hrs after shot severe hives, itching beginning on arms.  Over time hives rest of body.  4 days later still have hives.  Feel anxious, took benadryl
Small knot and sore arm first day post vaccine.  8 days post vaccine larger knot;  red, raised area measuring approximately 2"x1.5".  Red area itches. Concerned whether this reaction will affect second dose.
Left deltoid skin area with slight erythema.  Tender to touch.  Received injection 10/2/23. Symptoms began 10/6/23.
Fatigued from 5/20 - 5/21  Red itchy spot about 6 inches in diameter first appeared 5/20 and resolved on 5/23  the red itchy spot returned on 5/26 and looks like it will resolve by 5/28
shortly after patient received the vaccine she experienced a pain in her right leg and spine and the pain progressed to a sciatica like pain from her right hip down to the middle of her right thigh
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-OCT-2012 17:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
shingles on her body described as having rashes on her body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Lot Number: EL3246) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with 2 doses of Shingrix on an unspecified date. On 06Feb2021 she had shingles on her body which she described as having rashes on her body. She went to the hospital, they said it was shingles. So, now she was asking whether there was a relationship with the vaccine and shingles. She was scheduled to have the second dose on 18Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning an adult female with no known allergies who last year, in 2003, was vaccinated with a three dose series of hepatitis B virus vaccine (lot # unknown). This year, in 2004, the patient's titer showed a low result so the patient began a second dose series of vaccinations. One month ago, in approximately July 2004, the patient received the first dose of the second series (lot 643399/0367P). There were no problems after this vaccination. On 8/31/04, at 2 PM, the patient received the second dose of the second series (lot 647274/0426P). Approximately 7 hours later the patient developed hives and reported to the ER. The patient was not hospitalized and it was unknown if the patient was treated. It was reported that she is recovering. The reporter has expressed a concern with the lot 647274/0426P. No product quality complaint was involved. Additional information from the pharmacist indicated that this experience was being treated as an allergic reaction and that the third dose in the series was not going to be given. He reported that the patient has recovered with no other adverse effects or consequences from the experience. No additional information is known. The reporter considered the patient's hives an other important medical event (OMIC). A lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
I caught COVID on September 27, 2021. I had inflammation, back pain, and mild symptoms. Then I had went back to work, and everything was fine. In October 2021 or November 2021 I had started having stomach aches or a mild condition. On November 30, 2021 I got diagnosed with guillain barre syndrome. I had a plasmapheresis treatment. Then I had a IVIG treatment. Now I am in recovery for the nerve damage from the guillain barre syndrome. I had got a flu shot on September 16th, 2021.