chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 mins after receiving vaccination experienced lightheadedness, palpitations, and faintness; was assessed (BP, HR, RR) which were elevated; rested, water, and started to feel better; 20 mins later had another wave of lightheadedness and my vitals increase again which was more intense then the first time; put me on O2 and sent me down to the ER where they monitored me on telemetry, general blood work, EKG, and assess me for swelling, rash and further reaction; BP got to 134/100 but other then that no outstanding numbers; 15 mins after arriving at ER they gave me benedryl and a steriod per IV and IV fluids; right after they gave me that had another wave of lightheadedness which didn't last a long as the others; symptoms seem to subside and then the let me go home; had no further issues that night other then insomnia; Next day had shortness of breath on exertion but was able to go about my day and just ease up is I was tired; at 6pm that night I started having redness, hottness from the injection sight and the redness (like flushing, not rash) spread from my left arm across my chest to my right arm, and up to my face; felt over heated like I was having a hot flash and my left ear (side I received the vaccine) start to ring; took a dose of benedryl per the bottle instructions and it seemed to calm down; today (day 2) I woke up feeling somewhat ok but as the day is progressing my head feels floating and having trouble concentrating, my upper body from my chest up feels tingly, heavy and weak like I just worked out my muscles and my had are really cold esp on my right hand; my vaccine site is still very warm;
expired Ipol vaccine was administered to a patient with no AE; Initial information received on 19-Apr-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient who received an 0.5 mL dose of expired IPV (VERO) [IPOL] [lot number: R1B251M and expiry date: 13-Mar-2021] via an unknown intramuscular route in the left thigh for prophylactic vaccination on 15-Apr-2021 (Expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired product administered. [Latency: at the same time of vaccination].  At the time of reporting, patient had no adverse 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 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.
She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states that she went to work on Saturday, she is a food server, she started to feel not herself and felt like she ?snapped?.  She states that on the way home in her car she was nearly struck by the train crossing barriers.  She states that she went home and sat in her recliner on Saturday and did not get up until Wednesday at around lunchtime.  She states that she did not get up to eat or drink.  She used incontinence pads and depends.  She did not get up to use the restroom.  She did continue to take her medications. Patient states that she was motivated to get up today because her friends were concerned for her and 1 of her friends came over to take her out for lunch.     Elevated D Dimer History of DVT - mild leg pain, no swelling or erythema. No chest pain, cough or SOB. Low suspicion for PE - full dose lovenox - BLE duplex in the morning
Fever > 38 C, myalgias, and pain and redness at prior injection site.
Patient stated after she received both vaccines in the same arm, her arm was hot, swollen, and red and itchy soon afterwards (possibly the next day). She applied cortisone cream on that arm which helped a little.  Swelling, redness subsided after a few days. The itching never cleared up all the way and it just keeps getting worse. the itching has spread all over body. She states it feel s like hives. She states her skin is somewhat red but no hives. She's been to the ER and a few md offices. She was given prednisone twice for it, which helped but never cleared it up all the way.  Patient states her skin stings and itches at the same time.
PT rcvd vax; pt exp  muscle weakness, achiness, musculoskeletal chest pain; shortness of breath; left upper quadrant & epigastric pain, chills; malaise; fatigue; migratory joint pain & dizziness; cough;pt had acute CMV mononucleosis;
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------   ACUTE RESPIRATORY FAILURE 7/26/2021 ATRIAL FIBRILLATION, UNSPECIFIED
Abnormal vaginal bleeding (over 16 years after last period.) I was put into menopause in 2003 with my last period around 2005 due to chemotherapy for breast cancer.  So this was a shock!  It was definitely coming from the uterus, but the uterine lining was within normal thickness for post-menopause, so this was not explained.  This happened after the first and second dose of the Pfizer vaccine.  Very short duration - a few days, very light bleeding.
At the injection site there is slight bruising and an indentation in the arm. The spot is the width of two fingers. There is a slight soreness when raising arm to the left. There is muscle cramping when arm is bent for more than 5 minutes. Example, sitting at a desk at computer.
Second day following flu shot, felt very tired, painful sore throat accompanied by chills and pain down right side of neck took 500 mg TYLENOL and applied ice pack - results little relief. 3rd day awakened with blistered rash on right side of forehead into scalp, swollen right eye, very itchy infected eye. This letter is written to further explain the symptoms of my illness complication as related to the influenza vaccination. Two days following the vaccination a painful blistered rash appeared on the right side of my forehead along the side of the face and about 3/4 way into my scalp. The rash also covered the right eyelid with severe swelling, causing extensive medical treatment because my eye became infected. I received my treatment from provider, necessitating four or more visits, and the administration of costly prescription drugs for the eye. Additionally I also suffered severe dizziness and throwing up, and on 10/16/11 required emergency room treatment at hospital. As indicated on my attached VAERS reporting form my primary care physician diagnosed and treated the shingles virus. I am reporting this information in hopes that it will be valuable to CDC & FDA in evaluating public health safety and prevention. I have kept record of all doctor visits and diagnosis relating to the incident.
reaction in lymph nodes on both sides/ arm pits; she was awake all night; arm where the shot was placed hurt also; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "breast cancer survivor" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "reaction in lymph nodes on both sides/ arm pits"; POOR QUALITY SLEEP (non-serious), outcome "recovered", described as "she was awake all night"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "arm where the shot was placed hurt also". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient mentioned that she did lymphatic massage in arm pits, both sides. She stated all the events subsided by the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare professional, concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose shingles vaccine zoster vaccine live (manufacturer unknown) (dose, route and frequency were not reported) (Lot # was not reported). On an unknown date, the patient developed a lump under skin at the injection site. At the time of the report, the patient's outcome of lump under skin at injection site was unknown. Additional information is not expected.
16 y/o female with (L) arm soreness with elevation x 3 weeks post Influenza vaccine administration started 1 week after injection. No edema/erythema (-) fever, (-) weakness.
experienced an adverse reaction (no clarification); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (experienced an adverse reaction (no clarification)) in a female patient of an unknown age 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 IMMUNISATION REACTION (experienced an adverse reaction (no clarification)). At the time of the report, IMMUNISATION REACTION (experienced an adverse reaction (no clarification)) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Patient received Pfizer vaccine instead of Zostivax.  Has already received Janssen vaccine.  Sore at injection site.
no adverse event; We had a patient that received an expired dose Moderna Bivalent vaccine; Patient that received first dose of primary series of Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
I had chills and a fever and felt tired/fatigued about 2 days after the vaccine. I had swelling on the back of my head that was painful. Then gradually my temperature went down but I have continued to feel fatigued throughout the day. I think I have had something going on with my intestines. I have been very thirsty and after the swelling in the back of my head went down, I started to swell on my right temple. It is very painful. My doctor today 10/12/2021 said there is a swollen gland on the side of my head. My throat has also been hurting a little bit. I was unable to finish my exercise class this morning which is unusual for me. My doctor had suggested a few weeks ago to take zinc and vitamin D to help with energy levels but I am still fatigued. This last saturday I called the advice nurse and I went to urgent care 10/10/2021.
This is a 69-year-old female with significant past medical history of end-stage renal disease on dialysis that received her renal transplant, hypertension, type 2 diabetes and CKD that presented to the hospital with chief complaint of progressively worsening nausea and vomiting over the past several days.  Patient states that she has been sick for about 10 days with nausea vomiting and diarrhea.  She has been unable to keep food or drink down.  She states that she missed multiple days of medications due to her nausea and vomiting.  The patient notes diarrhea as well.  The patient denied any significant abdominal pain fevers or chills.  Patient did note a slight cough but was not short of breath.  The patient was vaccinated for Covid with a bone neurovaccine earlier in the year.  The patient denies any chest pain, palpitations, lightheadedness or dizziness.  Patient denies any dysuria, hematuria urinary frequency.  Patient started to feel weak and fatigued as well.
high pitch, shrill cry x 3hr, occurring in 1st 24hr p/vax;
At about the 12 hour mark, I had a sudden onset of symptoms. I developed a high fever, and I had severe chills that were rocking my body and almost felt like my joints were going to come out of socket. My fever and chills were so high  I couldn't even move to check my fever. Physically debilitated and I was in bed all day, had severe headaches and eye pain (had the same pain from COVID in Aug 2020). Joint pain and nausea, rash at injection site, developed slowly, but raised red itchy injection site. Severe tachycardia. Avg for me was 70 BPM. Resting was 135-150 at this time. Fever and headache and other symptoms persisted for 4 days, nausea & rash and tachycardia persisted for a little over 6 days. Pretty strong reaction because of the severity of the side effects. Asked doctors if it was safe to receive 2nd dose. I was physically unable to get medical help at the time, but as soon as I was feeling better, I no longer felt the need to go to the doctor and took over the counter medications to help me get through the rest of it. When I was able to record my temperatures during my fever, my temp was 103.1. After the health event, went to go see my doctor to discuss side effects and got a chest x-ray. Discussed safety of receiving 2nd vaccination after those symptoms.
Patient was spiked with a fever of 100.8; felt crappy for 4 days with body aches & malaise.; felt crappy for 4 days with body aches & malaise.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 046C21A and 028L20A) for COVID-19 vaccination.     Patient had not had COVID as far as she knows.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8). At the time of the report, MALAISE (felt crappy for 4 days with body aches & malaise.) and PAIN (felt crappy for 4 days with body aches & malaise.) had resolved and PYREXIA (Patient was spiked with a fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8.         No concomitant medication were reported. It was reported that patient had very, very strong reactions to these vaccines. No treatment medication were reported.   This case was linked to MOD-2022-600690, MOD-2022-600693.
This spontaneous report as received from a physician refers to a 18 year old male patient. Physician reported that "years ago" patient received complete VARIVAX (Merck) (dose, strength not reported) series. On an unknown date, patient developed a rash. The patient's parents told physician that "it looked like shingles". The reporter had not assessed this patient for shingles at time of call. The outcome of the event was unknown. The relatedness between event and VARIVAX (Merck) was not reported. No product quality complaint (PQC) reported. Additional information has been requested.
He got his vaccine, his arm hurt way more than usual, really quick it went sore.  Then as the day went on he started feeling tired and groggy, spacy feeling.  Then just started to get a burning sensation between the back and his shouldre blades, and then back into his chest.  Then legs and body felt hot, but he did not have a fever, almost like sunburn.  The feeling was pretty intense.  He went to sleep and then was woken up around 8-9 and then had stomach tightness, bloating, hot sensation, extremely hot.  He kept trying to walk it off and cough and move, and starting drinking a lot of fluids, and subsided a little bit.  he took his inhaler which kind of helped, but it almost made him feel more congested, and  feels like it triggered a reaction with his asthma.  Made his asthma worse and brought it out.  The symptoms today are better than list night but he is still having the feelings or burning in his abdomen, rib cage, tight feeling.    He has not contacted his doctor.
Yesterday evening just after 7 PM parents called me; Was in for his 4 month well visit today, and received his 4 month vaccines (DTaP-IPV-HIB, PCV-13 and RV-5) - about 6 hours prior. Just then they had given him a bath; after the bath he became very fussy, then started screaming, his eyes opened and closed, and he became very pale. He was afebrile. He was now asleep, his color was normal again - but he had red blotches on his shins. I suggested: Let him sleep a while - then try to feed him (his last bottle was about 1 1/2 hours ago). Call me back if he refuses to feed; becomes febrile; or deviates in any other way from normal. I already discussed with his parents that this is possibly a reaction to the DTaP vaccine - rare, but "serious". Mom tells me now that he slept almost 4 hours after this episode. Reviewing the history again, after the bath mom put on his pajamas - "like a switch, nothing we've heard before, he started screaming". He screamed for 3 minutes (red while screaming) - mom eventually put him down in his crib - he became pale, and his eyes kept opening and closing. No limb movements, no stiffness - just limp. Then - after a few minutes - his color came back, he made some grumbling noises, took his pacifier and fell asleep. Mom has seen him "almost hold his breath" in the past - but "this wasn't like it". He woke up at midnight, took 6 oz, by bottle and went right back to sleep. He was up every hour because he lost his pacifier, went straight back to sleep. Mom doesn't want to be looking for things - but he is making some throat noises, like throwing up in his mouth, and has already taken two naps this morning; but he is making eye contact, smiling, had had wet diapers.
swelling in both hands to the point pt had diff moving them, swelling went to feet & ankles;rx anti-inflam, Ibuprophen w/no response;MD felt vax was prob;dx rheumatoid arthritis, confirmed by specialist. Annual FU indicates pt was re-diagnosed with Lyme arthritis triggered by the vaccine.
Information has been received from a RN concerning a 60 year old female with no medical history and no allergies who, "in another state", on approximately 11/24/03 was vaccinated in the arm with a first dose of pneumococcal 23v polysaccharide vaccine. ON approximately 11/25/03, the day after her vaccination, the pt developed musculoskeletal pain in the arm. On 12/15/03 it was reported that the pain continues. Unspecified medical attention was  sought and the pt was treated with ibuprofen and heat. No diagnostic studies were performed. It was also reported that a prescription drug was required. It was also noted that "a few weeks before" the pt was vaccinated in the same arm with a dose of influenza virus vaccine (manufacturer unknown) and developed musculoskeletal pain in the arm but not as severe. No product quality complaint was involved. On 01/30/04 it was reported that there was no data on this pt and the reporter did not have the name of the person nor where the vaccination was given. She reported that she "was checking for someone that knew the person". The reporter noted that "as far as she knew, the problem did resolve on it's own." No further information is expected.
Approximately 5.5 hrs post vaccine - patient developed hives on his back, buttocks and backs of arm. No hives near injection site. No generalized swelling, no respiratory concerns, no shortness of breath, signs of anaphylaxis, etc. Patient got better that night after Benadryl. Next morning did go to school and approximately 11:30AM (20 hours post vaccine) hives returned - same description and places per mother's accounting. Was instructed to add Zyrtec to Benadryl and monitor for other concerning sx's (SOB, weakness, dizziness, rapid HR, etc). No further questions or calls from parents.
9/22/14 at 11am shot received, 9/22/14 evening arm burning and red and knotted. 9/23/14 still red and burning at knot no longer.
Right arm hard to lift, sore across shoulders and arm that started about 4 days after vaccine administration.
11 days post Moderna booster, I began ro itch on the back of my head, neck, and chest. I had dermatography on arms. Neck and small clusters of hi es that resolve in 30 minutes but them reappear in other random spots. The hives migrate and taking antihistamine help but I have had them daily since November 12.
Caller reports expired PROQUAD administered.  No other information provided.  No additional AEs or PQC reported.; Caller reports expired PROQUAD administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The concomitant medications included sterile diluent (STERILE DILUENT). Information regarding the patient's pertinent medical history, concurrent conditions, , previous drug reactions or allergies was unknown.  On 21-APR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live human recombinant albumin (rHA) (PROQUAD) at a dose of 0.5 milliliters (mL) administered subcutaneously (SQ) as prophylaxis (lot number T035409 has been verified to be a valid lot, expiration date reported and stablished as 14-APR-2022) (formulation, strength, anatomical location were not provided) (expired product administered). No adverse events (AE) reported (no adverse event).