chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #: not reported) (dose in the series unspecified). Subsequently the patient got pale and light-headed in the office when she received the GARDASIL injection. At the time of the report, the patient's paleness and light-headed improved. Patient sought unspecified medical attention. Follow up information has been received from the physician who reported that on 23-JUN-2010 the patient felt faint after receiving GARDASIL. It was resolved with in a few minutes. No further information is available.
Patient developed tongue swelling and facial swelling approximately 25 minutes after vaccination Patient was administered prednisone 20 mg po, benadryl 25 mg po and Epinephrine 0.3 mg IM
Headache, nausea, vomiting (2x), fever (~101F), chills. Lasted 36 hours.
Patient was given first dose and stated that she was nervous but otherwise stated that she had not had any issues with vaccines that would indicate she had every fainted or felt dizzy following vaccination. About 5 minutes after vaccination patient fainted but did not lose consciousness. Stated that she hurt her back but did not hit her head as she fell. Patient stated she had feeling in limbs but that she was feeling warm immediately upon sitting up which took place about a minute after the event occurred. Patient was instructed to stay seated on the floor and was given a bottle of water and fanned by her significant other. Paramedics were called and arrived about 5 minutes after the event and they took over patient management, testing blood pressure and for trauma. Patient indicated that she was okay with paramedics and managed to stand on her own while they were treating her. Paramedics departed within 10 minutes of arriving. Patient and significant other remained at the pharmacy another 10 minutes until the patient felt comfortable enough to leave. They checked in with the pharmacy to indicate that they were doing okay and to check if we were comfortable with them leaving the premises. We agreed and patient was released from the premises.
I had the vaccine shot 2 days ago and this morning I woke up with it being red; I woke up with it being red and swollen/Why is my arm swollen after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination). At the time of the report, VACCINATION SITE ERYTHEMA (I had the vaccine shot 2 days ago and this morning I woke up with it being red) and VACCINATION SITE SWELLING (I woke up with it being red and swollen/Why is my arm swollen after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment products were reported.
On 05/04/2021, just over two months after the second dose, a routine physical detected a Right Bundle Branch Block (RBBB) - an abnormal ECG result.  Onset of this condition is not known, but Patient had no history of this condition in physicals and ECGs prior to receiving the Pfizer-Bio-NTech vaccine.
Developed zoster rash to forehead/temple approximately 10 days after administration of VARIVAX. Started on Acyclovir PO 5/2/16 and monitoring for resolution. No fevers, pain, or itching.
Within 20 minutes after receiving shots, my daughter went extremly pale and complained of a stomach-ache. We had just left dr's office when she had a seizure/convulsion her body stiffened, her arms were raised and her fists were clenched. I ran back into the dr's office for help. When I returned to the car, she was still stiff and shaking. I pulled her from the car and ran with her to the doctor. At this point her body went limp and within minutes opened her eyes. She seemed awake but not alert for a minute more and remained extremly pale for 15-20 minutes. We remained in the dr's oiffice under observation for 30 minutes or so, then left. Doctor felt reaction was due more to stress of getting the shot than to the  actual vaccine; however I do not agree. Although she may have felt some anxiousness, she did not appear stressed she did not fuss or try to avoid getting the shots and did not cry or pull away when VA gave her the shots. They even commented on how great she was about getting the shots. I believe she had a reaction to the vaccine
Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management.     Thrombocytopenia:  - plt count stable today, Hgb stable  - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid  - will hold protonix as possible offender  - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present  - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine  - if plt remains stable, may d/c home with plan for f/u with Dr outpt    COVID-19:  - case discussed with Health Department, COVID test for variant testing sent 5/6  - for now, will cont care in isolation  - patient with positive COVID-19 test   - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021  - pt with no active respiratory sx  AMS: unchanged  - waxing and waning mental status  - improved AMS with improved renal fxn     Acute renal failure: improving  - Cr: 1.64, cont PO intake     LE edema:  - unchanged, low albumin levels, need to increase protein intake  Chronic systolic heart failure: stable  - cont to hold diuresis  Disposition:  - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).
My daughter complained of headache 1/27/2022 and we observed a red welt on her left arm at the one injection site. She complains it is sore to touch but it able to move arm with little discomfort.
Received dose one of Havrix on 22Sep2023 and dose two of Havrix on 28Sep2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 3-year-old male patient who received HAV (Havrix) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 28-SEP-2023, the patient received Havrix. On 28-SEP-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Received dose one of Havrix on 22Sep2023 and dose two of Havrix on 28Sep2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023. Medical Assistant reported that a patient received dose one of Havrix on 22-SEP-2023 and dose two of Havrix on 28-SEP-2023. The reporter consented to follow up. The patient received booster dose of Havrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Vaccine given 6/27/18 noted reaction 6/28/18 redness, erythema area 10 cm x 7 cm. Pain r-deltoid. Will moist warm compresses TYLENOL 650mg Q 6 hrs.
Information has been received from a physician concerning a 78 year old female patient with osteoporosis, hypertension and hyperlipidaemia and no drug reactions or allergies who on 20-JUL-2010 was vaccinated intramuscularly into the left arm with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # 665707/1407Y, expiration date 12-JUL-2010). Concomitant therapy included alendronate sodium (MSD) and lovastatin. Within 48 hours post vaccination, on 22-JUL-2010, the patient had pain, soreness, erythema and swelling at the injection site. Patient was seen at the office and was prescribed MOTRIN for 3 days. At the time of the report the patient had recovered. No lab diagnostics studies were performed. The physician reported that he wanted a lot check for Lot# 665707/1407Y. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The is one of several reports received from the same source. Additional information has been requested.
itchy almost everywhere; palms very pink and can see tiny vessels (petechia); palms very pink and can see tiny vessels (petechia); feels like a lot of blood to extremities - warm and tingly; feels like a lot of blood to extremities - warm and tingly; huge rashes on bilateral abdomen and neck.; This is a spontaneous report from a contactable consumer (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced huge rashes on bilateral abdomen and neck on 08Jan2021 and itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly on 10Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient received the first dose of vaccine on 05Jan2021 and three days later, on 08Jan2021, noticed huge rashes on bilateral abdomen and neck. The rash was noticed after shower and went away after about an hour and a half (as reported). The patient woke up on 10Jan2021, itchy almost everywhere. The palms were very pink and can see tiny vessels (petechia). It was reported to have felt like when you go for a run and feel like you get a lot of blood to your extremities - warm and tingly (as reported). The patient was seen at an urgent care and did a blood test, on an unspecified date, with results still pending (unknown results). The clinical outcome of huge rashes on bilateral abdomen and neck was recovered in Jan2021 and of itchy almost everywhere, palms very pink and can see tiny vessels (petechia), and feels like a lot of blood to extremities - warm and tingly was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
pt was nauseous diaphoretic and pale. Brought to EMS room @ 905am, vitals take patient states immediate relief. Patient given orange juic and monitored for 30 minutes discharged in stable condition.
There was pain at the location after the first shot that lasted a day or two but just a little stick when actually receiving the shot.   With the second shot it hurt a lot going in, while being given the shot, right after the shot, and while waiting 15 minutes to leave after the shot.  It burned a little when receiving it and while waiting afterwards.  The pain gradually lessened but a different kind of pain, like the pain I felt after the first one, continued into the next day and night.  That is where I am now with that.  Arm is still soar.   With the second shot after I left my waiting period and drove away I started to cry, during part of the drive, which was only about 7 minutes or so, I started sobbing.  When I arrived at my destination, I sat in the car and sobbed.  Not from pain or anything that had happened, it was just some kind of reaction my body was having.  After about 10  minutes I was okay.  The next day, today, I felt kind of not so happy.  Not depressed or anything, just kind of blah.  I don't know if that is any relation to the shot because I have days like that occasionally with spending so much time at home due to working from home during COVID.  It's night time now, the day after the second shot.  My arm hurts and I have some tension through my upper back.
This patient was supposed to receive Abrysvo due to its indication for pregnancy, however, Arexvy was given. Patient has not notified clinic with any side effects/complications.
Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a doe of Pneumococcal 23v (lot #651321/1036P). On 29-AUG-2006 the patients developed swelling, redness and heat in the injection site arms. The patient are being treated with BENADRYL and TYLENOL. It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036P). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES # 0608USA06977, 0609USA05103, and 0609USA05104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with BENADRYL and TYLENOL. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Office of Biological Research and Review and was released by the regulatory agency. Additional information is not expected.
SOB, sinus congestion, COVID +.  received regeneron prior to admission. Her SOB worsened prompting the ED visit. NO O2 required.UTI - given Meropenem and Ceftriaxone. IV hydration.  dc home on oral abx
Patient presented to pharmacy to receive the second dose of the primary series of her covid vaccine. Technician entered the immunization for the bivalent booster and this is also what was administered to patient.  After the vaccination was administered, she asked when she would be eligible for the new bivalent booster which alerted us to the fact that we administered the wrong dose. Patient returned 2 days later on 11/19/22 to receive the second dose in the covid series and reported no adverse effects to the booster dose that was previously administered.
tested positive for covid-19 after receiving 1st dose of vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine). At the time of the report, COVID-19 (tested positive for covid-19 after receiving 1st dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Correction of patient initials. On 19-Apr-2021: Follow-up received on 19-Apr-2021 included no new information. On 26-Jul-2021: Follow-up received 26-Jul-2021 included no new information.
joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information:In 2021, the patient experienced joints pain that affected movements/knee pain Sometimes right and left knee/wrist/elbow/ankles ached and headache. In 2021, the joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached and hand ached resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
admitted to hospital on 1/24/22 for cirrhosis/ascites, found COVID+ on 1/25/22
3/25/21 in CJ received Johnson & Johnson vaccine. Medical staff was not aware of this when Moderna Vaccine was administered on 9/3/21.  He did not complain of any health issues or concerns s/p Moderna Vaccine Administration  Moderna Case # MOD-21-150249  Johnson and Johnson # 02606856 Safety Ref # EZR20210159898
Knee effusion; Hoarse voice; Feeling hot; Anxiety; Bronchitis; Chest pain; Breathing difficult; Weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety) and BRONCHITIS (Bronchitis) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in an clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   In August 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever). The patient was treated with ALPRAZOLAM (XANAX) at a dose of 1 dosage form. At the time of the report, JOINT EFFUSION (Knee effusion) had not resolved and DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The causality for the events Knee effusion with respect to Humira was reported as reasonable possibility. The causality for the events Weakness,Feeling hot, Fever, Chest pain,Breathing difficult with respect to Humira was reported as No reasonable possibility.  The causality for the events Anxiety, Bronchitis with respect to Humira was reported as not reported.
Patient became dizzy and fainted on the way to the observation chair. He did not lose conciousness, he said he just felt very dizzy. He said it felt good to lay on the ground, so I him lay for 5 minutes, then I helped him to a chair. I told him I wanted him to stay seated for 30 minutes so I can monitor him. He called his father, who came to pick him up after the 30 minutes were up.  He slowly stood up and walked a few steps and then left the store with his father.
Aching, bruising progressing to extensive redness which spread outward and posteriorly from injection site. Paresthesias and weakness to arm, firm. Dx cellulitis- started on Keflex, warm compresses, ibuprofen for pain.
A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a 10-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
pt slouched over & was unresponsive for approx 3min;pt incontinent of urine;pt then responded & stated was fine;BP 108/56, P60 regular;skin warm & clammy;AMED notified & responded;pt refused eval & stated was fine;
This is a spontaneous report received from a contactable pharmacist. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 10, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for immunisation. The patient developed a rash (skin eruption), blister (blistering under armpits) and fatigue, onset 2021, with outcome of unknown. Skin eruption and blistering under armpits evaluated at a physician office visit. Additional information: The patient had a severe reaction after receiving the second shot of Pfizer COVID vaccine on Jun 10, 2021. Patient broke-out in skin eruption. Blistering under armpits. 80% of reaction was on the left-side (where she got the shot). Patient also had fatigue; both fatigue and blistering lasted 5-7 months. Patient saw an allergist but the allergist did not know anything about allergic reactions to COVID-19 vaccines. The  patient would like to know which specialist would be able to evaluate what caused her reaction to the vaccine, and also what Pfizer recommends in regards to booster shots. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.