chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not an immunocompromised patient; Hives; Stomach feels like burning and upset; Heart pumping occasionally; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset), PALPITATIONS (Heart pumping occasionally) and OFF LABEL USE (not an immunocompromised patient) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 029L20A and 0251202A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally). On an unknown date, the patient experienced OFF LABEL USE (not an immunocompromised patient). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at a dose of Every 6 hours. At the time of the report, URTICARIA (Hives), ABDOMINAL DISCOMFORT (Stomach feels like burning and upset) and PALPITATIONS (Heart pumping occasionally) outcome was unknown and OFF LABEL USE (not an immunocompromised patient) had resolved. Unknown          No Concomitant Medications were provided by the reporter
pt recvd vax; w/in 1 hr of second inject, devel fever 103  & chills;
Chicken pox- like rash across abdomen, with mild itching and burning.  Negative for shingles and monkeypox
Received FLUZONE HD on 9/23/15 - called pharmacy 9/26/15 and stated had a local rash around injection site. It doesn't itch and seems to be getting smaller. Followed up w/ pt on 9/27 and rash has gotten much better - almost all resolved. Has been taking BENADRYL.
Information has been received from a pharmacy student concerning a 6 month old patient who was vaccinated with a dose of PNEUMOVAX.  The patient developed a fever at the time of vaccination but had since recovered.  Unspecified medical attention was sought in office.  Additional information has been requested.
Moderna COVID-19 Vaccine EUA Injection site reaction:  Pain, swelling, redness in upper left arm at injection site that was noticeable the morning after the injection.
This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced more wrinkles on hands and forearms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more wrinkles on hands and forearms. This report was non-serious.
Nausea / vomiting, chills, fever 101 began 5/18/07 at 600 am. Patient given IV antibiotic and nausea medicine. Injection site swollen and tender. Patient continued to have nausea and was admitted for OBS.  06/11/2007 MR received for o/n observation for c/o fever, nausea, and vomiting after vaccination.  Seen in PCP office and given IVF, Cipro and Zofran without improvement, so admitted.  PE: revealed a weak appearing pt. with Temp of 101.9'F.  Pulse rate 140.  LUE shows induration and swelling at the injection site.  Impression:  Fever, nausea and vomiting. ? Adverse effect to vaccination.
Information has been received from a RN concerning an 80 yr old male who on 21Dec04 at 11:55 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). That evening, the pt developed a 3x5 inch welt. On 22Dec04, the welt increased to 6x10 inches down over his elbow, and was scarlet colored. It was also reported that there was swelling and the area was hot and very sore to the touch. On 23Dec04, the pt had an office visit with his provider and immunization information was requested. On 27Dec04, the swelling and redness decreased, the area was slightly warmer, and pruritus was noted. Unspecified medical attention was sought. It was reported that the pt fully recovered without complications. No product quality complaint was involved. Further information is not expected.
8 month old was in exam room with older sibling who was scheduled to get shots also. Pt inadvertly given MMR. (see back)
I contracted COVID-19 on 06/11/2022 with symptoms of congestion, fatigue, fever of 99.5, and cough. I was prescribed Paxlovid on 06/11/2022. I was ill for 2 days before my symptoms began to improve. I had lingering fatigue for 5 to 10 days after completing Paxlovid. I had 24 hours of symptom rebound 3 days after completing Paxlovid, but I am fully recovered with no lingering symptoms.
Patient came with mom for COVID 19 vaccination. Mom and daughter both gave patient's age, patient reported age as 12., but actual making her eleven years old at age of vaccination. This was discovered through audit of medical records.
I had immediate pain at injection site, which is still tender to the touch.  I have experienced extreme fatigue over the past three days.  I had diarrhea multiple times starting at 12AM on 03/07/2021.  I became extremely weak, dizzy, disoriented, and broke out into a cold, clammy sweat.  My skin was very ashen/pale.   Did not administer body temperature at time of incident but had cold chills.
Patient immunized 8/15/12, now c/o pain & itching. At inspection: Patient with swelling & redness on left deltoid, biceps and internal side of arm. Patient instructed to use ice pack and to take ibuprofen or TYLENOL for pain. RTC if no improvement.
Two days after I began having a severe sore throat, three days after I had a sever sore throat, body aches, chills, headache, coughing. Four days later I began coughing up phlegm, had to use my nebulizer and use prescription cough medicine. I had a bad asthmatic reaction.
Pt c/o dizziness, VSS, BS 102mcg/dl, pt states she had a lot of anxiety about getting vaccine.  Pt able to relax and anxiety & dizziness resolved.
HCP reports that improperly stored vaccines were administered; No adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) subcutaneous injection (1 time dose, lot #W028561, expiration date 06-MAR-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On unknown day, the suspect vaccine experienced a temperature excursion of 7.7 degrees Fahrenheit (F) for 8 hours and 54 minutes (product storage error). Previous temperature excursion of 7.7 F for 2 hours and 18 minutes from unknown day was reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event).
Second dose administration error per interval. The second dose (7/22/2021) was administered 14 days after the first dose (7/08/2021)
Shingles on both inner thighs; Muscle aches; Hamstring pain; Itchiness; Rash on her wrist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received on an unknown date, there were no adverse events).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, 1 hr after receiving Shingrix, the patient experienced rash. On 19th November 2020, the patient experienced shingles, muscle pain, pain in thigh and pruritus. On an unknown date, the outcome of the shingles, rash, muscle pain, pain in thigh and pruritus were unknown.   It was unknown if the reporter considered the shingles, rash, muscle pain, pain in thigh and pruritus to be related to Shingrix.  Additional details were provided as follows: After dose 2, the patient experienced a rash on her wrist.  Two weeks after the 2nd dose, the patient experienced muscle aches, hamstring pain, shingles on both inner thighs with itchiness.  Patient had no further contact information available for physician phone number or address. The reporter consented to follow up.
All over red skin and burning sensation, tachycardia to 165 bpm and near syncope.  Next day fever, body aches, chills and headache.
When leaving the clinic, she noticed a headache and increased salivation. She then had throat burning and some difficulty swallowing, which resolved in 2 hrs. No wheezing or dyspnea. Some injection site discomfort.
With the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side; Had swollen on the back on right side and now, she has swollen on the left side; This is a spontaneous report from a contactable Other Health Professional (nurse). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot Number: EW0161) via an unspecified route of administration, administered in right arm on 25Apr2021 (at the age of 57 years) as dose 2, single for COVID-19 immunization. The patient has no medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EN6206) via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 57 years) as dose 1, single dose for COVID-19 immunization and experienced inflammation and swelling on back. She started feeling the issues on 7 like 72 hours after the vaccine. On unspecified date, with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side and had swollen on the back on right side and now, she has swollen on the left side. Reporter (Nurse) calling on behalf of aunt who received a Pfizer vaccine on 04Apr and she got the second dose on 25Apr. After the first dose, she presented with an inflammation on the back on the same side as the dose (not clear) and with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side. Reporter wanted to know if it was normal. No treatment received for the events. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
(R) UA - had a rash site of FLUZONE. Now rash resolved & pin head size erythema, site of injection.
5/7/2023  I had a faint headache on the top and back of head and back of neck.  It felt like my head was being squeezed from both sides.  That evening I began sneezing and coughing quite a bit. I tested positive for COVID with an at home COVID test.  I called the doctor and was prescribed Paxlovid. I began taking the Paxlovid on 5/7/23. I tested negative for COVID with an at home COVID test on 5/11/23. On 5/14/23, I tested positive for COVID.  I felt much worse this time.  I called my doctor and he told me to continue to treat the symptoms with cough medicine, Tylenol and congestion medication. On 5/25/23 I tested negative for COVID.
gave an 18 year old patient a 1ml dose of Engerix-B as her first dose; gave an 18 year old patient a 1ml dose of Engerix-B as her first dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 239TF, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult use of a child product (serious criteria congenital anomaly). On an unknown date, the outcome of the overdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 18 years old patient taken 1ml of Engerix B first dose and experiencing overdose, Inappropriate age at vaccine administration.  The vaccination administration facility was same as primary reporter for his report. No further information was provided The reporter consented to follow up.
Fever; Chill; whole muscle ache; Headache; Runny nose; This is a spontaneous report from a contactable Other HCP reported for herself. This 32-year-old female (no pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscular at left arm on 20Dec2020 11:00 at single dose for COVID-19 immunization. None medical history reported. The patient's concomitant medications were not reported. No Covid prior vaccination, No Covid tested post vaccination. No other vaccine in four weeks. On 20Dec2020 02:00 PM, the patient experienced fever, chill, whole muscle ache, headache, runny nose. No treatment received for the events. The outcome of events was unknown.
Information has been received from a nurse concerning a 13 year old female with no pertinent medical history and no drug allergy who on 27-JUL-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# not reported). Concomitant vaccinations included MENACTRA and DTAP. On 05-AUG-2009 the patient experienced chickenpox type lesions all over her body after receiving a dose of VARIVAX (Merck). The lesions were itchy and the patient also had fever. There was no lab diagnostics performed. The patient called the nurse and she was recovering. Follow up information has been received from the licensed visiting nurse who stated that the rash was not chicken pox and there was no reaction to VARIVAX (Merck). Additional information has been requested.
Patient reported feeling uncomfortable. Observed red area down left arm and complaint of an acute pain that goes up neck.
Pt arrived for first dose vaccine. Guardian advised Pt was 11 years old. Registration and vaccinator confirmed birthday but missed that the Pt just turned 12 years old. Pt was given Pediatric pfizer by mistake instead of adult pfizer. Guardian made aware. Pt had no complications and left stable.
On 2/2/21, patient reported to vaccinator that new swollen tissue, warmth, and itchiness have begun one week from vaccination at vaccine site. On 2/3, Patient emailed that condition persists and PHN reported to VAERS and agency incident report and to supervisor. Patient encouraged to self report and seek care as needed if worsens.
~ 2 days following first dose significant joint pain in hips, moderate in knees and shoulders. Improving on day 7. Day 7 noticed enlarged lymph node slightly larger than a pea on left clavicle
Patient presented at facility for second dose of Pfizer. Patient received his first dose of Pfizer on 4/27/2021 at   location in another area. Patient developed a diffuse itchy rash over arms and legs one week after initial vaccine. Patient reports never had similar rash in the past. Continues to have severe itching and irritation now for past four weeks later. Dr recommended patient wait until rash has completely resolved. Patient can return for second Pfizer dose and will be monitored for one hour after.  Patient was referred to PCP for referral to allergist. Patient understood and is in agreement.
I visited the urgent care the following Tuesday. I felt very flushed and dizzy. 24hrs after I had major migraines which lasted two days. I had a flare up from my lupus. I also had extreme stomach pain which is why I went to the urgent care.
Onset of ataxia in lower extremities approx 2 days p/flu; tingling sensation in both arms; dysphasia & partial dysphagia;
Positive COVID 19; Positive COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 at 08:00 as dose 1, single (Lot number: EL9231), in left arm, on 12Jan2021 at 08:00 as dose 2, single (Lot number: EK9231), in left arm and on 25Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 66 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Positive COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: (positive Covid 19) Oct.  Clinical course: The patient had provide the information regarding the reported adverse event (s) with the use of the product. The Pfizer product had a casual effect to the adverse event: Yes. Vaccine was not administered at military facility. Prior vaccination (within 4 weeks) was none. Relevant test was none. Specific relevant test for thromboembolic events with thrombocytopenia was none.; Sender's Comments: Based on the available information in the case, an association between the reported events VACCINATION FAILURE & COVID-19 and The suspected drug cannot be ruled out.
NECK PAIN; CHILLS; SHOULDER PAIN; This spontaneous report received from a consumer concerned a 65 year old. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced neck pain. On 04-MAR-2021, the subject experienced chills. On 04-MAR-2021, the subject experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, and shoulder pain. This report was non-serious.
Stated the syringe was full and she thinks she saw a volume of 2ml; shot administered higher than deltoid region; injection site pain; red at injection site; Shear volume caused feel faint; States the shear volume of fluid is what caused her to feel faint; felt incapacitated; fever; chills; felt sick; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 4th January 2023, unknown after receiving Shingrix, the patient experienced overdose and vaccine administered at inappropriate site. In January 2023, the patient experienced injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell. On an unknown date, the outcome of the injection site pain, felt faint, fluid imbalance, feeling abnormal, fever, chills, feeling unwell, overdose and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, felt faint, fluid imbalance, feeling abnormal, fever, chills and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The consumer was the reporter. The patient received Shingrix in left deltoid region, but administered at a higher spot than normally given, near the joint area. The reporter stated that the shear volume of fluid was what caused her to feel faint.  The reporter stated the syringe was full and she thought she saw a volume of 2 ml. The reporter declined to provide PCP's (primary care physician) information as she wanted to speak with them first. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Shingrix near the joint area, which led to vaccine administered at inappropriate site and received more than the recommended volume of Shingrix, which led to overdose.
The event started on January 1st, lethargy, tiredness, and a fever of 101. I took a COVID19 test at home which came up negative. At that time I went to a walk in Urgent Care and they gave me a COVID19 test which came back positive. They didn't give me any medication just told me to go home and rest and take plenty of fluids. I developed a scratchy throat, nasal stuffiness, sneezing, and I lost my sense of taste for a few days. The fever only last a day. I gradually began to feel better. I isolated, stayed at home. I would say the whole thing lasted about 6 days.
Information has been received from a licensed practical nurse concerning a female with penicillin allergy and no pertinent medical history who was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot# not reported). Concomitant therapy included GLUCOPHAGE. Subsequently the patient developed rash and palpitations after receiving the first and only dose of RECOMBIVAX HB. Subsequently, the patient recovered from rash and palpitations on unspecified date. No lab diagnostics study was performed. The patient did not seek medical attention. Follow up information has been received from a health care professional indicated that the patient was given the vaccine at another doctor's office and they did not have any information. Additional information is not expected.
Raised erythema itching area 4.5" by 4.5" on upper right arm, slight itching noted on back, but no rash noted on back.
This initial spontaneous report was received from a physician referring to a 6 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015 at 16:06 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.