chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical assistant and refers to a 66-year-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 03-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for prophylaxis (lot# and expiration date were not reported). Other suspect therapies included sterile diluent (administered in approximately 03-OCT-2017, subcutaneously for prophylaxis; dose, frequency, lot# and expiration date were not reported). On the same day, the patient experienced redness, warmth, swelling, and itchiness at the injection site, which was also described as "a raised area about 8 inches by 1 inch." On the same day, the patient phoned to the office once again to report that symptoms were worsening. Consequently, the nurse practitioner instructed patient to take BENADRYL. It was also reported that the patient received the treatment for the events. Action taken with ZOSTAVAX and sterile diluent was not reported. The outcome of the events was unknown. The relatedness between the events and suspect therapies was not reported.
Patient states has body aches and headache morning following her influenza vaccine. Patient states she has "flu-like" symptoms. Recommended patient take OTC acetaminophen for body aches and pains and for relief of any fever should one be present.
As reported by Employee on 5/10/2021: "I went to my Primary, she said, she believes it was a possible reaction from the 2nd dose of the shot & that I have a slight Bell's Palsyl." Narrative: As reported by Employee on 5/102021: ********************************************* " I had my 2nd shot on 3/12 & the very next day, I guess I ha a reaction. I end up getting like on the left side of my face, it got tingly & numbness. It's still like that now & when I went to my Primary, she said, she believes it was a possible reaction from the 2nd dose of the shot & that I have a slight Bell's Palsy. It's not very, very noticeable but if you look at my mouth, you can see where it kind of droops a little bit. She had put me on steroids I think, maybe at the beginning, I'm not sure. Before this, the Bell's Palsy even happened, I had problems w/ Trigeminal Neuralgia. I take Gabpentin as need for that, for the Trigeminal Neuralgia. She says were going to wait ~6 months, to see if this will clear up on it's own."
No additional AE/PQC; HCP called to report late order of of VARIVAX that was administered to a patient.; This spontaneous report as received from a physician refers to a patient of unknown age and gender.      No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided.  On 07-MAR-2023 the patient was vaccinated with a late order of  varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis, expiration date: 05-OCT-2024 (dosage schedule, route, anatomical location and lot number) (product use issue). It was unknown if the vaccine was improperly stored.  No adverse events were reported.
She felt light headed and became pale after her fourth shot.  She said that all the colors in the room started blending together.  She felt light headed.  She never passed out.
On 4/26/2022 I had a sore throat so I tested for COVID-19 at home and it was positive. I got another at home test that was also positive. My symptoms got worse as they day went on with mild flu like symptoms. I had cough, congestion, and headache. The symptoms went on for the rest of the week. I have taken over the counter medication to help with the symptoms and I've been getting better each day. I called my doctor's office who advised that I take Ibuprofen and Mucinex.
Patient has been nauseated every day since receiving her Moderna vaccine. It will happen 1-2 times per day, and lasts for several hours. It comes and goes, has vomited only once last week. Eating fine, denies diarrhea or constipation; is not pregnant and did do pregnancy tests and were negative. A week after vaccination she said there was a huge red ring around the site of her injection; was hot, and swollen and hard. She said the next morning it was gone. Ginger ale and Tums help her tummy. She is due on March 10th for her 2nd dose, but she is not sure if she should get the second one.
This is not an adverse event. This report is regarding a possible administration error of a monovalent Pfizer 12+ Covid-19 of a  12 yo and older vaccine dose given to a 3-year-old patient.
Approximately 12 hours after vaccine awoke with hot burning/itching of soles of feet, outer ears and scalp, red rash observed on inner thighs, genitals, buttock, arms torso. Took BENADRYL 18 hours took LORATIDINE 20 mg and ATARAX 20 mg with good relief, have cont med next 6 days. On day 3 rash decreased on feet & head.  Torso had blanket of welts. Hoarse voice, sore throat and painful pyloric sphincter for 1-5 days.
Severe pain; Swelling at the site; Bruising; Shoulder pain; Not back to normal activities; Extreme fatigue; No strength; dizziness; Foggy head; Couldn't sleep; diarrhea; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019 01:00, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced diarrhea, feeling cold, fatigue, weakness, dizziness, foggy feeling in head and sleeplessness. On 5th September 2019 05:00, the patient experienced pain in arm, injection site swelling, injection site bruising, shoulder pain and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site bruising, shoulder pain, sleeplessness and activities of daily living impaired were unknown and the outcome of the diarrhea, fatigue and weakness were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved and the outcome of the dizziness and foggy feeling in head were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site bruising, diarrhea, feeling cold, fatigue, weakness, shoulder pain, dizziness, foggy feeling in head, sleeplessness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had severe pain and swelling at the site with bruising. She noted these began about 5pm and her vaccine received on at 1pm. She noted these also extended up into her shoulder area.  She does believe the vaccine was given in the muscle but noted she was only 4 feet 11 inches and 95 pounds.     She noted she did report these events to her physician via a message portal but has not been seen by her physician, who noted these did not require follow up.The patient states also on Thursday evening she had diarrhea, that has improved but not resolved. She was freezing but that resolved after 24 hours. She had extreme fatigue and no strength, which has gotten better but not resolved. She noted she had to cancel a vacation. She also had dizziness and what foggy head that continue but have improved.She noted she couldn't sleep due to the pain in her arm and shoulder. She was not back to normal activity but feels she is about 80 percent better.    The patient noted the continued issues are occurring longer than expected and was concerned about the long term effects would be.   The patient was referred to her physician and shared the information from post marketing adverse event reports from the prescribing Information.That document was also being emailed to the consumer. The reporter consented to follow up.
Hives; swelling; shortness of breath; chest tightness; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 37-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 05Apr2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies, mild asthma, reflex sympathetic dystrophy (RSD), and known allergies to apples and melons, all from unknown dates and unknown if ongoing. The patient did not receive any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included amoxicillin, clavulanate potassium (AUGMENTIN); cetirizine hydrochloride (ZYRTEC); and montelukast sodium (SINGULAIR); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6207) in the left arm on 15Mar2021 at 14:00 (at 37-years-old) for COVID-19 immunisation. On 05Apr2021 at 10:15 the patient experienced hives, swelling, shortness of breath, and chest tightness. The events were reported as non-serious and did not require hospitalization. The events required an emergency department visit and the patient was treated with intravenous medications. The clinical outcomes of hives, swelling, shortness of breath, and chest tightness were unknown. Since vaccination the patient had not been tested for COVID-19.
This spontaneous report was received from a pharmacist referring to a 84 year old male patient. The patient's pertinent medical history included: diabetes mellitus, hypothyroidism and benign prostatic hyperplasia.He had no drug reactions or allergies.Concomitant therapies included bupropion, nifedipine, glipizide, carvedilol, metformin, lisinopril (manufacturer unknown), levothyroxine sodium(manufacturer unknown) pioglitazone and tamsulosin hydrochloride. On 23-MAY-2018, the patient was vaccinated with pneumococcal PNEUMOVAX 23 lot # N031947 (expiration date:12-SEP-2019) intramuscular for vaccination(strength, dose, anatomical location and frequency were not reported). On 24-MAY-2018 (reported as the following day), the patient woke up and his entire upper arm was red (erythema) and warm (Feeling hot). He called his physician and was given unknown advice. It was reported that patient received treatment for the events. There were no lab diagnostics performed. The outcome of the events was reported as not resolved. At the time of the report the causality assessment between the events and PNEUMOVAX 23 was not reported.
The day after receiving my second vaccination 1/27/2021, I started getting Lymphadenitis, from a staff infection. This was confirmed after seeing my PCP. My PCP didn't do any testing or anything. This lasted for about 2 weeks, and I took oral Antibiotics until it went away. Overall, PCP did not think it was Vaccine related. But I still wanted to let the CDC know.
Left upper arm swelling, redness, tenderness and warmth. Seen 2 days after vaccine administration. Given Cephalexin for Cellulitis.
a two nurse assists to pivot pt to cot; pt laid at a 60 degree and, and moved to a 90-degree angle to drink Gatorade; she stated her legs felt ?heavy?, and ?tingled?; she complained of being cold, and towels were put on pt; pt stated this helped. pt requested to use the bathroom, and had some improvement in leg strength, so 2 nurses helped her to the bathroom; she needed a full 2 person assist, and she ?shuffled? her feet when ambulating.  Pt was able to wash hands on her own, however tremors were very noticeable.  Walked pt back to the cot, and she laid down.  Pt?s heartrate remained about 80bpm during the event; EMS was called, and her O2 sat was WDL, and her BP was elevated around 160 diastolic; Pt agreed to be seen in the local emergency room; On 9/24/21, I called the ER and they reported that the pt left before being seen by a provider, however an EKG was performed as intermittent chest pain was noted, and pt was in normal sinus rhythm.  I called the pt and she stated that she waited about 4 hours in the ED and wanted to go home because she was too uncomfortable to stay. Today, one day following vaccine, pt stated that she is ?feeling better?, but still ?weak?.  She stated that around bedtime last night, she felt ?itchy? and ?prickly? all over her body, and took a Benadryl, which she stated gave her some relief; She stated that both her hands did swell when she noticed that she had trouble removing a ring from them. Overnight she experienced fever-ish symptoms of chills and sweats, and is altering Tylenol and Motrin, which have given her relief.  She stated she is walking on her own without assist today, but still feels ?weak? and ?neuropathy-like? feeling in the legs and hands, and overall fatigue noted.  She stated that the photophobia and headache continues. She stated occasional chest pain with movement is continuing as well. Pt is in contact with her doctor and is looking for follow-up appointments with them.  Pt is aware VAERS report is being done for her.
Swollen and painful lymph nodes around injection site-left armpit, collar bone, neck. Tenderness at injection site worse than previous doses. Lasted 3 days.
Following vaccination the pt experienced elevated liver enzymes. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a nurse concerning a 11 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # unspecified). The nurse mentioned that on 31-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Pt went to the ER 10 days post vaccination with ACAM2000. Has local itchy rash, non-pustular. Pt was given Benadryl, Zofran, and Zantac and discharged to home.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient was vaccinated, on 11-JAN-2017, with the first doses of VAQTA intramuscularly, for prophylaxis, lot number M036458 with expiration date of 02-MAR-2018 (dose and anatomical location were not reported) and GARDASIL 9 for prophylaxis, lot number M034195 with expiration date of 14-APR-2019 (route, dose and anatomical location were not reported). It was reported that the patient inadvertently received the "immunization series too early compared with the recommended schedule", on 30-MAY-2017. He received, on that date, the second doses of VAQTA intramuscularly, for prophylaxis, lot number N005274 with expiration date of 03-APR-2018 (dose and anatomical location were not reported) and GARDASIL 9 for prophylaxis, lot number N001533 with expiration date of 16-OCT-2019 (route, dose and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
1 week post first dose of Moderna COVID-19 vaccination - individual called to report the appearance of a local reaction at the injection site.  Erythema (diameter of approximately 5 inches) and pruritis.  No other symptoms.   Antihistamine cream applied at the injection site on day 1.  No other treatment was taken.  Local reaction subsided completely within 7 day period.
Severe pain in shoulder following a flu shot; pain continues p/ tx w/NSAID, medrol dose pad & physical tx;
Patient has hives on entire body. Patient noticed hives after injection. Unknown if related to metal exposure from endovascular stent, which was surgically inserted on February 22, 2021.
Patient stated his heart rate was racing, he was visibly sweating, and had tunnel vision. He stated he felt like he was having an anxiety attack. This was 5-15 minutes post vaccination as he was being observed. We laid him on the ground and he immediately started to feel better. After a few minutes he sat up and drank some orange juice. Paramedics were called but patient was able to walk away on own accord. Called  later and was doing fine.
As recorded three weeks after the event by Allergist.  History reported by the patient. "63 year old we follow here for RAST test confirmed beef/pork/alpha gal allergy returns after a suspected reaction to a vaccine. He received the Shingles vaccine three weeks ago at pharmacy at about 12 noon.  Within 5 minutes, he reports developing ear, axillary and perineum itching, followed by generalized hives.  He drove home, then to the ER, and was given Benadryl in the ER.  No Epi. No trouble breathing.  Throat felt itchy.  NO N/V/D.   Hives all gone by 6 PM.  He reports this reaction was no where near as bad as some of his beef reactions." Zostavax; LOT#K008882; EXP. SEPTEMBER 20, 2015; RECIEVED VACCINE, JAN. 15,2015. The patient declined skin testing to vaccine components.  It is my judgement that this was an allergic reaction (anaphylaxis) to the Gelatin component, but I cannot rule out that is was a reaction to Bovine calf serum or another component.  The patient has been instructed to avoid vaccines containing Gelatin. Of note he has reacted to oral beef and pork, but has been tolerant of oral Gelatin.
This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, an unspecified number of patients were administered improperly stored doses of RECOMBIVAX HB (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports from the same reporter where other patients were administered improperly stored PNEUMOVAX23 (MARRS# 1407USA03820) and VAQTA (MARRS# 1407USA014449). Additional information is not expected because reporter refused additional contact.
Fever spiked to 102.7 and then dropped to 95.8 on 6/12.
pt recvd vax 24AUG94 & 25AUG mom called said arm was red, swollen warm to touch; pt ran no fever & was acting fine; was told to use compresses & APAP;
Rcvd vaccine at 2 pm, woke up at 1:30 am with pain in l/arm at site of injection.  Seen at clinic at 10am- iduration noted at site.  2cm x 3cm.  No itching, no fever.  Ice pack and tylenol given.
today i have a bump in my arm , it is  reddish , warm , itching  , size is almost  6 x4 cm
First dose was given 04/15/2021. We gave 2 nd  dose on 04/18/2022. Over  a year after the first dose.
Patient endured multiple uncontrolled symptoms, starting with (in order) 7 days of unusual headaches, nausea, vomiting, and chills, followed by multiple severe joint pains (including swelling and full body paralysis), ice cold feet that turned blue, and after all of these symptoms, there was very severe chest pain (I.e., pericarditis) that required emergency hospitalization for 3 days.   Afterwards, patient developed an autoimmune disease (I.e., Hypocomplementemia Urticarial Vasculitis) that had them urgently hospitalized for an additional 7 days.   To this day, patient has uncontrolled symptoms and is still disabled.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment was given to the patient.  The reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
On 5-20-06 noticed her feet were swollen and itchy.  Then bumps "like mosquito bites" would apear at different sites and go away.  No complaint of respiratory difficulties.  Wheals and itching continued through Tuesday when she called the health department.  Referred to her doctor or ER as soon as possible.  Was given a "shot and pills".  Wheals and itching resolved.  Recommended she talk to her doctor about whether or not she should get the second Hep A as he did not say anything at this time.
Swelling at smallpox site (started day 12) followed by weakness, fever, night sweats, chest discomfort.  Blood work found elevated Troponin on July 16, patient hospitalized.  Hospitalized July 16-20 2009 with myopericarditis, low blood pressure/tachycardia, ischemia.
Chest Pain Acute onset of Dilation and erythema of Temporal Blood vessels and vessels of the scalp Bilaterally
Noticed weakness in hands a week after I got my second shot. I'm losing more and more muscle daily.
Pneumococcal vaccine given on 12/2/04, pt experienced extreme pain in arm, weak, dizzy, faint, symptoms in the evening of 12/02/04. Symptoms passed after half hour. Pt called office in AM noted poss. reaction to vaccine on chart.
(L) arm swollen, red, hot to touch, shooting pain (L) arm down to fingers x several wks.
pt recv vax 8MAY95 & 9MAY95 exp fever, aches & pains, malaise h/a & was tired; 10MAY pt devel 5 lesions & presented to an internist who dx varicella; next day had 35-50 vesicles w/2 or 3 scabs;There was a papule noted on pt anterior tonsil
administered in Arm Left on 04Nov2021 11:30  as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.; Dysfunctional left hip, I regarded as a disabling bursitis flare-up (I cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 mo.; Dysfunctional left hip, I regarded as a disabling bursitis flare-up (I cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 mo.; This is a spontaneous report from a contactable physician (patient). A 77-year-old (age at vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 11:30 (Batch/Lot Number: FH8020) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included prostate cancer (Prostate ca (treatment seems to be successful). MI in 1995) from 1995 to an unknown date, dysfunctional left hip from an unknown date. Concomitant medications included abiraterone acetate (ZYTIGA); denosumab (XGEVA); prednisone and metoprolol all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose (at 77-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm on 12Apr2021 10:15 (Batch/Lot number: ER8729) and the second dose (at 77-years-old) administered in left arm on 03May2021 10:30 (Batch/Lot number: EN6205) for covid-19 immunisation. The patient experienced dysfunctional left hip, which he regarded as a disabling bursitis flare-up (he cannot walk now) of a non-disabling painful condition that had been annoying for about 1-2 months on 04Nov2021 22:30. The event was considered disabling. The patient did not receive treatment for the event. The patient did not recover from the event.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.