chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1805022) dose was not reported, administered on 09-MAR-2021 09:00 pm to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 deg, 100.2 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
0905-About 9mins in post vaccination room after taking Moderna Covid-19 shot, Pt started to complain of dizziness, VS 137/98, 64, 98.1, 20, 02 sat 92%, Pt placed on therapeutic 02 at 2lpm, 02 sat 98%, Blood S ugar133, Pt has Hx of HTN and she has not taken her meds today, She also stated that she has eaten this morning. Legs elevated. After about 45mins, Patient started having redness on her upper extremities, Skilled nurse gave Pt IM benardryl 50mg/ml on Rt deltoid-well tolerated. Pt verbalize stability of 2/10 0 been no discomfort at all, after staying in post vac monitoring room for 1hr.  Skilled nurse educated Pt to follow up with PCP, take BP meds as soon as possible. Take Tylenol for fever, pain or headache-she verbalize understanding. Benadryl was effective
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle reaction in a 55-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 9th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling. The patient was treated with Analgesics. On an unknown date, the outcome of the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle reaction, injection site muscle pain, injection site warmth, injection site induration, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that, the patient experienced redness and swelling at injection site, muscle pain and muscle stiffness at the injection site as well as hardness at the injection site. The HCP states that, the patient also had the injection site area which was warm to the touch. The patient had been taking over the counter (OTC) analgesics, which was not helping any of these symptoms. Till the time of reporting the patient was experiencing these symptoms and symptoms had not resolved. No further information was provided.
Exactly 1 week after receiving the vaccine, my right upper arm (the one in which I received the shot) started itching  a lot.  I noticed there was a lumpy swelling under my skin and the skin was red and warm. I have now had the itchy swelling  for 4 days and think it is going down a bit. It never hurt, just itched. I am telling you this so you can warn others to expect this mild reaction so they will not worry. I looked it up and it is  called "covid arm". It relieved me that I am not alone with this condition. Feel free to contact me with any questions. Thank you!
Congested and nasally -it started up with my nose flooding and then it stopped up and stayed like that. I had chills then and then a low grade fever - 101 was as high as it got. And then I got a cough. Face was swelled in my sinus part. I saw the doctor. It was a sinus infection - no testing. I got an antibiotic for 5 days. I still have the cough and the congestion. I do feel better. I am weak - I can't get my bearings yet though, feeling weak.
High-pitched tinnitus in my left ear within hours of receiving the vaccine.  Within the next couple weeks, severe fatigue, left side ear pressure and pain along with the tinnitus.  Tinnitus is still there but ear pain and pressure is better.  Ocassionally, I will have the pressure and slight pain.
Knot at injection site Irritable Redness at injection site Swollen injection site Eczema in elbow and knee creases
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet). At the time of the report, COVID-19 (Testing positive after the first dose)) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: This is a case of product dose omission issue and concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the  unexpected non-serious event of SARS-CoV-2 test positive. The event occurred unknown number of days after the dose of mRNA 1273 vaccine. It is not clear from the source document whether this was a first or second dose.  Re-challenge was not applicable as the dose number was not reported. The benefit-risk relationship of vaccine in not affected by this report.
Patient was in observation area and started feeling dizzy with difficulty to see 10 minutes after vaccine administration and decided to go from sitting on chair to sit and then lay down on floor on top of her jacket. Observation room clinic staff noticed and notified RN lead. Patient was attended to and noted that she was alert and oriented c/o dizziness. Patient transferred from floor w/ assist to wheelchair and then to side observation area where her VS were obtained: 0850 BP 79/39. HR 62, O2sat 100%. Mom accompanied patient and stated patient did not eat this morning. Patient given water and crackers. VS 0853 BP 98/56, HR 71 and O2sat 100%. Patient stating that vision is better, continued eating and drinking. VSS 0855 BP 99/64. HR 68,O2sat 100%. Patient stating vision much better and dizzy feeling gone. Patient stood up and did not experience any symptoms, walked to observation room with mom and RN and continued to sit for an additional 10 mins. Patient left with mom at 0915 stating she is back to normal. Encouraged to have patient eat and drink prior to next vaccination appointment.
Red blush in arm vaccinated and swelled arm  a m now taking Benadryl and antibiotics prescribed by Dr
Patient complained of fever and blistering rash like chickenpox that were all over her body and itching.
Patient returned to the clinic site approximately 30 minutes after receiving her flu vaccine. She reported left ear congestion/ numbness. She also reported pain of the left neck and throat. She described the sensation as "numb" and "feeling like Novocain." Lungs clear. Left jaw and ear appear swollen. Vitals were taken Pulse=68, RR=18, BP= 118/84, T=97.9. Patient reports unchanged status for next 20 minutes. Refused emergency medical assistance. Since mobile clinic, spoke with ordering MD (off-site), instructed to administer Benadryl. Benadryl administered L anterior thigh. Vitals re-checked. P=68 BP=108/82. Patient states sorness in throat in neck is a "little less." Per Dr., observe patient for 15 minutes. Cleared pt to return to class/ no need for emergency medical care. Pt reported feeling well after 15 minutes and returned to class. Was asked to return if symptoms re-appeared. Pt did not return.
tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient)  A 20 years old female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.
mental fatigue; Pain began in the shoulder and over the days it moved to the scapula, neck and head; unusual physical fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 07Apr2021 09:00 as 1st dose, single dose (at the age of 44-years-old) for covid-19 immunization. Medical history include allergy to Aspirin (e.c.) and raw fish. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On an unspecified date in 2021, the patient had pain began in the shoulder and over the days it moved to the scapula, neck, and head, only on the left side (arm in which it was injected). Unusual physical and mental fatigue that appeared after five days and lasted a week and a half. The patient was treated with anti-inflammatory medicine. On an unspecified date in 2021, the patient was recovered from the events.  Follow-up attempts are needed; information about lot/batch number has been requested.
Information has been received from a physician assistant concerning a female who was vaccinated the first dose of with GARDASIL and experienced numbness and weakness in one of her legs.  The patient sought medical attention.  The patient "got better".  The physician assistant indicated the patient would not be completing the vaccine series.  This is one of several reports from the same source.  Additional information has been requested.
Medical Assistant states that 1 dose of PEDVAX HIB was administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 01-DEC-2020, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R027321, which has been verified to be valid, expiration date reported and validated as 09-JUL-2021). The vaccine administered experienced a temperature excursion of 8.8 degrees Celsius (C), for a time frame of 45 minutes. There was a previous temperature excursion reported of 11C for 13 minutes as recorded by a data logger.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fourth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
fluzone high dose qiv was inadvertently administered to a 6 month old infant with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received via health professional. Agency number: 01321030  This case involves a 6-month-old female patient to whom vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, HIB vaccine CONJ (TET TOX), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (MRC 5), Tetanus Vaccine Toxoid (Pentacel) for Prophylactic vaccination; ROTAVIRUS VACCINE for Prophylactic vaccination; and Pneumococcal Vaccine 13V for Prophylactic vaccination.  On 13-Oct-2022, the 6-month female patient inadvertently administered Fluzone High-Dose Quadrivalent vaccine at dose 0.7 ml once via intramuscular route in the right thigh (lot: UT7718CA, expiry date: 30-Jun-2022) for immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency. The reported inquired what they should look out for; asks if it will cause harm to the infant?  Action taken: Not applicable. No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown.  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 the 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.
Information has been received from a consumer concerning her 15 month old son with no relevant medical history reported who on 11-DEC-2007 was vaccinated with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 11-MAR-2008, the patient was accidentally vaccinated with another dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient's mother reported that the patient was supposed to receive chickenpox vaccine on 11-MAR-2008 instead of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 11-MAR-2008, the patient was also vaccinated with another unspecified vaccine. On 13-MAR-2008, the patient started to develop a fever and had been very clingy. No medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested. Follow-up information received from registered nurse indicated that product confusion was not the issue. The physician ordered measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and the nurse administered the vaccine.
Patient had a severe allergic reaction to the flu shot, he was red all over and complained of feeling like he was on fire and itching all over. His breathing was fine and he was alert. I administered 50mg of diphenhydramine IM which seemed to help. He said he started to see stars and began to shiver. I called 911. Paramedics arrived. Patient was able to leave pharmacy with his mother after 30 min.
swelling to golf ball size, redness, tender no signs of systemic rxn reported no fever, no itching;
Redness and warmth at injection site after no reaction for 1 week.  Slight itching and tenderness.  Almost disappeared by 2 days.
Information has been received from the reporter who stated that she was told by a doctor. A 70 year old male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665402/1339Y). On 16-MAR-2010 the patient's arm she was given the dose in was extremely swollen and very red. The doctor prescribed an antihistamine and told the patient to use ice packs. The adverse event lasted for about a week and it was finished (on approximately 23-MAR-2010). The doctor told the reporter that he had 3 patients who all had the same reactions to injections given from the same 5 dose vial. Follow-up information was received which reported that the adult was vaccinated and had severe local reaction which appeared to be allergic. The patient was treated with ice packs and CLARITIN and the patient did well. The final outcome of the patient was not reported. Follow-up information received from a physician concerning the 70 year old (also reported as 80 year old) male patient who on 16-MAR-2010 had a reaction to PNEUMOVAX 23. The injection site on the patient's arm became extremely swollen and very red. The physician described the look of reaction as "awful". The physician stated "never saw reactions so severe in all the time he has been administering this product". The physician prescribed an antihistamine and had the patient put cold packs on the arm. The swelling and redness lasted about a week and the patient was fine as of 30-APR-2010. This is one of several reports from the same source. Additional information is not expected.
1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that the vaccine was in refrigerator and was administered after Beyond Use Date (BUD) which was 06-Dec-2021. No treatment information was reported.
got the shot at 10:45 am. it was administered in my right deltoid. felt fine when i went to sleep about 10p. woke up at approx 2am with very sore throat (right side) and very sore right ear. the ear pain subsided for the most part on 10-12 and as of today 10-13 the pain in both my throat and ear have greatly lessened but is still noticable. on 10-12 i was so weak that i spent most of the day in bed sleeping. i continue to feel weak today, but not as weak as yesterday.
fever; body ache; it so bad for me; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, general body pain and feeling bad. On an unknown date, the outcome of the fever, general body pain and feeling bad were unknown.   It was unknown if the reporter considered the fever, general body pain and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter mentioned, he/she got 2nd dose of Shingles but it was so bad for him/her. The patient got a fever and had a body ache. Follow-up would not possible as no contact details were available.
Lymphadenopathy in armpit and neck on the side of injections (right, on all 3 doses).
My tongue became numb, my tongue swelled up, my throat started to close and swallowing my saliva became difficult
Swelling in upper arm and armpit. Red, itchy rash on upper arm. Warm to the touch.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported pain and swelling at injection site. Swelling decreased within the hour but she was concerned because it hurt more than first dose. She declined follow up with MD, although RPh recommended follow up since patient was concerned.
Information has been received from a physician concerning an 16 year old female who on 14-OCT-1994 was vaccinated with the first dose of MMR II (HSA), and the second dose (HSA) on 04-SEP-1997. On 22-JAN-2010 the patient developed mumps. Date of mumps diagnosis reported as 24-JAN-2010. The patient was swelling and had bilateral parotitis. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
My mother received the flu shot on October 4, 2002 and two days later was having problems walking.  This progressed until the end of Dec. when she became sick and dehydrated and had double vision. The 60 day follow up states pt is in intensive care with encephalitis and as of today is not responding well.