chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon administration of HAVRIX to the left mid-deltoid, patient c/o significant pain. Then c/o tingling feeling in left 4th & 5th fingers. Injection site without redness, swelling. Ice applied to injection site.  After several minutes patient stated that arm felt better. Had full range of motion of arm, hand, and fingers. The patient filed a workman's comp claim the next day stating that her arm hurt so bad that she could not work. She was seen by an NP in a clinic who advised her to increase use and movement of the arm and to take OTC analgesics has needed.
Approx. 6 hrs after shot he felt jittery, restless and anxious. This lasted about 12 hrs. On 2nd day after shot he noted generalized muscle soreness and weakness. This increased in intensity until 4 days after shot when he had difficulty with any task requiring strength. Noted trouble opening pop can, trouble with grasp of pen, shaking if he tried to write. Symptoms gradually lessened in severity. He noted improvement of muscle condition with use of muscles. More pain in AM, decreasing pain as day went on. Medications used to treat the event included Motrin and Vicodin. All symptoms subsided as of August 6, 2002.
Vomiting and nauseated, sluggish, unable to go to work for 1 day. (3-27-07, 3-28-07), Body aches, Flu-type symptoms.
Pt recvd vax JUN92 & burning sensation upon inject as well as soreness &or an aching sensation in the arm; heaviness in the arm;
5 minutes after patient was vaccinated both legs became very warm and red to the touch.  MD notified, he examined patient, patient was given Benadryl 8mg and Tylenol.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Dec-2021, Lot 012H21B vials were placed in refrigerator.  Concomitant medications and treatment information were not provided by reporter.
PCV13 (pneumococcal conjugated) vaccine redness and pain to injection site, fever, chills. Pt went to ER 6/16/17 had chest x-ray (-), labs normal. F/U 6/17/17 pt given KEFLEX for cellulitis.
out of breath at times; Tiredness, fatigue; Sinus allergy; cold; sore throat; dryness feeling throat and nose; dryness feeling throat and nose; congestion; runny nose; cough; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in arm left on 10Feb2021 at 12:30 PM (at the age of 52-year-old) as dose 1, single for covid-19 immunisation . The patients medical history included allergies, known allergies to Aspirin, Penicillin, and Sulfas. The patients past drugs included Tetracycline, Advil, Ibuprofen, and experienced allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC), taken for unspecified indication, start and stop dates were not reported. Patient did not receive other vaccine in four weeks. On 16Feb2021 at 01:30 AM, five days later, she experienced tiredness, fatigue, out of breath at time, cold or sinus allergies. It started with a sore throat, dryness feeling throat and nose, congestion, runny nose and cough. Adverse events resulted in physician office visit. The patient did not receive treatment for adverse events. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (Nasal Swab, polymerase chain reaction, and Antigen): result unknown, on 17Feb2021. The clinical outcome of all the events was resolving. Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004033: US-009507513-1710USA009985: US-009507513-1711USA004035.
pt recv vax 3PM 21OCT98 & mom reports that pt devel a red, blotchy, rash on trunk not itchy & not raised on 22OCT98 @ 5PM which lasted 3hr;mom states phoned hosp ER but pt not seen;rash disappeared spontaneously & did not return;
This case was reported by a pharmacist via sales rep and described the occurrence of fever blister in a 65-year-old male patient who received SHINGRIX. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 4 days after receiving SHINGRIX, the patient experienced fever blister. The patient was treated with VALTREX. On an unknown date, the outcome of the fever blister was unknown. It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the prescription for VALTREX needed. Fever blisters were resolved after taking VALTREX BID for one day. The reporter agreed to follow up from GlaxoSmithKline. This case has been linked with case US2018GSK085327 and US2018GSK085329, reported by the same reporter.
Daughter suffered 3 "auras". She also seized during those auras. Neurologist stated the vaccine could have had an adverse effect. She reported after 2nd injection that she felt somewhat dizzy. She spent overnight in the observation wing of the hospital. She also received an EEG.  Her meds will be increased. It is highly probable that the vaccine had an adverse effect on her.
Patient received shot and went to wait in pharmacy waiting area. Within 5 minutes of receiving shot, patient became unresponsive and slumped out of chair to floor. Mother of patient caught patient and lowered to her floor and rolled her onto her side. The pharmacy staff grabbed emergency medical kit and activated emergency procedures. Patient was found to have heartbeat and was breathing but unresponsive. Tech called 911. Heartrate and breathing monitored while waiting for 911 to arrive and patient was constantly stimulated to try to help her regain consciousness. After two minutes, patient opened eyes but was disoriented and nonresponsive. After two more minutes patient became more responsive but disoriented. Patient was assessed by 911 when they arrived and patient's parents declined transportation to hospital based on patient history of vasovagal syncope.
Dry heaves; Get the urge to vomit but no actual vomit; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT), ALBUTEROL [SALBUTAMOL], FUROSEMIDE, PAROXETINE, THEOPHYLLINE, VITAMIN D [VITAMIN D NOS], NIFEDIPINE, PANTOPRAZOLE, DOXAZOSIN, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), APIXABAN and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RETCHING (Dry heaves) and NAUSEA (Get the urge to vomit but no actual vomit) outcome was unknown.            Patient received third booster dose on 01NOV2021 in the left non dominant arm, lot 032P21A.   This case was linked to MOD-2021-375483 (Patient Link).
Extreme itching of eyes and body parts.   When itching stopped the injection site on my right arm started to swell and feel painfully hot!  I placed the thermometer scanner on it and it was 104.5 It was extremely and painfully itchy.  I saw my doctor on January 20 since it had spread to over half my arm.  He prescribed Amoxi-Clav for 7 days.  Doctor said it was infected, but he's not familiar with Covid side effects.  I believe it was CELLUITUS!!!!!
my face, right eye and neck were swollen; my face, right eye and neck were swollen; my face, right eye and neck were swollen; face began to itch.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 12Mar2021 15:30 (Lot Number: EN6208) (at the age of 69-years-old) as 1st dose, single dose for covid-19 immunisation. The patient had no medical history. The patient has no known allergies. The patient did not receive other vaccines in four weeks. Concomitant medications included lisinopril, levothyroxine; psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]); calcium  and vitamin all taken for an unspecified indication, start and stop date were not reported. The patient reported that on the night of 12Mar2021 at 23:00 when she went to bed, her face began to itch.. When she woke up in the morning of 13Mar2021,  her face, right eye and neck were swollen. No treatment was received for the events.The patient had no COVID prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient developed blistering rash on chest 24 hours after vaccine was given. Mild itchiness.
vaginal bleeding; Patient is menopausal; This is a spontaneous report from a non-contactable nurse. A non-pregnant 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported), at the age of 65 years old, as dose 3 (booster), single for covid-19 immunisation.  Medical history included hypertension (HTN), asthma, hypothyroidism, known allergies: all walnuts, and menopausal. Not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 after vaccination. Concomitant medications were unknown. No other vaccines within 4 weeks were received prior to COVID vaccine. The patient previously received dose 1 and doe 2 of COVID-19 vaccine (manufacturer unknown) for COVID-19 immunisation. On 28Sep2021, the patient experienced vaginal bleeding 24 HRS after booster (3RD) vaccine. Patient is menopausal and also has been on medication to keep her from bleeding. The patient received megestrol 40MG to stop post-menopausal bleeding. The event was reported as non-serious. The patient has not recovered from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event.     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 RAs, Ethics Committees, and Investigators, as appropriate
Product beyond use date was 11/9/2022 and this product was used on 11/28/2022.  Writer contacted Pfizer and CDC.  No adverse reactions expected, advised to repeat dose ASAP.
intermittent arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknwn date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after getting the vaccines he developed pain in his arm, that was intermittent. He had not treated the pain; it resolves and returns without treatment. Physical exam by 2 health care professionals, shows no diagnosis or evidence of visible injury on patient's left arm. The reporter consented to follow up.
Pt recvd MMR vax in 1989; @ 3yrs of age pt had measles; no further details were provided;
Exactly two weeks after I got the Janssen COVID vaccine 10/15/2021 at 4:30 pm I was leaving a grocery store when all I started to hear in my right ear was ringing and muffled sounds and the inside of my ear feels numb, later that night I only heard ringing and vibrations. Today 10/18/2021 I woke up with extreme dizziness and nausea and hand tremors.
Tingling sensation for sometime; Numbness and soreness on her right arm; Numbness and soreness on her right arm, heavy; A spontaneous report was received from a non healthcare professional concerning a 40-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation for a sometime, numbness and soreness on her right arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced tingling sensation for a sometime, numbness and soreness on her right arm. Still her arm is feeling numb and heavy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  On an unknown date the outcome of tingling sensation, soreness on her right arm were unknown and for numbness not recovered.
p/vax#2, pt devel joint pain both shoulders, fingers of lt hand, rt wrist, both feet, spine
5 hours after injection pt reported symptoms of nausea, sweating, fatigue, headache.
pt recvd vax & 24 hrs p/vax exp screaming, gray color, fever, diarrhea & was irritable; pt was seen by MD & had a gradual recovery;
pt recv vax; devel tenderness w/ flexion of hip; irritable & inc T;MD advised no more pertussis;
I got super cold 2 hours after. I wrapped up. I had a heating pad. I had uncontrollable shaking. I went to the hospital. The shaking stopped. Sunday I was weak and fatigued. I am fine today 9/18.
Bumps along my waistline back then front, spread to inner right and left arms from elbows to wrists. On both knee caps, back of neck, left and right shoulders, buttocks and right leg from the knee down.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions.        On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX) vaccine, the pt was treated by a physician for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain and had medical care and treatment for these injuries, significant medical and related expenses of these injuries, including but not limited to medical losses and cost which included care for hospitalization (on an unspecified date), physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue suffering such losses and damages in the future. The reporter considered the vaccination with zoster vaccine live (ZOSTAVAX) to be related to shingles.
This spontaneous report was received from a licensed practical nurse concerning a female patient of unknown age. On 04-AUG-2009, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified) intramuscularly. On 15-AUG-2013 (reported as today), the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly which was over 4 years after she received her first dose. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Patient stated that her arm was very sore to the point that she didn't want to really move it the evening of getting the injection.  She stated she had trouble sleeping due to the pain and also had a fever.  She did state that she had done yardwork after receiving vaccine which may have contributed some to the soreness.   She said the injection site and surrounding area was not red or swollen.  She said today the soreness seemed to be getting a little better. She also reached out to MD regarding adverse reaction but had not scheduled MD appt as of our conversation.
pinkish color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (pinkish color) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (pinkish color). At the time of the report, VACCINATION SITE DISCOLOURATION (pinkish color) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported.  Treatment information not provided.   Reporter did not allow further contact
Fever 101.7 Chills Malaise Still ongoing. I left voicemail for my doctor yesterday but haven?t heard back.
Mother noticed a red raised area about the size of an orange that was itchy and hard and some bruising at injection site.
PATIENT WAS GIVEN ALL THREE VACCINES HEP A#1 (RIGHT ARM), MCV4 AND HPV#1 (LEFT ARM) IN THAT ORDER, WHEN I WAS APPLYING THE LAST BANDAID THE PT STATED SHE FELT DIZZY AND SLUMPED TO HER RIGHT SIDE ON THE EXAM TABLE THIS WAS 3:55 PM. I PULLED HER TOWARDS ME SO SHE WOULD BE FLAT ON HER BACK AND WHEN I DID SHE THEN LOOKED AT ME AND SAID DID I JUST PASS OUT. THIS WAS BRIEF MAYBE 5-10 SECONDS SHE HAD SOME PALLOR AFTER FAINTING SHE WAS GIVEN A COOL WASH CLOTH FOR HER FOREHEAD AND ADVISED TO STAY LAYING FOR A FEW MINUTES DR. WAS NOTIFIED AND BP WAS TAKEN AND @ 3:57 BP WAS 98/60. PATIENT WAS ALERT AND ORIENTED X3 AND JOKING AND REMEMBERS EVERYTHING BEFORE AND AFTER EVENT. BP PRIOR TO FAINTING WHICH WAS TAKEN AT ABOUT 3:45 WAS 100/50. PT WAS MONITORED APPEARED ASYMPTOMATIC COLOR CAME BACK AND LAST BP @ 4:22 WAS 100/60 PT WAS THEN ALLOWED TO LEAVE @ 4:30. SHE WAS ADVISED TO COME BACK TOMM (4/30/09) AND FOLLOW UP WITH DR. APPOINTMENT WAS MADE.
Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose). At the time of the report, RASH (Rash on foot between two toes and going on top of foot after 2nd dose/Rash on other side of foot after 2nd dose) outcome was unknown.            No concomitant products were reported.  Treatment information provided included cold compress on the rash.  She says that cleared up too, then she got one on the side of her foot, which she still has. She said she now had one on the other side of her foot.  Action taken with mRNA-1273 in response to the events was not applicable.
overall itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (overall itch) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BENZONATATE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (overall itch). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date at a dose of 1 dosage form. On 27-Feb-2021, PRURITUS (overall itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Immediately upon injecting patient, patient fell over and started having convulsions. Patient was not responding to our questions but was breathing. Patient could not open eyes and was sweating. After about 10 minutes patient came thru with no intervention needed. EMS was called, but patient refused to go with them.
I went in for my physical on 2/27/2021. My doctor had concerns about my Heart so she sent me for testing to verify about a week later. I was diagnosed with an ascending aorta with diameter 4.5 ml, and leakage of aortic valve. My Doctor is continuing to monitor this condition.