chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the consumer, a 70 year old female patient with drug allergy to Cevita, insulin, Januvia (MARRS#1311USA009049), Novak, penicillin, percocet, sulfa and Zocor (MARRS # 1311USA009050). The patient's medical history included polio in childhood and rheumatic fever in childhood. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX single injection in the left arm. Dosage was not reported. Concomitant therapies included fenofibrate, quinapril, COREG, DOXIMYCIN, LANTUS, and VICTOZA. ON 15-NOV-2013, in the evening on the date of administration, the patient experienced overall feeling of vibration (without break-outs) which she described as bunch of bees coming from top of the shoulder, through the neck into the jaw area. The patient did not seek for medical attention and no treatment was given. The outcome was reported as not recovered/not resolved. No causality assessment was provided. The case was linked to MARRS # 1311USA009049 and #1311USA009050 (same patient). Additional information has been requested.
14 hrs post vax pt devel h/a, non-specific raised erythematous rash noted on face & chin; a day later no itchiness; nausea & vomiting occurred 21 hrs post vax; all sx cleared w/in 2 days;
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date in Nov2014 (mentioned as 2 days before the report) at a single dose, in arm. The patient medical history and concomitant medications were not reported. On an unknown date in Nov2014, the patient had a severe reaction and had broken out with a pretty bad rash and scratches on her arms. The injection site was bright red about 4 cam by 4 cm and itchy. The clinical outcome of all the reported events was unknown. The reporter mentioned that the patient received the Shingles and flu vaccines on an unspecified date (unknown if before or after PREVNAR 13) and she had a "more than normal" reaction to those as well. Follow-up (21Nov2014): New information from the same contactable pharmacist includes: vaccination partial date, anatomical locations of administration, additional events and other vaccinations details. Follow-up (18JAN2015): Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning a 5 year old female who on 19-JAN-2007 at 10:30 AM was vaccinated SC on right arm with second dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, (Oka/Merck upgrade process) (Lot # 655751/1121F).  Concomitant therapy on same day and time included a first IM dose on left arm of Vaqta (MSD) (Lot # 656495/1209F).  On 30-JAN-2007 the patient was seen in the office with chicken pox exposed by her father.  It was reported that rash appeared on 29-JAN-2007 on face, body with itching and no fever.  No complications were reported and the patient was given symptomatic treatment.  It was reported that patient's chicken pox was mild case.  Additional information has been received from the registered nurse who stated that the patient was seen in office on 30-JAN-2007 for rash on his face and body.  The patient was diagnosed with chickenpox.  No complications were reported.  At the time of report the patient had recovered.  No further information is expected.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Pt states that her voice became raspy, she's fatigued, shortness of breath, when laying on her back at night it's hard to breath-Medium, Additional Details: Patient is currently 18 weeks pregnant. She was told that some of these symptoms could be caused from the pregnancy. She said she was not pregnant at the time that symptoms arose. She currently does not have regular insurance, only the RX for pregnancy.
1 cm rasied leason at injection site. Surounding tissue red in bullseye patter of red rings. Very Purritic leason. No drainage or pustule.
Myalgia, Fever, injection site pain and redness Narrative:  Other Relevant History:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 positive), AGEUSIA (lack of taste), ANOSMIA (lack of smell), COUGH (Cough) and HYPERSOMNIA (sleeping 10 or 11 hours a night) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Apr-2021.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (COVID-19 positive). On an unknown date, the patient experienced AGEUSIA (lack of taste), ANOSMIA (lack of smell), COUGH (Cough), HYPERSOMNIA (sleeping 10 or 11 hours a night) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 positive), AGEUSIA (lack of taste), ANOSMIA (lack of smell), COUGH (Cough), HYPERSOMNIA (sleeping 10 or 11 hours a night) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included antifungal medication during the past for an unknown indication.
Within roughly 15 mins of the 30 minute observation when she noted itching on her upper extremities.  There was a visible rash of the upper extremities b/l that extend from fingers to shoulders and across chest.  Assessed by observation room nurse who gave 50mg PO Benadryl per standing order protocol.  Vitals were taken HR 79, O2 97%.  Patient denied any SOB, CP, face/tongue swelling, no ulcerations of the mouth.  She was then taken to the ER for further observation.
Area of erythema and induration at site of injection 8.5cm x 6cm left arm.
Information has been received from a physician concerning a 12 month old female patient with no pertinent medical history and no drug reactions/allergies who on 16-AUG-2010, was vaccinated SQ with a dose 0.5 ml once of PROQUAD (Merck upgrade process) (Lot# not reported). There was no concomitant medication. On 22-AUG-2010, the patient presented red raised rash covering her body. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Admitted to Hospital 2/3/14 for repeat C-section. She has Guillain-Barre syndrome after a flu shot given during this pregnancy at the community clinic. She was admitted prior to delivery for 5 days IVIG treatment.
Pain immediately when vaccination was given. Pain down the arm to the elbow and through to the hand for at least a week. Continued weakness along with muscle spasms throughout the entire arm. Shoulder is still sore. Still twitching in places on entire arm.
Feelings of being flushed and urticarial rash, Benadryl and symptoms have resolved.
pt recv vax 5MAR97 pt devel a local rxn that was swollen (the size of egg) & warm to touch;pt presented to clinic w/c/o of finding a chipped tooth in food @ a local restaurant & came for checkup
Headache, Myalgia, NauseaVomiting, chills and arm pain Narrative: The symptoms from the second reaction included: fever, body aches, chills, nausea, vomiting, and arm pain. They started at approximately 0200 on 1/26 and lasted throughout the day. returned to work the very next day (1/27.)
While in the Observation room after his 2nd dose of the Pfizer COVID-19 vaccine, Patient informed me that he was having a little bit of a headache.  He inquired about having his blood pressure taken.  His blood pressure at this time was 193/111.  I gave him some water and discussed next steps.  He agreed to remain in the Observation room to see if the water helped, and if trying to relax would help his symtoms.  Patient has a history of high blood pressure.  After an additional 30 minutes of observation, his blood pressure was taken again and this time it was 199/127.  At this time, he agreed to be seen in the ER for an assessment by the ER physcian.  At this time, his care was turned over to the ER staff.
Pt vaccinated with HIB developed croup 2 hrs after shot. Child may have been developing viral croup due to lots of cases seen that week.
"dehydration" "back and shoulder aches" "feet swelled"  "legs wouldn't move, felt tight and dehydrated"  "legs felt locked up"
Rash on vaccine site (upper left arm) chill's, low grade temp (99.9) stomach queasiness. lasted approximately 12 hours
I experienced a massive heart attack on 05/07/2020. I was admitted to the ER next door to my office and two stents were placed in an artery that was clogged 60% along with one that had 100% blockage. I stayed in the hospital from Friday to Sunday and was in the ICU for 2 days.
Got shots, got shingles; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shots, got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter said do not get shots. That was how he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Patient became ill after J and J vaccine. She was seen in the ER on 5/1/21. C/o were temp > 100, headache, fatigue and myalgia. She presented to the ER on 5/2/21 with multiple complaints. Since that time she developed cellulitis, elevated LFTs and was seen by GI/hepatology. She developed peripheral edema and has been treated with diuretics. Her h/h dropped and hematology referral made.  She did not receive the vaccine at this clinic.
Left deltoid area became red and swollen within 2 hours after receiving the vaccine. Redness went away after a few days, but swelling remained with some discoloration. Swelling still present at injection site on 10/29/12 so patient was seen by an M.D. on 10/29/12 and was diagnosed with cellulitis and placed on Bactrim po.
p/vax pt w/"1/4" blister formation @ site of inj;otherwise asymptomatic;requested client to come to clinic for further eval; Per HCP follow up report- spoke with patient 11/18/99 at 6pm about prescence of blister formation-exact onset time not noted.
She was having difficulty hearing, and congestion. This went on for a couple weeks and we contacted her doctor. They prescribed Amoxicillin. She had to get a second round of Amoxicillin. She was better for a while then she got another ear infection. She got better from that and got another ear infection. She has had a total of 4 ear infections sometimes combined with a sinus infection.
Approximately 10 hours after the vaccination, I began experiencing chills which lasted approximately 8 hours. I did not check my temperature until approximately 24 hours after the vaccination, at which point the thermometer read 100F. I experienced muscle and joint pain/malaise, headache, and fatigue/lethargy which began approximately 12 hours after the vaccination and lasted for approximately 24 hours. I experienced nausea beginning approximately 19 hours after the vaccination and that resolved within approximately 3-4 hours. I took Tylenol 19 hours after the vaccination, 25 hours after the vaccination, and 36 hours after the vaccination.
the patient did not experience any side effects or adverse events from the PNEUMOVAX 23.; Medical assistant calling in to report an AE for a patient. Per caller patient received a dose of PNEUMOVAX 23 on 14JUN22022 instead of PREVNAR 13. Caller states that the patient did not experience any side effects or adverse events from the PNEUMOVA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-JUN-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscularly, lot # U010533, expiration date 29-OCT-2022 for prophylaxis; instead of the intended dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered). The patient did not experience any side effects or adverse events from the administered vaccine (no adverse event).
Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye  ache, rapid heartbeat, loss of appetite, nausea, hallucinations, cold sore.  Symptoms resolved 48 hours after injection.  Ibuprofen was taken to relieve headache and neck ache.
Pt received a dose that was past expiration time (at room temperature), no reported adverse events at this time
sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes.  dull ache in arm at injection site for four days after injection. flu-like symptoms including body ache, tiredness, weakness, fatigue, loss of appetite & general malaise starting approximately 24 hours after injection, lasting about 12 hours.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot# K016129, expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. was complained of some adverse reactions, she claims when she returned to the pharmacy 1 day later. After receiving shot she said a hour later her ear popped and after 8 hours she felt flushed, Dz and sick to her stomach, however, she did not vomit. At 24 hours, she was still Dz and sick to her stomach. I informed her to talk to her doctor right away.
Patient reported on 2/27/21 she woke up at 4AM feeling "dizzy, disoriented, nauseous, and weak." She stated the symptoms have been slowly getting better as the week progresses but that she continues to feel weak. She stated she also noticed her left arm was red, swollen, and sore/achy on approximately 2/27/21. She stated the redness was on her upper arm and progressed from just at the injection site to her shoulder down to her elbow.  Patient saw a provider on 3/2/21 who described the redness as "erythema, swelling and tenderness noted on the left arm.  The area was marked with a marker today." The provider diagnosed the patient with left arm cellulitis and prescribed doxycycline 100 mg twice daily for 7 days. Today 3/4/21, patient stated the redness has not spread outside the marked area but has not significantly improved.
A rash that showed up a week later.  At the time of reporting, it is about 2inx3in
Chest pain; Weak; Aching; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ASTHENIA (Weak) and PAIN (Aching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Dialysis on 03-Feb-2021. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN ), ATORVASTATIN, ISOSORBIDE, LEVOTHYROXINE, NIFEDIPINE, ALBUTEROL [SALBUTAMOL], CALCIUM CHLORIDE DIHYDRATE, GLUCOSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE (DIALYTE), CITALOPRAM and APIXABAN (ELIQUIS) for an unknown indication.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced CHEST PAIN (Chest pain), ASTHENIA (Weak) and PAIN (Aching). On 03-Feb-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, ASTHENIA (Weak) and PAIN (Aching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Consumer did not have an email address and never saw a HCP after receiving the vaccine. It was reported that patient  feels fine now and would rather not have any more follow up
Approximately one hour after vaccine administration, the patient reported itchiness on her upper extremities, as well as a localized rash on the right inner forearm and tingling on the tongue. Symptoms improved with a cold pack and cetirizine. The patient was monitored for one hour.
pt recv vax 12FEB96 & 16APR97 pt devel chickenpox;pt had no fever or itching;the reporter noted that pt sibling who did not have the vax & did not contract chickenpox;by 19APR97 pt recovered;
About 8 hours after receiving vaccine, the skin around my face, arms and chest became red and had whelps and burned like it was on fire.     I had a horrible headache.  Later around midnight I started vomiting and had uncontrollable chills but skin was still burning never had a fever.  The whelps and burning went away completely after about 12 hours and taking 2  (25 mg) Benadryl.  The nausea , headache and chills lasted several days.
Information has been received from a Registered Pharmacist (R.Ph.) concerning a 58 year old female with chronic obstructive pulmonary disease who on 22-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot#663889/0632Y; Exp:12-Nov-2010). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). On 23-SEP-2010 the patient was in the pharmacy complaining of warmth, swelling, and pain around the injection site and traveling toward the shoulder of her left arm. Pharmacist put the patient on the phone who stated she got the PNEUMOVAX 23 every 5 years, and had been since the vaccine was first released. There was no lab diagnostics studies performed. The patient said she has been putting a compress on the swelling. At the time of the report, the patient has not been recovered from these adverse events. Follow-up information was received from a Registered Pharmacist concerning a 58 year old female with no illness at time of vaccination, who at 3:00 PM on 22-SEP-2010 was vaccinated with a second dose of PNEUMOVAX 23 (Lot#663889/0632Y) in the deltoid. This was a revaccination. The patient experienced sore arm on 22-SEP-2010 at 3:00 PM. It resolved itself in 2 days. Additional information is not expected.
Swelling and pain of the left armpit and left arm from shoulder to wrist.  Red reticular rash appeared after a hot compress.  Went to ER.  Prescribed Keflex.  Next day, swelling began to spread into trapezius.  Day three swelling spread into jaw and left breast.  Doctor prescribed prednisone.  Doctor changed antibiotic to bactrim.  CBC/Sed rate/ANA/Lyme disease tests all negative or normal.  Swelling has now spread into back muscles around left scapula.  Doctor has removed all meds except for ibuprofen for pain accompanying the swelling.
Headache increasing in severity to worse ever felt from  Day 8th, February 17th through February 19th.  Some relief with Aleve  and Tylenol,  Having minor to moderate headaches on and off since, relieved by OTC, combination of OTC anti inflammatory or Tylenol.
Pt received first HPV 07/26/18.  Seen 04/05/22 for 15yo Well Child Visit.  HPV #2 vaccine was standing order for this age if 1st HPV is given.  Vaccine was given by MA prior to MD speaking with parent, who at that time said she didn't want patient to receive HPV #2.  Advised of indication for 2nd HPV, risks and benefits.  Patient had no adverse event from HPV #1.
Information has been received from a 60 year old female with insulin resistance, asthma and codeine allergy (reported as "could not take codeine") who on 08-FEB-2011 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX and a dose of PNEUMOVAX the same day. Concomitant therapy included LEVEROXINE, metformin, montelukast sodium (MSD), CRESTOR and ZOLOFT. On 09-FEB-2011 (the next day) the patient's arm became swollen, red and itchy. The patient was not sure which product might have caused the AE. No treatment was given. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating a 60 year old female who on 08-FEB-2011 (previously reported by the consumer as 09-FEB-2011) at 11:07 am was vaccinated subcutaneously in her left arm with the first 0.65 ml dose of ZOSTAVAX (Lot # 669537/1386Z). There was no illness at time of vaccination. On 08-FEB-2011 the patient experienced redness, swelling, itching and welt. There were no relevant diagnostic tests. On 18-FEB-2011, the patient recovered from redness swelling, itching and welt. No further information is available.