chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously.  Patient was monitored in the emergency department for improvement of symptoms.  Her throat fullness and pruritus resolved.  She feels well and wishes to be discharged home.  Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged.  She will return to the hospital should symptoms worsen.  She returned to the ED the next day and these are notes from that visit:  26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction.  Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash.  She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms.  She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel.  She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out.  She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone.  Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes.  Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms.  Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety.  I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes.  Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms.  Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety.  I have encouraged her to take the prescriptions as directed at her ER visit yesterday.
pt rcvd vax; pt had headaches, low back pain which radiated into groin area & leg, urine in blood, kidney problems; pt taken to hosp; pt had head & jaw soreness;could not grip w/ hands;feet were limped; MD said arthritis (Reiter's syndrome)
Pt between the age of 4 1/2-5 yrs old, w/in 24 hrs post immun exp inject site rxn (redness & swelling the size of a softball); redness & swelling traveled down the leg & pt was treated w/DPH;
Information has been received from a physician concerning a 40 month old male with no medical history or allergies who on 07-Aug-2003 was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Merck) (lot #644790/0333N). Concomitant vaccination on the same day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and a dose of poliovirus vaccine inactivated (Vero) (IPOL). The physician reported that the patient was seen in the office on 02-Jan-2006 for a classic case of shingles that started on 31-Dec-2005. The lesions were on his right arm with a C5 and C6 distribution and were too numerous to count. Treatment included oral acyclovir. The patient had post herpetic neuralgia for a month but had recovered when seen by the physician on 14-Feb-206. The lesions were noted to be healed. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Shingles and post herpetic neuralgia were considered to be other important medical events by the reporter (OMIC). Additional information has been requested. Follow-up information was received from the physician's office. It was reported that the patient developed a rash on his leg in late December 2005. An unspecified cream was applied to help with the itching. On 02-JAN-2006, shingles was diagnosed. The patient was seen by the physician on 14-FEB-2006 for a sore throat and at that time, his shingles (lesions) were considered to be healed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX (batch number T5242, expiry date April 2019) for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was complaining of his forearm bothering him, as it was achy and sore.
Feeling of heaviness in the back at shoulders, headache, sore throat heaves with nausea, trembling (very little) occurred several hours, post vax, lasting about 3 hours. Finally, had unusual occurence of a nose bleed at 04:00 on 5/15/01.
Developed swelling, redness, and itching near vaccine site 7 days after vaccination. Gradually subsided and resolved over the next 7 days. Also had fatigue and GI upset for approx 1 week after vaccine.
Mild dizziness about 4 hours after shot. Sometime after midnight, awakened with chills, fever, severe arm soreness. Severe headache and fatigue the following day. Writing this  2 days after, arm still a bit sore but otherwise fully recovered.
Patient reported feeling anxious, having trouble breathing, and like her tongue was tingling approximately 30 minutes after receiving her vaccine.  We called paramedics, they determined that she did not need to be transported to the hospital. Patient stayed another 30 minutes and felt fine.
Soreness and swelling at injection site that lasted at least 11 days post injection.  Soreness improving slightly at 10 days, but firm area at injection site still exists.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # J006365 with expiration date 05-DEC-2015 and lot # L004754 with expiration date 10-NOV-2016; dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
I received the shot in my left arm.  Later that night I was washing a dish .  The water felt extremely hot on my middle finger, pointer finger and thumb., however not on the rest of my hand.  It felt like I had burned that portion of my hand.  I stopped running the water over it.  The hot/numb feeling radiated from those 3 fingers up my arm , ending at about my shoulder.  The  hot numb feeling continued until about 12:00 a.m. that night.
The patient fainted after shot. He became unresponsive and came to about 30 seconds later. Blood pressure dropped to74 over 40.
Right arm extremely sore several hours after vaccines, lasting for two days. On 12/07 noticed rash at injection site and on 12/08 redness at injection site with recurring soreness.
So sick after each vaccine; Chest pain; fatigue; difficulty going up and down the stairs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2021 as dose 1, single (Lot number: EW175) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "So sick after each vaccine"; CHEST PAIN (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "difficulty going up and down the stairs". The events "so sick after each vaccine", "chest pain", "fatigue" and "difficulty going up and down the stairs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are needed. No further information is expected.
Facial swelling and pressure /tightness, tingling of lips, burning sensation in head. I went to the ER and was treated. I?m still Experiencing the symptoms
1-year old received 2-doses of 0.5 mL of Fluzone Quadrivalent Standard on the same day by accident with no adverse event; 1-year old received 2-doses of 0.5 mL of Fluzone Quadrivalent Standard on the same day by accident with no adverse event; Initial information regarding an unsolicited valid non-serious case via agency (Reference number- 00313940) was received from a nurse and transmitted to Sanofi on 13-Oct-2020.  This case involved a 1 years old patient who received 2 doses of 0.5 ml of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] standard on the same day by accident (scheduled monthly dosing taken more frequently and extra dose administered) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination, on 12-Oct-2020.  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.   At the time of reporting, no adverse event was reported.  It was a case of actual medical error due to scheduled monthly dosing taken more frequently and extra dose administered.  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 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.
Per patient and gf, started to develop "mosquito bite" type rash on both arms roughly 3 hours post second Moderna COVID 19 injection. Called to inquire if benadryl was appropriate to take. RPh confirmed the rash stops at the shoulder and elbow bilaterally with no itching or swelling on/in the throat, mouth, or tongue. Patient and girlfriend notified to seek medical attention should symptoms worsen or threaten breathing. Both parties verbalized understanding and stated they would take one 25 mg capsule with one additional if needed.
I believe in vaccinating children, my child had a HPV vaccine and shortly after began vomitting every morning and experiencing chronic fatigue and headaches. I brought it to our pediatricians attention and she told us she felt it was not from the vaccine.Then we went to several other Dr and the Pediatric stomach specialist felt because this happen almost immediately after the vaccine there could be some  correlation. She said the vomitting could last 6-8 weeks which it finally subsided(Thank God) but we are still dealing with chronic fatigue and headaches. My child also missed almost 3 full months of school and needed a tutor. I called the CDC to find out if there was anything i should do and this was how i was directed.
Feeling nauseous; Pain at the injection site after receiving vaccine; This is a spontaneous case reported by other non-health professional (consumer) to Company (reference number: SEQ20-00068) and initially received on 06-Jan-2020, concerning a male patient of an unspecified age.  The patient's medical history and concomitant medications were not provided.  On 04-Jan-2020, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiration date: not reported] as influenza prophylaxis.  On 04-Jan-2020, after unknown amount of time after receiving vaccine, the patient experienced pain at the injection site.  On 06-Jan-2020, two days after vaccination, the patient started feeling nauseous after eating pizza. The patient did not receive any corrective treatment for the events.  On an unspecified date in Jan-2020, the outcome of the event of vaccination site pain was resolved.  At the time of this report, the outcome of the event of nausea was not resolved.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  Company Comment: All events were considered as related to Flucelvax Quadrivalent.; Sender's Comments: All events were considered as related to Flucelvax Quadrivalent.
Mom noticed patient has a raised pimple with white head on left leg with redness about 1/2 inch around it, hard, not painful to touch, not itchy, no streaking.
Sore throat, cough, cold, headache, shortness of breath, stomachache
Pt given vaccines at 5:20p.  Got up and walked around office.  While doing so, asked "should I feel dizzy" and then collapsed into her mother's arms.  Was lowered to floor, still unconscious, but readily regained consciousness with ammonia stick.  Had pt lay down for ~20 min.  BPS: 118/70 and 120/70.  Left office at 5:50p.  No further sx per mom.
Sore arm, runny nose with discharge, chest congestion, ringing in ears, runny eyes, sore throat and pin like discomfort around genital area.
Hep a #2 was given 6 weeks after the first dose, not at the recommended interval as an error no adverse reactions were reported by the patient or noted on follow up exam 6 months later.
Moderna covid-19 vaccine eua  Next day had muscle aches,  the sweats, chills,  headache and stomach ache lasted until the next day afternoon.  Redness,  swollen, hot, can't move arm still persisting.
2 weeks after last shot, still til today, my menstruals are not regular, before the shots, i have a monthly regular period.  I also started having severe headaches after last shot. Till to this day, i have them from the time i wake up til i fall asleep. Nd then i still wake up throughout the night with headaches.
Right deltoid swelling, at injection site and below injection site. Red, hot to the touch.
Initial report received from a health care professional on 13 August 2010.  A 15-year-old male patient, with a history of asthma and an allergy to amoxicillin, received (dose 1) on 06 August 2010 a right deltoid intramuscular injection of MENACTRA, lot number U3478AA.  The patient had no illness at the time of vaccination and received no vaccinations within 4 weeks.  On 07 August 2010, he developed fever (no documented temperature), chills, dizziness, pale and headache.  The physician prescribed Advil.  The patient's mother reported that the symptoms resolved in 24 hours.  No relevant diagnostic testing was performed.  The outcome was reported as recovered.  Documents held by sender: None.
This spontaneous report as received from a pharmacist who reported that improperly stored RECOMBIVAX HB 10 microgram (route and lot # were unknown) might have been administered to unspecified number of patients on unspecified dates. RECOMBIVAX HB doses were exposed to unsupported temperature excursions and some doses might have been administered. Additional information has been requested.
On 2/25/16 mother noticed sm. lump (R) upper thigh where 2 of the vaccines were given. No redness or tenderness when palpated. Lump smaller this morning but still palpable. No other sx. Baby alert, active not irritable. Advised to report if worsens.
Flu vaccine received 11-11-08 0.25 Sanofi Past #UT27996A. Broke out in hives later that day, called 9-10P advised to go to ER.
This spontaneous report was received from a pharmacist refers to a female patient (reporter's mother) of unknown age. The concurrent condition of the patient included diabetes mellitus. No medical history was reported. The reporter stated that her mother received an unspecified pneumococcal vaccination every year on unspecified dates. PNEUMOVAX23 (dose and route of administration not provided) could not be ruled out (inappropriate schedule of vaccine administration). No concomitant therapy was reported. No adverse effects were reported. The outcome of the events was unknown.  Product quality issue was not involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date unspecified patients were vaccinated with several doses (reported as about 4 doses) of improperly stored VARIVAX (Merck) (0.5 ml, lot# was unknown) subcutaneously. No adverse effect was reported. Additional information has been requested.
I got the shingles right after shot- & arm pain - really bad could not get my family Dr. to help me with the Shingrix.
This case was reported by a physician via call center representative and described the occurrence of serum sickness in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, an unknown time after receiving ROTARIX, the patient experienced serum sickness. On an unknown date, the outcome of the serum sickness was unknown. It was unknown if the reporter considered the serum sickness to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received 4 vaccines at the same time. ROTARIX was one of those vaccines, but the other 3 vaccines were not known at the time of the call. No further information was provided.
they are red, raised, long lines; They are raised curves about 4 to 5 inches long; there is horrible itching with them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious) with onset Oct2021, outcome "recovering", described as "They are raised curves about 4 to 5 inches long"; PRURITUS (non-serious) with onset Oct2021, outcome "recovering", described as "there is horrible itching with them"; ERYTHEMA (non-serious) with onset Oct2021, outcome "recovering", described as "they are red, raised, long lines". The events "they are red, raised, long lines", "they are raised curves about 4 to 5 inches long" and "there is horrible itching with them" required physician office visit. Therapeutic measures were taken as a result of erythema, swelling, pruritus. Additional information: It is not round hives or lumps, they are red, raised, long lines.  They are raised curves about 4 to 5 inches long.  They change everyday.  The same thing happens every day, they come and go, and there is horrible itching with them.  The only remedy she has found that works is Hydroxyzine or Visteril.  Back in Oct2021 is when this all first started.  The itching was horrible and her Doctor prescribed her Zyrtec and another over-the-counter medication, but only in Dec2021 did she finally receive the prescription for Visteril, 10mg, that brought her any relief.  The medication makes her incredibly sleepy and she sleeps for 10 hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She slept most of the day and ate less than normal, she would not putting a lot of effort into eating.  She got very fussy at 4:30 and that lasted the rest of the night.  Very loud crying.  She was not focusing well, she was not "happy" or smiling as much, she's just not herself.  Her face looked puffier than normal.  At night she would breath normally then stop for up to 5 seconds then gasp.  She also stopped mimicking her mother. the following day she was still very fussy and not easily consoled when awake, still sleeping more than normal and not putting effort into eating, again nibbling on the nipple.   She showed a distinct change in behavior following this shot.  She is now going through therapy, of which, my medical insurance does not cover any of it.  After that shot, she refused to let people hold her, which has now become a detatchment toward all people and an inability to make friends.  She doesn't make eye contact with people, even her parents.
Patient was only given the Hib portion of Pentacel vaccine mixed with alternate diluent from MMR and the diluent was not given/No AE; Initial information was received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old female patient who was vaccinated with only Hib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which was mixed with alternate diluent from MMR and the diluent was not given (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diluent portion of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) (lot U6622AA) via intramuscular route in the right arm for prophylactic vaccination.  On 08-Jul-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ187AA and expiry date 16-Feb-2021) via intramuscular route in the right arm for prophylactic vaccination.  Case details: the reported stated that dose of Pentacel was administered to the patient and only the Hib portion was given reconstituted with diluent from MMR vaccine, diluent (DTap-IPV) was not administered.   It was an actual medication error case due to Inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.   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 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.
My right arm at the injection site developed a hive, that grew from around 1 inch on day 1 up to 2.5 inches on day two, then 3.5 inches on day three.  The site is also slightly red and is tender to the touch.  I took diphenhydramine and the itching decreased after 15-20 minutes. The hive is still present.
pt recvd vax;body aches, chills;cough productive of dark brown mucous, SOB 9oct95; seen by MD;ATB for 10 days; returned to work 23oct95;c/o some SOB; felt fully recovered 30oct95;dx w/ pneumonia;