chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; dose number: 3 brand: Pfizer/ dose number:4/5 brand other:Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm and on 27Sep2022 at 17:30 as dose 5 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "known allergies: some antibiotics" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: alcohol" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: apples" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions; "known allergies: raw onions" (unspecified if ongoing), notes: Yes, some antibiotics, alcohol, apples, raw onions. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022, outcome "unknown", described as "dose number: 3 brand: Pfizer/ dose number:4/5 brand other:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Nov2022) Positive, notes: Rebound COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
sore throat; This spontaneous report was received from  a female patient of unknown age who refers to herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 16-NOV-2021, the patient was vaccinated at her physician's office with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and lot # were not provided) for prophylaxis (reported as pneumonia vaccination). The patient stated that the product had an expiration date of 16-NOV-2021 and the physician said that it was safe to administer the vaccine until midnight of the date listed on the product.  On 17-NOV-2021 (reported as "this morning"), the patient experienced sore throat (oropharyngeal pain). The outcome of the event and the causality assessment were not provided.
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Influenza quadrivalent with an associated reaction of abdominal discomfort (received vaccine on unknown date for tolerance refer case US2020198044).   In December 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In December 2019, 1 week after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Flu vaccine in last December 2019. After 1 week of vaccination patient developed Shingles. The reporter consent to follow up. No additional contact information for physician was provided. This case was linked with case US2020198044 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198047:same reporter US-GLAXOSMITHKLINE-US2020198044:same reporter
October 8th - I had a pain in my eye that started and became (felt like something was in my eye) - then it became clear that there was a sty in my eye. Doctor (October 13) (on the said I had an eye infection and I had an ear infection also. My gland of the right side of my  neck was swollen. treated with Doxycycline and topical ointment of Erythromycin. I took one dose on October 13th in the pm. On October 14th in the morning - and the morning dose made me very sick. I vomited. I was really sleepy and uncomfortable. Over the next couple of days - experienced chills, fatigue and nose bleed and headache. I felt really awful. My skin got really scaly and dry and I got a rash on the backs of my hands. Then I quit taking it on the 18th - after the PM dose. I went to the doctor on the 18th and they said not to take it anymore. My ears are good now and my eye is on the mend - it's almost better. No medicine to replace the other but I'm continuing to use the Erythromycin gel.
102 degree F fever the night after injection. Left arm is still swollen and hot to touch, movement causes pain.
Blood pressure dropped dangerously low, dizzy, weak, off balance, exhausted, achy, headache, nauseous
Heavy vaginal bleeding and abdominal cramping. Symptoms lasted approx 20 hrs.
Pediatric Pfizer given for 2nd dose instead of Pfizer for 12 and older
A report was received from a health care professional on 13Jan04, concerning a 48 year old female who developed generalized myalgia and fatigue 5 days after she received Fluvirin on 20Nov03. On 20Nov03 the vaccinee received Fluvirin. On 25Nov03 the vaccinee began experiencing generalized myalgia. The fatigue and myalgia have persisted and were still present at the time of reporting. The vaccinee is being followed by her general practitioner who is in the process of determining the cause of her fatigue. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Headache,  body aches,  fever, chills and vomiting.  Lasted about 36 hours
Patient was brought in on 11-26-07.  Complained of limping on left leg and coping with pain in his leg.  Went to local hospital and was told glands are swollen and has lymph node.  Upon 11-26-07 exam, patient walked with a limp and hardly put any weight on left leg.  Hip normal, neurovascular system intact.  Patient was sent for x-ray and labs.  H-ray of left hip.  11-28-07 am spoke with dad.  Stated is still limping, but is some better.  On 11-29-07 am mother called stating child woke with a rash, no fever, and is acting weak.  RTC in am if no better.  Patient returned to clinic on 11-30-07 pm with complaints of leg limp and body rash.  Skin had maculor rash on trunk.  Left leg drags a bit with ambulation and left foot drags is noted.  Limp is a new onset.  Since immunization with apparent immunization reaction.  He was referred to hospital on that day and given Prednisone  3/4 tsp for 7 days.  Spoke with mom via phone on Dec. 4th.  States patient is still limping a little, but with noticeable improvement.  Can now lift both legs over something.  Instructed her to continue steriods and call us back when completed to check on improvement.
Received  vaccines 04/04/2005, 1 hour later developed one hive underneath each eye. No other SX;s present. Hives resolved by next morning. No respiratory problems, no other areas affected.
Patient reported  having heart palpitations 2 days after vaccine. Patient did not have any angina or blood pressure issues. Patient felt a little lightheaded. She did not see a doctor. She reports that symptoms went away and was on and off for 2 days.
Patient with transient synovitis of (L) hip noted 11/2/16, approximately 2 weeks after IPV injection in (L) thigh. Patient recovered well with ibuprofen.
pt recv vax 15AUG96 & exp an unspecified rxn;further details have been requested;
Abscess at site of injection developed 13 days after the immunizations were administered. No initial local reaction was reported. Treated with TMP-SMX, improved at 2 day follow-up.
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve",  butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
The next day parents report fevers of 102 to 103 and fussiness.  One episode of vomiting occurred approximately 24 hours later.  Pt has no URI symptoms.  No coughing with emesis.  Physical exam reveals swollen gums on mandible B/L that are not discolored that resemble eruption hemotomas.
After vaccine patient became febrile.  After becoming febrile patient suffered a simple febrile seizure, which caused him to fall from a chair and hit his head against the wall.  Seizure was 2 minutes long. Went away by itself, no need for diastat. Patient returned to his baseline. Ibuprofen was given for the fever.
Patient was here on MA schedule for second BEXSERO vaccination. However, he told the MA that he developed a rash on upper and lower extremities 2 weeks after the first injection. He did not have any breathing issues. Hyperpigmented macules with very mild scaling around the borders - located on both upper extremities and lower extremities. REFERRAL TO DERMATOLOGY.
PLEASE NOTE: The patient verbally reported this event to me on 01/14/2021. The event occurred 12/23/2020.  Seizure approximately 5-6 hours after receiving the vaccine. Repeat seizures approximately 30 and 54 hours post vaccination. Please note, the patient states she  is a newly diagnosed epileptic. She claimed her neurologist recently adjusted her seizure medications as well prior to the vaccination.
Area of redness on the skin surrounding site of injection and extending up to 4-6 inches from injection site, skin warm to the touch.
Within 12 hours: high fever, tender tonsils, vomiting, nausea, stomach pain, dizziness, chills, aches  Now over 48 hours later and still vomiting, dizzy and having stomach pains. Have been unable to eat since the vaccination without throwing up. Have only in the past hour been able to drink water.
I am not 100% certain whether vaccine was Pfizer (may have been Moderna).  Patient presented to my ED with signs and symptoms of Bell's palsy.  These had developed over the previous 24 hours prior to presentation.  She stated her vaccine (2nd dose) had been given within the last 7 days.  She was diagnosed by me, and discharged on valtrex and prednisone.
patient received an Adacel Vaccine that had been frozen and thawed, No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from consumer/non-health care professional.  This case is linked to cases 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224140, 2019SA224076, 2019SA224136, 2019SA224142, 2019SA224145 and 2019SA224137 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21 or Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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.  Documents held by sender: none.
Pt had first COVID19 vaccine at Pharmacy on 5/25/2021. It was Pfizer vaccine. Pt came in to see me on 5/26/2021 with blisters on right great toe, right 2nd toe. Painful only secondary to wearing shoes. Pt has good pulses and trace edema bilaterally which is normal for her. Pt reports the blister on her right great toe appeared on 5/26/2021 and the blister on right 2nd toe appeared on 5/27/2021
Two fingers, rings and middle, of left hand (same side as injection) are painful, stiff, and sore to the point of complete immobility.
Since receiving both Covid-19 Vaccines, my menstrual periods have gotten heavier, more painful, and last longer. After receiving the booster, I have also had spotting and cramping between periods. I also have dishydroditc eczema on my hands and it has gotten increasingly worse since receiving the vaccines.
Pt received Anthrax and Typhoid on the 20th of June. On the 22th of June patient returned to the immunizations clinic with a large red area from injection site down to 1 in above the AC. Slight swelling in read area with significant swelling around injection site. Followed up with patients PCM team. Received Doxycycline for possible cellulitis.
received 3 doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received 3 doses of Moderna vaccine) had resolved.            The caller told the customer care agent that her neighbor had both vaccine doses and then was given a 3rd dose .Moderna Customer Care agent only knew the gender of the patient the caller was calling on behalf of and that this patient who received 3 doses of Moderna vaccine. No Treatment medications were provided No  Concomitant medications were provided
Vaccine was diluted using  0.9% sodium chloride and not the diluent that was  provided with the vaccine.
Neuropathy, vomiting, migraine, loss of movement of legs for short period of time. 10/28/09 ED records received multiple service dates 10/19/09, 10/21/09, 10/24/09. Assessment: Neuropathy, hypokalemia, anxiety. Patient presents with tingling of both hands, feet, for 3 days. Returns to ED several days later with facial weakness, paresthesia, difficulty standing / walking. Dizziness, panic, trouble breathing, light-headedness, anxiety. Presents several days later with acute headache, sensitive to light, dizziness, nausea, vomiting. Nausea, (R) side numbness, 'spinning'.
2 doses of Menactra were administered to a patient within a few minutes with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00422035) and transmitted to Sanofi on 08-Jan-2021.  This case involves an 18 years old female patient who received two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] within a few minutes [batch number- U6787AA and expiration date not reported] via an unknown route and site for prophylactic vaccination on an unknown date (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was a case of an actual medication error due to extra dose administered (latency unknown).  At the time of report, no adverse event was reported.  Reporter wanted to know what side effects to look out for.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Woke up at 3AM on Friday morning (3/9) with stomach pain.  I went to an urgent care facility around 11AM and was sent for a CT scan which diagnosed appendicitis. I had my appendix removed at 11pm on Friday night.   I do not know if it was related to the vaccine, but thought I should report it just in case.
Dose 1, I had to wait 30 minutes due to my allergies. I felt I was having heart palpitations, so I stayed developed a migraine by the time I got home, which lasted a few days. I had minimal arm soreness. About 5 days later, I had body aches, chills and I felt like I had a cold or flu. I just felt crappy. Those symptoms lasted about 5 days. I had another COVID test to make sure I hadn't contracted it, but it was negative. Dose 2 - Sore arm and headache. Two days later, I was very achy and had chills. Took Tylenol and my symptoms lasted about 2-3 days.
My arm is very red and itchy near the injection site.  It started out itching in the middle of the night and looked kind of like hives.  Now about 15 hours later it is a solid red circle and is still very itchy.
Nausea Diarrhea  Multiple vomiting bouts-over 60 times in less than hour Fatigue Chili?s and sweating Shivers Bod ache and joint aches
Severe and persistent vertigo.  Self-treated using Epley Maneuver.  I spoke to my primary care physician afterward and he was unaware of any nexus between the vaccine and vertigo.  I had a recurrence about two months later (after second dose), and had a virtual appointment .  I again self-treated with the Epley maneuver.  Symptoms were room spinning, loss of balance and nausea.   Although I have not had another episode, I continue to experience episodes of light headedness.  I am aware now of several other people who have experienced the same reaction after their vaccinations.
Patient called pharmacy to report that adverse reactions, still hasn't gone away from the Jansen shot they recived on 6/3. They reported having nerve pain from the shot area up to the neck, It is sharp and burns. It has not subbsided since the injection. They had some swelling after the shot, but but has gone down. Patient will follow up with dr.
pt recvd vax approx 340PM; returned w/pt in arms approx 350 pt lethargic, cyanotic around mouth; to exam room state pt observed breathing on own, color improving;
Got red rash on neck, nausea & burning in back of throat right after vaccine injection to the right arm. Later in day, developed pain and weakness going down the entire right arm into the hand and wrist. My right forearm and first 3 fingers were twitching/shaky for 3 days. My neuropathy also flared up (freezing/burning sensation in both hands and feet). Still having some weakness in right wrist 1 week later, and cold/burning in hands and feet but seems to be slowly improving.
Patient was either mistaken or lied about getting their "first Pfizer shot".  After consent form was signed and indicated he received first Pfizer vaccine on 6/20/21, patient received Pfizer vaccine shot.  While billing shot it came to our attention he received the Janssen Vaccine on 6/13/21 at a different facility.  May have been his way of getting the booster shot by deceit.
Woke up nauseas.  Ended up vomiting after an hour or so.  Vomited twice more that morning.  I was 26 weeks pregnant.  I am due Aug 21st 2021.  Dr. Prescribed anti nausea meds and I took those.  The next day I was feeling better no more symptoms.
CONTRACTED THE COVID VIRUS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced contracted the covid virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted the covid virus was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
patient experienced an anxiety attack after second dose of vaccination. patient was examined by paramedics on site and recovered well
On Dec 20  2021 started to 3xpiernce intense itching of scalp. Itching buring of ears, neck and face.  A rash with hives , heat nd itching appears in different parts of body (arms, hands, chest ,back,legs,feet.face, neck scalp ,ears) for about 30 minutes at at time and the  moves to another part of the body.  This has been consistently happen everyday since Dec 20, 2021
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not provided. On 02-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency: 0.5 ml) intramuscularly which was expired on 22-AUG-2014 (lot # not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. Additional information has been requested.
Increased heart rate of 115 BPM 48 hours after the shot Pain in left arm Fever 38°C Sweating
2 prior COVID-19 doses Pfizer, fever 12/3/2021, 99.6 chills and nausea. I woke up 12/4/2021  unable to move my neck on left-side; severe HA. Temp 100. 12/5/2021 cloudy vision eye redness. Severe HA. Temp 99.6. 12/6/2021, woke up with severe left eye pain/photophobia and 10/10 HA. Left eye sclera red. DX with conjunctivitis and sinus infection. 12/7/2021, I woke up with severe bilateral eye pain and HA to both eyes. Nausea. Dizzy, cloudy vision and photophobia. 12/8/2021, woke up right eye pain, mild photophobia, HA, cloudy vision worse and bilateral sclera red. Went to ER.