chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, body aches, fatigue, lower back pain, and eye pain.  No treatment.  minor improvement will continue to monitor
Information has been received from a certified medical assistant concerning a 6 year old female consumer who on 31-MAR-2008 was inadvertently vaccinated IM with a first dose of zoster vaccine live (Oka/Merck) (lot # 658397/1820U) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that this was not a case of product confusion. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the nurse indicated that the confusion was in regards to not understanding the difference between the two vaccines. Additional information has been requested.
Breakthrough Chicken Pox rash.  No fevers, papular, vesicular rash in cops, very pruritic.  Approximately 20 lesions and still new ones occurring.
Initial report was received from a consumer on 19 December 2011 who is also the patient. A 62-year-old male patient who has a history of mild chronic pancreatitis, high blood pressure and gastrointestinal sensitivities, had received an intramuscular (IM) injection of Tdap (lot number not reported) in his right arm on 14 December 2011. On an unspecified date following vaccination, the patient developed nausea for several days and one episode "spit up blood" in a small amount for five to ten minutes. Concomitant medication included lisinopril, selenium and herbs. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Severe vasovagal reaction (hypotension, clamminess, nausea), which lasted about 50 minutes. He then had approximately 36 hours of lightheadedness, unable concentrating, poor appetite, dysphasia. All symptoms resolved spontaneously.
Client received the 1st dose of Pfizer COVID vaccine lot # EW0182 and expiration date 5/13/21 at 4:50PM.  Client's son approached PHN near security station to report something wrong with his mother. PHN arrived to observation area to find client seated upright alert and oriented x 4.  Client reports she just felt like fainting a few minutes ago.  Client reports she felt dizzy, heat and heaviness in her legs from the thigh down, and palpitations at the time she felt like she was going to faint. Client reports to  PHN that she did not eat.  Client reports she has no medical history, no known drug allergies and takes no medications. At 5pm vitals: blood pressure:155/84, pulse:80, and oxygen:98%. Client reports she usually has blurred vision when she reads, when asked if she had blurred vision. Client clarifies she needs glasses for reading. Client reports no shortness of breath, no chest pain, no headache and no current dizziness.  PHN offer client water, client accepted water. At 5:09PM  vitals: blood pressure:172/83, pulse:74, and oxygen:100%.  Client reports "feeling fine." At 5:14pm  vitals: blood pressure:140/90, pulse:81, and oxygen:100%.  Minutes before taking vitals client reports feeling heaviness in legs and heat and palpitations and dizziness for a few seconds. PHN  offers calling paramedics. Client reports no chest pain, no shortness of breath, no headache and  resolving of previous symptoms. At 5:17pm client reports that if she does not eat she will feel shaky and weak.  At 5:21pm vitals: blood pressure150/90:, pulse:70, and oxygen:100%. Client reports no chest pain, no headache, no dizziness, no trouble breathing, Client states that she "feels good."  At 5:30pm vitals: blood pressure:158/90 and pulse:77 and oxygen: 100%.  Client reports "feeling good." alert and oriented x4.  Provided client with ER precautions and discussed several options to either call paramedics, have family take client to urgent care or emergency room or to continue to monitor for 15 more minutes. Client decides to stay 15 more minutes and to keep monitoring blood pressure.  At 5:35pm vitals: blood pressure:158/90, pulse:80, and oxygen:100%. Client denies having any symptoms just feels worried since her 9 year old daughter has not eaten yet. Informed client she does not need to stay and can leave if she wants to.  Client stays the full 15 minutes. At 5:40pm vitals are blood pressure:162/89, pulse:76, and oxygen:100%. Client denies any chest pain, dizziness, headache. Provided client with ER precautions again and recorded all blood pressures on a separate paper so client could discuss with primary care provider.  Client walked out with a steady gait at 5:48PM.
feeling unusually tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2020, the patient received Shingrix. In October 2020, 20 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and 20 days later, he was feeling unusually tired. The reporter did not consented to follow up.
I was on my second series of my anthrax vaccine when I got my vaccine and become very dizzy and sick.  Called the clinic and they told me to go a head and get my third shot since they didnt see me get dizzy. I got my third series vaccine and within 7 minutes of it being administered to me, I went into sever anaphylatic shock and had to get two epi shots and two shots of benadryl.  Since then, I have been tired, fatigued, aching, I radomly pass out.  I have never felt the same since the vaccine.  Everytime I got to the VA the REFUSE to recognize that it just may be the anthrax vaccine that is causing all these weird gastro problems and everything else.
Fever, irritability, seizure-like twitching, though no loss of consciousness, and no alteration in conciousness.  Had normal CBC, electrolytes, CSF, normal CT of head, normal EEG, negative viral PCR panel.  Pyuria (10 WBC - negative culture) Fever and twitching movements resolved after 3 days.  10/23/09 Hospital records received service dates 10/20/09 to 10/21/09. Assessment: Pyuria, resolving movement disorder with normal EEG. Patient presents with recent hx of mild febrile illness and seizure like activity. "Crabby and sick", runny bowel movement. Woke up screaming at midnight. Jerking of whole body, then screaming/crying for several minutes. Continued to have these events. Mild congestion, runny nose, cough.  10/29/09 Discharge summary received for DOS 10/20-10/22: Final DX: Spasms.  Patient presented in ED with fever and spastic-like motions. Seizure concerns. Activity present during EEG. EEG and CT brain WNL. Discharged. Follow-up with PCP and possibly neuro as needed.   11/2/09 Medical records received for date 10/21/09 Neuro consult inpt. DX: febrile seizure, infantile spasms. Assessment: WNL other than h/o.  Pt. received H1N1 vax on 10/16 then experienced per parents increase in fussiness, tactile fever, and 1 loose stool. On 10/19 per parents pt experienced a 5 sec. episode of generalized jerking before falling asleep. Since this episode pt has had several more episodes per parents that are characterized by bilat. Upper extremity rhythmic shaking pt retains consciousness during episodes.
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot: M037770: expiry date: 01-JUN-2019). The vaccine was stored at 32F to 35F for 15 hours. No adverse effects were reported. There was no prior temperature excursions. This is one of the three reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, the patient experienced ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Mouth started hurting/pain started again after trying to eat lunch), NECK PAIN (entire left part under left ear to the neck started hurting), SWELLING (the entire left part under my left ear to the neck on the same side I got the vaccine was swollen) and HYPERAESTHESIA (Sensitive/sore to touch) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment included icepack. The patient went to see the doctor who said it could be a delayed reaction.
After my second dose of Moderna COVID-19 Vaccine EUA on Tuesday, I woke up to find a red circle with a large knot underneath on my left arm.  It continue to get worse both in size and pain through the day.  My school nurse looked at it.  On Thursday, my lymph nodes under my left arm where severally swollen.  My school nurse once again looked at it and advised me to contact my PCP.  After doing that, they told me to continue my Advil and Tylenol and to take Zyrtec.  As of Friday night the symptoms were better.
Seizures; blackout; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613), on 18Mar2021 at dose 1, single and the second dose (lot number: EW0150) on 18Apr2021 at dose 2, single both at the age of 38-years-old for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive prior vaccinations and had never even had a flu shot. The patient had a seizure maybe a week and a half after she had her first shot. She had never had a seizure in 38 years. The seizure occurred on 06Apr2021, that was the day that she had her first seizure, a blackout. She then got the second shot on 18Apr2021 which was the Sunday and she had another seizure on 23Apr2021 and she went to the emergency room; they did a EEG, a CT scan, a MRI and everything came back normal. The only thing she had done different was taking vaccine. The patient was concerned and she wanted to report it because they were not showing on EEG or anything else and she had another one just last Friday, on 04Jun2021, that was normal. She had never had seizures before in life before until she got the vaccine. The doctor put her on KEPPRA and trazadone because they did not see anything in the EEG, that was causing the seizures it, so they put her on KEPPRA after that. The patient really thought it was due to the Pfizer vaccine. The outcome of the events was unknown.
Presented with shortness of breath. EMS reported her pulse ox was in 80s.  It went up to 96% with 4 L oxygen supplement.  She is now on Airvo 40 L/min.  Her problem started 1 week ago with fever and chills.  She has been coughing.  She has lost taste and smell.  She has body ache.  No diarrhea. Her appetite has been low.  She has received 2 doses of Pfizer vaccine.  Her test for COVID-19 is positive.  Chest x-ray showed evidence of COVID pneumonia.  . Dexamethasone IV. Po Zinc.  Actemra was given.  Remdesivir was initiated, however, was discontinued due to abnormal LFTs.  Patient was placed on empiric Rocephin and doxycycline
Headache, Myalgia, NauseaVomiting, Chills, Discomfort to right arm Narrative:  Other Relevant History:
The injection itself did not seem out of the ordinary, other than the nurse used a diffuser pad.  This was my 5th flu vaccination in my liftetime and I was used to the deltoid soreness, however starting that evening, I had actual shoulder pain, not just muscular pain.  I developed a shoulder impingement pattern (painful arc, decreased proprioception resulting in inappropriate glenohumeral/scapulothoracic motor control associated with shoulder motion in function).  I was referred to work comp since the injection happened at work, as part of the hospital regulation that I must have the influenza vaccine.  When I saw the work comp physician he was very familiar with the fact that likely the nurse actually injected the vaccine in my joint and not in my muscle.  My prescribed treatment was anti-inflammatories which only helped when I was on them and some extremely poor physical therapy which was not helpful.  I had consistent pain with arm movement for at least 5 months and had residual pain at times of more significant shoulder exertion for about 13 months from the vaccination.  I asked my work comp physician if he would be reporting my vaccine injury/side effect and he told me no.  This is why I am reporting it now-I learned of this website today and felt it was my duty to personally report this since my physician did not.
Onset of symptoms July 25, 7Pm. COVID-19 positive rapid test, July 26. Symptoms: fatigue, body aches, nasal and sinus congestion, cough, fever. Telehealth visit on July 27.  Prescription for Paxlovid filled and dosing initiated on July 27.
Fever fussy all throught the night. Didn't see the swelling on the leg until this morning 12/15/16 at 5:00 AM.
she received an injection that was definitely brown with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 59 years old female patient who reported that she received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] that was definitely brown with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown strength, batch number and expiry date) via unknown route in the left arm for Immunisation.  On an unknown date, the patient received an Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine injection that was definitely brown with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, Caller would like to confirm appearance of ADACEL. she said she yesterday she received an injection that was definitely brown. Spoke with consumer who wants to know what color the product is supposed to be. Says she is waiting for a call from the physician and may need to hang up. Says the product was administered yesterday in the left arm and she was provided ADACEL as the product name. She received no other vaccines the same day and is not pregnant. She had to go and had no further time. Described color of the vaccine to her. Says it was definitely brown. Informed caller the Adacel is a white cloudy suspension and should not be injected if any other color.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a noncontactable healthcare professional. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#  EN6203), at the age of 54, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. On an unknown date (during her 15 minutes waiting period after the injection), patient experienced mouth dryness. Therapeutic measures taken as a result of mouth dryness included treatment with antihistamines and water. Follow-up response to treatment was good. The patient was stable to go home when discharged. She was advised follow-up with primary care physician. The outcome of the mouth dryness: unknown (at the time of this report). No follow-up attempts possible. No further information expected.
Light menstrual cycle started 2 weeks early and has been continuous. No heavy bleeding, no cramps
2 hours after vaccines, baby had high pitched cry. Sounding like screeching, crying for hours and hours. I called the doctor they kept telling me this is "normal just in pain from the injection swelling. Baby thigh actually wasn't red or swollen so I knew that was not it. Baby would not eat at all, had a blank stare and body jerked a little at times. If baby wasn't sleeping, he was crying. I could not console him. Nothing worked. I called on call doctor again that night still crying, whining all day, won't eat, blank stare. Explained baby just doesn't look like himself. Told me again "normal" just monitor him and if anything changes call us back, still very fussy the next day. Next day severe cough, wheezing, crackling in chest, took him to hospital. Albuterol treatments as needed, sent home for "viral Infection" again took him to hospital 2 days later, ?RSV, Bronchiolitis. No signs of improvement going on 11 -12 days, back to doctors. Performed swab nose, positive for 2 viral infections, 2 bacterial infections, which one was HIB.
body aches; headache; This is a spontaneous report from a contactable unspecified health professional.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the right arm, from 18Dec2020 15:15 at a single dose for covid-19 immunization. Patient is not pregnant. Medical history included sulfa drugs allergy from an unknown date. The patient's concomitant medications were not reported. On 19Dec2020, the patient began having body aches and headache 24 hours after injection that lasted 12 hours. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
9/25 pt received vaccine. 9/26 pt febrile. Seen at urgent care 9/27. 9/28 began vomiting with diarrhea. Seen in our office dxd with proteinuria and bilirubin in urine.
Intestinal pain, not relieved by passing gas or emptying bowels. Pain when moving, laughing, walking, etc.  "Feels like pain after being punched"
Rash and some hives all over his arms; Rash and some hives all over his arms; This is a spontaneous report from a contactable consumer. This consumer reported for her boyfriend (patient). A 52-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry Date was not reported), via an unspecified route of administration on 21May2021 (at the age of 52-year-old) as single dose for covid-19 immunization. Medical history included Blood pressure high. Concomitant medication included valsartan taken for Blood pressure high. Reporter stated, "The RX number is 166. The LOT# it looks like she cannot read it very well. It looks like it is PFRE000177. You know what that could be EW. It is just hard to read this writing. She do not know if it was EW 0177 or if it was E000177. Reporter stated, "Actually she had a question. Her boyfriend and she went on Friday to get their Pfizer shot, the first one and he had some like a rash and some hives all over his arms (May2021). Would it be okay for him to take Benadryl and also stated, no treatment was received as they haven't gone to the Doctor because she did not know if they can give him Benadryl or she mean that he just got like hives, know rash on his arms. The outcome of events was unknown.  Information on the lot/batch number has been requested.
sick; queasiness and an upset stomach; queasiness and an upset stomach; This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left (at the age of 62) on 13Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for blood cholesterol abnormal (start date probably 3 years ago). The patient experienced sick on an unspecified date, queasiness and an upset stomach on an unspecified date. Patient was treated with Pepto-Bismol. Patient took some Tylenol for soreness but her arm never got sored. She just took Tylenol for prophylaxis. The outcome of illness was unknown. The outcome of the other events was not recovered.    Additional information: Per the caller: 'I have never been sick with covid and now I feel like this after getting the vaccine. This has been going on for 4 days now for me. It may be a stomach bug going around, but I am not sure. I saw my doctor on Monday and did not think to ask about this. I will be having an ultrasound (reason not provided) and if things get worse I may ask about it then. How long are symptoms supposed to last after getting the vaccine?'  No follow-up attempts are possible; information about lot/batch number cannot be obtained
My periods have been off / late significantly late. They have never ever been late before. Every time my husband I have sex I bleed ever since I got the vaccine.