chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing symptoms similar to peripheral neuropathy; sharp pains shoot through my extremities; My whole body tingled.; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 as single dose for covid-19 immunization at Pharmacy or Drug Store. Medical history included asthma, depression, Patient had allergies to medications, food, or other products included Corn, wheat, and sesame. Patient was not pregnant at time of vaccination. Family history included peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Concomitant medication(s) within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC); montelukast sodium (SINGULAIR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6199), in left arm on 08Mar2021 14:30 for COVID-19 immunization. It was reported that starting about twelve hours after my second dose of the vaccine on 06Apr2021 03:00 AM the patient experienced symptoms similar to peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Her whole body tingled, and had sharp pains shoot through my extremities. Patient have never been diagnosed with peripheral neuropathy or experienced these symptoms before. It was 24 hours later. The sensations still persist but are less pronounced. The prozac that was on can cause leg twitches. Perhaps the vaccine was interacting with the prozac or triggering an underlying genetic condition. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Starting around 6 pm, on 11/10/21, I started getting really tired.  Fell asleep and woke up really thirsty but didn't have enough energy to get up and drink the water next to me.  Kept falling back to sleep.  Woke up at one time and it felt like my hands and knees were being squeezed in a vise and were on fire.  Horrible  headache.  Felt like all the moisture had been sucked out of my intestines. Swollen lymph glands,  worse under the left  arm.  Was feeling better better this morning,  11/12/21,   except for  sore left jaw, swollen glands and now I feel like I have a bad case of GERDS and still tired.
Patient received vaccine on 3/10 in the morning.  This morning (3/11)noted red flat rash-face, neck and chest. S/S decreased in 24 hours at time he was brought in for check.
Pt received 5y - 11y covid vaccine in error. No noted adverse side effects.
Hives approximately 2-3 hours after and continuous headache/"migraine" per patient for 2 months.
Urticaria and swelling of neck/face (resolved after 2 days of steroids and antihistamines);  dermatographia of face/neck/trunk/limbs (improved but still ongoing with daily antihistamines).
Tender, stiff muscle right after shot. Within 2 days lifting arm was painful as well as putting arm over the head. A lump developed in the middle of muscle at 3 weeks and patient kneeded it out over 1 week. Pain with moving arm remained for 6-7 months before getting better. It still hurts 1 year later at times when lifting arm and position of arm affects when pain occurs. More use makes it hurt more.
On 08/30/2021, at approximately at 1630, a 43-year-old non-immunocompromised male entered the Covid-19 vaccination clinic. Patient had scheduled an appointment to receive the Covid-19 Pfizer vaccine. Once he arrived at the clinic he went to check in and stated he was "here for his second Pfizer shot". Check-in personnel interpreted this as he had previously received a Pfizer shot as part of the normal two-shot Covid-19 vaccination series and was there for the second vaccination. He then filled out and read over the Pre-vaccination checklist, Emergency Use Authorization sheet, Covid-19 Vaccine Patient Information sheet, V-Safe After  Vaccination Health Check sheet and Pfizer Vaccine Information Fact Sheet. Once finished filling out and reading over the vaccination paperwork, he was seated at vaccine station where employee signed off on the completed paperwork and entered patient's number into the database and confirmed information listed. (Note that no previous vaccination had been documented into the database) employee then administered the Pfizer vaccine to patient. Once administered, patient removed his vaccination card from his pocket to which employee noticed that he had previously received one (1) dose of the Janssen Covid-19 vaccine; not the Pfizer Covid-19 vaccine. Employee wrote the vaccination lot number (EWO180) and expiration (08/2021) of the Pfizer dose given onto patient's vaccination card, and then reported to clinic supervisors of the error in vaccine given. Patient then waited the recommended 15 minutes after the vaccine was administered and went to the check out station. At check out, he attempted to schedule an additional dose of the Pfizer vaccine. Patient was denied his request to do so. Senior staff educated patient on adverse reactions and potential side effects of Pfizer vaccination and that the potential side effects are listed on the informational sheets. Patient was informed to contact his primary care provider or go to his local emergency department if he experienced any adverse reactions and/or side effects. The patient acknowledged the information provided by Senior Staff. Patient then questioned "so if I had went to a different clinic without my vaccine card I could get an additional dose?" Senior staff and check-out personnel explained why there was no need to do so as he was considered fully vaccinated at this time. Patient left the clinic. Upper management were informed about the situation. Patient's pertinent information including name, DOB, and address were acquired and documented appropriately.  Summary: Pt received Pfizer vaccine after previous Janssen dose. NO ADVERSE REACTION REPORTED
Three days after receiving my first Pfizer vaccine shot the volume of my tinnitus increased dramatically.  I have had mild tinnitus in my right ear for many years but it has always been at a volume that was low and very manageable.  Three days after receiving the first shot the volume of my tinnitus increased to a level that is very bothersome and at times difficult to deal with.  It has now been 4 months since this high volume condition started and there has been no relief.
On data entry into IIS, it was noted that patient had a first dose of the Pfizer vaccine on  4/27/21 at another facility. I called the patient to confirm if he got the Pfizer vaccine and he said yes. When patient came to get the vaccine,  he did not mention getting another kind of COVID-19 vaccine previously and that he mentioned that he wants to do the Janssen vaccine.  I told the patient that I will follow-up with him on what to do next after checking with DOH on next steps. To prevent future errors, the vaccinator will ask if the patient has gotten any other COVID-19 vaccine in the past and will double check data in IIS before administration.
@ 0953 patient reported feeling nauseated, sweaty and hot. Patient given ice pack  @0958 BP 106/57, HR 67 O2 97%  @1003 Patient reported feeling "normal" was discharged home.
Increased heart rate on the next day of taking the vaccine. Usual heart rate 70-80 bmp at rest, but increased to 100-120 bmp on that day.
Initial report received on 23 February 2012 from the investigator in a study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3731AA received on 10 January 2011, lot number C3731AA received on 10 March 2011 and lot number C3872AB received on 17 June 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 11 October 2011, almost 4 months after the last dose. On 15 October 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 18 October 2011 for 5 days. The subject was hospitalized for 2 days. At the time of final contact on 27 October 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 47-year-old male patient received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient was asthmatic and without spleen. Concomitant medications were not reported. The patient experienced body aches for a day on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Received second dose of Recombinant Zoster (Shingles) vaccine resulting in a shoulder injury (acute bursitis) due to erroneous vaccine administration directly into the bursa sac.  Approx. 2 hours after the vaccine was administered I began to have severe arm pain.  After 3 hours the pain had increased and I was not able to move my arm without extreme pain.  I was seen at ER and diagnosed with acute bursitis of left should due to a vaccination complication.  I was prescribed an oral steroid and pain medication and discharged from the ER.  Symptoms have improved over the the course of the last four days with steroids and pain medication on board.  Today is the last day of the steroid medication and the first day I have not taken medication for pain.  Pain at rest has resolved and range of motion without pain has greatly improved but is not completely resolved.
Pt brought to clinic by mom friend; felt pt was well but mom notified by phone because friend unsure about allergies, prev vax etc; mom reported NKA, no problems w/prev vax;
Information has been received from a health professional concerning an 11 year old male with no known allergies who in approximately 2001, was vaccinated in the left deltoid with hep b vaccine recombinant. Concomitant therapy included a dose in the right deltoid of hep a vaccine. Other concomitant therapy included Concerta. It was reported on 08/31/2001 that the pt "now" has a rash all over the body. Unspecified medical attention was sought. Additional info has been requested.
Patient began complaining about not feeling well. He was nauseated and began throwing up and going to the bathroom.  That continued off and on all night.  Around 6:30 - 6am the next morning he said he was feeling somewhat better but was very weak.  H e went back to  bed.  We checked on him around lunch time lying on his bed with his phone in his hand.  He appeared to be trying to text.  I checked on him a few minutes later and he had not moved.  I checked and saw he wasn't breathing.  At that time he had a heart beat.   We called 911 and I started CPR and continued for approx 25 until paramedics arrived.  They bagged him and used defibrillator but could not bring him back.
Patient complaint of dizziness after bending over. States she feels dehydrated and she did not drink anything today. BP 140/78 P 80 R 16, O2 98%.
Sxs started 15 minutes post vax, difficulty breathing, rash.  Sent to ED. Sxs resolved by 12/29/2020.
muscle pain, joint pain , severe headache, chills, right under arm swollen, even my teeth hurt and short of breath  I took Tylenol every 6 hours and drank plenty of fluids and rested 24 hours
7/19/2022 This started with a sore throat and stuffy nose. I also felt unwell in general. 7/20 Tested with an At Home COVID-19 test, positive. That day symptoms got worse, going into my chest with the congestion, more substantial sore throat, sinuses clogged. Over the next 10 days, symptoms got much worse. 7/28 Tele-visit with doctor due to very severe cough. Doctor recommended to keep treating symptomatically. I started dramatical improving on 7/30.  Cough was much diminished, sinuses were clearer, no headache. Cough lingered and about 2 weeks later I went to the doctor again due to a crackling sound in my lungs. I had antibiotics proscribed for that. I developed long COVID, where I had heart palpitations, significant fatigue, exercise insensitivity. Vyvanse became significantly less effective at previous dose.
mom reports pt broke out w/red circles w/normal colored centers on legs, arms & forehead 1 day p/vax; pt c/o itching from rash mom did not notice any lethargy inc temp, dec appetite; rash still present 13JAN92;
This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them VAQTA injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Two inch skin discoloration, on each side of her body; This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th August 2019, 2 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced skin discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the skin discoloration was recovered/resolved.   It was unknown if the reporter considered the skin discoloration to be related to Shingrix.  Additional details were reported as follows : The case was reported by patient herself. The patient received vaccine in right arm and experienced two inch skin discoloration, on each side of her body starting below the underarms and ending just below the panty line. The reporter stated that discoloration started a couple days after receiving Shingrix vaccine and completely disappeared about 2 months. The reporter did not consent to follow up. For tolerance of 1st dose refer case US2021045818.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021045818:Same reporter.
Patient was administered PNEUMOVAX 23 in the left arm according to standard operating procedures on the morning of 09/17/2018. At the time of the vaccination there were no adverse effects or issues. At approximately 11:00 AM on 09/19/2018 patient returned to the pharmacy. She informed me that she had seen a healthcare provider at an urgent care clinic earlier that morning. She stated she was diagnosed with cellulitis. Patient told me that she experienced soreness and swelling twelve hours after the injection on 09/17/2018 in her left arm. She stated the swelling spread from the injection site down to her elbow, which prompted her to seek out treatment at urgent care on 09/19/2018. When patient came into the pharmacy on 09/19/2018 she also informed us that she received treatment from the urgent care clinic and that she was going to follow up with her primary care physician that same day.
Vaccination site pain; All over body pain after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All over body pain after covid vaccine) and VACCINATION SITE PAIN (Vaccination site pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  No Medical History information was reported.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In April 2021, the patient experienced PAIN (All over body pain after covid vaccine). In April 2021, PAIN (All over body pain after covid vaccine) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. Processed by medical personnel on 25-Aug-2022 This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  This case was linked to MOD-2022-624780 (Patient Link).
This case is linked to case number: 2013-02221 (same reporter, same product and same adverse event). Initial report received from a healthcare professional on 04 February 2013. A 55-year-old female patient, had received third dose of IMOVAX (batch number: D0792-1, route and site of administration were not reported) on 01 June 2010. The patient had received 2 pre-exposure doses of IMOVAX previously. The patient had received dose 1 with lot number D0792-1 on 04 May 2010, expiry date 09/04/2011 and dose 2 with number D0792-1 on 11 May 2010, expiry date 09/04/2011. The patient's concomitant medications were not reported. On an unspecified date of June 2012, the titer value was below acceptable level. The patient's outcome was not reported. List of documents held by sender: none.
This case has been considered invalid as the event cannot be assessed with the information provided (unspecified AE). Is the Reporter a Healthcare Professional (HCP)? Yes Occupation/Specialty: Unknown is the reporter's contact information available to you or a sub-contracted party? Unknown is the reporter the prescribing HCP? Unknown Suspect product(s): Pfizer Covid-19 Vaccine Start date: Unknown Stop date: Unknown Verbatim and event description: Caller is a HC Provider. They have the adult and pediatric vaccines stored in the refrigerator. He said that it's supposed to be good for 31 days and the other one is 10 weeks but one of his colleagues opened the fridge and did not close all the way and the temperature went up to 60 degrees Fahrenheit for almost 3 hours. Caller is asking if the vaccines are still viable. Medical Information: Were any unaddressed medical questions referred or forwarded to medical information? Yes : Customer and/or medical inquiry forwarded or referred.
Immediate onset generalized pruritus following dose of vaccine. Gradually improved without treatment. No hives, wheezing or difficulty breathing noted. Vital signs were stable. Breath sounds were clear. Recipient was awake, alert and conversing with observation team leader (physician).
Redness, mild swelling at injection site. Total diameter approx 2". Warm to the touch, patient complains of itch.
pt recvd vax; c/o arm swelling & turning red; chest tightness; anxiety; dph given; sx resolved;
This case was reported by a healthcare professional and described the occurrence of metallic taste in month in a 29-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX GlaxoSmithKline given on 15 November 2010. Concurrent vaccination given on an unspecified date included TYPHIM (manufacturer unspecified) given in 2010 (within the last couple of days of reporting). There were no concurrent medications. On 22 November 2010 the subject received 2nd dose of TWINRIX (according to the accelerated dosing schedule before traveling). On 22 November 2010, 5 seconds after vaccination with TWINRIX, the subject experienced a metallic taste in her mouth. The metallic taste resolved within 5 seconds. The nurse practitioner kept the subject in the office for at least 15 minutes and she did no have any other problems. Her condition did not meet serious criteria.
pt devel hives on abd & neck shortly p/vax; DPH given sxs were stablized 40mins later; DPH cont @ home
Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Headache that has lasted six days, evolving into ocular migraine then regular migraine; Chills; Nausea; Diarrhea persisting the same length oftime.; Dose received: 3 / dose number = 3; Off label use; Interchange of vaccine product; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 at 14:00 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot Number: 019821A, Route of Administration: Unknown, Anatomical Location: Right arm), administration date: 24Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot Number: 045b21A, Route of Administration: Unknown, Anatomical Location: Left arm), administration date: 21Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Dose received: 3 / dose number = 3"; OFF LABEL USE (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Interchange of vaccine product"; HEADACHE (non-serious), OPHTHALMIC MIGRAINE (non-serious), MIGRAINE (non-serious), CHILLS (non-serious), NAUSEA (non-serious), DIARRHOEA (non-serious) all with onset 29Nov2021 at 15:00, outcome "not recovered", and all described as "Headache that has lasted six days, evolving into ocular migraine then regular migraine". Therapeutic measures were not taken as a result of headache, ophthalmic migraine, migraine, chills, nausea and diarrhoea.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Pt recvd vax inject which had not been properly refrigerated. At time of report there was no ADR.