chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt some numbing/ numbness; Some tenderness on all the parts I felt heat on yesterday; Like a small tingle; Little off on right side; Felt heat rushing in/ the heat went throughout my shoulder, neck, face, head, half way down my back. All on the right side where I got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 15:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: FEELING HOT (non-serious) with onset 19May2021 15:00, outcome "recovering", described as "Felt heat rushing in/ the heat went throughout my shoulder, neck, face, head, half way down my back. All on the right side where I got the vaccine"; HYPOAESTHESIA (non-serious) with onset 20May2021, outcome "recovering", described as "Felt some numbing/ numbness"; TENDERNESS (non-serious) with onset 20May2021, outcome "recovering", described as "Some tenderness on all the parts I felt heat on yesterday"; PARAESTHESIA (non-serious) with onset 20May2021, outcome "recovering", described as "Like a small tingle"; FEELING ABNORMAL (non-serious) with onset 20May2021, outcome "recovering", described as "Little off on right side". Therapeutic measures were not taken as a result of feeling hot, hypoaesthesia, tenderness, paraesthesia, feeling abnormal.  Additional information: The patient reported that the heat she felt the day before never flowed to her whole body, and was present only to the areas that she mentioned. She felt that it was very odd how the flow of heat only rushed to certain areas. Patient felt completely fine. She had no cold like symptoms at all. She was just a little off on her right side. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client complained of throat closing minutes after getting to observation tent. Then she c/o right side abdominal pain, "hot and tight." Then "weird taste in my mouth."  I spoke with client and she seemed not clear and a little confused.
This spontaneous report was received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 04-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Patient late for 2nd dose / Dose 1 / in 11/13/2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th November 2019 from batch 227FL and expiry date 26th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked whether they need to restart the vaccination series. The reporter consented to follow up.
had experienced a severe reaction to the M-M-R II and V ARlV AX vaccines; This spontaneous report was received from a consumer through a company representative referring to his daughter a 12 month old female patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported)  and varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, vaccination scheme frequency and anatomical location were not reported) (lot number T033166 and expiration date 29-SEP-2022) , and both suspect vaccines were administered as prophylaxis.    On an unknown date the patient experienced a severe adverse reaction to the  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (vaccination complication). The patient's father sought medical attention with 5 different doctors and none of them had ever seen a reaction so severe. It was unknown if the patient received treatment or if any lab diagnostics were performed. It was reported that the patient's condition was getting progressively worse; therefore, by the reporting time, she had not recovered from the vaccine complication.   The causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event vaccination complication was considered to be related.
BELL'S PALSY REACTION- DROOPY EYE, UNILATERAL FACIAL NUMBNESS, INFLAMMATION
Administered vaccine in pt (R) deltoid. Entire dose would not go into arm. 0.1 mL left in syringe gave 0.1 mL extra. Could have been syringe malfunction. After removing syringe from arm, still wouldn't retract or finish. Vaccine was "stuck" it was as though it was frozen however it was at correct temp.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 52-year-old, adult female patient. The patient had no relevant medical history and had not received any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml (explicitly coded as overdose), route of administration: intramuscular, anatomical location: right deltoid, batch number: 252235, expiry date: 30-Jun-2019). On the same day, after vaccination, the patient felt under the weather (ill feeling). On 10-Oct-2018, 1 day after vaccination, the patient had a pounding headache. On 15-Oct-2018, the patient called back the nurse and stated that she was feeling better but still had some tension on her neck (neck pain) and soreness at the injection site. It was reported that the health care professional (HCP) followed up with the patient. At the time of this report, the patient was recovering from the events ill-feeling and pounding headache. The patient had not recovered from the events neck pain and injection site pain. This case 201804660 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event 'extra dose administered' was recoded to 'overdose'. The introductory statement in case comment was modified to 'A 52-year-old female patient experienced ill feeling, on the same day after receipt of FLUCELVAX QIVc of dose 1.5 ml instead of 0.5ml (coded as overdose). The patient also experienced pounding headache, 1 day post vaccination and neck pain, injection site pain, unspecified period after vaccination.' The narrative and case comment were amended accordingly.
Initial report received from Consumer on 02 October 2014. A 69-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5044AA, expiry date 20 May 20155 and dose number was not reported) in to the deltoid left on 30 September 2014. The patient experienced half dollar sized bruised area at the injection site, redness below the injection and warm to touch on 01 October 2014. Lab investigations were not reported and corrective treatment included ice pack applied. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects includes allergic to penicillin, macrolides, ketolides, and lidocaine. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
Got vaccine on Monday 9/2/13 noted feeling itchy on Tues 9/3 later noted rash on bridge of nose noted on Wed 9/4 rash on forearm of left arm.
On 07/15/1999, pt received first vax. One hour post vax, the pt experienced chills and a headache. The symptoms were treated with Tylenol. The most recent information received on 07/15/1999 reports approximately 2 hours later the chills went away and the headache lessened.
Arm hurting; Stinging around site of injection after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose). At the time of the report, PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE PAIN (Stinging around site of injection after second dose) outcome was unknown.            Treatment information included the patient took rest and a warm shower. The patient felt still hurting but not as bad. She describes it as "stinging," and "feels like somebody punched me." No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-148041 (Patient Link).
Patient presented for Pfizer booster.  Patient was counseled prior to immunization and questioned as to how she tolerated previous injections.  She did not indicate that she had any previous reaction to the vaccine.  Patient was administered booster and was told to wait at least 15 minutes post-vaccination to monitor for any health changes.  Approximately 30 minutes afterwards, patient came back to pharmacy and indicated she felt needle-like feelings in body (or itching).  Patient was given a blood pressure check and visually examined for signs of an adverse reaction.  No skin changes were indicated, but the patient was slightly hypertensive 139/90 and a pulse of 70.  Patient was asked if she had been diagnosed with hypertension, and she indicated that she had not.  However, MD had prescribed her metoprolol.  Since patient demonstrated no further symptoms, she was given two diphenhydramine 25 tablets to take with her should she progress in symptoms.  She also was told to seek medical attention if she noticed skin lesions, labored breathing, or dramatic changes in blood pressure.
12/17/2020, 15 minutes after vaccination started to experience tingling on forehead and radiated on left side of face, nauseas, light headed, HR increased, 'funny on tongue' , 'felt like going to faint'. The BP was 149/109. The medical crew tried to calm down. BP would not come down. Placed in gurney, administered oxygen, given a 'benadryl and some sort of shot' to slow down the reaction. Given rest of the day off. 'I slept for a few hours' and after 4 hours, my chest started to tighten, radiated to back 'tightness' , felt like heartburn. I didn't sleep that whole night, had to keep sitting with the tightness in the chest.  By morning I was better, I went to work, took inhaler (flovent and albuterol). Headache at work, took Tylenol. At 12, I went to each lunch and felt there was a lot of mucous in throat / acid reflux feeling ; 'felt full in throat'. I went in a coughing spell, 'bubbly mucous'. I couldn't talk, drank water, sat in car until I had to go back to work. I couldn't breathe when I walked back into work. At approximately 2:15 they rushed me to urgent care, 25 childrens benadryl, administered oxygen and omeprezole for reflux. I stayed with the oxygen till 4:45; BP 140/98 and slowly came back down. 'At same time, co worker was experiencing same thing that just had had vaccination'.  My asthma 'kicked in', white blood count was elevated to 17.   Work in urgent care and where i was rushed to.   flu shot 2 months prior TB skin test one month prior; negative
Patient developed a "tingling feeling" approximately 30 minutes after her second Shingrix immunization. She was told by her physician at that time to take diphenhydramine, but states that she was unable to continue taking  it since she must remain alert while at work.  She developed a generalized rash approximately 1 hour and 15 minutes after receiving the vaccination.  She also stated that she has a warm red spot on her left arm that is below the injection site.  She returned to the pharmacy and urgent care clinic on the evening of 1/6/20.  She was seen by PA., and was prescribed hydroxyzine.
Post vax, the pt developed a local redness, swelling and pain (8cm diameter). NSAIDS
itching; bug bite on her left lower rib cage; itching/bug bite on her left lower rib cage/When she got the second shot, the itching got worse; shingles; This is a spontaneous report from a contactable consumer patient. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on an unspecified date (lot number and expiration date were not reported) as single dose (at the age of 74-years-old) for COVID-19 immunisation. Medical history included allergies to mussels, clams and oysters. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient took the first BNT162B2 on 05Feb2021, 10:30 (lot number: EL9269) administered in the right arm for Covid-19 immunisation (at the age of 74-years-old) and experienced "I had a small breakout of vaginal herpes which I haven't had for two years". The patient did not have other vaccine in four weeks. The patient did not have covid prior to vaccination and was not tested post vaccination. The week of the second shot she started itching. She thought it was a bug bite on her left lower rib cage. When she got the second shot, the itching got worse. She went to a walk-in clinic and it was diagnosed as shingles which was still lingering. The patient received an unspecified treatment for the event. At the time of the report, the patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
One week after receiving my vaccination the injection site became noticeably swollen, red, warm and itchy.
My limbs are tingling tickeling uncontrollable, hands, legs, and feet similar to Tardive Dyskinsia. It will not stop and is worse at night.
Started experiencing irregular heartbeat 1-6-21. Went to PCP for EKG 1-8-21. EKG was normal but I continued to experience palpitations intermittently for months.
Next day post vax, the pt experienced severe itching and burning of entire skin. This has continued intermittently to date with varying intensity.
Woke up the morning after vaccination and had "blisters" in mouth and itching all over.  States wife saw some "red spots" on his back but no other place.  Also immediately after injection felt the need to take inhaler.  Itching to hands and "all over" continues as of 12/28/2020 without evidence of hives or rash.
Provider note: "Patient was given influenza and Tdap immunizations in L arm following her office visit today, approximately around 11 AM. Shortly thereafter, patient began feeling lightheaded, warm, had clouding of her vision, and experienced nausea and abdominal pain. On exam she was diaphoretic and pale and tachycardic. She initially improved with lying down, but the abdominal cramping soon escalated leading to intense pain and nausea which lasted for ~30 minutes with persistent diaphoresis and warmth to touch. Patient took few small sips of water. Promethazine IM on standby but not given. Offered to call squad but patient refused. Vitals taken with no change in BP (still ~105-110 / 65-70), but noted patient was hypothermic at 93.5'F. Repeat 10 minutes later was 94.5'F. Toes and feet mildly dusky without change in sensation or pain. Over 30 more minutes, patient fully improved except remained hypothermic when she left at 1 PM."
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: swollen, red and warm to the touch
Vaccine was given after beyond usage date on packaging. Patient did not experience any adverse signs or symtoms.
Patient started course of 4 rabies IMOVAX vaccines on 09/15/2017 at Medical Center ER and was supposed to complete the series on 10/6/2017. He did also receive a dose of Rabies Immunoglobulin on 9/15/2017He presents to our office complaining of intermittent diarrhea on 10/11/2017 which started after receiving his rabies vaccine. Stool Cultures were negative and he was referred to gastroenterologist for further evaluation. Colonoscopy was remarkable for 4 small polyps. CT Scan Abd/Pelvis remarkable for a renal cyst on 12/17/2017. Symptoms to date have persisted with out finding an etiology. In addition, he had developed arthralgia symptoms, neck, hip and has been referred for Rheumatologic workup.
Received vaccination on 04/01/2021.  Next evening severe headache, joint pain, and chills occurred late at night around 3 am. Woke up with mild chills and severe joint pain.
Eleven pts did not seroconvert /p 4 th dose are waiting for possible 5th dose.  Three women did not seroconvert /p 5th dose.
the patient received an expired dose of vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00459652) and transmitted to Sanofi on 03-Feb-2021.  This case is linked to case 2021SA045576 (same reporter).  This case involves a 17 months old male patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ21AAA, expiry date: 21-Oct-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 26-Jan-2021 (Expired product administered)  The patient's past vaccination(s) included PENTACEL on 30-Oct-2019 (first dose) for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter stated that 2 patients have received expired doses of Pentacel and asked if they need to re-dose second patient who received expired Pentacel by mistake.  At the time of report, no adverse event was reported.  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.
severe pain in her upper middle part to the right portion of her back; pain is in the muscles; she couldn't take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 13:45 (69-year-old at time of vaccination) (Batch/Lot Number: EN6204) at a single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol d and thinks she was diagnosed about 3 years ago.  Patient was taking unspecified statins 5 mg, once a day, by mouth.    Patient got the first dose of the Pfizer COVID-19 vaccine on 10Mar2021 (Sunday). On 14Mar2021 at 10AM, she experienced a localized severe pain in her upper middle part to the right portion of her back. She said that it is a pain in the muscle where her scapula pulls and maybe the muscle that covers the lung. Because of that pain she couldn't take a deep breath. She has tried different things such as taking Tylenol and placing ice packs to numb the pain. It presented until yesterday (15Mar2021) then it became better, then it came back again last night. She was feeling better today. She can't think of anything physical that might have contributed to her adverse event. She is scheduled for her second shot on 31Mar2021.  Additional information included that there was a horrible sharp pain on the right side of her back underneath the scapula, hurt like crazy, couldn't take a deep breath . Patient took Pfizer BioNTech Covid vaccine (Verbatim): so that she will be able to see her grandkids again, and she wants to be safe. Patient reported she did not do anything to injure herself, so she was wondering if this could be caused by the vaccine. the pain was almost gone today; she can take a deep breath and it only hurts a little bit. She could not take a deep breath yesterday (14Mar2021), but she can today (15Mar2021). She described that it was really bad yesterday. She wants to know if other people have reported the pain on the muscle that goes around the back of the lung. She asked if this was related to the shot. The vaccine was given in a high school gym. There was no history of all previous immunization with the Pfizer vaccine considered as suspect neither additional vaccine administered on same date. Patient did not require to visit emergency room and physician office. She added thather husband received the vaccine at the same time and he didn't have any reactions. She also reports she was tested one time for covid and it was negative; clarified this was months ago and she doesn't remember any testing that came out bad. Outcome of the events back pain and muscle pain were unknown while Dyspnea was recovering.
pt recv vax 15JAN97 & 3wk post vax pt presented to the MD office & c/o arm sore & knot for 3 wk;