chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of anaphylaxis in a 35-year-old  female subject who received Flu seasonal TIV Dresden. This case refers to patient 32 in the literature article. Concurrent medical conditions included shellfish allergy, latex allergy, penicillin allergy, allergic reaction to antibiotics and allergic reaction to antibiotics. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized pruritus, swollen tongue, shortness of breath and throat tightness. The subject was treated with epinephrine, antihistamine, antihistamine and albuterol. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized pruritus (recovered/resolved), swollen tongue (recovered/resolved), shortness of breath (recovered/resolved) and throat tightness (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized pruritus, swollen tongue, shortness of breath and throat tightness may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 35-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown).  The patient was a female. The subject's medical history included atopic disease with shellfish, latex, amoxicillin, ciprofloxacin and gentamicin allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, within less than 30 minutes after the vaccination, the patient developed generalized pruritus, tongue swelling, shortness of breath and throat closure. This was classified as anaphylaxis by the family practice doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, parenteral antihistamine, intravenous therapy and albuterol. At the time of reporting the outcome orf the events was recovered. The event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Pt presented 10/2/17 with rash on same arm as injection. Rash was red and warm. Pt's PCP diagnosed as cellulitis.
Mumps like symptoms on left side of face; Chewing is painful/ Difficulty in chewing on left side; Swelling of face left side; This spontaneous case was reported by a consumer and describes the occurrence of MUMPS (Mumps like symptoms on left side of face), MASTICATION DISORDER (Chewing is painful/ Difficulty in chewing on left side) and SWELLING FACE (Swelling of face left side) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mumps.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MUMPS (Mumps like symptoms on left side of face), MASTICATION DISORDER (Chewing is painful/ Difficulty in chewing on left side) and SWELLING FACE (Swelling of face left side). At the time of the report, MUMPS (Mumps like symptoms on left side of face), MASTICATION DISORDER (Chewing is painful/ Difficulty in chewing on left side) and SWELLING FACE (Swelling of face left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure and  cholesterol medications.No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 contains non-significant information.
Initial solicited report received on 30 October 2017 from a health care professional. This is a prospective pregnancy registry case for Study. This case involves a female subject of unspecified age who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was reported as 27 May 2018. The mother and father's health status were not reported. The father's age was not reported. The current pregnancy history was reported as "no illness reported during this pregnancy". The subject's previous pregnancy was not reported. The subject's maternal drug exposure was not reported. The subject received a 0.5 ml intramuscular dose of FLUZONE QIV in the left deltoid on 30 October 2017 (frequency: one dosage, batch number not reported). The subject's pregnancy complication was not reported. It was not reported if the subject had any treatment for infertility. The subject's family history of congenital abnormality was not reported. On an unspecified date the subject experienced relevant non serious adverse event morning sickness with nausea and vomiting. The corrective treatment of the non-serious adverse event morning sickness with nausea and vomiting was not reported. Prenatal testing was not reported. Outcome of non-serious adverse event of morning sickness with nausea and vomiting was not reported. The pregnancy was ongoing at the time report. List of documents held by sender: none.; Sender's Comments: A pregnant female received a dose of study product. The subject had non-serious adverse event of morning sickness with nausea and vomiting. Based on the information available the sponsor assess the event as not related to the vaccine. "The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose".
Within 15-20 minutes after vaccination in left upper forearm, pt had urticarial rash on forearms, spreading to face and trunk, no respiratory sx, resolved with oral Benadryl and observation.
1st shot,  no reaction other than sore arm. Then 2 weeks to the day of injection,  my injection site developed a hot red rash, it lasted 5 days. After second shot I was VERY sick the next day with sore arm, headache, nausea, weakness symptoms and a 100.4 temp. Slept all day, ate nothing till 6 pm, then started to feel better. Seemed Ok the next day (Thursday) except a little weakness and sore neck. On Friday still a sore neck. On Saturday still a sore neck and a bit of headache then I noticed a lump in lower neck area around the clavicle which is very sore. That is where I am today 021321.
The next day after the vaccine, I had a slight headache. It started to progressively getting worse with a stiff neck and nausea. I started breaking out in a rash with red bumps all over my body. On my left bicep, it turned red and was hot to the touch. By 11/10/2021, I went to the ER. I had blood work that was normal. I was told it was an inflammatory response. I got a shot of Toradol that helped. This lasted for about 5 days. I did get a 4th booster but it was Pfizer yesterday and everything seems fine so far.
The patient experienced a burning pain at site of injection and within an hour the pain spread up to neck, down back, and down to wrist and began to feel heavy. The pain triggered her migraine headaches. The shoulder and arm  of the injection side was red and swollen. She called a doctor,  and was told to come in for a visit. The Doctor thought a nerve was hit when injected. The following day, upon visualization of the injection site, the redness and swelling resolved itself. The patient was prescribed Gabapentin to help with the burning pain in arm. The pain is no longer in entire arm after using gabapentin for a few days, but still in pain. She is missing work due to inability to list heavy objects.
Several Days of High fever of 104.6, red rash on left side of body, dizziness, Heart palpitation, low oxygen, pneumonia.
Nausea, dizziness, headache, sinus pain, extreme fatigue, intense vertigo, fast heart rate, chills
Severe pain in the right arm beginning about 30 minutes after the injection. Over the next 24 hours fatigue, headache, and muscle soreness. Redness that was warm to the touch. The redness continued and began to  spread over the arm and is now the size of a grapefruit . It has been 13 days since the injection and the redness, itchiness, and raised skin at the injection site continues to get worse.
pt recv vax 10DEC96 & 27JUN97 pt devel chickenpox 2wk p/sibling devel chickenpox (WAES 97061814);it was noted that both children were vaccinated @ the same time;
One week after I had dose 4 I woke up at about 2:30 in the morning itching severely but unsure what it was. I woke the next morning and my neck and arm and hand were red (right side) very red and itchy and dry and blotchy. The redness and rash like area spread from my eye brows to my feet. However, it would disappear, and then reappear in a different spot. I tried several OTC meds to help with itching. the rash like area also appeared on my left side. I have not seen the doctor yet but plan to this week if it not get better. After dose 2 I also had redness and itchy rash like area around the injection site that only lasted about a day.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 2nd dose of Shingrix. In August 2018, 11 hrs 30 min after receiving Shingrix, the patient experienced generalized aching, nausea, fever, sleep disturbance, chills, pain in hip and crying. On 21st August 2018, the patient experienced injection site pain, headache and stiff neck. On an unknown date, the outcome of the injection site pain, headache, generalized aching, nausea, fever, stiff neck, chills, pain in hip and crying were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, headache, generalized aching, nausea, fever, sleep disturbance, stiff neck, chills, pain in hip and crying to be related to Shingrix. Additional details were provided as follows: At 13:30, the patient received Shingrix in left arm. The patient reported feeling extreme pain when the injection was given. She said the medication hurt going in and her arm continued to hurt after that. At 8:00 pm, that night, 6 hours and 30 minutes after vaccination she felt stiffness in her neck and a headache. On 22nd August 2018, she woke up at 1:00 am morning with extreme arm pain, chills, pain in her hips, feeling achy all over, nauseous and a low grade fever. The arm pain was described as so extreme that when she moved it, it made her cry. The chills made her teeth chatter. She was not able to sleep the rest of the night. The contact details of the physician were provided.
Had a fever and a sore throat. Took a home COVID-19 test and was positive. Contacted doctor and was told that it was too late to take PAXLOVID. Rested and quarantined on my own. Tested negative for COVID-19, 11 days later.
(L) deltoid edema, erythema, pain, per NOC; dizziness, nausea, headache, chest pain, short of breath, fever congested. Seen on 9/11/07, hx of asthma, + SOB, + chest pain, nauseated, afebrile; 8x3 cm area of mild firm, slight erythema of (L) deltoid.
Headache for 2 days (as of today) no ibuprofen, acetaminophen etc. taken as I read they could suppress immune making ability.
Excessive sleepiness for 2 days p/immun w/DTP/OPV/HIB not reported to provider until 2 months later;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and demographics. The nurse reported that sometime in March 2014 the patients were vaccinated with VARIVAX (Merck), subcutaneous that was improperly stored. Concomitant medications were not reported. No symptoms reported. The outcome of administered improperly stored was unknown. Follow up information has been received from the registered nurse. The reporter was unable to provide the patient's initials, dates of birth or dates of vaccination. It was reported that there were two patients vaccinated with VARIVAX (Merck), one was vaccinated with the following lot; (lot number reported as J009987, expiration date 12-AUG-2015), dose and anatomical location unspecified, subcutaneously that experienced a temperature excursion. This report is linked with case 1403USA013203 via same reporter link. Additional information has been requested.
Immediate pain at injection site and unable to move left (ipsilateral) shoulder by next day. Frozen shoulder requiring surgical manipulation under anesthesia 4 months later.
Pt passed out briefly after receiving the vaccination. Pt recovered after being laid flat and legs elevated. Pt given fluids and snack
pt stated he felt faint within a couple minutes of having the shots, sweated profusely, seemed to fade in and out of feeling well...he seemed to lose control of his eyes several times and mumbled jibberish once and his body got heavy but he came back fine....wife requested ems services b/c she was frightened at one point but once they arrived pt refused to go with them and denied treatment
Patient called the pharmacy to inform that since she received the shot she has experienced an ongoing pain on her arm. This has been going on for 2+ months. There is no redness or nodules. No other symptoms except for pain.
This spontaneous report was received from a pharmacist referring to an adult female patient of unknown age (reported as adult). The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot # , dose, route and site of administration and expiration date were not reported). However, the reporter was not able to confirm if the patient had ever been vaccinated with VARIVAX in the past or if she had ever had chickenpox. On an unknown date, the patient had low varicella titers. The outcome of the event and causality assessment were not reported. This is one of two reports for the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011634:
first dose 2.5 years before, not received dose two; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two and a half years ago).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 29-JUN-2022  Reporter's comment: The reporter was the concerned patient. The physician reported that he received first dose of Shingrix two and a half years before this report and had not received dose two. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked to the case US2022099886, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099886:Same reporter
Case number PHEH2015US018518 is a spontaneous report initially received from a health care professional on 17 Sep 2014. This case refers to a 28 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse event was reported following this administration error. The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015. Clinical notes updated.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negligible, notes: antigen test was negligible. Today, it is dark and my symptoms have returned; (21Jun2023) dark, notes: antigen test was negligible. Today, it is dark and my symptoms have returned; (unspecified date) Positive, notes: positive test result rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment: From 11Jun2023 to 15Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/14/21/ at approx. 10:30 am. Patient was due for her 4th Dtap vaccine today. Tdap vaccine was administered instead of Dtap vaccine. Patient was observed in the exam room and had no s/s of a reaction to the vaccine.
Nausea; vomiting; Fever of 101.7; Body aches all over; Headache; Fatigue; Swelling and bruising at injection site; Swelling and bruising at injection site; dose number 1 on 27Dec2020/dose number 2 on 13Jan2021; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3302, expiry date May2021), via an unspecified route of administration, on 13Jan2021 08:45 am, at single dose, on the left arm, for covid-19 immunization. Medical history included GERD, asthma, and allergies: kiwi fruit. The patient's concomitant medications were not reported. The patient previously took hyoscyamine and experienced allergies; and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685, expiry date May2021) on 27Dec2020 09:15 am, for covid-19 immunization at the age of 23-years-old with vaccination location on the left arm. The patient experienced nausea with vomiting, fever of 101.7, body aches all over, headache, fatigue, swelling and bruising at injection site - all on 13Jan2021 at 15:45 (reported as 03:45 pm). No treatment was received for these events except for fever (with acetometaphine and ibuprofen in system). The patient had no COVID prior vaccination, had no other vaccines received in four weeks and, had not been COVID tested post-vaccination. The outcome of event dose number 1 on 27Dec2020/dose number 2 on 13Jan2021 was unknown; while the outcome of all the other remaining events was recovering.
Hives and measles like rash in underarms, groin and thighs. Swollen lymph nodes
Patient reported fever to 103.0, myalgias and weakness following Dtap administration.  Reported to Emergency Department 10/29/09, had temperature to 99.4 and sent home with motrin prn.
Fever 101.7, joint pain, severe headache, nausea, diarrhea, couldn't even walk
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients felt "itchy" at the injection site for an unknown amount of time. At the time of reporting, the outcome of the event was unknown. The relatedness between the event and ZOSTAVAX)was not reported. Follow up information has been received from pharmacist on 30-NOV-2016, via a phone call. The Pharmacist stated that she had provided all of the information for the one patient that experienced the above adverse event and that there were no other patients. No further information is available. Additional information is not expected as No further information is available.; Sender's Comments: ,MERCK 1610USA005046:Mfr number.
1/23/21 10 AM-got out of shower and noticed left arm injection site was red and swollen and noticed it started to spread. Pt. states that  the size of her arm swelling and redness is about the size of dollar bill and spreading. Pt. states that her left arm is really itchy. Pt.  states that she started experiencing chest tightness on 1/18/21. She was seen by her cardiologist and echo was performed and reportedly normal. Pt. states that her chest tightness is still present and is going to make appt with pcp to have chest tightness evaluated. Pt. denies taking anything for her symptoms.
Continuous tinnitus started the day after my second vaccine administration. No treatment taken. Has not gone away.
This spontaneous report was received from a doctor of pharmacy refers to a 61 year old female patient no drug reactions/allergies. On 11-OCT-2013 the patient was vaccinated with 0.65 milliliter ZOSTEVAX (lot # J004267, expiration date 12-JUL-2014) subcutaneously. On 12-OCT-2103, 2 days after onset of therapy, the patient developed redness about "silver dollar size", "warm to touch" at the injection site and diarrhea. The pharmacist stated that the redness was down to "about quarter size now". Treatment was not rendered for the events. Laboratory diagnostic studies were not performed for the events. Medical attention was not sought. The outcome of diarrhea and warm to touch at the injections site was unknown. The outcome of redness about silver dollar size was reported as recovering/resolving. Causality was not reported. This is one of the several reports from the same source. Additional information has been requested.
Mom reports the child having a generalized rash 1 day after vaccination.  Mom is a nurse, but she did contact the child's PCP who stated the child had a reaction to the DTAP.  Mom treated child at home. This information was obtained from mom.
Reports began to experience pain in left arm approx. 2 hours after receiving the tetanus immunization.  States later in the day 6/6/21 began to have a line of swelling from his immunization site to his elbow/ac area that was reddened and hard and cold to touch.  Denies increased warmth.  States pain continues and includes numbness, tingling and shooting pains in left arm.  Reports that due to swelling and pain is unable to lift or extend left arm.  Denies any other symptoms including any breathing problems.