chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has the worst headache; Felt like was hung over the next day; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: she has the worst headache) and feeling abnormal (Verbatim: Felt like was hung over the next day). The outcome of the headache was unknown and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the headache and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the headache and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2023050866   Additional Information: GSK Receipt date: 06-APR-2023 The reporter was the consumer.  The reporter reported that she had her first Shingrix vaccination administered that she had the worst headache and she felt like she was hungover the next day. The reporter was consented to followup.; Sender's Comments:  US-GSK-US2023050866:Same reporter US-GSK-US2023050865:Same reporter - husband case
She got her vaccine, was feeling drooping starting that afternoon.  She did not sleep that night at all, had a headache all through the night.  She had a fever through the night, chills all night, her arm hurt to the degree that she was not able to do anything with it, she had to sleep flat on her back which she cannot sleep that way.  She had urinary incontinence which she does not suffer from.  When she went to the bathroom she almost fainted and had to sit down on the top and wait until she felt like she was not going to fall.  She is not prone to any conditions of dizziness or anything.  She got back to the bed.  In the morning I was looking at her neck in the mirror and she had a swelling on the left side of her neck, above where the shot was from the base of the neck/collarbone, a soft tender swelling.  The symptoms started easing, she had the headache through the day, was able to sleep some that evening, still had the chills.  She was still having the urinary problem, and then was easing during the day.  She still has a sore arm and the swelling on the neck which is less.   She had a similar reaction with the third vaccine and left her a message for her.  The cancer center on the phone said it may have been due to the lymphoma that she has, but when they saw her they did not feel it had anything to do with that.  The headache went away  by the third day.    There was a doctor there when she had this vaccine, and told them about some of the problems she had in December of 2021 and they had her talk to the doctor and describe all of her symptoms, and he suggested that as soon as she get home to take 2 Ibuprofen which she did.    12/16/21 she had the vaccine and had the swelling on the neck and ended up calling the nurse on the weekend and she wanted her to go to the ER and she dealt with the doctor the following week.  She saw her and she looked at it all and did not feel like it was anything serious.   She has had a reaction of some kind with every vaccine, but not as severe as the third one and the swelling with the 3rd one and this one (5th vaccine).
Information has been received from a Registered Nurse (R.N.) concerning an unspecified age brother who on an unknown date, was vaccinated with MMR II (route, dose and lot# not reported). Nurse reported that the unspecified age brother, who might had received one or more doses of MMR II, might had come down with a case of Mumps. The unspecified brother was not seen by a physician, but during the office visit where the unvaccinated sibling was diagnosed with Mumps, the child's mother apparently described the unspecified brother as having identical symptoms. At the time of reporting, the outcome was unknown. Additional information has been requested.
suspected vaccination failure; got shingles; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles twice. The patient felt miserable. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Woke up with nausea and diarrhea at 0445, headache received 3 bags NS Zofran and Toradol.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient reported throat closure about 9 hours after Pfizer COVID injection. He did not seek medical treatment and it resolved. He called it an anaphylactic reaction. I did not administer the second dose of Pfizer vaccine as a precaution. I told him to seek advice from his doctor and if he chooses to get the second dose, he should get it at a medical facility or doctor's office.
Information has been received from a licensed practical nurse concerning a 51 year old male patient with Bacitracin and Sulfonamide allergy and no medical history who on 10-Dec-2008 was vaccinated subcutaneously with first 0.5ml dose of VARIVAX (Oka/Merck). There was no concomitant medication. The nurse reported that on 02-Jan-2009 the patient developed chickenpox. The vesicular rash is distributed on his torso, under arms, face, and back of neck. The patient was prescribed oatmeal baths to relieve itchiness. The patient sought medical attention during an office visit. At the time reporting the patient was recovering. Additional information has been requested.
Racing heart rate; Shaking; Headache; Chills; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 15May2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEART RATE INCREASED (non-serious) with onset 15May2021, outcome "recovering", described as "Racing heart rate"; TREMOR (non-serious) with onset 15May2021, outcome "recovering", described as "Shaking"; HEADACHE (non-serious) with onset 15May2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 15May2021, outcome "recovering", described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 15May2021, outcome "recovering", described as "Swollen lymph nodes".  Additional Information: There were not any Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine and no Adverse event following prior vaccinations. Patient had the following: Headache, chills, shaking, racing heart rate and terrible headache. Her chills were so bad, she was under the cover shaking. 1st day she had the headache was the day after the vaccine, and it was a headache like never before. It was on approximately 15May2021. Chills got worse before they got better and the lymph nodes got worse before they got better. It took about a week for her to feel better. Racing heart rate got worse before it got better. Everything got worse those few days and slowly got better. She got her vaccine in the evening and by the morning, her neck was twice the size that it usually is. Most of her symptoms started then. She did not have an exact time for any of the following: Headache, chills, shaking, racing heart rate, swollen lymph nodes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Severe, Additional Details: "popeye muscle" and intense nerve pain in left arm for the past 6 months - has still not recovered.
I had chest pains on the left side, a feeling of "cold dread" and lightheadedness (I thought I was having a heart attack).  These started in the night on Friday and were felt mildly several times on Saturday.  I was extremely fatigued.  Sunday, the frequency decreased, and I felt better (less fatigue).  On Monday, the symptoms increased.  I was having stronger pain and the original symptoms reoccured.  This happened three times in the morning, and I contacted the doctor and was seen for any emergency appointment.  After the 14th, the symptoms decreased in frequency (1-2 xs per days) until 6/17.
This spontaneous report as received from a nurse practitioner refers to a 15 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008874, expiration date, dose and route were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of M-M-R II lot # K024035, expiration date 26-DEC-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
the site  is discolored/ injection area on the arm got hard and black; the injection area on the arm got hard  and black; nerves in their hand  are bad; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerves in their hand  are bad), VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) and VACCINATION SITE INDURATION (the injection area on the arm got hard  and black) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced NERVE INJURY (nerves in their hand  are bad). On 05-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) and VACCINATION SITE INDURATION (the injection area on the arm got hard  and black). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, VACCINATION SITE INDURATION (the injection area on the arm got hard  and black) had resolved. At the time of the report, NERVE INJURY (nerves in their hand  are bad) and VACCINATION SITE DISCOLOURATION (the site  is discolored/ injection area on the arm got hard and black) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient went to the doctor on 2nd December 2021 and the doctor recommended them to not take the second dose. No concomitant medication were given.
Post vax, on 7/28/00, pt's mother called and stated pt had a rash around the injection site. She was instructed to use Benadryl is worsens. Called on 7/28/00 and stated that the area was worse and was instructed to bring child in to see doctor. Right thigh had hard, red area about 8cm X 10cm. The doctor ordered Westcort ointment and Prelone 1/2 tsp BID x 5 days. As of 8/1/00, not resolved.
developed heart issues ( PVCs and pots disease); developed heart issues ( PVCs and pots disease); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunedeficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions"; Bnt162b2 (DOSE 2), for Covid-19 Immunization, reaction(s): "Postural orthostatic tachycardia syndrome", "Premature ventricular contractions". The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown" and all described as "developed heart issues ( PVCs and pots disease)". Additional information: The patient have a severe immune deficiency and have received four Pfizer covid vaccines and have developed heart issues ( PVCs and pots disease) since getting the vaccine and boosters. The patient was asking recommendation on protection.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Dose 1: Onset of symptoms Day 9 at approx noon. Itching at the injection site, reddening, hardness. 3" circular. Seen by Urgent Car physician to rule out cellulitis, which symptoms are very similar. Symptoms increased overnight to bright red, very sore, less itchiness (Photo available.)  Brain fog for about 2 days. Fatigue for 2-4 days. Some joint/body soreness. Dose 2: 10:00 jab -  14:30 out like a light for 1h15m. 23:00 bed - very sore arm. 01:00 awake, restless all night, with tachycardia & possibly a fever but I did not take it. Finally slept at 7am for 3 solid hours of sleep. Headache on waking; Tylenol worked well.  Site of inoculation had slight redness and swelling and was sensitive to the touch for 4-5 days. Not nearly as red as Dose 1 reaction. By day 6 itching recurred across whole area. Day 7 slightly sensitive to the touch.
was in hosp weekend of 27NOV c/o aching all over & severe h/a; has cyst on thryoid gland;
cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A contactable 78-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on left arm on 04Feb2021 at single dose for COVID-19 immunization. The medical history of the patient included high blood pressure (Caller mentioned this was diagnosed in her late 50s or early 60s, and she was 78 now). She also had history of irritable bowel disease and hiatal hernia which was diagnosed years ago. She said that she did not had any other recent vaccinations or started any new medications. However she takes high blood pressure pills and stomach medicines and a medication for her bowels. It was reported that she had cataract in Feb2021 for which she underwent cataract surgery on 18Feb2021 taking eye drops- Prolensa every morning for 1 and half week. On an unknown date in Feb2021, she was nauseated and had diarrhea. She says she got the shot 04Feb2021 then a few days later she had diarrhea. She mentioned that she was scheduled to get the second shot today i.e. 26Feb2021 Friday, and her son saw on tv some people can get diarrhea, which she did not know before. She said that she had not gotten a temperature, and her BP was fine. She mentioned that she had irritable bowel disease anyway, and usually when she has that it clears in a week. She says that she would like to know if it is safe for her to get the second shot. On an unknown date in Feb2021, she experienced nervousness and it will have repercussions. She said that her son said there was some program on TV that listed all those things, some that were not in the paperwork she got. She had been nauseated or had diarrhea, and she called before, and some people get diarrhea, and she was supposed to check and see if she should get second shot. The outcome of all the events was unknown. Caller mentioned that she called her provider, but they were not going to get back to her in an hour and a half before she would go to get the second dose. She says she got the first dose of the vaccine at (Pharmacy) and says that she thought her diarrhea was better and then it came back the day before yesterday. She mentioned that her vaccine card was handwritten, and she could not read the writing on it. She says it mentioned (Clinic site) and that the handwriting was horrible on the card, and she could not tell if the LOT was E129EG. She says NDC/EXP were not provided on the card. The caller said that she has either got to get the shot or cancel this one, but if she cancels this one she does not know when she would be able to get second since the appointments are all booked up in (State).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received ZOSTAVAX on 7/9/12 & was diagnosed with Bell's Palsy on 9/16/12. Patient reported tearing & drooping of eye. Reported to pharmacy on 11/17/12.
Pt came in with red 10cmx12cm round warm area to Rt theigh.  Was approx. 45 hrs after injection.  Was instructed to apply ice to area per M.D.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's medical history included asthma with no drug reactions or allergies. The patient was on no concomitant medications. The patient previously had no antibodies to Hepatitis A. On 19-NOV-2013 the patient was vaccinated with VAQTA 25/0.5 U/ML. On 04-DEC-2013, the patient was vaccinated with VAQTA, RECOMBIVAX HB and an unspecified flu shot. The patient later requested testing for sexually transmitted diseases. The physician stated a test for IGM Hepatitis A antibodies were erroneously drawn and the results came back positive. The patient was reported of seeking medical attention. The outcome of IgM Hepatitis A antibodies positive was reported as not recovered. Additional information has been requested.
This is a spontaneous report obtained from a contactable pharmacist. A female patient of an unspecified age, gender and race received, on an unknown date, in Sep2015, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had antibody result abnormal. It was reported that her physician ran through her titers and said that were low. Clinical outcome was unknown at time of this report.
Rash at injection site, pharmacist recommended taking 50mg Benadryl and wait a couple hours to see if it helps then go to urgent care if not. 2 days later, on 9/30/2019, pt reported in the morning that the rash went down to her elbow, and she had to go to urgent care and was diagnosed with arm infection.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: 3 "injection marks" at sight-Mild, Additional Details: took off bandaid and saw 3 injection marks, as if pharmacist had tried to give shot 3 times? pharmacist made comment of "wow you have tough skin, you bent my needle" which worried father and led him to checking.
Rash around the injection site; Itchy around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
The same day in the afternoon I felt pain in the arm where the vaccine was administered (left arm). That night and on Sunday I had discomfort in my eyes (red and feeling of sand). Then on Monday 17 a sore throat started and it worsened in the next 4 days with intermittent fever. By Saturday May 22 I lost my voice (laryngitis). Seven days have gone by and I still have hoarseness and I can barely talk and I still have the discomfort in my arm-when I close my hand it hurts.
Chills, low-grade fever,  body aches, muscle and Joint and bone pain, sore throat
Walked out of exam room after vaccinations and experienced syncope at check out desk.  Event witnessed by/patient helped down by nursing who describes 30 second loss of consciousness- Did not look like a seizure to nursing but + enuresis  - Observed 5mins and released in good condition- no post-ictal behavior.
Left arm was sore for about 4-6 days. Rash with small bumps by the injection area, headache and stuffiness.
High fever 104 x 5 days. Broke 6th day then rash over body.
mild headache for several days after then resolved and had onset of tingling and "shooting pain sensation like electric shocks radiating toward her head and all extremities with increased weakness and pain in low back with pressure sensation with aching pain radiating in saddle formation from low back to bilateral hips toward her knees with heaviness in the feet.  Painful to walk down stairs specifically in the knees.  Significant reduction in range of motion with back.  Previously patient had been very active, lifting weights, working out, push ups, planks, running.  Now unable to tolerate plan position, running or any twisting of low back.  Denies any specific back injury or trauma, no falls or MVA (motor vehicle accident)
Pt had t102 ax x 1 wk following vax; temp fluctuated w/APAP; pt seen by MD during that time exam was nl; On 8th day pt devel body rash; today rash fading, no temp; pt fine;
Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee to feet.  Denied loss of sensation described as pins and needles.  Seen in the Emergency Department and released: Received IV fluids and all labs were within normal limits.