chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) had resolved.            No concomitant and treatment medications was reported . This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.
Information has been received from a health professional concerning an 8 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 26-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Additional information is expected.
A day after my vaccine I woke up and noticed that it bruned to pee a little. I saw a scratch on my right inner labia by the vaginal opening. It got worse and more painful and about three of four ulcers developed. Thelargest one was about a centimeter in diameter. All of them were on my right inner labia. I made an apointment with my gynecologist and I was perscribed 3% topical lidocaine for the pain. I was also perscibed a pill to take because the gynecologist did not know what it was so they treated me as if I had herpes. It took about a week for all of the ulcers to clear up.
It was reported that a female pt received a JE-VAX vaccination on 3/14/00. Reportedly sometime after the vaccination the pt developed erythema from axilla to elbow. Additional information is being requested. From Correspondence received on 5/2/00, it was reported, the pt experienced a local reaction to her 2nd JEV vaccination. Onset of itching to site followed by a 50 cent piece size welt and finally enlarging to involve her whole upper left arm from axilla to elbow. All of the skin has peeled. In further questioning, the pt did have "stinging, itchy sensation locally with the 1st injection of JEV." The pt also received a Typhim VI vaccination, the same day as the 2nd JEV vaccination. From follow-up correspondence received on 10/09/01, it was reported that the patient's recovery status is unknown. No further information is available regarding this patient or this case. This case is closed.
Starting 05/05/2022, I tested positive for COVID. I had a sore throat that started that evening and congestion that lasted for 3 days. I did not have a fever but was lethargic for about a week. On 05/08/2022, I developed a cough which lasted for about a week or so. From 05/06 - 05/07 I had a bad headache and 05/07 - 05/08 I had some bad anxiety and trouble sleeping. Within the past week or so, my depression which is normally in control, has been slight worse.
Two days after the shot, I woke up with severe left-sided (same arm as shot)  neck, upper back and whole arm pain.  It has lasted for two weeks now.  Nothing seems to help the pain. Heat seems to help some. But I cannot do activities of daily living without pain. I have been to a chiropractor besides my Primary Care Dr.  Not absolutely sure if it is from the shot but could be a contributing factor.
I was vaccinated on Wednesday, 10/20/21 at about 11am and woke up with a headache and chills on 10/21/21. At about 6pm on 10/21/21 I felt like my heart was racing, and my fitness watch showed that my heartrate was in the 120s-140s with little to no activity.  I did not have any chest pain, shortness of breath, or dizziness, and the tachycardia had resolved by the following morning. I also noticed the night of 10/21/21, around 8pm that I had lymphadenopathy in my left axilla. It improved significantly by 10/23/21, but has not yet fully resolved.
Pt reported palpitations and feeling flushed ,  as well as vertigo.  Symptoms resolved within 5-10 minutes with rest.  No uticaria, dyspnea, weakness.  Pt departed after 15 additional minutes
a sore arm which was the injected arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult 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, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and has experienced a sore arm which was the injected arm, for 6 weeks. The reporter consented to follow up. Very limited information was provided.
This is a spontaneous report from a contactable consumer reporting for himself. This 18-year-old male patient received the first dose of TRUMENBA at 0.5 ml single via an unspecified route of administration in the right arm on 05Mar2015 at 04:00 pm. The patient had not any other relevant medical conditions and he had not received any concomitant medications. His arm has been sore since he got the vaccine on 05Mar2015. In the morning of 07Mar2015 when he woke up at 07:00 am he had 3-4 red patches where he had to the vaccination. On 5 pm they hurt to the touch, not like bad, but just enough to be annoying when he touched them. He was not necessarily worried about it. The patient did not require an emergency room or doctor visit due to the reported events. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed. No further information expected.
Patient being given Moderna Bivalen Booster shot on 11/22/22.  Last COVID shot was Janssen on 7/29/21.   About 20min after administration patient complained of feeling lightheaded and a having a headache.  Patient denied any chest pain, SOB, or other resp problems.  LS clear bilat.  No wheezing.  HRR.  VS  BP 118/76, T 98, R 16, o2 96% RA, P 54.  Patient was prescribed tylenol and monitored.  symptoms resolved on there own.
Patient complained of body aches and pain and flu like symptoms. Her injection site was very swollen and red. She was also very very sleepy. Her teeth hurt and her fingers were numb. Patient was encouraged to contact physician.
Chest pain, heart palpitations, shortness of breath, and fatigue. Worse with exertion.
I received a mild rash and swelling. No big deal, and I have photos. I was happy to receive the vaccine and look forward to the second injection.
On 9/16/17 - patient went to a walk in medical complaining of reddening that had developed post injection and was spreading in the area where she had received the injection. She was prescribed an antibiotic (doxycyline 100mg tabs twice a day for 10 days). The next day the patient went to the emergency room (since she felt it was not improving and was given BACTRIM DS generic - one tablet every 12 hours for 10 days and BENADRYL OTC.
Infant began uncontrollably screaming and crying for 5 hours without stopping. Fever and swelling on thigh at shot site. A knot appeared. Took 2 months for knot to disappear.
Heart rate increased to 80-90 BPM from normal 72 BPM? this remained for about 36 hours?
pt vaxed 25AUG94 & w/in 15 mins exp SOB, tightness of throat, & inability to swallow; ER visit-rx'd w/Epi, DPH, & steroids; hospitalized 1 day; recovered;
Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering.  No follow-up activities are needed. No further information is expected.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates, multiple unspecified patients received improperly stored GARDASIL (lot#, expiration date, strength, dose, frequency and route were unknown). The patients' concomitant medication was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, leukopenia, thrombocytopenia, rash (measles-like) - erupted in that order (about 3 days after vaccine administration).
patient required vaccination, 1st dose approximately on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately in 2019).   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. The patient did not have information about exact date from 1st dose. Pharmacist reported that, the patient from another facility required Shingrix vaccination.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkown) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-031469 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031469:Patient Wife case
1 day after IZ's were given, PT developed redness, swelling, warmth to right upper arm inject site. Symptoms worsened over the next 2-3 days until seen by a medical prof'l and treated with Keflex for cellulitis. Follow up states: Vaccines were administered at an unknown clinic. Child presented in another clinic 3 days later on 02/25/2003. Since they were not the administering agency, the above vaccine information is not known.
Shortly after receiving second shit I broke out with hives on  the inside of my lower left arm,. I had a  burning/light redness to my face and stomach., this lasted for about four hours and then subsided. The following day spine a fever to 103.3 and  unresponsive. The following days I became fatigued and experiencing shortness of breath..  symptoms continue to date.  In July was seen at Urgent Care,  PCP and twice in the ER. I experienced a horrific outbreak with hives, , went into anaphylactic shock . I had the hives for fourteen straight days. ( have pictures of this).  I was seen by allergist.  Was  informed by docking the  presence of my boyfriend that the shot elevated my immune system.. I came into contact with alcohol which  resulted in the hives.  I am now on an inhaler .
pulmonary embolism 5/29/21, placed on Eliquis  subsequent hemothorax requiring thoracotomy 7/7/21
No AE; PROQUAD that experienced temperature excursion was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  Per the reporter, on 11-FEB-2023 a temperature excursion occurred to a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W032152 with expiration date 07-APR-2024) that was later administered to the patient on 15-FEB-2023 (route and anatomical location were not provided). No additional adverse event was reported.  The temperature excursion lasted 1 hour at a temperature between 6°F to 14°F. No previous temperature excursion occurred.   Lot number W032152 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA005310:
12/16/2021 I started to get a scratchy throat and it kind of felt like I had a cold. By the 17th, I had sinus infection symptoms, and on the 18th I thought maybe I had strep throat so I went to the Doctor to get tested for strep and it was negative, but my Covid was positive. I ended up with a bad earache and apparently my ear drum ruptured and I ended up with pink eye in both eyes as well. I still have a scratchy throat, can't hear very good out of ruptured ear, and I still had a little drainage in my throat.
Sudden onset partial palsy cranial nerve 5 leading to double vision, pain, and headaches.
Patient did not have any adverse event to vaccine, we were told to fill out form due to receiving Prevnar 20 instead of Prevnar 13.
Inappropriate schedule of vaccine; hallucination; weird dream; Injection site hardness; Injection site lump; pain; redness; swelling at the injection site is now about the size of a baseball; hot to touch; woozy; freezing cold; sweating; joint pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of woozy in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (received dose about 1.5 years before the date of reporting).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th October 2019, immediately after receiving Shingrix, the patient experienced woozy, feeling cold, sweating, joint pain and influenza-like symptoms. On 7th October 2019, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site warmth. On 8th October 2019, the patient experienced injection site induration and injection site lump. On 9th October 2019, the patient experienced bizarre dreams and hallucination. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the woozy, feeling cold, sweating, bizarre dreams, influenza-like symptoms, injection site induration, injection site lump, hallucination and product supply issue were unknown and the outcome of the joint pain was recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the woozy, feeling cold, sweating, joint pain, injection site pain, injection site erythema, injection site swelling, injection site warmth, bizarre dreams, influenza-like symptoms, injection site induration, injection site lump and hallucination to be related to Shingrix.  Additional details were provided as follows: The patient could not receive the 2nd dose of Shingrix earlier due to supply issues. As soon as she received Shingrix, she felt woozy. The patient started feeling worse and developed flu-like symptoms which included bad joint pain, freezing cold and sweating. The patient experienced pain and redness at the injection site, and it was hot to touch. The patient continued to feel bad and also experienced a hard lump about the size of a half-dollar at the injection site. The night before the date of reporting, the patient  woke up about 3 am, experienced freezing cold, and she was been experiencing every night since getting the vaccine. On the day of reporting, in the morning, the patient no longer had joint pain, but the swelling at the injection site was about the size of a baseball, but the redness and and hot to touch was still present at the time of reporting, but not as hard as it was the day before. The patient did not see any signs of injection.  The patient also had an experience like a weird dream or hallucination after dozing off, but she was not someone who remembered her dreams, so it was a very unusual experience for her.
My left arm was so painful the first few days I had to use my right hand to lift it Now a week later it?s still painful to the point I still can?t lift light hand weights that I normally use daily-I?m afraid it has damaged the muscle. Also after the vaccine I developed flu like symptoms and now a week later I have a sore throat and fever-I am testing negative for COVID 19-I generally have felt terribly unwell since this injection and am very nervous to get the second dose. Can I get the Pfizer injection or should I not get any second dose at all? Please advise me by phone, I have no rash on my arm and never had one-just muscle weakness and pain like a deep injury to the muscle-please advise what I should do?
On 4/5, I started with upper stomach pain and then two days later I had a fever and a very rapid pulse. I went the walk-in clinic on 4/7 and they performed COVID (negative), an EKG and CT Scan of abdomen (both were normal). The fever went away, the stomach pain eased but I still had SOB, fatigue and rapid pulse. Three days later, the symptoms remained, so I saw a gastro doctor and he said it could be COVID or blood clots, then sent me to hospital on Monday, 4/12 and 4/13. They did 2 more EKGs, COVID tests and bloodwork. I still had SOB and pain in my upper stomach towards my chest. On 4/14, I woke up with a massive headache and saw the news about the vaccine, so I went back to the ER to get checked for blood clots. They did an EKG, CT Scan of the abdomen and head, along with more bloodwork. Everything was normal, but my bloodwork showed an elevation of something that indicated that I have an infection, but they weren't sure what. They sent me home with no diagnosis. Over the next two days, I rested and I gradually started to get my strength back. I went back to work that Friday for the first time since 4/7.
Pt. complained of fatigue on day of vaccine administration.  The next day, pt. had shortness of breath.  Pt. then began to develop pruritis on entire body and then developed hives on wrists, groin, waist, back, stomach.  Pt. had a reddened rash to face and chest.  Pt. called her MD on 10/17/2008.  Pt. was instructed by MD to take Benadryl and follow-up with an appointment for allergry testing.
3rd day p/2 days soreness started having muscles spasm to shoulder up to the neck;unable to move head;pt arm recovered p/3 to 4 days;no medical attention sought;
Vaccination clinic was done which included pediatric doses and adult booster doses. I was notified by the volunteer vaccinator nurse that the patient requested Moderna COVID-vaccine for her booster dose but was given Pfizer Pediatric dose.  Pt received 0.2mL of Pfizer pediatrics. Local county health department was contacted and consulted (Nurse coordinator) and she advised how to proceed. She said that it is best to ask the patient to be given 2/3 of the amount of Pfizer adult booster dose since a pediatric dose is 1/3 of an adult dose. This way, patient will still complete the necessary dose for the adult booster. Mixing vaccines is now an option (e.g. If patient had Moderna for primary series, patient can now get Pfizer as booster).  The patient came back to the vaccination clinic and was given a 2nd vaccination the same day of Pfizer adult dose 0.2 ml. These are the vaccines that the patient received: Pfizer 10mcg/0.2ml = 0.2 ml and Pfizer 30mcg/0.3ml = 0.2 ml. Total dose received for the day is 30mcg.
pt recv vax 4JAN97 & 21AUG97 pt devel a zoster type rash which was not eval by MD first hand;
20MAY91 pt devel angioedema of lips & poss tongue about 2hrs post vax; Reported by father by phone; No resp problems; Seen by MD felt sx due to Pertussis in DTP; Reported talked w/father of pt by phone states swelling of lips subsided;