chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had some reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had some reaction to the first shot) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had some reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (had some reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Within minutes, my throat started to close; tongue swell.; There was a pain that traveled from my rt kidney area to the left; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Mar2021 at 14:00 (02:00 PM) (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. Medical history included guillain-barre syndrome, known allergies: yes, both from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 05Mar2021 at 14:00 (02:00 PM), the patient experienced within minutes, my throat started to close, tongue swell, there was a pain that traveled from my rt kidney area to the left. Adverse event: Within minutes, my throat started to close and tongue swell. There was a pain that traveled from my right kidney area to the left. Swelling decreased by half within 30 minutes and now (2 hours later) I feel nearly back to normal. The patient did not receive treatment for the events. Outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the vaccine yesterday, sat for 10 minutes and went to the bathroom and started sweating and trembling and had trouble breathing and I felt weak. They called the paramedics and the took my sugar it was 169 and my heart rate was up to 133, and I'm usually at 80-90. My doctor advised to not take the 2nd dose because of the reaction I had. Wanting to know what he should do because of the 2nd dose.
An 8 and 9 yr. old received adult HEP A vaccine instead of Pediatric dose. Age of patient at time of event: 9 years 10 months.
Developed rash on the tops of both feet. Small blisters, painful. Treating with calamine lotion and foot powder. So far the rash appears to be clearing on it's own.
Severe flu like symptoms, fever, chills, nausea, headache, bodyaches, muscle aches.
Narrative: COVID infection following COVID vaccine series 05/10, Pfizer, dose #1 06/09, Pfizer, dose #2 09/06 COVID swab, result: detected 09/06 pt cc: cough, bodyache, chills, generalized joint pain exposure: unknown 09/06 pt admit cc: cough, bodyache, chills, fever, generalized joint paindx: LOS: 1 day 09/06 CXR impression: No lobar pneumonia.09/06 SARS-COV-2 Variant Sequencing result: pending
1st swelling Right Arm Deltoid area 2x normal size. 2nd week  Migraines with Nausea and Vomiting. Intractable Migraines continue.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
This was the second dose, first dose given 11/22/2021. Second dose given too soon.
Joint Pain/Ankle Pain; Lower back pain; Fatigue; Received Two doses; pain ankle; A spontaneous report was received from an other health care professional concerning a 37-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an "extra dose administered", joint pain, ankle pain, lower back pain and fatigue.  The patient's medical history was not provided. Concomitant product use was not provided.  On 27 Jan 2021, the patient received her dose of mRNA-1273 (Lot number 09L20A) in the left arm for prophylaxis of COVID-19 infection.   The patient stated that she received two doses on 27 Jan 2021.  On 28 Jan 2021, the patient began experiencing joint pain, ankle pain, lower back pain and fatigue. Treatment of this event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, extra dose administered was resolved on 27 Jan 2021.  The outcome of the events, joint and ankle pain, lower back pain and fatigue were unknown.; Reporter's Comments: This case concerns a 37-year-old, female subject, who experienced non-serious unexpected event of Back pain, and non-serious expected events of Arthralgia (Joint pain and Ankle pain), and Fatigue.  Arthralgia, Back pain and Fatigue occurred after the first dose of the mRNA-1273 administration on the next day.   Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events of Arthralgia, Back pain and Fatigue, a causal relationship cannot be excluded.
Immediate soar arm, next day horrible body/joint/head aches, intermittent fever up to 103.4 degrees F, mind fog, severe malaise and fatigue, chills. All those lasted about 4 days. They really bad ?COVID toes? that were like chlybains and now 3 weeks later look like petechiae on top of toes (reddish - purple , a few are bleeding). By the way I had Mono 13 months ago that was pretty bad and had COVID in November not that severe at all.
Small red rash appearing on RT side of face, about 2 inches in length and width.
Pain at injection site.  Pain upper LA from site to elbow with swelling. HA, Chills. muscle aches body wide. Rash from chin to umbilicus. 4 days.  Treated with Ibuprofen 400 mg TID.  These side effects were 50% less in severity and duration than first dose.
Extreme nervousness and anxiety approximately 8 hours after shot. Buzzing, tingling, itchy feeling throughout body.
experiencing rather strong flu-like symptoms; This is a spontaneous report from a contactable consumer. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection),via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was not known if patient receive any other vaccines within 4 weeks prior to the COVID vaccine and if there was list of any other medications the patient received within 2 weeks of vaccination. It was unknown if patient was diagnosed with COVID-19, prior to vaccination and if patient has been tested for COVID-19, Since the vaccination. It was not known if patient had allergies to medications, food, or other products. On 02Apr2021, the patient experienced rather strong flu-like symptoms. It was unknown if treatment received for the event. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
big headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "big headache".  Additional information: The patient had received Pfizer Covid-19 vaccine first dose 13Mar2021 and experienced a big headache. Wanted to know if patient can take something like Tylenol or Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient noticed a rash at the injection site on her left arm and on her neck the day after receiving yellow fever vaccine. She also had hives on her face. She took 50mg of Benadryl and both the rash and hives resolved by the end of the day.
Friday night chills, fever, muscle spasms and headaches. Everything went away except headache, fingernails and toe nails turned purple Saturday.
Headache, Myalgia & Arthralgia  Narrative:  unable to work 2/-9-2/11 due to  symptoms- headache, extreme fatigue  Other Relevant History:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored doses of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is of several reports received from the same source. Additional information has been requested.
Within minutes, my fingers felt prickly, then flushing of face,  neck and chest; a prickly heat. Continued redness and slight itchiness on neck hours after onset.   No fever.  I?m reporting this while it is still an ongoing event
This spontaneous case, initially received from a pharmacist on 15-Oct-2018 and follow up received (initial and follow-up 1 combinedly processed), concerns a 38-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804539 was cross-linked to source case: 201804533 due to same reporter.
Headache, Myalgia, Tiredness, can't sleep, chills, then feel hot, back pain, joint pain Narrative:
This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a female patient who received Seasonal Influenza vaccine. Previously administered products included Seasonal influenza vaccine with an associated reaction of cough (experienced every year after receiving flu vaccine) and Seasonal influenza vaccine with an associated reaction of bronchitis (experienced every year after receiving flu vaccine). On an unknown date, the patient received Seasonal influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced bronchitis and cold. On an unknown date, the outcome of the bronchitis and cold were unknown. It was unknown if the reporter considered the bronchitis and cold to be related to Seasonal Influenza vaccine. Additional details were received as follows: The reporter was a friend or caregiver of the patient. Every year the patient received Flu vaccine and experienced cold and bronchitis. The patient recently received an annual dose of Flu vaccine and experienced cold and bronchitis. The reporter declined to provide any further details. This case was linked with case US2015GSK170888, reported for VENTOLIN HFA for the same patient.
03/24/21: Patient presented and was admitted through the emergency department for CC of Shortness of Breath, generalized body ache and low-grade fever for last 2 days. Patient  has a past medical history of Atrial fibrillation, Cancer, COPD, CRI , Diabetes mellitus, , HTN , Hyperlipidemia, On home oxygen therapy. Labs were remarkable for a leukocytosis of 18.2, hyperglycemia of 336, and an AKI with creatinine of 1.38. Chest x-ray was performed and revealed bilateral patchy opacities. COVID-PCR negative.  In the ED the patient was seen to have A. fib.  Per the EUA, Hospitalizations are to be reported irrespective to attribution to vaccine
Tinnitus started the day after receiving the vaccine. The sound is a loud, high-pitch noise and affecting both ears.
Burning arm within 30 min wait time, headache  afternoon . Day 2 total fatique. Day 3  lymph nodes in arm pit swollen , chills then hot sweats, day 4 to 6 fine day 7 itching at injection site small lump, day 8 by afternoon lump size of palm with redness swelling and tightness
Information has been received from a medical assistant concerning a 71 year old patient who in May or June 2007, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 655766/0038U). In May or June 2007, the patient experienced severe pain at the injection site and swelling. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient noted that almost immediately after receiving vaccine his opposite arm became sore as well, within a few hours his entire body was sore also - basically full body aches and pain in all joints by the end of the day.
The patient experienced jaw tightness and tingling in the face.  She felt better lying down.  No treatment was given; she was observed for about an hour and went home.    The patient did report having plastic surgery with facial fillers approximately 6 weeks ago.
Per Pt's daughter, He started experiencing a sharp pain in his left arm preventing motion from side to side and raising above head. Pt did not sleep last night and taking a Norco did not help with the pain.  Pain is a 5/10.
9 hours after injection, injection site started to swell significantly. after putting a cool towel and then trying to put covered ice pack,  started having significant joint and muscle and scar tissue pain in hands knee and feet and hip. Then bicep muscles tensed up in both arms and then relaxed several times, as well as pain in collarbone and tightness up neck as well as swelling of face and top lip. I did not know if I was going to have a stroke and if I needed to go to an emergency room but the symptoms subsided. Some diarrhea next day. I understand from my therapist that multiple people have reported the significant muscle issues and it is not printed anywhere as a side effect which would help.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases- 2018SA226820, 2018SA226774, 2018SA226819, 2018SA226816, 2018SA226817, same reporter for patients receiving same vaccine. This case involves an unknown age male patient who vaccinated with MENACTRA which had excursion actually for 9 days and ranged from 48-49 f. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date starting in May, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA, expiry date 25 Feb 2019 via intramuscular route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient was received MENACTRA vaccine which had excursion, was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
This case was reported by a consumer via call center representative and described the occurrence of localized tingling in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of paraesthesia (for tolerance of 1st dose, refer case US2019GSK065540). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced localized tingling, numbness facial and pimples. The patient was treated with antivirals for systemic use. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the localized tingling, numbness facial and pimples were unknown. It was unknown if the reporter considered the localized tingling, numbness facial and pimples to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. After receiving 2nd dose of SHINGRIX, the patient reported tingling, numbness and pimples on the right side of her face from the temple to her lips. The patient was under the care of her doctor and they had prescribed an Antiviral. The call center representative informed the patient that she was misdirected to medical Information but the patient was hostile and stated that she would not give any additional information until her questions were answered. The patient was directed to the GRC for further guidance and reporting. No additional details could be provided.
Dizziness, Headache, Sedation, Fever, Diarrhea, NauseaVomiting WEAKNESS, MALAISE, SHAKING, CHILLS Narrative:
Pt had second vaccine on 6/12/2021 - he continued to have fatigue for 1 month. L hand/L foot numbness started October of 2021 - pt has been evaluated by neurology, rheumatology, hematology - no known etiology. Pt is concerned that this is from his vaccine and refuses any booster doses.
A week after getting the vaccine 2/24  I experienced a headache that lasted two days, accompanied by fatigue and weakness.  Since I'm wearing a mask and social distancing I don't think I was exposed to anyone who was sick.  I did not see a doctor.  I just rested and on the second day  2/25 took an Advil.  I felt better the next day but became nauseous the following night 2/26.  I had some mild diarrhea and felt week again the following day 2/27.  That was followed by a full recovery.
Non stop crying for more than 4 hours non consolable and Swelling + erythema at the site of injection for PEDIARIX.
pt recv vax 2hr p/vax very tender, very achy muscle down to arm pit;stiff neck & shoulder muscle;cont not have sx >24hr p/vax;pt had general myalgias & sense of anxiety;
Sore inside left cheek, mouth, 2 day after shot, called ENT, went to ENT, for check up sore had gone.
intermittent feeling of racing heart after first dose of moderna vaccine, lasting about 2 weeks and slowly improving. also at injection site, mild itching, redness starting about 10 days after the injection
Pt came in for their 2nd Moderna shot. During pre screening she answer no to any allergies or serious reactions in past. When patient was waiting the required 15 minutes after shot, she said her throat was feeling weird. Pt was given oral liquid Benadryl , after another minute pt said she couldn't breath, 1 adult epi pen was administered. 911 was called. Ems escorted pt out of store. unknown out come.
menstrual headache; Rash in the injection site left arm; Redness around injection site; Warm to the touch around injection site; Itchy around injection siite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite), VACCINATION SITE RASH (Rash in the injection site left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and HEADACHE (menstrual headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 28-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site left arm). On an unknown date, the patient experienced HEADACHE (menstrual headache). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite), VACCINATION SITE RASH (Rash in the injection site left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and HEADACHE (menstrual headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporterTreatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up information received on 31 Mar 2021.Added new event. On 12-May-2021: Follow-up information received on 12 May 2021.Added reporter email address.
Pt recvd measles vax on 21NOV90; pt devel a high fever & a rash w/Koplik's spots 1 wk following vax; @ the time of the report, pt had completely recovered; No further details were provided;
Information has been received from a medical assistant concerning a patient who may had received a partial dose of GARDASIL. The patient did not report any pain upon injection and some vaccine ran down her arm. Additional information has been requested.
This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medication was not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # J00668, expiration date: 29-APR-2016; lot # K008931, expiration date: 04-MAR-2017, dose and route of administration were not reported). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recd IM H1N1 vaccine 12/9/09 then w/in 48 hours developed R sided facial pain and weakness, evaluated in ER w/head CT ? blood tests normal; ultimately rec'd w/u for stroke given risk factors when neg = Bell's Palsy
physical & shots done 10AM 1DEC93; 5PM 1DEC93 pt went into sz was under for 20 to 30 mins & was taken to hosp & kept, EEG, Bloodwork;  had another sz 5APR94 another 3MAY94; still working on treatment;
Sudden onset 6 hours after injection. Was feeling normal, and within minutes, severe feeling of vertigo, lightheaded and dizzy. Room seemed to spin as if I were intoxicated Needed to hold onto furniture to walk.  Could not walk straight, and could not focus on reading material. Slight headache.