chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on his neck and back; pain on his neck and back; unsteady headaches; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old male patient who experienced pain on his neck and back (bac pain and neck pain), and unsteady headaches (headache), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s): The patient stated that he had received the series of Imovax vaccines in the past and everything was fine.  The patient's past medical history, medical treatment(s) and family history were not provided.  No other vaccine was given.   On 24-Aug-2019, the patient received a first dose of 1 ml suspect RABIES (HDC) VACCINE lot CP1C85, exp date: 25-Sep-2020, via intramuscular route in the left arm. for an unknown indication.  On an unknown date, the patient developed a non-serious pain on his neck and back (neck pain and back pain) and unsteady headaches (headache) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  case details: Physician stated that the Imovax vaccine was administered and being experiencing headache from  time to time since. He was supposed to receive two doses but didn't do to the side effects of the fisrt dose. He went to see his doctor on the September 3th who confirmed the symptoms were due to the vaccine. As of today September 26th , he is still experiencing unsteady headaches. . His doctor suggested that he see a neurologic and he is going to see one today.  (Other relevant tests included no lab data.)  Final diagnosis was unsteady headaches, pain on his neck and back and pain on his neck and back.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for unsteady headaches, as Unknown for pain on his neck and back and as Unknown for pain on his neck and back.  Causality: Physician confirmed the symptoms were due to the vaccine.
Information has been received from a registered nurse concerning a 65 year old male patient with GERD and depression and no known drug allergies, who on 15-DEC-2006 was vaccinated with a first dose of Pneumovax 23 (lot# 655152/0889F). Concomitant therapy included PREVACID and ZOLOFT. On 16-DEC-2006, the patient experienced a local skin reaction including a 5x7 red, swelled area on the left deltoid region. It was reported that the area was pink and there was a blanchable reaction. By 18-DEC-2006, the patient was getting better. It was also reported that the patient never had any fever, chills, feeling ill or trouble breathing. No diagnostic laboratory studies were performed. On an unspecified date, the patient recovered. The patient had a similar experience following vaccination with  Zostavax (Oka/Merck) (MSD) (WAES # 0702USA00520). Additional information is not expected.
MMR given 5/25/06. Client states that on 5/27/06, she developed headaches, back pain in spine area and shoulder pain not relieved with Tylenol. Denies fever. Pain not bad in AM, gets worse later in day. Pain meds for fibromyalgia helps.
fell to the floor; shaking; feeling dizzy; stomach ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Jan2022 10:30 (Lot number: FLOOO7) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FALL (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "fell to the floor"; TREMOR (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "shaking"; DIZZINESS (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "feeling dizzy"; ABDOMINAL PAIN UPPER (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "stomach ache". The events "fell to the floor", "shaking", "feeling dizzy" and "stomach ache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fall, tremor, dizziness, abdominal pain upper.  Additional details: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient came for first Covid shot. Patient's mother denied any reaction in the past to other vaccines. Covid Vaccine was administered to his left arm. During 20 min of observation, patient started shaking and fell to the floor. MD came in right away and evaluated patient. Vital was taken. 127/56, 65hr, 100%. Patient reobserved for another 20 mins. Patient reported feeling dizzy again and stomach ache. Code MET was called patient transported to ER. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown if the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number; Expiry Date: unknown), via intramuscularly in the left arm on 16Jan2021 15:15 (at the age of 25-year-old) at single dose for Prevention/COVID-19 vaccination. Medical history included Mild Scoliosis and ADHD, which were both diagnosed prior to receiving the vaccine. He had mild allergy to penicillin. He has not had since he was a kid. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Family medical history included Dementia and heart attack. Concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. No other additional vaccines were administered on same date of the Pfizer suspect. The patient received first booster shot on 16Jan2021 15:15 and was scheduled to receive 2nd dose on 06Feb2021, but he has tested positive for COVID on 02Feb2021. No prescriber. Product strength and count size dispensed was unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test and results were positive on 02Feb2021. No ER (emergency room) or physician's office required. Adverse event following prior vaccinations was none. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old female patient who received SHINGRIX (batch number MG42F, expiry date 29th May 2021) for prophylaxis. On 27th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 28th February 2019, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in right deltoid. The patient woke up with a rash on their right forearm post vaccination. Unable to obtain any additional information. The reporter did not consent to follow-up.
10/17/22 HX of Rash that started last Friday at daycare. rash came on suddenly and started on her arms and eventually covered her whole body. daycare called mom and mom took patient to ER. they told mom it was probably a reaction to her vaccines and wrote her prednisone 15mg/5mL take 2.5 mL daily and told mom to give Benadryl as needed per box instructions. prednisone is complete but rash still comes and goes. mom does not think it is a reaction to vaccines. rash not present at this time but mom has pictures. patient has not had any fever, has had ongoing runny nose, new wet cough that started this am, no N/V/D. Mom reports no new foods or laundry detergent.
Very tired, arm pain, burning in chest, stinging down arm, became a deep ache. fever 100.2.
Extensive swelling erythema and discomfort 2 days after DTaP. Given Zyrtec, Keflex, and Zantac to Tx.
localized swelling, redness, warm (more like a hive), size 3 x 6 area still discolored 8NOV95;lasted 3-4 days;
Very soon after getting the vaccine I noticed tenderness when I put on deodorant.  Soon after that, my arm began to swell and the I would feel constriction, pain when I attempted to stretch out my arm.  I was having headaches, fatigue and pain.  Although improving, I am continuing to have slight swelling,  tenderness and pain in my left arm and hand, 2 and 1/2 months later.     I am using warm compressions, ace bandage and Tylenol.
Patient complains of extreme itchiness and pain at the injection site of where I gave the Varicella vaccine. According to the patient these symptoms began the afternoon following the injection. She told me that during the two days following the injection, she experienced light-headedness and a fever. Her father told her to put NEOSPORIN on the area and gave her TYLENOL. She appeared in my clinic at 10:40 AM on 1/10/19. I observed the area and it is red, firm and warm in a 2.5 inch circle around the injection site. The patient is afebrile and not experiencing any light-headedness. I explained that NEOSPORIN is for wound care, not a reaction of this type. I informed her she could see a local pharmacist for an antihistamine medication such as BENADRYL or ask about a cortisone cream. I also informed her if the area worsens or if she is not feeling better in a couple more days to see a physician. It was brought to my attention after she received the second dose of varicella vaccine that she was in our immunization registry and had received two other doses of varicella vaccine making the dose I gave her the fourth dose she had received. The first two doses were not indicated on her shot record that she displayed upon her first visit with us.
Pt had a syncopal event with associated flushing/sweating and dizziness. Vitals: 111/65, 82, 20 Pt stable and released from the vaccination site.
Pt recvd 3 series of Engerix-B (dates & doses unk) & was considered non-reactive; recvd booster dose of Engerix-B 11DEC91; titer report 17JAN92 titer non-reactive; 19FEB92 elected to have no further boosters on recommendation of family MD;
secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender to palpation, warm to touch, and spreading. Started on keflex
Presenting for 2 nd Hep B was asked if reaction to previous shot, stated arm was very sore. Mom stated that after the shot the pt reminded her she was allergic to yeast after reading. Mom stated she had not told of the allergy because the skin test reaction was slight and didn't think it would matter.
ZOSTAVAX immunization: Soreness, burning, redness, and swelling at the site of injection.
New onset Raynauds  New onset high  APL?s with increased clotting risk - intermittent Sinus Tachycardia up to HR of over 200 -
This is a spontaneous report from a contactable consumer reporting for herself via a sales representative. This 83 years old female consumer received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. Medical history included rheumatoid arthritis, thyroid disorder, seizure and allergy to latex. Ongoing concomitant medications included KEPPRA from 2013, for seizure, methotrexate, for rheumatoid arthritis, levothyroxine sodium for thyroid. The patient experienced pain in arm on 31May2015, fever on 31May2015, chills on 31May2015, itching on 04Jun2015, peeling on 04Jun2015. No admission to hospital was required. No treatment was received for pain in arm. Pain in arm had not yet resolved (still experiencing some). The outcome of the other events was unknown. Follow-up (19Sep2016): New information from the same contactable consumer includes: patient age, additional medical history, concomitant drugs details, events onset date, additional events itching and peeling, events outcome.
(2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Vaccine given around 4pm.  Within 30 seconds, the patient began having muscle spasm.  She initially had tightness in her throat, but it did not progress into an anaphylactic reaction.  The muscles in her hands and arms contracted severely- her hands into fists.  With pain.  She began to sweat profusely.  After a few minutes, her symptoms did not abate and the pain/spasms became worse.  We contacted EMS Ambulance who arrived and began monitoring.  They treated her with oxygen, then a nebulizer treatment with albuterol and ipratropium.  At around 5pm she was recovering and the EMS left.  We kept track of her until about 5:30pm when she felt well enough to drive home.  I checked on her at 7pm and she was feeling fine.
Information has been received from a medical assistant concerning a female patient who on 22-SEP-2010, was vaccinated with the first dose of ROTATEQ (lot# not reported) and on 20-DEC-2010, the patient was vaccinated with the second dose of ROTATEQ (lot# not reported), 11 weeks after the first dose. No adverse effect was reported. Additional information has been requested.
Inconsolable screaming, insomnia, diarrhea, anorexia, 6 DAYS STRAIGHT.
couldn't work for 12 days; couldn't get out of bed; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Marked swelling upper arm 2/3 and redness. Was on Amoxil for teeth abscess
vaccinator also put the bandage on first and then injected the vaccine right through the bandage; With her second dose, her mother bled on the arm but not as much as the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (With her second dose, her mother bled on the arm but not as much as the first dose) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccinator also put the bandage on first and then injected the vaccine right through the bandage) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (With her second dose, her mother bled on the arm but not as much as the first dose). On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccinator also put the bandage on first and then injected the vaccine right through the bandage). At the time of the report, VACCINATION SITE HAEMORRHAGE (With her second dose, her mother bled on the arm but not as much as the first dose) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vaccinator also put the bandage on first and then injected the vaccine right through the bandage) outcome was unknown. Not Provided          No Concomitant information  provided. No Treatment information  provided   This case was linked to , INC.-MOD-2021-077167, MOD-2021-077210 (E2B Linked Report).; Sender's Comments:  , INC.-MOD-2021-077167: , INC.-MOD-2021-077210:1st dose
No additional AE; expired VAQTA was administered to a patient; This spontaneous report was received from a medical assistant and referred to a patient of unknow age and gender. The medical history, current conditions and concomitant medications were not provided.  On 30-JUN-2022, the patient was administered with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #T031201, expiration date: 14-JUN-2022; strength, dose, frequency and route were unknown) for prophylaxis (expired product administered).  The hepatitis a vaccine, inactivated (VAQTA) had been stored according to the labeling through the date of administration. No additional AE details. No additional adverse event was reported.
Only the liquid component of menveo was administered to a patient; Only the liquid component of menveo was administered to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 34-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 31st March 2021, the patient received Menveo. On 31st March 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient was administered only with the liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The pharmacist further procedure to vaccinate the patient properly. The reporter consented to follow up.
Had extreme uterine bleeding; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), intramuscular, administration date 06Jan2021 08:30 (Lot number: EK5730) at the age of 47 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LISINOPRIL; LO LOESTRIN FE. No other vaccine in four weeks (as reported). No Known allergies. Vaccination history included: BNT162b2 (administrator route=Intra muscular, administration time=08:00 AM, dose number=1), administration date: 16Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: uterine haemorrhage (medically significant) with onset 25Jan2021, outcome recovered, described as 'Had extreme uterine bleeding'; Palpitations (non-serious) with onset 25Jan2021, outcome recovered, described as palpitations. The events had extreme uterine bleeding and palpitations were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine haemorrhage, palpitations. Clinical course: Had extreme uterine bleeding on 25Jan2021, required a Depo Provera shot to get the bleeding to stop. At that time did not know this could be related to vaccine; also had some heart palpitations after 2nd Covid shot but did not attribute to the shot until she received the booster dose in September and began having constant heart palpitations and increased pulse rate; saw a cardiologist for work up; was indeed having Palpitations was placed on Metoprolol. Recently read an article stating these could be related to the vaccine and thought she should report. AE resulted in: Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. Facility type vaccine: Hospital.; Sender's Comments: Based on information available, the company cannot exclude a drug-event causal association between the reported serious event uterine hemorrhage and BNT162b2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Feels like punched me in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Feels like punched me in the arm). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient got her/his shot but feels like punched her/his in the arm. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.