chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient who was vaccinated IM into the lower part of her arm (not sure if it was the deltoid, she felt it was in the fatty part of her arm) with a third 0.5ml dose of Gardasil.  Subsequently, the patient developed a lump in the injection area.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  Follow up information stated that the lump in the injection area has not gotten any bigger nor smaller.  No product quality complaint was involved.  Additional information has been requested.  1/5/10 follow up - injection site mass; drug administered at inappropriate site. inappropriate schedule of drug administration
Headache on 12-19-2020. Tested covid positive on 12-21-20
Information has been received from a healthcare professional concerning a 27 month old white female with no medical history who on 12/28/2004 was vaccinated SC with the first 0.5ml dose of varicella virus vaccine live (lot 649848/0763P). Concomitant vaccinations on that same day included a dose of diphtheria toxoid + pertussis vaccine Unspecified + tetanus toxoid and a dose of poliovirus vaccine inactivated unspecified. It was reported that on 06/20/2005 (also reported as 6/21/2005), the patient developed breakthrough varicella characterized by erythematous papules on her forehead. On 6/21/2005, the number of similar lesions increased on 8-9 on the forehead and increased to 1-2 on her forearms. It was noted that the lesions were all pruritic and that the patient was afebrile. unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patients breakthrough varicella persisted. Additional information has been requested.
Developed redness of L thigh at injection site, screamed for 3 hours and was seen in local ED.  Rx analgesics and improved.  Seen the following day and had residual non-tender mass at injection site and no irritability or fever.
Pain and swelling at injection site and radiating into shoulder, extreme fatigue and tiredness, headaches, dizziness and nausea. Overall feeling of maliase
On 10/30, started to develope redness of right upper arm. By 10/31, he was seen in office with 9 cm x 10 cm redness and induration. Started on antihistamines and referred to Allergist. On 10/30, he was seen in Urgent Care. Diagnosed as possible cellulitis and placed on BACTRIM.
8/1/02 child had 102 deg F temperature that broke around 12:30pm on 8/1/02 11pm says started with temperature at 6:30pm on day of shots. Gave 1tsp of Motrin  till fever broke. Notified red area on arm 12:30pm 8/1/02. Area of redness became large until about 2pm on 8/2/02, 11am took child to ER at 10:30pm on 8/1/02 because he vomited and due to redness on arm. No fever that time. ER did not register client was told by physician to pt ice to arm and follow-up with health dept. Today arm-red below injection site to elbow. No swelling, hot to touch. No soreness or knot at site. Child active-climbing, jumping, moving arm freely.
This is the first time in my life I have taken the flu or pneumonia shot. I was given both of these shots on August 20, 2011 and became ill on Monday morning, August 23, 2011. It began with a severe throbbing in my upper arm (not shoulder) where the nurse gave me the shot. I stood the throbbing as lone as I could and then went to Dr. who had his nurse call Orthopaedic immediately. I went to them that day and they X-rayed my shoulder. The first thing she said was, "You were allergic to the shot." She said my entire shoulder was inflamed. She gave me a shot of cortisone in the back of my shoulder where it was so tender. It almost killed me, I screamed to the top of my lungs. When I went back to her all the way, she said she wanted me to try therapy for six weeks and to choose a place close to me. I went one more time to have an MRI but it was not readable. On December 14, 2011 I had to have a cancer removed from my face. I am thankful to say that turned out real well and I have a very small scar. After that surgery I was called one night by someone that told me they wanted me to go for an MRI. I had that done on January 2, 2012. The therapist began therapy as soon as some Doctor authorized it. No Doctor knows anything about my condition, only that girl, who seemed very efficient. Filling out that form did not tell you anything and I don't think any doctor could tell you anything. I can assure you that I will never have another flu or pneumonia shot. My lungs are ruined and so is my kidneys. I am sure another shot would kill me. I hope this never happens to anyone else. Maybe the Lord thought I was a good candidate since I was so healthy particularly for my age. I am told that the serum will take a long time to get out of my system. I hope I make it. P.S.: I lose my breath coughing and I have to stay close to a bathroom. I did not have either of these conditions until after all the pain.
MIGRAINE; VOMITING; HEAVY CHILLS; FEVER OF 102.6; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced migraine. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced heavy chills. On 03-APR-2021, the subject experienced fever of 102.6. Laboratory data included: Body temperature (NR: not provided) 102.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, vomiting, heavy chills, and fever of 102.6 on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Information has been received from a licensed practical nurse concerning a 10 month old male with no pertinent medical history, drug reaction or allergies, who on 05, Feb 2007 at 14:30, was vaccinated subcutaneously, into the right leg, with his first dose of PROQUAD (lot # 656163/1354F). Concomitant therapy included Havrix and Prevnar. On 13, Feb 2007, the patient was seen at the doctor's office with an erythematous maculpapular rash primarily at the injection site on his leg, and fever of 102 F (via ear). Initial onset of symptoms was 12, February 2007. Treatment was Motrin and Tylenol. The patient is scheduled to return to the doctor's office on 19, February 2007, at which time it will be determined if Varicella Zoster Virus (VZV) is appropriate. The patient was considered to be recovered from the reported events at the time of this report. No lab diagnostic studies were performed. There was no product quality complaint. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of tremor limb in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml and PREVNAR 13. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced tremor limb and vomiting. On an unknown date, the outcome of the tremor limb and vomiting were recovered/resolved. It was unknown if the reporter considered the tremor limb and vomiting to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX in the deltoid muscle of upper left arm and PREVNAR 13 on right arm. The patient experienced shaking of the right arm. The patient's adverse events were ceased and the patient was symptom free in about a day. The patient did not contact the physician immediately, but she reported these adverse events about one month post vaccination, when the patient was being seen by the physician for another reason. The physician questioned whether the patient should receive her 2nd dose of SHINGRIX or not. The reporter agreed to be followed up.
Pt got MMRV, mother reports was red and fever. The next day mother noticed hives in area, swollen and given BENADRYL. Mother call 2 day after pt was seen 2 day after, no hives upper arm was swollen and complained of itching. Tx BENADRYL prn
pt recv vax 4JAN96&health care provider reports an allerg rxn probably to pertussis immed following vax;pt devel an inj site rxn,characterized by redness&swelling up to 5cm in size,excessive crying&irritability;
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. 11/24 f/u-reports weakness and slight temperature of 99.0F 1 day later.  11/26 f/u - reports cold sores and left arm tingling 1 day post vaccine on 11/20, states arm tingling has resolved and cold sores have improved.  12/01- reports "feeling fine, back to work.?  She added that ?after receiving her vaccine the next day she felt whole body aches and tingling in my arms and legs and headache for two days.?  These symptoms have since resolved.  No additional questions.
has been sick; immune system was not okay; This is a spontaneous report from a contactable consumer, the patient, via the sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021, the patient experienced being sick and she was getting worse. The patient had blood work on Feb2021, and her immune system was not okay. The patient underwent laboratory tests on Feb2021 including a COVID-19 test: negative. The patient wanted to confirm if these experiences were normal. The clinical outcome of "immune system was not okay" was unknown and of "has been sick" was not resolved.  Information about lot/batch number has been requested.
problems with hearing; hearing things, can hear heartbeat; tinnitus; This case was reported by a consumer via call center representative and described the occurrence of auditory disorder in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. In April 2022, less than 2 weeks after receiving Shingrix, the patient experienced auditory disorder, palpitation and tinnitus. On an unknown date, the outcome of the auditory disorder, palpitation and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the auditory disorder, palpitation and tinnitus to be related to Shingrix.     Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shingrix in left arm and about a month ago she began to had problems with her hearing. She stated the hearing in her left ear was bad, was hearing things in her left ear.  She said she could hear her heartbeat thumping in her left ear.  She used the word, tinnitus when describing it.  She had been seeing her physician for this but it had not resolved.   She was going to see an ear, nose and throat specialist next.   She called GlaxoSmithKline response center to ask if Shingrix might have had anything to do with her hearing issue. She did not had the lot number of the Shingrix that was injected but did provided her pharmacy's phone number as they should had the lot number on file. Consented to follow-up.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (lot # J005575, expiration date 16-DEC-2015) 1 ml, intramuscular. Dose underwent temperature excursion and was exposed to 60F for 24 hours (supported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
8SEP94 pt was examined & found to be hyporeactive, hyporesponsive excessively sleepy; slept form 10/1030AM - 1030PM; ate only twice on 8SEp94; both time p/1030AM; no screaming, no sz;
This spontaneous report as received from a other health professional refers to a 27 year old patient (gender not reported). On 18-JAN-2013 the patient was vaccinated with VAQTA , the dose number, route of administration, anatomical location, lot number and expiry date were not reported. On 01-MAR-2013 the patient was vaccinated with VAQTA., the dose number, route of administration, anatomical location, lot number and expiry date were not reported. No adverse event was reported. Treatment information was not reported. Additional information has been requested.
Fever (low grade at time of EC visit), erythema with well-defined border, tenderness & swelling.
55 patients received a dose of a vial after 12 hours of initial puncture; Improper storage conditions; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Improper storage conditions) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Improper storage conditions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Improper storage conditions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The vial was punctured on 11-Nov-2021, after dose administration, was kept in the refrigerator after puncture.
Within 15 minutes of the vaccination had onset of mouth tingling sensation followed by developed trouble swallowing and breathing. Use the epipen at that point and immediately felt better. Went to hospital after that. was given benadryl and famotidine and was observed for 3 hours. THEN 1 week after the vaccination she had itching at the site of vaccination and had a red ring on the skin and became raised as if a hive. was warm and itching with throat tingling/itching. Treated with Benadryl at home.
Developed urticarial lesions on left shoulder 10-12 hours after the vaccine was delivered into left deltoid.  The next morning had more lesions on right shoulder and back of neck.
Headache, Fever, NauseaVomiting injection site soreness and rash Narrative:
By the end of March, I began to feel nauseous, weak, and constipated.  On April 8th, I sought medical attention at Health Clinic .  Following lab results, I was sent directly to the Hospital facility.  My calcium was extremely high. dehydration, and AKI.   I was given bags and bags of IV solutions ..... to date 10/10/2021, my kidneys are still recovering.
This was an administration error.  Vaccinator drew up 0.25 cc Moderna for a booster shot. On the same table was a capped, 3cc empty, sterile syringe that  had been used for diluting a Pfizer vial.   Vaccinator asked clinic lead to double check the syringe for correct doseage and handed clinic lead the 3cc empty, sterile syringe. Clinic lead looked at syringe, noted that it looked slightly off, pushed the syringe to correct marking, saw that there were no air bubbles, so believed syringe was properly filled and had proper amount and handed the syringe back to the vaccinator, who then "administered" the empty syringe.   Vaccinator realized the error when she went to retract the needle and realized it was not the correct syringe. The patient had been jabbed with an empty syringe. Vaccinator notified the clinic lead, and we notified the patient of the error. He asked that we wait for his wife, a nurse, to arrive to decide what to do. When wife arrived, clinic lead explained the error and notified the wife that her husband had receieved an unnecessary jab, did not receieve any vaccine or even normal saline, and still needed the booster shot. Wife told vaccinator and clinic lead to go ahead and give the correct dose. Clinic lead drew up 0.25cc Moderna in front of wife, patient and vaccinator, and had both vaccinator and the wife (also RN) check the vial and the syringe. Vaccinator then administered correct dose and vaccine into the r arm of patient.
Hospitalization; This case was reported by a other health professional via patient support programs and described the occurrence of dog bite in a 48-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   On 6th November 2019, the patient received RabAvert 1 ml. On 6th November 2019, less than a day after receiving RabAvert, the patient experienced dog bite (serious criteria hospitalization). On an unknown date, the outcome of the dog bite was unknown.   It was unknown if the reporter considered the dog bite to be related to RabAvert.  Additional information was reported as follows: At the time of reporting, the patient was remained in the hospital after being admitted on 6th November 2019 due to the dog bite. The call center representative was not asked, if the patient's healthcare provider could be contacted. No other information was provided. The reporter did not consent to follow up.
Came in ER c/o 2 days of left arm pain and axilla pain and 1 hour vomiting. Had second dose of Moderna vaccination on 2/14/2022. And has been having pain at surrounding injection site. And noticed redness and swelling to the left axilla. And had been vomiting non bloody, non bilous x1 .
Flu vaccine given 10/19 left arm became sore by evening of 10/19 sore and pain on 10/20 pt spoke doctor, he told her to to use cold. Problems developed in joints by Sat swollen knee, ankles, hands, became shaky, severe weakness and shakiness. Went to ER on 10/24 continues, Dx with tic douloureux. Still has symptoms at this time.  11/28/06 Received ER medical records which reveal patient seen 10/24/06 w/complaints of several days of left arm pain which had begun & worsened after flu shot.  On 10/24, developed severe, sharp, lancinating, electrical pain in left face & jaw.  Treated w/tegretol & trileptal. Final Dx: trigeminal neuralgia.
Congestion; After getting the vaccine the COPD was worse; After getting the vaccine the COPD was worse, but now is better than before; did not feel well; recover appetite; headaches; Had no energy,felt weak for 3-4 days.; Chills; A spontaneous report  was received from a consumer who is a 67-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache. He also reported an improvement of the pre-existing COPD after receiving the vaccine and experiencing the exacerbation.  Medical history includes COPD (Chronic Obstructive Pulmonary Disease) and emphysema. Concomitant medications include oxygen, salmeterol xinafoate/fluticasone propionate and Tiotropium bromide.  On 27-JAN-2021, this patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 007M20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection.   On 27-JAN-2021, the day of vaccination, the patient felt fine, up until bedtime. When they started to undress for bed the patient experienced chills. He put on sweatpants, socks, and some warm clothes to get warm. The patient managed to get to sleep. The next day, the patient did not feel very well at all. The patient describe as having no energy and felt weak for 3-4 days. He also had headaches, for which he took some Tylenol. Towards the weekend he recovered his appetite and started to feel better. The patient mentioned they used a nebulizer to treat some congestion they experienced. He stated, at first after getting the vaccine, the COPD was worse, but now it was better than before the vaccine. Patient was suppose to get second dose next week and wonders if they should. Event congestion was considered medically significant. Laboratory test were not reported.  Action taken with the drug in response to the events is unknown.  The outcome for the events, congestion, COPD worsening, not feeling well, lack of energy, feeling weak for 3-4 days, chills and headache, was recovered. The outcome for the event preexisting condition improved is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Neck pain; Rash all over the body; This spontaneous case was reported by a physician and describes the occurrence of NECK PAIN (Neck pain) and RASH (Rash all over the body) in an 83-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. Concurrent medical conditions included Blood pressure and Thyroid disorder NOS.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced NECK PAIN (Neck pain) and RASH (Rash all over the body).   At the time of the report, NECK PAIN (Neck pain) outcome was unknown and RASH (Rash all over the body) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is currently taking Blood pressure and Thyroid medications. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient has had a headache ever since the H1N1 shot. Over 140 days. Headache sometimes gets to Migraine status. He has a headache EVERYDAY.
Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccinated with improperly stored doses (temperature: 35F, time frame: 84 hours) of ROTATEQ (lot# L033546 with an expiry date: 30-MAY-2017; lot# L046318 with an expiration date: 28-SEP-2017 and lot# M002252, expiration date not provided), orally dose was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
no adverse event reported  /consumer did not experience any side effects; The caller stated the consumer received the vaccine by accident; This spontaneous report was received from a patient`s mother, regarding a patient of 17-years-old, gender unknown, with historical conditions, historical drugs, and current concomitant therapies were not reported.  On 16-APR-2021 the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) for prophylaxis(route of administration, strength, formulation, dose, frequency and were not reported; lot number and expiration date were not provided).  The consumer`s mother reported that the patient received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) ( Wrong product administered).