chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 13-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
Patient began having excessive salivation and haaring voices in her head telling them that they were going to harm her.
04/20/2022 That evening my arm was sore, I had a  headache. The next day I was like a zombie. I had a day or two of mild discomfort, extremely tired and slept a lot. I did not have a severe reaction.
Vomited few mints after the vaccines was given redness of eye the mom called after 30 minutes to report for hives all over body but was breathing good. Mom gave BENADRYL, told mom to take to nearest hospital ER if diff breathing.
right arm weakness; right arm pain /  increased pain with swimming / arm pain escalated to sharp shooting pain; arm pain and weakness has left her unable to swim; This case was reported by a nurse via call center representative and described the occurrence of weakness of arms in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB09AZ, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2020, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 15th December 2020, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and activities of daily living impaired. On 16th December 2020, the patient experienced weakness of arms. The patient was treated with ibuprofen. On an unknown date, the outcome of the weakness of arms, pain in arm and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the weakness of arms, pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received her first dose of Bexsero in the right deltoid. Immediately following the injection the patient complained of right arm pain. On 16th December 2020, the patient began to experience right arm weakness.  The patient was a competive swimmer and the arm pain and weakness had left her unable to swim due to the increased pain with swimming. The right arm pain escalated to sharp shooting pain.  The patient self treated with ice, rest and ibuprofen.  The reporter consented to follow up.
Persistent nausea and vomiting. The patient was brought from the vaccination clinic to the ER where he received oral and IV medications for nausea/vomiting.
Child rec'd 11 yo imms on 7/3/12. Mom reported child woke up 7/4 AM with bil. deltoid redness/warmness/itching; Mom reports giving Motenil PRN and applying BENADRYL cream, clinic closed d/t holiday; Mom brought child to clinic 7/5 at 1:30; child seen by nurse; bil deltoid areas noted with redness/warm to touch/pt. c/o itching with no pain or increased temp reported; (R) deltoid with redness extending down to elbow area, child moves both arms freely - encouraged to apply wet begs or cold compress to both arms and to have child seen by PCP today, non verbalized.
Lymph node in Between collar bone and neck on Left side( injection side) .. it?s sore and fluffy
Received first dose of Augmentin before bed on 10/20/2022 and second dose the morning of 10/21/22. Broke out in hives several hours later. Given benedryl
INJECTION SITE PAIN; This spontaneous report received from a pharmacist concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Pt developed fatigue, numbness in arms and hands, pain in joints, and flu-like symptoms. The annual follow-up states arthritis pain, flu like symptoms, headache, fatigue and cold-no circulation. 07/25/2000 09:25 1st attempt to reach pt-message left on answering machine requesting a call back. 07/26/2000 09:40 2nd attempt to reach pt-message left on answering machine requesting a call back. 07/26/2000 call from pt-her symptoms are presistant and is being seen by rheumatologist and Tx'd with Celebrex. She had other vaccines with 4 weeks prior to Lymerix #3. Consent form sent for rheumatogy records.
This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUADIRIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUADRIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Entire back of arm where vaccine was administered SQ was swollen, red, warm and painful to touch. She also described significant pain/possible "nerve" pain in using the arm. She was advised to use take OTC NSAIDS and apply ice and if got worse throughout the day, go to the doctor. She took Naproxen and used ice and went to the urgent care facility around 5 pm on 7/19/16, where she was given a steroid injection and told to return if it spreads beyond the margin drawn or gets significantly worse. I followed up with her on 7/21/16 and the redness and swelling and pain had diminished but was not completely gone yet.
they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.
Approximately one week after vaccination the patient developed a disseminated rash with no fever and minimal itching. The patient sought unspecified medical attention. It was noted that a physician diagnosed varicella. Additional information has been requested.
Patient was given a Pneumovax 23 on 07/11/2022. Patient called the next day and reported upper arm swelling, redness, warmth, and swelling under her left armpit. Range of motion of the arm was not affected nor did she have a systemic symptoms. PCP was notified immediately and patient was instructed to use Tylenol, Benadryl, ice pack, and call back for any worsening symptoms.
Patient arrived for booster vaccination, primary series completed 8/15/2021. Patient signed consent and health aide accompanied patient. Patient reported need for booster. After vaccination provided, it was noted that the date of booster was too soon to the primary series. Patient was questioned and no immunocompromised conditions and no immunosuppressive therapy that would qualify the vaccination as a 3rd dose (additional dose of primary series). Patient educated on risks and side effects, instructed to notify primary care provider. Patient and health aide verbalized understanding. Patient left not in acute distress and without adverse affects after the observation period.
Developed some side effects after receiving the Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines). At the time of the report, VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter reported that she developed some side effects after receiving the Moderna vaccines and that she would like to receive the booster but she was nervous about it. She stated she had reported this in the past but didn't finish the process and that she would like to follow up on that.
Body aches (L) deltoid area with tenderness, erythema approx 7-8 cm in diameter, no induration or fluid collection. Fever as stated by patient 103 deg F x 3 to 4 days. Malaise x 7 days. Visit to physicians office x 3. Signs/symptoms resolved. Pt states no residual problems.
Generalized muscle fatigue, pains, nocturnal sweats. Emesis for 1 week. Polydypsia, lack of balance (ataxia).
Patient given a PENTACEL vaccine instead of a DAPTACEL and an IPV at the 4 yr physical. This meant that pt got an extra IPV and Hib.
11 year and 10 Months old girl was given Comirnaty Covid vaccine by Pfizer for 12 years and older
Periods have been heavy and more frequent, with about 3 per month; Periods have been heavy and more frequent, with about 3 per month; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Mar2021 (Lot number: ER2613) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: pfizer , Lot number: en6198  , Lot unknown: False, Administrator route: Intramuscular , Administration date: 04Mar2021 , Dose number:1, Vaccine location: Right arm), administration date: 04Mar2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), POLYMENORRHOEA (non-serious) all with onset 04Apr2021, outcome "not recovered" and all described as "Periods have been heavy and more frequent, with about 3 per month". Therapeutic measures were not taken as a result of heavy menstrual bleeding, polymenorrhoea.  Additional information: The patient had not covid prior vaccination. The patient had not tested covid post vaccination. The patient had no known allergies. Adverse event: Patient currently has IUD - prior to vaccination- periods light to non existent. Post vaccination- periods have been heavy and more frequent, with about 3 per month. No other vaccine in four weeks. Patient was tested covid positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Muscle aches and pains-throughout body as well as left arm. Headache-2 days. Severe redness in upper left arm from shoulder to elbow. 4 days to resolve. No fever-ongoing muscle pain in right arm for several weeks after injection.
Moderna vaccine given as a first dose for a 15 year old female. Pharmacy was notified by facility to send over Moderna vaccine to nursing facility for first dose, but was not informed the employee was for someone under the age of 18. Nursing facility had nurse administer the vaccine to the patient on the day of vaccine delivery by pharmacy.
MYALGIA , TINGLING SENSATION OF UPPER AND LOWER EXTREMITIES, FEVER 100.4, REDUCED APPETITE
Patient received smallpox vaccination on 7/22/05. Presented to the Medical Treatment Facility on 8/2/05 with c/o general malaise and achiness in his left arm. He was diagnosed with smallpox vaccination reaction at the time of the MD visit and was ordered Cephalexin. Patient did not take any of the medication and awoke from a nap around 5pm that day with increased sx. and elevated temperature. He also complained of dizziness and headache upon waking. He was seen at the ER and was noted with a 102 temperature at the time of his arrival that increased to 103. He was medicated with 1 gram of Tylenol. MD consulted with medical center and soldier was transferred for evaluation and treatment. Evaluation of the L shoulder revealed a black central eschar surrounded by slight erythematous crusting vesicles without weaping. Slight axillary lymphadenopathy that is tender. He was admitted on 8/2/05 for IV hydration and observation. He was released on 8/3/05 with improvement in his sx. Antibiotics were not given. Patient was discharged with Prn Tylenol, Ibuprofen and Darvocet.
6-8-11 3:10p Mother called. Reports child woke from nap with tender, round, purple mark on cheek (face). Advised to take child to pediatrician. 6-16-11 Mother does not respond to F/U call. 6-17-2011 No response to call.
No adverse event in patient; Temperature excursion; This spontaneous report was received from an office manager concerning a 12-year-old male patient. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 27-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #U032681, expiration date: 26-OCT-2023; lot #1780876, expiration date: 09-NOV-2023; and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient) (dosage regimen, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA002221:
Chest Tightness and shortness of breath 4-5hrs after anthrax injection. Evaluated by PMD. No Diagnostic test ordered, no treatment rendered.
like she had a lupus flare; Headache; feeling Tired; Trouble eating; Sweating; felt pretty sick; Intramuscular formulation administered by other route; This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd February 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 23rd February 2020, unknown after receiving Shingrix and an unknown time after starting Benlysta Autoinjector Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), headache, tiredness, eating disorder, sweating and feeling unwell. The patient was treated with belimumab autoinjector device (Benlysta Autoinjector Device). On an unknown date, the outcome of the systemic lupus erythematosus, headache and sweating were not recovered/not resolved and the outcome of the tiredness, eating disorder, feeling unwell and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the systemic lupus erythematosus, headache, tiredness, eating disorder, sweating and feeling unwell to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. She reported that she received a Shingrix shot on 23rd February 2020 as she had a history of getting Shingles. She said that after getting the Shingrix shot, she felt pretty sick like she had a lupus flare and experienced feeling tired, headache, trouble eating and sweating.  The patient was taking Benlysta and used the autoinjector for SLE. She stated she started Benlysta in December of 2020. She reported that after starting Benlysta she was experienced headaches and nausea. She said these symptoms were getting better that she pre-medicates for the headache, but they had not resolved. She did not have lot numbers to provide for either medication. The reporter consented to follow up. The case has been linked with the case US2021AMR055627 reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR055627:same patient
Macular rash(not pruritic) over torso, arms & legs, Sparing palms, soles & face
Office visit 6/22/10 for well child check up and in a good state of health. Received PREVNAR 13 vaccine at that visit - this was the only vaccine given. MOC states pruritus began that evening and broke out in a rash the next morning (6/23/10). Office visit 6/24/10 confirms urticaria.
Dizziness; Increase heart rate immediately following vaccine; Then just fatigue later in day and carried on a few days later; am experiencing increased Short of breath; heartburn; This is a spontaneous report from a contactable nurse. This 38-year-old female nurse (patient) reported for herself that a 38-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01May2021 12:30 (Batch/Lot Number: EWU171) as single dose for covid-19 immunisation. Medical history included hypertrophic cardiomyopathy. Concomitant medications included metoprolol taken for an unspecified indication, start and stop date were not reported. The patient experienced dizziness, increase heart rate immediately following vaccine. Then just fatigue later in day and carried on a few days later. Patient had hypertrophic cardiomyopathy and am experiencing increased SOB, heartburn and overall extreme fatigue from 01May2021 12:45. Outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Arm pain immediately lasted for about a week. Very bad brain fog very hard to connect thoughts and speak the first couple days. Over a week later and I still have that but slowly getting better. Constipated since I?ve gotten the vaccine, can?t go without laxatives and even then it?s just a little. My body odor has been very bad since I got the shot,. Shooting pains in organs throughout lasting a few seconds at each time off and on during the day, has subsided since day 1. Light Kidney pain since the vaccine that hasn?t gone away.
pt recv vax 9JUN98 & 17JUN98 pt devel hemorrhagic rash on legs that spread up the body;pt also c/o joint stiffness & fever;pt was told it was an allerg rxn to vax & it would resolve w/o tx;